Express Pharma June 16-30, 2014

VOL. 9 NO. 16 PAGES 80

www.expresspharmaonline.com

Cover Story Modi's mantra for pharma Management Product launches and patent expiries to push MDD treatment market by 2023: GlobalData Logistics Special 16-30 JUNE 2014,` 40

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CONTENTS MARKET Vol.9 No.16 JUNE 16-30, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

LOGISTICS SPECIAL

UNTANGLING PHARMASUPPLY CHAINS

Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble

Pharma supply chains in India have a lot of ground to cover before becoming at par with their counterparts in the developed markets | P34

Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma

P12: DEAL TRACKER

Photo Editor Sandeep Patil

Focus on cross-border deals

MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

P21: POST EVENT

GLENMARK OPENS ANTIBODY MANUFACTURING FACILITY IN SWITZERLAND

14

EVOLVA JOINS FORCES WITH MALAYSIAN UNIVERSITY

15

BMS AND SYNGENE INTERNATIONAL IN COLLABORATION

16

UL EDUNEERING, IDMA TO HOLD ONE DAY SEMINAR IN MUMBAI IN JULY

18

PHARMEXCIL INDIA PAVILION AT UPCOMING CPHI CHINA

24

DISSO ASIA 2014 HELD IN MUMBAI

MANAGEMENT

45

LSW concludes clinical research conference in Mumbai

P46: RESEARCH UPDATES Higher doses of statins linked to diabetes risk

10

PRODUCT LAUNCHES AND PATENT EXPIRIES TO PUSH MDD TREATMENT MARKET BY 2023: GLOBALDATA

PHARMA ALLY TURN TO PAGE 13 TO FIND SPECIAL DEALS

P49: WHITE PAPER Seven reasons to switch to vision sensors

Scheduling & Coordination Rohan Thakkar

P74: INITIATIVE

CIRCULATION Circulation Team Mohan Varadkar

Cadila Pharmaceuticals takes various initiatives on World Environment Day

49

TÜV RHEINLAND CONDUCTS ‘REACH’ AWARENESS PROGRAMME IN CHENNAI

50

QUINTILES HONOURED FOR IT INNOVATION

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited 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 @ 2011. The Indian Express 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

Riding the wave

A

cross industries, hopes are riding high on the Modi government. And the pharmaceutical industry is no different. Sector specialists never tire of pointing out that pharma has done well inspite of and not because of government policies but this time there seems to be renewed efforts to attract the attention of Prime Minister Modi. Will we be left empty handed once again?

Policy pundits have put together detailed 'must-do' lists for the PM and his team for the first 100 days in office. Primarily because he has shown results in his home state. Gujarat has over 3000 pharma manufacturing units, with pharma giants like the Zydus Group, Cadila Pharma, Torrent Pharma, Claris Lifesciences, Intas Pharma to name but a few of the big ones. According to a 2008 KPMG Report, Gujarat accounted for nearly 42 per cent share of India’s pharma turnover, 22 per cent of drug exports and 20 per cent of chemicals output.

Pre election, we asked industry to put forth what should be on the next PM's agenda (see Express Pharma issue dated April 16-30, 2014, http://pharma.financialexpress.com/pharma.financial express.com/latest-issue/3716-april-16-30-2014) and post election, in our issue dated June 16-30 we follow it up by asking industry to list down what should be Modi's mantra for pharma. (See pages 26-33). Within these pages, is a detailed analysis of what's wrong with the industry and how Modi and his band of ministers can go about putting it back on track.

The list reflects common concerns like the need to increase spend on healthcare, decrease taxes, increase transparency of regulations and streamline approval timelines. Ananth Kumar who took charge as Minister of Chemicals and Fertilizers, has reportedly said that he would approach pharma companies to reduce drug prices; a statement which was greeted with protests across all segments of the industry. On the other hand, there seems to be a commitment to introduce GST while addressing the concerns of states, which should get the thumbs up across sectors, not the least in pharma. (See story: A Green Light for GST; pages 38-41).

But there are also issues where certain segments of the industry are pitted against each other. One clear polarising point is intellectual property rights (IPRs). How will the government

8

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June 16-30, 2014

One clear polarising point is intellectual property rights.How will the government deal with pressure from the US,as well as pharma MNCs, which recently came to a flashpoint on the USTR 301 issue?

Taking a populist stance only to back down later may prove costly in the long run

deal with pressure from the US, as well as pharma MNCs, which recently came to a flashpoint on the USTR 301 issue? (See story: http://pharma.financialexpress.com/editorial/3823more-to-rules-than-the-carrot-and-stick-approach).

While we do need to incentivise innovation, what is the best way to balance this with access to affordable, good quality medicines? Taking a populist stance only to back down later may prove costly in the long run.

There is no doubt that Gujarat benefited from the industry friendly policies put in place during Modi's reign and corporates can't be blamed for hoping that he does the same at the centre. And it seems to be already happening. Just 20 days into his term, the government has given the okay to raise the height of the Narmada Dam by 17 metres; a decision which was a political hot potato for the last eight years. Sure, the decision is controversial; with activists like Medha Patkar of the Narmada Bachao Andolan pointing out that the increase in dam height will mean more displacement of project affected people, besides that fact that big dams have raised questions across the world. But with this decision, the Modi government has proved that it is capable of biting the bullet and taking tough decisions.

Will the stance be sustained or will it subside? In the pharma space, we need a tough long term view on IPRs, drug pricing strategies, regulations for clinical trials. Funds need to be allocated to upgrade pharma MSME companies while ensuring that they toe the line on good manufacturing practices. PM Modi has chosen ministers with strong domain expertise as well as political savvy. Union Health Minister Dr Harsha Vardhan has proved his stripes both as a doctor as well as administrator as minister of state for Delhi in an earlier avatar. So also, the minister of state for Science and Technology and Earth sciences Dr Jitendra Singh is a Professor of Diabetes and Endocrinology. Both have had long successful political careers and will hopefully help form policies which are people as well as industry friendly. Let us hope that the hype turns into reality.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

Mix with the world of pharma, products, people & solutions

2-4 December 2014

Bombay Convention & Exhibition Centre Mumbai, India

Network and do business

with 32,000 pharma professionals from all over the world @ CPhI & P-MEC India 2014!

CPhI India has always met our expectations. The quality of the visitor is very high and majority of the potential customers we have met will lead to additional business for us which has made our participation very worthwhile

Heldin, UK Trade & Investment

CPhI & P-MEC India is the single biggest event in India and anybody who is associated with Pharma should participate.

The quality of the visitor is pretty good and all the decision makers have been here. This time we had good walk-in along with good quality

Laxmikant, Mutisorb Technologies

CONTACT: Email: kumudini.bodha@ubm.com Call: +91 (22) 6172 7163 Email: rahul.deshpande@ubm.com Call: +91 (22) 6172 7165

www.cphi.com/india

Co-located with:

In partnership with:

Supported by:

MARKET COMPANY WATCH

Glenmark opens antibody manufacturing facility in Switzerland The manufacturing facility supplements the research and development capabilities and will facilitate production of clinical grade material GLENMARK PHARMACEUTICALS SA (GPSA), a whollyowned subsidiary of Glenmark Pharmaceuticals India, has opened its new cGMP compliant monoclonal antibody manufacturing facility in La Chauxde-Fonds, Switzerland. This manufacturing facility supplements Glenmark’s existing inhouse discovery and development capabilities and will supply material for clinical development.

Glenmark Pharmaceuticals’ Swiss research centre is an integrated antibody discovery and development unit. The research centre has fully devel-

oped in-house capabilities and infrastructure for conducting antibody discovery, cell line development, in-vitro testing and characterisation of antibodies, process development and analytical research. The new manufacturing facility supplements the research and development (R&D) capabilities and will facilitate production of clinical grade material.

The manufacturing facility has been designed for use of single use bioreactor systems and also houses a suite for manufacturing cell banks. The facility is fully compliant with quality, environmental and

The facility is fully compliant with quality, environmental and safety standards for manufacturing clinical trial material

safety standards for manufacturing clinical trial material.

Dr Michael Buschle, President – Biologics, Glenmark Pharmaceuticals commented, “This manufacturing facility is a testimony for Glenmark’s commitment to growing its R&D and manufacturing facility in the canton of Neuchâtel.

We have been doing cutting edge work in the area of novel monoclonal antibodies and have several monoclonal antibody candidates and bispecific antibodies in the pipeline.

The manufacturing facility would help us bring these antibodies to the clinic faster and

position Glenmark as a leading innovative pharmaceutical company.”

Glenmark’s biologics research centre in Switzerland has a robust pipeline of monoclonal antibodies in various stages of development including bispecific antibodies. The focus for the biologics R&D centre is to develop novel biologic entities for the treatment of pain, inflammatory, oncologic and respiratory conditions. Glenmark currently has 69 employees at its biologic research centre.

EP News Bureau – Mumbai

Indian consumers lack awareness on medical devices: AdvaMed 60 per cent of respondents think that medical devices are the same as pharmaceuticals A SURVEY of 1300 Indians from across 17 states conducted

by AdvaMed – an association of medical device manufacturers leading the effort to provide medical technology to the world – reveals that although an overwhelming 72 per cent of respondents use medical devices, 89 per cent do not know enough about them.

“Our survey suggests that people in India don’t know enough about medical devices but want to know more. It is quite astounding that 60 per cent of respondents think that medical devices are the same as

10

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June 16-30, 2014

pharmaceuticals,” said Sanjay Banerjee, Managing Director, Zimmer India and Chair of the AdvaMed India Working Group.

Interestingly, the survey also finds that although India is a price-conscious market, quality is an important consideration among the country’s growing middle class. It showed 75 percent of respondents believe that the quality of the medical device is important because the safety of the patient is paramount.

According to 72 per cent of respondents using a high-quality device would help them avoid the costs of repeated hospitalisa-

tion. Responding to this finding, AdvaMed Vice President, USbased Abby Pratt said, “Unlike in the case of many other products in India where people unequivocally choose the cheapest option, this survey suggests that when it comes to advanced medical devices, quality becomes important because of its correlation to safety. It is noteworthy that 80 per cent of respondents see a correlation between brand name and quality.

However, despite the prevalence of medical devices that the survey suggests, at a macro level, the industry constitutes

only five per cent of India’s $ 60 billion healthcare industry.

There is a major gap between medical devices currently used and what is required to address public health needs.

For example, in the case of diabetes, it is estimated that 93.75 per cent of the Indian diabetic population remains undiagnosed or untreated. The situation is similar for other diseases: heart disease, cancer, glaucoma and so on remain undiagnosed and untreated because the benefits of medical devices like stents, MRI machines or intraocular lenses are not known to those

suffering from them.

AdvaMed believes that the medical devices industry in India has the potential to fill these gaps. Banerjee said AdvaMed was hopeful the Modi Government, under the stewardship of Health Minister, Dr. Harsh Vardhan, would provide an enabling environment for the Bill to become law. AdvaMed has submitted a letter to the new Health Minister, urging collaborative discussions that will facilitate expeditious consideration of the Bill.

