Express Pharma (Vol.11, No.12) April 16-30, 2015

VOL. 11 NO. 12 PAGES 98

www.expresspharmaonline.com

Market Merck conducts EMPROVE Seminar Series on 'Enabling Informed Risk Assessment'

16-30 APRIL 2016,` 40

Sometimes I’m blunt.

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The Indian Express.

For the Indian Intelligent.

#IndianIntelligent

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CONTENTS MARKET Vol.11 No.12 APRIL 16-30, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Ravindra Pawar - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

Merck conducts EMPROVE Seminar Series on ‘Enabling Informed Risk Assessment’ The seminar series is an initiative to create a platform for the industry to discuss and disseminate information as well as develop strategies for the pharma sector’s growth | P16 P14: PRE EVENTS Pharma Pro & Pack Expo 2016 to be held in Mumbai

RESEARCH

26 27

P33: NEWS Agarwal Movers Group invests ` 100 crores in Trucking Cube

P34: INSIGHT New age storage systems for cell therapy products

Scheduling & Coordination Ashish Anchan

P90: NEWS

CIRCULATION Circulation Team Mohan Varadkar

Pharma to see increments of 13.5 per cent: Antal International

‘THE GOAL IS TO CONTINUE TO BUILD AN INTERNATIONALLY COMPETITIVE AND COLLABORATIVE SECTOR’

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CPHI INDIA WITH P-MEC INDIA TO BE HELD IN MUMBAI

CORRIGENDUM An interview of Mandar Athalekar,

P24: INSIGHT Online CMEs: An emerging need

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28

US FDA APPROVES BIOSIMILAR TO J&J’S REMICADE FOR MULTIPLE DISEASES RARE LIVER DISORDER DRUG FROM JAZZ WINS US APPROVAL EUROPE GIVES GREEN LIGHT TO FIRST GENE THERAPY FOR CHILDREN

29

FDA PANEL BACKS ACADIA DRUG FOR PSYCHOSIS LINKED TO PARKINSON’S

30

KERYX SAYS ANAEMIA DRUG SUCCEEDS IN STUDY OF KIDNEY PATIENTS

Strategy Leader,Thomson Reuters carried in the March 16 - 31, 2016 issue of Express Pharma carried the wrong photograph.The inadvertent error has since been rectified online.The corrected version is available at this link

http://www.financialexpress.com/ article/pharma/ market-pharma/integratingrobust-systems-would-havewidespread-influence-in-guardingagainst-market-volatility/227240/

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

Quality consciousness: A pre-requisite to progress

M

anufacturing quality has now become probably the single most important concern in the boardrooms of pharmaceutical companies in India. But decades of neglect cannot be reversed instantaneously and it will be some time before we start to see the results.

Ipca Laboratories was the latest to take a beating on this front. The company takes justifiable pride in its dedication to “Mission Malaria” so it was a body blow in early April when one of its most prestigious clients, the Swiss Global Fund, to which it supplied Artemisininbased Combination Therapy (ACTs), decided to discontinue supplies from the company. The Fund cited US FDA warning letters for lapses in manufacturing norms at three of its facilities as a justification for its action.

Anti-malarials are clearly a very important part of Ipca’s product basket, which claims to be one of the world’s largest manufacturers of artemisinin-based APIs and formulations, making up 18 per cent of its turnover, according to the company website. The company leads in India’s anti-malarial market with a share of over 34 per cent and relies on supply contracts with donor organisations like UNICEF, WHO, IDA, Mission Pharma, PSI, SCMS, MSF, MEG and Ministries of Health in Africa, to expand its export footprint.

The question is, will these organisations decide that they too need to follow Global Fund's example? The impact on Ipca’s bottomline will be dismal. Its first half year results of FY16 already show some strain, with net total income down 12 per cent at `1516.58 crores, exports income down 23 per cent at `751.56 crores, and EBIDTA margin at 11.37 per cent as against 21.30 per cent in the previous period last year (H1 FY15). Net profit too took a beating, which at `30.58 crores was down 85 per cent. The lone bright spot was that Indian formulations income was up 4 per cent at `648.80 crores.

Many companies could be facing the same predicament as Ipca if they brush off 483s and warnings. This is the reason why it looks like they are finally serious about plugging the gaps in the quality systems. Our upcoming Good Manufacturing Practices (GMP) special in the May 16-31 issue will hopefully find some success stories of companies leading the pack with an extra focus on manufacturing quality.

There are some signs that India’s drug regulator is also becoming more vigilant. Though this merits analysis on a long term basis, there seems to be an increase in the number of items listed as ‘Not of Standard Quality/Spurious/

10 EXPRESS PHARMA April 16-30, 2016

With regulators in all countries closing the net, defaulters will have no choice but to shape up.

Or ship out.

Adulterated/Misbranded’ in the monthly drug safety alerts released by the Central Drug Standards Control Organization (CDSCO). For instance, the alert for this March has 18 items on the list, while there were 27 in February and 25 in January. In contrast, January 2015 had 10 on the list, the following month had 17, while March last year had 14 items on the list.

The CDSCO has also moved ahead on its e-governance initiative, as part of the Prime Minister Modi's over-arching ‘ease of business’ mission, powered by the Digital India initiative.

SUGAM, CDSCO’s online portal was launched in November last year. The Import and Registration Division was the first division to accept online applications for licensing but slowly, all services are expected to move to the online mode. Will SUGAM live up to its name and provide easy access for our pharma industry? Or will it be hamstrung by infrastructure problems? The cover story in the April 16-30, 2016 issue asked this question to a cross section of the industry and got some interesting feedback. (See story, A portal for progress?', pages 20-23) In the same vein, on March 29, the Drug Controller General (India)'s office ordered all pending applications for clinical trials and new drugs to be cleared in three weeks. The same order also tries to ease other bottlenecks in the approval process. For instance, it clarifies that the pre-screening officer should only verify if the query has been answered, leaving the evaluation of the reply to the relevant division of the CDSCO and the Subject Matter Committee when applicable. Similarly, repeat queries on the same matter will be escalated to the DCG(I) himself during the processing of the applicant's third reply.

The DCG(I) followed this up with another order dated April 8, stating that the status of all pending applications would be uploaded on a monthly basis on the CDSCO website and he was to be informed if any application overshot the prescribed limit. Obviously, the DCG(I) is keen to prevent any further delays in the approval process. It will take time to rebuild the trust of the industry but this seems to be a good start. For starters, the scheduled meeting on May 12 with stakeholders from the clinical trials sector will be closely watched for signals on any more changes.

With regulators in all countries closing the net, defaulters will have no choice but to shape up.

Or ship out.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘The goal is to continue to build an internationally competitive and collaborative sector’ Sharon McKendry, Head, Scottish Development International shares details about the advantages offered to Indian lifesciences players investing in Scotland, SDI’s measures to make the business environment more conducive and more, in an interaction with Viveka Roychowdhury Britain is planning to exit the EU? Will Scotland once again seek a referendum to be independent of the UK if this happens? How will this impact Scotland as a destination for the global business community?

The EU referendum represents an important and historical decision for the British public.

But, regardless of the outcome, Scottish Enterprise (SE) and Scottish Development International (SDI) will continue to deliver with confidence, ready to make the most of the many opportunities that lie ahead for Scotland and its businesses, in the EU and globally. It is not appropriate to speculate on the possibility of a future referendum on Scottish independence based on this decision.

What are the components of the integrated package of support offered to life sciences companies who want to base their business out of Scotland?

The support for companies starts with that personal touch and interaction where we work closely with companies to understand their needs and where Scotland can help. SDI can make introductions to academics, clinicians, supply chain companies and potential collaborators. We can help with initial touch down space and we keep connected every step of

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April 16-30, 2016

the way. That’s really one of Scotland’s strengths. We are a well-connected and collaborative country. We have a thriving life sciences community with a number of initiatives and projects where the academia, industry and our single, integrated national health service collaborate for advancing science and technology.

We work as a wider team to bring in the relevant expertise to ensure that we can provide the appropriate package of support which includes financial support packages through regional selective assistance, research and development grants or training support. Add to that the on-going support, once you are here, through dedicated account management, innovation and international specialist support as well as reviews through our Scottish Manufacturing Advisory Service for those companies manufacturing in Scotland.

The support doesn’t end once you set up here, but that’s where some of the most valuable support takes place. It can also link you to the wider ecosystem whether it be looking at conducting trials, accessing skilled workers or collaborating across institutions, companies or geographical borders.

Any specific success stories involving Indian lifesciences

We have companies from India investing in Scotland and also Scottish companies who are experiencing success in the Indian market players that you’d like to highlight as learnings for both SE, SDI and their peers in India?

We have companies from India investing in Scotland and also Scottish companies who are experiencing success in the Indian market. One such company who choose to locate

in Scotland is the innovative life sciences company Piramal Healthcare which employs around 140 people at their operations in Grangemouth.

In November last year, they announced their plan to invest £2 million for expanding their manufacturing facility and creating 20 new high value jobs in the area. The expansion was supported by £200,000 of Regional Selective Assistance.

Scotland’s First Minister, Nicola Sturgeon opened their new facility last year.

On the other hand, Omega Diagnostics, a Scottish company that has been operating in India since 1992, inaugurated their first greenfield manufacturing facility at the International Biotech Park, Pune in November last year. With an investment of $0.9 million, the company estimates that it could be employing up to 50 people, including high quality positions in production management and technical/quality control roles over the next 12 months.

With the Indian healthcare market growing rapidly over the recent years, the move to establish a manufacturing base in India is a logical and exciting step forward for the Omega Diagnostics Group. The company sees potential for major growth, not just in the Indian domestic market, but also to export products produced in Pune to their

global distribution network which covers over 100 countries.

Is there a special fund for Indian/Asian companies?

There isn’t a fund that’s specific to any particular geography.

Regional Selective Assistance is open to any company that wants to locate and grow in Scotland but the level of assistance is specific to particular Scottish locations and the size and scale of business in Scotland itself.

There are a range of incentives that are available to support businesses in the shorter term and to help them grow and succeed in a medium to longer term.

What are the goals of Scotland on the life sciences sector to 2020?

As previously announced, the goal is to continue to build an internationally competitive and collaborative sector that continues to be at the cutting edge of developing new and innovative technologies to solve some of our global healthcare challenges. The ambition is to significantly grow the economic impact of the sector and double the turnover generated by 2020. It would be done by anchoring, building and attracting life science companies, talent and investment. viveka.r@expressindia.com

MARKET PRE EVENTS

Pharma Pro & Pack Expo 2016 to be held in Mumbai

iPHEX2016 to be held in Mumbai from April 27-29, 2016

IPMMA to organise the event PHARMA PRO & Pack Expo (PPPE) 2016, an international pharma exhibition on technologies and trade will be held at Mumbai Exhibition Centre from April 27-29, 2016. Organised by Indian Pharma Machinery Manufacturers' Association (IPMMA), the show will witness 20,000 pharma trade professionals / decision makers and 250 industry majors. The entire pharma fraternity will be able to share the knowledge, discuss the updates and evolve new ideas towards advancements in the pharma technologies. Express Pharma is the official media partner for the event.

Exhibitor's profile includes pharma processing

The entire pharma fraternity will be able to share the knowledge, discuss the updates and evolve new ideas towards advancementsin the pharma technologies. Express Pharma is the official media partner for the event machineries (tablet / capsule / liquid / injectables / ointment / dry syrup), packaging machineries, packaging materials and consumables,

API, bulk drugs, additives, excipients, pharma finished products, formulations, lab reagents, glassware and equipment, analytical, R&D

equipment and biotech instruments, environment control equipment and services, utilities products and services, turn-key contractors, project consultants.

Visitor's profile includes CEO and top management, corporate management, plant management, plant engineering, manufacturing / production officers, maintenance engineering, vendor development and purchase, QA, QC and R&D officers, pharmacists, contract manufacturer's, compliance and regulatory officers, equipment, machinery manufacture, suppliers and distributors.

EP News Bureau-Mumbai

iPHEX 2016, an exhibition that brings together the drugs, pharmaceutical and healthcare industry, all under one roof, will be held at Bombay Exhibition Centre, Mumbai, from April 27-29, 2016. 400 overseas buyers are likely to participate in the exhibition. Co-located with PHARMA Pro&Pack Expo 2016, a show for pharma machinery manufacturers, iPHEX 2016 will offer the industry majors from India and all across the world a great platform to connect and do business.

The organisers for iPHEX 2016 are the Ministry of Commerce and Industry, Department of Commerce, Government of India and Pharmaceuticals Export Promotion Council of India.

EP News Bureau-Mumbai

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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EXPRESS PHARMA

April 16-30, 2016

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 editorial.ep@expressindia.com

MARKET

CPhI India with P-MEC India to be held in Mumbai Pharma Week, to be held for the first time will see more than 12 events across the city CPHI INDIA co-located with P-MEC India, a leading pharma event, will be held in Bombay Exhibition Centre and MMRDA Grounds, BKC, Mumbai from November 21 to 23, 2016. This year, the expo has grown from a three-day exhibition to a show spanning a week, Pharma Week, to be held from November 17 to 23, 2016. While celebrating a decade of CPhI India, the

This year, the expo has grown from a three-day exhibition to a show spanning a week, Pharma Week, to be held from November 17 to 23, 2016 Pharma Week will hold more than 12 events that will take place across the city of Mum-

bai focusing on business, knowledge, leadership, innovation and recognition in the

field of pharma.

Organised by UBM EMEA, more than 32000 dedicated

pharma professionals are likely to attend the event.

In 2015 CPhI India and PMEC India attracted 32,000+ attendees from 97countries across the globe over three days. The event witnessed a record participation of 1,100+ exhibitors from 25 countries, spread over 55,000 sq metres at the Bombay Convention and Exhibition Centre, Mumbai.

EP News Bureau-Mumbai

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EXPRESS PHARMA

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April 16-30, 2016

MARKET POST EVENT

Merck conducts EMPROVE Seminar Series on 'Enabling Informed RiskAssessment' The seminar series is an initiative to create a platform for the industry to discuss and disseminate information as well as develop strategies for the pharma sector’s growth THE 2016 chapter of the Emprove Seminar Series was recently held in Mumbai. The seminar witnessed the presence of experts from the industry as speakers and panelists. ‘Enabling Informed Risk Assessment' was the theme for the year. The seminar series is an initiative to create a platform for the industry to discuss, debate and disseminate information as well as develop strategies for the future of the pharma industry.

