Express Pharma (Vol.12, No.2) November 16-30, 2016

VOL. 12 NO. 2 PAGES 202

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CONTENTS

RAISING STANDARDS

Vol.12 No.2 NOVEMBER 16-30, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

After a few false starts and delays, India’s pharmacopoeia is finally being updated and harmonised with global norms | 48

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

I

N

T

E

P32: Pharma brands must

think first about patients' lives, then how their products can improve those lives

Brian Fox, Marketing & Sales practice, Pharmaceuticals & Medical Products, McKinsey & Company

R

V

I

E

P82: ‘Any and

every pharma company will be our client sooner or later’

MARKET

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PHARMASAFE INDIA SUCCESSFULLY CONCLUDES ITS SECOND EDITION

MANAGEMENT

54

COMBINATION DRUGS: EASING OUT OF EXISTENCE?

W P86: Optel Vision

scales up its global manufacturing capability with India operations

P33: ‘Our next vaccine will be a three-dose rabies vaccine based on nano-particle technology’ Dr Rajiv Modi, CMD, CPL Biologicals

P78: ‘Mack Pharmatech is all set to spread its wings in international markets’

Shaunak J Dave, Asian Market Director, Optel Vision

Dr Kiran Badgujar, Founder and Director, Mack Pharmatech

P80: ‘Serialisation needs careful assessment’

Pradeep Dhargalkar, Head-Packaging Development, Unichem Laboratories

Prayagdatt Mishra, MD, HVAX Technologies

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

India Pharma Inc’s Trump card

D

onald J Trump has beaten all odds to win the US election, much like the Indian pharmaceutical industry’s hard won rise as the go-to country for affordable medicine. The US is also the world’s largest pharma market, so it was to be expected that the US election results would impact stock prices of both global and Indian pharma companies.

Trump has promised to roll back and replace the Obamacare, the Affordable Care Act, which is as much a reflection of Republican policy as an effort to discredit the most ambitious project of President Obama’s two terms. Trump’s seven point healthcare agenda, Trumpcare if you like, has the same intent as Obamacare, i.e. to reduce the price of healthcare, but differs in the method.

Indian generic companies are expected to directly benefit from Trumpcare’s seventh bullet point, which promises to break down import barriers to allow US drug providers and consumers access to less expensive, safe products from overseas. India already accounts for more than a third of medicines sold in the US. Stock prices of companies like Sun Pharma, Lupin, and DRL, which have a sizable presence in this market, are being tipped as good buys as their revenues from the US market could see an uptick thanks to Trumpcare.

All indications are that President Trump will want to start with a bang and silence his critics, much in the same way India’s Prime Minister Narendra Modi did in his first year. Modiji’s latest decree to demonetise `500 and `1000 notes, which make up more than 80 per cent of the currency in circulation, is his prescription to curb counterfeit currency and corruption/ black money. But his critics point out that while strong medicine can cure

Obamacare or Trumpcare, generic medicines from India remain the right choice

the disease, it must not end up killing the patient.

Pharma companies in India see regulatory reform in much the same way. Besides the migration to Indian Accounting Standards (Ind AS) this June and the GST regime next year, other sector specific decisions due in 2017 could be a mandatory code for marketing of pharma products, a decision on the legality of combination drugs, guidelines for online pharmacies as well as a ban (partial or complete) on PET as a packaging material for medicines.

Some of these regulations are already mandatory in global pharma markets and any resistance is counterproductive. For instance, resistance to India’s track and trace initiative has seen smaller companies lag global serialisation deadlines, which may keep them out of global markets.

Could 2017 see some moderation in regulatory pressure on some fronts, as Modiji prepares for a re-election in 2019? As part of the ease of doing business initiative, the Prime Minister’s Office seems to have stepped up the pressure on India’s medicine pricing watch dog, the National Pharmaceutical Pricing Authority, as well as pharma and health secretaries to address concerns of pharma companies. Health activists warn that dilution of pricing norms might be good for the industry but painful for patients.

Our last issue of the year, as always, will be a survival guide for 2017, with exclusive insights, predictions and prescriptions from industry veterans on such impending changes. Make sure you don’t miss it!

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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November 16-30, 2016

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I N T E R V I E W

Pharma brands must think first about patients' lives, then how their products can improve those lives Brian Fox, as global leader, Marketing & Sales practice, Pharmaceuticals & Medical Products, McKinsey & Company, as well as a member of Google’s Healthcare Advisory Board, has advised many pharma companies as they transition towards digital platforms. He shares some insights with Viveka Roychowdhury

As a social psychology major, what are the major social issues which shape the buying decisions of a patient /consumer / caregiver when they need to make buying decisions regarding pharma and medical products and services?

I think it’s very important that when thinking about the decisions people make about their medications we don’t imagine those decisions to be isolated from the rest of the lives that people live. As an example, people aren’t specifically hoping to modify the progression of their rheumatoid arthritis when they decide on a particular drug, they’re looking to be able to pick up their child without pain. People aren’t specifically hoping to reduce the duration of their acne, they’re hoping to be more confident when seeing their peers, or more attractive in their photos on social media.

Pharma brands must think first about the lives of their patients and the experiences they’re having. Then, they need to focus on how their

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products can improve those lives and enhance experiences.

The 3Ds of the book are all about this – discovering what truly matters in people’s lives; designing experiences that are enhanced through the relationship a person has with the pharmaceutical company; and delivering those experiences consistently and excellently How does digital health fit into this framework?

People are not digitally connected and oriented when they’re living the rest of their lives and then someone different when handling their health. The same behaviours that we observe in other domains (e.g., retail, travel) bleed directly into healthcare.

That’s why 1 in 20 Google searches are now healthrelated (a number that has grown steadily, by 15 per cent a year, for the past five years), or why there’s now 8.2 billion views of health-related YouTube videos each year.

People are reaching for the same tools and sources when seeking insight on an appliance

or a medication. The rise of health-related apps and wearables helps accelerate that trend.

What are the hallmarks of a successful digital health marketing platform and strategy? Which markets, from a geographic and socioeconomic point of view, have similarities to India?

A successful digital health strategy starts with the patient and physician, understands (or discovers) what motivates them to make decisions as they do, designs new experiences that fit in with and enhance the

experiences of those decisionmakers and then delivers those experiences consistently and superbly. That’s why we named our book, Pharma 3D, after Discover, Design and Deliver, which are the three keys to marketing in the digital age. There are a handful of brands that have done this exceptionally well. In the book, we profile Pfizer’s BeLive and P&G’s Intimate Words campaign in Mexico.

Each of these markets has some similarities to the India market. The opportunity to design and execute unique experiences, however, is not limited by geography – there are clear benefits in every part of the world.

How can digital marketing help organisations extract better performance across the value chain? Can you illustrate with some examples.

First, it’s important to emphasise that we shouldn’t think of digital marketing as distinct from other types of marketing. In today’s digital age, patients, physicians and

other healthcare stakeholders are interacting far more through digital channels. As a result, marketers (if they want to connect to these decisionmakers) need to be far more fluent in the same digital channels, tools and technologies. That said, there is a clear role for traditional media and engagement channels. The key is for execution across all channels to be complementary with one another. Making that happen starts with having a deep understanding of the behaviours and drivers of decisions amongst patients and physicians and designing innovative experiences based on those behavioural insights.

Companies that do that see steadier sales growth and more predictability in their supply chains. Retailers like Burberry and Williams Sonoma have really benefitted from their digital investments.

Burberry’s sales growth is twice that of its average peers.

That type of performance has great benefits enterprise-wide. viveka.r@expressindia.com

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I N T E R V I E W

‘Our next vaccine will be a three-dose rabies vaccine based on nano-particle technology’ Dr Rajiv Modi, CMD, CPL Biologicals, elaborates on the vaccines developed by his company, the huge positive impact they can have on healthcare delivery, the company’s role in facilitating and drive adult vaccination in India and more, in an interaction with Usha Sharma Can you explain the JV model of CPL Biologicals? How does it work?

Based in Ahmedabad, India, CPL Biologicals is an independent joint-venture biotechnology company established in 2009 by Novavax Inc, US and Cadila Pharmaceuticals, one of India’s largest privately held pharma companies. The company develops vaccines based on Novavax Inc’s Virus Like Particles (VLPs), recombinant nanoparticles and adjuvant technologies, which are groundbreaking innovations that improve global health through safe and effective vaccines. CPL Biologicals conducts end-to-end research, development and manufacturing based on these

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November 16-30, 2016

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technologies in India. The current biologics and diagnostics portfolio of CPL Biologicals comes from original technologies developed at Cadila Pharmaceuticals. CPL Biologicals is currently developing new biologics and diagnostics products on its own. The company has a strong management team comprising deep expertise and experience in the areas of research, process development, medical affairs, manufacturing, commercialisation etc. and is governed by the Board of Directors with representation from both Novavax and Cadila Pharmaceuticals leadership.

products or risks of bovine diseases.

According to Global Business Intelligence Research

CPL Biologicals has developed and commercialised recombinant influenza vaccine and is currently focusing on developing innovative second generation vaccine for rabies.

Can you elaborate about it in detail?

Our already licensed recombinant influenza vaccines for H1N1 (swine flu) and seasonal flu are world’s first VLP based influenza vaccines and offer significant advantages over the currently available conventional influenza vaccines. Our next vaccine, a 3 dose Rabies vaccine, with a three dose regimen (0-3-7 days) will be a significant improvement over currently available vaccines around the globe where one needs five doses over a period of 28 days (0-3-7-14-28). Our vaccine will significantly improve compliance towards full course of immunisation as the dropout rate for the current rabies vaccines is maximum for doses four and five (Day 14 and 28). Our eventual target is to reduce the number of doses for the rabies vaccine to a single dose. That will help us significantly improve coverage and compliance of the vaccine and save human lives across the world. Our vaccine will be world’s first recombinant nanoparticle based rabies vaccine.

forecasts, India's vaccine market is likely to grow to $871million by 2016. Which segments will drive growth and will we be able to touch the target?

The growth for the vaccine market in India will be driven by expansion of vaccination coverage for new borne, new approvals and inclusion of new vaccines like rota virus in national immunisation programme as well as emerging area of adult vaccination. Adult vaccination is a proven way of improving overall health and productivity of the society, however, it has not caught up in India due to lack of awareness and availability of options. CPL Biologicals is spearheading the campaign for adult vaccination in India with its seasonal influenza and swine flu vaccines.

The company is involved in

34 EXPRESS PHARMA November 16-30, 2016

How many vaccines are in the pipeline and when are you planning to launch it in the Indian market?

We already have swine flu (H1N1) and seasonal influenza vaccines licensed in India. We will be applying for registration in multiple countries outside India for these vaccines in the coming year. Our three dose rabies vaccine in currently undergoing clinical phase III trials and will be licensed in 2018, followed by single dose Rabies and Varicella Zoster Virus (VZV) vaccines.

developing vaccines based on ‘Virus Like Particles’ (VLP) and nano-particle based technology. Tell us more about these technologies and and how advanced are they in India?

Virus Like Particles (VLPs) are similar to a virus in structure but without the genetic material required for viral replication. Once injected into the body, VLPs trigger a specific and target immune response against the VLP, thereby generating a strong response and protection against the disease. Also, as VLPs and nano-particles do not contain viral nucleic acids, they present no threat of infection to a person being vaccinated,

unlike other vaccines where there is a chance of disease being caused by the vaccine itself. Being proprietary and patented technologies, no body other than CPL Biologicals has the technologies or capabilities to develop vaccines using these technologies in India. Our swine flu (H1N1) and seasonal influenza vaccines are the first licensed vaccines in the world based on VLP technology.

How do we ensure that vaccines produced through VLP technology is safer and more effective than other available vaccines? Tell us about the other technologies available for developing vaccines and how effective

are those?

As VLPs and nano-particles do not contain viral nucleic acids, they present no threat of infection to a person being vaccinated, unlike other vaccines which are developed based on the viruses which can replicate in human body thereby causing disease by the vaccine itself. Our recombinant VLP and nanoparticle technology completely takes that risk away providing safer and more effective vaccine compared to other available vaccines. Unlike traditional vaccines the VLP technology does not use bovine serum or eggs in its manufacturing, thus no allergies related to egg

CPL Biologicals offers novel, affordable solutions for global healthcare via

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vaccines, biologics and diagnostics with integrated capabilities, please explain the need for these vaccines in the Indian market? In which new markets are you planning to launch these vaccines and why?

First of all, with our technologies, we can quickly respond to any potential pandemic in India in the future.

Our cutting edge technology allows us to have a vaccine ready for human use against a new target within three to four months of identification of genome sequence of the virus while the vaccines based on conventional technologies may require more than eight to nine months for the same. Influenza vaccines are a very important intervention to improve health and productivity of both paediatric and adult populations, however, it has not caught up in India due to lack of awareness and availability of options. CPL Biologicals' seasonal influenza and swine flu vaccines are an important steps in this direction. Our three dose and, eventually, single dose rabies vaccine will significantly improve coverage and compliance of the vaccine and save human lives in India and across the world.

Currently, no VZV vaccine is manufactured in India and all of them are imported as bulk or finished formulations. This results limited supply/shortage of the vaccine. Our VZV vaccine will be the first VZV vaccine to be completely developed and manufactured in India and will address the current shortage of this critical vaccine for Indian market. We will license our vaccines globally, starting with India first and will manufacturing these vaccines for the whole world in India. Given the superior technology, our vaccines will be either first-inclass or best-in-class across the globe.

Tell us about the company's future plans The strategy is growth oriented, realistic and focused on biologicals. For vaccines, along with the vaccines based

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on VLP and nano-particle technology described above, we also have an innovative pancreatic cancer vaccine, completely developed in India, in phase I human clinical trial.

This cancer vaccine is a platform technology and can be applied for other types of

cancers as well. We will leverage our in-house innovative technology and R&D capabilities, augmented by strategic partnerships to take a leadership position in chosen biologics market segments. We will expand our presence in the biologics area

with novel and biosimilar antibodies-based therapeutics in oncology. In diagnostics, we are developing novel immunediagnostics for infectious and non-infectious diseases to provide complete solutions for global heath from prevention (vaccines) and diagnosis

(diagnostics) to treatment (biologics).

The overall strategy is to continuously consolidate the market position by building a robust pipeline and enhance our product portfolio. u.sharma@expressindia.com

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PRE EVENTS

CPhI & P-MEC India to be held in Mumbai UBM India set to celebrate 10 years of success with one week of glory

T

he Indian pharmaceutical industry is all set to experience South Asia’s largest pharma event, CPhI & PMEC India in an unprecedented manner by commemorating its 10th successful year in India with India Pharma Week (November 17 to 23, 2016), a week-long celebration packed with avant-garde events prior to the expo. Traditionally, a three-day exhibition at the Bombay Exhibition Centre (BEC), this year for the first time, CPhI & P-MEC India (November 21 to 23, 2016) will be held concurrently at two venues- BEC and the MMRDA Grounds, Bandra Kurla Com-

plex (BKC). While celebrating a decade of CPhI India, the India Pharma Week will hold more than 10 events and activities taking place across the city of Mumbai focusing on business, knowledge, leadership, innovation, recognition and networking in the field of pharma. The week will include a Pre-Connect Congress; Women in Pharma – Power Breakfast; the India Pharma Awards; Networking Evening; Plant Visits, Pharma Leaders’ Golf; the CPhI & P-MEC India Exhibition, a closed door CEO Roundtable and many more activities.

This year’s event will see more than 1,300 exhibitors, a

100-plus countries’ participation and close to 40,000 attendees spread across the two locations in Mumbai. While BEC will have traditional participants for CPhI and P-MEC, the

concurrent venue – BKC will also include participants for ICSE and BioPh. Yogesh Mudras, MD, UBM India said, “CPhI & P-MEC 2016 is perfectly placed to provide a most comprehensive industry platform for every company that deals with pharmaceuticals in India. We have consistently received an overwhelming response from the participants. In addition to the Pre- Connect Congress and CEO Roundtable the introduction of ‘India Pharma Exporters - Collector's Edition’ & ‘The World of P-MEC - Collector’s Edition’ will bring in more insightful exchanges amongst the

industry veterans.”

CPhI India is an industry platform for CROs, CMOs and manufacturers of API, generics, excipients and drug formulation, fine chemicals, biosimilars, finished formulations, lab chemicals and biotechnology.

Whereas, P-MEC includes manufacturers of pharma machinery and equipment, analytical equipment, automation and robotics, packaging equipment and supplies, plant/facility equipment, automation & controls, processing equipment, tableting / capsule fillers, clean room equipment, filling equipment and laboratory products.

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CubeXto host conference on consumer healthcare in Mumbai It would cover diverse topics such as building mega brands to penetrating unchartered territories, creating multiple touch points for consumers and devising collaborative strategies through multiple stakeholders

multiple touch points for consumers and devising collaborative strategies through multiple stakeholders.

Reportedly, some of the speakers at the conference will be Susan Josi, Managing Partner, Sorento Healthcare Communications; Kedar Rajadnye, COO, Piramal Enterprises; Prof.Piyush Kumar Sinha, IIMA; Swapneel Naidu, VP, Glenmark Pharmaceuticals; Subodh Marwah, Head, Consumer Healthcare, Sun Pharmaceutical Industries T; Gangadhar, MD, MEC-South Asia; Dalveer Singh, CEO, GroupM Dialogue Factory; Dinar Mhatre, Head Integration, Johnson and Johnson Consumer; N Rajaram, Country Head & GM – Pharmaceutical Operations, Sanofi India and K Ganapathy Subramaniam, Head – OTC category, Dabur India.

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November 16-30, 2016

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CUBEX, A division of Sorento, in association with Nicholas Hall & Company, will organise a conference titled, ‘Achieving Scale in Consumer Healthcare’.

It will be held on December 9, 2016 at Sofitel, Mumbai. Along with global OTC expert Nicholas Hall, prominent industry experts who have led the path for their companies, will share their success stories on this single platform. They will throw light on various facets ranging from building mega brands to penetrating unchartered territories, creating

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68th IPCE to be held in Hyderabad Delegates from across the world will congregate in Visakhapatnam from December 16 to 18, 2016 THE 68 TH successive edition of Indian Pharmaceutical Congress and Exhibition (IPCE) organised jointly by the Indian Pharmaceutical Association (IPA) and Orbit Exhibitions is all set to host a large volume of business delegates from all parts of the world from December 16 to 18, 2016 in Visakhapatnam, under the patronage of Chandrababu Naidu, Chief Minister, Andhra Pradesh.

The first ever summit for the pharma industry in India was the inaugural edition of

ations of IPCA are Indian Pharmaceutical Association (IPA), Indian Hospital Phar-

macists’ Association (IHPA), Association of Pharmaceutical Teachers of India (APTI),

Indian Pharmacy Graduates’ Association (IPGA) and All India Drugs Control Officers'

Confederation (AIDCOC).

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ICPMS-2030 IPCE in 1948 at Kolkata. Over the years, this industry specific exhibition has played a vital role in bringing the complete spectrum of the pharma industry and IPCE was always the growth engine the Indian pharma industry hoped for. The show has been a perfect platform for Indian pharma industry to showcase their advancement in technology and product profile in front of a large audience of national and International delegates.

With India’s new initiative of ‘Make in India’ campaign, the show will witness a huge boost with national and international participation.

IPCE will see active support from Central and state government and non-government bodies such as IDMA, Pharmexil, etc.

The five federating associ-

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November 16-30, 2016

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Pharmasafe India successfully concludes its second edition The conference brought together 102 attendees along with 25 eminent speakers to focus on the strategies and identify solutions to curb the $4.25 billion fake drugs market THE SECOND annual edition of Pharmasafe India, a comprehensive conference on anticounterfeiting and brand protection witnessed a notable presence of eminent speakers from major pharmaceutical companies, government and regulatory bodies and industry associations representing the entire cross section of pharma eco-system.

The conference brought together 102 attendees along with 25 eminent speakers to focus on the strategies and identify solutions to curb the $4.25 billion fake drugs market, which causes not only a major revenue dent to the industry, but also poses serious threats to public health. The widespread menace of spurious drugs and counterfeit medicines tarnishes the name of the pharma manufacturers and puts the brand image in jeopardy. The conference, well in its second edition proved to be a valuable platform for all the stakeholders to address this major concern of counterfeit drugs.

Business leaders and key

40 EXPRESS PHARMA November 16-30, 2016

decision makers from top pharma companies including Abbott India, Ajanta Pharma, Alembic Pharmaceuticals, Alkem Laboratories, Amgen Biopharmaceuticals, Bayer Zydus Pharmaceuticals, Cadila Pharmaceuticals, Cipla, FDC, Glenmark Pharmaceuticals, MSD, Novartis, Pfizer, GlaxoSmithKline, Sanofi, and Unichem Laboratories, anticounterfeiting technology experts and solution providers including OptelVision and HP, customs, government and regulatory authorities and leading industry bodies such as Organization of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Association (IPA), Confederation of Indian

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Industry (CII), Authentication Solution Providers’ Association (ASPA) and International Pharmaceutical Excipients Council of India (IPEC) as well as speakers from Sanofi, Central Drug Standards Control Organization, MSD, Optel Vision, HP Indigo and Inkjet Solutions and 1mg among others, became the common voice of the industry.

Shaunak Dave, Asian Market Manager, Optel Vision said, “Pharmasafe India is a unique initiative for combating global counterfeiting by bringing various stakeholders on a common platform, to share information and knowledge on what they have been doing on individual capacities, to brainstorm on creating a synergy fight effectively against counterfeiting with an understanding of nature of challenges faced to protect their brands and businesses. The audience was well aware about the seriousness of the problem of counterfeiting and genuinely participated in the panel discussion to voice their views and insights, in order to understand what type of technology is technically feasible and commercially affordable.”

The initiative taken by Messe Frankfurt was also appreciated by Samson Chiu, Director, Asia Pacific Region, Pharmaceutical Security Institute, who said, “Indian pharma business works very differently and we require India focused strategies and products which was my main purpose to be here and to raise awareness. I found this conference very constructive because attendees here want solutions and are asking questions that can work towards solutions to help eradicate counterfeiting. It is a good start for different stakeholders to work together and improve public and private partnerships.”

Messe Frankfurt has been the first trade fair organiser worldwide to launch an initiative against brand and product piracy, ‘Messe Frankfurt against Copying,’ which aims to ensure that exhibitors and visitors are fully informed and advised about the registration and assertion of intellectual property

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November 16-30, 2016

The conference proved to be a valuable platform for all the stakeholders to address this major concern of counterfeit

rights. In India, Messe Frankfurt has been actively involved in addressing the rising concerns on counterfeit products sold in the automotive aftermarket together with the Automotive Component Manufacturers Association of India (ACMA).

Extending this initiative to

the Indian pharma sector, Messe Frankfurt aims to draw attention to the source of counterfeit medicines and effective initiatives, regulations, and policies that can curb the menace of spurious and sub-standard drugs through Pharmasafe India.

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7th PHARMAC INDIA,Pharmaceutical Ancillary Expo held in Ahmedabad The main highlight for this year’s event was participation from China 7TH PHARMAC INDIA, the international pharmaceutical R&D and manufacturing expo and conference, and Pharmaceutical Ancillary Expo, the international pharma packaging, logistics and refrigeration expo, was recently held at Gujarat University Convention and Exhibition Centre, Ahmedabad.

The conference was attended by 150+ exhibitors and 5500+ visitors. The main highlight for this year’s event was participation from China and

factory visits by Pharmac India team for the Chinese exhibitors.

PHARMAC INDIA covered a wide range of pharma R&D and manufacturing, from various kinds of manufacturing/ processing equipment to lab equipment, contract services, packaging and other total solutions. The exhibition is considered as a substantive business platform which attracted visitors with purchasing authorities. There were equipment and products displayed during the event and and detailed technical consultations were conducted as well. Pharmac India 2016 also witnessed

42 EXPRESS PHARMA November 16-30, 2016

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dia and Shankar Chaudhari, Minister of Health & Family, Government of Gujarat. The inauguration was graced by Pankaj Patel, CMD, Cadilla Healthcare, Sudhir Mehta, MD, Torrent Pharma, SV Veeramani, MD, Fourrts India and National President,

delegations from countries such as Russia, China, Afghanistan and Nigeria in addition to many overseas suppliers attending the showat theirdistributors'booths.

The conference was inaugurated by VijayRupani, Chief Minister, Gujarat alongside Ananth Kumar, Union Minister of Chemicals and Fertilisers, Mansukhlal Mandaviya, Minister for State, Chemical & Fertilizers, Government of In-

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November 16-30, 2016

IDMA, Viranchi Shah, Chairman, IDMA Gujarat State board alongside Chirag Doshi, Chairman, Pharmac India Exhibition Committee and Rupen Vikamsey, MD, Orbit Exhibitions.

The industry-oriented technical conference was one

of the major attraction of the conference in which more than 1000+ delegates attended the six technical sessions through the exhibition period. Guest speakers who took part in the event were C Venkatraman, Director Corporate Affair, Lupin, Jigar Joshi, Lakshmiku-

maran & Sridharan Attorneys, Sandeep Gupta, National Spokesperson, FSSAI, Sachin Gupte, Head Business Development, Pidilite and Abdulkader Bengali, Divisional HeadProjects, Pidilite.

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Analytica Anacon India and India Lab Expo close on a high note The event welcomed 254 exhibitors from 11 countries and gathered 7,042 trade visitors ANALYTICA ANACON India and India Lab Expo 2016, leading trade fairs for laboratory technology, analysis, biotechnology and diagnostics, was recently held at HITEX Exhibition Center, Hyderabad. The event welcomed 254 exhibitors from 11 countries and gathered 7,042 trade visitors in three days.

On 9,500 square metres of exhibition space, the event brought together internationally renowned manufacturers, laboratory users, consultants

and key government officials on one common platform to discuss best practices and seek solutions to some of the most pressing challenges related to the industry and research.

The trade fairs staged a Live Lab, where visitors had visual experience of lab demonstrations. Exhibitors performed live experiments for the visitors by displaying and running instruments from the pharma analysis area.

Burkhard Baier, Chief Representative, Sympa Tec says, “Our expectation is clearly defined that we get an opportunity to network with the pharmaceutical companies in Hyderabad, which is considered the hub for

44 EXPRESS PHARMA November 16-30, 2016

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the pharma sector. Apart from being an exhibitor, we also had the opportunity to showcase our products, working live at the Live Lab pharma analysis which was a first for us. Personally, my experience was very good.”

Key buyers engaged in close to 750 face to face meetings as part of the buyer seller programme running alongside the trade fairs. Exhibitors and decision makers directly networked and interacted with clients and other industry delegates from international and domestic market and discussed about new equipment, technologies and solutions.

Analytica Anacon India conference was another highlight of the event. Under the title ‘Sci-

The trade fairs staged a Live Lab,where visitors had visual experience of lab demonstrations ence meets Technology’, the conference focused on ‘Regulatory Aspects of Pharmaceutical Laboratories’, ‘Biopharmaceuticals and Bioanalysis’, ‘Food Safety’ and ‘Clinical Diagnosis’.

The theoretical sessions were rounded out by tutorials where practical application tips were passed on the audience. Eminent speakers, scientists, industry representatives and more than 320 delegates were engaged in knowledge-share and exchange of expertise. The analytica Anacon India conference was co-organised by Messe München India and the Indian Analytical Instruments Association (IAIA) and chaired by Nitin Kabbin from Indian Analytical Instruments Association (IAIA) and Oliver J Schmitz from the University of Duisburg-Essen, Germany.

Sharing his experience at the buyer Seller Forum, Dr Swapnil

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November 16-30, 2016

P Sonawane, Associate Director, Dr Reddy’s Laboratories says, “This is the second time that we are attending analytica Anacon India and India Lab Expo. Last time we met with a number of domestic players but this time we explored new technologies that are coming into

the Indian market place. In the buyer seller forum, we have been able to interact with several industry players in a short span of time and especially with global companies from the sector. Our experience at the buyerseller meet is invaluable and we are eagerly looking forward to

many more.”

Bhupinder Singh, CEO, Messe München India says, “We are happy to see a great response at analytica Anacon India and India Lab Expo 2016 in terms of quality visitor turnout and engagement from our participants. Our key programmes,

buyer seller meetings along with a much anticipated Live Lab demonstrations completely added value in terms of enhancing visitor and business experience at analytica Anacon India and India Lab Expo 2016.”

EP News Bureau

EVENT BRIEF One Brand Total Solution

NOVEMBER-2016 TO FEBRUARY-2017 17

CPhI Preconnect- Day Zero

21

CPhI and P-MEC India

16

IPC Expo 2016

9

India Pharma 2017

CPHI PRECONNECT- DAY ZERO Date: November 17, 2016 Venue: Mumbai Description: CPhI’s Pre Connect Congress will bring together thought leaders under one roof to discuss on the latest trends and advancements in the Indian pharma industry.

Discussions will be held on key topics such as M&A, regulatory challenges, drug discovery and other critical topics which are a burning issue in the pharma industry.

Contact: E: sean.palanna@ubm.com T: 91-22-61727072

CPHI AND P-MEC INDIA Date: November 21 – 23, 2016 Venue: Bombay Exhibition Centre & MMRDA Grounds, BKC, Mumbai Summary: The event will be an ideal congregation for companies to pick up on the latest trends and innovations the market has to offer. CPhI India is also co-located with P-MEC India, the pharma machinery show in Asia. This year, the expo has grown from a three-day exhibition to a show spanning a week, Pharma Week, (November 17 to 23, 2016). The Pharma Week will hold more than 12 events that will take place across the city of Mumbai focusing on business, knowledge, leadership, innovation and recognition in the field of pharma.

With two venues this year, Bombay Exhibition Centre and Bandra Kurla Complex in Mumbai, CPhI & P-MEC 2016 will include exhibitor showcase, innovation gallery,

46 EXPRESS PHARMA November 16-30, 2016

Visakhapatnam, Andhra Pradesh-530003 Ph: 0891 2526143 Mob: 7036164555 Email: loc@68ipc.com Website: www.68ipc.com

speed meetings, live entertainment and much more.

Contact details UBM India TIMES SQUARE Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273

IPC EXPO 2016 Date: December 16-18, 2016 Venue: Visakhapatnam The 68th Indian Pharmaceutical Congress (IPC) will host IPC Expo 2016, which will be jointly organised by the Indian Pharmaceutical Association (IPA) and Orbit Exhibitions.

The expo will see a congregation of business delegates from all parts of the world. Visakhapatnam,

INDIA PHARMA 2017

the upcoming pharma hub will host the fair under the patronage of N Chandrababu Naidu, Chief Minister, Andhra Pradesh. With India’s new initiative of ‘Make in India’ campaign, the show will witness a huge boost with national and international participation.

Contact details University College of Pharmaceutical Sciences, Andhra University,

Date: February 9-11, 2017 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: India Pharma 2017, an international exhibition and conference on pharmaceutical industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among the

conference delegates and business visitors provided by the event.

India Pharma 2017 will cover all the sectors of the pharmaceutical industry starting from finished formulations, APIs, biopharmaceuticals, fine chemicals and intermediates, natural extracts, excipients and many more.

Latest pharmaceutical machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will be showcased.

Contact details Kamal Bhardwaj Deputy Director Mob: 9899392930 Email: kamal.bhardwaj@ ficci.com Federation of Indian Chambers of Commerce & Industry (FICCI) Federation House, Tansen Marg, New Delhi 110001

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NEWS

International RegulatoryCooperation Meeting for Herbal Medicines held Over 33 delegates from 17 countries participated in the three day-long annual meeting of IRCH THE MINISTER of State for AYUSH (Independent Charge), Shripad Yesso Naik inaugurated the 9th Annual Meeting of International Regulatory Cooperation for Herbal Medicines (IRCH) in New Delhi. The threeday meet was organised by the Ministry of AYUSH in New Delhi from November 8-10, 2016.

Over 33 delegates from 17 countries are participating in the three day-long Annual Meeting of IRCH. Addressing the delegates, Naik said it is very essential to develop evidence-based remedies in traditional medicine. “It is for this reason that since long we are working on pharmacopoeias and formularies and have laid down quality standards of ayurvedic drugs including herbal extracts”, the AYUSH minister added. He said that pharmacopoeia work has been given a lot of importance and Pharmacopoeia Commission of Indian medicine has been set up to develop quality standards of Indian medicine drugs to meet global requirements of quality.

Naik said that regulations for education, practice and drugs are are amended and reinforced from time to time in accordance with emerging requirements.

Ajit Mohan Sharan, Secretary, AYUSH, said that IRCH has been working in the direction of promoting and facilitating safe use of herbal medicines globally. It has been strengthening cooperation between national regulatory authorities by sharing experience, information and knowledge related to regulation, quality, safety and efficacy of herbal medicines. He further said that the Government of India offers active support and is committed to achieve the objectives of IRCH. WHO Representative to India, Dr Henk Bekedam, said that India’s commitment and efforts to accelerate this sector is commendable. The holistic approach of ayurveda can make a global impact like yoga, he added. Highlighting issues of

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safety and quality in traditional medicines, Dr Bekedam said that they require proper regulation. Conferences like those of IRCH go a long way in knowl-

edge sharing with WHO as well as between member countries, he said.

Drug Controller General (India) Dr GN Singh, and Regional

Director for South-East Asia, WHO, Dr Poonam Khetrapal also emphasised the need to set standards for traditional medicines, enforce regulatory meas-

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48 EXPRESS PHARMA November 16-30, 2016

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I

n a welcome move, Indian Pharmacopoeia Commission (IPC), along with the health ministry, has initiated interactions with key global pharmacopoeias. This step is expected to help strengthen and harmonise Indian pharmacopoeia standards. Harmonisation of Indian pharmacopoeia (IP) will help the Indian pharmaceutical industry achieve its dream of being a global pharma power.

Need for harmonisation Despite being third largest in volume, the Indian pharma industry has time and again found itself embroiled in qual-

BY SACHIN JAGDALE

ity-related issues. In recent times, overseas regulatory authorities have issued warning letters to some major Indian pharma companies for lack of adherence with regulatory norms. Standardisation of quality and tests will help resolve this problem to a considerable extent.

A US Pharmacopoeia (USP) spokesperson also

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stresses on the necessity for harmonisation of standards.

He says, “Standards facilitate registration, market surveillance, free movement and trade of medicines among countries. Globalisation and expansion in international trade present a growing need to develop global quality standards for medicines. Public standards are an integral part of the global medicine public safety net that protects patients and helps ensures access to quality medicines. Public quality standards for medicines protect patients and consumers, increase practitioners’ confidence in the quality of medicine, provide benchmarking tools and predictability to industry, and safeguard the integrity of the supply chain, helping to ensure patients’ access to quality medicines. Harmonisation is the process through collaborative effort where by differing requirements among participating ' authorities' move towards alignment on common requirements that yield the same outcome.”

Dr Vinay Nayak, Executive Director, Marksans Pharma, echoes USP spokesperson's views and stresses on the need for Indian pharmacopoeia's standards. He says, “India is a major player in the supply of medicines. Pharma is the sunrise industry in India. Now many pharma companies are showing significant interest in exports. There are three major markets- regulated (Europe, the US and Japan), Latin America and Rest Of the World (ROW) market. So if we have to compete with MNCs in these markets then the quality standards should also match with them. The method of testing should also be on par with USP and British Pharmacopoeia (BP). So harmonisation of standards is necessary.”

It is evident that there is no option for Indian pharma companies but to match international quality standards to achieve their global ambitions.

Collection of standards in any pharmacopoeia is legally binding. So, if Indian pharma

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There are no shortfalls in IP. It has covered a lot of ground. In fact, now we are trying to make our own monographs. So, developments are positive.Even countries like Sri Lanka and Myanmar are using our pharmacopoeia Dr Vinay Nayak Executive Director, Marksans Pharma

companies want to tap world’s largest medicine markets like the US, they cannot afford to be lax where quality is concerned and would need to adopt measures for constant quality upgradation.

Dr Suresh Saravdekar, Clinical Pharmacologist and Secretary-Hospital Division, Indian Pharmaceutical Association (IPA) explains, “All the drugs are invented by a few developed countries, mainly from Europe, North America, Japan etc. Consequently, all the standards are developed by the pharmacopoeias of these countries. Rest of the countries form their pharmacopoeias on similar lines. However, developed countries are well aware of the fact that quality is an evolutionary concept and hence needs to be continuously upgraded. So, these countries do continuous research and upgrade the standards in their

50 EXPRESS PHARMA November 16-30, 2016

All the drugs are invented by a few developed countries, mainly from Europe, North America, Japan etc. Consequently, all the standards are developed by the pharmacopoeias of these countries.

Dr Suresh Saravdekar Clinical Pharmacologist and Secretary-Hospital Division, Indian Pharmaceutical Association (IPA)

pharmacopoeias so that good and latest quality standard medicines are made available to their population.” He recommends that Indian pharmacopoeia should also adopt similar measures to be at par with global standards.

He criticises the complacent approach of some of the countries towards harmonisation by saying that, “This updating is not done regularly by rest of the countries who had copied their pharmacopoeias long back from either European/US/BP pharmacopoeias etc. Today, these countries are thinking of updating pharmacopoeia under the name of harmonisation.”

A late beginner According to industry experts, though harmonisation efforts have been underway for some time, India took considerable time to get the ball rolling. So,

I feel the harmonisation process started quite late.

Historically, IP was adopting monographs from other pharmacopoeias (mostly BP) as such and those standards were accepted. These monographs were mainly of APIs

Harmonisation will make IP’s standards globally accepted and increase business opportunities for Indian manufacturers. We will have the capability to manufacture highest quality of drugs at affordable prices

Kapil Bhargava

Director, Neon Laboratories

Former Dy Drugs Controller (I) CDSCO

what caused the delay?

A major reason is that Indian pharma industry didn’t bother about the exports as the focus was on domestic market.

As a majority of the pharma industry was content with domestic business, even the government took its time to go ahead with harmonisation of IP. However, with Indian pharma companies exploring the overseas markets and the country's growth as a generics medicines supplier the need for IP harmonisation also gained urgency.

Kapil Bhargava, Former Dy Drugs Controller (I) CDSCO says, “I feel the harmonisation process started quite late. Historically, IP was adopting monographs from other pharmacopoeias (mostly BP) as such and those standards were accepted. These monographs were mainly of APIs. We started producing a number of

Uttam Jain

As per our knowledge, IP does not include ayurvedic monographs so far.

IP contains monographs on 13 herbs (like Hingu, Brahmi, Shankhapushpi, Marich, etc.) however, those cannot be considered as ayurvedic monographs Shashank Sandu Director, Sandu Pharma

APIs ourselves in late eighties, so the content of monographs became more pertinent, especially for impurities and their profiling. Indian manufacturers started producing IP as well as BP/USP quality materials as standards were different in these pharmacopoeias. After exports from India increased, good API manufacturers realised the importance of monographs and started producing only one quality material conforming to IP/BP/USP (which made good business sense too).”

He adds, “You will also notice that a few monographs of IP were ditto of that appearing in other foreign pharmacopoeias and this must have been done to bring about harmonisation of pharmacopoeias.