EP News Bureau – Mumbai

MARKET DEAL TRACKER

Focus on cross-border deals Regional expansion to increase presence in the global markets drives M&A activity in the month of May 2014 M&A ACTIVITY in the pharmaceutical sector was focused on cross-border transactions for long term sales growth. In line with the above trend, Abbott Laboratories agreed to acquire CFR Pharmaceuticals, a Chile-based pharmaceutical company, for approximately $3.33 billion. This acquisition would enhance and broaden Abbott's Latin American footprint. CFR’s product portfolio is well aligned with Abbott's current pharma therapeutic focus

M&A (INCLUDING PRIVATE EQUITY) TREND ANALYSIS

FIGURE: VENTURE FINANCING TREND ANALYSIS

Source:

Source:

TOP M&A DEALS (MAY 2014) Rank

Date

Target

Acquirer

Deal value ($m)

1

05/16/14

CFR Pharmaceuticals S.A. (CL)

Abbott Laboratories (US)

2900

2

05/28/14

Valeant Pharmaceuticals International, Inc. - aesthetic dermatology assets (CA)

Nestle S.A. (CH)

1400

3

05/08/14

Chelsea Therapeutics International, Ltd. (US)

H. Lundbeck A/S (DK)

658

4

05/13/14

Merck Sharp & Dohme Corp. - Ophthalmology Products (US)

Santen Pharmaceutical Co., Ltd. (JP)

600

5

05/09/14

VersaPharm Incorporated (US)

Akorn, Inc. (US)

440

6

05/12/14

Lumena Pharmaceuticals, Inc. (US)

Shire plc (IE)

260

7

05/09/14

Viracor-IBT Laboratories, Inc. (US)

Eurofins Scientific S.A. (BE)

255

8

05/02/14

Fibrotech Therapeutics Limited (AU)

Shire plc (IE)

75

9

05/06/14

Frontage Laboratories, Inc. (US)

Hangzhou Tigermed Consulting Co., Ltd. (CN)

50.25

10

05/16/14

Proteon Therapeutics, Inc. (US)

Abingworth Management Limited; TVM Capital Life Science; Prism VentureWorks (Prism Venture Management, LLC); Intersouth Partners; Skyline Ventures; MPM Capital; Devon Park Bioventures; Bessemer Venture Partners; Vectis Healthcare and Life Sciences Fund; Deerfield Management Company; Pharmstandard International S.A.

25

Source:

TOP VENTURE FINANCING DEALS (MAY 2014) Rank

Date

Target

Investors

Deal value ($m)

1

05/27/14

Spark Therapeutics, LLC (US)

Sofinnova Ventures,Inc.; Brookside Capital; Deerfield Management Company; Rockspring Capital; T.Rowe Price Associates,Inc.; Wellington Management Company,LLP; The Children’s Hospital of Philadelphia; Undisclosed Investors*

72.8

2

05/19/14

Coherus Biosciences, Inc. (US)

Kohlberg Kravis Roberts & Co. L.P.; Venrock; RA Capital Management, LLC; Rockspring Capital; Sofinnova Ventures, Inc.; Lilly Ventures; Vivo Capital, LLP; Fidelity Biosciences

55

3

05/28/14

ARMO BioSciences, Inc. (US)

NanoDimension Management Limited; Kleiner Perkins Caufield & Byers; OrbiMed Advisors, LLC; DAG Ventures

30

4

05/06/14

Loxo Oncology, Inc. (US)

New Enterprise Associates, Inc. (NEA); Aisling Capital; OrbiMed Advisors, LLC

24

5

05/21/14

Lysogene (FR)

Sofinnova Partners; InnoBio; Novo Seeds

22.61

Source:

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June 16-30, 2014

MARKET areas in women's health, central nervous system, cardiovascular and respiratory diseases.

This transaction would improve Abbott's position in several markets, and provide the opportunity to expand its portfolio across Latin America. In addition, Abbott expects the acquisition to add approximately $900 million to its sales in the first full year (2015), with expected doubledigit sales growth over the next several years.

In another key deal, Santen Pharmaceuticals agreed to acquire ophthalmology assets of Merck, a US-based pharma company, for approximately $600 million. This acquisition would strengthen Santen’s line-up of glaucoma products, and expand its footprint in Japan, Asia and Europe, while allowing it to increase presence in the global ophthalmology market.

Through this transaction, Santen would gain access to Merck’s ophthalmology products: COSOPT, COSOPT PF, TRUSOPT, TRUSOPT PF, TIMOPTIC, TIMOPTIC PF, TIMOPTIC XE, SAFLUTAN and TAPTIQOM in Japan, Europe, and Asia Pacific.

M&A activity in the pharma sector decreased in volume and value terms, when compared to the average of the previous six months’ (Nov 2013 – Apr 2014). According to Datamonitor's Medtrack database, the pharma sector recorded 25 M&A transactions in May 2014, against the previous six months’ average of 31.8 transactions. In value terms, the sector recorded deals worth $6.7 billion, against the previous six months’ average of $16.1 billion.

The Indian pharma sector witnessed one deal during May 2014, against the average of 0.8 deals over the previous six months, in which US-based Cancer Genetics agreed to acquire BioServe Biotechnologies, an India-based provider of genomic and molecular services, for approximately $1.9 million. This acquisition positions Cancer Genetics to immediately participate in the Indian molecular diagnostics

EXPRESS PHARMA

13

June 16-30, 2014

and oncology services market.

Venture Funding Companies in the pharma sector raised $275.7 million during May 2014, against the previous six months’ average of $310.9 million. In terms of volume, the sector recorded 12 venture funded deals, when compared to the previous six months’ average of 16.5 transactions.

Notes and Definitions Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic

set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and de-

velopmental benchmarking.

For more information, visit us at www.medtrack.com

Definitions 1.Deal value trend is based on transactions where associate values have been disclosed.

2.Trend analysis excludes rumored and terminated deals.

3.Value and volume analysis excludes private equity exits

MARKET

Evolva joins forces with Malaysian University To establish a scientific Centre of Excellence for natural products that will initially focus on the production of agarwood fragrances via yeast fermentation EVOLVA HOLDING announced that it will collaborate with University Malaysia Pahang (UMP) to establish a scientific Centre of Excellence for natural products from Malaysia as part of the Flavor and Fragrance Cluster in the state of Pahang. The Centre of Excellence, which is being facilitated by the Malaysian Biotechnology Corporation (BiotechCorp), under Malaysia’s flagship Bioeconomy Transformation Programme, Bio-Accelerators for Technology Development and Innovation, will focus on the development of natural compounds using Evolva’s yeast fermentation production platform. The goal is to create a new paradigm in the sustainable production of Malaysia’s high value indigenous natural products.

“Malaysia has abundant natural products with high potential to be developed into high purity as well as active ingredients for the cosmetic, pharmaceutical, and other high-end industries. With Evolva’s unique platform and UMP’s research strength, the Centre is impetus in our efforts to establish the links between the science knowledge base and the business community. This will create value for other industries with significant economic opportunities to benefit Malaysia’s Bioeconomy agenda,” said BiotechCorp’s Chief Executive Officer, Dato’ Dr Mohd NazleeKamal.

The first programme at the Centre will focus on the production of agarwood fragrances via yeast fermentation. The development of a range of agarwood products by fermentation will allow

14

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June 16-30, 2014

Malaysia to significantly widen the use of agarwood worldwide, and will complement the existing traditional production approaches. UMP Vice Chancellor, Professor Dato’ Daing Nasir Ibrahim said, “It is a privilege and honor to be able to collaborate with our two esteemed partners in the establishment of the Centre of Excellence. Our capacity building in scientific facilities and academic talents in the last two years has positioned UMP to play a meaningful role in this truly interesting partnership venture”.

Agarwood of the Aquilaria and Gyrinops variety has been

Gyrinops in tree nurseries and organic tree farms, these evergreens are rapidly vanishing from forests due to high demand.

According to data collected by the Wild Trade Monitoring Network, the global supply of wild agarwood could vanish from the planet in less than two years. Chief Executive Officer of Evolva, Neil Goldsmith said, “We are delighted to participate in this venture in Malaysia and would like to commend the efforts of BiotechCorp for facilitating this collaboration. We are looking forward to working with the passionate and

The first programme at the Centre will focus on the production of agarwood fragrances via yeast fermentation. The development of a range of agarwood products by fermentation will allow Malaysia to significantly widen the use of agarwood worldwide prized for centuries by incense and perfume makers, and traditional medicine practitioners. More recently, agarwood has been designated as an endangered species by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). Despite conservation measures and concerted efforts to grow Aquilaria and

talented researchers at UMP to determine if agarwood compounds might be amenable to production via biosynthesis and yeast fermentation. If successful, this Centre’s global and multi-disciplinary efforts will produce both positive economic and environmental benefits for us all.”

EP News Bureau – Mumbai

US FDA approves first generic versions of celecoxib Celecoxib is a non-Steroidal anti-inflammatory drug THE US Food and Drug Administration (US FDA) has approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research. “Healthcare professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib is a NonSteroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it,

Celecoxib is a NSAIDs and have a boxed warning in their prescribing information (label) such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs. In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhoea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.

EP News Bureau – Mumbai

MARKET

BMS and Syngene International in collaboration Extends five-year extension of their drug discovery and development collaboration BRISTOL-MYERS Squibb (BMS) and Syngene International have announced a fiveyear extension of their drug discovery and development collaboration in India. Financial terms were not disclosed.

Since 2007, BMS has been working with Syngene and its corporate parent, Biocon, to develop integrated capabilities in medicinal and process chemistry, biology, biotechnology, biomarkers, drug metabolism and pharmacokinetics, analytical research, and pharmaceutical development at the Biocon Bristol-Myers Squibb Research Centre (BBRC) in Bangalore.

The US-India collaboration has produced six drug candidates for further study and also helped BMS reduce the time and costs associated with advancing new compounds to first-in-human studies. One drug candidate currently in clinical trials was discovered at BBRC and early nonclinical development work done at BBRC has enabled most of Bristol-Myers Squibb’s small molecule assets to advance to later stages of development over the last five years.

Peter Bains, Director, Syngene International said, “We are delighted to extend our discovery and development partnership with Bristol-Myers Squibb for another five years. The scope of Syngene’s engagement has expanded to encompass a broad range of integrated service offerings across the drug discovery and development continuum. We remain committed to supporting BMS in their pursuit of developing new and innovative medicines for the future.”

Francis Cuss, Executive Vice President and Chief

EXPRESS PHARMA

15

June 16-30, 2014

Scientific Officer, BMS said, “The BBRC has supported the non-clinical development of a

large proportion of our smallmolecule portfolio assets since its inception, and is a

premier example of the high-quality innovative drug hunting that is taking

place in India today.”