Welcoming the distinguished speakers and the audience to the 5th edition of the EMPROVE Seminar Series, Peter Salazar, Head of the Process Solutions Business, Merck, said, “The milestones in regulatory affairs are changing very fast and so the objective of this seminar, 'Enabling Informed Risk Assessment' fits well into the need of the hour. The seriousness towards risk assessment has increased over the past few years.

Sushrut Kulkarni, Senior Vice President and Head Pharmaceutical Technology Center, Zydus Cadila in his inaugural speech highlighted that risk assessment covers two main aspects. They are risk to patient and business risk. Different regulatory bodies have different expectations and the requirements in regulatory today have become similar to that required for NDAs. Dr Najib Sehat, Head-Global Regulatory Management, Merck - Life Science Business talked on the topic 'EU Guidelines on the formalised risk assessment for ascertaining the appropriate GMP for pharma excipients.'

He said, “The European directive 2011/62/EU, known as the 'Falsified Medicine

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EXPRESS PHARMA

April 16-30, 2016

Peter Salazar, Head of the Process Solutions Business, Merck

Dr Nishodh Saxena, Vice President (Head Quality and Regulatory), Jubilant Life Sciences

Dr Jose Cardoso de Menezes, CEO and Founder, 4Tune Engineering

Ivy Louis, Founder, Vienni Training and Consulting

Dr Anjali Apte-Deshpande, Director / Founder, Central Dogma

Dr Najib Sehat, Head-Global Regulatory Management, Merck - Life Science Business

MARKET Directive' requires that the pharma manufacturer has to perform a formalised risk assessment and has to verify the appropriate GMP for excipients.”

Dr Anjali Apte-Deshpande, Director / Founder, Central Dogma presented studies on recombinant protein production in E Coli with auto inducing medium.

Dr Nishodh Saxena, Vice President (Head Quality and Regulatory), Jubilant Life Sciences was also one of the speakers. In his presentation, he said, “In the pharma industry, every product and every process

The seminar series is an initiative to create a platform for the industry to discuss, debate and disseminate information as well as develop strategies for the future of the pharma industry is associated with risks to the patient’s health. To maintain product quality throughout the product life cycle, a considerable amount of time and resources are allocated.” He presented practical ways to analyse the risks to the quality system and provided guidance to achieve efficient quality management as well as compliance through quality risk management.

Michael Payne, Senior Technical Bio safety Consultant, Merck Millipore, spoke on the importance of risk assessment in clinical trials. He said , “It is important that robust decisions on quality and scaling are made as soon as possible to avoid

To subscribe: bpd.subscription@expressindia.com

unwelcome surprises in the middle of clinical trials”.

The event concluded with a presentation by Ivy Louis, Founder, Vienni Training and Consulting. Louis dealt with the topic ‘Quality & Culture –The Interchangeable Ingredient’. She

highlighted how the culture of the organisation has a huge impact on the quality of work among the employees and how quality and culture are two sides of the same coin.

EP News Bureau-Mumbai

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EXPRESS PHARMA

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April 16-30, 2016

EVENT BRIEF APRIL-NOVEMBER 2016 27

PHARMA Pro&Pack Expo 2016

PHARMA PRO&PACK EXPO 2016 Date: April 27-29, 2016 Venue: Mumbai Exhibition Centre, Mumbai Summary: IPMMA and GPE Expo will organise PHARMA Pro&Pack Expo 2016. The exhibitors profile include: machineries and equipment: Pharma processing M/c (tablet, capsule, injectables, ointments, dry syrup powder) packaging machineries lab and biotech instruments, glassware, packaging materials, lab-wares and consumable, clean room and environment control products and services, utilities equipment and services, project consultants and turn key contractors.

Contact details PHARMA Pro&Pack Expo 2016 / Mumbai GPE Expo Global, 402-403, Abhijyot Square B/h Divya Bhaskar, SG Highway Ahmedabad 380 051 T: +91-79-40008233 / 40008253 E:mail@PharmaProPack.com W: www.PharmaProPack.com

TECHNICALTALK BYAIR TECHNIQUES USA & MEASURETEST CORPORATION Date: April 28, 2016 Venue: Vile Parle, Mumbai Summary: Contamination Control Society of India (CCSI), in association with ASHRAE & ISHRAE Mumbai Chapters, will organise a technical talk on 'Latest Trends in HEPA filter Testing & New Developments in Contamination Control' by Air Techniques USA, together with MeasureTest Corporation, Mumbai.

Contact details Jyoti Gangwani, Executive Secretary, CCSI Phone: 022-22027982 Cell: 9022686802 email: jyoticcsi@gmail.com

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28

Technical talk

by Air Techniques USA & MeasureTest Corporation

PHARMALYTICA 2016 Date: August 5 and 6, 2016 Venue: HITEX Exhibition Centre in Hyderabad Summary: The third edition of PharmaLytica 2016, will see the pharmaceutical community pick up on the latest industry trends, innovations and do business with analytical, bio tech, lab, pharma machinery and

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PharmaLytica 2016

Mumbai - 400 059 Tel: +91 22 61727272 Fax +91 22 61727273

PHARMATECH EXPO 2016 Date: August 21-23, 2016 VENUE: Ahmedabad Summary: The 4th Edition of 'PharmaTech Expo 2016, a PharmaTechnology- Index.com venture will organise a pharma

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PharmaTech Expo 2016

E-mail: expo@pharmatechnologyindex .com / events@knsmedia.com Website: www.PharmaTechExpo.com / www.PackPrinTechExpo.com / www.SwarnimVision.com

2ND EDITION OFASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University

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analytica Anacon India and IndiaLabExpo 2016

trade fair for the analysis, laboratory-technology and biotechnology sectors. As the industry's leading marketplace, it brings together scientists, entrepreneurs and users from around the subcontinent.

At the analytica Anacon India and India Lab Expo Conference, scientists from around the world will present their innovative analysis solutions.

Contact details Email: info@analyticaindia.com

CPHI AND P-MEC INDIA

outsourcing services.

PharmaLytica conference, collocated with the exhibition is the knowledge forum and important industry gathering will bring an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector.

The event is likely to witness 150+ leading local, regional, and international exhibitors, with 4500 expected visitors. It will be an industry focused conference with latest pharma market insights, in-depth case studies, and exceptional networking opportunities. Both the events are supported by Ministry of Science & Technology, Government of India Contact details: UBM India Times Square Unit No. 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East)

expo. The expo will be concurrently held with 'Pack & PrinTech Expo' and introduction of 'PIC India Expo.' It will focus on pharma ingredients and chemicals, giving a large scale exposure to pharma machinery, pharmaceutical ingredients and chemicals, packaging, printing, lab and analytical equipment etc. More than 150 exhibitors are likely to participate in the event.

A special pavilion has been created for 'Track & Trace and Vision Inspection Equipment' to focus on the superior technologies available in India and the major Industry Players involved.

Contact details Aarjav Shah PharmaTechnologyIndex.com (A Division of KNS Group) Phone: +91 – 79 – 27540493 / +91 – 79 – 40306340, 9879616665

Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotechnology, research and testing instruments and consumables. The exhibition will be organised by Fenza Exhibitons.

Contact details: Fenza Exhibitions Plot No 1, 2nd Floor, GT Karnal Road, Opposite PNB Bank, New Delhi – 110033

ANALYTICAANACON INDIA AND INDIALABEXPO 2016 Date: October 20-22, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: analytica Anacon India and India Lab Expo happens to be India's largest

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 PMEC 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, 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

cover )

T

he government launched the Digital India programme in July last year aiming to transform the entire ecosystem of public services through the use of information technology.

According to the programme's official website, the vision is to 'transform India into a digitally empowered society and knowledge

20 EXPRESS PHARMA April 16-30, 2016

economy.' The pharmaceutical sector followed suit with the launch of SUGAM on November 14.

Driven by the Central Drugs Standard Control Organization (CDSCO), SUGAM is envisioned as an online application system for licensing of medicines, along the lines of other e-governance initiatives of the present government. The first phase saw the launch of filing of applications

for import and registration of drugs. In the second phase, the online service was extended to import and registration of medical devices and diagnostics. The website also provides a brief step wise procedure for submission of the application, processing and grant of permissions for medical devices.

During the launch of SUGAM, Dr GN Singh, DCG(I) said, “The objective of

the portal is to build a transparent system and incorporate global benchmarks and practices and head towards a paper free world. It is in line with the governance initiatives in other sectors, as it intends to move to online filing of applications for various services rendered by the CDSCO.” Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of

India, welcomed the government's initiative and says, “Technology is a great enabler and we have experienced its positive intervention across sectors. SUGAM is a welcome step towards a quicker and more efficient process to submit applications for import licenses and registrations.”

Dr HG Koshia, FDA Commissioner, Gujarat, says, “eGovernance is the key to bring

(

THE MAIN FOCUS

It is only five months since India’s central drug authority launched its online licensing services portal, SUGAM. But the regulator needs to settle niggling doubts fast if it wants to catch the Digital India wave

BY USHA SHARMA

The successful execution of this e-initiative will require enabling infrastructure and appropriate back-end support.

All in all, this is a welcome introduction with the potential to add value for all users Ranjana Smetacek Director General, Organisation of Pharmaceutical Producers of India

I think they should release a user guide which gives a detailed step wise process of submission of applications.

This would reduce the mistakes that are made during the filing procedure due to lack of knowledge of the system Suresh Pareek Managing Director, Ideal Cures

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April 16-30, 2016

cover ) e-Governance is the key to bring transparency and speed in expedition of the applications Dr HG Koshia FDA Commissioner, Gujarat

We recommend the CDSCO should conduct training workshop for the industry for effective implementation of SUGAM DB Mody Director, JB Chemicals

Unlike a manual submission where we get an acknowledgment.

The CDSCO should also ensure that the application is acknowledged for receipt TS Jaishankar Managing Director, Quest Life Sciences

22

EXPRESS PHARMA

April 16-30, 2016

transparency and speed in expedition of the applications. FDCA, Gujarat was the first State Licensing Authority (SLA) to introduce web-based portals iDMLA and DMLA for submission of various applications for pharma manufacturers of Gujarat. This initiative has helped the manufacturers not only get the application process done faster but also enabled them to know the status and query, if any, through the portal.”

He adds, “SUGAM, shall definitely help make the process faster at DCG(I) office. It will also help to reduce personal visits of applicants to DCG(I) office.”

Suresh Pareek, Managing Director, Ideal Cures, informs, “The process is quite simple, which is supported with FAQs for general queries that may arise in the minds of a normal user. I think they should release an user guide which will provide a detailed stepwise process for submission of applications. It will eventually reduce mistakes, which happens during filing procedure due to lack of knowledge of the system by the user.”

Dr Kiran Marthak, Head of Clinical Development, Lambda Therapeutics, too seems positive about SUGAM and says, “The implementation has already started. The ultimate goal is to have total online submissions for every aspect in pharma industry including clinical trials, test licenses, manufacturing, marketing, license for pharmacy, import, export of products etc.

This will hasten the process and it will become more transparent as there is no scope of corruption.”

Commenting on the SUGAM portal, DB Mody, Director, JB Chemicals briefs, “The CDSCO has proactively taken up online application submission system for licensing, the e-portal SUGAM in right earnest.

The online system is cur-

The industry will be able to receive approvals in set/mentioned timeline, which will help in doing business.

However, there are several glitches as well that needs to be considered by DCG(I) and other responsible authorities

rently operational for import and registration, medical devices and diagnostics division for registration certificate and import license.

All Form 10 applications and import registrations applications can now be filed online. We expect that the service will ease registration process, which will help the CDSCO issue import licenses faster. The process will be more transparent and enable applicants to track their applications.”

Industry expectations The industry has a lot of expectations from the government regarding 'SUGAM'.

The industry will be able to receive approvals in set/mentioned timeline, which will help in doing business. However, there are several glitches as well that needs to be considered by DCG(I) and other responsible authorities.

TS Jaishankar, Managing Director, Quest Life Sciences says, “Online applications by pharmaceutical manufacturers to the DCG(I) seeking approvals seems a good progress and is certainly welcome. However, the very thought that over hundreds of applications would be received by CDSCO, raises doubts about the prompt attention by the concerned regulatory officers. Unlike a manual submission where we get an acknowledgment, CDSCO

should also ensure that the application is acknowledged for receipt.”

Since the mode of application is online, replies are expected to come online.

Jaishankar says, “Irrespective of whether the application is made manually or online, the applicant company will always be anxious to know the progress of their application. This would mean calling on CDSCO personally or through an agent.

If this continues, then the very purpose of online application is defeated.”

Measures The government's move towards a paper free world is a good approach, but if companies still require to conduct manual follow up then and it has not served the purpose. In order to avoid it Smetacek suggests, “The successful execution of this e-initiative will require enabling infrastructure and appropriate back-end support. All in all, this is a welcome introduction with the potential to add value for all users.”

Since the system is new, there are chances that users might get confused and ill informed about the process.

Jaishankar suggests, “The application form should clearly state the place of submission. In the event of any query, the department should also send mails seeking clarifications or wher-

ever personal interview is required with date and time of appointment. The government should not initiate eGovernance of online application unless the above factors are fully complied with. It is good to have one time pre-registration for application of the services.

This pre-registration should carry manufacturing license number and expiry date.

Based on it, a company can create a password to secure and safeguard the applicant.”

Koshia says, “SUGAM has been prepared with IT expertise of CDAC, a competent IT wing of DeYIT, GoI and one-time preregistration is required in order to avoid spams.”

Marthak adds, “ “Authorities need to ensure that the portal is ‘firewall' proof and confidential information is not hacked or leaked.”

The finer nuances Certain areas need to be identified and evaluated.

Jaishankar feels, “Ideally, CDSCO should evolve a deadline for final disposal of each application and honour it. It will save an enormous amount of time, energy and cost. It is expected that CDSCO regional officers in India should have the authority to receive and dispose the files without further transferring final signature to the DCG(I).”

Commenting on the relevance of the online application process in the medical device industry while making suggestion how to make the system more user friendly, Pareek says, “It is estimated that around 70 per cent of India's medical device needs are catered to by imports. At present the registration, procurement of licence to import medical devices and its renewal after three years, is a tedious process. With such involvement by foreign suppliers, a user-friendly online facility for submission and obtaining registration and licences

( the drug strength of the drug has been incorrectly entered, then an email shall be sent to the applicant pointing out the mistake. Suggestions will be given on correct way to file applications stating that the application in its present form

The authorities will have to see that it is ‘firewall’ proof and the confidential information does not get hacked or leaked Dr Kiran Marthak Head of Clinical Development, Lambda Therapeutics

to import medical devices was much awaited.”