Secondly, around the same time IPC came into existence, scientific body and its director assumed more authority for

monograph contents and harmonisation work began in more systematic manner. Thirdly, after introduction of anti-retroviral (ARVs) monographs for the first time in world, the other pharmacopoeia bodies realised the value of IP, its approach and started coming forward for monographs harmonisation (from IP to their pharmacopoeias). This took time.

Though sub-committees of IPC may be working with time bound targets and good deliverables, a few of the groups may not be sticking to timelines and I feel that may be lagging time. You know that IP is a social document and its contents (the standards) need not be unnecessarily cost escalating. This thinking also might play an important role in harmonisation process.”

Strengths and shortfalls However, there are a few

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shortfalls in the current edition of IP which remain neglected. Unless they are addressed, the harmonisation process will not achieve desired success. Bhargava informs, “The 'General Notices' chapter is to be looked into more carefully. Since requirements of general notices do not directly affect any monographs and release, these are not properly worded.”

He draws attention to IP's general notices page 11, second column, para 1, which states, “An article is not of pharmacopoeial quality unless it complies with all the requirements stated in the monograph. This does not imply that performance of all the tests in a monograph is necessarily a prerequisite for a manufacturer in assessing compliance with Pharmacopoeia before release of a product.” He points out that a general understanding of this sentence is that all the tests mentioned in the monograph need to be performed, however even before completion of all the tests the product can be released.

He further explains, “In the above example, I have a feeling that even if the above sentence is not mentioned in IP, nothing substantial will affect the quality of IP products. There are several such examples that can be cited. For instance, manufacturing technology of APIs has improved and the whiteness of IP materials has improved substantially, but IP continues to have description 'off white powder' and the junior chemist is compelled to mention a very white powder as off white. You will agree that IP is used equally both by junior analysts who are at the beginning of their careers and senior ones and IP should correct such anomalies. I remotely have a feeling that IPC’s officials 'justify' more than correct even though the corrections are minor,” says Bhargava.

However, according to Nayak, the current edition of IP has many positives as well. He

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November 16-30, 2016

explains, “There are no shortfalls in IP. It has covered a lot of ground. In fact, now we are trying to make our own

monographs. So, developments are positive. Even countries like Sri Lanka and Myanmar are using our pharmacopoeia.”

A continuous process Harmonisation is expected to be a continuous process but for late starters like IP it will be a

big challenge. IP is still in the process of filling the backlogs.

As per USP spokesperson, harmonisation processes differ

cover ) One Brand Total Solution

depending upon participation.

He gives an example, “Pharmacopoeial Discussion Group (PDG) has a formal process that is publicly available and a timeline for individual standards. Harmonisation is achieved when all pharmacopoeias have highlighted harmonisation and any residual differences, based on a general policy in the national or regional area.”

Industry experts feel that though currently India has a lot of ground to cover, as far as harmonisation is concerned.

They also recommend a system by which harmonisation will remain a continuous process.

They caution that a laid-back attitude in this regard will continue to hamper the reputation of Indian pharma companies in the international market.

Bhargava informs, “Though IP publishes draft monographs for public opinion and also corrections, I am not too sure if there an IP newsletter for technical inputs, publishing its approach for harmonisation.

Since there is a world pharmacopoeia forum and IPC's Scientific Director is an active member, progress towards harmonisation and possible outcome may be made available to public through such newsletters.”

A win-win situation Though the Indian pharma sector is globally known for its generic prowess, unfortunately, there have been cases when it has been criticised for its below par product quality. Harmonisation of IP will surely change this scenario. It is a major step towards making export oriented pharma players improve their standards.

Uttam Jain, Director, Neon Laboratories, informs, “While exporting to overseas markets, Indian companies have to comply with USP/BP/EP standards. At the same time, they have to use raw materials of IP standards and manufacture products as per IP standards

52 EXPRESS PHARMA November 16-30, 2016

while supplying to the Indian market. This increases cost, time and energy. It will be saved after harmonisation.”

Once harmonisation of commonly used monograph is done then all the manufacturers have to just comply with the

globally accepted standards.

This will not only strengthen the image and standard of IP but also increase the country's confidence levels in the international market.

Jain adds, “Harmonisation will make IP's standards

globally accepted and increase business opportunities for Indian manufacturers. We will have the capability to manufacture highest quality of drugs at affordable prices. So, harmonisation of pharmacopoeia will be very beneficial to all.”

USP spokesperson opines, “Generally speaking, harmonisation reduces manufacturers' burden of having to perform analytical procedures in different ways, using different acceptance criteria, in order to satisfy pharmacopoeial

(

THE MAIN FOCUS

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requirements that vary across regions. And ultimately, harmonisation increases access to quality assured medicines to patients, especially in the context of generics.”

Though modern medicines have always remained central to the harmonisation debate, India has to look at the AYUSH sector. Ayurveda, a major component of AYUSH, has also faced quality related issues in the global market. A big chunk of the Indian population consumes ayurvedic medicines. However, for ayurvedic manufacturers, it is still a neglected sector as far as harmonisation is

Though the Indian pharma sector is globally known for its generic prowess, unfortunately, there have been cases when it has been criticised for its below par product quality. Harmonisation of IP will surely change this scenario. It is a major step towards making export oriented pharma players improve their standards concerned. But, at the same time, they are also optimistic that the newly formed AYUSH Ministry will take necessary steps in this regard.

To subscribe: bpd.subscription@expressindia.com

“IPC is responsible for editing/revising/updating/publishing IP while Ayurvedic pharmacopoeia of India (API) is under responsibility of

AYUSH. As per our knowledge, IP does not include ayurvedic monographs so far. IP contains monographs on 13 herbs (like Hingu, Brahmi,

Shankhapushpi, Marich, etc.) however, those cannot be considered as ayurvedic monographs,” opines Shashank Sandu, Director, Sandu Pharma.

Bhargava signs off saying, “The biggest advantage of harmonisation for manufacturers will be uniformity of quality standards, no more different IP/BP/USP requirements.

There will be standardised quality, all countries will follow the same standards. Formulations of medicines for public will be a much simpler exercise, ultimately benefitting the patients.” sachin.jagdale@expressindia.com

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INSIGHT

Combination drugs: Easing out of existence?

Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, gives an insight on various regulatory hurdles hindering the growth of the pharma industry in India

I

ndian pharmaceutical industry’s growth has been phenomenal from the 70s onwards, primarily due to the combination of ‘friend, philosopher and guide’ attitude of the nationalist government as well as the vision, passion and enthusiasm of the pharma CEOs of current industry leaders who commenced domestic pharma manufacturing activities with modest beginnings. The role that contribution therapy supported by introduction of rational patient convenienceoriented drug combinations such as anti-TB, anti-diabetes, antibacterial, anti-retroviral etc. played in increasing customer confidence on indigenously manufactured combination drugs has been phenomenal. It has helped enhance financial viabilities and encourage innovative approaches. In the later years, from late 90s, when the DPCO provisions started getting tweaked by the NPPA to include (and expand) the list of price-controlled single ingredient medicines, pharma industry resorted to their indigenous innovative adaptations of combination drugs and therapies to escape NPPA’s noose. Oral dosage forms of antibiotics or anti-colic pain relievers were combined with anti-ulcer medications or probiotics and even proton pump inhibitors to provide patient comfort and convenience. Subsequent new drug policies with recommendations of the Mashelkar Committee and other expert committees advised innova-

54 EXPRESS PHARMA November 16-30, 2016

tive, patented medicines to be exempted from price control. However, over the years, the NPPA, encouraged

by NGOs, have been pricing innovative, patented New Drug Delivery Systems (NDDS) based sustained release/slow release/modified release/delayed release/orally dispensable/mouth-melting dosage forms and combination drugs as their standard generic forms in spite the superior patient benefits built into the design of these dosage forms. Domestic or indigenously developed technological advancements have, of late, started receiving scant respect and appreciation, while trivial or incremental improvements on imported patented medicines have become more respectable and appreciated in the market place in spite of their multifold, unaffordable pricing.

Such scavenger pricing is welcomed by all intermediaries since their commissions or trade margins are linked to the MRPs or the final price to the patient. This is all the more attractive to reputed dispensing hospitals.

Dr Gopakumar G Nair – CEO, Gopakumar Nair Associates

In the history of all medicines, it has been common practice to ‘kill the goose that stops laying the golden eggs.’

The patented blockbusters over the last fifty years, were proven to be harmful to health and have serious side effects after their ‘useful patented’ life was over. The very same innovator who has been singing the praise of their path-breaking drug during the life time of the patent, finds independent research (probably with their own inputs) leading to research

studies and publications, to highlight life threatening side effects of the now ‘patent expired’ drug. With the fullfledged onset of ‘TRIPs’ based product patent regime, the mostly imported (or locally licenced to distribute) patented drugs need to open up markets in India by displacing low priced patentfriendly combination drugs which were in use for years without any report of adverse effects. It has to be admitted that the ‘concurrent nature’ of the Indian pharma drug control authority wherein the roles of the Central Drug (CDSCO) and State Drug (FDA) authorities are defined in the 1940 Drugs & Cosmetics Act has not been able to keep pace with the technological advances in the recent years.

Consequently, there have been some abuses of the system which led to introduction of a few irrational combinations. However, it is uncalled for to ban combination drugs across the board to weed out some bad drugs. Many traditional formulations, including those based on probiotic or nutritional support-based

The innovators who have been singing the praise of their path-breaking drug during the life time of the patent, finds independent research (probably with their own inputs) leading to research studies and publications, to highlight life threatening side effects of the now ‘patent expired’ drug

combinations are likely to be the targets and victims in this massive exercise.

To add insult to injury, the new FSSAI rules on nutraceuticals will cause explosive impact on the Indian pharma industry. The potential of the Indian nutraceutical industry (which is reported to be around `20,000 crores) can even surpass the pharma industry in its growth, if relieved of excessive controls and constraints. Nutraceuticals are mostly combinations based on ingredients proven to be safe and efficacious, including prophylactic and preventive. The combined attack on the otherwise overregulated Indian pharma industry from the Health Ministry through the CDSCO and the FSSAI reminds me of the ‘Jalianwala Baug Massacre.’ While some victims will be identifiable by the impact on their financial results, the Indian entrepreneurial thrust which has hitherto been on converting challenges and threats to opportunities, will come out with innovative options and alternatives to continue to grow, survive and offer their services to the stakeholders, in spite of these manmade catastrophes and growth barriers.

Amidst these challenges and threats, one wonders, whether the pharma industry is being deprived from ease of doing business in India, relief from Licence Raj and the policies of self-reliance and import-substitution of yesteryears.

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Online pharmacies: Atrouble maker or game changer?

Bejon Kumar Misra, Founder, Partnership for Safe Medicines (PSM) India Initiative, feels that online pharmacies are here to stay as they offer myriad advantages but recommends better regulation and more consumer awareness to mitigate concerns and optimise the potential of these online entities CONSUMERS GLOBALLY have the right to access products and services, which are healthy and safe, based on credible information, choice and fair business practices. At no cost should the quality of products and services be compromised, especially those concerning life and safety.

Today, the consumers are capable of deciding what is best for them and seek transactions online without physically visiting the point of sale, thanks to technology. India is no exception, nor is the Indian consumer. Online sale has emerged as a game changer, not only in metro cities but also in tier-I and tier -II cities and towns. Slowly, it is also penetrating the rural areas of India, touching 638,000 villages spread over 36 states

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with a population of 1.34 billion consumers.

Online pharmacies: Serving a need Purchasing cloth, food, books, cinema tickets, tours and travels – even groceries – over the Internet is perceived as normal behaviour by all. Online shopping is convenient and products are delivered directly to your doorstep, promptly and efficiently. Similarly, purchasing medicines online is becoming popular amongst the consumers in India and also globally. Online pharmacies will soon be seen as the most reliable mode of purchase, giving tough competition to the existing chemists’ and druggists’ brick and mortar stores.

Concerns galore…

But, despite the ease of use, purchasing products like medication over the Internet can be dangerous, if not deadly. Medications purchased from illegal online drug sellers are often not what patients expect. These products have been found to contain dangerous substances such as powdered concrete and antifreeze. Additionally, prescription drugs, if taken without a prescription, lack necessary and appropriate medical supervision. Drug overdose was a leading cause of injury and death in 2010. Among people 25-64 years old, drug overdose caused more deaths than motor vehicle crashes. Accidental overdose is increasingly common when using drugs online.

Thus, online pharmacies can become a troublemaker if not handed appropriately by the regulators and the consumers.

We must agree that we can never ever afford to ignore the hazards of accessing medicines in an indiscriminate manner.

They have to be efficiently governed by a robust regulation based on global best practices and applicable to all the agencies, whether online or off-line to ensure safety and quality to the consumers.

“Selling medicines without prescription is a common practice in India,” say 50 per cent of people in a survey conducted by Bureau of Research on Industry

56 EXPRESS PHARMA November 16-30, 2016

& Economic Fundamentals (BRIEF). This survey was commissioned by Consumer Online Foundation, a registered voluntary consumer organisation in India, to understand the consumer behaviour towards purchase of medicines online based on the information provided on websites and telephone helpline numbers. A major shift in consumer preference in buying medicines online has been noticed across all age groups. The study reveals the following: ◗ Rise in unsafe purchase of drugs through offline chemists ◗ The sale of medicines without prescription seems to be a market norm as reported by half of the respondents. ◗ Around 36 per cent of the sample consumers reported that they do not get bills with batch number and expiry date for their purchases. ◗ 50 per cent of people admitted to buying medicines without prescription from chemist shops.

A total of 4600 consumer respondents from all the age groups participated in the survey with a fair representation across all the age groups.

Bejon Kumar Misra, Founder, Partnership for Safe Medicines (PSM) India Initiative

own by personally visiting medicine outlets (68 per cent) and about 20 per cent of them order medicines over the telephone from such outlets. ◗ A majority of the online orders are being placed by senior citizens due to convenience, proper systems facilitating easy validation of prescriptions and choice of affordable options were the main reasons. The preference of buying medicines through phys-

curred over medicine by 86 per cent of the respondent consumers is up to ` 5000. Off them, 39 per cent reportedly spent between ` 1001 to ` 2500 per month. ◗ Around 48 per cent respondents reported that they have to visit multiple pharmacies to buy medicines as the doctor’s prescription does not allow patients to access all the prescribed medicines from one shop due to large variety of same medicine are available in different brand names, even though they carry the same salts or formulations. ◗ A significant 67 per cent of the samples have been through occasions where they were charged different prices for the same medicine at different pharmacies and unavailability of qualified pharmacists to dispense medicines at pharmacies has emerged as one of the major issue as reported by 32 per cent of the consumers. ◗ Approximately 63 per cent respondents don’t get proper counselling about the administration of medicines at their preferred medical stores while majority (67 per cent) of the respondents recalled instances

Online pharmacies can become a troublemaker if not handed appropriately by the regulators and the consumers. They have to be efficiently governed by a robust regulation based on global best practices and applicable to all the agencies, whether online or off-line to ensure safety and quality to the consumers Around half the respondents were in the age group of 18 to 34 years. ◗ A majority (83 per cent) of the consumer respondent’s agreed conducting their banking activities or shopping online. Additionally, online shopping or banking is not restricted to any particular age group, especially the young, which is highly risk taking and can cause addiction unintentionally. ◗ A majority of the sampled consumers buy medicines on their

ical visits to the medical stores decreases (from 72 per cent to 55 per cent) with increase in age.

Subsequently, placing orders for medicines over the telephone (from 15 per cent to 29 per cent) increases with increasing age. ◗ A majority (63 per cent) of consumers need to buy medicines for chronic diseases and with increase in age, the frequency of buying medicines for chronic diseases was found to increase (from 52 per cent to 86 per cent). ◗ The monthly expenditure in-

wherein they were offered an alternate or substitute brand for the same composition during purchase. Of them, 42 per cent found the alternate brands to be cheaper in price and 37 per cent found the alternate brands to be of the same price.

…nevertheless a game changer However, my opening remarks that online pharmacies are going to become game changers is reaffirmed as the study estab-

lishes the fact that 90 per cent of the respondents showed inclination towards online purchase of their medicinal requirements in the near future. Further, consumers in the age groups 65 to 70 years (92 percent) and 35 to 44 years (91 per cent) have shown the highest intent to use e-pharmacy in the future. Also, 94 per cent of the respondents currently buying medicines for chronic diseases have shown inclination to accept e-pharmacies in the future. Approximately 76 per cent respondents think that e-pharmacies will be more convenient as compared to the existing mode of purchase they are using. A majority (76 per cent) of the respondents stated that a single store or website would suffice their medicinal requirements and would be a major benefit for consumers.

Around 87 per cent respondents perceive that home delivery of medicines would be a major benefit propelling the increase in acceptance of online shopping of medicines. 84 per cent of the respondents are of the opinion that low prices, discounts and savings on purchases would be a big feature that would attract consumers towards e-pharmacy.

Around 74 per cent of the respondents agreed that convenience in choosing the time and location for delivery of orders would improve acceptability of e-pharmacies in the market. 74 per cent are of the opinion that quality of medicines would not be compromised at e-pharmacy stores, and will eventually be the main factor attracting consumers to this platform.

Approximately 72 per cent of the respondents perceive that ease of tracking orders, convenience in cancellation of orders and the option of reimbursement in online purchase of medicines are advantages that consumers will enjoy if they opt for e-pharmacies.

Clarity in regulation is key Some of these pharmacies require prescriptions, while others do not. Of those that do not require prescriptions, some ask the customer to fill in a health questionnaire with their order.

Many drugs available at legiti-

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mate online pharmacies are produced by well-known manufacturers such as Pfizer, Wyeth, Roche, and generic drug makers like Cipla and others. However, it remains difficult for a patient to ascertain whether an online pharmacy is legitimate. Medicines obtained from rogue online pharmacies come with no guarantees with regard to their identity, history and source. A study in three cities of Netherlands found that over 60 per cent of the consumed sildenafil was obtained from illegal sources. In India, we need to conduct similar studies to insulate the consumers from accessing spurious and not-of-standard medicines from online pharmacies.

We must amend the existing Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, as it does not provide clarity about online pharmacies and their functioning in India. The existing law has guidelines on the sale of Schedule H and Schedule X drugs.

These can be sold only on by prescription and there are specific rules, including for labelling and bar coding.

It appears that electronic prescriptions should be valid, especially in the light of the Pharmacy Practice Regulations of 2015 declared by Pharmacy Council of India in January 2015.

In these regulations, “Prescription” is defined by regulation 2 (j) [3] as “a written or electronic direction from a Registered Medical Practitioner…….” On the basis of existing regulations it appears that a scanned copy of the prescription will be perfectly valid. However, whether such electronic prescriptions can be used to buy medicines from online pharmacies has been questioned.

The way forward It is very difficult – if not impossible, to tell which websites are legitimate. You can never spot the fake website unless you are an expert on the subject. Fake online pharmacies can manipulate their websites to appear legitimate, so checking the pharmacy’s license through your state drug regulator is an important step to know whether

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you are using a safe and legal online pharmacy. Unfortunately, in our country the state drug regulators never make such information public and accessible.

However, certain states like Gujarat, Maharashtra, Karnataka, Tamil Nadu and others, with support from the Government

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of India have established portals for sharing such information online, in the interest of the consumers. If you cannot confirm that an online pharmacy is licensed and safe, consumers should avoid using them till they are not fully satisfied about its credentials and credibility. Even

if you have identified a proper online pharmacy, be sure that the pharmacy requires a valid prescription from your doctor before dispensing the medicine and you are provided with a physical address and telephone number in India by the online pharmacy, which would have is-

sued the license to conduct the business as per our existing laws. It should also have a licensed pharmacist to answer your questions. You should never think of compromising your health and safety while purchasing medicines online or offline.

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Pharmacovigilance as a value addition for the pharma industry Dr J Vijay Venkatraman, MD and CEO, Oviya MedSafe and Karunakaran Shanmugam, QA Associate, Oviya MedSafe,advocate implementing pharmacovigilance in a prudent manner to augment the growth of the Indian pharma industry PHARMACOVIGILANCE (PV) is a scientific discipline that significantly impacts public health. It involves several stakeholders such as the pharmaceutical industry, academia, healthcare professionals, consumers and drug regulatory agencies. Pharmacovigilance is often perceived by pharmaceutical companies as an obstructive regulatory ordeal rather than an integral pre-requisite for marketing their products. The traditional perception that PV is a cost centre that does not generate any return on investment is so deep-rooted in the industry that the title of this article itself may seem oxymoronic to many. However, the practice of performing pharmacovigilance in a prudent manner may rather be an augmenter for the pharma industry, which this article explores in detail.

Introduction The World Health Organization (WHO) defines PV as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

The specific aims of PV are to: ◗ Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions, ◗ Improve public health and safety in relation to the use of medicines, ◗ Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective

58 EXPRESS PHARMA November 16-30, 2016

Dr J Vijay Venkatraman MD & CEO, Oviya MedSafe

Karunakaran Shanmugam QA Associate, Oviya MedSafe

(including cost-effective) use, and ◗ Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

The above-said objectives should be considered the cardinal responsibilities of all PV stakeholders who can never be justified in compromising on their duties. As any other PV stakeholder, the pharmaceutical industry is also bound to fulfil these obligations. In fact, patients are entitled, as customers, to expect accountability on the part of pharma companies, in cases of any complaints. But, this has led to the unfortunate interpretation of the pharma industry that PV is a detrimental activity that could challenge their prosperity. However, what has not been realised yet is that PV can also add significant value to the pharma industry beyond its commitment to being the custodian of patient safety.

Value addition Value addition is defined as the increase in value of a product or service as it goes through the stages of being developed and produced.

Value-added products or services are worth more because they have been improved or had something added to them.

In other words, value addition is something that justifies the higher worth deserved by a product or a service which has the value added feature versus a similar product or service that does not have it.

Given this background, adoption of the principles of PV may be considered to add value to the concerned pharma companies by: ◗ Enhancing corporate image; ◗ Ensuring financial security; ◗ Envisioning scientific challenges; and ◗ Enabling business expansion.

Enhancing Corporate Image Corporate image or reputa-

tion denotes the way in which a business house, its activities and its products are perceived by outsiders. Corporate image is a composite psychological impression that continually changes with the company's circumstances, media coverage, performance, pronouncements, etc. In a competitive business scenario, many businesses actively work to create and communicate a positive image to their consumers, shareholders, regulatory authorities and the general public. A company that allows its corporate image to be messed up is more likely to find itself in a variety of problems. PV is an enhancer of corporate image in the following aspects: ◗ A company performing good PV is seen as a responsible and patient-centric organisation — In case a patient develops an adverse event following the intake of a particular drug and contacts the concerned pharma company, a prompt and appropriate response is bound to make them feel cared for. ◗ News of non-compliance has worldwide impacts on the reputation of the company — History has shown us that share prices of pharma companies have crashed overnight following revelations of compromises in handling product safety data. Such impacts are not restricted to a particular region or country because in today’s electronic era, it takes little time for news to spread globally. This is of particular concern as most pharma companies operate in multiple countries.

◗ PV is seen as surrogate marker of quality — Pharma companies usually prefer to highlight information on their quality standards, especially on their compliance with Good Manufacturing Practices (GMP) and certifications like ISO (International Organisation for Standardisation), on their websites and other business literature. If some information on their PV system is also provided along with these details, the consumer would feel that the company is quality-conscious, because for the patient, quality is a combination of both efficacy and safety. ◗ Projects the company as a science-focused organisation — Consumers tend to believe that a company that vigilantly researches on their negative feedback is driven not only by business motives but also focused on science. While this is true for any industry, this attitude is more desirable in the pharma domain where the company directly deals with the health of its consumers.

Ensuring financial security Every pharma company wants to be financially secured by preventing loss due to safety-related product recalls and consumer lawsuits.

Such scenarios will also lead to decline in company sales, share prices and erosion of shareholder wealth.

It is a fact that no drug exists without its adverse effects and therefore, no pharma company will be penalised just for encountering an Adverse

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Drug Reaction (ADR) unless the company does not act on it per the applicable regulatory requirements or conceals safety information from the competent authorities. If such non-compliance is noted and if a lawsuit is in the picture, the Court of Law may question the PV system in the company and, in the worst case, this scenario may lead to heavy penalties or even closure of the company. Therefore, having a proper PV setup protects pharma companies from litigation-related loss by enforcing and documenting compliance with the regulatory norms. In fact, PV is an insurance policy, the

Having a proper PV set-up protects pharma companies from litigationrelated loss by enforcing and documenting compliance with the regulatory norms value of which is not often realised until a crisis occurs.

Generic companies often come across scenarios wherein they need to choose a few among many products of comparable revenue potential, for commercialisation. In such situations, it may be advisable to select less risky products in terms of safety. To do so, the activity of assessing the safety profiles of the products in question needs to be performed. A simple global literature search for each revenue-wise comparable product may be enough to stratify

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them based on their risk profiles and provide evidencebased recommendations to the business decision-makers in this regard.

Envisioning scientific challenges The PV unit opens up a two-

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way communication channel between the consumers and the company for discussing any issue involving the company product. During this process, the reporters may share data such as off label use, medication error, product quality defect, etc, which may

not necessarily be linked to any adverse event. There is also an opportunity for the company to understand product usage patterns and practical difficulties the consumers face with the company products, which may then be passed on to the respective

departments within the company for identification of the root cause and for improvisation of the product.

Such data is usually received from Patient Support Programs (PSPs) and Market Research Programs (MRPs) in particular. PSPs and MRPs

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EVOLUTION OF A TYPICAL PHARMACEUTICAL COMPANY

Drug Manufacturing

Marketing in Home Country & Unregulated Markets

Marketing in RoW regions where PV is required but implementation poor

Marketing in RoW regions where PV is required and well implemented

Developed Markets

Figure 1: The receding green arrow indicates the advancement of PV leading to PV requirements coming in much earlier in the life cycle of a pharmaceutical company

are aimed to help patients and/or healthcare professionals (HCPs) better manage disease and optimise treatment.

Identifying adverse events is not an objective of PSPs and in fact, PSPs are usually not designed to be organised data collection schemes. However, the information obtained from PSPs will provide new scientific insights which may significantly aid product development. PV data can also support product R&D by spotlighting bioavailability/absorption issues, safety issues associated with impurities/excipients, formulation-linked safety issues and so on. Several life-threatening drugs which have been withdrawn at various stages of drug development and many drugs which were perceived and subsequently announced unsafe in the past have later re-entered the market with appropriate safety recommendations either for the same or for different indications. Both of these scenarios are results of proper pharmacovigilance being performed.

For example, the thalidomide disaster is considered one of the darkest episodes in pharma research history as it caused phocomelia in new born babies, a rare congenital abnormality in which the long bones fail to develop, when the drug was taken by antenatal mothers. More than 10,000 babies with phocomelia were reported in 1961 and the drug

60 EXPRESS PHARMA November 16-30, 2016

A robust PV system is a vital need for pharma companies intending to market their products in developed countries. In fact, the very presence of a product in a developed market is considered as a surrogate measure of safety by many developing countries in which the PV system is passive and still emerging was banned the following year all over the world. Over a period of time, the beneficial effects of thalidomide were acknowledged and it is now recommended for the treatment of multiple myeloma, erythema nodosum leprosum, aphthous ulcers in HIV-infected patients, chronic graftversus-host-disease and a variety of tumours. Today, thalidomide is available even in regulated markets like the US and the UK with appropriate usage restrictions. This has been possible due to the risk management programmes centred on pregnancy which were put in place for the product failing which we would have lost the product forever.

The statin group of drugs which are widely prescribed today were once feared due to rhabdomyolysis associated with their usage. Careful PV activity revealed that rhabdomyolysis was caused only when statins were taken in

higher starting doses, especially in Asian patients. Once the root cause was identified, proper warnings were put in place and it resulted in retention of the drug in the market.

Although the mandate of protecting consumers from harmful effects of drugs is a core objective of PV, the above cases have been illustrated to emphasise the fact that PV also protects products from being blindly withdrawn from the market citing safety issues.

PV sometimes opens up new avenues for drug development, often in a hitherto unknown indication. Minoxidil, which was initially approved as an anti-hypertensive drug was later identified to cause hair growth as an adverse effect which resulted in the drug being re-developed for the indication of hair loss.

Today, Minoxidil is available over the counter for the treatment of androgenic alopecia, thanks to a ‘beneficial adverse effect.’

Enabling business expansion A robust PV system is a vital need for pharma companies intending to market their products in developed countries. In fact, the very presence of a product in a developed market is considered as a surrogate measure of safety by many developing countries in which the PV system is passive and still emerging.

Figure 1 outlines the life cycle of a pharma company which begins its business usually as a drug manufacturer.

Most of its business could be in contract manufacturing in which scenario it may have little PV liability. As part of its growth, it starts to market its products in its home country and in unregulated markets where PV liabilities may be rudimentary. In the next steps, when it moves into the Rest of the World (RoW) countries which have mandates for PV. Finally, the dream destination for such a

company would be to have its own market authorisations in the developed markets like North America and Europe, which have the most stringent PV obligations. It is thus obvious that business expansion is impossible to achieve without investing in PV. However, what needs to be highlighted is that PV requirements have begun to emerge even at a manufacturing stage, in recent times, indicating that PV is necessary even to achieve growth in domestic business.

Further, in the global scenario, many multinational pharma companies with innovative products look at establishing joint ventures with other pharmaceutical drug manufacturing marketing in home country and unregulated markets marketing in RoW regions where PV is required but implementation poor Marketing in RoW regions where PV is required and well implemented developed markets companies which have better market penetrations in other parts of the world. Obviously, local pharma companies with good PV compliance track records stand better chances to win such business deals, although there may be many other parameters for partnership decisions to be made.

The pressing need of pharma companies to have PV systems in place in order to seamlessly run and grow their businesses have gener-

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ated quite a lot of demand for PV capabilities. Not all companies are willing and able to set up their in-house PV systems, which has resulted in the evolution of the fast-growing PV outsourcing industry, which is expected to continue its exponential growth for the next decade too.

Conclusion PV is a cross-functional subject that used to be ignored in the past. But in recent times, PV has asserted itself as a key regulatory obligation for the pharma industry. It is a fact that many pharma companies feel that PV is a speed-breaker, which perception is not en-

Many pharma companies feel that PV is a speed-breaker, which perception is not entirely untrue

tirely untrue. However, all of us will agree that speed-breakers are essential to ensure everyone’s safety when one drives through a crowded street. On the other hand, PV to a pharma company in the growth mode is like a seat belt to a luxury car speeding on a motorway. It would be illogical to assume that PV would be a speed-breaker on a motorway, but this is how PV is seen by many pharma companies.

Hence, it is high time for us to realise that the pharma industry cannot safely exist without PV. In fact, PV is an ‘Unsung Hero’ which monitors the benefit-risk ratio of not only the pharma products but also that of the pharma companies that manufacture or market them.

References 1. Encyclopedia of Small Busi-

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ness - http://www.referenceforbusiness.com/small/CoDi/Corporate-Image.htm - Accessed 21 OCT 2016 2. Does safety sell medicines? http://www.pmlive.com/pharm a_intelligence/does_safety_sell _medicines_1007678 - Accessed 21 OCT 2016

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3. Cambridge dictionary http://dictionary.cambridge.or g - Accessed 21 OCT 2016 4. World Health Organization http://www.who.int/medicines/areas/quality_safety/safe ty_efficacy/pharmvigi/en/ - Accessed 21 OCT 2016 5. Business dictionary -

http://www.businessdictionary.com/definition/corporate-image.html - Accessed 21 OCT 2016 6. Oviya MedSafe excels in Pharmacovigilance of Patient Support Programmes & Market Research Programmes http://www.oviyamedsafe.com

/news/oviya-medsafe-excels-inpharmacovigilance-of-patientsupport-programmes-marketresearch-programmes Accessed 21 OCT 2016 7. JIACM 2004; 5(1): 34-7 http://medind.nic.in/jac/t04/i1 /jact04i1p34.pdf - Accessed 21 OCT 2016

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How Ind AS impacts pharma businesses?

Sumit Seth, Partner, Price Waterhouse & Co explains how the introduction of the new accounting standards will impact the financial and net-value of pharma companies INDIAN ACCOUNTING Standards (Ind AS) converged with International Financial Reporting Standards (IFRS) is now the new Generally Accepted Accounting Policies (GAAP) for many companies. As a result, commencing June 2016 quarter, Phase I companies reported their results under Ind AS. The shift from the historical cost convention to increased use of fair value and increased focus over substance rather than the legal form of the underlying transaction has impacted every company and industry sectors, including pharmaceutical businesses.

The adoption of Ind AS has shown a variety of changes to a company’s key metrics, including reported top line, bottom line, financial position and net worth. The significant areas of impact for the pharma sector are discussed below.

Revenue recognition Revenue guidance under Ind AS is quite exhaustive as compared to the current Indian GAAP providing detailed guidance on customer arrangements e.g. multiple element deliverables, service transactions etc. Adoption of Ind AS has resulted in reduction of reported revenue due to netting of awards and incentives, discounts and other consideration paid to customers such as provision for expected sales returns. Revenues have also declined due to Ind AS impact on accounting of ‘linked transactions’ generally involving sale and subsequent repurchase from suppliers. A typical example is a toll manufacturing arrangement, where a manufacturing entity sells intermediate products to a tolling entity which then completes the finished products and sells it

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back to the manufacturing entity. Finished products are finally sold to the end customers by the manufacturing entity. Under Indian GAAP, on the basis of legal form of such transactions, the manufacturing entity may have recorded revenue at the time of sale of intermediate products to the tolling entity and also subsequently on sale of its finished product to end customers. Under Ind AS, revenue in respect of such transactions would get recorded once the finished products are sold to the end customers (the sale of intermediate products to the tolling entity would get reversed). Revenue may also decline due to gross vs net presentation of revenue based on whether the reporting entity is acting in the capacity of a principal or an agent. If it is an agent then only the net commission or fee is recognised as revenue vis-à-vis the entire amount of billings. On the other hand, reporting of revenue gross of excise duty, with a corresponding adjustment to expense may lead to increased reporting of revenue with no impact on profits.

Sumit Seth, Partner, Price Waterhouse & Co

Financial instruments and fair value India has decided to be the first to adopt IFRS 9 equivalent— Ind AS 109, the new standard on financial instruments. Ind AS 109 provides extensive guidance on identification, classification, recognition and measurement of financial instruments. Additionally, it provides guidance on de-recognition of financial instruments and hedge accounting, and has extensive disclosure requirements.

Presently, there is no comprehensive mandatory guidance

on financial instruments under Indian GAAP. At a high level, the use of fair value and present value in recording financial instruments such as investments, derivatives, long-term deposits and provisions has increased. Additionally, the new model for the recognition of impairment losses i.e. the ‘expected credit loss’ model as compared to the ‘incurred losses’ model under Indian GAAP has also lead to an increased charge on impairment loss –especially when the receivables have a longer credit period.

Taxes Under Ind AS, deferred taxes are recorded based on the temporary difference as opposed to timing differences under Indian GAAP. This approach under Ind AS is broader resulting in deferred taxes on more items such as undistributed earnings from subsidiaries and joint ventures and unrealised profits on intra-group inventory transactions. Moreover, the lower recognition threshold under Ind AS compared to the virtual certainty supported by convincing evidence presently required to recognise de-

Revenue guidance under Ind AS is quite exhaustive as compared to the current Indian GAAP providing detailed guidance on customer arrangements e.g. multiple element deliverables, service transactions etc. Adoption of Ind AS has resulted in reduction of reported revenue due to netting of awards and incentives, discounts and other consideration paid to customers such as provision for expected sales returns

ferred tax assets on carried forward losses under Indian GAAP may also increase reported deferred tax assets/tax credits under Ind AS.

Other areas Finally, impact is noted in the area of employee benefits, generally resulting in higher expense due to recognition of stock compensation using fair value of the share-based awards. Adjustments due to actuarial gains/losses on defined benefit obligations are now getting accounted in other comprehensive income under Ind AS instead of the income statement under Indian GAAP. The impact of Ind AS adoption is pervasive beyond accounting, cutting across organisation and various functions/ areas such as direct and indirect taxes, contractual arrangements with customers, suppliers, lenders, HR and incentive policies, IT systems and controls, including requiring timely communication with various stakeholders. The quantum of disclosures will also increase multifold, though it will surely allow companies to tell their story to investors and provide more meaningful information for informed users of financial information.

Based on experience of companies that have already adopted Ind As, others preparing now for Ind As transition will have to invest time and effort and meticulously plan for consequential accounting and organisational changes, extensive data requirements including disclosures. They will have to start discussing disclosures on significant judgments and estimates in more detail, including what goes behind the reported numbers.

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How to effectively address the issue of unaffordable drug pricing in India?

Abhishek Thakur in this article tells us about how to improve overall affordability of healthcare in India

Abhishek Thakur

HEALTHCARE affordability, especially of drugs, remains a major concern in India. As per the latest National Sample Survey (NSS) released in April 2016, over 80 per cent of the Indian population is not covered by any form of health insurance. The more alarming finding is that 82 per cent of urban population doesn’t have health insurance, which is very close to the figure of almost 86 per cent for the rural population. Hence, out-of-pocket expenses comprises a major chunk of all health financing, with a large share incurred on out-patient treatment by the way of purchasing medicines.

With one of the highest poverty levels as per WHO (around 21 per cent earning less than $1.9 per day) and lowest per capita incomes in the world as per International Monetary

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Fund (ranked 122 out of 185 countries in 2015 on GDP per capita), overpriced drugs remain a major challenge for the common man in India. For instance, as per the Central TB division of the Ministry of Health and Family Welfare, the DOTS treatment for normal TB costs `500-600 for six months. On the other hand, multi-drug resistant tuberculosis (MDR-TB) treatment for 24-30 months costs around `100,000. This is an alarming figure as the incidence of MDR-TB is increasing at a fast pace in India.

The combination of low individual purchasing power and high treatment costs put a lot of pressure on the Indian consumers, and the lack of healthcare financing covering out-patient medicine expenses further adds to this burden.

While the drug prices and healthcare overall are skewed against the poor, pharmaceutical companies are also forced to increase price due to increasing cost pressures.

The Government of India has been trying to curb drug prices through the Drug Price Control Order (DPCO), 2013, which brought 348 drugs into India’s National List of Essential Medicines (NLEM) in 2011. Currently, there are over 900 formulations in the NLEM 2015 list under the scheduled category of DPCO. On October 10, 2016, the National Pharma Pricing Authority (NPPA) fixed the ceiling prices for 31 drug formulations, bringing the total to 498 drug formulations under the price

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The overall affordability of healthcare in India, can be improved with a two-pronged approach.

Firstly, the focus should be to provide universal healthcare coverage to majority of the population and secondly, the government must recognise the need for pharma companies to be financially sustainable and provide the right support in the form of legislations control. The NPPA Chairman recently announced that they are moving fast towards the target of bringing 800 plus formulations under the price control. The price cuts have been substantial and as high as over 40 per cent for the formulations brought under the price control in March 2016.

Inspite of such aggressive price control steps taken by the government, there are still loopholes in the system. For instance, in the case of paracetamol, formulations comprising only 20 per cent of the market share are under price control.

Overall, the Drug (Prices Control) Order, 2013 covers only around 18 per cent of the domestic market that has little impact on the affordability of drugs.