EP News Bureau – Mumbai

MARKET PRE EVENT

ULEduNeering,IDMAto hold one day seminar in Mumbai in July We see ourselves as agents of change through training, explains Kavita Mehrotra, Head, Global Strategic Alliances, UL and give more details to Express Pharma about their plans in India On May 8-9, you and your team attended a workshop co-driven by US FDA and CDSCO. What was your experience at the meeting?

On May 8-9th, I had the privilege of attending workshop held in Goa co-driven by US FDA and CDSCO to learn firsthand about GMP, cGMP, and quality management. Our participation on that workshop was based as an attendee: we wanted to see how the Indian top pharma companies carve their roadmap through the

learning in this workshop.

Speaking as a long-term online learning partner to US FDA, it was thrilling to see the standardised global learning modules come to life in this very focused workshop, with insightful GMP topics like quality control, process validation, and many others.

As an organisation involved in GMP training, what were your key impressions from the Goa meeting?

I was personally and profes-

Kavita Mehrotra, Head, Global Strategic Alliances, UL

sionally very impressed with many industry relevant topics covered by the US FDA, as that is completely aligned with our areas of focus and expertise, and we see ourselves as agents of change through training as a vehicle for culture of quality.

Also, these topics are timely, in the wake of a torrent of warning letters that Indian pharma companies are receiving, and the full attendance in these workshops is a testament to their desire to strengthen their processes and knowledge.

What is exciting for me personally is that all the topics covered by US FDA: OOS, GMP, cGMP, GCP, electronic records, and 21 CFR guidelines are represented and covered in our online suite of modules. This is not surprising, since our content on GMP is authored by US FDA subject matter experts.

In fact, our 21CFR 11 compliant award winning Learning Management System, Compliance Wire, is being used to train US FDA inspectors for over a decade, and we have

MARKET already trained 36000 inspectors and counting. We take the responsibility of bringing the right training to the right people at the right time very seriously, knowing that ultimately we are answerable to patient health and safety by owning the role of thought leaders on compliance, quality and GMP training in the industry globally.

What is UL's mission in India and development plan to reinforce these messages from the US FDA workshop?

UL’s corporate mission is to make a safer world, and at UL EduNeering we view the production of quality pharmaceuticals and medical devices as a vital part of making the world safe. We have development teams here, and a large office in Bangalore. Our commitment and plan now is to provide pharma-specific feet on the ground dedicated to advising companies on how to leverage technology to sustain these messages and propagate them within their own organisations. We can also help companies tailor those messages to their specific needs. Additional to our relationship with the FDA, we also have knowledge assets that map to other global regulatory bodies. India is playing a vital role in the global pharma industry, and to be true to our mission we need to be here and be of service to Indian pharma.

We are building effective strategic partnerships with similar minded organisations to reinforce this message of a culture of Quality. For example, UL

We hope to replace fear and anxiety with knowledge, empowering companies to master the etiquette of audit readiness both from a technical and soft skills perspective

EduNeering, in partnership with IDMA, is holding a one day seminar on Roadmap for India pharma in Mumbai in July, where we will bring hand-on knowledge and techniques to help audit proof pharma companies by actionable steps and approaches. We hope to replace fear and anxiety with knowledge, empowering companies to master the etiquette of audit readiness both from a technical and soft skills perspective.

And ultimately, provide India with resources that enable companies to reclaim their position in the global landscape.

Chennai to host Pharmac South 2014 The event is being held on July 18-19 at the Chennai Trade Center INDIAN DRUG Manufacturers Association (IDMA-TNPSB) and Orbit Exhibitions are organising Pharmac South 2014 from July 18 -19 2014 at Chennai Trade Center, Chennai, India.

The event will provide new opportunities for contract manufacturers of allopathy, ayurvedic, siddha, unani, nutraceutical and dietary supplements, outsourcing and export managers and brand managers along with sections of the pharma industry.

The event is poised to attract players in pharmaceutical, nutraceuticals,

herbal and veterinary formulations as well as experts from the medical and pharma sectors.

This specialised conference will include seminars and panel discussions on both days, along with the exhibition.

In short, Pharmac South 2014 will pool the latest know how, networking opportunities and business prospects from both domestic and international lands.

EP News Bureau – Mumbai

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MARKET

Pharmexcil to participate in CPhI South America To organise CPhI SA & India-LAC pharma business meet PHARMEXCIL IS participating in CPhI, South America, which will be held during August 5-7, 2014 at Expo Center Norte, Sao Paulo, Brazil.

The council will be organising India Pavilion by taking 132 sq. meter space. In order to make this event more useful for the exporters who would like to explore the LAC markets, Pharmexcil is organising ‘India-LAC Pharma Business Meet’ at the same time, coinciding CPhI SA.

Salient features of the exhibition and pharma meet:

ganised at the same venue.

■ With help of India-Brazil Chamber

of Commerce, pharma distributors / importers /manufacturers from Sao Paulo and neighbouring cities will also be invited for the meet.

■ Technical seminars, visits to local pharma companies will be arranged.

■ It is proposed to organise a trade delegation/Buyer Seller Meet (BSM) to 3-4 Latin American countries, immediately followed by BSM/exhibition in Brazil.

■ Participants of exhibition/BSM can join the trade delegation to 3-4 Latin American countries.

■

During the event, about 50-60 prominent buyers / importers from neighbouring Latin American and Caribbean countries will be invited and one-to-one meetings will be or-

For more details contact Pharmexcil at info@pharmexcil.com EP News Bureau-Mumbai

Pharmexcil India Pavilion at upcoming CPhI China Pharmexcil is organising an India Pavilion at the upcoming CPhI China 2014, being held for the fifth time at Shanghai, China from June 26- 28, 2014 CHINA HAS increasingly become a focal point of the pharma world and will be third largest pharmaceutical market in the world making medicines worth $40 billion which will provide a very good opportunity to enhance India’s export performance to China and neighboring countries.CPhI China is an event focused on APIs, excipients, plant extracts, contract manufacturing etc. About 35,000 visitors from 115 countries at-

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tended this event last year. Considering the importance of the event, Council is organising India Pavilion in 156 sq. meters of space in Hall E 1 H 36.

Pharmexcil will also be participating at the iPHEX Africa 2014, Lagos, Nigeria (August 27-29, 2014).

For more details, contact Pharmexcil at info@pharmexcil.com EP News Bureau – Mumbai

EVENT BRIEF JULY—SEPTEMBER 2014 11

Contract Manufacturing 2014

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Pharmac South 2014

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Emerging Trends in Drug Discovery: AICADD – 2014

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The Indian Pharmaceutical Association Convention – 2014

CONTRACT MANUFACTURING 2014 Date: July 11, 2014 Venue: Hotel Hilton, Sahar, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Contract Manufacturing Subcommittee will organise the first conference on Contract Manufacturing 2014. The main theme of this conference is ‘360 degrees of Contract Manufacturing.’ Eminent experts in contract manufacturing, research, and regulatory spheres from the Indian pharmaceutical industry will converge and interact on various recent developments.

Contact details T R Gopalakrishnan Deputy Secretary-General Indian Drug Manufacturers’ Association 102, ‘A’ Wing, Poonam Chambers Dr Annie Besant Road, Worli, Mumbai – 400018 Tel: +91-22-24944624/24974308 Mobile No. 9819035076 Fax: +91-22-24950723 Email: admin@idmaindia.com Website: www.idma-assn.org

PHARMAC SOUTH 2014 Date July 18 -19 2014 Venue: Chennai Trade Center, Chennai, India Summary: Indian Drug Manufacturers Association (IDMATNPSB) and Orbit Exhibitions organising Pharmac South 2014 on July 18 -19 2014 at Chennai Trade Center, Chennai, India. The event

will provide new opportunities for contract manufacturers of allopathy, ayurvedic, siddha, unani, nutraceutical and dietary supplements, outsourcing and export managers, brand managers along with with sections of the pharma industry. With a special emphasis on contract manufacturing the event is poised to attract pharmaceuticals, nutraceuticals, herbal, veterinary formulations and experts from the medical and pharmaceutical sectors.

Contact details Varsha Surve – 09322037955 E-mail: info@pharmacindia.com

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: Amrita Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference which aims to make a ‘industry-scientists-academics’ collaboration to meet the major challenges of drug discovery. The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including nobel laureates/ scientists/ researchers/ students and professionals from academia and industries from all over the country and abroad. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharma-

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EVENT BRIEF

cogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Contact details Dr PK Krishnan Namboori Asso. Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug Discovery- AICADD-2014 Computational Chemistry Group (CCG) Computational Engineering and Networking AMRITA Vishwa VidyapeethamAmrita University Amritanagar, Coimbatore - 641 112 Tel: (0422) 2685000 (Extn: 5592) Email: aicadd_2014@cb.amrita.edu / aicadd2014@gmail.com Website: http://www.amritaccg.inConference URL: http://www.amritaccg.in /aicadd2014

THE INDIAN PHARMACEUTICAL ASSOCIATION CONVENTION – 2014 Date: August 9, 2014 Venue: NIMHANS Convention Centre, Bangalore Summary: The Indian Pharmaceutical Association is celebrating its Platinum Jubliee this year. IPA and IPA-Karnataka State Branch is organising a seminar on 'Excellence in Quality -Applying Learning to Practice'. This seminar is an inauguration of the IPA's Platinum Jubliee . Celebration. The seminar is planned for regulatory

20 EXPRESS PHARMA June 16-30, 2014

and industry professionals, community pharmacists and hospital pharmacists and academic professionals and students.

Contact details www.ipapharma.org

PHARMALYTICA 2014 Date: September 25-27, 2014 Venue: BIEC, Bangalore Summary: UBM India will host PharmaLytica 2014 in Bangalore from September 25-27, 2014.

PharmaLytica 2014 will be a combination of a trade fair and conference where participants can pick up on the latest industry trends, techniques and methods.

It is a platform connecting the pharmaceutical community with outsourcing solution providers, including clinical trials, contract research, custom manufacturing, biotech, IT and analytical services. PharmaLytica 2014 will spread over 2,000 sq mt featuring over 100 plus exhibitors. The event will be supported by Karnataka Drugs and Pharmaceuticals Manufacturers' Association (KDPMA). Also, India Pharmaceutical Association (IPA), Confederation of Indian Pharmaceutical Industry (CiPi) and Association of Contract Research Organisation (ACRO) will support the event.

Contact details Rahul Deshpande Sr Manager - Projects Email: rahul.deshpande@ubm.com Tel: +91 22 61727165 | Mobile: +91 98209 02476

MARKET POST EVENT

LSWconcludes clinical research conference in Mumbai Provides platform to various industry stakeholders to discuss challenges associated with clinical research Usha Sharma Mumbai THE CLINICAL research industry in India is in the doldrums and both the government as well as industry are trying their best to find common ground early as possible. With an aim to foster better understanding of the issues at stake, LifeScience World (LSW) in as-

sociation with Association of Clinical Research Organisations (ACRO) and Indian Pharmaceutical Association (IPA) recently organised a one day conference on 'Clinical research - regulatory norms -current challenges and the future of pharma industry in India'. in Mumbai.