He further elaborates, “I feel that an online portal for application submission and permissions will definitely be a boon as it will reduce the time involved with the formalities of licensing etc. However, as with other online services, it will have its disadvantages of security, the systems not being upgraded, or being down for maintenance etc.”

Mody recommends, “ CDSCO should conduct training workshops for the industry in order to effectively implement SUGAM. More than us, it is the government which can confirm whether they are satisfied with the response.

We are fully supporting the government in spreading awareness about the portal to our members and the industry.”

Way forward CDSCO is reviewing the progress of SUGAM and on March 21 it issued a notice which disclosed that after a review of the functioning of the portal was decided that at the first examination stage of any application either for registration certificate (RC) or import license, addresses have been filled wrongly or if

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April 16-30, 2016

was rejected. The applicant could re-apply with the provision that in such cases no fresh fees will be charged.

However Jaishankar says, “There is absolutely no confidence among the manufacturers regarding the implemen-

THE MAIN FOCUS

tation of e-Governance. There is hardly any awareness about the portal among manufacturers. The government should call for a meeting of all the associations, interact with them and then finalise based on the outcome of the meetings. This

way, the government can avoid unnecessary opinions from various quarters and the insecure feeling of the manufacturers, on this bold effort

by CDSCO.” u.sharma@expressindia.com

MANAGEMENT INSIGHT

Online CMEs: An emerging need Phanish Chandra,CEO and Co-founder,Docplexus Online Services gives an insight on how time and cost constraints have led to the adoption of online CMEs as they offer myriad benefits like flexibility,cost advantage and recognition

M

edical professionals can’t stop learning once they earn their degrees as they need to maintain competency and keep themselves updated about the latest advances in the field of medicine. In most of the states, doctors and other healthcare professionals are required to undertake regular continuing medical education (CME) courses. More than any other professionals, perhaps physicians are expected to keep pace with the latest developments in their fields.

Currently, doctors attend lectures and seminars at local medical universities or nearby medical facilities.

In some cases, physicians also need to travel to other locations to participate in classes led by renowned experts and leading doctors.

However, that practice may soon end in the near future since the online CMEs are taking over!

Current trends around the globe Physicians around the globe are faced with similar problems with respect to updating their medical knowledge. Lack of time and lack of adequate budgets are among the top hurdles. Most of the CMEs also require the doctors to dedicate a certain of fixed time which becomes difficult due to their heavy workload. In addition, CMEs are very expensive and doctors need to pay for additional expenses such as travel, accommodation and alternative arrangements for their ongoing practices.

Due to these hurdles, the doctors in the Western countries have already started

24 EXPRESS PHARMA April 16-30, 2016

adopting online CMEs. A survey from a leading healthcare IT company in the US revealed that around 85 per cent of the doctors from various specialities in the US prefer to take online CME courses, than enrolling in a CME course where they are required to be present in person. The doctors from India also showed the similar inclinations while responding to the questions on Docplexus’ website.

Emerging need for online CMEs in India Indian doctors are adapting to the change quite fast as compared to other professions.

Due to constraints related to time and cost of the CMEs, doctors are openly expressing their interest in online CMEs. Moreover, inadequate facilities constrain the number of participants in each CME programme. Therefore, doctors are scouting for the CME programmes which fulfill all their criteria: flexibility, cost effectiveness, depth and recognition.

Online CMEs have the potential to cater to these needs.

They offer: Flexibility of time: Doctors can take these courses or seminars at any time they prefer. Neither do they need to adhere to a strict time schedule, nor do they need to finish their training in one session. Multiple sessions conducted as video lectures, slideshows and quizzes offer doctors flexibility which is a great benefit.

Reduced costs: Online CMEs help course conveners achieve economies of scale to such To the doctors, that transpires into reduced enrollment fees. In addition, as other

associated costs such as transportation and accommodation costs are reduced, doctors are feeling more comfortable with online CMEs than in-person CMEs in most specialties.

Depth of the knowledge gained: Online CMEs allow doctors to undertake these courses at their own pace. It means that doctors can spend more time learning about new developments, treatments, techniques, drugs and innovations in their field. Doctors can also engage more with key opinion leaders (KOLs) in their field through interactive sessions

PHANISH CHANDRA, CEO and Co-founder, Docplexus Online Services

and interviews. Overall, doctors are finding great value in online CME programmes.

Recognition for CMEs: Most of the online CMEs in the Western countries are conducted by the universities or medical associations. However, in India, there are not many institutes which are equipped with the resources to conduct such CMEs. During the latest online CME offered by Docplexus, we ensured that doctors got the best available knowledge along with proper certification for their efforts. This generated a lot of enthusiasm among the doctors who wanted to excel in their practice.

What did we learn at Docplexus?

When we launched our online CME course, we received an unprecedented response.

Doctors from all corners of the country could easily gain the knowledge at their convenience.

We covered 293 cities and towns through our CME course. In the first week itself over 1600 doctors registered for the course.

Our eminent members were really happy that we are doing something good for the medical fraternity, perhaps the most essential thing for them, helping achieve their learning goals in the most convenient manner.

Our partners in the course too were happy that they could connect to a vast number of the doctors in the country. They were also delighted that through our joint effort we could bring about change and awareness in their area of expertise. We think, this is how we should be bringing about the fundamental change in the healthcare sector of India.

How can pharma benefit from online CMEs? Pharma industry is already under tremendous pressure from the regulatory and monetary point of view. Neither can they engage with the doctors directly nor can they understand medical fraternity’s real concerns first-hand.

However, the pharma industry has its own huge resources of knowledge. In addition, the industry also interacts with the world’s leading scientists to facilitate medical

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April 16-30, 2016

research. These insights are most sought after by the doctors all over in the world.

Doctors in India are no exception to this trend.

Undoubtedly, this relationship has to be the most ethical one and there is ‘nothing more ethical’ than sharing ‘knowledge’ for the best cause. Any

such cooperative efforts are also well received by the doctors, making the relationship between pharma companies and doctors long-lasting.

The pharma industry also benefits when doctors are continuously engaged in medical education. Marketing the products can also get

easier, as the ‘knowledge gap’ and gap between product offerings narrows. Online CMEs provide huge opportunity for pharma companies to gauge the response to a product or a particular therapy. This is a great marketing insight as future monetisation will heavily depend upon it. Companies

will also get ‘visibility’ which medical representatives (MRs) are struggling to achieve. Altogether, it will be imperative for pharma companies to be actively engaged in delivering such knowledge offerings. After all, in this fastmoving, techno-savvy world only knowledge will prevail.

RESEARCH RESEARCH UPDATES

US FDAapproves biosimilar to J&J’s Remicade for multiple diseases Remicade, as well as similar drugs made by AbbVie and Amgen, work by blocking an inflammation-causing protein called Tumor Necrosis Factor, or TNF

T

he US Food and Drug Administration (US FDA) has approved Inflectra, a cheaper version of Johnson & Johnson’s drug Remicade, to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Inflectra, made by South Korea’s Celltrion in partnership with Pfizer’s Hospira unit, was the second biosimilar approved by the FDA. Kim Hyoung-ki, Chief Executive Officer, Celltrion said that Inflectra is expected to be priced about 20 to 30 per cent lower than Remicade in the US market, but the final price would need to be decided after discussions with partner Pfizer.

Remicade generated annual worldwide sales of $6.5 billion.

Of that, $4.5 billion were in the US. Merck & Co sells Remicade in Europe. Celltrion sells the biosimilar overseas under the brand Remsima. Celltrion said in a statement Inflectra gained more than 20 per cent share of the Remicade market in terms of patient numbers in European countries where the copy is sold as of December 2015. The drug was approved by European regulators in 2013 and began sales in Europe’s largest countries in February 2015.

A year ago, the FDA approved the first biosimilar - Novartis’ Zarxio, which is similar to Amgen’s white blood cellboosting drug, Neupogen. Remicade and Neupogen are biologic drugs made from living organisms. Copies of biologic products cannot easily be repli-

cated and are known as biosimilar, not generic, because they are similar, not identical, to the original.

Remicade, as well as similar drugs made by AbbVie and Amgen, work by blocking an inflammation-causing protein called Tumor Necrosis Factor, or TNF. Dozens of anti-TNF biosimilars are in development.

Celltrion said its biosimilar version of Roche’s breast cancer biotech drug Herceptin expects to apply for global approval in the second half of this year, and its copy of Roche’s nonHodgkin’s lymphoma biotech drug Rituxan, also called MabThera, is currently awaiting European approval after applying in October.

Reuters

Vericel stem cell heart failure therapy cuts deaths: Study However, the treatment failed to improve secondary goals of the trial, such as heart-pumping efficiency and six-minute walking distance A STEM cell therapy developed

by Vericel Corp help reduce deaths and hospitalisations in advanced heart failure patients, according to data from a midstage study, potentially providing a treatment that could delay the need for heart transplants.

However, the treatment failed to improve secondary goals of the trial, such as heart-pumping efficiency and six-minute walking distance.

“It’s a little baffling that you’re keeping patients alive, but not having any effect on those secondary endpoints,”

26 EXPRESS PHARMA April 16-30, 2016

said Needham & Co analyst Chad Messer. “People were looking for downside and they had one.” The data compared Vericel’s bone marrow-derived ixmyelocel-T stem cells with placebo in 109 well-treated patients with advanced heart failure who had exhausted medical and device therapies.

After one year, the Vericel treatment led to a 37 per cent reduction versus placebo in a composite of adverse events, including death, heart-related hospitalisations and unplanned clinic visits related to heart

failure.

Vericel last month reported that the study succeeded. Detailed results were unveiled at an American College of Cardiology meeting in Chicago and in The Lancet medical journal. The result was primarily driven by the difference in deaths of 13.7 per cent in the placebo group, or 7 deaths, compared with 3.4 per cent, or 2 deaths, for the ixmyelocel-T group. In addition, 38 perc ent of stem cell patients required hospitalisation, versus 47 per cent for placebo.

“This is strong evidence in a

well-designed trial that we can decrease events,” said Dr Timothy Henry, the study's lead investigator and chief of cardiology at Cedars Sinai Heart Institute in Los Angeles.

Henry, who presented the data at the ACC meeting, stressed the need for larger trials to prove the benefit of ixmyelocel-T For the treatment, bone marrow is taken from the patient and enhanced over two weeks to increase two types of cells associated with healing.

They are then injected directly into the patient's heart. With

advanced heart failure, a leading cause of hospitalisations, blood-pumping ability is diminished as the heart's left ventricle becomes enlarged and weakened.

If the disease worsens despite all available medicinal and interventional therapies, the only options are heart transplant or a pumping assist device. “The idea is to find a treatment for this group of people before they get to that stage,” Henry said.

Reuters

Rare liver disorder drug from Jazz wins US approval The drug, defibrotide, targets patients with hepatic veno-occlusive disease (VOD), a potentially fatal complication of stem-cell transplantation THE US Food and Drug Administration (US FDA) has cleared Jazz Pharmaceuticals’ drug to treat a rare kind of liver disease, making it the first treatment to win US approval for the condition.

The drug, defibrotide, targets patients with hepatic veno-occlusive disease (VOD), a potentially fatal complication of stemcell transplantation in which some of the veins in the liver become blocked, causing swelling

added to the drugmaker’s pipeline through the acquisition

of Gentium, is already available in Europe and is marketed

under the brand name Defitelio.

Defitelio raked in sales of about

$70.7 million in 2015.

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The disease can lead to liver damage, and in its most severe form patients develop failure of the kidneys and lungs, the FDA said. Out of the nearly 20,000 stem cell transplantation procedures done in the US annually, about 8.8 to 13.8 per cent of the patients suffer from severe VOD, Stifel Nicolaus analyst Annabel Samimy said, citing a published research. Samimy said she expects the drug to be launched in the US immediately.

Defibrotide, which was

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METTLER TOLEDO

Reuters

RESEARCH

Europe gives green light to first gene therapy for children Strimvelis is expected to secure formal marketing authorisation from the European Commission in a couple of months THE WORLD'S first life-saving gene therapy for children, developed by Italian scientists and GlaxoSmithKline, has been recommended for approval in Europe, boosting the pioneering technology to fix faulty genes.

The European Medicines Agency (EMA) said it had endorsed the therapy, called Strimvelis, for a tiny number of children with ADA Severe Combined Immune Deficiency (ADA-SCID) for whom no matching bone marrow donor is available.

Around 15 children a year are born in Europe with the ultrarare genetic disorder, which leaves them unable to make a type of white blood cell. They rarely survive beyond two years unless their immune function is restored with a suitable bone marrow transplant. SCID is

sometimes known as “bubble baby” disease, since children born with it have immune systems so weak they must live in germ-free environments.

Strimvelis is expected to secure formal marketing authorisation from the European Commission in a couple of months, making it the second gene therapy to be approved in Europe, after UniQure's Glybera, which treats a rare adult blood disorder. The US Food and Drug Administration has yet to approve any gene therapies but a growing number of US biotech companies, such as Bluebird Bio, have products in development.

Other large pharma companies are also eyeing the field, including Bristol-Myers Squibb, which has a tie-up with UniQure.

Research into gene therapy goes back a quarter of a century

but the field has experienced many setbacks, including the high-profile death of an American patient in 1999 and some

disastrous clinical trial results in the late 1990s and early 2000s.

Now, though, optimism is building, helped by the discovery of better ways to carry replacement genes into cells. Martin Andrews, head of GlaxoSmithKline's rare diseases unit, believes the technology is proving itself, although it remains at an early stage of development.

“We’re on page one of chapter one of a new medicine text book,” he said. A host of challenges still need to be overcome, including the complexity of delivering a product like GSK’s new treatment, which requires bone marrow cells to be taken from the patient, processed and injected back.

Trickiest of all may be pricing, given the tiny market for a therapy like Strimvelis.

UniQure’s Glybera made history

in 2014 as the first drug to carry a $1 million price tag. GSK is not putting a price on its product but a source close to the company said that, if approved, Strimvelis would cost “very significantly less than $1 million”. GSK has several other gene therapies under development with researchers at Fondazione Telethon and Ospedale San Raffaele in Italy, including treatments for metachromatic leukodystrophy and WiskottAldrich syndrome that could be submitted for regulatory approval in the next couple of years. Its Strimvelis treatment for ADA-SCID is also being lined up for submission to US regulators, although Andrews said this would not happen before the end of next year.