Hence, the price control steps, while hurting the pharma companies that are serving the Indian market, are not making a big difference in improving the affordability for the common man. Additionally, the significant information regarding drug

pricing and available options, patients often end up buying the priciest product. This unfavourable scenario leaves a lot of potential for improving India’s drug pricing regime in a way that can benefit the pharma companies and the patients.

The overall affordability of healthcare in India, especially with regards to drugs, can be improved with a two-pronged approach. Firstly, the focus should be to provide universal healthcare coverage to majority of the population, including the coverage of the cost of out-patient drug purchases. Secondly, the government must recognise the need for pharma companies to be financially sustainable and should provide the right support in the form of legislations.

The government’s push for low cost in-patient insurance should also extend to the out-patient expenses on purchasing drugs. It should also undertake major initiatives to establish facilities for low-cost diagnosis/treatment of chronic

life threatening diseases like TB, and for purchasing affordable generic drugs. This will help provide health insurance and affordable healthcare to patients Below are the steps which should be taken into account to improve affordability of drugs in collaboration with pharma companies 1. Revamp the drug price control mechanism. ◗ Drug price controls are an effective way to ensure affordability and the government should continue to regulate the ceiling prices. Even free markets in other parts of the world, such as Canada or even Egypt, have been resorting to price controls. ◗ The NLEM should be revised every year and the focus should be to regulate the price of the particular therapy area rather than that of the drug only. ◗ Central Drugs Standard Control Organization should dissipate the price control power and include more stakeholders in the decision making process. Overall, it should not be

mandatory for the NPPA to regulate the prices of all the drugs under the NLEM. Instead of using diktat to fix the drugs prices, the NPPA should consider working in collaboration with the pharma companies to arrive at negotiated cheaper prices.

This would incorporate the welfare and sustainability of the industry as well.

2. Emulate the centralised procurement system for procuring drugs, as utilised by Tamil Nadu, in other states. This would help in enhancing the competition in the industry and bring down the cost of generic drugs for patients.

3. Institutionalise strict regulations against the unethical and unfair drug selling practices, such as gifting and sponsoring events, which are used to influence doctors and key bureaucrats.

4. Engage and educate patients regarding the competitive brand and generic prices for different therapy areas by marketing and popularising NPPA’s ‘Pharma Sahi Daam’ mobile app.

While the task of improving the medicine affordability scenario in India is an uphill task, these steps will build the momentum in the positive direction. However, change will only come through effective implantation of strategies by the collaborative efforts of the government and the pharma industry.

(The author is an MBA student from SP Jain Institute of Management & Research (SPJIMR)

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REPORTS

Seasonal influenza vaccines market will hit $4.3 bn by 2025 The market will grow at a compound annual growth rate of 3.3 per cent THE SEASONAL influenza vaccine market across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will rise from $3.1 billion in 2015 to $4.3 billion by 2025, at a compound annual growth rate of 3.3 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that the main growth drivers during the forecast period will include amendments to the national immunisation schedules of the US and the UK, the expansion of egg-based quadrivalent seasonal influenza vaccines across Germany, Italy, France, and Spain, and the transition from egg-based to cell culture-based vaccines.

Christopher J Pace, Director of Infectious Diseases, GlobalData explains, “For the past few decades, children have not been the focus of season influenza immunisation recommendations in developed nations. More recently, developed countries such as the US and the UK have issued expanded recommendations for the vaccination of healthy children and adolescents against seasonal influenza, thereby indirectly protecting high-risk groups such as the elderly and the immunocompromised from disease by disrupting community transmission.”

Quadrivalent influenza vaccines, which contain antigens against two influenza type A and two influenza type B subtypes, offer broader coverage than trivalent (two influenza A and a single influenza B strain) formulations. In 2015, Japan replaced its trivalent, seasonal influenza vaccines with quadrivalent formulations, and it is expected that trivalent vaccines will be virtually absent from the US market within the next five years. Quadrivalent vaccines will also expand throughout Europe by 2025.

Pace continues, “Although the vaccination rate across the 7MM is anticipated to remain

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stable during the next decade, the higher price commanded by

quadrivalent vaccines and other next-generation immunisations,

such as Sanofi’s Fluzone HighDose and CSL's Fluad, is ex-

pected to drive market growth.

EP News Bureau

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Gastrointestinal drugs market to hit $48.4 bn by 2022

Major depressive disorder market will reach $5.8 bn by 2025 as awareness and drugs improve

Approval of new drugs, as well as rising prevalence, are expected to drive considerable growth

The market will be primarily driven by the growth of atypical antipsychotics, along with the increasing global diagnosed prevalence of MDD

THE MARKET size for gastrointestinal therapeutics is set to grow from $35.7 billion in 2015 to $48.4 billion by 2022, representing a compound annual growth rate of 4.45 per cent, according to business intelligence provider GBI Research.

The company’s latest report states that although the market has recently been hit by the patent expirations of a number of the leading gastrointestinal products, such as Nexium and Remicade, the approval of new drugs, as well as rising prevalence, are expected to drive considerable growth.

Jennifer Goossens, Associate Analyst, GBI Research, explains, “Recently approved products include Intercept’s Ocaliva, for the treatment of primary biliary cirrhosis, and Takeda’s Takecab for acid-related diseases such as gastroesophageal reflux disease – which are both forecast to generate annual revenue of over $1 billion by 2022 – as well as Entyvio for inflammatory bowel disease (IBD).”

In terms of the gastrointestinal pipeline, there are 937 products in active development, most of which are small molecules and biologics. The therapy area is highly active and has the seventh-largest pipeline across the pharma industry, with more active pipeline products than therapy areas such as respiratory, ophthalmology, and dermatology.

Goossens continues, “The large portion of biologics in the early- and late-stage

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pipeline reflects the growing interest in biologic therapy in the treatment of gastrointestinal disorders. Currently, marketed biologics, including the monoclonal antibodies (mAbs) Humira and Remicade, only have an established market presence for the treatment of IBD. Due to the high costs and adverse effects, biologic treatment is primarily

87 products are being developed for ulcerative colitis and Crohn’s disease, while 226 are in development for other gastrointestinal indications.”

Biologics in clinical development include the mAbs Stelara (ustekinumab) for Crohn's disease and ulcerative colitis, AMG-714 for celiac disease, and dupilumab for eosinophilic esophagitis, and

In terms of top companies within the treatment space, Takeda is expected to take the title of market leader from AbbVie by the end of the forecast period. Johnson & Johnson, Allergan and AstraZeneca also remain key players in the gastrointestinal market used in patients with refractory IBD, but this may change once newer products with a more favorable safety profile enter the market.

“Biologics have revolutionised IBD treatment, and their success in the treatment of these indications has driven enthusiasm for the use of biologics in other immune-related gastrointestinal conditions, such as celiac disease, eosinophilic esophagitis and autoimmune hepatitis. Of the 329 biologics in the pipeline,

the recombinant protein BMS-9860 for nonalcoholic steatohepatitis.

In terms of top companies within the treatment space, Takeda is expected to take the title of market leader from AbbVie by the end of the forecast period. Johnson & Johnson, Allergan and AstraZeneca also remain key players in the gastrointestinal market, although AstraZeneca is forecast to lose a considerable portion of market share.

EP News Bureau

THE MAJOR depressive disorder (MDD) market, which covers various forms of depression and seasonal affective disorder, is set to rise from $3.2 billion in 2015 to $5.8 billion by 2025, at a compound annual growth rate of 6.1 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that this substantial growth, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will primarily be driven by the growth of atypical antipsychotics, along with the increasing global diagnosed prevalence of MDD, and the potential introduction of six latestage pipeline products.

Christos Michaelides, Analyst, GlobalData’s covering neurology and ophthalmology, explains, “Atypical antipsychotics such as Otsuka/Bristol-Myers Squibb’s Abilify, AstraZeneca’s Seroquel XR, and Otsuka/Lundbeck’s Rexulti are expected to collectively capture approximately 39 per cent of the global market in 2025, and generate an impressive $2.2 billion in sales. Although Abilify and Seroquel will experience some generic erosion over the forecast period, Rexulti will continue to drive sales upwards following its expected launches in the US and Europe in 2018.

“In addition, the prevalence of MDD is expected to increase, mainly due to improving public

awareness of depressive disorders, an increase in routine screening, and the rise in economic stress factors in the 7MM. In January 2016, the US Preventive Services Task Force recommended screening for depression in adults aged 18 and older within the general population, after the organisation found convincing evidence that the practice improves the accurate identification of adult patients with depression in primary care settings.”

The six late-stage pipeline products set to enter the market over the next decade include Alkermes’ ALKS-5461, Otsuka’s ASC-01, Axsome Therapeutics’ AXS-05, Janssen’s esketamine, Allergan’s rapastinel, and Allergan/Gedeon Richter/Mitsubishi Tanabe Pharma’s Vraylar. All six show promise for improving efficacy and safety in the treatment of patients with MDD, thus addressing some of the many unmet needs in the market.

Michaelides continues, “GlobalData expects these latestage pipeline products to drive combined sales of around $877 million by 2025 in the 7MM. The most promising product will be Janssen’s esketamine, which could become a new therapy option for patients who do not respond to atypical antipsychotics and available antidepressant therapies.”

EP News Bureau

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UPDATES

Stanford uses CRISPR to correct sickle cell, human trials planned CRISPR works as a type of molecular scissors that can selectively trim away unwanted parts of the genome, and replace it with new stretches of DNA

S

cientists at Stanford University School of Medicine have used the CRISPR gene editing tool to repair the gene that causes sickle cell disease in stem cells from diseased patients, paving the way for a potential cure for the disease, which affects up to five million people globally.

"What we've finally shown is that we can do it. It's not just on the chalkboard," said Dr Matthew Porteus, senior author of the study published in the journal Nature.

With the study, and unpublished findings from his lab, Porteus believes his team has amassed enough proof to start planning the first human clinical trial using the powerful CRISPR-Cas9 gene editing system to correct the genetic mutation that causes sickle cell disease.

"We think we have a complete data set to present to the FDA (Food and Drug Administration) to say we've done all preclinical experiments to show this is ready for a clinical trial," Porteus said. CRISPRCas9 has quickly become the preferred method of gene editing in research labs because of its ease of use compared with older techniques. CRISPR works as a type of molecular scissors that can selectively trim away unwanted parts of the genome, and replace it with new stretches of DNA. Research using the powerful technique is plowing ahead even as researchers from the University of California and the Broad Institute battle for control over the CRISPR patent. Oral arguments in the case are expected on Dec. 6 at the US Patent and Trademark Office in Alexandria, Va. In sickle cell disease, the body makes mutant, sickle-shaped hemoglobin, the protein in red blood cells that carries oxygen to the body's tissues.

It is caused by a single mutation in a gene that makes a hemoglobin protein.

In a study published last month in Science Translational Medicine, a team from

the University of California, Berkeley, and colleagues used the CRISPR gene editing tool to snip out the diseased gene and deliver a new stretch of DNA to correct the mutation in human stem cells. In that study, some 25 per cent of blood-forming cells were corrected. In the Stanford study, Porteus and colleagues took a different approach. They used CRISPR to snip the gene, but they used a harmless virus to introduce the repair mechanism into cells. After a series of tests in healthy cells, the team tested the gene editing system in blood-forming cells from four patients with sickle cell disease. They showed they could correct the mutation in 30 to 50 per cent of these diseased cells.

Sixteen weeks after they injected the cells into young mice, the team found the cells were still thriving in the bone marrow. Porteus said the findings were very encouraging because prior studies have shown that if you can correct mutations in 10 per cent of cells, that should create enough to cure the disease.

Stanford is now scaling up its laboratory processes to support human trials.

The process will involve using chemotherapy to wipe out a patient's blood system but not their immune system, as is done in a stem cell transplant. Then, the team would inject the patient's own corrected stem cells, which the researchers hope would engraft into the bone marrow and produce healthy blood cells. Porteus has equity interest in CRISPR Therapeutics of Cambridge, Massachusetts, but he said the sickle cell work has been independent of it. The university has built a cell manufacturing plant for this purpose.

Porteus said the team plans to make an initial submission to the FDA in the next few months to map out the clinical trial, and hopes to treat the first patient in 2018.

Reuters

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Prostate cancer hormone therapy tied to higher dementia risk Researchers focused on a common treatment known as androgen deprivation therapy, which works by depriving tumour cells of testosterone

MEN WHO take hormone therapy for prostate cancer may have a higher risk of dementia than patients who receive different treatment for these malignancies, a US study suggests. Prostate cancer cells need testosterone to grow and spread. Researchers focused on a common treatment known as androgen deprivation therapy (ADT), which works by depriving tumor cells of testosterone. Side effects

can include sexual dysfunction, weight gain and fatigue.

“Multiple studies now suggest that androgen deprivation therapy may be associated with cognitive changes, including dementia, and the current study certainly supports this,” said lead study author Dr Kevin Nead of the University of Pennsylvania in Philadelphia.

Patients with prostate cancer who received hormone therapy were more than twice as likely

to develop dementia as men who received alternative treatments, Nead and his colleagues found.

“There is certainly a concern that we may be over treating some men with prostate cancer and the current study reinforces the importance of appropriately and thoughtfully selecting patients for all treatments,” Nead, who conducted the research at Stanford University, added. To explore the link between hormone therapy and dementia, Nead’s team analyzed data on 9,272 men with prostate cancer treated at an academic medical center from 1994 to 2013.The study group included 1,826 men who were treated with ADT. Men were typically around 67 years old, on average, though the patients on ADT tended to be older. Researchers followed half of them for at least 3.4 years.

Overall, 7.9 per cent of men who received hormones developed dementia within five

years, compared with 3.5 per cent of men who got other treatments, researchers report in JAMA Oncology. Men had a greater risk of dementia if they stayed on ADT for at least one year compared to taking hormones for a shorter period of time, the study also found. Risk also appeared to increase with age, with men 70 years and older who used hormones less likely to remain dementia-free. Limitations of the study include the lack of data for some of the men in the study on the severity of prostate tumors, the authors note.

Another drawback is the observational design of the study, Dr Colin Walsh and Dr Kevin Johnson of Vanderbilt University in Nashville, Tennessee, note in an accompanying editorial. A trial that randomly assigns some men to ADT and others to different therapies would be needed to see if the hormones directly cause dementia, they said. It’s

also possible that at least some of the difference in dementia risk found in the study might be due to the characteristics of patients on ADT, said Dr Paul Nguyen, a researcher at Brigham and Women’s Hospital and Harvard Medical School in Boston who wasn’t involved in the study. Men on hormone therapy tend to be older and sicker, with more underlying health issues. Even so, the findings add to growing evidence suggesting that men should consider the cognitive risks of hormone therapy before starting this treatment, Nguyen said.

“For high risk or locally advanced prostate cancer treated with radiation, we know from randomized trials that ADT cuts the risk of death in half and so for these men, ADT should generally still be used,” he said. “For low risk men, ADT has no benefit and should be avoided.”

Reuters

FDA places Regeneron and Teva’s pain-drug study on hold Regeneron has completed an unplanned interim review of data and has stopped dosing patients REGENERON Pharmaceuticals and partner Teva Pharmaceutical Industries said the US health regulator placed a clinical hold on a study testing their pain treatment, dealing another blow to companies looking to develop a safer alternative to opioid painkillers. The Food and Drug Administration (FDA) imposed the hold in the mid-stage trial in patients with chronic lower back pain, after a form of joint damage was observed in an advanced osteoarthritis patient who was given a high dose of the

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injectable drug, fasinumab.

Monday's announcement suggests fasinumab will be plagued by the same limitations as other drugs in its class, including heightened scrutiny, repeated delays, and labeling restrictions, Leerink Partners’ Geoffrey Porges said. The brokerage reduced its probability of success for the drug to zero, and cut Regeneron’s price target to $513 from $530. The treatment is designed to block nerve growth factor (NGF), a protein involved in transmission of pain

signals. Fasinumab has the potential to be an alternative to prescription opioids, that are effective for pain relief but are associated with high rates of addiction, overdose and death.

Following the FDA decision, Regeneron has completed an unplanned interim review of data and has stopped dosing patients, the companies said. The analysis showed clear evidence of an improvement in pain scores in patients dosed with fasinumab, compared with placebo. Regeneron was "lucky" to sell half the

drug to Teva in a timely fashion," noted Sanford C. Bernstein's Ronny Gal. The news of the hold comes less than a month after Regeneron announced the up to $1.3 billion deal with Teva to codevelop fasinumab.

The two drugmakers now plan to discuss with the FDA a late-stage study for chronic lower back pain, excluding patients with advanced osteoarthritis. Fasinumab is also being tested for use in osteoarthritis-related pain. Rival drugmakers Eli Lilly and Co and

Pfizer plan by 2018 to seek approval for their similar treatment, tanezumab, which is being tested as part of a $1.8 billion collaboration. Regeneron has been attempting for years to develop an anti-NGF drug for pain, but has been stymied by safety concerns. The FDA had placed fasinumab and other experimental agents targeting NGF on partial clinical hold in late 2012, after reports that animals on the drugs had suffered nerve damage. The hold has since been lifted.

Reuters

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Roche advances skin cancer trials as part of combination therapy strategy Though the Roche studies are just getting off the ground, analysts said the news so far looks good

ROCHE IS pressing ahead with two skin cancer trials that combine its immunotherapy Tecentriq with other drugs after early data showed the treatments were well-tolerated and effective in a small number of patients, the company said. One study combined Tecentriq with Cotellic and Zelboraf in 30 patients with untreated BRAFV600 mutation-positive metastatic melanoma, the other Tecentriq with Cotellic for 10 patients with BRAF-wildtype and BRAF-mutant metastatic melanoma. Both now move into phase III late-stage pivotal trials.

After winning approval for Tecentriq earlier this year, first for bladder cancer and more recently for lung cancer, Roche is now trying it with other drugs in hopes that new combinations will result in potent weapons against cancer. Of Roche’s 50 immunotherapy

trials underway, 40 are with different combinations of medicines. "We are encouraged by these early results which demonstrate a high proportion of people responded to these investigational combination therapies," said Sandra Horning, CMO, Roche, in a statement.

Though the Roche studies are just getting off the ground, analysts said the news so far looks good.

“Even when the data they are presenting was taken from a sample of only a few patients, the efficacy without the use of any chemotherapy is certainly extraordinarily high,” Zuercher Kantonalbank analyst Michael Nawrath wrote in a note to investors. Other companies, including Bristol-Myers Squibb, are also pursuing immunotherapy combinations.

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Glucose tablets likely better for easing low blood sugar symptoms Neither dietary sugars nor glucose tablets reliably returned blood sugar levels to normal within 10 to 15 minutes, according to the research team WHEN PEOPLE with diabetes experience a dangerous drop in blood sugar, glucose tablets might be a better option than a sugary food or drink, a study suggests. People with diabetes can develop hypoglycemia, or low blood sugar, if they skip a meal, exercise harder than usual or take too much insulin or other diabetes medications. Low blood sugar can cause fatigue, anxiety, rapid heartbeat, sweating, mental confusion or even coma or seizures if not treated quickly. For a new study, researchers pooled data from four papers in the medical literature that compared the effect of dietary sugars and glucose tablets on relieving low blood sugar symptoms, including three randomised trials, which are generally the most reliable kind of medical study.

As reported in the Emergency Medicine Journal, the adults and children in the studies had type I or type II diabetes. All of them were awake throughout their episodes of low blood sugar.

Altogether, 515 low blood sugar episodes were treated with dietary sugar and 232 were treated with glucose tablets. Across the four studies, different forms of dietary sugars were used, including Skittles candies, orange juice, Mentos candies, jelly beans, cornstarch, milk and glucose gels. In general, the individual substances were about as effective as the glucose tablets for getting blood sugar levels to rise.

When results from all four studies were combined, neither dietary sugars nor glucose tablets reliably returned

blood sugar levels to normal within 10 to 15 minutes, according to the research team.

“Regardless of the oral (method) used to treat hypoglycemia, time is required for absorption before the measured blood returns to the normal range and the patient’s symptoms improve,” the authors said.

However, people who used glucose tablets seemed to feel better faster. Patients who used sugary foods were 11 per cent less likely to feel relief from their symptoms within 15 minutes. Glucose tablets are available in drugstores and online. Prices on Amazon.com range from about $5 for a pack of 10 tablets, to about $9 for a bottle of 50. “Although the results lean toward glucose tablets, everybody reacts differently to low blood sugar,”

FDA grants accelerated approval to Eli Lilly’s soft tissue sarcoma drug Soft tissue sarcoma refers to cancers that develop in muscles, fat, tendons or other soft tissues THE US Food and Drug Administration granted accelerated approval to Eli Lilly and Co's drug for treating adults with advanced soft tissue sarcoma (STS). Lilly’ s drug, Lartruvo, is approved for use with FDA-approved chemotherapy doxorubicin in STS patients who cannot be cured with radiation or surgery or who have a type of STS for which chemotherapeutic agent anthracycline is an appropriate treatment. Soft tissue sarcoma refers to cancers that develop in muscles, fat, tendons

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or other soft tissues.

The National Cancer Institute estimates that 12,310 new cases of STS and nearly 5,000 related deaths are likely to occur in 2016. The European Medicines Agency last month recommended conditional marketing approval for the drug in combination with doxorubicin in the European Union. Lartruvo has already been granted orphan drug status and breakthrough therapy status by the US health regulator.

Reuters

said Susan Renda, a certified diabetes educator at Johns Hopkins Comprehensive Diabetes Center who was not involved with the study. “We can’t say that this study controls for individual differences in low blood sugar, like measuring a patient’s glucose level or checking to see how they feel,” she told. “We don’t want to discourage people from using dietary sugars,” said study co-author Dr Jestin Carlson, an emergency physician at Saint Vincent Hospital in Erie, Pennsylvania.

“Glucose tablets seem to

work better, but if you’re using dietary sugar, that’s OK too,” he told. What’s most important is to treat low blood sugar right away, according to Renda. She said, “Whether it’s Skittles or glucose tablets, people should carry something with them at all times for whenever they feel a drop in blood sugar.” As of 2014, approximately 29 million Americans - about 9 per cent of the US population – had been diagnosed with diabetes, according to the Centers for Disease Control and Prevention.

Reuters

Merck’s antiviral drug meets main goal in late-stage trial MERCK & CO said its experimental drug to prevent cytomegalovirus infection in high-risk bone marrow transplant patients met its primary goal in a late-stage trial.

The trial evaluated the efficacy and safety of the drug, letermovir, for prevention of cytomegalovirus infection in adult recipients of a stem cell transplant. The drug was administered once daily, either in oral tablet or IV formulation, to patients and continued for about 100 days after the transplant. Cytomegalovirus is a member of the herpes virus family and remains a significant cause of viral infections in transplant recipients.

Reuters

RESEARCH

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US FDApanel narrowly backs Cempra’s antibiotic solithromycin Clinical trials showed a greater number of patients taking solithromycin developed elevated liver enzymes than those taking moxifloxacin THE EFFECTIVENESS of Cempra’s antibiotic to treat community-acquired pneumonia outweighs the risk of liver injury, an advisory panel to the US Food and Drug Administration narrowly concluded.

The panel voted 7-6 that the drug, solithromycin, should be approved to treat the kind of pneumonia that recently affected US presidential candidate Hillary Clinton. The FDA is not obliged to follow the recommendations of its advisory panels but typically does so. Panelists voted unanimously that the drug works as well as the potent antibiotic moxifloxacin. But most said the company had not fully characterised the potential risk of liver injury. Clinical trials showed a greater number of patients taking solithromycin developed elevated liver enzymes than those taking moxifloxacin. Elevated liver enzymes can be a sign of underlying liver damage. In Cempra's clinical trials the elevations were transient and there were no cases of acute liver injury. Even so, panelists recommended the company be required to conduct additional studies to further assess the potential liver risk after the drug has been approved.

"I feel we could wait if the bugs would just slow down," said Ellen Andrews, executive director of the Connecticut Health Policy Project. Solithromycin is descended from a notorious drug made by Sanofi SA called Ketek, or telithromycin.

Ketek was approved by the FDA in 2004 but later linked to dozens of serious or fatal liver problems. It was eventually discontinued. The Ketek episode prompted congressional investigations and accusations that the agency stifled concerns over the drug voiced by its own reviewers.

Agency reviewers stated that "there is a very clear signature of hepatic injury" in the solithromycin clinical trial data.

Solithromycin belongs to a class of antibiotics known as macrolides that include erythromycin, clarithromycin and azithromycin and are used to treat a wide range of bacterial infections. Roughly 50 per cent of the most common bacterium, the pneumococcus that cause chest and other infections, are resistant to macrolides, making the quest for new antibiotics pressing. Community-acquired pneumonia develops in people with limited or no contact with medical institutions or settings.

Reuters

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RESEARCH One Brand Total Solution

Study finds gene markers for drug-resistant malaria in Cambodia The emergence of piperaquine resistance in Cambodia has led to treatment failing altogether SCIENTISTS HAVE discovered genetic markers in malaria parasites linked to resistance to the key anti-malarial medicine piperaquine, and say their work could help doctors and health officials monitor and limit the spread of such resistance. In research published in the Lancet Infectious Diseases journal, the team also said a simple test using blood taken from a finger pinprick could show whether a malaria patient has parasites with the genetic markers - allowing doctors to prescribe an alternative treatment.

Resistance to piperaquine recently emerged in Cambodia and has led to the complete failure of malaria treatment there.

This and other spreading areas of drug-resistance are threatening global efforts to eliminate

the mosquito-borne disease.

Piperaquine is a powerful drug which is used in many parts of the world in combination with another anti-malarial drug called artemisinin. Resistance to artemisinin emerged around seven years ago in Southeast

Asia, but until recently the combination of the two drugs had successfully killed the malaria parasites there. Now, however, the emergence of piperaquine resistance in Cambodia has led to treatment failing altogether.

"These malaria parasites are now resistant to both drugs, and since they are no longer being killed, resistance to both drugs will spread," said Roberto Amato, who co-led the research at Britain's Sanger Institute. According to the World Health Organization, an estimated 200 million people worldwide were infected with malaria in 2015, and nearly half a million people died from the disease. The vast majority of those killed by it are children under five. Malaria is treatable if it is caught early, but growing drug resistance is becoming a major problem in many areas.

For this study, Amato’s team worked with Rick Fairhurst, a professor at the National Institute of Allergy and Infectious Diseases at the United States National Institute of Health,

and carried out what is known as a genome-wide association study to look at the genetic basis behind piperaquine resistance. They looked at around 300 samples from Cambodia, analysing thousands of variations in the DNA sequence of the parasites and comparing these across samples with different levels of resistance to piperaquine.

“By studying the genomes of these parasites we found two genetic markers that are linked with piperaquine resistance," Amato said. "Not only can we now use these markers to monitor the spread of the drug resistant malaria, they will also help towards understanding as much as possible about the biology and evolution of the (malaria) parasite.”

Reuters

Adverse events in trial dent hopes for Roche haemophilia drug The problems relate to thrombosis with two thromboembolic events and two cases of thrombotic microangiopathy in patients FOUR PATIENTS have suffered serious adverse events in a clinical trial of an experimental haemophilia medicine from Roche, the Swiss group said on Wednesday, clouding prospects for its potential blockbuster product. The problems relate to thrombosis, or blood clots, with two thromboembolic events and two cases of thrombotic microangiopathy in patients who were being treated for breakthrough bleeding in the trial of Roche's ACE910. Roche said additional monitoring had now been instigated in the study.

The drugmaker is hoping to win a slice of the $11 billion-a-year haemophilia drug market with ACE910, which represents a threat to more traditional treatments from Novo Nordisk and Shire. Deutsche Bank analyst

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Richard Parkes said the problems suggested that patients were still experi-

encing breakthrough bleeds despite getting ACE910, cutting the chance that

ACE910 was so effective as to abrogate all bleeding risk. “We view the news as the first blemish on ACE910's profile,” he said.

A Roche spokesman said the cases involved patients with breakthrough bleeding who were treated using one of two so-called bypassing agents. He added that both agents -- Shire's FEIBA and Novo's NovoSeven -- carried thrombosis warnings. Haemophilia patients, whose blood does not clot properly, need life-saving infusions of clotting factors, but development of inhibitors in many of those being treated can interfere with efforts to control their bleeding. Roche's ACE910, also known as emicizumab, is being closely watched because it could change the way the disease is treated.

Reuters

RESEARCH

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FDAhighlights liver safety issues in Cempra drug review Solithromycin would be the first oral and intravenous antibiotic for community-acquired pneumonia since moxifloxacin in 1999 CEMPRA’S EXPERIMENTAL drug to treat communityacquired pneumonia, the kind recently suffered by presidential candidate Hillary Clinton, causes a potentially concerning rise in liver enzymes, according to a preliminary review by the US Food and Drug Administration.

The review, posted on the FDA’s website, comes two days ahead of a meeting of outside experts who will discuss the drug, solithromycin, and recommend whether or not it should be approved. The FDA is not obliged to follow its advisory panel’s advice but typically does so. “A significant safety signal for hepatotoxicity was observed in the solithromycin development programme,” agency reviewers noted. Another area of concern, they said, was “the high rate of infusion site-related reactions.” Solithromycin is descended from a notorious drug made by Sanofi SA called

Ketek, or telithromycin, which was approved by the FDA in 2004 but later linked to dozens of serious or fatal liver problems and largely withdrawn.

Cempra constructed the same drug but without the elements it believes were responsible for the side effects associated with Ketek, which included visual, neurological and liver problems. The company is seeking approval for an oral and intravenous version of solithromycin. Clinical trials show solithromycin to be as effective as the antibiotic moxifloxacin, the FDA said in its review, but rates of liver enzyme elevations were higher in patients treated with solithromycin than with moxifloxacin. High liver enzymes can be a signal of an underlying liver problem, especially if they remain elevated.

In the Cempra trials enzyme elevations were transitory. Patients did not develop

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clinical symptoms of liver problems, such as jaundice, and there was no evidence of acute liver damage. Nonetheless, the FDA is likely to be especially cautious as the Ketek episode was scarring for the agency. It prompted Congressional investigations and accusations from FDA insiders that the agency

stifled concerns over the drug voiced by its own reviewers and dismissed suspicious clinical data that was later shown to be fraudulent.

"We think the institutional memory of Ketek will force the division into a highly conservative and defensive stance on solithromycin’s safety profile," Ritu Baral, Analyst, Cowen and Company, said in a recent research note. Even so, she said, “We believe the agency would respect what we see as a likely positive panel vote for approval.” Solithromycin belongs to a class of antibiotics known as macrolides that include erythromycin, clarithromycin and azithromycin and are used to treat a wide range of bacterial infections. Roughly 50 per cent of the most common bacterium, the pneumococcus that cause chest and other infections, are resistant to macrolides, making the quest for new antibiotics pressing.

The advisory panel will be asked to assess whether the efficacy of solithromycin in treating infections that kill more than 50,000 people a year in the US outweigh a potential risk of liver toxicity. “Although we expect a positive vote and approval, potential adverse outcomes for Cempra include a request for a large safety trial to further characterize risks,” Alan Carr, Analyst, Needham & Company, said in a research note.

If approved, he sees the drug generating peak worldwide sales of $2 billion. Pharmaceutical companies have been slow to develop new antibiotics. Solithromycin would be the first oral and intravenous antibiotic for community-acquired pneumonia since moxifloxacin in 1999. Since then several oral-only or intravenous-only drugs have been developed.

Reuters

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RESEARCH One Brand Total Solution

Zika causes infertility, lasting harm to testes in mice: Study Researchers found that Zika infects and kills Sertoli cells, which maintain the barrier between the bloodstream and the testes and foster sperm growth A STUDY of mice infected with Zika showed the virus caused lasting damage to key cells in the male reproductive system, resulting in shrunken testicles, lower levels of sex hormones and reduced fertility, US researchers said. So far, the findings are only in mice, but the result is worrisome enough to warrant further study because of possible implications for people, said Dr Michael Diamond of Washington University in St Louis, whose research was published in the journal Nature.

“It has to be corroborated,” Diamond, a professor of pathology, immunology and molecular microbiology, said. Much of the global effort to fight Zika has focused on protecting pregnant women from infection be-

cause of the grave implications for their unborn children. Zika infections in pregnant women have been shown to cause microcephaly, a severe birth defect in which the head and brain are undersized, as well as other brain abnormalities. Previous studies have shown that Zika can remain in semen for as long as six months. But little is known about whether prolonged exposure to the virus in the testes can cause harm. To study this, Diamond and colleagues injected male mice with Zika. After a week, the researchers recovered infectious virus from the testes and sperm, and they found evidence of viral genes in certain cells of the testes. But overall, the testes appeared normal

compared with other lab mice.

After three weeks, however, the differences were stark. The testes in the Zika-infected mice had shrunk to a tenth of their normal size, and the internal structure was destroyed. “We saw significant evidence of destruction of the seminiferous tubules, which are important for generating new sperm,” Diamond said. The researchers also found that Zika infects and kills Sertoli cells, which maintain the barrier between the bloodstream and the testes and foster sperm growth. Sertoli cells do not regenerate.

That raises the specter of long-lasting damage. “The virus is infecting a site which doesn't really renew if it gets damaged. That is the problem,”

Diamond said. Tests of testicular function showed sperm counts, sex hormones and fertility had dropped. Infected mice were four times less likely to impregnate a healthy female mouse than healthy males.

“This is the only virus I know of

that causes such severe symptoms of infertility,” added Dr Kelle Moley, a fertility specialist at Washington University and a study co-author.

There is no vaccine or treatment for Zika.

Reuters

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RESEARCH

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Injectable birth control for men holds promise,risks remain The study had to be stopped due to safety concerns INJECTING MEN with two different hormones every eight weeks suppressed their sperm production enough to act as birth control, according to a new study. The study had to be stopped due to safety concerns, however. An independent safety board found that side effects, which included depression and other mood disorders, outweighed the potential benefits of the injections. "Researchers are trying to identify a hormonal male contraceptive that is effective, reversible, safe, acceptable, affordable, and available," the study's technical team wrote to Reuters Health.

The researchers, led by Dr Hermann Behre of Martin Luther University of Halle-Wittenberg in Germany, recruited 320 healthy men ages 18 to 45 from several countries. All had been in monogamous relationships for at least a year with women between 18 and 38 years old. The couples did not want to get pregnant within the next two years.

Every eight weeks, the men received injections of long-acting testosterone and progestin. "Giving testosterone in high doses suppresses sperm production in the male reproductive organ or the testes over several weeks," according to the researchers. Adding another hormone, "usually a progestin, helps increase the suppression of sperm production to lower levels, in more numbers of men," they continued. “It will also help to sustain it, so that injections may be given less frequently.”

In 274 men, or 86 per cent, sperm counts dropped to the target of less than 1 million per milliliter of semen after 24 weeks. Normal sperm counts range from 40 to 300 million per milliliter, according to the National Infertility Association. Four pregnancies occurred among 266 couples over 56 weeks of follow up, the researchers report in the Journal of Clinical Endocrinology and Metabolism.

The failure rate of this form of birth control was 7.5 per cent, they found.

The US Centers for Disease Control and Prevention says male condoms have a failure rate of 12 per cent. In women, birth control pills, patches and rings have a failure rate of about 9 per cent. Failure rates are below 1 per cent for female implants and intrauterine

devices and sterilisation surgeries in both men and women.

Nearly 1,500 adverse events were reported during the study. About 39 per cent were not related to the injections, however. Of the side events thought to be related to the injections, about 46 per cent of men reported acne, about 23 per cent reported injection site pain, about 38 per cent reported an increase in libido and several reported mood disorders, including emotional disorders,

Of the side events thought to be related to the injections, there were reports of acne, injection site pain, increase in libido and several reported mood disorders, including emotional disorders, hostility, depression and aggression hostility, depression and aggression.

In addition to safety concerns, there are other unknowns about this approach to birth control, said Dr Landon Trost, who is head of andrology and male infertility at the Mayo Clinic in Rochester, Minnesota. For example, in most participants, sperm production rebounded after the injections stopped - but the study only include men with health sperm counts. “What we don’t know is how it affects men without healthy sperm counts,” said Trost, who wasn't involved with the new study. It's important to realize, he added, that this form of birth control - unlike condoms - would not protect against sexually transmitted infections or disease.

Reuters

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CPhI & P-MEC INDIA 2016 SPECIAL I N T E R V I E W

‘We are working on several projects that will result in some revolutionary film coating products’ Suresh Pareek,MD, Ideal Cures, elaborates on his company's offerings for the pharma sector, its growth strategies and his expectations from CPhI 2016, in an interview with Viveka Roychowdhury What have been the dominant trends in pharma excipients and film coating systems in 2016?

Quality, service and supply excellence are pre-requisites to be a vendor to the pharma industry. The major trend has been responding to reducing supply risk. As a result, there has been an increase in qualification of alternate excipient vendors who have the right credentials such as cGMP manufacturing with ISO and EXCiPACT certification by discerning pharma manufacturers.

What have been the major drivers of these trends?

There are obvious drivers such as supply chain security to reduce dependence on monopolistic suppliers and encourage healthy competition. The not so obvious one is to limit the proliferation of 'fighter brands' by dominant players who are moving the goal post citing cost and service standard differences to retain profit margins and hoodwink the pharma industry as it is detrimental to the industry since it promotes two-tier pricing and perception of quality. By developing alternate vendors, the dominant companies will have to compete with the premium brands at the right price.

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This is actually a great service to the domestic and unregulated markets which will have access to the premium brands on par with products for the regulated markets. At Ideal Cures, we believe that all the seven billion people on this planet are first class citizens and should have access to first class medicines so we promote our first class brand 'Instacoat' for all markets.

What have been the most recent additions, line extensions to Ideal Cures' range?

Ideal Cures was the first film coating company to launch the highest productivity coating 'Instacoat 4G' in the world and we have recently fine-tuned our offerings with specialised coatings for better colour stability and talc free/peg free coatings.

We are also expanding our wet dispersion offerings. We are currently working on several projects that will result in some revolutionary film coating products.

The company already has an office in the US, what are the growth strategies for this market?

The US is the largest pharma market and one of the most regulated as well. There are several players already in this market, however, a dominant one has contracted

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At CPhI India 2016, we plan to showcase our differentiating set of best-in-class products, pre-arrange meetings with our key customers, introduce them to our international colleagues as well as entertain the random footfalls majority of the fully formulated coating business and that makes the customers very uncomfortable.

While looking for alternatives these customers are reluctant to partner with the other dominant players as they have a large exposure to them as well for other products. In fact, many have approached us directly to support them for their new applications knowing fully well that in the short term we will be supporting them by supplying products from India. Generic companies who have filed ANDAs with our products from India are comfortable with sourcing from India whether the final formulation is made in India or the US. After all, there are so many ingredients that are imported by the pharma companies in the US. There is also the large inhouse market of large and small players which is waiting to be tapped as they find the cost of the fully formulated suppliers either too expensive or the supplier too arrogant to support and supply to the so called “segmented small customers.� In any case, we are fully aware as have been the Indian pharma industry that we need to be local in the US. We have a business plan in play and have some options on how we will enter the market. Now, all we can say is that our strategy will be unique and we want you to watch this space.