The conference witnessed participants from varied disciplines: pharma, law, CROs,

MARKET insurance and enabled a platform to discuss various issues associated with the industry.

The conference registered active participation between the speakers and delegates.

The organisers of the conference invited speakers and panelist to discuss issues and share their knowledge with participants. Dr Surinder Kher, Chief Executive Officer, Ecron Acunova; Dr K Bangarurajan, Deputy Drugs Controller (India), Dr Rao Vadlamudi, President, IPA, Jeroze J Dalal, General Manager, Clinical Research, GlaxoSmithKline; Apurva Shah, Managing Director, Veeda Clinical Research; Dr Kumar Prabhash, Tata Memorial Hospital; Dr Gururaj Rao, Managing Director, International Stem Cell Services;Viveka Roychowdhury, Editor, Express Pharma; Dr YK Gupta, Head, Department of Pharmacology, AIIMS; Dr AK Agarwal, Chairman, Compensation Committee, Government of

22 EXPRESS PHARMA June 16-30, 2014

India; Dr Suganthi Iyer, Assistant Director- Legal and Medical, Hinduja Hospital; Dr Viraj Suvarna, Medical Director, Boehringer Ingelheim India; Dr Milind Antani, Nishith Desai Associates, Legal & Tax Counseling Worldwide and Dr Venu Madhav, COO, Veeda Clinical Research were the speakers of the conference.

The programme began with Dr B M Gandhi, Former Advisor, DBT, Government of India, and currently, CEO, Neo Biomed services sharing an overview of the conference agenda. The day's proceedings were anchored by Dr Surinder Kher, Chief Executive Officer, Ecron Acunova who ably steered each panel discussion as well as summarised the speakers' comments. Dr Rao Vadlamudi, President, IPA delivered the keynote address of the event, who opined that India-specific requirements needed to be kept in kind while creating an ecosystem for clini-

AK Agarwal, Chairman, Compensation Committee, Government of India revealed the efforts which his committee has taken before presenting the compensation formula to the industry cal research in the country.

The first session of the day featured viewpoints from each stakeholder. While Dr Kumar Prabhash, associate professor and medical oncologist, Tata Memorial Hospital spoke about the his experiences as a principal investigator, Jeroze J Dalal, General Manager, Clinical Research, GlaxoSmithKline gave the sponsor's perspective on the stringent regulations and uncertainty regarding timelines.

Apurva Shah, Managing Director, Veeda Clinical Research gave the CRO perspective while Dr SGA Rao, former senior scientist, Cancer Research Institute, Tata Memorial, and managing trustee, Stem Foundation spoke on stem cell trials.

Viveka Roychowdhury, Editor, Express Pharma represented the media while Shraddha Tawade, General Manager – Quality and Training Global Clinical Research, Wockhardt

provided the perspective of patients as well as their relatives who wished to join clinical trials.

She stressed that it is the patient who needs to really analyse the possible benefits with risks associated with the clinical trial before taking a decision. She also cited several research papers analysing the mindset of clinical trial participants in an effort to gauge why they took part in a trial or not. While summing up her presentation, Tawade emphasised, “The Government can play an vital role in propagating information about clinical trials.

I feel they (Government) can put detailed information on their website, and informing people in the society about the importance of the clinical trial in today's world and assuring patients about the safety features.”

It seemed that she has high hopes from the new government particularly for the clinical trial sector, as she repeated the now famous election campaign

MARKET slogan of the BJP: 'Aache Din Aane Wale Hain'!

In the second session dealing with compensation and related issues, Dr YK Gupta, Head, Department of Pharmacology, AIIMS explained details of the compensation formula. He stressed that the regulator was open to consider modifications in the existing formula and is currently evaluating and reviewing issues related to 'failure of investigation product', 'use of placebo' and 'as long as required'. He asked industry representatives to share their inputs on same, ending his speech with the message: “Clarity evolves as we go along.”

Another speaker from the same session, Yasmin Shenoy,

There are avenues open for the modification / changes as the Health Ministry is ready for the amendments in the compensatio n formula Senior Director- Regulatory Affairs mentioned that today compensation is a delicate issue in the industry. “There will be lot of changes in reporting process and time-line required once the current (24 April 2014 draft guideline) becomes a final rule.

We have to follow the new formula of reporting process in the clinical trial,” mentioned Shenoy.

She further added, “Clinical research is a system for the advancement of science and benefits of mankind. And it must be supported with appropriate regulations and needs to assure that the right checks and balance are in place. We have to start the approval process very fast as we have already missed the bus and need to speed up and bring the drugs to markets which are currently in various stages of the

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trial process globally.”

It is always better to have regulatory personnel so that the industry understands the if's and but's of a new rule or act. Dr AK Agarwal, Chairman, Compensation Committee, Government of India revealed the pain and efforts which his committee has taken before presenting the compensation formula to the industry. He shared, “Framing a formula for compensation was a

big challenge for us as there is no formula available today globally.

We had started working on this formula in March 2013 and delivered it in September. It took us long time, because we tried to analyse all possibilities before presenting it. And there are still avenues open for modifications/ changes as the Health Ministry is ready for amendments in the compensation formula.” Agarwal also revealed, “The commit-

tee receives nearly 50-60 causality assessment related to deaths cases and each of these are debated internally after a lot of homework. The final outcome is always a combination of clinical sense and pharmacovigilance.”

Agarwal handed over the session to Gupta and the discussion went on to become more interactive as participants, both on and off stage, sought to discuss many ambiguities in the current

compensation guidelines.

For instance, Dr Suganthi Iyer, Assistant Director- Legal and Medical, Hinduja Hospital raised many questions on the legalities. What were the consequences if a patient suffers permanent damage during the clinical trial? Is he eligible for compensation and how much?

Who should be made a nominee?

Continued on Page 25

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MARKET

DISSO ASIA2014 held in Mumbai Organised by Society for Pharmaceutical Dissolution Science (SPDS), the event was attended by eminent professionals from the pharma industry SOCIETY FOR Pharmaceutical Dissolution Science (SPDS) conducted its 2nd Annual International Convention DISSO ASIA 2014 on May 5-6, 2014 in Mumbai. The event promoted introduction of new technology and innovation apart from deliberating on various issues related to dissolution. DISSO ASIA 2014 was attended by eminent professionals from the pharma industry.

This event was organised under the Chairmanship of Dr Nandakumar Chodankar, CEO & Promoter (Director on Board), ASolution Pharmaceuticals and the Organising Secretary, Dr L Ramaswamy, Managing Director, Sotax India. The scientific sessions were programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD and Professor of Pharmaceutics, Bombay College of Pharmacy, Mumbai.

The International Symposium was inaugurated by Dr GD Yadav, Vice Chancellor, Institute of Chemical Technology ( ICT ), Mumbai.

Dr Vatlamudi Rao, current President of Indian Pharmaceutical Association (IPA) was the Guest of Honour. In his address he expressed that IPA shall support SPDS and may organise collaborative programmes across the country.

At this occasion, SPDS published a Desk Book of Pharmaceutical Dissolution Science reportedly written by more than 10 eminent authors and edited by Dr Sandeep Tiwari, Dr Umesh Banakar, and Dr Vinod Shah.

Around 150 delegates from industry and academia attended the event. Sotax India was the platinum partner of the event.

Shah and Banakar were awarded with the SPDS excellence award for contribution

24 EXPRESS PHARMA June 16-30, 2014

Inauguration - Disso Asia 2014

to the field of Dissolution Science

The event comprised: ❖ Plenary lecture ❖ Poster exhibits ❖ Panel discussion ❖ Exhibits The event had global speakers who spoke on a variety of topics: Vijay Kshirsagar, Director and CEO, TRAC Consulting, Mumbai spoke on 'Relevance of Current Batch Centric BE Studies' Vinod Shah, Ex US FDA, Pharmaceutical Consultant, US enlightened on 'FDA/USP Perspectives on Dissolution Testing from Regulatory Filing Point of View' Prof Dr Jean Michel Cardot, Professor, Department of Biopharmaceutics, and Pharmaceutical Technology, Auvergne University, France elaborated on 'In-Vitro Dissolution as In-Vivo Surrogate' Samir Haddouchi,

Dr Vatlamudi Rao, current President of IPA was the Guest of Honour. In his address he expressed that IPA shall support SPDS and may organise collaborative programmes across the country

Managing Director, SPS Pharma Services, Clermont Ferrand – France gave an 'Overview of Challenges and Solutions to Dissolution Testing of Non-Oral Formulations' Umesh Banakar, Professor and President, Banakar Consultancy Services, US spoke on the topic, 'Biosimilars - The Emerging Frontier for Generics: Role of Dissolution Testing' Michel Magnier, Product Manager/Application Specialist, SOTAX AG explained about 'Automation for Dissolution Testing' Bryan Crist, Manager, Scientific Affairs, Agilent technologies, US spoke about 'Validation of Components and data of Automated Dissolution Methods' Prof Dr Sompol Prakongpan, Professor of Pharmacy, Burapha University, Thailand expounded on 'Biowaiver of Biopharmaceutics Classification System Class III

Drug Products' Dr Sid Bhoopathy, Chief Operating Officer, Absorption Systems, US gave an insight on 'Strategies for Establishing Equivalence of Complex Drug Products' Dr Flavian Stefan Radulescu, University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania elaborated on the 'Correlation between rheology, in-vitro release and in- vivo performance of topical dosage forms' A panel discussion on 'Handling Dissolution Challenges' was also held and eminent professionals from the pharma industry participated in it.

DISSO ASIA 2014 was specifically designed for all the professionals from R&D, QA and QC as well as the academia. Next year SPDS is planning to organise DISSO America in US. EP News Bureau-Mumbai

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LSWconcludes clinical research conference in Mumbai Can it be anybody or will it be have to be the immediate dependent from the family or someone outside the family like friends? In reply, Gupta reasoned that this was the decision of the trial participant/patient.

Similarly, regarding permanent damage, Gupta revealed that a lot of work is currently underway to finalise on this issue and he invited her to share her inputs on the April 23 2014 draft as well.

Expressing her views, in her individual capacity Dr Rashmi Hegde, Director-Medical & Regulatory Affairs, Abbott pointed out that the current approval process is delaying the entire process and she opined that the CDSCO office needed to increase manpower strength and invest in upgrading the current infrastructure.

“The approval timeline for new products / clinical trials

by DCGI needs to be defined and shortened. I feel there is an urgent need of transparency in the process of entire clinical trial system,” she said, Insurance providers also play an key role in providing trial insurance and Deepak Gupta, Assistant Vice President – Underwriting, HDFC ERGO General Insurance highlighted the services provided by his company to the clinical trial industry.

Speaking from the legal perspective, Dr Milind Antani, Nishith Desai Associates, Legal & Tax Counseling Worldwide highlighted the importance of appropriate contracts. As an example, he requested all principal investigators to verify their employment contracts to check their liability when it comes to both clinical practice as well as clinical research and trials.