Reuters

Regeneron, Sanofi eczema drug clears hurdles in big trials The drugmakers will seek US approval this year for their injectable drug, dupilumab, based upon strong results in the trials involving almost 1,400 adults with moderate to severe disease REGENERON Pharmaceuticals and Sanofi said their experimental treatment for eczema proved highly effective in two large studies, without serious side effects often seen with standard treatments for the chronic inflammatory skin disease. The drugmakers said they would seek US approval this year for their injectable drug, dupilumab, based upon strong results in the trials involving almost 1,400 adults with moderate to severe disease.

If cleared by regulators, it would be the first approved systemic treatment for the condition, which in severe cases produces infectionprone rashes over much of the body and a constant itch as bad as poison ivy. Some

28 EXPRESS PHARMA April 16-30, 2016

analysts expect dupilumab to cost up to $30,000 a year and to capture eventual annual sales of more than $5 billion.

In the two identical Phase III studies, respectively, there

was a clearing or near clearing of skin lesions among 37 per cent and 36 per cent of patients who received dupilumab weekly and 38 per cent and 36 per cent who

received injections every two weeks. An average of roughly 70 per cent improvement in rash area and eczema severity was seen among patients taking the drug in both trials, about twice the improvement seen among those receiving placebo. The rate of serious side effects, including infections, was less for dupilumab than for placebos.

Dupilumab works by blocking IL-4 and IL-13, proteins Regeneron believe to be underlying causes not only of eczema, but of other allergic conditions like asthma and nasal polyps for which the drug has shown favourable results in smaller Regeneron studies.

Eczema, also called atopic dermatitis, affects an esti-

mated 2 per cent of US adults, and as many as 10 per cent to 20 per cent of children - the majority of cases being of mild to moderate severity.

Regeneron is best known for its blockbuster Eylea treatment for macular degeneration, a leading cause of blindness, and recently won approval for a new type of cholesterol fighter. Current treatments for eczema include cyclosporine, an oral immune suppressant that is not approved for the condition and raises risks of infection and kidney problems. Topical steroid ointments are the mainstay of treatment, but also provide limited long-term relief and can cause worrisome side effects.

Reuters

RESEARCH

FDApanel backs Acadia drug for psychosis linked to Parkinson’s Psychosis, characterised by hallucinations and delusions, occurs in about 40 per cent of patients AN ADVISORY panel to the US Food and Drug Administration backed an approval for Acadia Pharmaceuticals’ drug for psychosis related to Parkinson’s disease. Nuplazid’s benefits outweighed the risks, the panel said, after 12 members voted in favor of the treatment and two against.

Several panel members said that while the drug’s efficacy was not as robust as they would have liked, it was "certainly better than nothing."

They said Nuplazid addressed

the lack of treatment options for patients suffering from the condition.

According to the National Parkinson Foundation, about 1 million people in the US and 46 million people worldwide suffer from Parkinson’s disease, Acadia said in a statement.

Psychosis, characterised by hallucinations and delusions, occurs in about 40 per cent of patients, the company said.

Currently, there is no drug approved in the US specifically for psychosis linked to Parkin-

son’s disease and common antipsychotic treatments including Quetiapine, Clozapine, Risperidone and Zyprexa are used for these patients. However, these drugs offer limited effectiveness and they also carry a black box warning, the strongest warning imposed by the FDA, for increased mortality in elderly patients.

Nuplazid may also have to carry a black box warning, but this is unlikely to affect its adoption, analysts have said.

The FDA is not obligated to fol-

low the panel's recommendations, but it usually does. The health regulator is scheduled to decide on Nuplazid by May 1. FDA staff said that Nuplazid

was effective, but raised questions about whether the observed treatment effect was clinically meaningful.

Reuters

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RESEARCH

Keryx says anaemia drug succeeds in study of kidney patients The drug was previously approved under the brand name Auryxia to lower the amount of phosphate in the blood of chronic kidney disease patients on dialysis KERYX Biopharmaceuticals said its drug to treat iron deficiency anaemia in chronic kidney disease patients not yet requiring dialysis met the goals of a late stage clinical trial, potentially paving the way for an expanded approval of the treatment. In the 16-week study of 234 patients with moderate to severe kidney disease, 52 per cent of those who received Keryx's ferric citrate saw their hemoglobin levels rise by at least 1 gram per deciliter (g/dl) of blood during the trial. That compared with 19 per cent in the placebo group who experienced a 1g/dl increase.

The initial results for the oral,

iron-based drug were both statistically significant and clinically meaningful, the company said. Based on the study of patients who had not adequately

responded to or were unable to tolerate current oral iron therapies, Keryx said it would apply in the third quarter for an expanded approval with US regu-

lators for ferric citrate in moderate to advanced chronic kidney patients not dependent on dialysis. The drug was previously approved under the brand name Auryxia to lower the amount of phosphate in the blood of chronic kidney disease patients on dialysis.

An estimated 1.6 million people in the US suffer from stage 3 to stage 5 non-dialysis dependent chronic kidney disease and iron deficiency anaemia, Keryx said. Side effects were primarily mild to moderate and included diarrhea, constipation and nausea. Twelve of 31 ferric citrate patients who discontinued treatment did so because of side ef-

fects, the company reported.

Two patients in the drug group died during the study, but researchers deemed those deaths to be unrelated to the treatment. The drug also met secondary goals of the trial compared with placebo, including mean change in haemoglobin and proportion of patients with a durable response, Keryx reported. “We believe that the ability to treat iron deficiency anemia, managing haemoglobin and iron levels, could have an important effect on the way kidney specialists treat these patients,” John Neylan, Chief Medical Officer, Keryx .

Reuters

US scientists develop mouse model to test Zika vaccines, drugs Testing on the mice showed virus particles in many major organs, including high concentrations in the spleen, brain and testes US SCIENTISTS have identified a genetically modified strain of mice that develop Zika, an important tool needed for testing vaccines and medicines to treat the virus that is rapidly spreading across the Americas and the Caribbean. Early tests on the mice show the virus growing in the testes, offering clues about how a virus typically spread by mosquito bites can be transmitted sexually.

"We are going to do experiments to see if we can produce sexual transmission" in these mice, said Scott Weaver, a virologist at the University of Texas Medical Branch in Galveston who worked on the study published in the American Journal of Tropical Medicine and Hygiene.

Weaver said the Zika mouse

30 EXPRESS PHARMA April 16-30, 2016

model will provide a critical tool to allow companies and scientists to test vaccines and antiviral drugs against Zika, which has been linked with thousands of cases of microcephaly, a rare birth defect marked by unusually small head size and possible developmental problems.

Zika has not been proven to cause microcephaly, but strong evidence connecting Zika infections with microcephaly cases in Brazil prompted the World Health Organization to declare Zika a global health emergency recently. Normally, creating this kind of mouse model would take several months. But the urgency of the Zika outbreak called for rapid response, and the team put together the results in just three weeks, said Shannan Rossi, a

UTMB virologist who led the study. Normally, mice do not become sick from a Zika infection.

The team tested the virus on several genetically altered mice that had weakened immune systems. The young mice quickly

succumbed to the virus, becoming lethargic, losing weight and typically dying six days later.

Testing on the mice showed virus particles in many major organs, including high concentrations in the spleen, brain and

testes. While Weaver says there are limits to what mouse models can tell about human infections, they may at least provide some early clues that could be followed up in non-human primates, a more costly animal model that is a better predictor of human disease. “The mouse will mainly be used to do the very earliest testing of vaccines or drugs where the mechanism of disease doesn't have to be a perfect model to what happens in humans,” Weaver said. Brazil has confirmed more than 900 microcephaly cases and considers most related to Zika infections in the mothers. It is investigating nearly 4,300 additional suspected cases of microcephaly.

Reuters

RESEARCH

Alder drug to prevent migraines successful in mid-stage study Multiple doses of the drug, ALD403, were tested against a placebo in patients suffering from chronic migraines, those who experienced 15 or more headache days per month ALDER BioPharmaceuticals said its injection to prevent migraines had met the main goal in a mid-stage study, the results of which supported a dosing strategy of four doses a year. About 38 million Americans suffer from migraines — intense headaches characterised by throbbing pain, sensitivity to light and nausea. The condition, in which attacks can last for days, is not curable.

Multiple doses of the drug, ALD403, were tested against a placebo in patients suffering from chronic migraines, those who experienced 15 or more headache days per month, of which at least eight were assessed as migraine days.

The two highest doses of the

drug, 300 mg and 100 mg, brought about a 75 per cent reduction in migraine days in 33 per cent and 31 per cent of patients respectively, meeting the main goal of the study. Drugs taken to treat migraines don’t always work, while the side-effects

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of preventative medicines typically approved for other conditions, including beta blockers and botox, discourage their use.

Prophylactic treatments lower headache frequency by about half in the 40 per cent of sufferers who use them, the

American Migraine Foundation estimates. Alder joins companies such as Amgen, Eli Lilly Co and Teva Pharmaceutical Industries that are developing similar drugs to target calcitonin generelated peptide, or CGRP, a protein involved in pain-signaling during migraines.

Alder's data addresses outstanding questions about the drug's competitiveness on dosing and administration, indicating the antibody should be as good if not better than others in development, Jefferies analysts wrote in a note. The drug is differentiated by how fast it acts and the durability of its effect, said Randall Schatzman, Chief Executive Officer, Alder BioPharmaceuticals. "We're pro-

posing that patients are dosed four times a year. Most other developers are looking at once-amonth dosing," he said, adding that separate early-stage data also showed the treatment could potentially be self-administered.

The drug is currently in a late-stage trial for use in frequent episodic migraine. A latestage study for chronic migraine sufferers is slated to begin later this year. If all goes well, ALD403 could win US Food and Drug Administration approval by 2019, said Schatzman. Alder plans to independently sell the medicine in the US to serve the 13 million patients eligible for migraine prevention therapy.

Reuters

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PHARMA PRO & PACK EXPO 2016 SPECIAL I N T E R V I E W

‘We have a wide range of products with unique features’ Biolinx Labsystems is one of the leading suppliers of laboratory instruments in India.

Mittal Gor, Director, Biolinx Labsystems explains why the company enjoys a commanding position in this category, in an interaction with Sachin Jagdale Describe the criteria based on which you select the manufacturers of laboratory instruments?

The most important criteria is the quality and after sales support which we look for before any possible association.

Tell us about the features of lab instruments that you supply to the pharma/ biotech industry?

After sales and services is key for all the products that we supply to pharma/ biotech/research organisations. However, we have a wide range of products and each product has its own unique feature/s viz. Miele Professional is a brand we represent for automated glassware washer and disinfectors.

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Features of Miele Professional Miele Professional is a German company which has been in the washing business since the last 130 years. The company manufactures each component in-house including motors and electronics unlike all competitors who outsource most of the components and then assemble them at their factories. It is compliant with all regulatory authorities and certifications across globe, one of the most important factors in the pharma sector. Apart from this, unique features include patented variable speed motor with in-built heating elements, sensors for spray arms to ensure that there are no blockages, pH monitoring with pre-set value to ensure perfect cleaning and, if values doesn’t match, automatic modifier of rinse

down time. Similarly, all our products have distinguishing features.

Which brands do you represent?

We represent ThermoFisher, US, Bio-Rad laboratories, US, Miele-Germany, NaberthermGermany, Post-NovaGermany, Kruss- Germany, Solaris-Italy.

cycle with user intervention, 3-staged-HEPA filters for drying, pre-programmes for all types of wash possibilities like oil/grease/organic/inorganic/ blood etc.

Supported by trained engineers at the German factory with ample spare support to ensure the least

Who are your clients?

Major pharma companies across the country namely, Lupin, Serum, Zydus, Cadila, Reliance, Dr Reddy’s Laboratories, IPCA, Sun Pharma, Emcure, USV and many more.

Major research institutes like IITs, ACTREC, AIIMS, NIPER, IISER, NCCS, PERD, NIPERs, NCL, NIV, NIO, NCBS,CCMB and many more.

Major hospitals in our

clients’ list are Jaslok, Hinduja, KEM, JJ, KDAH, TMH etc.

What is your annual turnover?

Our annual turnover is Rs 25 crores.

How do you manage to keep imported products cost effective for your clients?

We have all options for clients for direct import as well as bonded warehouse facilities to get optimum cost effectiveness.

Do you have any new products in the pipeline?

We are working on developing general purpose products locally, with international quality and aesthetics, under the 'Make in India' plan. We will launch the same in the last quarter of 2016. sachin.jagdale@expressindia.com

NEWS

Agarwal Movers Group invests ` 100 crores in Trucking Cube Transportation in ‘cubes’ assures zero loss during transhipment; crucial for pharma and food shipments AGARWAL MOVERS Group, a major player in the relocation industry, announced an investment of ` 100 crore in Trucking Cube (http://www.truckingcube.com), which has reportedly introduced the concept of transporting goods in ‘cubes’ exclusively assigned to them. This prevents shipments like pharmaceutical and food products, from damage as the shipment makes its way through the supply chain. The cubes come in six sizes — 4, 6, 8, 12, 16 and 20 feet.

The company looks at the pharma industry as one of its most important clients. Since many of the pharma products are temperature sensitive they are making special arrangements for the same. Saransh Agarwal, Director and Head, Trucking Cube Division, Agarwal Movers Group , informs, “Currently, we are working on the trial version of how the goods will be maintained at room temperature. Once we are done with our study and the entire process is evaluated with two to three compa-

The company looks at the pharma industry as one of its most important clients. Since many of the pharma products are temperature sensitive they are making special arrangements for the same According to a press release, a study carried out over the past years

by Agarwal Movers Group has shown that the country sees an annual damage of over ` 42,000 crores in transhipment due to surface logistics. Trucking Cube assures safe-delivery of goods with Zero Transhipment, Zero Damage, Zero Loss to its house-hold and commercial customer by protecting goods from expiring before the expiry date. The goods are transported in ‘cubes’ exclusively assigned to them avoiding any rancidity/damage. This problem is more prevalent in food and pharma industry and has a direct impact on the health of the consumer and can prove fatal for the brand's name. Agarwal Movers Group will move 100 per cent to Trucking Cube by July 2016.

nies and if they give their go ahead then a significant percentage of cubes will be as per the pharma industry’s requirements. For the specific temperature requirements of the pharma industry, we will be launching reefer containers/cubes in the second phase.”