Ideal Cures has been a regular participant at CPhi Worldwide, how was the experience this year?

Over the years, CPhI Worldwide has grown tremendously. It started off small to become what it is today. At CPhI Worldwide, you can network with thousands of pharma industry companies and professionals from more than 150 countries across the world in one place over three days.

Not only is it a convenient way to further business with existing customers and suppliers but also an opportunity to source new suppliers,

build new relationships, identify new business opportunities, getting introduced to new products and business ideas. In the past it functioned as a typical B2C exhibition where buyers and suppliers turned up and met in an ad hoc fashion. It has now evolved into a true B2B convention with many prearranged meetings which dominated our interaction with the customers in contrast to dependence on random footfalls of the past.

On the domestic side, you are adding a fourth manufacturing unit in Sikkim, in addition to the three existing plants in Vasai, Jammu and Khambat along with two modern R&D facilities at Mumbai and Vasai. At what stage is the plant construction etc.?

Our plant construction is on schedule to commence operations before March 2017.

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We expect to inaugurate it in late January or early February of 2017.

What are the expectations and strategies for CPhI India 2016?

At CPhI India 2016, we can expect to continue the networking style and opportunity that is presented at CPhI worldwide. This one tends to be regional and we have customer intimacy being an Indian company which we will leverage. We plan to showcase our differentiating set of best-in-class products, pre-arrange meetings with our key customers, introduce them to our international colleagues as well as entertain the random footfalls. The end game for us is to increase our business opportunities in the region through customer delight. We know our customers have choices and we want that choice to be us because we offer ease of business.

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CPhI & P-MEC INDIA 2016 SPECIAL One Brand Total Solution

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‘Mack Pharmatech is all set to spread its wings in international markets’ Dr Kiran Badgujar, Founder and Director, Mack Pharmatech, talks about Mack Pharmatech’s services to the pharma industry in a discussion with Sachin Jagdale

Take us through the journey of Mack Pharmatech.

The journey has been exciting so far. Mack Pharmatech produces technologically most advanced products for India’s dynamically evolving pharmaceutical sector. We started with very humble beginning in the year 1999 with a team of two visionaries, Founders and Directors, Manoj Chaudhari and Dr Kiran Badgujar. Our company is now a remarkable player and a trend setter in the industry.

Mack Pharmatech has always been in the forefront when it comes to develop something absolutely new, that too keeping up with the stringent requirements of the regulating authorities. We were the first manufacturers who acquired the “European CE Certification”. All our machines and equipment are ‘CE’ Certified. It’s a standard feature of our products, irrespective of whether it is produced for the Indian market or for exports.

‘PLC-based controlled system’ is a concept we brought into reality when the pharma industry was looking for automation in environmental chambers. Mack Pharmatech introduced and successfully launched a US based PLC: ‘Allen Bradley’ in the Indian market.

Technology always has been our forte. “21 CFR Part 11 Compliant Software” is one of the key features when it comes to Mack Pharmatech machines.

What initial challenges did you come across when you

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‘PLC-based controlled system’ is a concept we brought into reality when the pharma industry was looking for automation in environmental chambers. Mack Pharmatech introduced and successfully launched a US based PLC: ‘Allen Bradley’ in the Indian market

were new into the business?

We started as a team of two, and got into servicing of already installed equipment in pharma companies. It was only after we gained enough experience and confidence, we ventured into production of environmental chambers under ‘Mack Pharmatech’ brand name. As we started right from the scratch, we had to learn everything from purchasing, production, accounting, marketing etc,. We were absolutely sure and confident, that we can make a difference-

for better, as we definitely knew what the market exactly wants which the existing players were unable to serve them . It was the focus, determination and hard work of our team to accomplish our vision and mission that kept us on our path for excellence.

How are your products cost effective?

We actually are premium priced, but our products are ‘fully loaded’, i.e. for all the critical functions we have a stand-by installed in case of

CPhI & P-MEC INDIA 2016 SPECIAL

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failure of primary. Plus, there are no hidden costs, whatsoever. As in our products we use all critical parts the best in its class and are very reliable and genuine. We are transparent to our clients when it comes to pricing and costing.

What sets you apart from your competitors?

Innovation and technologically advanced products with an assurance of best in its class service set us apart and we have carved a niche for ourselves.

What are your growth plans for the next three years?

We are focusing on spreading our wings internationally and are eying on expanding in geometric progression year on year for the forthcoming three to five years.

Are there any new products in the pipeline?

Recently, Mack Pharmatech has launched “DAAS 3.0” : the most advanced version of our software, successfully in keeping up with our promise to evolve continuously for more user friendly products and software. DAAS 3.0 is being welcomed by industry stalwarts with great enthusiasm. In recent times, ‘data’ and ‘data integrity’ are the key words, it is all the more important for the users to acquire and safeguard more data as the regulators are raising questions regarding the same. To get and save more of the vital key data at the very place it is generated, Mack Pharmatech has launched a path breaking new age HMI in our machines for the users who have this specific requirement.

This new HMI is capable of storing 4 GB of data in the PDF Format, which can be transferred to a server/PC which is connected via ethernet, or you can take a backup using a USB drive or a SD Card. With this kind of capacity this HMI itself can store a data of about 4 to 5 years! This HMI is capable of providing direct printing facility right from the very equipment. You can connect a

printer and have the printouts.

This new development has powered the users with a 'trouble free' and 'headache free' operations. These technological advancements over a period of time in quick succession helped Mack Pharmatech to propel itself to win new projects and create our loyal and satisfied customers in India and abroad.

Do you have any developments to share on the international front?

Mack is all set to spread its wings in international markets.

We’re completing few big projects in international markets. Our satisfied Indian

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customers have generously recommended us to their foreign counterparts. It’s Mack’s pan India experience to serve and satisfy customers that has done the trick to help us win clients in the overseas markets as well.

Tell us about your after sales service Mack has industry’s most respected service team stationed all across India in our service centres 24*7. Our team of qualified professionals are on a mission to provide a seamless service to our esteemed customers to avoid downtime resulting from failures. Our local service centres are

equipped with all the critical spares to address any and all faults and failures in our machines. We have a capability to correct the situation in stipulated time, so that neither the user nor the management need to have sleepless nights and or burn midnight oil about the consequence of break down. Such after sales services have taken us from a small player to a formidable force in market.

You are also the Founder and Director of Mack Auraa. Tell us more about this venture.

Mack Auraa was established in 2012 with a vision to serve Indian pharma industry with

products which are vital for a pharma companies' labs. We even customise these products as per customer's need. With a vast experience and expertise in pharma machinery I have managed get these specialise lab equipments manufactured to serve demand of specific needs of specific customers.(viz. Autoclaves etc.)

Mack Auraa has carved its niche for itself in pharma industry and is regarded as a dependable and reliable partner for its clients. It is this dedication and loyalty towards the customers and vendors, Mack Auraa is paving its way towards success. sachin.jagdale@expressindia.com

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‘Serialisation needs careful assessment’ Pradeep Dhargalkar, HeadPackaging Development, Unichem Laboratories, talks about the implementation of serialisation and challenges to pharma companies, in a discussion with Sachin Jagdale

How did your company approach the serialisation project? Can you outline 10 steps to get started with serialisation?

In the adoption of global track and trace regulations to protect patient safety and ensure product integrity, serialisation is common across most adopted regulations.

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10 steps to get started with serialisation are: ◗ Create reusable serial number generation profiles for all product types, logistical units (item, case, bundle, pallet) and market destinations ◗ Support global standard and country-specific formats to create GS1 standard formats (SGTIN, SSCC) ◗ Generate custom formats

for places like Brazil and import custom formats ◗ Manage and monitor allocations automatically for all packaging codes by defining serial number creation rules for request limits, minimum thresholds, uniqueness checks, randomisation requirements ◗ Establish a common interface to capture and respond to provisioning

requests from internal packaging sites and external CMO/CPO partners using dozens of diverse line management systems ◗ Manage serialised inventory operations such as product movement capture or pharmaceutical product aggregation changes across plant and warehouse operations whether they are internal

locations or executed at CMO or 3PL partner locations ◗ Trigger compliance activities resulting from serialised product events to meet traceability data exchange or government reporting requirements. ◗ Manufacturers, wholesale distributors, dispensers and repackagers must pass, capture and maintain certain

CPhI & P-MEC INDIA 2016 SPECIAL

It requires significant investment to validate the packaging line, beyond process and equipment validation.

Managing and administering serialisation is a complex process that leads to additional cost if not managed properly

information with respect to each transaction ◗ Emphasis should be on lot-level info (vs. SNI or unit) ◗ Now ‘pedigree’ or ‘product tracing’ requirements are triggered by changes in ownership (or transactions) between trading partners Were there any gaps in the implementation process that showed up in the pilot testing phase? Could you share the learnings and how your company went about setting it right?

Serialisation addresses several challenges facing supply chain security in today’s global marketplace: ◗ Controlling and monitoring a highly complex distribution network from manufacturers to consumers in which products change hands as many as 10 times ◗ Authentication of the product at various levels in the supply chain becomes very difficult without data sharing across the supply chain ◗ Current business processes are very labour-intensive and, as a result, the price paid by the consumer for pharma products is high ◗ The high price of prescription drugs and the relative ease of duplication and diversion make them a prime target for counterfeiters.

What are the issues faced by project leaders in terms of training staff, etc? Does India have skilled talent at these levels on the packaging lines, software IT departments?

Serialisation needs careful

assessment, diligent planning and swift implementation. This white paper offers pharma company’s critical information on leveraging global best practices when implementing serialisation.

Serialisation involves optimum utilisation of existing technologies/machineries.

Employees must be trained to handle the new equipment.

What are the implications of a serialisation project in terms of line and plant level software?

It requires significant investment to validate the packaging line, beyond process and equipment validation.

Managing and administering serialisation is a complex process that leads to additional cost if not managed properly.

Key operational challenges include: ◗ Creation of unique serialisation codes for individual products during the production process ◗ High-speed printing and verification of the codes generated What should a company keep in mind when preparing for and rolling out the pilot testing phase?

Most companies are just evaluating how they want to move forward.

Serialisation will force packagers not only to upgrade manufacturing Execution Systems (MES) but to integrate new hardware and software with serialisation and traceability and back office Enterprise Resource Planning (ERP) systems, responsible for managing serial numbers and business data sent to the packaging line. sachin.jagdale@expressindia.com

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‘Any and every pharma company will be our client sooner or later’ HVAX Technologies is a turnkey solution provider to build infrastructure for all kind of pharmaceutical applications. Prayagdatt Mishra, MD, HVAX Technologies, reveals more to Sachin Jagdale Which products do you offer for the pharma industry?

HVAX is a turnkey solution provider to build infrastructure for all kind of pharmaceutical applications. Any pharma plant which has to be constructed or upgraded needs specific infrastructure considering the product / process demands and regulatory demands. When we say specific infrastructure, it includes the building layout with man and material movement flow plans, size of the areas as per machines and production capacities in target, unique utilities required to operate the machines like power, water, gas, compressed air etc., environment and contamination control as per clean room requirements, air pressure balancing across the rooms as per process, selection of machines, electrical power distribution and instrumentation controls for automation, lighting, fire and safety norms and instruments, lab equipment and furniture etc.

At HVAX, we provide a complete package from concept design to execution for all above and even more as required by the particular project / product in consideration.

How are your products important to the pharma industry from the regulatory point of view?

For any process industry, the factory / plant infrastructure is very important to achieve the quality and quantity of production. A correct balance between inventory and

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We strongly believe that any decision or action is right only if the same is done within the right time. Hence we give equal importance to the timely completion of the project. This combination of technocommercial approach with scheduled commitments give us a different stand and respect in the industry.

dispatches needs to be taken care of while designing the layouts. Also, from a regulatory point of view, pollution control, safety norms, material handling and pharma being a consumable product for all mankind, the FDA regulations play a vital role not only for quality control but also for all the national and international plant audits. At HVAX, our expert team takes extreme care to make the concepts in such a way that all the regulatory demands are fulfilled and the plant user team may maintain the same for a long time

without any efforts.

With many competitors already present in the market how would you like to project your products for your clients?

Being a project or turnkey solution provider company, we know that a client is putting a lot of trust and money on our skills as the infrastructure works done cannot be rectified easily for any shortcomings.

Hence, we have taken extreme care to develop our team to handle different verticals of a project with technical and commercial optimisation.

How do you manage to strike a balance between quality and the cost of the product?

HVAX, being a project company, is basically an application engineers’ team. So we take enough care to apply new technologies to improve quality. Also, the balance between capital investment and savings on running cost of a plant is always in centre while we do all the value engineering for any project.

Today, across the world all the engineers are striving to develop technologies which may save fuel and power. We proudly see ourselves as a part of the global engineering team working for a better tomorrow.

Who are your clients in the pharma industry?

Any and every pharma company will be our client sooner or later. As on date to name a few, our existing clients are Patanjali, Divis, Alembic, Nutricia, Sava Global, Lanxess, Biocon, Sandoz, Alkem, Akzonoble, Navin Flourine , Aarti Industries and many more.

Do you export your products?

If yes, what percentage of

your revenue comes from the overseas market? What is your market share in India in your respective product categories?

Yes, we design and execute the complete turnkey projects abroad. Nearly 40 per cent of our income is from exports, which is likely to grow in the coming years. Currently, we cater to countries like Africa, Asia, the Middle east and CIS countries.

Tell us about your after sales service.

Although all the capital items are covered with 12 months warranty, we always target to take extreme care to avoid any complaints of break down. Still in case if we come across any such issue, we have made arrangements by keeping dedicated team whose primary responsibility is to attend the issue and preventive maintenance for some applications in free time.

Are there any new products in the pipeline?

We are working on quite a few technology-driven services which would enhance the quality of many products currently used.

What are your future growth plans?

In future, we intend to be a major player by offering turnkey cleanroom solutions in India and abroad. We wish to offer technology-driven solutions to the industry. sachin.jagdale@expressindia.com

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‘Globally many large pharma companies have implemented a holistic digital strategy with Veeva’ Doug Etzel, GM – Japan, China, APAC, LatAm, Veeva speaks on the need for pharma companies to adopt a sound digital strategy and the role Veeva can play in helping them traverse their digital journey, to Viveka Roychowdhury Where do Indian pharmaceutical companies stand when it comes to adopting digital tools, compared to their counterparts in other Asian and global markets? India prides itself on being one of the IT super powers but has the life sciences sector lagged other sectors? How does Veeva help them understand

and implement such solutions?

Indian pharma companies are working their way through digital at this moment and trying to see how best they can enhance their customer engagement using technology.

Take a closer look at the top 50 Indian companies and you will see increasing adoption of technology over the last couple

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of years – tablets for daily reporting and detailing, mobile apps, email marketing, webinars, online meetings, web portals, and much more to increase physician engagement. However, companies are realising that this is currently a fragmented approach with multiple digital initiatives and owners. This was the problem faced by

companies in the West about 10 years ago. The real power of digital is realised when the representative is able to orchestrate his calls with the usage of right digital channels for the right customer in a single robust platform.

Pharma companies now realise the need for a customercentric strategy. While the need to adopt is not found across the

industry, there are leaders who are building internal capability to respond in the ‘digital first world’ in a structured and integrated fashion with a combination of digitally enabled representatives and building multichannel capabilities.

Pharma companies in India are at various stages of the digital journey. The broader

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question is not ‘Why’ digital but ‘How’ to get digital right. We work with our customers closely to define how technology can help them with their business goals. Our customers now realise that with Veeva they have access to the best platform to deploy a multi-channel strategy.

channels. With that success, they will now add new Veeva Commercial Cloud applications as part of its ongoing programme to transform customer engagement globally.

When the roll out is complete, GSK will have deployed Veeva’s solutions to 90 countries globally, including India.

Across the world, regulators are cracking down on the ‘pharma-physician nexus’ with regulations like the Sunshine Act in the US. India’s code for pharma marketing practices is still voluntary but how do Veeva’s systems address these compliance concerns?

Governments across the world are setting compliance norms for pharma marketing practices. India too has a marketing code. Though there are guidelines currently, soon it is likely to be passed as a law in the next few years. When you have multiple systems/ processes where you capture physician-pharma interactions it is difficult to execute, track and report on compliance.

Veeva has solutions which will help pharma companies report to authorities in terms of engagements and spend across these interactions and stay compliant.

Implementing a digital strategy requires investment in systems, processes, training etc. How does Veeva help on this front?

Veeva is a great combination of product and people – they are the strong pillars that help our customers move forward.

As for the product, customers know that Veeva is an appreciating asset and they will always benefit from Veeva’s innovation to deliver new features, enhancements and usability improvements.

Custom-developed software is a depreciating asset, the longer it is there, the more it costs to maintain and enhance.

Customer success is one of our core values. Our people work with customers right from the time they think digital strategy, understand their business problems, deploy a high-value solution and train their teams. Our model ensures that our customers achieve their business goals with Veeva.

Could you give us an idea of the RoI benefits of Veeva Systems’ products and services in terms of improved marketing of medicines, better and more complaint engagement with the medical fraternity, faster time to market, etc?

Veeva’s commercial cloud addresses the need to have an orchestrated execution model, a hybrid model with representatives and other digital channels with real-time data at the hands of the representatives and the headquarters. It provides an ability to execute and manage representatives-physicians interactions and usage of multiple channels like (portal/email/webinars) from a single platform keeping physician at the centre of all activities. Veeva’s online and

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offline tools help the field team capture data from any location at any time, whilst giving realtime visibility to the managers and sales leaders for monitoring progress.

Veeva allows the team to not just report but also speeden up the response to customer requirements. What it means for the sales teams is that you don’t have to wait six months to send out newer/more relevant content to the physician, you stay current and updated.

That’s bringing a level of customer focus to the pharma industry. With a ‘single source of truth’, pharma companies can strategise more effectively, and at the same time the field team can have meaningful interactions with the physician.

The biggest advantage with the upcoming regulatory and compliance guidelines is that pharma companies can now roll-out approved content using compliant systems, be it any channel, through any representatives from even the remotest area of the country.

They will also be able to report

to authorities without going through multiple systems and databases.

In May this year, Forbes ranked Veeva as the fourth fastest growing public tech company and the company is targeting the $1 billion mark by 2020. Which are the services and products fuelling this growth? Which geographies are your biggest markets?

Veeva’s ranking signifies the growing importance of industry cloud – a new breed of specialised cloud solutions that are tailored to meet the needs of a particular industry. Veeva’s industry cloud solutions are specifically designed to help life sciences companies achieve their most pressing strategic objectives in bringing drugs to market faster and more efficiently, marketing and selling them more effectively, and maintaining compliance with government regulations.

Veeva’s growing base of 400+ customers spans all regions. Of course the US and Europe are

key markets, but life sciences is truly a global industry. Veeva has a rapidly growing customer base in India, China, Japan and other parts of Asia as well as Latin America.

Pharma companies have been using digital solutions in silos. In your opinion, which MNC pharma companies have been pioneers, early adopters in implementing a holistic digital strategy through Veeva or other players?

Globally, many large pharma companies have implemented a holistic digital strategy with Veeva. GSK is one good example. GSK, one of the world’s leading research-based pharma and healthcare companies, is deploying Veeva CRM globally as part of its ongoing programme to transform customer engagement. GSK has seen a tremendous progress with Veeva CRM in delivering more informed, tailored interactions with their customers across many touch points and

Veeva Systems was founded in 2007 and entered the India market around a year back but you already have some strong MNC customers who have implemented your CRM solutions, as an extension of their overseas parents. How was the Indian roll out different and what were the challenges?

The Indian market, like any other markets, has its own nuances. Given the large field force, the traditional model has been to ensure that representatives’ tour plan (for a cycle) is firmed up to enable execution. Recency and Frequency metrics were the key KPI's i.e when and how many times a representative met the physician. Hence, you will find systems in India which help execute that strategy. i.e

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tools/systems which have the capability to ensure that a medical representative’s tour plan is prepared and approved, a daily activity reporting (DAR) platform for daily reporting, tools to track that expenses are recorded, incentive compensation, sample management etc.

These are rep management tools to track and monitor rep activities than a CRM Solution. While companies are trying to be customer-centric we find solutions to be more administration focused.

With Veeva, the whole paradigm has changed. We are bringing customer to the centre of the execution model. We are looking at capturing rich information as the execution happens in

Our current focus is the commercial suite of solutions which help pharma companies build a strong CRM platform and digital channels to engage effectively with their audience the physician’s office and not at the end of day. Also, with the advent of newer ways to engage email, portals, video calling etc., the system needs to be a combination of Rep + Digital interactions. This requires buy in from the leadership teams on both the sales and marketing teams to realise the value of Veeva. We are engaged with industry leaders to help them realise that Veeva is not a replacement of old systems but a new way to engage with the physicians.

Veeva is a comparatively late entrant to the market in India so what is the differentiator? What is the strategy for growth? What are the products being launched first? What is the target revenue from India? How many customers are you targeting as early adopters? Can Indian companies leapfrog some of the legacy issues?

Although it may seem that Veeva is a late entrant, we believe we are in the market at the right time. Now, companies are looking to leverage digital not just as a project but as a strategy. We have seen in the last two to

three years, across top 50 companies, there is an increasing investment in devices i.e. tablets for medical representatives and increasing use of digital channels. Some of the organisations have digital leaders in place.

Our current focus is the commercial suite of solutions which help pharma companies build a strong CRM platform and digital channels to engage effectively with their target audience.

We are working with some of the top MNCs and domestic customers in India to deploy Veeva CRM. In the next few years, we will launch our suite of solutions, which will help pharma companies manage their clinical, regulatory and quality processes.

Indian companies traditionally have invested in Sales Force Automation (SFA) solutions, mostly on a mobile phone or on the web. The other investments have been the project centric way of investing in digital channels. Hence, there is little in terms of legacy issues that they have to deal with in the West. We think some firms in India have the opportunity to deploy industry cloud applications quickly, and perhaps even ‘leap frog’ firms in other markets who are burdened with these legacy technologies.

What has been the feedback from existing customers in India since its launch? Being a highly regulated and competitive industry, there are concerns about data safety, so how do industry-specific cloud systems take care of this risk?

Customers are excited to see how Veeva can help them in their digital journey.

We had a great customer event in Mumbai with leading pharma companies attending and deliberating on the possibilities digital offers the industry. In an industry survey conducted by us revealed that around 60 per cent of respondents feel that there will be increased digital adoption in the next one to three years and companies are looking at transforming their ‘silo’ based approach. We foresee Veeva playing a significant role in their transformation journey.

Data security is paramount for Veeva and our customers. Veeva protects customer data with world-class physical, network, application, and datalevel security. Veeva maintains a comprehensive security programme based on ISO 27001 to ensure confidentiality, integrity, and availability of customer data.

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viveka.r@expressindia.com

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Optel Vision scales up its global manufacturing capability with India operations Shaunak J Dave, Asian Market Director, Optel Vision in an interaction with Viveka Roychowdhury, talks about Optel Vision’s focus for the Indian pharma market What has been Optel Vision’s experience in the Indian pharmaceutical sector? Are companies up to date with global norms and trends?

Since last 27 years, Optel Vision has been serving the global pharmaceutical industry with its vision inspection systems and global track and trace solutions for pharma packaging lines. The core business objective is to enhance patient safety, to increase product, packaging line and supply chain integrity and to combat against global counterfeit. Optel Vision had limited number of installations in Asia - Pacific region erstwhile (prior to 2011).

For our Founder Group President, Louis Roy, India had always been an attractive market to explore.

India, being a global manufacturing hub for generics (contributing 20 per cent of global generics business) along with a big number of US FDA/MHRA approved plants, double digit industry growth and a large pool of skilled engineers, is our key preferred market in the Asia Pacific region. We believe that the Indian pharma market has a huge potential, which is largely volume-driven, focused on cost competitiveness and backed by ‘make it happen’ attitude of highly skilled people.

Being a North American company, coming to India was a big challenge. The key challenge was to change the perception of Indian customers in terms of affordability, acceptability and meeting India-specific requirements (which are truly global, as India exports to more than 200 countries). Optel Vision adopted an India-specific

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business model and created a service network in more than 13 cities which is backed by highly skilled, customer-centric support team. This was the reason for our exponential growth in India.

How are Indian pharma companies coping with the Drug Supply Chain Security Act (DSCSA) deadline of November 27, 2017?

What we have observed that global multinational companies who have their plants in India, are fully aware and well structured to meet the DSCSA requirement. One of the reason being that their global serialisation team has been working on this project for the last 10 years. They have enough experience and knowledge about track and trace regulations. They have a separate team to manage this

compliance across their global plants. So, obviously, those plants have been working to comply the same for many years now. The big Indian multinational companies started working on track and trace a few years ago to meet the export regulations. They have implemented the solutions and are now well aware about the challenges in deployment.

They have also realised that the apparently easy looking project is highly complex and it takes a long time for successful deployment. The approach has also changed from product to solution. It will not be an easy task to meet the November 2017 deadline as their customers are also asking for aggregation data (which is not a requirement of the 2017 deadline).

How is Optel Vision partnering with pharma

companies in India to meet these deadlines?

Since 2012, Optel Vision has been working with Indian pharma companies to assist them in meeting global compliances including Turkey, India, China, Brazil, Korea, DSCSA and EU FMD. Our business model is consultative, educative and offers a total solution. I must admit that we had some challenges in changing the mindset of Indian industry about track and trace.

It is imperative to recognise that serialisation and aggregation is much more than just simply printing barcodes. If you do not deploy the right solution with the right approach at the right time, meeting the compliance will be a tough task. Selection of inappropriate aggregation solution may significantly reduce packaging line efficiency. Initially, Optel Vision had started working with global MNCs in India but later on, a number of Indian companies selected Optel Vision as their solution partner because they realised that they need a longterm stable partner who knows the global scenario, has the capability to meet present and future regulations, understands uniqueness of packaging lines and Indianspecific challenges and can build highly reliable and customised solutions backed by a dedicated programme management team.

Being a cost-competitive global generics hub, Indian manufacturers were initially reluctant to invest highly in packaging lines unless they see the impact on productivity and process quality. Serialisation is deemed as non-value added

activity, just to meet compliance only. Companies should not underestimate the compliance risks and evaluate vendor on TCO (total cost of ownership) rather than initial capital investment.

What is the progress on Optel Vision’s operations in India?

I am glad to share that we are now the number one company (valuewise, quality and brand perception) in pharma vision and track and trace segment in India, in just five years. Though this is just a mile stone, not the destination. In line with our corporate mission (Growth, Profit and People), we want to expand our reach to medium and small companies by offering an affordable solution, without compromising on the quality. We are in business, so basic expectation is to have profitable operations. However, everyone at Optel Vision works for a larger mission - to enhance patient safety and to combat against global counterfeit.

We are inaugurating our fourth manufacturing site in the world, in India, having 42,000 sq feet facility under the kind patronage of Laxmikant Yashwant Parsekar, Chief Minister, Goa. How big a team does Optel Vision have in India? What are the plans to expand this headcount?

As of now, we have a team of approximately 45 members in the country and we feel confident that India operations will be a significant contributor to Optel group diversification and sustainable global expansion plans. viveka.r@expressindia.com

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‘We intend to continue our initiatives on innovation and greater manufacturing excellence’ The Indian medical device industry is currently going through a regulatory reform.

Himanshu Baid, MD, Polymedicure, talks about the business opportunities in this sector and shares his expectations from the government, in an interaction with Usha Sharma The government plans to hold a meeting to resolve the issue related to banning imports of refurbished medical devices with extended warranty. What are your views on this?

Import of many critical equipment is on hold due to this new notification from

Ministry of Environment and Forest. Refurbished equipment should be allowed to be imported, if original equipment manufacturers (OEM) guarantee the residual life of equipment. Utilisation of refurbished equipment at medical facilities in tier-II and tier-III cities will enhance the

affordability.

At present, what is the size of Indian medical devices industry and what percentage of growth has been recorded in the last two to three years? What percentage of the market share has been captured

by you?

The medical technology sector in India was valued at $7.5 billion in 2015 at end consumer prices. The Indian market is currently growing at a healthy CAGR of around 1012 per cent, significantly higher than global industry growth of four to six per cent.

The Indian medical devices industry estimates indicate a much larger potential to grow at 28 per cent to $50 billion by 2025 with policy framework and ecosystem support from the Government of India. This growth is expected to be driven by indigenous manufacturing and exports

We from Optima Pharma are convinced: A demanding customer should never have to settle for mediocre solutions and - above all - not when it comes to safety and hygiene.

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and, sales from local innovation. Polymed have approximately four to five per cent share in the Indian Red Tech market for FY 2015-16.

expansion plans includes: Increase the basket of products with existing customers, organise training programmes for global distributors, more participation in various conferences and exhibitions and appointment of representatives in key markets.

Do you see opportunities for the Indian medical device industry to expand in other Asian and African markets?

What support is the government offering in this regard?

Yes, India has the potential for global market opportunity for innovative and cost-effective medical devices especially in the Asian and African markets. With an enabling policy framework and ecosystem as well as support from the government, India can be a global medical devices hub. There is a huge opportunity for the Indian medical devices manufacturers. We expect four per cent Merchandise Exports from India Scheme (MEIS) waiver of Additional Duty of Customs (ADC) for exports, waiver of brand approval for exports.

Tell us what efforts have been already taken to boost the Indian medical devices industry?

Several positive initiatives have been taken by the government recently for example, medical devices are included in the ‘Make in India’ initiative, which will drive indigenous manufacturing.

The government has opened up 100 per cent FDI through automatic route, which is attracting more investment in the medical devices sector.

There has been correction in inverted duty structure in January 2016 through notification no 5/2016 to help local manufactures import duty on raw material reduced to 2.5 per cent from earlier 10 per cent. The ground work has already started for two medical devices park in Gujarat and Andhra Pradesh.

Moreover, NIPER Ahmedabad plans to provide testing facilities to medical devices industry. Launch of SUGAM portal by CDSCO for e-Filing of documents is another move,

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which considerably reduces time to file documents.

Separate medical device bill is a long outstanding demand from the industry. The government recently published the Draft Medical Devices Rules to invite comments from stakeholders, which is expected to be tabled in the Winter Session of the Parliament. The National Medical Devices Policy will offer benefits to local manufacturers, directly subsidise various local businesses and offer preferential tax treatment.

What are your company’s ongoing activities?

Our new research and development centre at Faridabad is ready for operations. This will double our current infrastructure and add 15-20 qualified dedicated research staff. The state-of-the-art software will

help us to create new generation medical devices.

Based on the efforts of our existing research and development division, we have been successfully granted 144 products and process patents globally and have also filed for grant of an additional 394 patents in India and worldwide.

How many news products are in the pipeline?

We have a diversified product portfolio with over 100 varieties of disposable medical devices in product verticals of infusion therapy, central venous access catheters, anaesthesia, blood management and blood collection, urology, surgery and wound drainage, gastroenterology and dialysis and certain veterinary disposable devices. We have also developed a number of safety medical devices across

product lines. With our existing product offering of safety medical devices in various product lines and our increasing focus on developing such products in the future, we believe that we are well-positioned to benefit from increasing private and public investment in healthcare and growing demand for quality healthcare.

Presently, how strong is your international presence and are there any plans to expand it?

Our exports contribute around 70 per cent of our revenue during FY 2015-16.

We export our products to over 90+ countries in Europe, South-East Asia, the Middle East, South and Central America and Africa through over 150 distributors in these jurisdictions.

Our international market

Tell us about your corporate plans for current as well as the next financial year.

Through our new investment of `60 crore in the green field project at IMT Faridabad in Haryana, which is likely to be commissioned in third quarter of 2017 with all statutory approvals, we will significantly broaden our existing manufacturing facilities to tap on new market opportunities. This will enhance our journey to capitalise on the growth opportunities in the medical devices sector and also to expand our product offerings by introducing a slew of products. We are introducing new products in oncology, nephrology and respiratory care. Our domestic sales and marketing future plans include vast brand awareness and product training campaigns by our existing 190+ sales team, where medical education programmes in key hospitals in the country will be conducted. We are also planning to double our sales team strength in the next three years to reach out 6000+ hospitals across India.

We believe that enhancing our manufacturing capabilities and further diversifying our product portfolio will enable us to capitalise on expected growth opportunities in this sector and increase our market share in the domestic and international markets. We intend to continue our initiatives on innovation and greater manufacturing excellence to create better awareness of products and pass on the benefits of cost savings to our stakeholders including patients. u.sharma@expressindia.com

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VALUE ADD

IWT: Bringing solutions to meet strategic goals Having an experience of more than a decade, Mack Universal has set up new benchmarks in the sphere by supplying a wide gamut of pharmaceutical equipment and spares ◗ Time All the variables are strictly linked to each other and have a specific relative weight. The key is to find the right balance in order to achieve the expected cleaning results.

MACK UNIVERSAL was founded by Manoj Chaudhari in the year 2012 to serve the Indian pharmaceutical companies with technologies, products and services required for their ultra modern laboratoriess and plant. The company has launched International Washing Technologies (IWT) of Italy, which is world renowned for its state-of-theart low and high pressure washing equipment and technologies. Techniplast is the parent company of IWT. IWT has specialised itself in washing, cleaning and drying of production utilities and change parts. IWT has its installations world over in most of the best known pharma companies.

Mechanical action According to the material and the product, it is possible to choose the most effective washing technique: ◗ Low-pressure washing according to the re-circulation of the washing fluids combined with high flow rate ◗ High-pressure washing technology which is gradually taking place in the recent years HP washing principle is based on huge mechanical action generated by water sprayed at over 70 bar pressure through orbital nozzles perfectly covering the surface to clean.

IWT provides solutions that enhance:

◗ Quality, safety and ergonomic of the workplace ◗ Conservation of the environment (green approach) ◗ The outcomes of production Cost effective, high quality and safe equipment have always been IWT’s first priority.

As a company culture, IWT is constantly looking for solutions to enhance its products to suit client’s business better.

Temperature

IWT’s high-pressure washing solution for pharma industry The following issues and points should be taken into consideration: ◗ The issue of washing ◗ Washing science ◗ Technology behind washing systems ◗ High pressure range of washers ◗ Main features and ways of use ◗ Conclusion

dated washing process is capable of eliminating the cross contamination that can be medically significant. Analytical methods, sufficiently sensitive to detect relatively small amounts of APIs, can be the aim for the validation of the cleaning process.

The issue

Cleaning: From art to science

A proven, efficient and vali-

Cleaning has evolved over the

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years from an ‘art’ activity to a ‘scientific’ task.

A new generation of cleaning procedures has begun to emerge. Cleaning processes are no longer an ‘afterthought’ or some aspect that could be developed at a later stage. Efforts were put into the cleaning process to determine what makes a residue difficult to remove and the roles of solubility, mechanical action, flow rates,

temperature, contact time and many other fundamental variables.

Wahing science The removal of the contamination is influenced by several critical factors that must be take into consideration: ◗ Mechanical action (combined with coverage of the load) ◗ Temperature ◗ Chemical action

Temperature is a fundamental parameter that concurs to achieve outstanding cleaning performances: ◗ As a general role, although there are some exceptions, the higher the temperature of the washing solution, the higher is the solubility level ◗ The increase of the solubility leads to a reduction of the washing time which means shorter cycles. ◗ Water temperature is increased by means of several type of heat exchangers (steam or electrical) and constantly monitored by means of accurate temperature probes PT100 or higher .

Chemical action Chemicals (commonly known as detergents) are used in cleaning activities: ◗ Detergents can either be al-

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kaline, acid and/or neutral ◗ The use of detergents lowers the cleaning time and water consumption, but needs to be properly removed in order to avoid any contamination of the load ◗ Removal is carried out by means of one or more rinse cycles and it is mainly verified by water conductivity monitoring other analytical methods.

Time The compounds in use in pharma production are of different nature, in different forms and with different characteristics: ◗ Solids, semisolids, gels, ointments and liquids These can then be divided in: ◗ soluble in water ◗ insoluble and/or hydrophobic The solubility in water, and therefore the cleaning time, can vary for each type of product. The longer the washing time the longer the exposure of the load to chemical and mechanical action.

The high pressure technology An innovative range of ◗ Mobile (M-Line) ◗ Stationary (S-Line) ◗ Cabin (C-Line) ◗ Equipment for washing and drying a wide variety of loads. ◗ These units are built in compliance with cGMP and 21CFRpart11. ◗ The mobile machines can be used as stand alone in production areas (in place process) or in dedicated washing areas. ◗ The mobile units can also be connected to a washing/drying cabinand/or to equipment featuring a suitable built-in CIP system. ◗ The Focus of IWT is to provide automated washing technologies that bring several tangible benefits to the organisation, namely: ◆ Minimise the need for the operators to come into contact with APIs and chemicals, thus improve health and safety conditions ◆ Eliminate the possibility of cross-contamination between batches ◆ Reduce the energy consumption

90 EXPRESS PHARMA November 16-30, 2016

◆ Reduce the water consumption (a precious resource) ◆ Reduce the effluent pollution thanks to low use detergent consumption and water ◆ Guarantee the repeatability of the results ◆ Give evidence (printed batch report) of the cleaning activity.

IWT products 1. M Line The salient features are ◗ High pressure mobile washing unit ◗ Washing pressure from 20 up to 80 bar ◗ Stainless steel draining pump ◗ cGMP and FDA compliant ◗ Two detergent dosing pumps ◗ Equipped with hydro-kinetic water gun ◗ Steam or electrical heat exchanger

◗ PLC + HMI + on board printer.

Drying section 2. S Line High pressure stationarywashing unit: ◗ Washing pressure from 20 up to 80 bar ◗ Multiple hydro-kinetic jet guns ◗ Orbital nozzles to suit specific needs ◗ Built of AISI 316L stainless steel ◗ Pharma grade heat exchanger ◗ Detergent dosing pump ◗ PLC + HMI ◗ On board printer 3). C Line: High Pressure washing and drying cabin:

◗ Three different sizes: small/medium/large ◗ Washing pressure from to 80 bar ◗ cGMP and FDA compliant ◗ Telescopic orbital nozzles ◗ Self cleaning function ◗ PLC + HMI ◗ On board printer ◗ Drying section 4).IWT also has ‘Column washing and drying unit’ for containers and flexible hoses suitable for: ◗ Cabins ◗ Cleaning rooms.

Documentation: Apart from the standard documentation, on request, additional cGMP documentation for the validation work is provided: ◗ Design qualification ◗ Installation qualification

◗ Operational qualification ◗ Service is also provided, directly from the factory or through ◗ Our partners worldwide (Mack Universal in India).

So, to conclude, automatic cleaning procedures are crucial to achieve high hygienic standards in pharma production ◗ Automatic cleaning allow validatable process and regulatory compliance ◗ A well planned working method regulated by proper SOPs assures a better cleanliness with a guarantee of no cross contamination ◗ Flexibility MSC product line allow an unlimited range of washing solutions from a stand alone drum/bin all the way through very specific and custom sized CPI applications .

CPhI & P-MEC INDIA 2016 SPECIAL One Brand Total Solution

The United Engineering Company: Serving the pharma industry for the last five decades THE UNITED ENGINEERING COMPANY (UEC) with the brand name ‘UNITED’ is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in the year 1963 by GD Roy, has attained high reputation in providing machines and services of highest standards since the beginning. With the founder’s innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for its customers.