Dr Viraj Suvarna, Medical Director, Boehringer Ingelheim, requested CDSCO for a responsible approach and opines that the recommendations of the Ranjit Roy Chaudhury committee

should be acceptable as early as possible.

Throughout the day's programme, Dr K Bangarurajan, Deputy Drugs Controller (India) answered queries and clarified points while updating

the industry about ongoing discussions at the central level. He invited industry representatives to share their concerns so that drug controller officers can make joint representations to the Health Ministry. As the new

government is now in place, there are long list of the expectations from industry.

Concluding the event, Kher revealed, “We have already proposed a '100 days agenda' with the help of various industry as-

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sociations. The discussions at this event will be compiled into a report for the government in the hopes that it will help create facilitative rather than regressive regulations. ” u.sharma@expressindia.com

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cover ) Industryneeds more a predictable IPenvironment

I RANJIT SHAHANI Vice Chairman and Managing Director, Novartis India

t is after a long hiatus that India has got a government at the centre with a clear majority. This is an opportunity that Prime Minister Modi must leverage to the maximum. We, as an industry, are hopeful that healthcare, which hasn’t received the kind of attention it should, will now be accorded infrastructure status. This will not only bring increased investments to the sector but also contribute in a significant way to improving access to quality healthcare. India spends hardly 1.2 per cent of its GDP on healthcare which is lower than what countries that are far smaller in terms of economy size do.

Our healthcare spend must be increased to at least three per cent of the GDP to

ensure universal health coverage.

India has a rich pool of highly qualified scientists and we believe that an environment that fosters innovation will result in India being respected as a country that can deliver products innovated here. The right environment will serve to encourage more collaboration between global and local companies. Further, industry needs a more predictable IP environment; one that respects and encourages innovation. The setting up of fast track courts to decide IP cases is the need of the hour.

Clinical trials in India have all but come to a standstill.

Industry is very much in favour of a robust and a transparent process and

Less government and more governance will do the magic

W

e have been fortunate to work closely with Prime Minister Narendra Modi during his tenure as the Chief Minister of Gujarat, especially during ‘Vibrant Gujarat’. It is high time that the government stopped looking at businessmen negatively. The pharma industry has been providing efficacious affordable quality medicines and growing despite dismal government support as well as international pressures. A more industryfriendly approach would en-

28 EXPRESS PHARMA June 16-30, 2014

thuse our pharma industry to provide almost all our people with access to quality affordable medicines at a faster pace. Labour laws also have to be made more realistic.

We, the poople of India, have entrusted the new government with a clear mandate. It is now for the government to reciprocate and create a transparent atmosphere of confidence and trust. We are confident that the principle of 'less government and more governance' will do the magic.

believes that India’s regulatory framework must be in line with global best practices. It is in the Indian patient’s interest to ensure that clinical trials are encouraged with adequate safeguards built into the process at every stage.

With the budget round the corner, we hope that this government will present a budget that is truly visionary.

It will do well to introduce research tax credits which can be used to offset future tax liability similar to what exists in developed economies. This will provide the much required impetus to local companies in their research endeavours. Similarly, benefits should be accorded to companies engaged in R&D and income generated from utilisa-

tion of IP rights should be tax exempt.

All life-saving drugs should be free of import and other duties. This will serve to broaden access to the latest in healthcare. Access and affordability are two sides of the same coin. All stakeholders must come together to work towards delivering quality healthcare.

Government and industry must collaborate to make medicines available to those who are economically weak while allowing market forces to decide prices for the balance.

There is much that can and must be done.

And if it happens, the healthcare landscape in India will forever change for the better.

Pharma manufacturing should be excise free

If the government wants to make healthcare more affordable then all pharma manufacturing should be excise free like the Baddi model. @kiranshaw ·

DAARA B PATEL Secretary-General, IDMA

If the government wants To reduce drug prices, the easiest option is to remove taxes on drugs which will immediately provide 15-25 per cent reduction. @kiranshaw·

KIRAN MAZUMDAR SHAW, Chairman and Managing Director, Biocon

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We need to relookat our IPR laws

T

he Modi Government should focus on three As of healthcare delivery viz. Availability, Affordability and Access. To achieve this, the first priority is to increase our spend on healthcare from current just about one per cent of GDP to at least four per cent. To generate funds and in keeping with Modiji’s mantra of ‘maximum governance and minimum government’ all sick pharma PSUs should be privatised.

Since we are a resource starved country, these funds should be deployed to promote preventive healthcare such as vaccination, immunisation, clean drinking water, sanitation and hygiene, cessation of bad habits like tobacco smoking, pollution control, safe sex

habits such as wearing condoms etc.

Government should also form a task force to study the NHS model of UK, the largest publicly funded healthcare programme in the world.

Also, it is worth studying the Affordable Healthcare Act of US (Obamacare) and learn from its pitfalls. Today, more than 80 per cent of the Indian population pays from its own pocket for healthcare. It is therefore important to expand the scope of health insurance by allowing 49 per cent FDI (or even more) in this sector.

On the regulatory front, CDSCO needs to be restructured . Today , although the Drugs Act is central in nature, the degree of its enforcement varies from state to state giv-

ing rise to issues related to GMP non compliance, counterfeit drugs , irrational FDCs etc . The recommendation made by Dr Mashelkar Committee several years ago and approved by the then cabinet to form Central Drug Authority on the lines of US FDA should be implemented forthwith. CRO sector today is struggling for survival due to ambiguous and impractical guidelines which need to be harmonised with global standards. The Biotechnology Regulatory Bill should be tabled forthwith to spur investment in this emerging sector.

CDSCO should also come out with well defined guidelines for OTC drugs, as ‘Responsible Self Medication’ is

an integral part of modern healthcare system. Many minor ailments like headache, cough and cold, fever, diarrhea, skin infections, body pain etc. can be cured by self medication using OTC drugs.

We also need to relook at our IPR laws to protect the intellectual property of our own scientists and to foster innovation.

And finally, no government has talked so far about population control. With a burgeoning population of 1.25 billion , India' s healthcare indicators will always remain under pressure. Policy makers should come out with innovative methods like tax incentives , social subsidies, free education etc. to check population growth.

DR AJIT DANGI President and CEO, Danssen Consulting

Create an ecosystem that encourages innovative R&D in the pharma space

W RAJESH DESAI Executive Director – Finance, Glenmark Pharma

e believe that a decisive mandate for the Modi Government is definitely a welcome outcome. A decisive mandate will create a favourable environment for speedy resolution of policy bottlenecks and reforms and will contribute in spurring economic growth.

There will be quicker decision making which will be beneficial for the industry and economy at large.

Modi’s mantra for pharma should be: ◆ Increase GDP allocation on healthcare with a more favourable policy environment

◆ Make universal healthcare a priority and create a road map for ensuring quality, affordability and accessibility of medicines and treatment to patients at all times ◆ Create an ecosystem that encourages innovative R&D in the pharma space in the form of tax incentives, regulations and grants for various research projects in the sector. ◆ Address the critical challenge of providing access to high quality medicines and medical treatment to our 1.2 billion plus population ◆ Government should work to make India the hub for discovery research and development, to usher the same

change that software brought to the country in the late 1990s and early 2000 ◆ Strengthen and increase capital outlay for academic institutions engaged in scientific research ◆ Accord ‘National Priority Status’ to healthcare and pharma sectors

government will need to play a key role to drive India’s healthcare ◆ Create an ecosystem that encourages and fosters innovation ◆ Substantially increase government spend on healthcare and reform the public health system

Top five priority areas

Send out right signals to global markets by:

◆ Government should have a clear set of economic policies to kick start a period of higher growth for the economy ◆ Take efforts to create jobs, curb inflation ◆ Healthcare for all is a critical need and the

◆ Providing incentives to boost exports ◆ Focusing on infrastructure development ◆ Ushering in transparency in operations ◆ Lowering corporate taxes, simplify tax laws

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cover ) Government should workas a facilitator and not as a regulator

Bulkdrug industryneeds special financial package

T

ndian bulk drug industry has been losing to Chinese competition and our dependence on Chinese APIs has been increasing. It is time that we encourage the Indian bulk drug industry by removing bottlenecks in environmental clearance, working capital availability and power cost ◆ SMEs are growth engines of any industry. Pharma SMEs in India need a boost by way of plant upgradation and GMP training. If given the right support, they can become excellent exporters and quality contract manufacturers ◆ Prices of medicines in India are amongst the lowest in the world. While there can be further scope for improvement we should not over-stretch it.

Drug prices in India are just stabilising after DPCO 2013.

Further changes in NLEM list can bring instability and affect availability. ◆ FDCs are preferred by the medical profession in India due to their efficacy, convenience and economy. While there may be a few irrational FDCs there are many FDCs that need to be continued for patients' benefits. ◆ NDDS and formulation R&D

he Modi governmen should encourage Indian pharma industry to have the slogan "Discover in India" and not "Made in India " ◆Introduce a tough auditing system as is being done by many regulators in developed countries. ◆Introduce single ministry instead of two ministries ◆Introduction of E-governance in the correct spirit ◆Encourage complimentary medicines like Homeopathy, Unani, Ayurveda, etc. ◆Industry should support the government for segments like HIV/AIDS, TB, malaria, cancer etc. with special rates ◆Stakeholders should be involved in all policy related government committees ◆Prove that the government is working in a really transparent way and adhere to a strict time frame for each clearance. ◆Bring it to the notice of the world that India is the cheapest producer of good quality, efficacious medicines ◆Encourage industry to invest in R&D which should be treated as a part of the CSR obligation.

BR SIKRI, Vice President, BDMA, Vice President, IDMA

◆Put sincere efforts to revive MSME units which were closed down over a period. Out of 10000 manufacturing units in the country, more than 75 per cent are in the MSME segment. ◆Restructure the tax system. Pharma industry faces so many taxes at present and many government department/agencies are controlling it. There should be a single win-

dow system in the real sense. ◆Encourage cluster system and set up mega pharma towns like Vizag and those found in China. ◆Remove disparity in excise of bulk drugs and formulation ◆Instead of price control, government should have a good monitoring system. China has recently withdrawn control on medicines to avoid shortage of life saving drugs ◆Educate the common man that the pharma is not a commodity industry but a lifesaving industry. Cost is secondary and life is primary. ◆Utilise the huge infrastructure of PSU units through the PPP system.' ◆Set up state owned institutes like AIIMS in all states. ◆Government should work as a facilitator and not as a regulator. Make a think tank of industry experts to help the government in improving the volume, exports, and development of new molecules ◆Encourage insurance for the common man so that there is no direct burden on the government for the treatment of patients and to increase budget allocation for health.

I

S V VEERRAMANI President, IDMA

need to be encouraged to bring innovative and patentable dosage forms.