“Trucking Cube assures zero transhipment, improved efficiency by 200 per cent and six per cent reduction in the packaging cost. The ` 100-crore investment will be made over the next three years to grow the ecosystem and the number of cubes to 10,000 from 2,000,” said Ramesh Agarwal, Chairman, Agarwal Movers Group, further pointing out that choosing the incorrect logistics partner could ruin the brand's reputation overnight.

EP News Bureau-Mumbai

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PHARMA PRO & PACK EXPO 2016 SPECIAL

INSIGHT

New age storage systems for cell therapy products Vinod Vilivalam, Senior Director, Marketing and Lloyd Waxman, Principal Chemist from West Pharmaceutical Services share insights on new containment systems for cell therapy products and the benefits they offer to meet the pharma industry’s need for scale and integrity RESEARCH HAS shown that some injectable drug vial systems can effectively be utilised to freeze, store and ship cryopreserved living cell products in a format that enables large-scale manufacturing and fill-finish operations, in addition to providing caregivers and patients with a system that is easy to handlei. This finding comes at a time when manufacturers are beginning to realise that the current blood-banking bag technology may not work on the scale they will require, as therapeutic cell products reach later stages of clinical trials.

Blood bags are sufficient for small-scale processes that generate tens of product doses per lot. However, commercialscale sizes of hundreds to thousands of living cell doses per lot will be required to supply a commercial-scale cellular product, a volume that may preclude the use of bags.

Thus, more consideration is being placed on manufacturing processes that are capable of producing commercial-scale quantities of living cell productsii.

With the emergence of cellular therapy as a more widely used clinical practice, improved containers and closure systems for effective, safe use and cell preservation are required. While still effective for some indications, there has been more focus on the shortcomings of cryopreserved bag storage. A study by Khuu et al investigated a series of catastrophic bag failures first noticed in 2001iii. In that study, high rates of bag failure were associated with four specific bag lots made from poly (ethylene co-vinyl acetate). While no serious adverse patient effects oc-

34 EXPRESS PHARMA April 16-30, 2016

curred, extensive bag failures led to microbial contamination of the cell product, along with increased product preparation time, antibiotic use and resource expenditure to replace products.

Pharma-grade vials provide ease of delivery by caregivers.

They also leverage the pharma manufacturing infrastructure.

Importantly, there are established standards in sizes, quality and regulatory attributes that can be capitalised upon in order to facilitate uptake into the rapidly developing cell therapy industry.

The ideal vial-based container system should be suited for packaging, storing and transporting cell therapy products at low temperatures and meet pharma quality requirements to maintain cell viability over its intended shelf life.

Polypropylene is a plastic resin that has been used for decades in various packaging applications, including bottles, pouches, tubes and containers.

However, these plastic resins have made minimal headway in the area of parenteral vials and prefillable syringes owing to various quality attributesiv.

Recent availability of newer plastic resinsv with key features such as glass-like clarity, lower potential for extractables, allowing for various modes of sterilisation, very low moisture permeability, biocompatibility and lower particulates – has enabled the use of these superior plastics for pharmaceutical and biopharmaceuti-cal drug delivery applications. However, the use of vials has not yet been translated to cell-based biologic products, due in part to the lack of data on the ability of cells to be successfully

cryopre-served and stored while maintaining viability and important functionalities relevant to therapies over a reasonable shelf life (e.g., six months).

In a recent study,i the suitability of a commercially available vial, West’s Daikyo Crystal Zenith, consisting of cyclic olefin polymer resin, was evaluated for low-temperature and cryopreserved storage of cell sys-tems.

These vials are currently being used to package and deliver pharma drugs in global markets, and are in development for biologic drugs, such as peptides, proteins and monoclonal antibodies vi, vii, viii.

Being nonpolar, this particular vial has low moisture absorption and excellent drainability, which prevents water and liquid drug preparations from adhering to the vial surface. It is compatible with a wide range of pHs (2–12) and solvents, such as alcohols, ketones and dimethyl sulfoxide.

It also has excellent thermal characteristics and can withstand cryogenic temperatures as well as sterilisation by autoclaving. Compared with polypropylene, it also has lower gas and moisture permeabilityix.

Furthermore, the pharma industry is already accustomed to the filling of various-sized vials with drug and biologic products on a large automated scale, which is not available for bags.

From a mechanical standpoint, the Crystal Zenith vials exhibited excellent durability. No study vial exhibited gross breakage or cracking after a frozen drop test, which involves freezing 60 per cent full vials, dropping them at a height of one meter at a 15o angle to the lab floor, thawing them, and visually inspecting them. Slight damage

occurred occasionally to the flipoff caps, but this did not compromise the closure integrity as demonstrated by the post-thaw dye and microbial immersion studies performed fol-lowing typical transportation methods.

These results, combined with the fact that none of the cell cultures became contaminated, provide good evidence that in any standard clinical application, vials provide robust container closure maintenance.

Overall, this initial proof-ofconcept study indicated that the vials are highly suitable for cold and cryogenic storage of biological cells, and provide a suitable container system for clinical and commercial cell therapy products. The vials were easy to freeze and more convenient to use as compared with bags, as they could be adapted to existing storage configurations. From a practical stand-point, these vials are designed with standard dimensions (13 and 20 mm openings) that are capable of fitting into traditional pharma manufacturing filling lines.

Compliance with compendial requirements for containers and closures used in packaging sys-tems for cellular therapy applications should be evaluated based on the final use of the product. However, based on recent research, Crystal Zenith vials may be the ideal replacement for bags as cellular therapies scale up in use and production for today’s clinical pathways.

Reference i. Woods E, Aniruddha B, Goebel WS, Nase, R, Vilivalam, V: Container system for enabling commercial production of cryopreserved cell therapy products.

Regen.Med. 5(4), 659-667(2010).

VINOD VILIVALAM Senior Director, Marketing, West Pharmaceutical Services

LLOYD WAXMAN Principal Chemist, West Pharmaceutical Services

ii. Kirouac DC, Zandstra PW: The systematic production of cells for cell therapies. Cell Stem Cell 3, 369–381 (2008). iii. Khuu HM, Cowley H, DavidOcampo V et al.: Catastrophic failures of freezing bags for cellular therapy products: description, cause, and consequences. Cytotherapy 4(6), 539–549 (2002). iv. Akers MJ, Nail SL, SaffellClemmer W: Top ten topics in parenteral science and technology.

PDA J. Sci. Technol. 61(5), 337–361 (2007). v. Eakins MN: New plastics for old vials. Bioprocess Int. 3(6), 52–58 (2005). vi. Esfandiary R, Joshi SB, Vilivalam V, Middaugh CR: Characterization of protein aggregation and adsorption on prefillable syringe surfaces. Presented at: AAPS National Biotechnology Conference. Toronto, Canada, 22–25 June 2008. vii. Waxman L, Vilivalam V: Development of analytical techniques to determine protein adsorption on sterilized parenteral packaging containers and stoppers. Presented at: AAPS National Biotechnology Conference.

Seattle, WA, USA, 21–24 June 2009. viii. Qadry SS, Roshdy TH, Char H, Del Terzo S, Tarantino R, Moschera J: Evaluation of CZresin vials for packaging proteinbased parenteral formulations.

Int. J. Pharm. 252, 207–212 (2003). ix. Daikyo Resin CZ Technical Report, West Pharmaceutical Services (2002) www.westpharma.com/ap/en/pro ducts/ Pages/ CrystalZenithRU.aspx.

INSIGHT

Effective data management to meet serialisation requirements Nicola Rapley, Global Marketing Manager for Pharmaceutical and Medical Devices at Videojet Technologies, looks at the importance of effective data management solutions in the pharmaceutical industry COMPLEX CODING requirements driven by serialisation regulations are creating an increased demand for multifaceted data management solutions. As a result, manufacturers are looking for printers equipped to handle vast data management responsibilities.

In India, the Directorate General of Foreign Trade (DGFT) is responsible for serialisation requirements for those companies looking to export pharmaceutical products to foreign markets. In January of this year an amendment to policy was announced with regard to ‘The implementation of track and trace requirements for the export of pharma-

NICOLA RAPLEY, Global Marketing Manager for Pharmaceutical and Medical Devices, Videojet Technologies

ceuticals and drug consignments’i. At a primary level, companies were required to incorporate a 2D barcode encoding a unique and universal global product identification code in the form of a Global Trade Item Number (GTIN) – this also included a batch number, expiry date and a unique serial number. This bar code labelling at a primary level has been exempted by DGFT until further notice, but is required to be printed in human readable form on an optional basis.

On a secondary level, one or two dimensional barcodes including GTIN, expiry date and a unique serial number are required, while for outer cases one dimensional barcodes are stated with the same requirements. For parent child relationships – the relationship of the data between all three levels of packaging, with outer cases as parent to secondary and secondary as parent to primary packs – data must be uploaded onto a central portal (DAVA). Non-SSI (or large) manufacturers have been required to maintain records and report data to DAVA across all packaging levels

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PHARMA PRO & PACK EXPO 2016 SPECIAL since April 1, 2016, whereas SSI companies are only required to upload data at the outer casing level. After March 31, 2017, SSI companies will be required to perform the same level of data management and reporting as non-SSI.

How printers can help with data management?

Serialisation is impossible without coding and marking, and regulatory compliance is likewise impossible without accurate and effective data management. Printing solutions, such as thermal inkjet (TIJ) and laser coders, are designed to be highly versatile, with advanced communication and data handling capabilities, enabling them to integrate with whichever track and trace technology a manufacturer has adopted.

Asynchronous communications is one such capability. In the past, if there was an issue with a printer the management

interface would have to send a message from the line management system to check whether it was functioning correctly – referred to as polling. The printer, in turn, would report back to the system that there was an issue. The latest technology allows the printer to send unsolicited information to the line control system the second there is a printer event. If you are dealing with a large amount of data, this proactive

reporting of errors can help to achieve major savings in terms of stopping the line immediately and resolving issues quickly, leading to higher potential throughput and significantly reduced data traffic. It is preferable to polling as the data is received in real time.

Printer memory is also important when looking at serialisation solutions. Some serialisation solutions transfer serial numbers to the printer printed

one record at a time, referred to as unbuffered printing. When multiple records are sent at once but printed only once each, a buffer is used to store numbers until they are printed, increasing the demands on the printer. If there is an unexpected stoppage on the line, intelligent coding devices are able to communicate which codes are still available for use, meaning codes can be reclaimed as opposed to wasted. This capability is especially relevant when codes have been purchased for use – as is the case with the Chinese government.

The latest TIJ printer from Videojet, for example, has a buffer capacity to store hundreds of codes. An index is also kept of the last printed code, which allows manufacturers to continue from the correct code should the line be stopped for any reason.

In addition, given the global markets pharma manufactur-

ers operate within, printers need to have the ability to operate using an extensive number of characters, including Cyrillic, Arabic and pan-Asian languages. By employing Unicode encoding technology, printers are able to encode over 1m characters, which in turn unlocks access to a wide range of global languages.As serialisation deadlines loom, and in some instances have passed, it is imperative that data is managed in an effective, accurate manner that will allow manufacturers to remain compliant and to continue running lines at optimum speeds.

Ensuring your coding and marking systems are up to the job will be an essential element to consider, as serialisation simply cannot work without this vital piece of the puzzle.

Reference i. http://dava.gov.in/ files/PublicNotice_05_2016.pdf

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POST EVENT

ACREXINDIA2016 demonstrates potential of domestic HVAC&R industry through sustained growth in manufacturing The three-day event, attended by 34,597 visitors, comprised a series of interesting seminars, workshops and presentations ACREX INDIA 2016, one of the largest exhibitions on air conditioning, ventilation, refrigerating and building services showcased the manufacturing potential of domestic HVAC&R industry. Spread over three days at the Bombay Convention and Exhibition Centre, the event reportedly witnessed more than 400 exhibitors and 34,597 visitors. The exhibition was spread over a display area of 35,000 sq mts.

ACREX INDIA 2016 kicked off with a panel discussion on 'Importance of Design and Architecture for Sustainability, Big Savings and Performance in the Long Run.' The discussion was designed to promote ACREX INDIA’s vision of energy sustainability. The panelists included Arun Bhatia, Managing Director, UTC–Climate Controls & Security; Anuj Agarwal, Head, Infrastructure Management & Service Group, ICICI Bank; Rajan Rawal, Executive Director, Centre for Advanced Research in Building Science & Energy; T David Underwood, P Eng, Fellow ASHRAE Life Member, PRP Ramakrishnan, Area Director of Engineering –South Asia, Marriot International; and Pankaj Dharkar, Chair, Steering Committee of ACREX India 2016.

Primary discussions revolved around building management, performance and the related technology innovations, challenges in end-to-end mergers etc. The event witnessed an increase in global participation by major players. Special designated areas called 'country pavilions' were created to accommodate

ACREX India witnessed participation from Korea, Japan, England, the UK, France, Canada, Taiwan, Singapore, New Zealand, Thailand, Czech Republic, Switzerland, Sweden, Malaysia, Vietnam and many more participants from Germany, the US, China and Turkey. The pavilions provided a great opportunity for domestic manufacturers and SMEs to ideate, network and get an understanding of current global trends in designing, energy sustainability andthe related product innovations primarily developed around air quality and refrigeration.

ACREX India 2016 witnessed participation from countries such as

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April 16-30, 2016

PHARMA PRO & PACK EXPO 2016 SPECIAL Korea, Japan, England, the UK, France, Canada, Taiwan, Singapore, New Zealand, Thailand, Czech Republic, Switzerland, Sweden, Malaysia, Vietnam and many more.

ACREX 2016 also organised ACREX Hall of Fame Awards.

The event recognised key endeavours by the industry around energy sustainability and green initiatives. ACREX Awards of Excellence – recognition of product innovations and green technology and for the first time conceptualised by Danfoss, the hall of fame was introduced at the ACREX INDIA 2016.

The exhibition also served as a global networking platform for the industry with heads of international associations which included Associazione Italiana Frigoristi, The Federation of Thai Industries, Turkish HVAC-R Exporters Union, Air Conditioning and Refrigeration Manufacturers' Association, American Society of Heating, Refrigerating, and Air-Conditioning Engineers, Society of Environmental Engineering, Eurammom, Air-Conditioning and Refrigeration Industry Club, Chinese Association of Refrigeration.