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

UEC, which was started in the year 1963

by GD Roy, has attained high reputation in providing machines and services of highest standards since the beginning EXPRESS PHARMA

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The company has also expanded its footprints abroad in a large way. Today, ‘UNITED’ machines are exported to more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, the UAE, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, ‘UNITED’ machines provide technically advanced solution for its customers.

Presently UEC is having its head office in Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having its marketing and sales office in Mumbai to cater to the eastern part of the nation and overseas. The company has also set up well equipped service shop in Mumbai to service its clients.

The United Engineering Company has been honoured by the prestigious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development and continuous value additions to the pharma packaging industry.

Today, at UEC, machines are equipped with the latest technology. For its customers, UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service.

UEC is equally focused on being a corporate citizen. It has never shirked the responsibility of the society and has always been an active participant in numerous social events which help in uplifting the quality of living of the deprived.

With almost every pharma formulation manufacturer being an ‘UNITED’ machine user coupled with 50 years experience, UEC commits in becoming better than the best in the near future.

Founder: GD Roy (R)

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HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India.

Board line: 0120-6651500.

Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com Our Associate: Dinesh Sharma Mobile: 09810264368 E-mail: 4pdesigno@gmail.com CHENNAI Arun J The Indian Express (P) Ltd. Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 91 9940058412

Fax: 044- 28543035 Email id: arun.j@expressindia.com BANGALORE Mathen Mathew The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Mobile: +91 9840826366 Fax: 080- 22231925 Email id: mathen.mathew@expressindia.com HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936, Fax: 040 23418675

Email Id: e.mujahid@expressindia.com KOLKATA Ajanta Sengupta The Indian Express (P) Ltd. Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati, Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com AHMEDABAD Nirav Mistry The Indian Express (P) Ltd. 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015, Mobile: +91 9586424033 Email Id: nirav.mistry@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

92 EXPRESS PHARMA November 16-30, 2016

CPhI & P-MEC INDIA 2016 SPECIAL One Brand Total Solution

NEOMACHINE MFG CO: Aleader in automatic coating technology KOLKATA-BASED NEOMACHINE MFG CO was started in 1973 with an objective of manufacturing quality pharmaceutical machinery. For a decade, the company catered to the requirements of the Indian pharma companies in injectable, liquid, tablet, capsule and ointment sections machinery.

While catering to this market segment, NEOMACHINE happened to come across a Kolkata-based pharmaceutical producer, who were envisaging problems in film coating of tablets. Till then, the tablets were being coated in conventional pans, which were not only

causing health hazards to the coating personnel, but was also a time-consuming process. Inspired by this opportunity, NEOMACHINE started the process of developing an automatic coating machine. After, two years of research and development, the first 'Neocota Automatic Coating System’ was manufactured in 1984.

During the last three decades, NEOMACHINE manufactured and marketed more than 550 machines, out of which 100 machines were exported to the different countries like the US, Australia, China, Jordan, Yemen, the UAE, Uganda, Kenya, Sudan, Cyprus, Saudi

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Arabia, Austria, Brazil, Bangladesh and Bolivia etc.

NEOMACHINE, a professionally managed organisation now has two manufacturing units in Kolkata, which are equipped with state-of-the-art equipment like fabrication, machining, assembling, finishing and other related jobs.

The company has been strictly following all the quality control guidelines during manufacturing. The bought-out items are inspected at the manufacturers’ works periodically. The company has a dedicated team of engineers for providing erection and commissioning and prompt after-sales service to

the clients.

The in-house R&D facility is abreast with latest technology upgradation and developments in ‘coating technology. This helps in continuous improvement of the product. NEOMACHINE also provides DQ/IQ/OQ/ documents for automatic coating system and are in the process of getting CE certification.

Over the years, the company has gained vast experiences in manufacturing 'automatic coating system' by interacting with various Indian and multinational pharma and confectionery units based in India and abroad.

Neomachine being a single product company manufacturing only automatic tablet coating system for coating of pharma tablets has gained vast experiences in latest coating technology as well as validation and qualification of coating equipment to qualify for audit of various national and international agencies. The latest models of NEOCOTA are having all the constructional features for validation and qualification. The equipment are supplied with all the necessary documents for proper validation during installation and commissioning as well as trial production.

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PHARMA LIFE

One Brand Total Solution

AWARD

Novartis wins two Prix Galien Foundation Awards Gleevec has been recognised as ‘Discovery of the Decade’ for Best Pharmaceutical Product, Cosentyx as Best Biotechnology Product

N

ovartis has received the 2016 Prix Galien USA Award for Best Biotechnology Product for Cosentyx (secukinumab), as well as the Prix Galien Foundation ‘Discovery of the Decade’ Award for Best Pharmaceutical Product for the drug Gleevec (imatinib mesylate). The awards were presented at a ceremony in New York City. “We are honoured to receive these prestigious awards for Cosentyx and Gleevec, which not only have

94 EXPRESS PHARMA November 16-30, 2016

changed the practice of medicine for certain conditions, but also represent years of hard work by our scientists. These wins underscore our commitment to addressing the unmet medical needs of patients through science-based innovation,” said Joseph Jimenez, CEO, Novartis.

Cosentyx was the first fully human interleukin-17A (IL-17A) antagonist approved by the US Food and Drug Administration (FDA) in 2015 for the treatment

The awards were presented at a ceremony in New York City of adults with moderate to severe plaque psoriasis. Cosentyx was also approved for the treat-

ment of active ankylosing spondylitis and psoriatic arthritis in 2016.

The discovery of Gleevec marked the first time in the history of cancer treatment that scientists were able to identify a chromosomal abnormality and then develop a drug that would target that specific protein.

Gleevec, a molecularly targeted treatment, became a therapy of choice for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and KIT

(CD117)-positive gastrointestinal stromal tumours (KIT+ GIST). By showing that certain diseases can share a drug-sensitive target with seemingly unrelated ailments, and that molecular targeting can be medically and commercially successful, Gleevec helped establish a new paradigm for drug development. The Prix Galien rewards excellence in scientific innovation that improves the state of human health.

EP News Bureau

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Making Stainless steel Stain free

See it to believe

Quick and effective removal of rouge deposits from stainless steel water systems and process vessels. No damage to substrates Especially suited for derouging of stainless steel: • Production systems, storage tanks and distribution systems for water (PW or WFI) • Pure steam systems • Process vessels e.g. in vaccine production • Autoclaves, lyophilizers etc Benefits: • Short process times hence shorter downtimes.

• pH-neutral process so water does not require neutralising.

• Residue free process so waste disposal is simple and cost-effective.

• Increased safety as aggressive acids are not required.

• Simple in-process control as expensive analytical equipment. not required.

• Rapid results with short derouging cycle times and improved efficiency.

• Validated analytical methods

Pharmalab’s services in collaboration with global leader

at your doorstep.

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Product List Humidity Chamber

Walk in Chambers I Humidity ( Stability) Chambers Cooling Chambers I BOD Incubators Bacteriological Incubators I Deep Freezers Ovens I Photo Stability Chambers I Vacuum Oven Muffle Furnace I Auto Clave I Water Chillers

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Walk in Chamber Cooling Chamber

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Alternative PLC with touch screen display with Ethernet with automatic change over facility.

Computer Interface with 21 CFR Compliance software.

Complete validation package comprising DQ, IQ, OQ & PQ. 24 x 7 Online service support.

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MFGRS. PHARMA AND LAB EQUIPMENTS

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SPECIALIZED IN PLATINUM CURED SILICONE TUBES,BRAIDED HOSES & INFLATABLE SEALS/GASKETS 1st Indian Silicone Rubber Product Mfg. Co. certified with Clean Room of Class 10000

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Airtech is a customized air solutions provider. Since its inception in 1992, Airtech has cultivated an in-depth understanding and expertise of executing turnkey HVAC & Clean Room Projects.

Airtech undertakes complete project management comprisig of design, supply, installation & commissioning and validation of HVAC and Clean Room Systems.

Airtech’s Clean Room system provides an ultra-clean environment ranging from Class 100 to Class 100000 with effective control of Air flow, Pressure, temperature, Relative humidity and Filteration suitable for Clan room applications.

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Salient Features

Please Contact: Mr. Sandip Lagad

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HVAX Technologies Pvt. Ltd. HVAX House, Opp Viviana, Khopat, Thane (W), India.

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

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Accelerating Complex Generics Development With complex generics potentially being a major source of pharmaceutical industry growth over the coming years it is important that strategies are adopted to develop and characterise such therapeutics. Malvern has developed a suite of technologies that aid in the development of nasal sprays, microemulsions, injectables and novel drug delivery systems.

Morphologi G3-ID

OMNISEC

NanoSight NTA

Use FDA-advocated MDRS to show bioequivalence – morphological analysis through image analysis and chemical identification of different components using Raman Spectroscopy

Most advanced Multi-detection SEC system – Comprehensive structural characterization of polymeric excipients, drug delivery vectors and protein therapeutics

High Resolution size distributions over the submicron range – Drug Delivery Dosage comparability analysis through concentration-based size measurement

Visit us at: P-MEC 2016 • Hall No : 5 • Stall No : N18 Date: 21-23 Nov, 2016 Venue: BC&EC, Goregaon Mumbai

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Shah Brothers introducing

PHOTON CLEANTECH INC. Manufacturer and Supplier of Modular Operation Room, Cleanroom Turnkey Projects & Cleanroom Equipments

ISO 9001:2015 Certified Company

BIOPROCESSING SOLUTION: SINGLE USE BAGS BY CHARTER MEDICAL u

Products are qualified for : l

Ceiling Suspended LAF

Operation Room

Dispensing Booth

l

l

l

Class VI Biological test for Plastics USP <88> Physicochemical test for plastics USP<661> Cytotoxicity USP <87> & Hemolytic Effects Oxidizable Substances & ADCF

u

ISO class 7 & 8 manufacturing suites

u

Custom designs for process flexibility

Clear-Pak® Bio-Containers Air Shower

Bio Safety Cabinet

Cleanroom Panel

u

Co-extruded single web film with ULDPE, EVOH & PE

u

Offers Superior clarity & Excellent gas barrier properties

Freeze PakTM STS Bio Container u

Uses Freeze PakTM Flim of single web 12 mil polyolefin monolayer

u

Support frozen storage and transport to -196°C & Retains film flexibility while in a frozen state

Freeze PakTM with FP FlexTM Tubing for Working Cell Bank(WCB) Applications u

Closed System aseptic transfer solution for WCB enabling frozen storage as low as -196°C

u

Reduces handling & seed train expansion step for therapeutic production

PHOTON CLEANTECH INC.

Contact Details: Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg, Wadala, Mumbai - 400 031, Maharashtra India.

Phone: +91 22 4356 0400 Fax: +91 22 4356 0425 Email: pharma@shahbros.com

Survey No. 106 A/3, Office No. A-6, Surya Lok Nagari, Pune - 411028, MS, India.

Mobile: +91 8805060111 l Email: photoncleantech@gmail.com l Website: www.photoncleantech.com

www.shahbros.com

Doors

DY PB

Garment Cabinet

Fore more info contact:

Pharmaceutical Applications NASAL

ORAL

TOPICAL

The One Point Source for Tamper Evident Sprayers

FEATURES u

Tamper Evident

u

u

Sterilizable

u

Tablet Applicators

u

Accurate dosage delivery

u

Cream Applicators

u

Available in different dosages

u

Tablet Containers

SANTAPET POLYMERS LIMITED Office: 8 Sheriff Devji Street, 1st Floor, Mumbai - 400 003. India Tel.: +91-22-23420381 l 66151691 Fax: +91-22-23441578 Email: suraj@santapetpolymers.com l Website: www.santapetpolymers.com

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One Company 3 Manufacturing Facilities 1100+ Employees 10 Years Experience in Manufacturing & Project Management 800+ Satisfied Clients in India 80+ Project in Overseas 15+ Resepsentative across the Globe

CLEANROOM PARTITIONS CLEANROOM DOORS FIRE RATED DOORS CLEAN ROOM EQUIPMENTS LIGHTING HVAC SYSTEM FLOORINGS INTEGRATED BUILDING â&#x20AC;&#x201C; MANAGEMENT SYSTEM TURNKEY SOLUTIONS

Gunai Road Kurawala, Village Mandhala, Post Office Mandhala, Via Barotiwala, District Solan, Himachal Pradesh- 174103, India Email: mkt@gmptech.net, Website: www.gmppartitions.com, Toll Free Number: 1800 3070 5588 EXPRESS PHARMA

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Barrier Controlled Packaging Prolong Your Drug Stability Log offers 3 solutions:

Reduces Oxygen Permeation & OTR

Reduces Water Vapor & Oxygen Permeation

Reduces Water Vapor Permeation & WVTR

The beneďŹ ts of LOG's Barrier Bottles include:

Visit us at

Higher formulation stability over time Less absorbents in the bottle Reduced development time & costs Same generic design of standard HDPE bottles

Bombay Exhibition Centre, Mumbai, India Hall 1, # E-35

LOG continues to offer a wide range of standard primary packaging with compliancy to the U.S. Pharmaceutical requirements and are registered in the DMF. S. Zhaveri Pharmakem Pvt. Ltd 308/310, Shiv Smriti Chambers, 49 Dr. A. B. Road, Worli, Mumbai - 400 018. India Tel.: +91 22 43676666 info@szhaveri.net www.szhaveri.com

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LOG Plastic Products Ltd Global Corporate Headqurters, R&D center and manufacturing site Ashdot Ya'akov Ichud, 1515500, Israel Tel.: +972-4-6756338 sales@logpac.com www.logpac.com

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PETER GREVEN Your partner for pharmaceutical excipients All LIGAMED® Premium Excipients are produced on dedicated production lines according to GMP guidelines and meet all pharmacopeias: USP/NF, BP, PH.Eur, DAB, JP.

LIGAMED® product line: LIGAMED MF® Magnesium Stearates LIGAMED CPR® Calcium Stearates LIGAMED SA® Stearic Acids

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PETER GREVEN extended its RSPO certified product line.

LIGAMED® products are available with the following certification grades: MASS BALANCE SEGREGATED

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Reduced Cross-Linking Gelatine • Improved shelf life • Enhanced dissolution properties • New capsule fills

Visit us at

CPHI INDIA Hall 1, # E-35

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SYNTHETIC COLOURS

FLAVORS

Lake & Water Soluble Colours as per Regulated Markets

Wide range of portfolio of proprietary technologies

Quinoline Yellow, Ponceau 4R, Sunset Yellow, Brillant Blue, Indigo Carmine, Erythrosine, Tartazine, etc

NATURAL COLOURS TITANIUM DIOXIDE ANATASE GRADE

Beta-Carotene, Chlorophyll, Beetroot, Caramel, etc

IRON OXIDE SPECTRACOAT (MASTERCOAT)

Red, Yellow, Black & Brown

Spectracoat Sugar: A range of liquid colour dispersion designed for use in the production of elegent sugar coated tablets.

Spectracoat Inks: A range of offset gravure inks designed for the printing of sugar and film coated tablets as well as hard/soft gelatine capsule

Contact Sole Agents - Distributors:

at 6 us ia-1 -35 t d E si Vi - In all I St H CP - 1, ll Ha

S. ZHAVERI PHARMAKEM PVT. LTD. 308-310, Shiv Smriti Chambers, 49, Dr. A. B. Road, Mumbai- 400 018.

Phone - +91-22-43676666 Fax - +91-22-66607758 Email - info@szhaveri.net Website - www.szhaveri.com

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An Enterprise Providing Professional Value of Optimized Technology Name Source : Advantage + Technology + Praxis + Practice

From Technique for Humanity

From Zero Base to Innovation

Breakthrough the existing frame, users-centered and innovative new product

Optimized Technology

Tablet Press

Capsule Filling

Sejong Coater

P Series

F Series

C Series

Sole Selling Agent in India

A 404, Rajeshri Accord, Teli Galli Cross Lane Andheri East, Mumbai 400 069 Tel: +91 97691 99633. Email: mail@allpharm.in Web: www.allpharm.in

Visit us at Stand Hall No. 6/B-18, 21-23 November 2016, Bombay Exhibition Centre, Mumbai, India EXPRESS PHARMA

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LABORATORY EQUIPMENTS l l l l l l l l l l l l

Walk in stability Chamber/Cold Room -860C Ultra-low Temperature Freezer Humidity Chamber/Stability Chamber Cooling Incubator Bench Top and Refrigerated Centrifuge Deep Freezer/Laboratory Refrigerator Cold Cabinet Orbital Shaking Incubator Rotary Shaker Laboratory/Magnetic Stirrer Vortex Mixer Blood Bank Equipments Walk in Chamber

NEW PRODUCTS

Roller Tube Mixer

Micro/Mini Centrifuge

UTC Freezer

Microplate Shaker

Magnetic Stirrers

Single Door Refrigerator

Upright Freezer

Multi Vortexer Medico Plus

Magnetic Coupling

Laboratory Centrifuges

Gerber Centrifuge

Neya Centrifuges

Laboratory Stirrers

Bench Top Orbital Shaking Incubator

Humidity Chamber with TFT Display

Refrigerator Cum Freezer

REMI SALES & ENGINEERING LTD.

Remi House, 3rd Floor, 11, Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai-400 063. India Tel: +91 22 4058 9888 / 2685 1998 l Fax: +91 22 4058 9890 l E-mail: sales@remilabworld.com l Website: www.remilabworld.com

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AGROGEM (A Division of Agron Remedies Private Limited)

Kind Attention

Tablets

More than

600

Stockists & Marketing Professionals

Products

Covering Nursing Homes, Private Hospitals, Big Multi-Specialities Hospitals, Polyclinics, Institutions, Trauma Centers and Doctors.

Capsules

Manufacturing of all Products in our own state of art Plants Manufacturing of injectables (Beta Lactam and non Beta lactam ) , Tablets , Capsules, Ointments, Lotions, Liquid orals, Eye/Ear Drops etc.

Very Competitive Price with high margin of profit Stock Available round the Clock-Timely services & on time supplies Elegant Packing with unmatched Quality.

Long lasting Relationship, Committed Dealings Road Permit not required for supplies from U.P Depot and Bihar Depot

Injections

Ointments

Export and 3rd Party inquiries are solicited.

Business Opportunity

AGROGEM

Agron Vet Care (Over 100 Products)

Ear & Eye/Nasal Drops

CARDIRON

CARDIRON (Over 70 Products)

For Dynamic Enthusiastic and Energetic marketing Professionals Wholesale Chemists AGROVISION

(Over 600 Products)

(Over 200 Products)

Inquiries for stockistship and superstockistship are solicited Experienced Pharma Personnels can also contact for excellent opportunity.

(Over 150 Products)

D DERMARON

DERMARON

AGRON OTC

HORON YC

Syrups

Eye/Ear And Nasal Drops Dermatological Products Antidiabetic Drugs Anthelmintics Dental Products Antiallergic Drugs/Antifungal Drugs Antiviral Drugs/Antimalarials Irons, Vitamins & Neutraceuticals Products

(Over 70 Products)

AGRON OTC (Over 11 Products)

PSYCHORON

PS

Antibiotics/Antibacterials/Antiamoebics NSAID'S/Anti-Inflammatory/Analgesics Gastro-enterological & Antiulcer Drugs Paediatric Products Gynecological Products Orthopedic/surgeon Products Cardiovascular Drugs Neuro-Psycotropic Drugs

(Over 75 Products)

AGRON REMEDIES PVT. LTD. (An ISO 9001:2008, Revised Schedule ‘M’ GMP Certified Company) Sarverkhera, Moradabad Road,Kashipur-244713 (Uttarakhand) Website: www. agronremedies.com, E-mail: agronremedies@gmail.com, agronremedies@yahoo.co.in STD: 05947-275279, Phone :275279, 272639, 271759, Fax: 274929

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1st Indian Company to launch “CE” approaved equipment.

1st Indian Company to launch “PLC Based” Control System.

21CFR Part 11 Compliant Software

GSM Technology: SMS Mobile Alert.

“Best Service in its Class”. Acclaimed by our Proud Customers.

Our World Class & World Renowned Equipment n

Walk-In Humidity Chambers.

n

BOD Incubators.

n

Humidity Chambers.

n

Bacteriological Incubators.

n

Walk-In Cold Chambers

n

Photostability Chambers.

n

Cold Chambers.

n

Deep Freezers.

n

Walk-In Incubators.

n

Ovens.

Mack Pharmatech Pvt Ltd. B-48, Malegaon MIDC, Sinnar, Dist. Nashik, Pin - 422 113, Maharashtra, India

+91 2551230877

+91 2551230877

sales@mackpharmatech.com

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www.mackpharmatech.com

service@mackpharmatech.com

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When you want a little more â&#x20AC;¦ NETZSCH machines and process technology for pharmaceutical and cosmetic applications The NETZSCH VITA line of mills, mixers and dispersers are customengineered for your specific application. With scalability in mind, every solution we engineer is easily sized for production capacity.

NETZSCH Technologies India Pvt Ltd No A-30, SSIO Complex Gandhi Street, Vanagaram Road, Athipet Chennai 600 058 Tel.: +91 44 2653 6821 E-Mail: info.gd@netzsch.com Homogenizing Mixers KAPPAVITA Type HM

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D. S. Enterprises

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Company for cold accessories

The Company for Cool Pack Supplies n

n

D S Enterprises manufactures cool packs for temperature sensitive products in the 2-8 0C segment The company supplies these reusable packs to customers on a Pan India Level

PAMS HVAC CONTROLS

C L E A N R O O M H VA C S O L U T I O N

Since 1990

PAMS HVAC executing turnkey HVAC & Clean room project. Comprising Design, Supply, Installation, Commissioning & Validation Certificate of DQ, IQ, OQ & PQ of HVAC & Clean room system rating from class 100 to class 100000 with control Pressure, Temprature, Relative humidity & Filteration suitable for clean room system.

Product Range

OUR PRODUCTS l

Pouch Gelpacks

l

Bottle Gelpacks

l

Foam bricks

Cleanroom Partition, Doors & View Pannels Double Skin AHU with DX / Chilled Water Coil.

HEPA, Microvee & Prefilters.

Pass Box, Air curtain, Dispensing / Sampling booth in SS / CRCA D S ENTERPRISES

Plot No 81 D, Level II, Road No 8, Jigani Industrial Area,Bangalore 562106,Karnataka, India www.dseindia.co.in dsenterprises@vsnl.net Tel.: +91 80 41647401 Mobile: 9880302293, 9845902308 l

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Mumbai : 2/4, BMC Tenament Bldg., G.D. Ambekar Marg, Dadar (E), Mumbai -400 014 Goa : 581/2, Tuem, Pernem, Goa - 403 512 Tel.: +91-22-24124257 • M: 09322298502 / 9820880641 • Email : pams.sales@gmail.com

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Excellence far beyond

An ISO 9001 : 2015 Certified Company

TURNKEY CLEANROOM SOLUTIONS

CLEANROOM PANELS

CLEANROOM DOORS

CLEANROOM HVAC

Static Pass box

Dynamic Pass box

Sampling Booth

Horizontal LAF

Laminar Air Flow

Bio-Safety Cabinet

Air Showers

Mobile LAF

CLEANROOM EQUIPMENT 108,Swastik Regalia, Waghbil, Off Ghodbunder Road, Thane West, Mumbai

+91-22-2597 1641 / 42

EXPRESS PHARMA

+91-809 777 9747 / 992 032 4980

sales@pharmintech.net

www.pharmintech.net

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PACKAGING PRODUCTS FOR HEALTH CARE

RUBBER STOPPERS

RUBBER DISCS & PLUNGER FOR DENTAL CARTRIDGES

TABLET & GELL APPLICATOR

EYE / EAR DROP BOTTLES (CONTROLLED DROP SYSTEM)

30ML, 60ML & 100ML DRY SYRUP BOTTLE WITH CAP & MEASUGINC CUP

DROPPER ASSEMBLY

RUBBER DISCS WITH EUROHEAD CAPS AND FLASH BLUB

DIAGNOSTIC PACKAGING DIFFERENT SIZE CAPS

PLASTIC MEASURING CUPS/SPOONS (for LIQUIDS & Dry Powders)/ PLASTIC CAPS (ROPP)

SYRUP SPOON

DOSING SYRINGE WITH ADAPTOR

SCOOPS

Visit us

RUBBER WADS

BEAK TYPE DROPPER, OPVD DROPPER & BUILT IN DROPPER

LIDS FOR TIN CONTAINERS

LIDS FOR TIN CONTAINERS

: I-50 Booth No :6 HALL No

@

regaon, BEC Go Mumbai

BHARAT RUBBER WORKS PVT LTD.

B-46, Girikunj Industrial Estate, Off. Mahakali Caves Road, Andheri (East), Mumbai - 400 003. INDIA. Tel.: +91-22-2687 5361 - 64 l Fax: +91-22-2687 5221 / 22 Email: marketing@brworksindia. com l Website: www.bharatrubberworks.com

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BATCH-PRINTINGG / PACKAGING

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Your trusted partner in delivering complete instrumentation solutions for…

ANALYTICAL LABS / PROCESS DEVELOPMENT & SAFETY / VALIDATION / SPECTROSCOPY

AAS (ATOMIC ABSORPTION SPECTROMETER) u

Wavelength range of 175-900 nm.

u

Continuously adjustable slit width from 0.1 to 2.0 nm for both normal and reduced height.

UV-VIS SPECTROMETER

Automatic Burner Rotation for measurement of over range samples without the need for dilution.

u

u

Wave length 190-1200nm

u

Complete range of accessories

u

Electronic sample viewing (ESV) enables view of furnace injection, sample drying and ashing from computer monitor to facilitate method development.

u

7*7 carousel allows 7 samples and 7 reference samples or programmed for 12 sample & 2 reference sample for increased batch size sample analysis

u

Coded hollow cathode lamp recognition.

u

Deuterium/Zeeman Background Correction available.

GBC’s trusted Spectroscopy Instruments Now backed by Proven Services of skytech...

EMMA X-RAY DIFFRACTOMETER u

The enhance Multi-materials Analyzer.

u

3Kw high power X-ray Generator.

u

SSD Scan Speed of 120 deg/min.

u

Theta/2Theta and Theta/Theta configuration.

ICP-OTOFMS (OPTIMASS 9600) u

World’s only SIMULTANEOUS TIME OF FLIGHT ICP-MS

u

Mass range 1 to 260 amu.

u

Very low ppt detection limits.

u

Over 7 times faster sample throughput compared to Quadrupole ICP-MS.

u

Octopole Collision Cell with mass independence for interference management during sample analysis.

u

Fast screening for all masses

ICP-OES (QUANTIMA) u

The 4th generation Quantima represents a quantum leap technology in the world of ICP spectroscopy.

u

Innovative features like the plasma cam tm and PIP, the Quantima is sure to take your research to another level

u

The Quantima consumes the least amount of Argon for any ICPOES available.

u

11% increase in monochromator speed.

SKYTECH SYSTEMS (INDIA) PVT. LTD

s

Visit u

Booth No-P71 HALL NO-5BA

@

Bombay Exhibition Center Goregaon

403-404, Siddheshwar Arcade, Opp Suraj Water Park, Ghodbunder Road, Thane (W) - 400615 Tel: 022 - 4153 3342 l Fax: 022 - 4153 3388 l Email: marketing@skytechindia.com l Website : www.skytechindia.com

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ADVANTAGES OF

PRE-PREPARED TROLLEY System over BUCKET TROLLEY System Today´s Cleaning Innovative Pre-prepared

3 No Heavy buckets 3 No Cross-contamination 3 > 50% less consumption of water and chemicals 3 High on ergonomics 3 Sustainable 3 Microfiber technologie 3 Small footprint of trolley´s

The pre-prepared method is exactly what it says – every mop and cloth required for that days’ cleaning is prepared in advance with the correct amount of water and customers validated disinfectant.

Pre-preparation and the mechanical action of the microfibre mops dramatically reduces the amount of chemicals required and leaves each mop moist enough to remove contamination and leave an disinfectant layer behind. Also, as the mops are pre-dosed they replace heavy double or triple buckets, the time intensive need for wringing mop heads with contamination risks, changing and wasting disinfection solution. After cleaning one room/area of 20-25 m² the mop is simply changed and another pre-prepared mop is placed on the frame for use in the next room/area/surface. The used mop is then placed into a bag for laundering, so preventing cross contamination between rooms/areas.

B902 / 903 / 904, O2 Galleria, Minerava Industrial Estate, Mulund (West), Mumbai - 400 080 Tel : +912261716666 l Cell : +91-8976610332 Website: www.vileda-professional.com l Email: prasad.crg@fhp-ww.com

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AQUA MECH ENGINEERING CORPORATION. ARE PARTICIPATING IN UPCOMING EVENT CPHI INDIA P-MEC 2016. LOOKING FORWARD TO MEETING YOU IN BKC MUMBAI

What’s NEW in 2016?

HIPURITY WATER SYSTEMS u u u

VISIT US AT BKC, MUMBAI, INDIA, BOOTH NO-BA1A, HALL NO-5, 21-23 NOVEMBER 2016

SANITARY PIPING AND STORAGE TANKS FOR CLEAN UTILITIES

HIPURITY WATER SYSTEMS WATER TREATMENT SYSTEMS. Pure water quality compares with USP/IP/WHO/MHRA water requirement.

u

u u

u u u

Piping system designed, tested to comply with international regulations (USP/Ph. Eur.) Optimized for Clean Utilities Piping.

Stainless steel Distribution Skid with piping, valves and fittings, Instrument and PLC Based Control Panel.

Purified water / WFI Storage Tank available.

CIP/SIP Systems / Solvent transfer systems.

Liquid manufacturing vessels / API reactors.

POU HEAT EXCHANGER u

u u u u u

In WFI distribution systems there would be a few user points who would need water at 20 c – 50 c install point of user heat exchanger Heat exchanger are design & supply by remoin Quality as per asme bpe /ped97/23/ce Automation & control panel integrated by aquamech He are available from 100lph & as per client requirement Technical data: rectilinear pipes with double fixed plates

MULTI-EFFECT DISTILLERS / VAPOR COMPRESSION SYSTEMS / PURE STEAM GENERATOR FOR WFI (WATER FOR INJECTION) FROM REMOIN ITALY u

u

u u

We are Partnering with REMOIN, Italy company specialized in the design and construction of MULTIEFFECT DISTILLERS / VAPOR COMPRESSION SYSTEMS/ PURE STEAM GENERATOR, according to International Pharmacopoeias.

u

u

Compliance with guidelines as per ISPE, ASME BPE & cGMPs. Complete Automatic system with sterilization of plant at startup & stop.

Continuous control of conductivity/Level.

Automatic drainage if water is not as per limits.

Entire distiller built in Stainless Steel AISI 316L & passivated according ASTM 967 Rules Full documentation as per FDA norms including DQ, IQ, OQ, PQ, instrument calibration & computer validation.

COLD STORAGE FOR PHARMACEUTICAL INDUSTRY u u u u u u

Authorized dealers of BLUE STAR LTD PUF panels with cam lock arrangement and Evaporator units with stainless steel body Walk in Chiller / Freezer units built as per room size available.

Stainless steel Racks provided.

CFR 21/ Part 11 Compliant Data Logger.

Complete PLC Based / Microprocessor Control System.

Aqua Mech Engineering Corporation 186/187, Central FAcility Building II, APMC Market II, Phase II, Sector 19, Vashi, Navi Mumbai - 400 703.

Tel.: +91-22-40490800 l Fax: +91 22-40490825 l Mobile: +91-9820198085 l Email: sales@aqumech.co.in l Website: www.aquamech.co.in

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EXPRESS PHARMA Experiment With The Truth Certified ISO 9001: 2008

A BENCHMARK FOR

ISO 9001:2015 CERTIFIED COMPANY

QUALITY SOLUTIONS

STABILITY CHAMBER

WALK-IN STABILITY CHAMBER

AUTOCLAVE-WINGNUT

PRODUCT RANGE l l l l l l

Autoclave BOD Incubator Bacteriological Incubator Cooling Incubator Deep Freezer Hot Air Oven

l l l l l l

Muffle Furnace Photo Stability Chamber Pharma Refrigerator Stability Chamber Vacuum Oven Walk-in Stability Chamber

Osworld Scientific Equipments Pvt. Ltd.

B-44, New Empire Industrial Premises, Kondivita, J. B. Nagar, Andheri (East), Mumbai - 400 059. India Tel.: +91-22-28320880 / 28390487 E-mail: info@osworldindia.com

B.O.D INCUBATOR

www. a. ldindi oswor com

To Advertise in

Business Avenues Please Contact: ■

Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■

Delhi: Ambuj Kumar 09999070900

■

Chennai ■ Bangalore:

Mathen Mathew/Amit Tiwari 09840826366 / 8095502597 ■

Hyderabad: Mujahid 09849039936 ■

Kolkata: Ajanta 09831182580

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PHARMA TECHNOLOGY REVIEW

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I N T E R V I E W

The pharma industry is looking to emerging markets for growth Agarwal Packers and Movers Ltd (APML), a globally recognised logistics company, recently ventured into the pharma logistics segment. Ramesh Agarwal, Chairman, Agarwal Packers and Movers, in an interaction with Sachin Jagdale, reveals more about his company’s growth strategies and future prospects APML is a well known name for shifting household goods. What prompted you to get into pharma logistics?

In almost three decades, APML has emerged as India’s largest mover of household goods. It has been recognised

by Limca Book of Records for four consecutive years, from 2012-2015.

Transport is one sector where no changes in work pattern have been observed.

Same old methods have been followed for ages, but with changing lifestyle and technology, we have to keep pace with other sectors.

APML has always been ready to accept changes and our R&D team has been highly innovative in estimating the needs of its clients. We, as a logistics partner, ensure that the processes and technologies being implemented adhere to quality assurance standards.

What kind of research did you conduct before venturing into the pharma segment?

A study conducted by BITS –Pilani found out that according to logistics industry standards, approximately three to four per cent of the vehicles breakdown during transit. As a result, goods need to be transhipped in another vehicle. Also, there have been instances where due to pressure of time-bound deliveries, transporters carried pharma or FMCG

require special training.

How have you overcome these challenges?

As mentioned above, all the procedures have been designed to provide shipper confidence in end-to-end shipping process for pharma products. A testament to the success of this multi-layered, high-visibility approach is that customers who started the journey with us as a pilot programme have continued to use 'Trucking Cube' for their temperature-controlled shipments.

products, in vehicles which might have been previously used to transport urea or any other hazardous chemicals.

Health hazards may arise when an unaware customer, without the knowledge of how the products have been transhipped, consume these products. The study confirmed that due to the above reasons, products lose their effectiveness.

Hence, zero transhipment during transit ensured that if food, pharma products and FMCG being transported are untouched and unseen then quality assurance yardsticks abided by companies remain intact. Hence, we thought of making 'Trucking Cube.'

How much do you plan to

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invest in 'Trucking Cubes’?

In 'Trucking Cubes', we will invest `100 crores in a phased manner in the next three years.

How will you use 'Trucking Cubes' in pharma logistics?

At 'Trucking Cube,' we have implemented a multi-layered, high-visibility system that combines state-of-the-art cubes with accredited, highlytrained cargo personnel in major cities across India. Our cubes are fitted with Air Circulation System (ACS) which maintains the air temperature in the cubes.

Pharma products have specific temperature requirements. Even the handlers of these products

Have you received any specific inputs from pharma operators?

Both domestic and global pharma companies follow stringent regulations and hygiene while manufacturing and packaging medicines at their respective units, yet sometimes we come across cases where medicines transhipped are not being effective.

"Potency/virulence/viabilit y goes down if and when bio-pharma goods are subjected to temperature excursion and 'Trucking Cube' will help to resolve supply chain issues. It will go a long way in a country like India, which has different climate and weather conditions," said Arumugam Muruganandam, Managing Director and Chief Scientific Officer, Affigenix, a Bengaluru-based lifesciences company.

Will you be taking care of reverse logistics as well?

At present, we have no plans to do reverse logistics. We will think of it two years from now.

Where do you see your pharma logistics business in the next five years?

Developed countries are considered mature in terms of pharma logistics. For growth, the pharma industry is looking to emerging markets like Southeast Asia, the Middle East etc. As these emerging nations have become more affluent, demand is increasing for modern medical treatments and healthcare products.

Lifesciences companies who were previously reliant on the developed countries are moving into unfamiliar territories and cultures, and discovering the accompanying supply chain challenges.

The shift in pharma growth, away from the established drivers towards high–potential 'pharma emerging' markets, offer tremendous opportunities for pharma manufacturers who face pressures in more mature markets.

In a developing country like ours, I think it will be a challenge due to unstable regulatory environment and less developed logistics infrastructure, but if we are able to innovate and read the necessities beforehand then it can be a smooth ride. sachin.jagdale@expressindia.com

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PHARMA TECHNOLOGY REVIEW

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I N T E R V I E W

GST is likely to bring down total cost as a percentage of sales by 1 - 1.5% India’s Logistics Performance Index (LPI) rank improved 19 places as per the LPI 2016 World Bank report and is set to improve further as the Goods and Service Tax (GST) bill is implemented. Vidhyasagar L, Asst General Manager, Corporate Ratings, Credit Analysis & Research (CARE Ratings), gives highlights of the impact of GST on the pharmaceutical industry and the interest of PE players in India's overall logistics sector, to Viveka Roychowdhury

As per the CARE report, 'Indian Logistics Industry gaining the traction', India’s logistic performance index (LPI) rank has improved by 19 places to 35th position from 54th position as per LPI 2016 report by World Bank.

What have been the factors behind this increase?

A country’s competitiveness is measured by the ease of doing business. India stands at 35th (improved from 54th position as per LPI 2014 report by World Bank) position in the Logistics Performance Index (LPI) amongst 160 countries around the world, with Germany on the top, Singapore, China and US in 5th, 9th, and 10th positions, respectively, as per the World Bank report 2016.

India’s logistics performance has seen a rise in all the six key performance indicators used to compute international LPI. The factors which led to growth in improvement of LPI includes increase in infrastructure (especially road, railways and ports) spending along with their successful commissioning, growth in investments and participation of international logistics players in Indian firms which attracted better technology along with rise in

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international shipments coupled with leveraging the established network of the investor and implementation of effective IT systems used for tracking and tracing of goods.

Has there been a corresponding improvement in pharma logistics like cold chain facilities, warehousing, etc?

Instead of using ‘cold chain’, it would be more appropriate to use ‘temperaturecontrolled logistics’ which covers more broader segments. The industry pertaining to temperaturecontrolled logistics is estimated to be about ` 1,50, 000 crore and is expected to grow at a CAGR of about 20 per cent during next three to five years as per industry experts. The major contributors for the growth in the aforesaid logistic segment would be larger use of goods falling under the categories such as pharmaceutical and perishable goods. The Indian pharma industry during FY12~FY16 has shown a significant change in the trend of operations by paying more attention to introduction of quality products in the market and part of that initiative is

increase in preference towards temperaturecontrolled logistics.

Thus, in an overall sense, the prospects of temperaturecontrolled logistics segment has been favourable and expected to improve going forward.

The implementation of Goods and Service Tax (GST) bill is expected to trim the logistic costs upto 20 per cent from the current levels. What will be the impact of the roll out of GST on pharma logistics?