Top priority areas ❐ Increase healthcare spend to atleast four per cent ❐ Step up medical insurance in a big way ❐ Bulk drug industry needs special financial package. ❐ R&D investments need to be subsidised . ❐ Give exports incentives to enhance our global market share of pharma products

Prioritise IPrights,to create a constant cycle of innovation that will help sustain India’s economy

P JOHN J CASTELLANI President and Chief Executive Officer, PhRMA

30 EXPRESS PHARMA June 16-30, 2014

hRMA and its member companies are eager to work with the new government to strengthen the biopharma industry’s relationship with India in order to increase access to medications for Indian citizens.

The Modi Government represents an excellent

opportunity for American industries to strengthen and rekindle their relationships with India. We look forward to collaborating with India on ways to improve our partnerships in one of the world’s most dynamic and fastestgrowing markets.

Modi understands the

crucial role innovation plays in economic development. By prioritising IP rights, a constant cycle of innovation in India could be created that will help sustain India’s economy for years to come.

The Indian people stand to benefit from the new economy envisioned by Modi, as

they will ultimately be the beneficiaries of better access to safe, innovative treatments.

(Excerpts from the blog post : http://www.phrma.org/catalyst/new-primeminister-could-usher-ina-new-era-for-india)

(

THE MAIN FOCUS

Main focus should be on developing a mass-based health insurance system

F

ive years ago, in the same publication, I wrote about what are healthcare matters and what should be the priorities of the then new government. (See link: Mr Prime Minister, healthcare matters! http://pharma.financialexpress.co m/20090731/management02.shtml ) In the last few years, there has been significant improvements in several public health indicators. Life expectancy of Indians has reached nearly 70 years, infant and maternal mortality have decreased though they still continue to be higher than many other countries, polio has been eradicated. Several good public health insurance schemes such as those in Maharashtra have been working quite well with good acceptance and benefits.

Both the urban and rural healthcare missions have shown good success. In spite of this, we are far away from what our ultimate goal should be. Indecision and policy paralysis has plagued the country resulting in inordinate delays in healthcare reforms and affecting several aspects of healthcare. I will essentially focus on four aspects.

Accessibility and affordability: Healthcare is becoming more and more expensive. Many rural Indians still have to rush to urban India for even not so serious communicable and nearly all non-communicable diseases.

Our distribution channels have only been partially successful in delivering medicines to the end user at the ‘point of contact’. On the accessibility front, the government must develop either alternate channels of supply system or remove the clogs in the current one. On the affordability part, it is high time that we start developing a healthcare insurance system for Indians. In addition to the traditional European model of public, governmentfunded health insurance and the American model of private

health insurance, there are several examples such as that in Singapore who has placed health as a responsibility of the individual and the family but has created a system wherein government helps in whatever way it can in the right way and at the right time. This way, people can self finance to a very great extent. It creates more accountability as well as possible better outcomes. We should now be developing a sustained, massbased health insurance system.

In India itself, there are case studies such as those from Narayana Hrudayalaya where this has been developed and implemented successfully. We must now expand this at an allIndia level.

Healthcare delivery: In India, private and public healthcare coexist.

The former is expensive, the latter overcrowded. To keep oneself updated on recent developments in medicine so as to improve quality of delivery and outcomes, healthcare personnel have to find dedicated time. This has to be the next priority. Regular on the job, online or even classroom-based training to all healthcare providers should be made mandatory. The Medical Council in Maharashtra has made this mandatory for all doctors, but this again has to be expanded nationally. Special focus should be made on competency and capability development for physicians, nurses, pharmacists and other allied health professionals. Improving our primary healthcare centres in rural India would incentivise several physicians to visit them on a regular basis and contribute to improvement. Utilising technology to address referral issues would also be a good step.

Research: From being a leader, we have become a laggard in the last few years.

It has become extremely

DR VIRAJ RAJADHYAKSHA Asia Area Medical Affairs Manager AstraZeneca

difficult to do a single clinical trial project though we have had one of the most evolved regulatory guidelines and processes.

Countries like Korea have gone way ahead in terms of number of research projects (including those addressing national needs) with protection to research subjects a top-most priority. There is a need to immediately remove all inefficiencies of the system, delayed approval times and lack of clarity at the highest level. It is necessary to give this a top priority - streamline and speed up all processes, ensure that decision makers are really cognizant of the ground reality and monitor the process by trained and capable personnel.

This would also stimulate researchers to develop capabilities for in-house research on diseases of national importance i.e. malaria, multi-drug resistant TB, dengue etc. Unless some concrete radical steps are initiated immediately, we may reach an irreversible stage in the near future.

Public health: The vast improvements in health occur because of good water supply and adequate sanitation. This

has to be the focus of the new government. In one of the world’s biggest economies, we should not be having any deaths because of lack of these two basic aspects. The government must focus on these in our overcrowded urban infrastructure as well as deep interiors. For non-communicable diseases, it is important that we protect our citizens from diabetes, cardiovascular diseases and cancer. For this, we require primary prevention strategiesavailability of free open spaces, mandatory fortification of foods, availability of free regular check-ups again at ‘point of contact’. It is the government’s role to provide all the required focus on our national health programmes with an objective of removing red tapism and bureaucratic delays.

In short, the main focus should be on developing a mass-based health insurance system, capability development of healthcare delivery personnel and improvements in quality of delivery, prioritising research and stimulating it by removing all inefficiencies and developing an infrastructure to address public health issues.

How do we achieve this?

In a democratic country like India, it is our responsibility to work closely with those in the government to achieve these goals together through measures like: Public private partnerships (PPPs): Experience in operational excellence is a big advantage of the private sector. The government must set in policies and encourage dedicated private partners to operationalise and run the plans. This would reduce the burden on the government so that they focus more on the pressing challenges and issues.

Professional participation: The government must pro-actively take guidance as well as seek active participation of professionals who are ready to work on selected projects or on a regular basis. For this, they must identify those who are closer to the real world, have the dedication and will to look ‘out of the system’. Several professionals in the industry would be more than willing to participate if there is a genuine effort and clarity.

Use of technology: We need to significantly upscale the use of technology in most of our operating areas. This may include capability development, electronisation of medical records, monitoring of public health programmes etc. Using local cooperative networks could be a way of moving ahead.

To summarise, I am aware that the government has a lot on its plate to do and there are several priorities: economy, infrastructure, labour reforms etc. However, healthcare probably affects each of these. This is a unique opportunity for the new government to put in place several structural changes, far reaching programmes which would affect all of us in the midto-long term. For many of these, it requires a strong will and commitment.

The new government appears to have both. As stakeholders in healthcare, we must work together in a co-ordinated manner with measurable and performance driven metrices in place to make a firm mark in India’s healthcare story. The choice is entirely ours.

(The author is a pharmaceutical physician who works as Asia Medical Lead in a MNC pharma organisation.

All views are entirely personal and do not reflect those of the organisation. )

EXPRESS PHARMA

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June 16-30, 2014

cover ) Set up fast trackcourts to address IPR disputes

T RANJANA SMETACEK Director General, OPPI

he Organisation of Pharmaceutical Producers in India (OPPI), much like the rest of industry has high expectations of the new government and we hope that it will usher in a new era of economic growth for India. As the government shapes policies to put India back on the growth track, we look to it to prioritise healthcare and focus on universal health coverage for all Indians.

India needs sound policies that drive collaboration and incentivise the sustained development of modern medicine while addressing the challenges of infrastructure and talent to improve healthcare delivery. Our new government must lead the way, playing a pivotal role to strengthen our healthcare system and make quality healthcare accessible to all.

As an industry, we ask for dialogue between government and all stakeholders.

We will come forward to play our part in finding sustainable solutions that balance the need for innovation with the need for more accessible medicines, within a robustIP environment.

On behalf of the research driven pharma industry, we make the following policy recommendations:

▲ Stronger IP protection Patent protection is necessary for continued investment in innovative life-saving drugs. To meet the challenges of existing and new diseases in India, much research is needed. The high investment required for the development of innovative medicines cannot be justified without policy conditions that protect intellectual property. If countries show scant respect for patent laws, the increasing health needs and expectations of patients in those very countries will not be met. The new

32 EXPRESS PHARMA June 16-30, 2014

Our new government must lead the way, playing a pivotal role to strengthen our healthcare system and make quality healthcare accessible to all.

As an industry, we ask for dialogue between government and all stakeholders government should exercise a careful balance between encouraging pharma innovation and expanding access to the fruits of that innovation for all patients in the country. To truly improve access to medicines in India, we must continue to work together toward policy solutions to address healthcare financing, infrastructure, and human resources challenges, among others.

Judicious use of compulsory licenses Global experience shows that patents for innovative medicines are not a barrier to patient access and compulsory licenses (CLs) are not a solution to healthcare challenges. CLs must remain the exception rather than the rule.

Fast track IP courts to address disputes We welcome the proposal to set up fast track courts as stated in the BJP manifesto, to address intellectual property related disputes in a timebound manner.

Careful consideration of decisions taken under Section 3(d) Incremental innovation can play a fundamental role in improving health outcomes

and delivers real benefits to patients.

Regulatory Data Protection (RDP) Regulatory Data Protection is an integral part of IPR. Lack of RDP provisions will be a disincentive to R&D-based companies and innovators.

▲ Clear and transparent regulatory framework for clinical trials It is in India’s interest to encourage clinical trials, with adequate safeguards. We need policies and regulations that will build confidence among innovators (domestic and foreign) carrying out such research in India.

To this end, it is important that we implement a robust and transparent process for conducting clinical trials in India, and to obtain regulatory approval for new drugs while supporting the government’s effort to create a compensation framework. Global best practices for clinical trials regulation should be adopted in India as well.

▲ Improved access to quality healthcare A study conducted on healthcare access by IMS Institute for Healthcare Informatics states that access to medicine extends beyond the issue of

cost, to the proximity and functionality of the infrastructure that supports that access.

More than affordability, the barrier to access is often the inability to pay outof-pocket and the lack of insurance cover. OPPI looks forward to jointly exploring with the Government of India, ways to play a meaningful role in the nation’s new healthcare system and ensure sustainable access to modern medicine at Indian healthcare centres.

▲ Increase healthcare resource allocation Government should allocate more resources to building healthcare infrastructure in the next five years. It should look at developing simple, workable and well-equipped primary healthcare infrastructure across the country.

▲ Enforcement of a Uniform Code of Pharma Marketing Practices The Uniform Code of Pharmaceutical Marketing Practices (UCPMP) submitted

by OPPI lays down guidelines for ethical behaviour in pharma marketing. The Department of Pharmaceuticals (DoP) took this up in March 2012 as a proposed voluntary code of marketing practices for the Indian pharma industry, with the intent to review it in six months. We would urge the new government to consider making this a statutory code, to inspire confidence among patients and to demonstrate India’s commitment to the highest level of ethics and compliance.

The Organisation of Pharmaceutical Producers of India (OPPI) will continue to support the Indian government’s quest for more accessible and affordable medicines and we welcome a more comprehensive dialogue among all stakeholders.

(

THE MAIN FOCUS

Newgovernment should get its regulatory role restored

O

ver the last three years medical research in India has been brought to standstill.