Indian Society of Heating, Refrigerating and Air Conditioning Engineers (ISHRAE) also organised Quest, a student quiz competition for the second year in a row, sponsored by Hitachi.

The quiz was primarily designed to introduce engineering students to the HVAC&R industry.

ACREX India 2016 presented a series of educative sessions during the three-day event. The knowledge sessions provided an opportunity to gain market insights from professionals in the industry and acted as a platform to interact and share thoughts between the industry experts and attendees. The workshops and seminars were conducted by internationally acclaimed experts from the industry and provided a rare opportunity to the participants to learn, share expertise and hone their skills on the latest trends and topics related to HVAC&R industry. Various workshops were also organised to address issues related to industries like dairy, horticulture, food and vegetables.

EP News Bureau-Mumbai

38 EXPRESS PHARMA April 16-30, 2016

PRODUCTS

Cleanroom doors by Gandhi Automations 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 can be limited in the manufacturing area.

Medical instrument manufacturing and packaging, electronics and com-

and closing of door is quick enough to separate outside environment and internal facility.

puter manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement of specific product or process. Clean rooms have become integral part of pharma manufacturing facilities.

One of the important aspects of cleanrooms are the doors that are chosen for clean room facility. Time for which the door is open will play a critical factor in avoiding dust, outside temperature, humidity etc.

Opening and closure of door has to be quick enough to isolate the outside environment and internal facility.

At Gandhi Automations, clean room high speed doors are provided which have been specifically designed for the above purpose. The clean room high speed doors are best suited for facilities where controlled environment is needed. The opening

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

High speed clean room doors designed by Gandhi automation are engineered carefully with the following features:◗ Concept of low air permeability in

Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West), Mumbai - 400064, India +91-22-66720200 / 66720300 (200 lines)

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HALL NO.5 BOOTH NO. A-7 Mumbai Exhibition Center, Mumbai INDIA 27-29 April 2016

PHARMA PRO & PACK EXPO 2016 SPECIAL

AMI Polymer unveils silicone inflatable gaskets and Imaflexxie AMI POLYMER is a pioneer in silicone inflatable gaskets which supplies to renowned pharmaceutical manufacturers in India. The company has successfully installed import substitute silicone inflatable gaskets for fluid bed processor for Pam/Glatt/GEA machines of different models.

Quality and craftsmanship of inflatable gaskets are at par with international standards and aesthetically look good.

European technology is used to manufacture these gaskets.

Inflatable gaskets functions like a cycle tube. When inflated, it seals the gap and ensures proper sealing. It is made up of transparent silicone rubber. These gaskets are inflated by 6-10 mm when 2-4 kg pressure is applied.

These gaskets find application where gaps need to be sealed, which are uneven due to fabrication limitation such as in fluid bed dryer, sliding door autoclave, isolators. etc.

There are in-house tool making facility in CMC and VMC. These gaskets are manufactured with world class European machine and advance technology. Raw materials used to manufacture these gaskets are sourced from the US and Europe.

Ami Polymer has also developed gaskets for isolator and glove box, fedegari, autoclave, autocoater, lypholiser.

40 EXPRESS PHARMA April 16-30, 2016

Aapplication of inflatable gaskets ◗ Powder and bulk solid handling machineries ◗ Processing equipment ◗ Food processing equipment ◗ Conveyor ◗ Robotics and fluid sealing ◗ Material handling and medical sterilisers ◗ Electronic/Wafer semiconductor processing ◗ Nuclear door seals ◗ Industrial washing and extractor machines ◗ Fluid bed dryers in pharma application ◗ Industries for inflatable gaskets ◗ Airlock door seals ◗ Personnel access door seals ◗ Equipment hatch seals ◗ Torus and wet well access hatch seals ◗ Refuelling canal hatch seals ◗ Pool gate seals ◗ Airlock shaft seals ◗ Dry well head seals ◗ Inflatable door and valve seals

handling in high temperature. ◗ Prevents operator/users injury due to ‘frayed’ SS braids. ◗ Temperature rated -maximum temperature: -60ºC to +250ºC. ◗ Can be autoclaved. ◗ Excellent chemical compatibility with organic &inorganic solvent. ◗ Conforms to USFDA 21CFR 177.2600.

Application ◗ Fluid handling ◗ Pharmaceutical ◗ Food and beverage ◗ Cosmetics ◗ Steam application, Etc Construction ◗ Inside tube: Smooth PTFE for sterile application ◗ Cover: Platinum cured silicone ◗ Reinforcement: Stainless steel braiding Note:- Corrugated PTFE can be made available for better flexibility and bending radius.

Imaflexxie General features ◗ Platinum cured silicone covered over stainless steel (SS 304) braided with inside PTFE tube. ◗ Permits easy cleaning. ◗ Pharmaceutical, food and beverage, and chemical applications. ◗ Smooth silicone cover provides safety to operator while

Contact details Ami Polymer Mahesh Indl Estate, Opp Silver Park, Mira Bhayander Rd, Mira Rd (E), Thane - 401104 Tel: +91-22-28555107 / 631 / 914 Fax: +91-22-28555378 Email: info@amipolymer.com Web: www.amipolymer.com

Phenomenex launches Luna Omega 1.6μm columns

HyZone Class II Microbiological Safety Cabinets & HyZone Unidirectional Vertical Downflow Unit

PHENOMENEX, A global leader in the research, design and manufacture of advanced technologies for the separation sciences, has introduced Luna Omega 1.6μm columns, an expansion of its flagship liquid chromatography line for UHPLC applications. Luna is one of the most recognised HPLC brands on the market, delivering high efficiency, ruggedness, reproducibility and dependability for a wide range of analyses since its launch in 1996.

The new Luna Omega 1.6μm builds upon this legacy with an innovative UHPLC silica particle architecture, designed and manufactured by Phe-

proprietary, post-synthetic thermal treatment processes for mechanical strength and inertness. This provides significantly better peak shape for compounds of interest and minimises unwanted secondary interactions.

Proprietary Phenomenex bonding technologies ensure wide stationary phase coverage and excellent separation power.

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

(Laminar Air Flow Unit)

Manufactured As Per International Quality

Standards

Microprocessor Based Monitoring Control System

Ergonomic Design Which Reduces User Fatigue

Protection

For Product, Operator, Environment

Luna Omega columns are suited for a wide range of applications including drug discovery and development, food contaminant analysis etc

Keeps The Work Area

Ultra Clean & Sterile Accuracy To Meet Your Research Application

Audio Visual Alarms For Discrepancies In Operating Function

Soft Touch Keyboard &

nomenex based on more than 20 years of applied knowledge, invention and customer experience. The new 1.6μm UHPLC columns deliver improved performance compared to other sub-2μm products on the market, along with exceptionally tight particle size distribution, high column packing efficiencies, steady selectivity and excellent reproducibility. 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.

Luna Omega UHPLC columns feature a novel silica with a constant particle morphology that is modified with

pairing of core-shell and fully porous UHPLC products affords customers a better choice for immediate gains in productivity, resolution and retention.

Combinations such as such as Luna Omega 1.6μm C18 with Kinetex 1.7μm Biphenyl and Kinetex 1.7μm F5 promote greater method development success.

Contact details Jennifer Dahlgren, Dahlgren Communications Phone: (530) 263-6817 E-mail: dahlgrenpr@comcast.net Simon Lomas, Phenomenex, Inc. Phone: (310) 212-0555 Ext. 2267 E-mail: simonl@phenomenex.com www.phenomenex.com

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April 16-30, 2016

Rear Lit LCD Display For Keeping Up-To-Date Records Quality Assurance From Thermolab’s Testing Services To Assist You In Routine Maintenance & Revalidation.

Thermolab Scientific Equipments Pvt. Ltd. Thermolab House, Plot No. 19, Vasai Municipal Ind. Area, Umela Road, Vasai (West) - 401207, Maharashtra, India. I (F) +91-0250-2321656 I (E) info@thermolabscientific.com I (W) www.thermolabscientific.com I

PHARMA PRO & PACK EXPO 2016 SPECIAL

Bosch introduces new pharma cartoner SigpackTTMP BOSCH PACKAGING Technology, a leading supplier of process and packaging technology, has added a new topload cartoner to its well-known TTM product portfolio.

The proven features of the TTM platform have been advanced specifically for the packaging of ampoules, vials, syringes, pens and further products from the pharmaceutical industry. A simple and safe changeover concept, high process safety and a broad format and product flexibility characterise the machine. Due to its modular design, the machine layout can be adjusted to different product infeeds. With an output of 30 up to 200 cartons, the TTMP provides individual solutions for both small and large production batches.

The Sigpack TTMP can be seamlessly combined with the Sigpack TTMC case packer.

42 EXPRESS PHARMA April 16-30, 2016

PHARMA PRO & PACK EXPO 2016 SPECIAL This offers customers a uniform, user-friendly operating concept for the entire line.

Thanks to the patented format changeover concept, tool-less format changes with vertical restart can be carried out within a few minutes. The open and easily accessible machine design provides for a very fast line clearance.

A wide range of product infeed solutions and loading possibilities ensure the gentle handling of sensitive products such as vials, ampoules, syringes and injection pens. Various gripper technologies provide for smooth packaging of the products. Depending on requirements, different mechanic, vacuum-based or grippers with airflow technology are being used. Modules for

forming and inserting partitioners, package inserts and tray denesting can also be integrated. Maximum efficiency and 100 per cent process safety.

The Sigpack TTMP is easily accessible and open. The compact, GMP-compliant design supports process safety.

Additional Track & Trace-solutions such as the CPS module (Carton Printing System) from Bosch or third-party suppliers can be easily integrated. The machine can also be equipped with the Bosch CPI software, which manages serialisation from the allocation of serial numbers through to the last aggregation step.

Thus, the Sigpack TTMP fulfils the most recent serialisation requirements for phar-

maceutical products.

Various monitoring functions inspect the packaging process at several points. For instance, the carton blanks are already scanned at the infeed. Vision systems and code verification allow to examine carton contents, the correct infeed of the package inserts, as well as the intact shape of the cartons. Incorrect packs are automatically dispatched from the system by discharging devices. This concept ensures 100 per cent process control and also speeds up line clearance during batch change.

Contact details Michael Haas, Christin Poenisch phone: +41 58 674-8594

AIMS launches non-contact ink jet printers ADVANCED INDUSTRIAL MICRO SYSTEMS (AIMS), a leading manufacturer and exporter of high precision marking, printing and packaging systems for coding variable information like Batch No., Mfg. Date, Exp. Date, Max. Retail Price, etc. on any substrate, which is stationary or moving, has launched hand held ink jet printers model U2-Mobile.

The light industrial handheld non-contact ink jet printer model IJP – Elfin IH, is a 4-in-1 compact design, zero maintenance, 300 dpi high resolution, battery powered six line (character height 1 to 12.7 mm) printer and can be used on porous / nonporous products to print B.No., Exp.Date, Time, Serial No. (AGMARK), logos, scannable variable bar codes, etc. on labels, cartons, pouches, drums, containers, etc. It is fully programmable using the five inch full colour touch screen LCD with stand-alone operation (no PC required) where it can print six lines data and all computer fonts (local languages).

The other product launched

by AIMS is low cost on-line industrial non-contact ink jet

printer model IJP – P2128 (Maplejet-Canada). It is a zero maintenance, high resolution, four line (character height 1 to 18 mm) English / Arabic printer. It has stainless steel construction and can be installed on porous and non-porous production lines to print B.No., Mfg.Date, Exp.Date, MRP, Time, Serial No. (AGMARK), etc. on bottles, pouches, labels, cartons, pipes,

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etc. Through the COM Port (RS-232) computer link, it is also capable of printing high quality logos, scannable bar codes, Hindi / local language and upto eight lines data in any computer font.

All the products have been designed and developed with inhouse R&D facilities keeping in mind the extreme conditions of the industrial environment.

They have been developed to give highly dependable, trouble free, consistent and high performance at a very competitive price.

Contact details Advanced Industrial Micro Systems 201, Triumph Industrial Estate, Itt Bhatti - Paanch Baawdi, Opp Express Zone – A Wing,

Near Dindoshi Signal, Goregaon (E), Mumbai - 400 063, INDIA. Phone: (022) 32964272, 28766351, 28756353 Fax: (+91-22) 28766352 Email: SamirGarg.

AIMS@gmail.com, info@coding-india.com Website: www.codingindia.com, www.printpackaging.in

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PHARMA PRO & PACK EXPO 2016 SPECIAL

CPC unveils genderless AseptiQuik G Connectors COLDER PRODUCTS Company (CPC), a leader of singleuse connection technology, unveiled its genderless AseptiQuik G Connectors with increased pressure rating at the BioPharma Asia Convention 2016.

The connectors which drew significant attention at the show, are rated to 60 psi for 30 days and 75 psi for 48 hours.

Genderless AseptiQuik G Connectors maximise process flexibility and simplify modular system design. The robust and easy-to-use design of AseptiQuik G allows universal mating between any G series connector without the need for clamps or fixtures, resulting in simplified systems integration. AseptiQuik G Connectors deliver reliable, repeatable performance while minimising operator error and

streamlining supply chain efficiencies.

Offered in gamma and high-

temperature versions, the AseptiQuik G series connectors provide a full range

of interchangeable flow solutions including 1/4-inch hose barb, 3/8-inch hose barb, 1/2inch hose barb, 3/4-inch hose barb and 3/4-inch sanitary.

CPC’s bioprocessing connections are manufactured in an ISO Class 7 certified cleanroom and meet USP Class VI material standards.

AseptiQuik G Connectors are a part of CPC’s family of sterile connectors that include sterile connect and disconnect solutions. Available in a full range of 1/8- to 1-inch flow configurations, the connectors provide ease-of-use, robust construction and reliable performance for transferring valuable media for a wide range of applications including single-use bag and tubing assemblies, cell banking systems, bioreactors, mixers, sampling

and filling. These are great alternatives to tube welders which may be expensive to purchase and maintain, do not work with silicone tubing, take several minutes to weld, cannot weld two tubes of different ID, and difficult to operate in tight spaces.

Contact details Pavan Urs M Regional Sales Manager, India CPC Tel: +91 953 8356 333 pavan.urs@cpcworldwide.com Web: cpcworldwide.com Ernest Chan Director of Sales, Asia Pacific CPC Tel: +852 2987 5272 ernest.chan@cpcworldwide.com Web: cpcworldwide.com

VALUE ADDS

Kleantech Engineering Systems launches largest manufacturing for cleanroom technology Kleantech has in-house capability for designing and executing any size of projects in a short period KLEANTECH Engineering Systems, established in 2008, is a fully stabilised company and has completed 100 pharma projects for formulation, bulk drugs and API, etc.