The implementation of GST, in the longer run, is likely to bring down total cost as a percentage of sales somewhere between 1 to 1.5 per cent, depending on the company’s total logistics cost, which is determined by the product portfolio.

However, there is a market expectation that the pharma industry would pass on the partial benefit to the downstream, which remains to be seen.

As per the CARE report, the Indian logistics industry is projected to grow at a CAGR of 15-20 per cent during FY16~FY20.

What percentage of the sector could be attributed to pharma/life sciences logistics?

The Indian pharma industry

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has shown consistent growth during the past decade and has marked its presence having ranked third globally in terms of volume and 13th in terms of value. As per CARE estimates, the pharma industry attributes to about 15 per cent towards the entire Indian logistics industry.

India’s logistics sector has seen interest from PE players during FY15 and FY16, with two PE players, Mandela Capital and Asia Climate Partners investing into cold chain logistics (` 120 crore in GATI and ` 250 crore in Cold Ex respectively) But India still is fairly low, at 35th position, in the LPI. What are the government’s initiatives to improve this ranking?

During the last five years, the Government of India has been taking various initiatives in order to develop road infrastructure. The net road projects awarded by National Highways Authority

of India (NHAI) during FY16 have increased to 4368 km in comparison with 3250 km level of FY12. NHAI plans to increase both awards and execution of road projects in FY17 by four times over FY16 levels, i.e., with target execution of 8000 km (@21.92 km/day) and target awards at 15,000 km.

Furthermore, on account of various government initiatives, focus on hybrid annuity as well as engineering, procurement and construction (EPC) contract and structural changes in the concession agreement, CARE expects substantial increase in pace of award and execution of road projects during FY17 over FY16.

As per the Railway Budget for the year 2016-17, the capital plan has been pegged at ` 1.21 lakh crore. The railway ministry has given emphasis on rapid expansion of freight business to take up freight corridors: NorthSouth connecting Delhi to

Chennai, East-West connecting Kharagpur to Mumbai and East Coast connecting Kharagpur to Vijayawada. Apart from above, various initiatives such as setting up the broad gauge lines, capacity building plans and to improve the customer interface through IT systems to provide better quality of services have been taken up.

As a part of reviving the existing ports of the country, the Indian government has developed 10 coastal economic regions, which led to improvement in the capacity of all the major ports to 892.92 MMT as on January 31, 2016 (871.52 MMT as on March 31, 2015).

Furthermore, the government is taking up various initiatives such as investing ` 70,000 crore under ‘Sagarmala project’ in 12 major ports in the next five years, allowing upto 100 per cent FDI under automatic route for port development projects and providing

income tax incentives.

India, although gearing towards (being0 logistic friendly on its performance index, has been facing inhibitions that primarily include higher logistic costs and complex tax structure.

The implementation of GST Bill is expected to trim the logistic costs upto 20 per cent from the current levels, however, the persisting high logistic costs could only be resolved by development of logistics infrastructure.

Transportation alone holds 60 per cent share of the logistic industry and rest 40 per cent is contributed by warehousing, freight forwarding, value-added logistics, etc.

Thus, the growth in logistics sector to a large extent depends upon successful implementation of the aforesaid initiatives taken by the government.

Any specific measures that will impact/ improve life sciences logistics ?

It would be difficult to specifically pin down the impact of the measures taken by the government to improve the selective segment of life sciences logistics, however, there are other initiatives apart from the aforementioned which would help the industry grow. Indian pharma companies already have 100 per cent FDI under automatic route for greenfield projects, however, the same has not encouraged many investors in the past.

Therefore the government in order to benefit the pharma industry has raised the FDI for brownfield projects to 74 per cent under automatic route. This initiative by the government is expected to enthuse the global pharma players to invest in domestic companies leading to JVs, mergers or acquisitions, which in turn would benefit the entire stratum of pharma industry. viveka.r@expressindia.com

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'The plant has a manufacturing capacity of 30,00,000 sq ft of panels and 45,000 doors per annum' GMP Technical Solutions, in its continuing expansion strategy, started its new manufacturing unit (Unit-III) in Bhiwandi recently. The unit was inaugurated by R Vasudevan, its Group Managing Director. Express Pharma spoke to Ajay Mehta, Director, GMP Technical Solutions on the company's strategy behind opening this unit near Mumbai despite having two manufacturing units in Baddi, Himachal Pradesh

What made GMP establish a new manufacturing unit in Mumbai?

As you know, the pharma industry is on a sharp growth path in India. In the past few years, GMP has grown to a leadership position in the cleanroom partitions and cleanroom equipment industry. Since the growth of the pharma industry is expected to be robust in the next 10 years; there was an immediate need to increase the manufacturing capacity of our products to meet the growing demand.

In November 2015, we expanded our existing manufacturing unit in Baddi.

This new manufacturing unit (Unit-III in Bhiwandi) is the second level of expansion. The decision of selecting the Mumbai location was purely strategic. It will give us an edge for various markets in India like the South, the West and for exports too.

What is the manufacturing capacity of the new unit?

We have designed the plant for a manufacturing capacity of 30,00,000 sq ft of panels and 45,000 doors per annum.

Apart from this, the unit-III will also manufacture 720 units of cleanroom equipment per year. This has lead to

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approximately 30 per cent increase in our existing manufacturing capacity from our previous two units in Baddi.

from the Unit-III which will save time and inland freight costs too. However, if there is a capacity concern at some particular stage then the option of Unit-I and Unit-II are always open. We will work on the optimisation of capacity for all three units.

What kind of location advantages do you expect from this unit near Mumbai?

The unitâ&#x20AC;&#x2122;s location was decided keeping in mind some important markets. We will serve the markets of the South, the West and exports from this unit. This will result in better time commitments and savings in terms of freight, transportation time etc.

We are the only manufacturer with such hitech manufacturing unit for cleanroom partitions near Mumbai. This factor will benefit our clients and in turn, our business.

As you told that the unit will be taking care of majority of South, West and export markets; is there any technological advancement done in this new unit as compared to the other two units of GMP? Yes! This plant is with the latest technology available in the sheet metal industry. All the major machines are procured from the top known suppliers of the world. It is the only partitions and equipment

How do you see the cleanroom partitions and equipment market in next five years?

Our expectations from the domestic markets are very high. It will be on a growth path for the next ten years.

However, better government policies and industrial environment are necessary to boost this growth.

As regards to the exports, the markets have become very volatile and unpredictable due to many issues like currency crises, BREXIT, oil prices, civil wars etc. But, we are hoping for good growth in the export markets too in the years to come. manufacturing plant to have laser cutting machine procured from Trumph (Germany), turrent punching machine from Amada (Japan).

Both these machines have an accuracy level of 0.1 mm. The powder coating plant is procured from Gema (Switzerland), decoiling and

roll forming machines from Bulldog (UK) and has automatic bar coding system for all the manufactured products.

How much exports are you planning to do from this new unit?

We are planning to manufacture all export orders

What are the future plans of GMP? We believe in taking actions.

So, it is better we discuss this after taking the decisions. At the moment, we are excited for this new unit and will take all efforts to make it successful.

EP News Bureau-Mumbai

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‘We would like to spend the next few years concentrating on primary glass packaging’ Shreevar Kheruka, Managing Director, Borosil Glass Works, in an interaction with Sanjiv Das, talks about Borosil’s recent acquisition of Klasspack, its plans to leverage opportunities in pharma glass packaging and strategies to become India’s most customercentric company

By upgrading Klasspack's manufacturing facilities, we will deliver to the increasingly stringent norms required by the pharma industry. Our vision is to be a partner which provides reliable, high quality, on time primary glass packaging to our customers To subscribe: bpd.subscription@expressindia.com

Recently, Borosil announced the acquisition of 60.3 per cent shares in Klasspack. Why did you go in for the acquisition?

At Borosil, our endeavour is to be India’s most customercentric company. Borosil has been a trusted supplier of high quality products for the Indian pharma industry for the past 50+ years. In feedback sessions, our customers have indicated to us that there is an opportunity to supply them high quality pharma glass packaging products owing to an increased requirement of compliance in the industry.

Based on this input, we looked at various options for entering this sector including a greenfield project. However, when we came across Klasspack, a company that has many of the same value systems as Borosil, it seemed a natural point of entry into this space.

With compliance becoming increasingly stringent in the Indian pharma sector, what made Borosil Glass Works enter the primary pharma glass packaging business?

We see compliance stringency

as an opportunity. Borosil currently provides glassware to pharma laboratories. We pride ourselves on accuracy and traceability, with some of our products delivering an accuracy of 0.006 ml. We have always worked to provide products that far exceed compliance demands and we are confident that by upgrading Klasspack’s manufacturing facilities, we will deliver to the increasingly stringent norms required by the pharma industry.

Klasspack already had a strong reputation for service and product development. Our vision is to be a partner which provides reliable, high quality, on time primary glass packaging to our customers.

Do you also plan to enter the secondary and tertiary pharma packaging business in future?

Primary packaging is a large market with a huge opportunity for us. We would like to spend the next few years concentrating on primary glass packaging.

Why do you think pharma companies will be keen to use your packaging products?

As with all customers, pharma companies will accept us if we provide value. Borosil stands for trust, and we will upgrade the manufacturing facilities with clean rooms, world class machines, automatic lines and automated vision inspection systems. If we execute these plans well, there is no doubt that our customers will support us.

Are there plans to set up any new facilities besides the one located in Bharuch, Gujarat?

Borosil group already has large facilities in Jaipur, Bharuch and Tarapur.

However, for the primary glass packaging space, Klasspack’s Nashik facility has significant capacity to accommodate our immediate and near future plans.

Any additions to the core team after the acquisition?

While our existing team is very competent to execute immediate growth plans, Borosil is always on the look out for motivated and competent individuals who can contribute during this exciting phase of the company’s growth. sanjiv.das@expressindia.com

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VALUE ADD

Optel Vision launches Open SiteMaster OPEN SITEMASTER (OSM) 2.0 is Optel Vision’s new interoperable site server software for serialisation data management. Located at the plant level, OSM masters the entire serialisation process, streamlining the data exchanges between various systems, while adapting to your specific IT environment and business logic.

Expert serialisation functions OSM offers all the features and capabilities a branded or generic pharma may need, and takes them to the next level, allowing you to fully control and oversee all serialisation actions. ◗ Process order repository: OSM can request or directly receive process orders from the ERP system to handle and allocate them for local packaging. ◗ Serial number management: Right out of the box, OSM supports several types of coding: SGTIN, SSCC and custom serial numbers, as well as barcodes such as GS1 Application Identifiers, Chinese ECode, Brazil IUM, Data Matrix, etc. Moreover, OSM can allocate serial numbers in different ways—sequential, random, prerandomised, or shuffled. It can also cache serial numbers for multiple lots; restock when set threshold is reached; obtain serial numbers on a lot basis; and even generate numbers locally. ◗ Serialisation Reporting (EPCIS): After a serialised batch, OSM can locally store and display various reports—reconciliation, performance, inspection, batch, audit—for all lines and send them to the serialisation database or corporate EPCIS repository. Plus, OSM has the unique ability to act as a temporary in-batch EPCIS repository for a broken flow or a palletising room. ◗ Production Master Data (Recipes): With OSM, production parameters can originate

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OSM encapsulates all of OptelVision’s proven expertise in serialisation and aggregation,complying with the numerous laws and legislations around the world.

Acting as a hub that coordinates actions for your plant,OSM gathers data from the packaging lines and communicates information and workorders through the existing ERPand up to the corporate level,getting serial numbers and sending back EPCIS reports.

In addition,OSM can be customised as needed and can connect to anysystem and anypackaging line — which means no vendor lock-in!

from the ERP, OSM master data, or a combination of both. ◗ Central Configuration Point: OSM can be a single point of entry for all line set ups — no need to go from line to line. One can create recipes; establish batch flow configurations; set up multiple flows; assign recipes to customers or markets; set triggers; add more steps to your process (e.g., pallet, shipping); select report

formats, etc.

Plus, the agility of open scripts To maximise customisation, OSM includes an exclusive open scripting feature that allows it to accommodate each and every unique process and IT environment. This includes connecting to any system and any vendor, allowing you to control all the different applicable

machines on your lines, under one serialisation umbrella.

In addition, these opensource script files enable you to extend OSM's functionalities and IT connectivity as required.

Using Python, your IT professionals can create all the scripts needed for OSM to run according to your specific infrastructure. There is one script per connection, and an unlimited number of connections are

permitted, allowing you to interface with as many corporate repositories as you need. And the best part is that any time an IT interface changes, only the associated script must be updated—not the entire system.

Contact details http://www.optelvision.com/ solutions/open-sitemaster/ http://www.optelvision.com/ contact/

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INSIGHT

Pharmaceutical serialisation: It’s more than meets the eye Siddhant Bhambhani, Product Manager, ACG Inspection Systems, highlights about the benefits of serialisation other than mere regulatory compliance and also proposes few directions for efficient implementation of serialisation

C

ounterfeiting of medications is a major problem faced by the global pharmaceutical industry. As per WHO estimates around 30 per cent of the medicines sold in developing countries are counterfeit.i Owing to globalisation, the supply chain for medicines has become lengthier with every step offering another opportunity for counterfeiters. As a result, global track and trace requirements have become stringent putting tremendous pressure on the supply chain’s transparency. Pharma companies do believe that counterfeiting can be reduced significantly by implementing product serialisation. Serialisation requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Therefore, serialisation is often looked upon as an effort and cost-intensive process and often a regulatory mandate.

and information technology to not only ensure regulatory compliance, but also use this for their own business gain: safeguarding brand reputation and ensuring patient safety to name a few. Serialisation and traceability can also be used for effective management of supply chain and management of medicine inventory at wholesale and retail levels.

Serialisation: Looking beyond regulatory compliance

◗ Improved processes Serialisation and traceability can standardise and harmonise operational processes in across manufacturing units, warehouses and distribution hubs, resulting in smooth operations.

It also assists in scanning and removing expired, faulty or damaged product ensuring that only genuine product reaches the consumer. Further, it helps manufacturer by preventing revenue loss occurring due to recall of faulty or damaged product. Track and trace system can help in finding the exact reason for the damage of the drug.

Using serialisation as a business strategy

Serialisation projects are primarily driven by regulatory compliance. However, pharma companies can unlock additional value if they implement the serialisation projects with a holistic view and considering serialisation as a business strategy as against compliance need.

Pharma companies are now increasingly adopting a strategic business view for overall adoption of serialisation. They have started developing packaging

◗ Protecting brand reputation Counterfeit drugs pose a huge risk to pharma companies.

It not only affects potential sales, but also leads to deterioration of brand reputation and brand value. Brand reputation is of utmost importance for the pharma industry, as compromised drugs can potentially harm the patients’ health.

Therefore, serialisation and traceability allows pharma companies curb counterfeiting and protect the brand image.

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◗ Ensures better control over parallel trading Parallel trading is when goods are bought in low price and sold in the market when their price increases. This is considered as an illegal process in certain industries where the cost of the product is a cumulative of the actual cost and additional import and export taxes.

Track and trace is quite useful to curb parallel trading.

Serialisation is a cost-saving exercise Serialisation and track and trace projects are often perceived as a process that leads to loss of revenue. This loss is majorly due to loss of time due to complex serialisation framework and equipment handling.

Often pharma companies do not

consider the upside to implementation of serialisation projects. Currently, the global counterfeit drug market allegedly makes for approximately $200 billion. Successful implementation of the serialisation projects can help curtail the problem of counterfeiting saving restoring the revenue lost due to counterfeit medicines.

Serialisation also helps eliminate manual errors, such as incorrect entry of GTIN or batch numbers (prevalent in manually operated machines), that are linked with loss of productivity.

Furthermore, loss of time due to human intervention adds to the loss of production and subsequently revenue. Automation in the serialisation machines can minimise the loss of productivity; however, these machines are expensive.

Four directives for effective implementation of serialisation

◗ Use master data management effectively In the pharma industry, data pertaining products, such as APIs, the production facility, product packaging or product market information is managed inconsistently without a proper structure. This is because data management entails substantial data governance and project management hurdles. However, the scenario is changing with pharma companies embracing Master Data Management (MDM) by investing in data harmonisation and analysis solutions after realising the myriad benefits including business and customer relationship benefits.

It is important to integrate serialisation in master data management. Data pertaining to serialisation enables product authentication for trading partners, dispensers and government agencies. However, most companies disregard fundamental aspect of MDM laying emphasis at only on applying serial number to the products and then on transactional data.

However, it is important to apply efforts beyond just getting a number on a package and set up a structured and clearly-managed master data. ◗ Understand that serialisation is a cross-functional endeavour The process of serialisation is not (and should) be restricted to a particular department.

Adoption and effective implementation of serialisation involves strategic integration of various departments, primarily the packaging, quality control, distribution and IT departments. For example, serialisation necessitates packaging team and IT to communicate in a bi-directional. As discussed earlier, serialisation creates value beyond regulatory drivers. Therefore, effective crossfunctional efforts during strategy, planning, deployment and operation stages can ensure efficient and cost-effective implementation of serialisation. ◗ Understand cross country serialisation regulations to be global ready Understanding cross counContinued on Page 173

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Serialising it right Anand Modi, VP Sales, India, TraceLink, outlines the five key issues that Indian pharma manufacturers need to consider while building serialisation programmes to make them more effective and efficacious SERIALISATION AND track and trace regulations are now a strategic requirement for the pharmaceutical industry. By 2019, over 75 per cent of the global drug supply will be covered by requirements for drug serialisation, supply chain traceability, and government reporting across more than 40 countries ranging from India, and the EU member states to the US, South Korea and more. Whether a company owns drug product authorisations for a market, manufacture and package finished dose medicines, distribute medicines across the supply chain or dispense medicines to patients, every partner within the pharma supply chain will be faced with myriad diverse and often conflicting regulations.

As the 2017 US DSCSA deadline approaches, Indian pharma companies are preparing to face unparalleled complexity, cost and risk in implementing strategies to build a serialisation infrastructure that encompasses their entire manufacturing facilities.

When medicines are produced, packaged and readied for shipment, the life sciences cloud manages all serialisation requirements and serialised product inventory data exchanges internally with packaging facilities and warehouses and externally with CMO/CPOs and 3PLs. As medicines are shipped to the target markets, life sciences cloud configures and shares the required compliance data and reports with downstream trade partners and governmental organisations.

DSCSA regulations and timeline The Drug Supply Chain Security Act’s (DSCSA) ten year timetable outlines critical steps to build an electronic, interoper-

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able system to identify and trace prescription drugs from manufacturer to dispenser across the supply chain serving the USmarket. Implementation of the forty pages of complex DSCSA regulations can be broken down into three general phases: ◗ 2015: Lot-level traceability and verification of products and transactions ◗ 2017-2020: Serialisation of drug products and enhanced verification of serialised product identity ◗ 2023: Unit-level traceability On the surface, preparing for DSCSA serialisation deadlines doesn’t seem that challenging – at least in comparison to other global serialisation regulations.

Pharma companies and their CMO/CPO partners must generate serial numbers for each saleable unit and sealed homogeneous case of drug product produced. The serial numbers with associated National Drug Codes (NDCs), lot numbers, and expiration dates need to be encoded into 2D data matrix barcodes (for units) and either 2D data matrix or linear barcodes (for cases) following generally recognised industry standards.

There are five key issues that Indian pharma companies need to consider as they build their serialisation programmes:

Take a top-down, network approach – Beginning with level 4 and level 5 When determining a strategy for serialisation, the tendency is to start at the package level and focus first on placing the barcode label. However, serialisation goes far beyond simply printing bar codes on a package.

Instead, pharma manufacturers should think from the top-down, determining all of the external compliance requirements that will need to be met, the systems

that will have to be integrated and the data flows that will need to be managed.

For the serialisation system as a whole, there are multiple interconnected levels of systems which must synchronise together, including the Network, Enterprise, Site-level, Line/Warehouse, and Devicelevel systems. Leveraging interconnectivity and interoperability at every level of the stack (Levels 1 - 5) is important. When specifically implementing serialisation, Level 4 (enterprise system) and Level 5 (network system) are essential systems that enable all regulatory data and business processes throughout the enterprise and beyond, to partners, customers, and regulatory authorities.

Below is a breakdown of the different levels within a packaging line and the roles in serialisation: ◗ Levels 1 -3 (line management system): These systems are provided by line management system (LMS) vendors. ◆ Level 1 includes the physical packaging lines with devices such as printers, cameras, scanners, lights, integrated into machines that produce cartons, cases and pallets. ◆ Level 2 and Level 3 are the line controller and site server, providing capabilities at the packag-

ing line and packaging site level, which only assists with the application and verification of serialised packaging. ◗ LMS vendors providing levels 1 – 3 do not maintain repositories to retain previously commissioned serial numbers for the required regulatory data retention period (for example, 12 years in the US). Some will purge all records associated with the previous batch upon line changeover for the next batch, while others will purge upon shipment or shortly thereafter.

Since the LMS isn’t storing this data, there is no ability to check for duplicates against previously commissioned serial numbers from prior batches. ◆ Level 4 (enterprise system) and Level 5 (network system): Prior to serialisation mandates, the focus was only on the product. Realising that each serialised product that is shipping now also requires an accompanying ‘shipment of data’ has expanded attention to the Level 4 and 5 systems that need to be in place. ◆ Level 4 allows for the management of serialised inventory after it leaves the line, storing all previously commissioned serial numbers in an active available state allowing for immediate verification upon commission.

This layer of visibility ensures that no duplicate serial numbers exist from previous batches, offering protection against significant compliance risk.

A Level 5 system provides a supply chain track and trace serialisation data event repository, enabling a secure and accurate data exchange at the correct event trigger across multiple sites.

Serialisation forces supply and trade partner networks to evolve

Indian pharma companies will need to understand all potential network connections (internal, supply, trade, governmental) over which serialisation information needs to flow, not just internal packaging site or CMO/CPO links, in order to understand the regulatory and business data flows that an infrastructure needs to support. The serialisation infrastructure will likely have to support a surprising diversity of data types, connection methods, business preferences and regulatory interpretations across various network relationships.

For DSCSA, there will be multiple serial number requests and responses with the different packaging line systems, commissioning events will need to be captured and potential aggregation data exchanges managed as product travels from packaging line to packaging site warehouse, through internal warehouses and into 3PL facilities.

Shortages, damaged product and other exceptions need to be dealt with in new ways where serialised product is involved.

Downstream, pharma companies may have to send aggregation data to direct trade partners and capture and respond to SNI verification inquiries from any entity that has the product in their possession. Each of these partners may have its own preferences, system capabilities or interpretations which can impact how the serialisation system is designed and how the packaging lines are deployed.

Serialisation creates unprecedented scalability challenges Today, the pharma industry is accustomed to work on batches, where shipping a batch of 10,000 units requires just four simple transactions. The batch is cre-

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ated, the pallet is picked and shipped and an advanced shipping notice (ASN) is sent.

However, serialisation requires the management of a unique identity for every single product. Now, this shipment of a 10,000 unit batch will require at least 60,000 database transactions to be processed in order to update the data corresponding to every single unit. Provisioning serial numbers will require 10,000 transactions and commissioning the batch will be 10,000 more. And new tasks, such as aggregation or shipment notifications, introduce thousands of new transactions. The bottom line is that the four transactions completed today to ship 10,000 units will be – at minimum – 60,000 transactions in a serialised world. And as the transaction volumes expand, so will the information processing requirements: they will be 15,000 times more and the size of the database will be 5,500 times larger, for the same volume of products shipped today.

Most solution providers use an EPCIS scheme with a relational database management system (RDBMS) for serialisation. Maintaining performance in a relational database focuses on keeping the number of rows at a reasonable level, sized ac-

cording to the hardware that is available. Typically, all the processing of a relational database goes through a single machine.

To do this, database administrators are forced to invest time and effort managing the number of rows in their database to maintain performance. If they don’t, they run the risk that performance degrades so far that the database stops working altogether. The only other option in these cases is to scale up, which means they must acquire bigger hardware and more powerful machines.

Even if your company manages low volumes, a RDBMS will begin to fail when handling the exponential rate in which serialisation data is created and replicated across tables, along with the transaction processing speeds required to perform at operational scale.

In the case of serialisation, pharma manufacturers cannot risk performance, otherwise product will cease to ship.

Knowing that RDBMS won’t scale, a majority of the pharma companies facing serialisation requirements have quickly realised that NoSQL is the preferred approach. Used by Facebook, Twitter and Google, NoSQL is a non-relational database widely recognised for its

high scalability and performance that remains near-constant, regardless of the data store.

When evaluating serialisation providers, pharma manufacturers should ask for a demonstration on serial number provisioning, commissioning, aggregating, shipping, and read/write speeds on a database containing several years of accumulated data. A demonstration on a clean, empty database - or a pilot that doesn’t reflect anticipated daily volumes - will not provide any insight into the solution’s operational scalability and performance and may likely raise a red flag.

Serialisation fundamen tally changes how a company conducts business It’s crucial to reach out across the organisation, from quality and artwork, to supply planning, trade relations and commercial operations, to understand how corporate functions are impacted by serialisation. Continuous education on serialisation regulations and their implementation rules, data standards and industry implementation trends across the organisation is important to gain informed feedback on organisational needs, preferences and requirements to optimise serialisation planning. For

example, good distribution practices in the warehouses may conflict with the needs to maintain aggregation relationships across the organisation.

Most companies will undergo a transition from lot-level identified to serialised product over time. So the systems, processes and connections to supply and trade partners will need to be flexible in managing both serialised and lot-level product throughout an organisation and network.

Serialisation preparation timelines are always longer than they appear Enabling a packaging site for serialisation is a long and complicated project. In fact, many companies have started planning for serialisation 18 months ahead of the November 2017 deadline. In order to leave enough time to test new systems and processes, as well as make any necessary adjustments. The preparatory work is multifaceted and not accounting for all factors could lead to a flawed implementation.

Depending on product stock levels and velocity through the supply chain, it may take months to bleed out existing lot level product from internal warehouses and external distribution

sites. Existing supply plans need to be incorporated to determine how often production runs are executed, how long they take and when existing production lines can be idled for retrofit.

Rarely can all serialisation lines be upgraded in parallel due to cost or resource constraints.

So, projects must be staged in phases. As each line and site is being serialisation-enabled, it must be integrated into the internal serialisation architecture linking the enterprise systems, warehouse management systems, edge devices and trading partner systems across which serialisation data and serialisation events must flow. This places a requirement on the business to understand how this architecture should be developed well in advance of line deployment. With only one year left before the DSCSA serialisation deadline for pharma manufacturers, there are still many issues to address.

The requirements far exceed just putting numbers on bottles, as those that have started serialisation projects can attest. Indian pharma companies that need to comply with DSCSA regulations should be starting now and building a strategic plan to meet both DSCSA and global regulatory requirements.

Continued from Page 171

Pharmaceutical serialisation... try regulations for serialisation, track and trace is very important for the pharma companies to be global ready. Countries across the globe are defining their own regulations for serialisation, track and trace. However, currently there are no globally standardised regulations. As a result, pharma companies have to comply with different regional regulations to export their products. For instance, the US does not mandate parent child aggregation under its norms, whereas, the upcoming European regulations do. To bridge this gap, and to fa-

cilitate export of the pharma products, it is of paramount importance for the pharma companies to be well versed with the local as well as regional regulations. Accordingly, pharma companies must adapt their IT infrastructure, production levels, packaging lines solutions and business processes.

Consulting companies provide traceability solutions through track and trace systems and applications. This is to ensure pharma companies are compliant to key compliance requirements such as 21 CFR Part 11, GMP etc.

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◗ Select the right partner Adopting serialisation is a highly complex process. Selecting a right partner plays a critical role in the success of serialisation projects. Different countries have different requirements for serialisation based on the regional needs.

Furthermore, track and trace and defining parent-child relationship is also mandated in some countries like India, Turkey and South Korea. This generates a need for a partner that specialises in that region for implementation of serialisation. To cope up with this,

companies have started providing multi-country, multilanguage solutions in serialisation. It is important for pharma companies to select serialisation partner prudently based on its expertise in cross country regulations at various levels of packaging.

Conclusion Serialisation and traceability is a complex process. However, an efficiently implemented serialisation and traceability processes can offer benefits that are beyond regulatory compliance such as patient

safety, safeguarding brand equity and reduce revenue loss.

Diligent data management and an integrated approach to serialisation can help in proper implementation. However, there are companies who have experience in both pharma and inspection technologies that can smoothen the process and ensure cross-country regulatory compliance. It is essential for particular pharma companies to partner with trusted and experienced solutions provider to achieve successful serialisation and traceability.

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INSIGHT

Generic drugs: Make an impact with advanced coding and marking technologies Nicola Rapley, Global Marketing Manager for Pharmaceutical and Medical Devices, Videojet Technologies, looks at coding and marking technology in the generics market and the importance of selecting a knowledgeable integration partner THE USE of generic drugs has never been more prevalent. With the expiration of more and more patents from the so-called blockbuster drugs, pharmaceutical manufacturers are able to reproduce these expensive branded products and market them at a far lower cost, as the product itself has been developed, formulated and approved already. A report by IMS Health, Global Medicines Use in 2020: Outlook and Implications1, highlights that by 2020 the global volume of medicines used will reach 4.5 trillion doses. Generics will play a key role in this rise, with an overall annualised growth rate of 10.6 per cent, and with an aging population and rising healthcare costs to consider, it isn’t hard to see why. As an example of the huge volumes used, in the US alone generic drugs are expected to be used to fill 91-92 per cent of all dispensed prescriptions by 2020.

This is good news for the manufacturers of generic drugs in terms of volume sales, as it is the volume which needs to remain profitable, but pharma manufacturers must all adhere to the strict and vast array of regulatory requirements – such as serialisation and track and trace – regardless of their size, which in turn has cost implications on a production line. Margins are much tighter in the generics market, with high demand in terms of production schedules, therefore every second of productivity that can be gained is vital to the bottom

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line. Unscheduled downtime and product wastage due to poor coding is highly undesirable.

Preferred technologies Uptime, reliability and legibility are key, and many pharma manufacturers will lean towards Thermal inkjet (TIJ) or laser marking systems due to their suitability to the ‘clean’ manufacturing environment.

Thermal inkjet systems available on the market today give a high quality, high resolution print at up to 600 x 600dpi and are simple to use and simple to maintain. Systems are capable of printing multiple

Nicola Rapley, Global Marketing Manager for Pharmaceutical and Medical Devices, Videojet Technologies

very little maintenance. Given the clean environments synonymous with the pharma industry, lenses can often be left for significant amounts of time before cleaning is required, reducing downtime.

Laser is considered to be a completely clean technology as there are absolutely no consumables to take into consideration. A new CO 2 laser is due to enter the market this

Margins are much tighter in the generics market, with high demand in terms of production schedules, therefore every second of productivity that can be gained is vital to the bottom line linear and 2D bar codes, including DataMatrix, QR, GS1, PPN and HIBC, at speeds of up to 300m per minute (984ft / min). On certain systems, up to six printheads can be added (with any four printing simultaneously), enabling electronic changeover between batches that require different print locations or packaging.

Removing the requirement for manual print-head setup to change print locations means that changeover times can be reduced significantly, leading to higher throughput

levels for the manufacturer.

The risk of operator errors occurring due to manual intervention is also taken out of the equation. New inks are in development constantly, such as Flex Solvent. This new solvent ink for TIJ applications opens up new opportunities to mark more durable codes on non-porous substrates that were previously difficult to mark, such as bi-axially oriented polypropylene (BOPP), for example. Laser coders are also popular due to their ability to code continuously with

year which, as a result of listening closely to customers’ challenges and requirements, has been developed to increase throughput capabilities. It will feature rapid data processing capabilities that will allow the system to produce complex codes at speeds not seen from a 30 Watt laser in pharma production.

Working in partnership It is impossible to achieve high levels of productivity if the coder on the line is not efficient and implementing these

systems effectively needs to be a swift and organised process. Many generics manufacturers are small to medium sized enterprises, who must take on the challenges of serialisation, for example, internally in order to comply with regulations such as the Drug Supply Chain Security Act (DSCSA) for the US market and the Falsified Medicines Directive (FMD) in Europe.

The legislation applies to all pharma manufacturers, so the necessary steps must be taken to ensure compliance with the timelines as set out.

Profit margins, as we have mentioned, are tight, and to add additional equipment to facilitate new regulations adds to production costs therefore, optimising production lines is a priority. Finding a partner who is able to support that process from start to finish has significant benefits, as the smoother the transition, the less downtime will be experienced. Having the backing of a global service network is something to be mindful of, as is finding a partner who has significant experience in implementing serialixation solutions and the structure in place to deliver to requirements – from a single coding unit to a turnkey project.

PHARMA TECHNOLOGY REVIEW One Brand Total Solution

VENDOR NEWS

Ashland opens pharma technical centre in Shanghai The centre will help companies operating in China to improve the performance of tablets and other solid dosage forms ASHLAND HAS formally opened its pharmaceutical technical centre in Shanghai, China. The state-of-the-art complex now accommodates all the scientists and equipment Ashland requires to solve complex challenges for China’s producers of solid dosage forms.

Doubling the size of the original complex built in 2008, Ashland is now able to provide a range of pharma technical services to create and apply specialised chemistry in ways that enable customers to amplify the efficacy, refine the usability, add to the allure, ensure the integrity, and improve the profitability of their products and applications.

These include binding enhancement, disintegration improvement, modified release, solubilisation and film coating in China, to help companies operating in the country to improve the performance of tablets and other solid dosage forms.

Speaking to an audience of more than 80 guests during a dedication ceremony, William A Wulfsohn, Chairman and

William A Wulfsohn, Chairman and CEO, Ashland, speaks at the recent pharma and nutrition technical centre opening in Shanghai

CEO, Ashland expressed the extra value that the company brings to China’s pharma industry with an advanced facility and technical team firmly grounded in science-based solutions.

Ashland currently oper-

ates three pharma technical centres throughout the world, including one in Wilmington, Delaware (US), and one in Hyderabad, India. All three facilities operate individually – and in tandem – for the benefit of Ashland’s customers work-

ing regionally or globally.

Scientists at Ashland’s Shanghai facility now use more advanced equipment on site to help customers in Asia enhance the solubility and bioavailability of sophisticated drugs with novel applications

of excipients – the inactive but functional substances that serve as drug delivery systems.

David Neuberger, Vice President of Pharmaceutical, Nutrition and Agricultural Specialties, Ashland, expressed the importance of a full-service laboratory in Shanghai that enables the full and proper use of Ashland’s excipients in today’s more complicated world of oral drug formulating.

The company is set to produce its Klucel HPC, Plasdone PVP, and Polyplasdone PVPP brands at its Nanjing complex.

Besides, the company is ready to assist the food and beverage industry in the Asia Pacific region with a range of technical solutions following the completion of an expansion project at its technical centre. The new state-of-theart equipment is in place that affords food scientists at Ashland the ability to work closely with dairy, bakery, beverage and meat product makers to solve complex formulation and processing challenges.

EP News Bureau

ASHLAND REVEALS NEW 'ALWAYS SOLVING' CORPORATE IDENTITY New Ashland brand signals acceleration of corporate mission ASHLAND HAS separated from Valvoline, revealing its new 'Always Solving' corporate identity and unveiling the organisational culture that will continue to differentiate the company as it continues its mission to become the premier speciality chemical company in the world.

“We’ve been on a thoughtful and determined journey since announcing plans to separate Valvoline and Ashland into two great standalone companies,” said William A

Wulfsohn, Chairman and CEO, Ashland.

Along with his global leadership team, Wulfsohn developed a competitive strategy which empowers each of Ashland’s chemical businesses to develop its own comprehensive strategic approach as to where to compete and how to win in their marketplace. Each will employ its own core competencies in specialised problem-solving that brings real and consistent value to customers. To-

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gether as one global team, Ashland will build a high-performance organisation focused on innovation, commercial excellence, world-class operations, and disciplined capital deployment. Its foundation will continue to be built on safe, compliant and responsible operations, its winning strategy, and operating as a high-performance organisation. Ashland will continue fostering growth through a pipeline of innovations and sales opportunities, and continue

capturing value delivered to customers while driving its cost competitiveness.

The most public facing element of the evolution of Ashland, is its new corporate identity – Always Solving – which reflects the company’s positioning and people across diverse industries as broad as pharma to automotive, personal care to paints, adhesives to biofunctionals, and more.

EP News Bureau

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Pelican BioThermal expands Asia operations Launches a new network of distribution partners in the region PELICAN BIOTHERMAL, a global leader providing the largest range of innovative temperature-controlled packaging solutions serving the life sciences industry, has expanded its operations in Asia with the launch of a new network of distribution partners in the region.

Pelican BioThermal has joined forces with the region’s distinguished distributors, Pharmaserv Express of the Philippines and CMC Element of China, to further enhance its operations in Asia. Pharmaserv Express works closely with national health services to skillfully transport pharmaceutical products throughout the complex geography of the Philippines. CMC Element

The new industry partnerships with these key distributors signals another major development in Pelican BioThermal’s expanding presence and support network in Asia, further enhancing the extending range of products and services offered by the company in the region distributes a variety of healthcare products, including pharmaceuticals protected in temperature-controlled packaging, across the vast Chinese market using their extensive network.

The latest development demonstrates Pelican Bio-

Thermal’s continued growth in Asia and follows the company’s recent launch of its new operational facility in Singapore.

The new industry partnerships with these key distributors signals another major development in Pelican

Waters in agreement with SOTAX Group The agreement will give SOTAX distribution rights to Waters ACQUITY UPLC H-Class System within small molecule pharmaceutical accounts WATERS CORPORATION has entered into an agreement with the SOTAX Group, a global developer and manufacturer of equipment for dissolution testing, automated sample preparation, and physical testing of pharmaceutical dosage forms. Under the terms of the agreement, Waters will make available to SOTAX its ACQUITY UPLC HClass System for sale to drug manufacturers performing small-molecule, solid-dosage analysis in quality control and analytical research and development.

“Improved sample preparation to keep pace with the

176 EXPRESS PHARMA November 16-30, 2016

speed of our ACQUITY UPLC instrumentation platform has often been requested by our customers,” said Mike Harrington, Senior VP – Global Markets. “This new collaboration links Waters and SOTAX technologies enabling our mutual customers to streamline their analysis, characterisation and preparation of pharma samples, and improve their productivity and profitability.”

Under the terms of the agreement, Waters licenses SOTAX as an independent distributor for the Waters ACQUITY UPLC H-Class System. SOTAX will market, sell

and distribute the ACQUITY UPLC H-Class System through its own direct sales force to pharma laboratories in the following countries, the US, Canada, the UK, France, Germany, Italy, Switzerland and the Czech Republic.

“Working closely with Waters will allow us to generate significant value for our mutual customers in the current, data integrity driven environment. We are excited to have been selected by Waters to collaborate in the dissolution testing and sample preparation space,” said Patrick Ballmer, VP, SOTAX Group.

EP News Bureau

BioThermal’s expanding presence and support network in Asia, further enhancing the extending range of products and services offered by the company in the region. In particular, the new distributors enhance customer support for global customers shared with

Pelican BioThermal, by offering local hours, local language and local service and inventory at the point of final distribution of pharma products.