Clinical trials are essential for affordable and accessible healthcare. In 2013, India approved 80 per cent less clinical trials than in 2010. Major problems to be resolved by the Health Minister and PMO are:

Supreme Court formulating clinical research regulation A PIL in the Supreme Court by an NGO has alleged that patient safety is not adequately protected by DCGI. Ineffective response in the last two years by Ministry of Health (MOH) and its lawyer, led to the Supreme Court losing confidence in DCGI as a regulator. It directed MOH, to modify the regulation to protect the interests of just one stakeholder - the patient, whereas responsible medical research requires several stakeholders’ interest to be balanced.

Not balancing the interests of other stakeholders like medical researchers, pharma companies and the Government (which wants to bring affordable vaccines, medicines to citizens), has made conduct of medical research very onerous, risky, leading to the research grinding to a halt.

SC, having lost confidence in DCGI, suggested that instead of DCGI, Health Secretary (HS) should be personally accountable for research.

To honour SC, the previous government created committees like NDAC, Technical Committee, Apex Committee between DCGI and Health Secretary.

Committees have slowed down scientific/medical decisions in new drug

Ministry of Health has to win back Supreme Court’s lost trust in DCGI and get its regulatory role restored

development, without adding value. This has resulted in very few inordinately delayed decisions, which has further devalued DCGI. The new government should get its regulatory role restored. MoH has to win back SC’s lost trust in DCGI. A competent government lawyer should argue the importance of restoration of the regulatory role to the Government and the necessity of balancing the interest of patients, doctors, government, pharma companies etc while laying down regulations. It can propose to the court that:

Center of Harvard Medical School), MOH (Health Secretary, Dr Desiraju and team), pharma companies and patient advocacy group. Recommendations of this group will be adopted to make the modified regulation take care of multi stakeholders’ interest.

❐ Instead of HS becoming accountable for responsible clinical research, DCGI’s position should be upgraded to the level of HS and DCGI will be made an independent regulator. This has been recommended by the past Parliamentary committees and is the norm in advanced countries.

The approval for clinical trial of new drugs takes six to nine months and approvals go through three committees. The recommendation is to decrease the decision cycle to six months including clearance from all the committees. Once DCGI’s position is elevated to the HS’s level, it will no longer be necessary to pass application through Technical and Apex Committees.

For BA/BE studies this approval process should be decreased from 45 days to 30 days.

At DCGI there should be a one-window consultancy opportunity in line with Scientific Advise in EU and Pre IND meeting with US FDA. Pharma companies and CROs should have an opportunity to discuss the drug de-

❐ One sided regulatory changes implemented in last two years, which has made other stakeholders shy to take up medical research should be modified as per ‘Stakeholder Recommendation Jan 2014’. This involved a two-day review of regulations by stakeholders which included medical researchers (AIIMS), global practitioners (Multi-Regional Clinical Trial

❐ If argued forcefully and if a time-bound implementation of three months is offered, the SC is likely to restore the regulatory role back to MOH.

Approval process and timelines

velopment strategy with competent authorities and make an application addressing the discussion points.

Compensation guidelines For the compensation guidelines related to injuries in case of deaths and serious adverse events, the opinion of all the stakeholders needs to be looked into. A lot of ambiguity in compensation needs to be removed through guidelines based on clear rational thought.

DA PRASANNA, Chairman, ACRO India

Medical management Currently there is lack of clarity on situations where medical management needs to be paid and sponsors are asked to pay for related or non-related serious adverse events. Additionally, too much liability is being put on sponsors. This practice is against the standard practice followed all over the world.

Limit on number of trials per investigator The cap on maximum number of studies that an investigator can do should be removed. As per current regulations the number of trials an investigator can do is three.

This number should be decided by institutional Ethics Committees who are better aware of investigators’ capability, site infrastructure and investigators’ experience to support higher number of trials.

With a result-oriented PM, physician Health Minister and physician Minister of Science, we have confidence that the above changes will be brought about. This will stimulate medical research in the country and bring new drugs to the market faster!

EXPRESS PHARMA

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June 16-30, 2014

MANAGEMENT The pharma industry has a significant need for high-end logistics, given that these products are temperaturesensitive, require specialised handling and bespoke solutions

Currently, in a country like India, most global players are competing with local players for a slice of the local business, barring one or two examples of tie-ups

Samar Nath,

Rahul Agarwal,

Chief Executive Officer, DHL Global Forwarding, India

Director, Bhoruka Logistics

LOGISTICS SPECIAL

UNTANGLING PHARMASUPPLY CHAINS Pharma supply chains in India have a lot of ground to cover before becoming at par with their counterparts in the developed markets

BY SACHIN JAGDALE

34 EXPRESS PHARMA June 16-30, 2014

S

uccess of the pharma industry in emerging or developed markets largely depends on a successful pharma supply chain. According to industry experts, the might of developed markets lies in the fact that they have pharma supply chains that are far superior to their counterparts in the emerging markets.

However, pharma supply chain solution providers in emerging markets like India are working towards

becoming valuable contributors to the growth of pharma sector. But, this is an uphill task which requires meticulous planning and world class logistics infrastructure.

Managing supply chains: A costly affair Keeping drug prices under control is nothing short of a balancing act for the pharma industry. However, the agony is that expensive supply chains have been contributing to drug price escalations.

As a considerable chunk of money goes into managing pharma supply chains the goal of keeping drug prices under control continues to

take a hit.

Samar Nath, Chief Executive Officer, DHL Global Forwarding, India, put forth his views on why supply chains are expensive. He says, “Providing life-saving products is a big responsibility, one with risks that far outweigh those in a typical supply chain environment.

The pharma industry has a significant need for high-end logistics, given that these products are temperaturesensitive, require specialised handling and bespoke solutions. A robust infrastructure is vital to preserve their efficacy and ensure safe delivery without any damage to the products.”

Fluctuating market conditions always find a place in the list of culprits that drive the costs of pharma supply chains. Demand-supply gap greatly influences the final bill in logistics. Rahul Agarwal, Director, Bhoruka Logistics, reveals more, “In an endeavour to reduce transit inventory, clients are using more expensive modes of transportation such as air/express. Additionally, mismatch between production supply and sales demand leads to movement of loads in smaller lots, thereby taking up transportation cost.”

Giving the healthcare perspective, Shailendra Bobhate, Director, Supply Chain

and Operations EPD India, Abbott Healthcare, says, “Rising costs on one hand and price control (NLEM/DPCO 2013) on the other hand are putting a squeeze on margins. Costs such as rent, transport (diesel), labour and power have been continuously rising.”

“It is likely that the globalised nature of the industry will mean that India will need to plug itself into regulatory requirements, including good automated manufacturing practices (GAMP) and good distribution practices (GDP). With the prospect of global requirements being enforced in the Indian pharma industry, it is inevitable that the cost of compliance to global standards could rise,” informs

Nitin Dahad, Marketing, Dyzle.

Measures for cost containment There are ways to contain rising costs in supply chains. Besides good planning of transport, collective approach is the most preferred solution to keep check on additional expenses.

“One way of containing costs is by engaging in a more collaborative approach where pharma companies are willing to work closely and use a common supply chain with integrated players like DHL. We all are well aware of the infrastructure challenges in the country and as such, a collaborative approach could address most of of the concerns, while continuing to adapt to

newer technologies which would further enhance the lifespan of these products,” says Nath.

According to Agarwal, if proper planning is done along with more accurate forecasting, such problems can be better tackled, helping reduce overall cost. Echoing Nath's views, Agarwal says, “The concept of shared services needs to be implemented at major manufacturing locations, wherein pharma companies pool their requirements to LSPs thereby creating a win-win situation for both.”

Though cost is a limiting factor, there are certain expenses that can not be avoided. Fluctuation in fuel prices is a global phe-

nomenon.

Government has to adjust fuel prices depending on the price changes per barrel in the global market. Increased fuel prices make supply chain operators hike charges for their services. However, despite these unfavourable developments, cost can still be managed by implementing some pertinent steps.

“One can be innovative in cost management. Consolidation, leveraging economies of scale, effective use of negotiation and e-sourcing tools are some of

the measures to keep cost under control,” says Bobhate.

Reshma Zaheer, Vice-President, TTL Active feels that a way to keep costs down is to make appropriate investments now in good practices to reduce the risk of non-compliance (and

EXPRESS PHARMA

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June 16-30, 2014

MANAGEMENT

also wastage). Zaheer adds, “Implementation of any new process might add a small operational cost initially, but then once the process is bedded down and starts generating more business, the incremental cost is more than recovered.”

Rising costs on one hand and price control (NLEM/DPCO 2013) on the other hand are putting a squeeze on margins.

Costs such as rent, transport (diesel), labour and power have been continuously rising Shailendra Bobhate Director, Supply Chain and Operations EPD India, Abbott Healthcare

It is likely that the globalised nature of the industry will mean that India will need to plug itself into regulatory requirements, including good automated manufacturing practices (GAMP) and good distribution practices (GDP) Nitin Dahad Marketing, Dyzle

36 EXPRESS PHARMA June 16-30, 2014

Challenges in globalising supply chains Indian pharma supply chain operators have global ambitions but conditions in the international arena are often hostile. Regulatory requirements has been a big hurdle in globalising pharma supply chains, however, lack of interaction with global supply chain players is also a factor that decides the success of domestic pharma supply chain solution providers in the global market.

Bobhate says, “Frequent changes in regulations, erratic fluctuations in demand, uncertainties in supply, inefficient transport network and pending tax reforms are some of the challenges.”

“In a global market, an efficient supply chain can be achieved by tie-ups between global LSP’s and local players having strength in their respective markets,” states Agarwal. He points out, “Currently, in a country like India, most global players are competing with local players for a slice of the local business, barring one or two examples of tie-ups.

Hence the main challenge is the synergy of thoughts between the two sides, which will lead to a more efficient and effective global supply chain.”

Global and domestic supply chains: How do they differ?

The size of pharma supply chains in developed markets is huge. Their economic strength allows them to build top class supply chain infrastructure.

Economic power also allows pharma supply chain operators to withstand market fluctuations. However, as far as emerging markets like India are concerned, domestic supply chain operators are struggling to tackle things on all

Implementation of any new process might add a small operational cost initially, but then once the process is bedded down and starts generating more business, the incremental cost is more than recovered Reshma Zaheer Vice-President, TTL Active

these accounts. Though a force to reckon with in generics market, pharma supply chain infrastructure in India is always taken to task by concerned authorities.

Agarwal says, “In developed markets, LSPs have huge economies of scale thereby enabling services up to the last mile without any bottlenecks.

Infrastructure available in such markets also augment such services. Customers have a range of services and multiple options. Most LSPs in organised markets have huge infrastructure of their own. In emerging markets, infrastructure is a major bottleneck.”

While explaining the situation in India, Agarwal adds, “In India, major bottlenecks are poor infrastructure, very high taxation, infrastructure boundaries (sales tax check posts), poor driver training facilities, no clear legislation for the road transport industry, very heavy corruption at state boundaries, lack of wayside amenities, highly fragmented supplier base leading to rise of intermediaries and very low accountability by small suppliers in terms of service levels leading to high level of unreliability.”