It has also executed projects for electronic industries, food industries, etc. Kleantech has an in-house capability for designing and executing any size of projects in a short period.

Kleantech Engineering Systems has recently launched India’s largest manufacturing unit for turnkey air conditioning, refrigeration, ventilation and bio-cleanroom applications in Karnataka, 110 kms from Hyderabad Interna-

44 EXPRESS PHARMA April 16-30, 2016

tional Airport.

The company is into the manufacturing of cleanroom equipment and all types of cleanrooms, sandwiched type of prefabricated panels, doors, air handling units, Dx units, cold storage, SS cleanroom furnitures, electrical control panels, HEPA Filters and pre filters, fine filters, microvee-filters.

All equipment and accessories are made in the factory and since there is no relying on

other suppliers, hence the execution of project becomes more faster.

The company is also instrumental in providing services for cleanrooms. The products and services meet the requirements of food, pharmaceutical and electronic industries. Further, it also provides turnkey solutions for clean room applications at its current manufacturing units, located at Vasai (E) Palghar (Maharashtra) and Karnataka.

The company is also into designing and commissioning of cleanroom HVAC projects, modular clean room systems for pharma and other allied in-

dustries. Backed by a team of professionals, Kleantech Engineering Systems also assist or clients in the preparation of facility layout and process equipment validation. Support of diligent professionals and high-tech amenities help to provide most reliable solution to its clients.

Currently, the company has an annual turnover of ` 40-50 crores and it is expecting a 50 per cent growth in 2016-2017. The products and services are reliable and are availed by electronic, food and pharma industries.

Kleantech Engineering Systems is a client-centric organisation.

Kleantech Engineering Systems has a large network of clients in India and abroad. Apart from India, its clients are located in North Africa, East/Middle Africa, South/West Africa, the Middle East and South America. Due to a continuous support of its professionals, the company is expecting an exponential growth in the near future. The manufacturing units have large production capacity and helps in meeting the bulk requirements of its clients.

Today, the cleanroom technology and HVAC and its built products have witnessed an increasing and continuous growth all over the world.

Kleantech Engineering Systems has a large network of clients in India and abroad. Apart from India, its clients are located in North Africa, East/ Middle Africa, South/ West Africa, the Middle East and South America Contact details Kleantech Engineering Systems Pvt Ltd, Tel: +91 0250 2458869 / 2458870 Mob: +91 97642 81212 / 90048 35550 E mail: info@kleantecheng.com kleantech08@yahoo.com www.kleantecheng.com

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April 16-30, 2016

PHARMA PRO & PACK EXPO 2016 SPECIAL VALUE ADDS

Balsam Life Sciences & Technologies offers fast track solutions for pharma manufacturing facilities ◗ It undertakes total turnkey projects (from designing, erection, commissioning to commercial production)to Set up a state of art plants for multipurpose products with all facilities to produce any API or Intermediate or finished product formulation with quality and yield ◗ GMP/GDP and US FDA Compliance Guidance ◗ Marketing

BALSAM LIFE Sciences & Technologies, is a pharmaceutical turnkey project consultant and a contract research and manufacturing services provider company. The company provides fast track services and solution to emerging pharma and biotech companies across the globe.

Balsam Life Sciences & Technologies has a diverse team of talented and dedicated technocrat with accumulated experience of almost

Strength and development ◗ Chemical process develop-

Coating pan

Fluid bed dryer

◗ Customer focus ◗ Regulatory ◗ Time management ◗ Intellectual property right ◗ Cost effectiveness ◗ Science and innovation

Services

Fluid bed processor

◗ Technology development and transfer for API, intermediates and formulation manufacturing know how ◗ It has the most ultra modern facility for contract manufacturing of any API or Intermediate and formulation

150 years in the field of healthcare, pharma, contract research and manufacturing of active pharma ingredients (API), generic formulation.

The company is growing to ramp up fast track solutions for the pharma manufacturing facilities, capable custom research organisation/contract manufacturing organisation with broad portfolio ranging from discovery chemistry to high quality manufacturing of impurities/metabolites/intermediate & API’s.

Core strengths

46 EXPRESS PHARMA April 16-30, 2016

Rapid mixer granulator

Liquid syrup manufacturing

ment for API & intermediate. ◗ Formulation development ◗ Analytical development ◗ Quality Control batch Release ◗ Stability studies ◗ Registration dossier ◗ Commercial manufacturing of API, intermediate and finish formulation ◗ Commercial manufacturing of pharma Equipment and machineries Scientists and technocrats at Balsam Life Sciences & Technologies have successfully developed a number of commercially

viable eco-friendly patent non infringing manufacturing technologies to produce the API and its intermediate and formulation.

The company provides full-fledge services starting from preparation of feasibility studies to manufacturing.

Contact Dr Zahid Shaikh Mob: +91 9967975365 Saberah Khan Mob: +91 9922260666 E-mail: info@balsamlifesciences.com

Surging demand for cleanroom technology Ravi Thakur, Director, Pharmintech Turnkey Solutions, elaborates on the immense growth potential for cleanroom technology THE CLEANROOM technology is witnessing continuous growth across the world.

There are countless factors which are responsible for the growth of pharma products and cleanroom technology such as stricter healthcare regulations, rigid standards, demand for good and quality products, growing frequency and awareness of contagious and infectious diseases, need for medicines and vaccines, growing facilities in the healthcare sector etc.

As per the current statistics and reports, the Asia market is witnessing a positive growth due to an increase in demand for medicines, cleanroom built products, semiconductors and micro biotechnology industry, increasing government initiatives for health, renewed focus on safety and efficiency of products and increase in demand for quality products. A majority of the growth in this region is due to growth and development of the healthcare industry in India.

Nowadays, the Indian cleanroom technology market is highly industrialised but unfortunately uneven and fragmented. New companies are looking forward to invest in cleanroom technology owing to its high demand in the Indian market and the numbers in the times to come will go beyond the predicted figures.

Development in cleanroom technology is also an important factor for the growth of manufacturers and turnkey contractors like us.

Pharmintech has been able to keep up its pace with the latest trends and has developed skill sets to provide the best quality products and services instantaneously so that there are no gaps between the growing trends and technology.

The clean-room technology market is expected to gain huge benefits in India. It is expected to be in the list of the top growing countries in the clean room market.

Quality, technology and needs are

Pharmintech uses the best team of designers, engineers, officials to ensure that everything is done systematically and efficiently driving the industry at a very high speed. Cleanroom turnkey projects executors and contractors should take the opportunity to provide the best technology and quality to clients.

Pharmintech uses the best team of designers, engineers, officials to ensure that everything is done systematically and efficiently. This generates trust among the clients and makes the company a leader in the industry. Therefore, we have become one of the preferred choices of our customers in a short period of time.

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April 16-30, 2016

PHARMA PRO & PACK EXPO 2016 SPECIAL

Turnkey projects execution in pharmaceutical, food and cosmetics machines and allied equipment by Intertech Technologies 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 2005 with effort and courage brought the knowledge to design and construct stainless steel equipment, to provide technical project engineering of pharmaceutical, chemical production lines, advisory design services along with design and development of equipments and machines. Many years of experience in the planning and developing of greenfield project and turnkey production facilities in India and around the world has turned its engineers into specialists according to WHO GMP, FDA and EU-GMP standard. The company stresses on an environmentally-friendly industry as a common target. It endeavours towards achieving an engineered solutions for process demand of all pharma, food, cosmetics and other allied industries. The company has a newly constructed state-of the-art facility of 1,00,000 sq ft at Vasai near Mumbai with inhouse design and development facilities.

Turnkey solutions: ◗ Feasibility studies and project cost estimates ◗ Return on investment evaluations ◗ Project financing (may be available) ◗ Conceptual designing ◗ Alternative process and equipment evaluations

48 EXPRESS PHARMA April 16-30, 2016

know-how enabled the company to project its presence as a leader of manufacturer and exporter having a strong presence in the US, CIS regions, Far East countries. Asian and African region. Intertech has substantial experience in executing pharma projects from conceptualisation to validation and will be an ideal partner for each solid dose processing, liquid dose processing and cream processing phase.

Contact details

◗ Process flow diagrams and P&I diagrams ◗ Complete equipment specifications and design engineering (URS) ◗ Procurement of materials and equipment ◗ Project/Program Management through BAR chart & PERT technique ◗ Facility check, commissioning,

Validation/qualification

◗ Facility start-up and batch trial completion ◗ Project closing documentation

Vision ◗ The company will continue make major investments in knowledge base and plan to expand our scope of services ◗ There are plans to continue to expand its operations throughout the CIS & European coun-

tries. The INTERTECH concept as a high quality supplier and service provider will be applied to all future territories.

Intertech Technologies offers new generation end-toend pharma, cosmetics, food and chemical industries related machinery which are cGMP/ CE certified. The strong technical background, young enterprising skills and best available engineering

Intertech Technologies Building No: 1 & 2, 'A' Wing, Unique Industrial Estate, S.No. 36, H.No. 10, Dhumal Nagar, Waliv, Vasai (E), Dist Thane – 401208 Tel: +91 250 6053372 / 74, E-mail: packaging@intertechglobal.com / info@intertechglobal.com

Desai Enterprises: Leading manufacturer of pharma packaging INCEPTED IN the year 1995, Desai Enterprises, is engaged in the manufacturing of aluminium coloured vial seals, plain seals, flip-off seals, plastic dropper assembly, measuring cups, plastic spoons, ointment and tablet applicator, eye and ear dropper and plastic dropper bottles.

The quality analyst ensures that

pharma products.

The towering success is the result of relentless efforts towards achieving quality in the range of seals, droppers and measuring cups and spoons. These are manufactured using quality raw material that is procured from reliable vendors.

Since the range of products is re-

pharmaceutical products are stringently sterile with BARC GAMMA or ETO gas to ensure hygienic and safe to use products. The products are highly appreciated by the clients for durability and tamper resistant features. Owing to the efforts of offering qualitative range, the company has earned a huge client base across India.

Desai Enterprises' strength lies in state-of-the-art infrastructure and inhouse design unit, which enable the company to meet varied requirements of its clients in stipulated time frame.

The company is backed by a team of efficient workforce, who assist them in producing a quality range of products as per industrial standards.

Desai Enterprises is a client-centric organisation and facilitate clients with customised range as per their specifications and requirements. It also offers customised packaging as well as free sampling policy, to make clients ensure about the work.

The company is owned by Kirit Desai and Sanjay Desai under whose guidance. Their vast industrial experience have enabled the company to become one of the eminent manufacturers of

lated to medical sector, the company strictly maintains quality and hygienic value. Quality analysts aid in delivering flawless range of products, which is at par with the international standards.

The quality of range of pharma products is maintained through stringent quality tests, continuous R&D activities, effective packaging and timely deliveries.

The company also offers products with BARC GAMMA sterile or ETO gas sterile to ensure safety, efficiency and reliability while using the products.

Additionally, the company has an experienced team, which helps it to provide customised solutions to its clients.

Keeping in mind the requirements of its clients, Desai Enterprises' team of professionals keeps a track of global market demand and offers the best.

Contact details E/4, Agrawal Industrial Estate 139, Swami Vivekanand Road, Jogeshwari, West Mumbai, Maharashtra 400102, +(91)-(22)- 26784535/ 26788148 Email: desaienterprises@gmail.com, sales@desaienterprises.co.in

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PHARMA PRO & PACK EXPO 2016 SPECIAL VALUE ADD

Addressing the needs of drug discovery with Microcal PEAQ-ITC Dr Michael Caves, India Business Development Manager, Malvern Instruments, in this article describes one of many key features of new Microcal PEAQ-ITC used to improve the efficiency of drug discovery and development

MEASUREMENTS AND characterisation of binding interactions between proteins and low-molecular weight ligands are fundamental for drug discovery. Among the most recognised challenges in characterising binding interactions are (1) The need to accurately assess a wide span of binding affinities (KD) and (2) Accurately rank and characterise low-molecular weight (LMW) ligands based on affinity, mechanism of action, and energetics of interaction.

Isothermal titration calorimetry (ITC) directly measures heat released or absorbed in a binding event, providing means for studying protein-small molecule interactions in solution without the need for labelling or immobilisation. A highly sensitive ITC instrument and properly designed experimental conditions make it possible to account for inaccurately assessed protein concentration or inactive protein fraction, and to account for imprecise concentration of compound solutions. From quality control (QC) to assay development and lead optimisation, ITC has a role in improving our understanding of biochemical data. Normalising for protein or compound concentrations and accounting for inactive populations of protein can improve decisionmaking processes, one example being a more careful assessment of changes in enthalpic contributions to

Figure 1: MicroCal iTC200 data for the titration of enantiomeric compound into target protein (client-provided data).The binding isotherm is clearly biphasic; however, analysis of the data with Origin ITC data analysis was not straight forward

In late-stage drug discovery, a significant number of compounds are synthesised as mixtures of enantiomers or isomers. In many of these cases, the compound mixture can be separated by HPLC and one or more isomers can be tested individually. However, in many cases, particularly those involving mixtures of enantiomers, separation can be difficult and time-consuming, and in these cases the mixtures must be tested directly

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binding, which are critical in many best-in-class drug studies.

Simultaneous affinity determination for isomers and enantiomers In late-stage drug discovery, a significant number of compounds are synthesised as mixtures of enantiomers or isomers. In many of these cases, the compound mixture can be separated by high-per-

formance liquid chromatography (HPLC) and one or more isomers can be tested individually. However, in many cases, particularly those involving mixtures of enantiomers, separation can be difficult and time-consuming, and in these cases the mixtures must be tested directly. Biochemical assays primarily provide information on the tightest binding component in the mixture. In contrast, ITC can provide

EXPRESS PHARMA

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PHARMA PRO & PACK EXPO 2016 SPECIAL binding information about both the strong and the weaker binder simultaneously in a single experiment.

The biphasic binding isotherm in Figure 1 represents an example how the ITC data may look for the injection of an enantiomeric ligand mixture into a target protein in the cell. Similarly, biphasic isotherms are observed when high affinity ligands are intentionally mixed with weaker ligands as a form of competition experiment to determine KDs outside the range of direct measurements. This differs from the more typical approach of injecting the tight binding ligand into a mixture of the target and the weak inhibitor but has the advantage that both inhibitors can be resolved simultaneously and without prior knowledge of the interaction parameters of the weak interaction.