The increasing network of distribution partners complements the company’s newly established Asia headquarters, which is co-located with Pelican BioThermal’s authorised distributor for Singapore, Enviropac.

The region continues to be an area of pronounced growth for Pelican BioThermal and forging links with these wellestablished distribution partners will increase the company’s global reach and support network for customers.

EP News Bureau

Domino Printech India organises knowledge forum in Gangtok The forum was attended by the top management of organisations like Torrents India, Sun Pharma, Zydus, Alkem etc DOMINO PRINTECH India recently organised a knowledge forum, ‘Variable Data Coding and It’s Compliance’ in Gangtok, Sikkim. The forum was attended by the top management of organisations like Torrents India, Sun Pharma, Zydus, Alkem to name a few. Domino Printech had demonstrated thermal inkjet printer from its product portfolio which is ideally suited for pharma industries for coding alphanumeric text along with 1D/ 2D data matrix, logo or graphic on to primary and secondary packs.

Domino demonstrated TIJ product features apart from few other technologies, which were appreciated by customers. Domino Printech was supported by event partners Cognex who demonstrated its entire range of Machine Vision system and Sundaram Technologies.

The idea was to create a platform to understand the needs and challenges of customers in pharma for coding and marking, vision system and track and trace.x EP News Bureau

PHARMA TECHNOLOGY REVIEW One Brand Total Solution

eClinical Solutions launches self-service analytics platform The platform will provide an end-to-end solution for biotechnology, pharma companies and other life sciences providers ECLINICAL SOLUTIONS, provider of end-to-end data management services and technologies announced the release of their data Intelligence Hub – elluminate. This fit for purpose platform provides an end-to-end solution for biotechnology, pharmaceutical companies and other life sciences providers looking to leverage the power of the data they are already collecting without going through a time and cost intensive implementation effort. elluminate is a cloud-based data intelligence hub with an ability to integrate diverse datasets from different clinical systems and data sources and combines them seamlessly to help users access powerful ana-

lytics. The platform has been designed to open up an unlimited possibility for data analysis across a broad cross section of stakeholders. Companies can implement the entire platform or select capabilities below based on the needs of their organisation. ◗ Clinical data analytics Facilitate data exploration to identify trends and outliers while providing traditional line listings, descriptive statistics and visual patient profiles. ◗ Clinical trial operations analytics Monitoring for deeper insights into the operational health of clinical trials, delivering access to trial performance across multiple data streams in one integrated view.

◗ Risk-based monitoring Utilise central monitoring practices and implement riskbased monitoring based on TransCelerate BioPharma and other strategies that enable insights into the risk aspects of clinical trial data quality, monitoring and site performance.

Elluminate was launched in 2011 as a clinical data repository and subsequent collaborations with customers and service organisations coupled with significant investment in R&D has resulted in this next generation platform. elluminate enables clinical teams to achieve deeper insights in real-time allowing organisations to achieve their business goals.

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Phenomenex to be acquired by Danaher Corporation Phenomenex will operate as a standalone operating company PHENOMENEX HAS signed a definitive agreement to be acquired by Danaher Corporation, a Fortune 150 science and technology company. Phenomenex will operate as a standalone operating company, retaining the Phenomenex brand, its personnel and site locations.

Phenomenex is a leading player in proprietary chromatography consumables, serving the liquid and gas chromatography market. Over the past 30 years Phenomenex has grown to become a leader in the market with more than 7,000 products supporting a broad diversity of applications in drug discovery and development, clinical research, forensic toxicology, petrochemical, environmental analysis and food safety. Its more than 700 employees sell and provide support into 92 countries through direct and distributor channels.

The transaction, which is expected to close by late 2016, is subject to customary closing conditions and regulatory approvals.

EP News Bureau

WHITE PAPER

Benefits of computerised dispensary John Roberts, Technology Director, CI Precision explains the role of a computerised system of dispensing medicines to enhance GMP compliance during manufacturing of pharma products THE CHALLENGE is to ensure that the correct quantity of an approved raw material of known origin and quality is used during the manufacture of pharmaceutical products.

The conventional approach requires a standard operating procedure to be followed by a first person and the details of the weighing recorded with a second operator acting as a checker.

With a computerised system, the operator is guided through a predefined se-

quence of checks and actions and is not allowed to proceed if any of the checks fail. Accurate details of the weighing are recorded automatically, and the system prints barcoded labels for the containers of dispensed material, with the operator acting as the checker at every stage to confirm that the details are correct. This process ensures consistency of dispensing, enhanced GMP and reduced risk of rejected batches. The benefits of an MES weigh and dispense mod-

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ule highlighted in this white paper are as follows:

Scope As with any manufacturing sector, pharma production varies considerably in scale.

At one end, there are plants producing comparatively large volumes of product, at the other end, there are smallscale operations producing ‘specials’ or small batches for clinical trials. In some cases, these ‘specials’ operations are factory-based, whereas others

are incorporated within hospitals. Whatever the size of the operation, a computerised weigh and dispense system can bring significant benefits.

The dispensing process Accurately dispensing raw material ingredients is a fundamental requirement for manufacturing high-quality pharma products. Furthermore, it is essential that a manufacturer can demonstrate that secure systems are in place to ensure that only

the correct quantity of an approved raw material of known origin and quality is used.

Good Manufacturing Practices (GMP) requires that weighing and measuring is adequately supervised and checked to ensure that the component has been released by the quality control unit after test, the weight or measure conforms to the quantity required by the batch formula, and that each container of weighed material is labelled correctly. When performed

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manually, the dispensing process requires handwritten records and labels that are produced by a first person and checked by a second person. Separate records are maintained for weighing instrument calibration and for cleaning weighing equipment and the weighing area. Although errors occur infrequently in raw material dispensing, they have far-reaching implications in terms of GMP, so systems must be in place to ensure that, as far as reasonably practicable, they do not occur.

The elimination of dispensing errors is therefore a prime reason for implementing an MES weigh and dispense module.

Common causes of error Dispense the wrong ingredient: There is the possibility that an operator can accidentally dispense the wrong ingredient by misreading the material name on the stock label. A computerised system uses the barcode on the stock label to identify the material to be dispensed. The barcode enables retrieval of key information concerning the contents of the container.

For this reason it is not possible to identify and dispense the wrong ingredient.

Dispense the wrong weight It is possible for an operator to dispense an incorrect raw material quantity. The causes of this are varied, but include: an arithmetical mistake (such as might be the result of dispensing into multiple containers), misreading the balance display, an incorrect potency calculation, an incorrect unit of measure conversion or misreading a quantity from the dispensing instructions.

A computerised system

◗ Recalculates the remaining quantity on change of dispensed container ◗ Forces the balance to be zeroed and the container tared before each weighing ◗ Enforces the use of calibrated, checked equipment

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One Brand Total Solution

NO.

BENEFIT

SECTION

1

Barcoded material identification

Dispense the wrong ingredient

2

Electronic capture of dispensed quantities

Dispense the wrong weight

3

Electronic verification of the material lot QC status and expiry date

Dispense an invalid lot

4

A controlled dispensing process (electronic SOP)

Operator errors

5

Electronic signatures for all significant actions

Operator errors

6

Enforced cleaning regimes

Contamination

7

Cost savings due to reduced cycle times, reduced need for a second checker, electronic transfer of stock consumption to the ERP system

Effects of dispensing errors

8

Recording of health and safety compliance

Further benefits

9

Better stock control and reduced scope for errors

Further benefits

10

Software and hardware connectivity

Connectivity and scalability

11

Scalability into further areas of the manufacturing and packaging processes

Connectivity and scalability

12

Reporting and trending of product performance

Reporting

only (e.g. by using daily balance validation checks) ◗ Performs potency calculations and unit-of-measure conversions ◗ Requires the dispensed quantity to be within predefined tolerances before the dispensing may be completed ◗ Maintains an audit trail of all events.

Dispense an invalid lot It is possible for an operator to pick and dispense an expired lot or a lot with an invalid QC status.

A computerised system reads the barcode on the stock label and, if the lot has expired or has an incorrect status, warns the operator and does not allow the material to be dispensed.

with the SOP. Although periodic audits can be used to ensure SOPs are being followed, there is no guarantee that procedures are being followed in the periods between audits.

A computerised system

◗ Enforces a consistent means of dispensing the ingredients for an order, so all operators must perform the same steps and dispense the ingredients in the same way ◗ Enables approval points to be configured to apply during particular stages of the dispensing cycle (eg when acknowledging health and safety warnings or reprinting dispensing labels) to ensure that GMP is adhered to at all times.

Contamination Operator errors Mistakes can be the result of operators taking shortcuts in the dispensing process or not following the standard operating procedure (SOP). Different operators sometimes have their own dispensing techniques. Mistakes can also occur due to over-familiarity

Contamination of the ingredients dispensed for a product can occur when the incorrect cleaning procedure has been applied following the dispensing of a material. This is especially applicable to cleaning after the dispensing of active materials. A computerised system enforces the cleaning

regime, electronic signatures can be used to ensure that the correct procedures are always applied. Specific cleaning regimes may be applied to particular materials/products. And the computerised system may be configured to require a second operator to approve either the cleaning when complete, or each stage of the cleaning process. A log of the cleaning activity is also maintained electronically.

Effects of dispensing errors In general, errors made in the dispensary are identified by the QA department when they qualify the finished product.

This mitigates the risk of bad product being released and a subsequent recall. Therefore, dispensing errors tend to result in GMP issues and costly overheads to the manufacturer. Even with a computerised system, however, there is a requirement to audit the processes and for the Qualified Person (QP) to sign-off each batch. This all requires a substantial amount of paperwork to be checked, but a

computerised system can significantly reduce the time required to produce and check the relevant reports. Firstly, the data is entered in the computerised system automatically during the weighing process, with no need for any additional inputs from the operator. This means that the necessary reports can be output virtually instantly when required, which is very different from the hours that might be needed to manually create reports for auditors. Furthermore, if the manual report creation process requires data to be handwritten or rekeyed into a spreadsheet or other computer-based package, there is a risk that further errors will be introduced or that figures will be rounded up or down.

For the auditor or QP, checking reports is far quicker if they are presented in a consistent way, with all of the data clearly legible.

M/S Process Technologies & Electronics Pvt. Ltd. Tel: (022) 6505 5819 Fax: (022) 2613 4269 Email: info@ptepl.com

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Cipla installs Danfoss VLT6000 HVAC at Goa plant for 24/7 air conditioned cleanroom environment

When India’s leading drug maker Cipla decided to build a world class drug manufacturing plant at Goa, it chose the Danfoss VLT 6000 HVAC drives to control around 350 AHUs and 20 Pumps to maintain inside conditions and differential pressure in the manufacturing areas CIPLA, ONE of India’s top five pharmaceutical companies created news, stunned the global drug firms, when in February 2003 it offered to export a trio of AIDS drugs to the poor regions through the French Charity Medecins Sans Frontieres, at the lowest international price of $350 per patient, annually.

Cipla had its beginning in 1935 as ‘Chemical, Industrial and Pharmaceutical Laboratories’ and is today India’s third largest drug maker by market share with a turnover of $325 million in 2002. Headquartered at Mumbai in India, its range of products are manufactured in 18 state-of-the-art manufacturing facilities throughout the country. Its product range consists of tablets, capsules, liquids, injections, ophthalmic, topical and nasal preparations, inhalers and powders etc.

The project Cipla broke ground for their new state-of-the-art pharma manufacturing plant at Goa in 2001. Since the plant has to comply with US FDA, WHO, MCA, MCC, TGA and CGMP requirements, the emphasis was on quality. The Goa manufacturing plant consists of eight independent manufacturing areas - Units I to VIII. Cipla decided to use double skin air handling units (AHU) to maintain the required inside conditions. Different type of fan options such as belt driven, direct coupled centrifugal, plug

Selection of the right VFD

fans etc., were considered. Finally they zeroed in on direct driven plug fans to avoid problems of contamination of the manufacturing area because of belt dust, energy losses due to slippage of belts and minimise the maintenance and down time.

However, plug fans need to be directly coupled to the motor and to achieve the design air flow (CFM) required, the fan has to run at speeds above or below the nominal speed of the motor. That was when Variable Frequency Drives (VFD) were thought of and Danfoss proposed a solution with VLT 6000 HVAC series drives, specially designed for HVAC applications. Further more, VFDs gave them the flexibility to automatically maintain a constant CFM to the conditioned area irrespective of filter condition - without any user intervention (like manual operation of outlet dampers) - while at the same time providing them with high energy savings.

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BB Shah

AHU with Danfoss VLT 6000 in operation along side BB Shah. Inset shows the VLT 6000 inside the panel. The above image shows the typical service floor layout

Cipla was very particular in selection of the equipment for their new plant for approval from international regulatory authorities for exports, such as MCA, MCC, TGA and USFDA etc. When it came to VFDs, the criteria for selection was the following: ◗ Considering the fact that there were around 40-50 drives in each plant, harmonics was one big issue confronting them.

As a knowledgeable customer, the project team were already aware that harmonics generated due to VFDs could affect the power quality and transformer loading. ◗ All the plants were planned to be eventually BMS monitored and controlled. Moreover, many machines in the manufacturing area were PLC controlled. Hence, it was a criteria that Radio Frequency Interference (RFI) emission by drives do not play havoc with the BMS or PLC systems. ◗ While investing in such sophisticated equipment like a VFD, they also wanted the maximum energy savings accruable out of its use. ◗ Minimum user intervention was envisaged in the operations and hence the VFD had to be suitable for such type of operating environment. ◗ The AHU motors shall not be subjected to over stress related to harmonics and peak voltage arising out of VFD applications. ◗ All the plants, were not

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planned to be on BMS operation immediately. So the customer wanted an in-built control system in the VFD which will automatically maintain the CFM being supplied to the conditioned area. ◗ Maximum flexibility in operations was the foremost requirement. To that effect the customer looked for the maximum availability of inputs and outputs so that he can configure them as per their site and individual plant requirement.

(when user intervention is required for e.g. testing and maintenance). ◗ The availability of energy meter on the VFD gives us the flexibility to track the individual power consumption of the AHUs and Pumps and then transfer this data to the central BMS.”

PG Patil

Energy savings

Fitting the bill The following features offered by the Danfoss VLT 6000 HVAC appealed to the project team which was headed by BB Shah.

Shah says, “When we compared various makes of VFDs for the technical qualification, we found that Danfoss was offering their HVAC specific model – the VLT 6000 HVAC. Now, that made sense to us. All of our concerns towards applying VFDs so extensively in the project were taken care of in this product. It had inbuilt harmonic filters and RFI filters.

Usage of inverter grade motors were not required, which reduced our first cost. Further, it had also the provision to control the CFM output of the AHU in closed loop with a static pressure sensor, to be located in the duct. This was extremely useful for us in the plants, where we were not immediately implementing BMS.” The electrical and instrumentation part of the project was lead by PG Patil, who appreciates the flexibility of the VLT 6000 HVAC drives. Patil, who currently is responsible for the electrical and instrumentation department says, “When we commissioned the VLT 6000 HVAC drives in 2001, we were amazed at its flexibility in operation. We used the following features of the drives at our plant, while commissioning the system: ◗ Closed loop operation of the VFD with a static pressure transmitter to ensure that the design CFM is supplied to the conditioned area. ◗ Wherever BMS is installed the VFD is seamlessly

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VLT 6100 (75 kW) for SCHW pumps installed in an MCC shown along side PG Patil. The above image shows their pump layout

communicating with the BMS for speed control signal, Auto/Manual status, AHU On/Off/Trip status, Speed and Energy consumption feedback. ◗ Interlock of the VFD with smoke detector. In case smoke is detected, the VFD will not start, even if there is a start command. ◗ The supply to the fire damper motor is routed through the VFD. Hence, the fire damper operates only if the VFD is ON. This ensures that the fire damper is always kept off in non-operating times.

◗ We have set the display of all the VFDs to show the RPM. This helps the operator to know what speed the motor is running. ◗ Further, we also get the feedback and setpoint of pressure in Pascals, which makes monitoring of the AHU filter status easy. We also know from the VFD the time to clean / change the filter. ◗ The Auto / Manual switch on the VFD helps us to access the operation of the VFD either from the BMS (in normal operation) and from the VFD panel

Patil is upbeat about the energy savings achieved through the usage of VFDs. He shares his experience and says, “In most of the cases, the VFDs are operating 15 to 20 Hz below the design frequency. Now, without the VFD we would have naturally used a damper to maintain the constant CFM to the conditioned area and this would have saved no energy.

This savings is very valuable to us and is helping to keep our operational costs under control. In Unit-I where we are logging the energy consumption on the BMS, we see that we are saving approximately 40 per cent of the energy compared to full speed operation. We have already recovered the cost of VFDs and BMS within a period of two years from the above energy savings.”

Application on pumps The VFDs were installed on the chilled water pumping system also. In line with the criteria to achieve maximum energy savings, primary – secondary sys-

The actual BMS system screen showing an AHU with VFD running details. Note that the VFD is operating at 1800 rpm where the nominal speed of the motor is 2800 rpm

tem of chilled water pumping was adopted. The VFDs were installed on secondary pumps whose speeds are modulated to maintain a set differential pressure across the supply and return headers under all load conditions. The pump ratings vary from 11 kW to 75 kW and are working round the clock to ensure optimal energy consumption.

Reliability in operation The VFDs have been in operation from December 2001. In fact, Shah and Patil are now happy with their selection of their VLT 6000 HVAC. Since the plant operates continuously, the engineering department normally keeps a stock of essential spares. In accordance with the above, when Danfoss submitted a proposal for essential spares and standby VFDs, the same was not approved by the Engineering In-Charge AV Mahajan citing the fact that there have not been a single instance of failure of the VFDs. We need not say more about the reliability of VLT 6000 HVAC.

Emulating the success in the company’s other manufacturing locations The Goa plant has been a trend setter in the VFD applications in Cipla. Further to the satisfaction derived from the Goa application, VFDs for AHUs have been applied on their other plants at Daman, Patalganga and Satara. In some of these plants, the VFDs, in conjunction with a differential pressure transmitter, work as a dedicated controller to maintain the positive pressure to be maintained between different manufacturing areas and corridors.

As of March 2004, Cipla group had 374 VFDs for AHUs and 23 for pumping applications. Furthermore, as many as 27 other VFDs are working in other pharma machinery applications inside the manufacturing area. This makes the biggest installation of VFDs for HVAC applications in India, totaling to more than 400 drives at a single location.

PHARMA TECHNOLOGY REVIEW PRODUCTS

Gandhi Automations’cleanroom high speed doors for controlled environment DOES YOUR business plan include the development of an area in your plant for clean manufacturing?

Better quality or better yield is the primary reason for investing in a cleanroom space.

Numerous manufacturing facilities now require a controlled environment in which the amount of dust and dirt is limited in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. Clean rooms have become integral part of pharma manufacturing facilities.

One of the most important aspects of cleanrooms is the doors which are chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity

ability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA. ◗ Control device enclosure in Stainless Steel SS 316

etc. Opening and closure of door has to be quick enough to isolate the outside environment and internal facility.

At Gandhi Automations, cleanroom high speed doors are specifically designed for

the above purpose. The cleanroom high speed doors are best suited for facilities where need controlled environment.

The opening and closing of door is quick enough to separate outside environment and

internal facility.

High Speed Clean Room Doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air perme-

Contact details Corporate Office Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West), Mumbai - 400064 Tel: +91-22-66720200 / 66720300 (200 lines) Email: sales@geapl.co.in

VICAM offers single extraction test for aflatoxins and fumonisins in corn and grain WATERS CORPORATION announced that VICAM, a Waters Business, now offers a single extraction method for the detection of aflatoxins and fumonisins in corn and grain. The Afla-V AQUA and Fumo-V AQUA provide quantitative results in only five-minutes (after extraction/sample prep). The simple, one-step, water-based process eliminates solvent use completely. Extraction is performed using a simple, environmentally safe solution which requires no special handling, mixing or blending.

Traditional testing methods often re-

ing time, effort and consumables cost.

quire individual extraction procedures for each toxin, some requiring the use of costly chemicals such as methanol, a chemical solvent which requires special storage and handling. In addition, spe-

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cialised shipping often adds to the expense and complexity of on-site mycotoxin detection. In contrast, the Afla-V AQUA and Fumo–V AQUA tests can be run on the same sample extract, reduc-

Contact details Dayamani Santosh Sr Admin Officer Waters India 36A, II Phase Peenya Industrial Area Bangalore 560 058 [T] 080-49292200-03 [F] 080-49292204 [M] 9632786899 [W] www.waters.com [E] dayamani_santosh@waters.com

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Bosch expands pharmaceutical portfolio

Phenomenex adds polar, mixed-mode selectivities to Luna HPLC/UHPLC Column Line PHENOMENEX, A global leader in the research, design and manufacture of advanced technologies for the separation sciences, has introduced new mixed-mode selectivities and particle sizes for UHPLC, HPLC and preparative work in the Luna column family. The first is the new Luna Omega Polar C18 stationary phase – a unique selectivity on an innovative silica particle that delivers a wide elution window and combined high retention for polar and nonpolar analytes. This new phase is 100 per cent aqueous-stable due to a polar-modified surface, providing flexibility in solvent and gradient system selection needed to achieve desired polar/non polar analyte separation. The Luna Omega Polar C18 is offered in a high-performance 1.6µm particle for UHPLC instruments as well as a low-pressure 5µm particle for direct scalability to analytical HPLC or preparative work. The 5µm particle is available in Phenomenex’s patented Axia-packed preparative columns.

Phenomenex is also introducing the 100 per cent aqueous-stable Luna Omega PS C18 that delivers two distinct separation mechanisms at the same time. The particle surface of the PS C18 contains a positive charge that facilitates greater acidic compound retention through ionic interaction, while the C18 ligand delivers general reversed-phase retention. This mixed-mode selectivity is a valuable tool for greater separation between mixtures of compounds that have varying functional groups, such as peptides, pesticides or

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metabolite profiles. Additionally, the positive surface charge encourages excellent basic compound peak shape through the ionic repulsion of these compound species.

Luna Omega columns are well suited for a wide range of applications including drug discovery and development, food contaminant analysis, environmental testing, toxicology and clinical research. Phenomenex Kinetex Core-Shell Technology and Luna Omega columns together provide an ideal complementary UHPLC solution for greater efficiency and separation power. With a growing range of valuable selectivities, this pairing of core-shell and fully porous UHPLC products affords customers a better choice for immediate gains in productivity, resolution and retention.

Combining the Luna Omega Polar C18 with the previously released fully porous Luna Omega 1.6µm C18 and Kinetex 1.7µm core-shell phases further expands the options for UHPLC method development and improvement.

Contact details Raj Kiran, Marketing Communication Associate Phenomenex India Laxmi Cyber City, Ground Floor, B Block, Survey no: 10, Kondapur, Hyderabad 500084 Tel: 040-3012 2400 Fax: 040-3012 2411 E: Rajk@phenomenex.com W: http://www.phenomenex.com

BOSCH PACKAGING Technology, a leading supplier of processing and packaging technology, has expanded its expertise in the non-aseptic packaging process for pharmaceuticals. Following the introduction of the Sigpack TTMP topload cartoner for pharma products, the company now adds two further machines to its portfolio: the Sigpack VPF vertical flat pouch machine and the horizontal flow wrapping machine Sigpack HML. The new vertical flat pouch machine Sigpack VPF was developed especially for the packaging of powders. Pain killers in powder form are amongst the products typically filled into sachets.

pendently or integrated seamlessly into a complete line.

The Sigpack HMUL or HML is available either with ultrasonic or heat sealing technology. With the expanded machine portfolio, Bosch now offers packaging solutions for every production step from a single source – for example for the treatment of diabetes.

Insulin can be produced with bioreactors from Bosch, subsequently filled into cartridges and assembled to insulin pens on further Bosch equipment. CIP/SIP cleaning systems and sterilisation equipment can also be integrated into the production process. With the new machine range, manufacturers now also have the possibility to hermeti-

Thanks to the innovative sealing technology from Bosch, the machine produces hermetically sealed packages, which safely protect the product. The VPF allows manufacturers to flexibly expand their sachet production by up to twelve lanes. The pouch size can also be quickly and easily adapted according to customer requirements. Thanks to the high dosing accuracy and excellent sealing properties, the machine can produce and fill up to 1500 sachets per minute precisely and at the highest quality.

Compact horizontal flow wrapping machine for hermetic packaging Bosch further extends its portfolio by a compact horizontal flow wrapping machine, which can either be loaded inde-

cally package the insulin pens into flow wraps. End-of-line solutions such as the Sigpack TTMP cartoner round off Bosch’s line competence.

In September 2016, the Sigpack VPF received the German Packaging Award from the German Packaging Institute (DVI) in the category packaging machinery.

Contact details Annette Crowther Communication Harmonists Poststraße 48 D-69115 Heidelberg T: +49 6221 18779-27 F: +49 6221 18779-11 bosch@commha.de www.communicationharmonists.de

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ACG Worldwide Group offers Convel Srl’s products in visual inspection and leak testing in SAARC countries Siddhant Bhambhani, Product Manager,ACG Inspection Systems, elaborates on the reasons behind the launch of Convel Srl’s C2 and C2D particles inspection machine

THE ASIAN injectable drug delivery market is expected to reach $75.6 billion in 2020 growing at a CAGR of 13 per cent. Today, Asia is considered the fastest growing injectables market due to factors like the rising prevalence of chronic diseases, growth of biologics and biosimilars, technological developments and rapidly rising demand for self-injection medical devices.1 Taking cognizance of this growing demand for injectables and the need for stringent regulatory compliance of liquid inspection has increased.

With this increase in demand, the requirement of regulation compliant inspection systems has also increased and that’s why ACG Inspection has

launched Convel Srl’s C2 and C2D particles inspection machine. Convel is an Italian R&D-driven company focused on developing liquid inspection solutions for pharma industry with more than 50 installations worldwide. These visual inspection machines, C2 and C2D carry out reliable, efficient inspection of ampoules and vials for foreign matter and cosmetic defects. C2 is

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ideal for medium-scale production inspecting up to 200 pcs/min; whereas C2D is used for larger scale inspecting up to 400 pcs/min. These machines have three stations for particle inspection with specialised light, configurable for both reflecting and not-reflecting particles. It can also be configured with stations for inspection of vial seals, ampoules tips, black spots and

code rings. Both C2 and C2D are CFR 21 Part 11 compliant products and offer userfriendly HMI based interface with password protected access and ‘Audit trail’ functions.

ACG Inspection (ACG-i), a hi-tech vision inspection and track and trace company and a part of the ACG Worldwide Group now offers Convel Srl’s products in visual inspection and leak testing in SAARC

countries. Inclusion of Convel’s products add a new dimension to ACG Inspection’s already diverse product portfolio to serve its Indian and global customers. With this addition, the ACG-i offers a comprehensive range of inspection solutions for solid as well as liquid dosage forms.

Reference 1: Marketsandmarkets

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Value of nanoparticle tracking analysis Michael Caves, India Business Development Manager, Malvern Instruments, elaborates on how nanoparticle tracking analysis (NTA) has been able to accurately measure size and concentration of nanoparticles THE USE of nanoparticles in drug delivery continues to grow rapidly. Nanoparticles offer excellent pharmacokinetic properties, controlled and sustained release, and targeting of specific cells, tissues or organs.

Interest in nanoparticle drug delivery is also driven by the diminishing rate of discovery of new biologically active compounds that can be exploited therapeutically to treat disease.

With fewer new drugs entering the market, interest in the use of nanoparticles’ versatile and multifunctional structures for the delivery of drugs is swiftly increasing. All these features can improve the efficacy of existing drugs.

Nanoparticles used in drug delivery have been defined as colloidal systems of submicron size that can be constructed from a large variety of materials in a large variety of compositions. Commonly defined nanoparticle vectors include: liposomes, micelles, dendrimers, solid lipid nanoparticles, metallic nanoparticles, semiconductor nanoparticles and polymeric nanoparticles. In their many guises, nanoparticles have been extensively employed to deliver drugs, genes, vaccines and diagnostics into specific cells/tissues.

When considering a nanomaterial drug delivery system, size of the nanoparticle is a key parameter as it directly influences the processes of delivery, uptake, degradation and clearance from the body. For example, nanoparticles in the range of 30 nm to a few hundred nm in diameter can passively accumulate at the site of tumours due to leaky vasculature, phagocytosis favours particles

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When considering a nanomaterial drug delivery system, size of the nanoparticle is a key parameter as it directly influences the processes of delivery, uptake, degradation and clearance from the body >500 nm, whilst biliary and renal clearance occurs with particles <30 nm and <8 nm respectively. In addition, the liver has a lower uptake of smaller particles (25 nm and 50 nm) compared to larger particles (200 nm and 300 nm). Accurate measurement of the size and concentration of particles being administered is therefore imperative to many systems

and processes.

Analysis of Iiposomal drug delivery systems by NTA Liposomes (Figure 1) have been the subject of significant research and development efforts for many years and are currently the most common targeted drug delivery system. Liposomes have been approved as a delivery system for ampho-

tericin B for fungal or protozoal infections, doxorubicin for breast cancer treatment, and for vaccines for hepatitis A and influenza. The use and potential of liposomes in drug delivery continues to grow in importance. The reasons are clear: ◗ Therapeutics delivered via liposomes may be protected from the actions of metabolising enzymes ◗ Lipophilic substances may be made soluble by the use of liposomes ◗ Therapeutics can be targeted to specific areas by attaching specific ligands to the liposome ◗ Liposomes are readily absorbed by cells ◗ The rate of release may be controlled by the selection of liposome ◗ Using liposomes as a delivery vehicle allows potentially lower or less frequent doses to be used, potentially reducing toxicity and side-effects ◗ Liposomes can carry biological substances such as proteins and DNA In addition to concentration, the size of the liposomes used is increasingly being recognised as an important factor in treatment efficacy. A drug delivery liposome’s size may affect its circulation and residence time in the blood, the efficacy of the targeting, its rate of cell absorption (or endocytosis) and, ultimately, the successful release of its payload.

Such size considerations are hugely important to all nanoscale drug delivery systems.

Sizing liposomes with NTA Malvern’s NanoSight instrument range accurately and rapidly sizes and measures concen-

tration of liposomes in water and other solvents. Only small volumes and very little sample preparation is required. The instruments enable individual liposomes in suspension to be visualised and their Brownian motion tracked – enabling concentration-based particle size distributions, based on individual particles, to be built up in a matter of seconds.

Simultaneous multiparameter analysis of nanoparticles in real-time using 21 CFR part 11 compliant software In addition to size and concentration, NTA also provides the following parameters, simultaneously and particle-by-particle: ◗ Scatter intensity, which resolves adjacent populations of particles and differentiates materials of sufficiently-differing refractive indices. ◗ This unique ability potentially allows the user to probe whether nanoscale drug delivery structures such as liposomes vary in their contents, i.e. empty liposomes may have a lower refractive index (light scattering power) than those loaded with a higher refractive index material. This would allow them to be differentiated even though they may be of very similar sizes.

Examples of drug delivery systems understood using NTA Poly(ß-amino ester)s (PBAEs) are potential delivery systems for genetic therapies to treat various cancers. They have an advantage over some other systems in that many combinations of polymer with DNA can

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be made through the combinatorial route. They also have rapid release properties due to hydrolytic degradation, but this creates challenges for dosing, production and storage.

Lyophilisation is a typical storage method and NTA is to evaluate the effect of lyophilisation on aggregation (increase in size) and destruction (decrease in size) of PBAE-DNA nanoparticles.

Poly(lactic-co-glycolic acid) (PLGA) is an FDA-approved drug delivery system. It breaks down into lactic acid and glycolic acid, both of which are endpoints of metabolic pathways in the body.

PLGA has been used as a drug delivery system for amoxicillin and also for gonodotropin-releasing hormone for the treatment of advanced prostate cancer. The immunosuppressant mycophenolic acid has been encapsulated in PLGA with a view to decrease dosing levels and thus reduce toxic side effects. NTA is used to determine the size and concentration of these nanoparticles, a critical parameter to ensure good delivery and allow researchers to compare results across studies.

The successful transport of molecules across the cell membrane is a key point in their delivery. In many cases, molecules alone cannot penetrate the cell membrane, therefore an efficient carrier is needed.

Calcium phosphate nanoparticles (diameter: 100 nm - 250 nm, depending on the functionalisation) have been investigated as versatile carriers for small and large molecules across cell membranes using a number of techniques including NTA, Dynamic Light Scattering (DLS) and Electron Microscopy (EM).

NTA is also used to control the effect of modifications to the chemistry of lipopolyamines and spermines in various nonviral plasmid DNA and siRNA delivery systems, in addition to the characterization of dendritic nanocarriers for siRNA delivery and gene delivery polymers in cell culture. As a robust method for the accurate characterisation of nanoparticle size and

Figure 1. Typical Liposome Structure

concentration, NTA Is used to maintain low levels of nonspecific cytotoxicity and to increase stability during storage.

Size and concentration of drug delivery systems must be understood as these parameters directly influence the processes of delivery, uptake, degradation and clearance from the body. This explains the value of NTA, as a technique unique in being able to accurately measure size and concentration of nanoparticles, to the development and qualitytesting of such systems.

Figure 2. Typical image of liposomes provided by a Malvern NanoSight instrument

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Contact details Malvern Aimil Instruments Naimex House, A-8 Mohan Co-operative Industrial Estate, Mathura Road, New Delhi â&#x20AC;&#x201C; 110044 Tel : 011-30810244 Fax : 011-26950011 Email : delhi@aimil.com

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What’s the best technology for adding unique codes to pharmaceutical packaging?

Trevor Nichols, Business Development Manager, Domino Printing Sciences, talks more about item-level serialisation and thermal inkjet technology IF YOU haven’t already, now is the time to begin planning for item-level serialisation in the pharmaceutical industry. Soon you will be legally obliged to make sure that every packet or bottle of prescribed medication carries the correct coding information. Here’s how thermal inkjet printers can help.

Item-level serialisation and the race for compliance The pharma industry is grappling with its biggest ever legislative shakeup. It will soon be a legal requirement for pharma manufacturers to make sure every bottle and pack of prescribed medication carries its own unique machine-readable code. This legislation applies to all EU countries plus Iceland, Norway, Switzerland and Liechtenstein.

The deadline to reach full compliance is tabled for early 2019 – although this will be slightly later in Belgium, Italy and Greece.

Each bottle or pack of medication must be assigned its own unique identity that is traceable throughout the supply chain – from production line to patient. The unique identifier proposed by the Delegated Act for packaging is a 2D barcode carrying a serial number, product code, batch number, expiry date and an optional national reimbursement number when required. The legislation affects prescription medication only.

For the full lowdown, we recommend our short guide: A complete guide to item-level serialisation in the pharma industry

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Introducing thermal inkjet technology Thermal inkjet is a digital coding technology that uses electrical heat to eject ink droplets and apply them to a substrate.

It’s incredibly clean, fast and easy to use. Replacing ink cartridges is straightforward and you can achieve extremely high production line speeds without compromising the integrity of your coding quality.

Why is thermal inkjet so good for the pharma industry?

Speed is absolutely crucial on pharmaceutical production lines. Reducing your throughput can have a significant impact on your bottom line, while avoiding downtime is businesscritical. With Domino’s G-Series range of thermal inkjet printers, production interruptions are a thing of the past.

You can apply unique codes – repeat, unique codes – to up to 600 products per minute. All

common 1D and 2D code formats including GS1 codes and China Code 128 are supported.

Razor sharp ink clarity, with rapid drying times We have developed a regulation-compliant ink especially for the pharma industry. It’s called BK652 and independent reports have proven its lightfastness to be significantly above the two year industry standard. What’s more it dries in around half a second. That means you end up with highcontrast, scratch resistant codes that last for the full lifespan of your product – minimising the number of false rejects produced by machine vision systems.

Are you ready for item-level serialisation?

The move to item-level serialisation is a major operational challenge. For pharma manufacturers and packagers it means new protocols, new cod-

ing equipment and a new way of running your business. As you might expect, manufacturers across Europe are at wildly differing stages of adoption.

Some are pilot testing new equipment, others are still at the research stage.

Making your move early and adopting new technology for compliance with item-level serialisation legislation is a great way to get ahead of the curve, minimising stress and operational disruption down the line.

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Smart Labtech: Scientifically yours SMART Labtech, a premier supplier of laboratory analytical, biotechnological, environmental, microscopic and weighing equipment, renders its services by supplying time tested and quality products from internationally renowned manufacturers SMART LABTECH is an established leader in sales and marketing of analytical instrumentation line for more than a decade. The companyâ&#x20AC;&#x2122;s wide range of product lines meet one touch performance criteria while offering not only quality but also add value to it. When it comes to customersâ&#x20AC;&#x2122; total solutions, clients are provided with experience and functional technological innovation of its internationally reputed principles, which keep Smart Labtech ahead in the competition. The company has adopted a flexible approach and customises its products in accordance with customersâ&#x20AC;&#x2122; requests and accessories.

Smart Labtech has a strong commitment in innovation and continuously reviews new technologies as they emerge and invests significant resources to expand its horizon to reach the market. To meet this requirement, Smart Labtech has been striving hard not only in expanding product lines but also established its offices across the country by following certain ethics and principles in rendering the optimum level of customer satisfaction.

The product range falls right from the simple chromatography column or a NIST Traceable Buffer to a sophisticated ultra micro balance and X-Ray diffractometer.

Smart Labtech is the distributor to the following companies mentioned below.

Sartorius: Sartorius is an internationally leading laboratory and process technology provider with core areas of expertise in biotechnology and weighing. The technological process, high quality of products and services of Sartorius has certainly made Smart

most care to bring in these highly accurate and technological products to its clientele matching their level of laboratories to international standards.

PV Satya Prasad,MD,Smart Lab Tech,Hyderabad

Labtech one of the preferred partners for the pharmaceutical, biotech, chemical and cosmetics industries, as well as the food and beverage industry.

Smart Labtech has carried the Sartorius brand, has symbolised the trust and performance and value that Sartorius, a Guinness World Record holder, for producing nanogram balances and is known globally through its steadfast commitment in product development for over 140 years. The product portfolio of its weighing division focuses on high value laboratory instruments such as lab balances and laboratory water purification systems to all customers from research and quality assurance laboratories of pharma, chemical and food industries as well from the academic sector.

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Memmert: Memmert is a German professional company and an expert in thermostatic professionals since the last 80 years. It develops and produces thermal ovens, incubators and stability chambers meeting all thermal applications including in the fields of industrial material and component testing biological, chemical and food research, a wide range of quality tests in sophisticated production process of human and veterinary medicine. The technology used in the development of control technology and systems for heating and cooling and uncompromising quality-control measures make Memmert a leading manufacturer of thermal products worldwide serving around 190 countries.

Smart Labtech has taken ut-

Bourevestnik: Bourevestnik is a Russian company, which for more than half a century, has been creating devices and catering to the needs of different industries and areas of scientific and technical activities such as mining and ore, dressing industry, atomic power, oil refining, metallurgy and machine industry, electronic industry, nano industry and environmental monitoring. It also offers analytical instruments including diffractometers, analysers, sulphur in petroleum, on line water monitoring.