To demonstrate the utility of the MicroCal PEAQ-ITC Analysis Software for the analysis of complex binding isotherms we have performed experiments with mixed ligands (ethoxzolamide (EZA), and furosemide (FUR)) in the syringe injected into a target protein (Bovine carbonic anhydrase II, bCAII) in the cell.

The data are shown in Figure 2 and represent the type of biphasic isotherm data that is expected for an enantiomeric mixture or a ‘syringe’ competition experiment.

These experiments demonstrate the level of resolution that can be achieved using the MicroCal PEAQ-ITC and the potential for quantitative characterisation of the binding of mixtures. The fitting of complex ITC data, and in particular the fitting of these competitive experiments, has been made simpler in the MicroCal PEAQ-ITC software than in analysis software previously available on earlier models. While the input of good initial guesses into the fitting software is always a good start, the current software contains more appropriate numerical boundaries increasing the chances of a successful fit and minimising the risk of the fitting process getting trapped in a local min-

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Figure 2: Raw and normalised heat plots for the titrations of the 1:1 mixture of EZA and FUR into bCAII.The titrations were carried out at 160 μM total concentration of the compounds in the syringe and 10 μM concentation of bCAII in the cell (left) or at 100 μM concentration of the compound mixture and 5 μM concentation of bCAII in the cell (right). 18 × 2 μl injection were made and the buffer was PBS, 2 v/v % DMSO at 25°C

Table 1: Results of the analysis of the data collected for titrations of the 1:1 mixtures of EZA and FUR inhibitors into bCAII with a new MicroCal PEAQ-ITC Analysis Software. For comparison, binding parameters established in separate titrations (n = 3) of the compounds were: for EZA KD= 1.3 ± 1.0 nM, enthalpy ΔH = -15.10 ± 0.01 kcal/mol; for FUR KD = 360 ± 70 nM, ΔH = -6.30 ± 0.02 kcal/mol.All titrations were conducted on the new MicroCal PEAQ-ITC system in PBS and 2% v/v DMSO, at 25°C.The binding parameters are reported along with the standard errors given in brackets

bCAII in cell, mM

N1 (sites)

KD1 (nM)

DH1 (kcal/mol)

N2 (sites)

KD2 (nM)

DH1 (kcal/mol)

5

0.5 (4)

0.8 (100)

-15.1 (1)

0.6 (7)

700 (43)

-7 (13)

10

0.49 (3)

1 (93)

-15.2 (2)

0.56 (3)

630 (42)

-7.1 (5)

ima. Fitting these data also benefited from combining the Simplex fitting and Marquardt-Levenberg fitting approaches available in the software. More specifically, using the Simplex approach at the start and finalising using the Marquardt-Levenberg fitting algorithm. The thermodynamic parameters obtained using this approach with the ‘two-sites’ model and ‘ligand in cell’ setting are summarised in Table 1.

Summary and conclusions The new MicroCal PEAQ-ITC instrument along with improved signal stability, mixing and signal-to-noise characteristics has data analysis software well-suited for use in the biophysical laboratories involved in small-molecule drug discovery.

The analysis is completely automated, minimising user subjectivity in assessing data quality and the analysis

process. Data quality assessment and fitting is performed rapidly allowing for analysis of large data sets of 50 or more experiments in seconds.

Key additional features of the new MicroCal PEAQ-ITC Analysis Software package allow for the determination of the active concentration of the target protein or the ligand concentration or both when the appropriate controls are used. This provides for the more accurate determination

of the affinity and thermodynamic allowing for rigorous structure-activity relationship in hit validation and lead optimisation programmes.

In addition, the new ITC data analysis software has tools that simplify the fitting of complex binding isotherms that may be observed when titrating with enantiomeric mixtures, some competition experiments or with targets with more than one binding sites.

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EXPRESS PHARMA

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WANTED ASOUTH INDIAN PHARMACEUTICAL COMPANYhaving Marketing Network in South India,Maharashtraand parts of North India worth Rs 15 Crore is looking to sell its Registered and Non Registered Marketing BrandsApprox 100 Products.

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Optimising Drug Discovery and Development

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PHARMA LIFE NEWS

Pharma to see increments of 13.5 per cent: Antal International Hiring is predicted at 64 per cent for the next quarter, as the pharma sector is seeing a lot of growth in the market with new tie-ups Viveka Roychowdhury Mumbai

E

very April, employers and employees across sectors gear up for the annual appraisals. With the 18th edition of the Antal Global Snapshot released in November last year predicting that the pharma sector will be in buoyant mode, average increments are expected to average around 13.5 per cent, according to Mayank Chandra, Managing Partner, Antal International, Lucknow.

Hiring is predicted at 64 per cent for the next quarter, as the pharma sector is seeing a lot of growth in the market with new tie-ups. Roles in clinical research and quality are growing, according Chandra.

One of the fallouts of the appraisal cycle is employee dissatisfaction with the results of the evaluation. Attrition levels thus spike post appraisal as “employees who look for greener pastures are either not happy with increments and seek elevation.

Job satisfaction is lacking. At times, employees move due to location preference,” explains Chandra.

He suggests that like other sectors, pharma companies can bridge the gap between employee expectations and reality by maintaining a smooth flow of communication. The November 2015 Antal Global Snapshot predicts attrition will be at 12 -14 per cent in the pharma sector.

Some sectors have seen counteroffers emerge as a way

Mayank Chandra, Managing Partner, Antal International, Lucknow

to retain talent but this is double edged sword as such offers could demotivate the rest of the workforce. But Chandra disagrees with this reasoning saying, “Counteroffers do not demotivate other employees. On the other hand, the practice encourages other employees to also indulge in the practice of bargaining with current employers by dangling the threat of moving out. In fact the entire harm is borne by the company which puts itself in a negative position and shows weakness of the management and their dependence on the people. In fact few large MNCs are increasingly going the ‘no counter offer’ way just for these reasons.”

Increments in the sector continue to be in the traditional

'cash in hand' format rather than other modes of increments like ESOPS, which are favoured by in sectors like IT. According to Chandra, “Very few companies in the pharma sector follow the practice of giving ESOPs. As a general rule people prefer increments – cash in hand, and the same is being followed this year.”

However, some changes in the formal appraisal process have crept in. Chandra has observed that most companies have adopted personal interactions over traditional appraisal procedures over the years. This is to ensure each employee has a clearer view and understanding of his / her performance and career progression. viveka.r@expressindia.com

Gujarat State TB Association,Sparsh with Cadila Pharma organise medical camps Awareness was raised on tuberculosis where more than 300 villagers underwent health checkups and were given consultations CADILA PHARMACEUTICALS in association with Gujarat State Tuberculosis Association and Sparsh Hospital recently organised a ‘Sarva Rog Nidan Camp’ at Visalpur village, Ahmedabad. The focus was to raise awareness about tuberculosis where more than 300 villagers underwent health checkups and were given consultations and medicine free of cost.

Dr Tushar Patel and his team of doctors, including cardiologists and other specialists in orthopaedic, dental, ophthalmology, ENT, skin specialists and general surgeons from Kalikund Hospital, Ahmedabad examined villagers during the camp.

90 EXPRESS PHARMA April 16-30, 2016

A blood donation camp was organised where around 40 villagers participated. Villagers

also took oath for tobacco de-addiction in order to eradicate TB under Swachh Bharat, Swasth

Bharat Mission.

The campaign included awareness talks on radio in 35

cities, TB awareness rallies in 10 cities.

EP News Bureau-Mumbai

PHARMA LIFE APPOINTMENT

CAMPUS BEAT

Dr Rao VSVVadlamudi re-elected as President of IPA He has a stint of over three decades in industry and academia DR RAO VSV Vadlamudi has been re-elected unopposed as the President of Indian Pharmaceutical Association (IPA) for the term 2016-18. Vadlamudi has been the Editor of Indian Journal of Pharmaceutical Sciences (IJPS), the scientific publication of IPA since 1998 and is currently, the Director of St Peter’s Institute of Pharmaceutical Sciences, Warangal. With a stint of over three decades in industry and academia, Vadlamudi brings with him an assorted mix of skill sets that are essential for

leading IPA. The other office bearers who have also been elected for the term include Kaushik Desai as Honorary General Secre-

To subscribe: bpd.subscription@expressindia.com

tary, Dr Hemant Mondkar as Honorary Treasurer, Dr Alka Mukne as Editor – Pharma Times, Dr Divakar Goli as Editor – IJPS, Dr TV Narayana as Chairperson – Education Division, Manjiri Gharat as Chairperson – Community Pharmacy Division, Dr Subhash Rijhwani as Chairperson – Industrial Pharmacy Division, Dr Subhash Mandal as Chairperson – Regulatory Affairs Division and Dr Ramesh Adepu as Chairperson – Hospital Pharmacy Division.

EP News Bureau-Mumbai

SCOPE,Indore to organise seminar on herbal medicines The event, to be held on April 29, 2016, will be sponsored by MPCST SMRITI COLLEGE of Pharmaceutical Education (SCOPE), Indore will organise a national seminar on 'Herbal medicines: Journey from lab research to the marketed formulations.' The event to be held on April 29, 2016 will be sponsored by Madhya Pradesh Council of Science & Technology (MPCST) Bhopal.

Reportedly, the seminar would witness around 400 participants and will host

world-class speakers from academia and industry, who will discuss on herbal drug discovery and development from medicinal plants. The seminar will highlight the latest scientific breakthroughs, explore innovative technologies. Participants will be able to submit their abstracts for poster presentations related to distinctive themes of pharmaceutical sciences.

EP News Bureau-Mumbai

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PHARMA LIFE INSIGHT

Asimple,effective formula to build capability in pharma

RICHARD COWLEY, Founder, WorkAmmo

Richard Cowley, Founder, WorkAmmo, outlines strategies to create an effective capability building programme and emphasises on its importance for any pharma company’s growth EVERY ORGANISATION wants to make the best of its business opportunities and grow. However, to do so, there is a great need that must become a given and not remain a ‘nice to have’. Be it business leaders, supervisors, HR teams or employees, a greater clarity on how to develop organisation, team and individual capabilities is going to be critical going forward, and will determine any pharma company’s future.

To this end, I love the simplicity and focus that the following formula can provide for any organisation:

Business opportunities + Capability = Result The macro opportunities have been shared in many articles and have become the boardroom chat of most pharma organisations. The opportunities for Indian pharma companies are therefore a matter of identifying the most valuable and appropriate ones to achieve their ultimate vision. Generally, these can be identified using a SWOT analysis. Is there an opportunity that leverages our company's strengths (e.g. strong consumer brand recognition)? Do we need to take to action to address our weaknesses (e.g. poor rural distribution)? What new opportunities can we identify that would leverage our fixed cost base, (e.g. manufacturing for small brands)? Last but not the least, can we strengthen our proposition by addressing a threat by a competitor, (e.g. they have introduced key account segmentation and offered improved service)?

Once all the opportunities have been identified, the next

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Be it business leaders, supervisors, HR teams or employees, a greater clarity on how to develop organisation, team and individual capabilities is going to be critical going forward, and will determine any pharma company’s future step is to document the capabilities required to deliver this list of opportunities. The focus at this point should be to ‘go slow to go quick’ with the leadership team. Rushing this part of the process will most definitely lead to wasting resources later.

The critical outcome has to be the identification of organisational capabilities. At this level we are not discussing individual capability, we will leave that to the performance management process, which most companies have.

There are various definitions of ‘capability’. For me, it is simple and can be summarised as anything that enables you to deliver your business opportunities organisationally, e.g. intellectual property, organisation structure, sales negotiation process, leadership, work processes, security and knowledge.

One of the potential challenges for pharma organisations is the vastness and complexity of their sub-business areas, e.g. pharma, healthcare, pathology, drug and medication, life sciences, medical facility, biopharma, biotech, drug discovery and development, research and development, logistics and freight, and medical devices to

name a few! Each will demand differing exercises to identify their particular capability requirements.

To help illustrate how to build a capability programme, let us focus on the current need for a different type of sales organisation – one that needs to connect with customers in a different context, as markets see more and more branded products.

The starting point is to consider the existing capabilities.

The two priorities for me are the organisation structure and whether it was built to deliver this opportunity, and the key leadership team experience – both of which were probably hired to deliver a different outcome. Given the principle that ‘strategy drives structure’, it may well be that we will need to reposition our teams or introduce new departments with a different focus.

In this case, a review of sales and marketing capability may well lead to the conclusion that we need a sub-organisation that is more like a fast moving consumer goods (FMCG) company.

There are a number of companies that would be good to learn from, e.g. Kimberly-Clark, who have products that are similar in

their nature to pharma as they relate to people’s well being and often require FDA approval.

Building capability can often be about building, borrowing or buying talent. In this example, we may need to buy (recruit) experienced leaders who can take their FMCG knowledge and apply it in a new product context, and at the same time start building organisational knowledge.

With structure and leadership in place, the next capability I would work on is related to customer and internal processes. The following areas come to mind immediately:

Marketing Marketing to hospitals and doctors is vastly different than marketing to consumers. The quality, depth, and tone of communications will need to be varied as per the audience. The use of digital and social media is a critical capability today, as referral in this industry will be significant. Analysis, pricing and marketing are key capability areas that may require more aligned customer approaches.

Selling and distribution Developing and embedding a new sales call process with

supporting product comparison materials is a key capability, and difficult to achieve as it demands a new belief and behaviour by the sales team.

The greatest challenge I have observed is moving the team from being sales ‘order takers’ to sales people who generate the demand through deep sales capability. The new sales channels may also not be as ‘attractive’ to the existing sales team because of the different working environment and of course, the pressure of selling products instead of taking an order. Overcoming objections and conflict management will thus become new development areas for the company to focus on.

If you are a line manager or a HR business partner/manager, my recommendation on the next steps to build a capability programme is to take two hours out of your day, visit the top managers and document all the opportunities. Then ask them what are the top three capabilities they need to deliver the opportunities? My next step would be to speak to the MD and say, “have a look at what I have collected from the senior leaders, do you think there is value in a collective team meeting to prioritise?” The answer will always be 'yes', in my view.

In summary, capabilities are not a ‘nice to have’. They are going to become the mantra of organisations who understand the importance of aligning and being ahead of the curve so that opportunities are fully utilised.

If your company does not have a communicated plan to develop capability, speak up and make the difference.

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REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18,PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001