Smart Labtech, with a lot of confidence in these product lines, has captivated and taken the responsibility for the Indian market.

Reagecon: Reagecon is an Irish manufacturer and largest producer of physical and chemical standards and reagents. Reagecon occupies a unique position in terms of range, scope, breadth and depth of products offered. Techniques, technologies and scientific disciplines covered includes standards, reagents and reference materials under ISO 17025 accreditation.

Plas-Labs: Plas-Labs is a world leader in acrylic glove boxes, anaerobic chambers, nitrogen dry glove boxes, and HEPA-filtered isolation glove boxes. Since 1967, Plas-Labs product line of glove boxes have been used in research laboratories all over the world.

The Hypoxia Chamber Glove Box is the latest in CO2 control,

oxygen control, and temperature-controlled containment system. Plas-Labs also offers a variety of animal care and research products like poultry isolators, rodent containment systems and intensive care units.

Biomeriux: Biomeriux is a French leading company in the field of microbiology. The company produces the largest range of microbial control solutions (reagents, instruments, software and services). Biomeriux provides answers from sample preparation to final identification and typing micro-organism catering to food/water, bio-pharmaceutical, cosmetic/personal care segments and many more.

Smart Labtech is pleased to announce its association with Biomeriux.

Smart Labtech also represents many other companies like Waters Corporation for column chemistry products and Perkin Elmer for their range of products in the allotted geometrical sections. Smart Labtech also represents other reputed principles and offer their products for quality control/research and development laboratories.

The complete process of sales and customer support is organised by highly qualified and well trained sales and service team in order to protect the image of principles as well as to uplift the self-image to a higher orbit.

Contact details Corporate office 7-1-621/421/1, Behind Andhra Bank, SR Nagar, Hyderabad - 500038 Tel: 040 - 66624394 email: info@smartlabtech.net

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Evaluation of capric glycerides as anti-tack agent in coating formulations Mike Easterbrook, Chief Technical Officer and Sanjay Negi, DGM- Film Coatings, Ideal Cures, determine the feasibility of formulating a ready mixed immediate release coating system containing polymer, plasticiser, and a non-talc anti-adherent agent TALC HAS been traditionally used as an anti-tack agent in various immediate release and enteric coating formulations. However, it is subject to sedimentation and may cause system instability. Sedimentation of talc can lead to process concerns such as gun clogging which may lead to frequent process interruptions.

Objective The objective is to determine the feasibility of formulating a ready mixed immediate release coating system containing polymer, plasticiser, and a nontalc anti-adherent agent. The experiments mentioned in the article demonstrate the possibility of using capric glycerides as the non-talc anti tack agent.

Experimental work Coating formulation preparation PVA-based coating formulations were formulated with either talc or capric glycerides as anti-tack agents. Laboratory scale mixers were used to prepare the coating formulations. The ingredients were added and blended together in the mixer until uniform powder blends were obtained.

Coating suspension preparation and tablet coating Suspensions of both coating formulations were prepared using a laboratory scale stirrer. These were found to be smooth and sprayable.

Plain placebo tablets were coated using these suspensions in a six inch conven-

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Mike Esterbrook

tional coating pan with predetermined coating parameters.

Evaluation of coated tablets and stability studies Coated tablets were evaluated for appearance, disintegration time and coating defects.

The appearance and disintegration characteristics of the coated tablets from both the formulations were comparable. Coated tablets of the talc-based formulations were slightly better in term of gloss than the capric glyceridebased formulations. No coating process related issues were observed with either system during the coating process.

Results and discussion Coating suspensions that had been reconstituted at 20 per cent w/w were found to be smooth and possess good sprayability. No coating issues were observed during the

Sanjay Negi

Coated tablets of the talc-based formulations were slightly better in term of gloss than the capric glyceridebased formulations

Talc formulation

Capric glycerides formulation

coating process. In all trials, coated tablet surfaces were found to be good.

Conclusion Based on these studies it can be concluded that capric glycerides may be used as

anti-tack agents to replace talc in ready mix coating formulations. Compared with talc, capric glycerides can be used at lower concentrations (5 per centw/w) thus avoiding the sedimentation and gun

clogging issues often seen where talc based formulations (15 per cent w/w) have been used.

Contact details info@idealcures.co.in

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Tofflon: Aleader in pharma equipment manufacturer Tofflon is making important investments in advanced innovations, facility expansion and organisation restructuring SHANGHAI TOFFLON Science & Technology Co, the global manufacturer of largest freeze drying system, has done more than 3500 freeze drying system projects across 50 countries and regions. Tofflon believes that automation, isolation, and system integration are becoming the main stream for aseptic processing of sterile manufacturing.

Since the last few years, Tofflon has been able to understand sterile manufacturing regulatory requirements and stringent pharmaceutical guidelines. The company provides complete upstream and downstream machines for freeze drying system.

It focuses on mechanical integration with upstream and downstream equipment as well as complete process automation integration so as to achieve uninterrupted and consistent process establishment to continuously improve drug quality and production efficiency.

Recently, Tofflon has completed injectable line project in Shilpa Medicare, Hyderabad.

Project overview Shilpa Medicare, Hyderabad Jadcherla unit is a world-class finished dosage manufacturing facility, spread over 36414 sq metres and is located around 70 kms from Hyderabad international airport. The unit is planned for carrying contract manufacturing and dosage developments, designed to meet cGMP, USFDA, EUGMP, TGA, MHRA, PMDA and all other regulatory requirements. The facility has dedicated oncology injectable block and consists of liquid/ lyophilised injectable

All sterile processing machines are laid down in linear fashion in the same platform such as autoclaves, vial washing, sterilising tunnel, solution preparation tanks, aseptic filling, freeze dryer and auto loading and unloading, capping and labelling.

The machines are set up in such way that the space needed for the highest clean room class is optimised and increased the employee’s productivity.

All the systems are interconnected with central SCADA system to monitor batch record and data and are made easy in data review during audits. Since all the equipment is from a single supplier, it is much easy for the system and data integration compared to different machines from different manufacturers.

Since it is oncology injectable manufacturing plant, integrated pass-through designs are provided so that materials can always be moved from one production stage to next stage with most efficient route and personal safety. By minimising the movement of materials and personnel in sterile facility, it helps to eliminate end product contaminations. Complete line is incorporated with isolators to maintain Class A area inside the filling line and class B grade in the room.

commercial scale manufacturing line with 120 vials/ min capacity and dry powder vial filling line 50 vials / min capacity.

All major crucial and assisting machineries for injectable manufacturing is supplied by Tofflon. Crucial machines like auto solution preparation tanks, vial filling line, freeze dryer, auto loading system and dry powder vial filling line and assisting machines like autoclaves, external vial washer etc, are provided by Tofflon.

Project challenges

◗ It is a systematic automatic project in compliance with USFDA and other regulatory standards ◗ All critical machines should be in the same platform and integrated with each other ◗ All systems are data integrated, centrally controlled and monitored ◗ It is oncology injectable unit.

The product OEL (operator exposure limit) is four and above grade, hence complete isolation of product from contamination and operator safety is required.

Project solutions Complete automation is incor-

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porated in all sterile processing machines to avoid human intervention as much as possible to avoid cross contamination as per GAMP 4. All the machines

are manufactured considering plant layout, functionality and safety and harmonic ensemble to improve production efficiency.

Contact details Tofflon India 6th Main, 2nd Cross, Tayappa Garden Bilekahalli, Bangalore – 560076 marketing.in@tofflon.com www. tofflon.com

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Anovel film coating formulation to minimise colour fading Mike Easterbrook, Chief Technical Officer and Sanjay Negi, DGM- Film Coatings, Ideal Cures, in this study investigate the colour stability, tested under different storage conditions of tablets that were coated with HPMC and HPMC/ Copovidone coating formulations containing indigo carmine

IT IS a common practice within the pharmaceutical industry to enhance the aesthetic appearance of dosage forms by using suitably coloured film coatings1.

Coloured coatings increase patient acceptability and compliance, improve safety via easy identification and differentiation and may reduce degradation via increased opacity to light. Indigo Carmine (FD & C Blue #2) or Indigotine is approved in the US and European markets to be used as a colourant in oral and topical preparations. It is known to have good heat stability but poor stability to light and oxidising agents. Thus formulations containing Indigo Carmine tend to fade with time.

Co-povidone is a one of the polymers which has been used to reduce colour fading issues in film coating systems 2.

Purpose The objective of this study was to investigate the colour stability, tested under different storage conditions of tablets that were coated with HPMC and HPMC/ Copovidone coating formulations containing indigo carmine.

Experimental work Coating formulation preparation To investigate colour stability differences, HPMC-PEG based and HPMC-Copovidonebased coating systems were prepared. Both formulations contained the same concentrations of Indigo Carmine. Laboratory scale mixers were used to pre-

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pare the coating formulations.

The ingredients were added and blended together in the mixer until uniform powder blends were obtained.

Evaluation of dry powders The powders were evaluated visually and samples were retained for stability studies packed in HDPE bottles at different conditions i.e. Ambient (250C± 20C/60 per cent RH±5 per cent) and accelerated stability conditions (400C± 20C / 75 per cent RH RH±5 per cent) to evaluate the colour fading tendency.

Coating suspension preparation and tablet coating The coating suspensions were prepared using a laboratory scale stirrer. Plain placebo tablets were coated using these suspensions in a six inch conventional coating pan with pre-determined coating parameters.

Evaluation of coated tablets and stability studies Coated tablets were evaluated for appearance, colour uniformity, colour difference, disintegration time and coating defects.

Tablets coated with both formulations were packed in polyethylene bags within HDPE bottles (screw capped). These were stored for stability studies at the following conditions: i. Ambient (25ºC± 2ºC/60 per cent RH±5 per cent) ii. Accelerated (40ºC± 2ºC / 75 per cent RH ±5 per cent) Open dish samples were ex-

Mike Esterbrook

Sanjay Negi

posed to ambient conditions.

The tablets were evaluated for appearance and colour difference. Colour difference was checked using a Reflectance Spectrophotometer. The dE values were measured over a sixmonth period to evaluate colour fading over time.

Results and discussion The HPMC-PEG and HPMCCopovidone-based formulations were prepared using a laboratory scale mixer. The plain placebo tablets were coated with both the formulations using the standard coating process parameters recommended for a HPMC-based coating formulation. The coated tablets were

evaluated for physical characteristics and found comparable. All samples stored under all conditions showed some colour fading with time as shown in the photographs at Table No. 1. Colour differences between coated tablets stored under ambient and accelerated conditions for different time periods were measured using the Reflectance Spectrophotometer and expressed in terms of total colour difference (dE) with respect to initial samples.

Copovidone-based formulations exhibited good colour stability at all the stability conditions as compared to other HPMC-based formulation.

Conclusion

From the findings of this study, colour fading was reduced with HPMC/Copovidone coating formulations compared with a standard HPMC-based coating system. It is suggested that product stability may be improved by including copovidone in the coating formulations.

References 1.Colorants-The Cosmetics for the Pharmaceutical Dosage Forms, Krishna Vamshi Allam, Gannu Praveen Kumar, Int J Pharm Pharm Sci, Vol 3, Suppl 3, 2011, Pg.No.13-21.

2.Moroni A.et.al, Pharmaceutical Tablet Coating Composition, US Patent 20040001884A1, January 1 2014.

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HMX-FAAC makes storage of drugs safe and cost effective HMX’s concept of fresh air air-conditioning (FAAC) is revolutionary that brings the best of indirect direct evaporative cooling and refrigerated air-conditioning THE HIMALAYA Drug Company is a leading multinational medicinal drug company. It produces healthcare products under the name Himalaya Herbal Healthcare. It has grown manifold and is spread across locations in India and abroad. Today, brand Himalaya is synonymous with safe and efficacious herbal products. Their products are prescribed by 400,000 doctors worldwide and millions of customers trust them for their health and personal care needs.

Challenges Himalaya’s state-of-the-art factory in Bengaluru commenced its operation in 2006 and is spread over 200 acres.

Its existing finished goods warehouse of approximately 16,000 square feet area faced issues of maintaining a constant temperature inside throughout the year. This had an adverse effect on the stored finished goods resulting in the reduction of their shelf life.

The ideal environment to store the manufactured goods was to maintain temperatures under 26°c throughout the year.

The management had planned to install an 80 TR air-conditioning system to maintain the desired conditions but envisaging the high operational expenditure they started to look for alternate solutions.

Solution Encouraged by the satisfac-

tory performance of the previously installed HMX-Ambiator in the raw material warehouse, Himalaya again turned to HMX for a feasible solution.

HMX carried out an exten-

both the worlds of indirect direct evaporative cooling and refrigerated air-conditioning.

The FAAC is designed to provide comfort in all seasons and ideal for applications

when the outside weather is hot and dry and in air-conditioning mode during the monsoon season. The switch between the two modes would be automatic, based on the

single HMX-FAAC unit of 25,000 CFM capacity with a cooling coil of 25 TR.

Result Temperature readings were

TEMPERATURE RECORDINGS TAKEN ON 6 MAY 2015, WHEN THE UNIT WAS RUNNING IN 100% FRESH AIR MODE Unit details

Ambient

Room

DBT (°C)

DBT (°C)

01.30 pm

36.00

25.00

03.30 pm

34.00

25.00

Time

HMX-Ambiator 25k

TEMPERATURE RECORDINGS TAKEN ON 7 AUGUST 2015, WHEN THE UNIT WAS RUNNING IN AIR-CONDITIONING MODE Unit details

Ambient

Room

DBT (°C)

DBT (°C)

01.30 pm

27.00

25.00

03.30 pm

26.00

25.00

Time

HMX-Ambiator 25k

The Himalaya Drug Company is quite happy with the performance of the HMX-FAAC unit and the benefits it provides.

sive study of the seasonal weather conditions in Bengaluru and found out that the HMX-Ambiator on its own was capable of maintaining the desired conditions for 70 per cent time of the year. For the balance 30 per cent time of the year, air-conditioning of the warehouse was the ideal solution. As a result, an airconditioning system of only 25 TR was required instead of the originally planned 80 TR. This is when HMX came out with the concept of fresh air air-conditioning (FAAC). It is a revolutionary concept in comfort that brings best of

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Encouraged by the satisfactory performance of the previously installed HMX-Ambiator in the raw material warehouse, Himalaya again turned to HMX for a feasible solution where maintaining temperature is critical.

This unit would work in evaporative cooling mode

ambient weather conditions.

Looking at the apparent benefits, the management at Himalaya decided to install a

taken inside the warehouse after the installation of the HMX-FAAC unit, in both the summer and monsoon seasons.

Contact details Rishabh Matta Assistant Manager Business Development & Marketing ATE ENTERPRISES (Business Unit: HMX) T-126, T Block, MIDC, Bhosari, Pune 411 026 Tel:+91-20-30881100 Ext. 302 M:+91-9158308880 W: www.ategroup.com/hmx

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Mark Makers: Excellence in processing equipment Vinayak Jagdish Adke, CEO, Mark Makers Pharma Engineering talks about his company’s services and their advantages to the pharma sector MARK MAKERS is a pioneer in processing equipment for pharmaceutical companies. The company is run by a young and dynamic group of people who believe in superior quality products and quick after sales service. The company's expertise lies in manufacturing and exporting finest quality machines used in pharma formulation, bulk drug, food and chemical industries.

In the year 2010, MARK MAKERS was established with an aim to manufacture machinery parts and fabrication work of different tablet granulation section machinery.

Since then the company has grown from strength to strength in the last couple of months and introduced a number of new products. Today, the company is manufacturing process machineries in the ointment, liquid and tablet granulation section such as ointment/cream manufacturing plant, liquid/ oral process plant, dry heat sterilizer, fluid bed dryer, rotocone dryer, rapid mixer granulator, octagonal blender with vaccumised charging system and other machinery. The main motto of the company is to deliver best quality products at the most economic prices and excellent customer service after delivery.

The company is equipped with trained technical personnel, sound electrical and mechanical engineers as well as skilled workers with modern production technology

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every customer of the company is satisfied with its equipment. Our company has several achievements in pharma manufacturing equipment field through the execution of our brand name ‘Mark Makers’ - Developing Strategy.

These products offer proven performance and can be seen in use at small scale industries as well as leading Indian companies. Soon, they would be seen in multinationals as well. The products can also be exported to various African, Gulf, the Middle East and European countries, both directly and also through third party exports.

and excellent working methods to manufacture quality products. We shall of course continue on a fast growth track and will provide many more innovative products in times to come. Development of our product line has been an end result of interactions with industry people based on their requirements, experience and expectations. This is a continuous process which we carry out regularly. We

take pride in the fact that our designers are based on the field and understand the industry well. The company offers state-of-the-art standard model/GMP model with the option of fully automatic Programmable Logic Controls (PLC) for various process equipment designed to suit a specific process as required by the client's product. Our products are globally accepted due to advanced inter-

national technology, steady performance, superior quality and best services. Our customers see us as a professional partner and supplier.

At MARK MAKERS, its efficient team spares no stone unturned, to be the best in custom-built engineering by combining stateof- the-art design and technology. The company is committed to ensure that no trouble is spared to see that

Our range of products include as given below: ◗ Mechanical sifter from lab model to production model ◗ Multimill from lab model to production model ◗ Conventional coating pan from lab model to production mode ◗ Rapid mixer granulator from R&D model to production mode ◗ Fluid bed dryer from lab model to production model ◗ Planetory mixer from lab model to production model ◗ Vibro sifter from lab model to production model ◗ Octagonal blender, conta blender, v blender, double cone mixer Contact adke.vinayak@gmail.com, sales@markmakerpharma.com vinayak@markmakerpharma.com

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DHI,Govt of India,to launch Industry 4.0 at WIN INDIA2016 Three in one event to feature leading companies to showcase state-of-the-art technologies, products and solutions for manufacturing sectors HANNOVER MILANO Fairs India, organisers of the world’s largest trade fair Hannover Messe, announced the 10 th edition of WIN INDIA 2016, India’s leading industrial and engineering trade fair, scheduled to be held from December 1-3, 2016 at the MMRDA Grounds, Bandra-Kurla Complex, Mumbai. Further to this, the Department of Heavy Industry (DHI), Government of India and WIN INDIA announced its continued partnership to work jointly towards promoting India’s high tech engineering and capital goods manufacturing industry as a part of Government of India’s ‘Make In India’ campaign. WIN INDIA 2016 will cover the entire lifecycle of Industry 4.0 - industrial automation, hydraulics and pneumatics, warehousing and logistics, in three specialised trade fairs - Industrial Automation India (IA India), Motion Drive & Automation India (MDA India) and CeMAT India.

To announce the collaboration, present at the conference were Girish Shankar, Secretary, Department of Heavy Industry, Government of India, SN Roy, Chairman FICCI Capital Goods Committee and CEO and MD, L&T Power, Kannan Vishvanath, Senior Member, SIMHEM (Society for Indian Materials Handling Equipment Manufacturers), Dattatreya Gaur, VP, Robert Bosch Engineering and Business Solutions, and Mehul Lanvers-Shah,

(L-R) Dattatreya Gaur, VP, Robert Bosch Engineering and Business Solutions, Mehul – Lanvers Shah - MD, Hannover Milano Fairs India, Girish Shankar - Secretary, Department of Heavy Industry, Government of India, SN Roy,- Chairman, Capital Goods Committee, FICCI and Kannan Vishvanath - Founding Member, SIMHEM

MD, Hannover Milano Fairs India.

WIN INDIA 2016, a platform for showcasing the relevance of Industry 4.0 to Indian manufacturing industry, will highlight India’s unrelenting march towards becoming a manufacturing powerhouse in the region. As per a recent report compiled by Nikkei and research firm Markit, the overall order booking for the Indian manufacturing sector rose to a 22-month high in October 2016. This indicates that the vital signs for the sector are truly on course and would be aptly demonstrated at the trade fairs.

Shankar said, “As per various government schemes, we are expecting a threefold increase in growth in capital

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goods production and employment by 2025 and a 3.5 times increase in the manufacturing sector by 2026. With this boost in the manufacturing sector, WIN INDIA 2016 will be an exciting avenue for the industry to launch and showcase new products and industry 4.0 technologies. WIN INDIA serves the modern technology induction aspect of ‘Make In India’. The government is committed to raising technology levels in Indian manufacturing. WIN INDIA enables Indian MSMEs to get exposed to select German modern technologies. WIN INDIA being at their door steps, allows them to network with innovative products manufacturing exhibitors, normally present at Hannover

Messe. Support by the Government of India to WIN INDIA is to enable Indian manufacturing industry to get to know global best, right here in India. We are pleased to continue our partnership with Hannover Milano Fairs India and we extend our full support to WIN INDIA 2016.”

Cavas Dumasia, Secretary – SIMHEM and VP – Marketing & Sales, Godrej Material Handling said, “One of the important objectives of SIMHEM is to inform users of the benefits of mechanised material handling equipment through training programmes, seminars, trade fairs etc. CeMAT India is a great platform for the material handling sector in India and with its partnership with SIMHEM, we see

growth opportunities for our members as well as other integrated industry to promote their business and develop leads. SIMHEM and CeMAT India are two leading brands in the material handling sector in India and what better than joining hands to expand the market.”

WIN INDIA is expected to see a participation of more than 200 exhibitors, launching and showcasing their new products and technologies from around the globe. WIN INDIA 2016 has representations from China, Germany, India, Italy, Netherlands, South Korea, Spain, Taiwan, the UAE and the US. Some of the leading brands that will be participating are Siemens, Robert Bosch Engineering,

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Festo, Camozzi, Larsen & Toubro, Rittal, Nord Systems, Jungheinrich Lift Trucks India, Godrej & Boyce Mfg, Mahindra Logistics, Pilz India, Intouch, Grey Orange Robotics, Kompress India, Exide Industries, NASH Robotics & Automation, Concord Hydraulics, ABM Drivers India, Eppinger and Ningbo Degson amongst others.

Gaur talked about their products and technologies that will be displayed at WIN INDIA and the role of the government and WIN INDIA in boosting the industry.

“FICCI is happy to partner with Department of Heavy Industry (DHI) and Hannover Milano Fairs India (HMFI), once again in organising WIN INDIA, which is emerging as

a prominent show for the capital goods and automation industry. The capital goods sector in India in which 80 per cent enterprises are from MSME sector, needs latest and strategic technology in various spheres. The sector is also gearing up for the new wave of Industry 4.0. With Prime Minister’s Make in India initiative, we are aspiring to be the manufacturing hub for capital goods across the value chain,” said Roy Speaking at the press conference, Lanvers Shah said, “In the pursuit of increasing the manufacturing capacity of India, we see a major potential for the growth of capital goods manufacturing industry. With support from Department of Heavy Industries

One Brand Total Solution

WIN INDIA is organised by Hannover Milano Fairs India, Deutsche Messe’s subsidiary in India and various other industrial associations like FICCI, SIMHEM, FPSI, VDMA, AIA and IVS, the industry is here to stay and grow. We have witnessed the commitment and

efforts from our exhibiting companies for driving new and innovative technologies and products in the manufacturing space. At WIN INDIA, we continue to provide this large platform for enterprise and user industry to interact, creating a complete solution marketplace.”

WIN INDIA 2016 will present interactive features such as ‘Automation Training Zone’ along with Automation Industry Association (AIA), MDA FORUM by VDMA, Intralogistics 4.0 Conference and Masterclass for Supply Chain Professionals organised by ISCM, CEO Conclave by FPSI, Vacuum Technology Workshop etc. With the objective of bringing industrial associations together, WIN IN-

DIA has partnered with associations such as SIMHEM, Fluid Power Society of India (FPSI), VDMA (German Engineering Association), AIA, Indian Vacuum Society, SME Chambers of Commerce, Bombay Industries Associations, Association for Multimodal transporters, Taloja Industries Association and Bombay Goods Transport Association.

WIN INDIA is organised

by Hannover Milano Fairs India, Deutsche Messe’s subsidiary in India, and belongs to Deutsche Messe’s HANNOVER MESSE Worldwide portfolio, which includes events in Brazil, China, Italy, Turkey, and the US. EP News Bureau

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REMI launches new products – lab stirrers and magnetic couplers The products are available in the market from September 2016 onwards REMI IS growing, evolving and changing. As a part of its growth strategy, REMI has always been at the forefront in adopting latest technology to its existing product range. In this on-going process, they have launched new products, available to its customers from September 2016.

The two new products are:

◗ Lab stirrers: On continuous demand from the users of lab stirrers, the company has introduced two new models of stirrers RQ-5Plus & RQ-100 Plus. RQ-5 Plus is a lab stirrer with BLDC motor and meant for stirring applications in very small volume of maximum five litres. RQ-100 Plus stirrer is with AC induction motor & Variable Frequency Drive (VFD) for stirring volume ap-

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plications up to 100 litres. Both the stirrers will be available with LED display for speed. ◗ Magnetic couplers: Many customers require stirring with corrosive chemicals or with active media. For such applications glass reaction vessels are used. Magnetic couplers ensure that the motor and speed indicator is isolated from the stirring medium by making the system leak-proof. These couplers will be available for use with glass reaction vessels up to 80 litres capacity.

Contact MT D’Souza Product Manager Remi Sales & Engineering Remi House, 11 Cama Industrial Estate,Walbhat Road, Goregaon (East), Mumbai - 400 063

Magentic coupling

Laboratory stirrers

Tel: +91 - 22 - 4058 9888 Fax: +91 - 22 - 4058 9890 Mobile: 9322213105 Email: dsouza@remilabworld.com

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Virosil Pharma: ASwiss eco-friendly disinfectant It is a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment Sanosil Biotech, a Mumbaibased company is the first company to pioneer the novel concept of eco-friendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin.

The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can be used where other chlorine-based disinfectants have been feared.

Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, Ranbaxy, J&J, Abbott, Serum Institute, Dr Reddy’s, Lupin Labs, Cadila Healthcare, Wockhardt, Biocon, Astrazeneca, etc., as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment The added benefits of Virosil Pharma is that it does not give any foul odour, irritation to the eyes, requires no de-fumigation and is very easy to handle. There are also no tears or fears for overdosing. A room of 1000 cubic feet can be ready and completely sterile within a maximum period of 60 minutes using a 20 per cent of solution of Virosil Pharma. With a recommended MicroMist ULV fogger gives a very fine mist

that even penetrates between cracks of surfaces ensuring a safe and sterile environment.

Virosil is also very widely used for disinfection of surfaces, equipment, raw water, pipelines and DM plants. The formulation has been tested in various reputed institutions in Switzerland, France, Germany

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and Australia.

The company has great respect for human health and the environment. The CEO, Dev Gupta, an MBA from the Bentley Graduate School of Business, Boston has been actively marketing it under the brand Virosil Pharma, nationally. According to Gupta, “Virosil

Pharma has simplified the lives of so many people who work in the pharma industry as they are guaranteed sterility with minimum risk exposure from the fumes of Formaldehydebased products.”

The company also offers a customised disinfection audit on its website; www.sanosil-

biotech.com Contact Dev Gupta CEO, Sanosil Biotech, Warden House, 1st floor, Sir PM Road, Fort, Mumbai 400 001 Tel No: 022 22872295 Email: info@sanosilbiotech.com

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Intertech Technologies: Equipping for progress Intertech Technologies is a leading provider of turnkey projects execution in pharma, food and cosmetics machines and allied equipment INTERTECH TECHNOLOGIES is one of the largest and most reputed manufacturers of processing, packaging machineries. It works in technical/ financial collaboration with the world’s leading companies, exporting its products all over the world. It has warehouses, marketing establishments and service centres in several countries across the globe.

Established in the year 2005, the company has implemented its knowledge in designing and constructing stainless steel equipment to provide technical project engineering of pharma and chemical production lines, advisory design services along with design and development of equipment and machines.

Many years of experience in planning and developing of greenfield projects and turnkey production facilities in India

and around the world has turned Intertech Technologies’ engineers into specialists who are well-versed with WHO FMP, FDA and EU-GMP standards.

The company stresses on an environmentally-friendly industry. The company endeavours to achieve engineered solutions for process demand of all pharma, food, cosmetics and other allied industries. The newly constructed state-of-the-art facility of 1,00,000 sq.ft in Vasai, on the outskirts of Mumbai, is equipped with in-house design and development facilities.

INTERTECH turnkey solutions include:

◗ Feasibility studies and project cost estimates ◗ Return on investment evaluations ◗ Project financing (may be available)

◗ Conceptual designing ◗ Alternative process and equipment evaluations ◗ Process flow diagrams and P&I diagrams ◗ Complete equipment specifications and design engineering (URS) ◗ Procurement of materials and equipment ◗ Project/programme manage-

ment thru BAR chart & PERT technique ◗ Facility check, commissioning, validation/qualification ◗ Facility start-up and batch trial completion ◗ Project closing documentation Contact: Building No. 1 & 2, ‘A’ Wing,

Unique Industrial Estate, S.No. 36, H.No. 10, Dhumal Nagar, Waliv, Vasai (E), Dist Thane-401208, Maharashtra Tel.+91-250-6053371-79 E-mail: factory@intertechglobal.com Website: www.intertechglobal.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

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Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

PHARMA TECHNOLOGY REVIEW

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VALUE ADD

Waters expands CORTECS analytical column portfolio Will allow scientists to obtain more information per analysis and reduce the cost of analysing complex samples WATERS CORPORATION expanded its CORTECS Columns product line with the introduction of two new chemistries: Waters CORTECS T3 and CORTECS Shield RP18. These new CORTECS column chemistries allow scientists to obtain more information per analysis and reduce the cost of analysing complex samples such as biomarkers, natural products, counterfeit cosmetics, synthetic cannabinoids, veterinary drugs, drinking water, and vitamins.

Today’s scientists want more tools for improving the resolution, speed, selectivity, and sensitivity of their UPLC, UHPLC, and HPLC separations,” said Doug McCabe, Director of Product Management - Consumables Group.

“CORTECS Columns deliver the batch-to-batch reproducibility, robustness, and quality that customers have come to expect from Waters.”

When used with an ultralow dispersion ACQUITY UPLC instrument platform, the CORTECS UPLC 1.6 micron particle columns are designed to deliver approximately 40 per cent greater increase in separations efficiency when compared to fully porous particles of an equivalent particle size. The highly-efficient CORTECS 2.7 micron particle columns are for use on both the ACQUITY Arc UHPLC system and the Waters Alliance HPLC system and operate at lower backpressures allowing for the use of longer

When used with an ultra-low dispersion ACQUITY UPLC instrument platform, the CORTECS UPLC 1.6 micron particle columns are designed to deliver approximately 40 per cent greater increase in separations efficiency when compared to fully porous particles of an equivalent particle size. column lengths to improve resolution or shorten analysis times and increase throughput.

The CORTECS T3 and

To subscribe: bpd.subscription@expressindia.com

CORTECS Shield RP18 chemistries compliment the currently available CORTECS C18+, C18, C8, Phenyl, and

HILIC chemistries.

All CORTECS chemistries are fully scalable between the 1.6 micron and 2.7 micron parti-

cle sizes. The CORTECS T3 and CORTECS Shield RP18 chemistries are offered in 48 unique column configurations and are immediately available for shipping worldwide.

With different particle characteristics and innovative charged surface modifications, CORTECS Columns are suitable for use in a wide variety of applications.

CORTECS T3 columns provide balanced retention for polar and non-polar molecules when run under reversedphase LC conditions. The increased pore diameter (120Å vs. 90Å) along with the lower C18 ligand density and proprietary end capping enables the CORTECS T3 chemistry to operate in 100 per cent aqueous mobile phase without the fear of the phase dewetting.

Shield RP18 columns utilise an embedded carbamate functional group into the alkyl ligand which provides alternative selectivity for basic and polyphenolic compounds when compared to typically bonded C18 phases. The embedded polar carbamate groups act as hydrogen bond acceptors, and provide unique selectivity especially for basic and polyphenolic compounds.

Contact details Dayamani Santosh Sr Admin Officer [T] 080-49292200-03 [F] 080-49292204 [M] 9632786899 [W] www.waters.com [E] dayamani_santosh@waters.com

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PHARMA TECHNOLOGY REVIEW

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Key factors in data integrity Chandresh Jain, GM – Informatics, Waters, elaborates more on data integrity issues, which has seen a steep rise, with the opening of a large number of regulated laboratories DATA INTEGRITY is the new buzz word in laboratories today. There is a distinct trend in the number of data-related issues uncovered by regulators. Since 2013, there has been a steep rise in the number of data integrity related incidences. And this is not just an India-specific phenomenon.

Data integrity-related issues have been uncovered around the world. Given the large number of regulated laboratories operating in India, the numbers of incidences were expected to be high.

Data integrity is generally defined as maintaining and assuring the accuracy and consistency of the complete data over its entire life-cycle.

The US FDA’s Data Integrity and Compliance with CGMP Guidance for Industry, Draft Guidance 2016 document describes it as: Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 document defines data integrity as The extent to which all data are complete, consistent and accurate throughout the data lifecycle. Even WHO’s Annex 5 Guidance on good data and record management practices 2016 refers to Data Integrity as - Data integrity is the degree to which data are complete, consistent, accurate, trustworthy and reliable and that these characteristics of the data are maintained throughout the data life cycle.

The data should be collected and maintained in a secure

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manner, such that they are attributable, legible, contemporaneously recorded, original or a true copy and accurate.

Integrity of data ensures safety, efficacy, and quality of drugs. It is a fundamental requirement of pharmaceutical quality system.

ALCOA comes up in almost all the data integrity-related discussions. The elements of Data quality in ALCOA are: ‘A’ stands for Attributable.

It is expected that data be linked to its source. The data should be attributable to the individual who observed and recorded the data, as well as traceable to the source of the data itself. All entries on paper should be dated on the date of entry and signed or initialed by the person entering the data. The same is true for data collected on an electronic system. In an electronic system, the audit trails keep a track of this element.

In the warning letters, the data integrity issues related to ‘A’ show up as ‘All laboratory analysts share the same password for the HPLCs in the QC analytical chemistry lab and Omnilog in the microbiology lab’, ‘All employees in your firm used the same username and password’ and ‘several of the HPLCs had the audit trail functions disabled’. It is important that the users do not share their usernames and passwords. The audit trails lose their meaning and activities become untraceable when users share usernames and passwords.

Waters Empower3 Enterprise is the most commonly used chromatography data system in compliant laboratories today. All method information and raw data is stored with results, in a secure and

embedded database. Nothing is overwritten and all versions are available for review. Audit trails allow traceability and proof of modification or deletion. Specific features have been implemented to allow compliance with ER/ES (21 CRF Part 11), Annex 11 etc. for customers who must comply with regulations.

A new Empower3 tool called ‘Result Audit Viewer’ allows the review of all sample result related audit trails in one window.

‘L’ stands for Legible. Legibility means that data are readable. It implies that data must be recorded permanently in a durable medium i.e. pen and ink on paper.

‘C’ stands for contemporaneous. Data should be recorded at the time the observation is made. This has showed up in warning letters as ‘Recording weights, LOD tests and manufacturing steps in documents before they were executed/measured’, ‘Making balance printouts retrospectively after chromatographic runs were made’ and ‘Non contemporaneous recording of signatures on calibration and media preparation activities’.

‘O’ stands for Original.

Original data is generally considered to be the first and therefore the most accurate

and reliable recording of data.

Examples given as, ‘There is no system in place to ensure that all electronic raw data from the laboratory is backed up and/or retained’, ‘Your firm had no system in place to ensure appropriate backup of electronic raw data and no standard procedure for naming and saving data for retrieval at a later date’, ‘our investigator requested to review the electronic analytical raw data to compare the values for (b)(4) assay and degradation products.

However, your firm provided only the printed copies of the raw data because your firm did not have the software programme available to view the electronic raw data’ and ‘Your firm did not retain complete raw data from testing performed to ensure the quality of your APIs. Specifically, your firm deleted all electronic raw data supporting your (HPLC) testing of all API products released to the US market’ are some of the issues uncovered related to original raw data.

MHRA GMP Data Integrity Definitions and Guidance for Industry document describes raw data retention in more detail. ‘Raw data (or a true copy thereof) generated in paper format may be retained for example by scanning, provided that there is a process in place to ensure that the copy is verified to ensure its completeness. In another section, Original Record/True Copy, there is more explanation on electronic data – ‘It is conceivable for raw data generated by electronic means to be retained in an acceptable paper or PDF format, where it can be justified that a static record maintains the integrity of the

original data. However, the data retention process must be shown to include verified copies of all raw data, metadata, relevant audit trail and result files, software / system configuration settings specific to each analytical run, and all data processing runs (including methods and audit trails) necessary for reconstruction of a given raw data set. It would also require a documented means to verify that the printed records were an accurate representation. This approach is likely to be onerous in its administration to enable a GMP compliant record.’

Data retention may be classified as archive or backup.

Data and document retention arrangements should ensure the protection of records from deliberate or inadvertent alteration or loss. Secure controls must be in place to ensure the data Integrity of the record throughout the retention period, and validated where appropriate.’ Labs must have systems in place to archive the raw data. One of the commonly used archival solutions for electronic raw data is NuGenesis Scientific Data Management System.

And the last ‘A’ stands for Accurate. It implies that no errors or editing was performed without documented amendments. Within an electronic system, the audit trails will record the original version and the changed version of the changes made, along with user identity and data/time stamp.

References of failing accuracy have showed up as ‘Your management failed to prevent the practices of product sample retesting without investigation, and rewriting and/or omission of original CGMP records persisted without im-

PHARMA TECHNOLOGY REVIEW One Brand Total Solution

plementation of controls to prevent data manipulationâ&#x20AC;&#x2122;.

The acronym ALCOA+ stands for ALCOA in addition to the following attributes: Complete, Consistent, Enduring, and Available. Complete data includes all data to obtain the final result. It includes all metadata, calibration curves, system suitability tests and even failed runs, including audit trails. Consistent data is created using methods or procedures that can be repeated following a logical sequence of activities. Procedural controls or standard operating procedures are critical for creating consistent data. Enduring means data must be protected from loss, damage, and/or alteration and must be available throughout the defined retention period. Data should be stored on a medium such that it is available for review during the entire retention period. It is advisable to store data backups at a different location than the original/raw data. Available means that the data are readily retrieved throughout the lifecycle of the system, or the appropriate retention period, and that it must be available in human readable form.

The repercussions of data integrity failures are immense.

The first and foremost is the financial impact. On receiving a Warning Letter or a Notice of Concern or similar adverse comments, the stock value of the pharmaceutical company goes down. There is a risk of losing markets due to import alerts and eventually revenues. Next, the company reputation takes a big hit. The investorâ&#x20AC;&#x2122;s and the customerâ&#x20AC;&#x2122;s confidence is eroded. Finally, there could be legal consequences as well. In a worst case scenario, the pharma company may invite lawsuits and debarments.

A strong company culture of compliance is very important in avoiding data integrity issues. It is important to find a balance between compliance and business goals because both are important. The employees should be trained on compliance and must be rewarded for the right behaviour.

In the majority of cases, concerns about data integrity are in no way related to deliberate creation of fraudulent results, but stem from a lack of understanding, either about the goals and purpose of laboratory testing or manufacturing controls, or about the cor-

November 16-30, 2016

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