According to Bobhate, supply chains in emerging and developed markets are different in several aspects. He explains, “Developed markets are matured with very low growth and steady demand pattern, excellent infrastructure, high level of predictability and streamlined operations whereas, emerging markets are characterised by volatile demand, evolving regulations, poor infrastructure and high level of uncertainties in supply.”

Cold shoulder to cold chain?

With a spur in global R&D activities many temperaturesensitive pharma products are being introduced into the market. Their transport requires special cold chain infrastructure. Though developed markets, which are considered leading producers of cold chain products, have successfully set up pharma cold chain infrastructure, generics-focussed markets like India are still perhaps not interested in repeating what its overseas counterparts are doing.

The cold chain scenario in India is in a bad shape. Bobhate describes it as ‘very poor and far from satisfactory.’ He says, “Ensuring integrity of cold chain through the entire value chain is the biggest challenge. Poor transport infrastructure, poor connectivity, lack of electricity etc. are some of the challenges in this arena.”

According to Nath, in the past few years, there has been a growing awareness on the importance of the cold or cool supply chain for temperature sensitive products in India. In the recent past, Nath’s company had organised several programmes within the life sciences industry to share best practices with important stakeholders. In conjunction with the Organisation of Pharmaceutical Producers of India (OPPI), a study called ‘Transforming Life Sciences Logistics in India’ was also conducted.

Agarwal also joins the bandwagon of experts who feel that pharma cold chain scenario in India needs an immediate facelift. He informs,

“There is no proper system for storage of goods. Private cold storages store pharma and non-pharma goods in the same space which is not accepted by FDA standards. Insulation standards are very bad. Moreover, very less use of technology and no real time information are also drawbacks. In addition to this, wide use of passive cold chain technology is also an issue as it is expensive and unreliable.”

Way forward Supply chain operators and Indian pharma have to come out of their comfort zones. Indian pharma industry’s strength is low-cost generic medicines which mostly do not require high end logistics. Hence supply chain operators in India have limited themselves to certain levels of logistics solutions. On the other hand, developed markets tend to depend more on innovative products requiring high end logistics which has led to the establishment of sophisticated supply chains.

Besides these market dynamics, as pointed out by logistics experts, India lacks the infrastructure in terms of electricity, roads, etc. Variable taxes across states is also a key obstacle which the Government in India should look into. If the pharma manufacturers and supply chain operators change their attitude and government changes its approach towards this highly sensitive industry, pharma supply chains in emerging markets like India will surely get global acceptance. sachin.jagdale@expressindia.com

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MANAGEMENT

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LOGISTICS SPECIAL

GREEN LIGHTFOR GST In India, pharma logistics is riddled with several speed breakers: poor infrastructure, multiplicity of state and central taxes, varying climatic zones and untrained manpower, to name just a few. Uniformity of tax structures across states would be a big step in the right direction and for this reason, the pharma industry anxiously awaits the new government's final verdict on the Goods and Sales Tax (GST) issue

BY USHA SHARMA

38 EXPRESS PHARMA June 16-30, 2014

MANAGEMENT

ket poses several challenges coupled with various taxation and road permit regulations.

Very few regional or pan-India players are currently in existence. Large multi-user facilities can provide the leverage to use economies of scale as a competitive advantage in transport too.”

T

he pharmaceutical sector in India is one of the most developed and highly regulated industries, with consistent growth and performance. Today, the Indian pharma industry has the capability to produce an entire range of pharma finished formulations for mild to chronic disease. It takes years of R&D efforts before a molecule is certified as safe and efficacious for patients, but all these exacting efforts could be jeopardised on the product's final journey to the patient. This is because each medicine pack is potentially subject to varying climatic zones and infrastructure before it reaches the chemist's shelf and then the patient. Logistics therefore plays an important role in maintaining the efficacy of the drug during the entire transit process.

Underlining the importance of logistics in the pharma supply chain Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting informs, “With more and more biologics being manufactured locally as well as those imported on the increase, cold chain logistics have gained importance. It is estimated by the World Health Organisation (WHO) that about 15 per cent of vaccines

lose their potency due to a break in the cold chain in developing and in less developed countries. It is not uncommon to see a consignment of biologics arriving by air from Europe lying in the hot Indian sun for hours on the tarmac before being shifted to a cold warehouse. Fortunately, due to efforts made by some associations like Organisation of Pharmaceutical Producers of India (OPPI), there is significant improvement in the storage conditions at some Indian airports.”

Challenges en route The Indian pharma industry has a large supply chain of over 60,000 stockists and about 6.5 lakh retail outlets spread across the country.

Dangi stresses, “The problem is compounded in a large country like India with poor infrastructure, multiplicity of state and central taxes, varying climatic zones and untrained manpower. If you add cost of recalls, rejections, wrong / late deliveries and loss of company reputation due to harm it may pose to consumer health due to poor storage of the product, the total cost

could be significant.”

Each problem has a solution, and pharma companies too have worked on finding a solution to this hitch. Fortunately the situation is beginning to improve albeit slowly.

Dangi explains, “The Central Drugs Standard Control Organization (CDSCO) after long deliberations has now issued guidelines for Good Distribution Practices (GDPs) including those for biologicals. As more and more biologicals enter the pharma pipeline, their storage and distribution throughout the journey from manufacturing to the patient is also becoming a challenge.”

Citing an example, he says that in August 2012, a massive blackout occurred in the country for two days due to failure of the electrical grid. Major parts of the country do not have 24X7 electricity and without a robust back up, cold chain integrity can be compromised.

Logistics players too face hurdles while striving to meet industry needs. As Vikas Anand, Managing Director, DHL Supply Chain India explains, “The highly fragmented Indian transport mar-

Identifying the speed breakers The distribution costs of a typical pharma company is often less than two per cent of sales resulting in most senior managements paying less attention to this critical function.

Recommending a systematic approach, Dangi says, “The criticality of supply chain function should become an important agenda for the senior management with GDPs becoming an integral part of the company’s logistics and supply chain policy. All deviations, recalls, destruction of damaged and returned goods etc. should be properly documented and authorised. Continuous training of the employees including those in the field should become part of the guidelines. Management also needs to give attention to high inventories to stockists which often range between 20 -30 days. Most companies have skewed delivery schedules with a sudden spurt in the last week of the month due to poor planning and lack of field force discipline. Companies often go on adding new stock keeping units (SKUs) every year and periodic rationalisation of SKUs should be an

The problem is compounded in a large country like India with poor infrastructure, multiplicity of state and central taxes, varying climatic zones and untrained manpower Dr Ajit Dangi President and Chief Executive Officer, Danssen Consulting

The tearing agenda of the new Government is to put the economy back on track without wasting much time. GST is one agenda where all political parties, corporate, and Governments have supported ideologically as an effective tool to enhance the flow of movement of Goods and Services Anil Arora Managing Director, MJ Logistic Services

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MANAGEMENT ongoing exercise.”

Dr Reddy's Laboratories (DRL) has spent considerable time and effort to streamline it's supply chain. For instance, the company switched from the forecast-based supply chain model to the replenishmentbased system even though the latter might have been seen as an unconventional choice for a supply chain system for the pharma business in India. As a company spokesperson explains, there are substantial number of success stories around the world, which gave replenishment systems enough credibility to be considered for implementation at DRL. Comparing the two systems, the spokesperson points out that forecast based systems can deliver very good performance on performance metrics, only if the accuracy of the forecast is good.

For products and business segments which are relatively stable and predictable, replenishment based systems are very effective in ensuring high OnTime In-Full (OTIF) and tight control on inventory. But due to frequent replenishments of small lots, transaction costs need to be managed. In cases of products which are in early or later stages of product life cycle, where demand variability is very high, replenishment based systems need to be tailored accordingly.

DRL seems to have reaped the benefits of the time and efforts spent on this exercise. According to the spokesperson, “Incorporating the throughput logic into planning and decision making has ensured that the organisation is able to incorporate the financial cost-benefits into supply chain planning. This ensures that products and markets having high impact, based on business objectives, are given due priority. This has contributed significantly to the growth which DRL has had till date.“ Nor does the company seem content with past success. The spokesperson informs that DRL is now embarking on an intelligent Integration approach, where the organisation is working towards end to end integrated planning across its global network where planning logic is

40 EXPRESS PHARMA June 16-30, 2014

Anand explains the need for GST in India and its benefits to corporates saying, “A single unified tax on both 'goods' and 'services' with the objective of eliminating tax cascades will bring about a transition from the existing origin-based to a destination-based taxation regime.

Hence, under the proposed GST scenario, by using network strategy, every distribution-intensive company has an opportunity to re-look at their supply chain structure and gear up for the proposed tax reforms, to align their supply chain distribution network to customer markets moving away from tax issues.”

Benefits galore

The Indian pharma industry has a large supply chain of over 60,000 stockists and about 6.5 lakh retail outlets spread across the country. The distribution costs of a typical pharma company is often less than two per cent of sales resulting in most senior managements paying less attention to this critical function being modelled to address the differential needs of various market segments, by using both forecast based and replenishment based models as needed in its planning systems.

Apart from this, business intelligence and analytics are being leveraged to get key insights into business trends and performance metrics on real-time basis, so DRL is geared towards addressing the real issues and root causes on a proactive basis.

This will ensure that the company will continue to be a flexible and fast paced organisation, even as it grows in scale and size.

The case for GST In spite of the fact that logistics and supply chain is a very critical function to ensure product integrity in the pharma value chain, it has received little attention from the Government as well as managements of pharma companies. With a huge man-

date, Prime Minister Narendra Modi's Government is expected to be more stable. Corporates seem to be more optimistic and are expecting an industryfriendly approach. Sectors like pharma and automobiles have already started anticipating a push to long-awaited policy reforms like Goods and Services Tax (GST) from the new government. GST was first proposed in the 2006-07 budget speech, was to be implemented in April 2010 but implementation was postponed each year.

So will the new government put GST back on the front burner? Anil Arora, Managing Director, MJ Logistic Services says, “The tearing agenda of the new Government is to put the economy back on track without wasting much time. GST is one agenda which all political parties, corporates, and governments have supported ideologically as an effective tool to

enhance the flow of movement of goods and services as it prima facie removes the barriers of multiple taxation, repetitive documentation and state wise red tape.”

Anand too is positive on this front rationalising, “There is renewed optimism in the air and the expectations of a young aspirational India are high from the new Government. Several urgent issues need to be addressed quickly; among them are tax reforms. Clearly on the agenda will be simplification of the tax structure with a quick move towards implementing the GST. This could see some progress, provided it receives support from the states.”

It is equally important to know why the industry is talking about GST. Current supply chain structures in India are engineered to harness fiscal benefits arising from difference in tax structures across regions.

Arora tries to explain the reasons for the delay of rolling out GST saying, “The current avatar of the legislation was formulated by finance minister of a state ruled by current Government; the pitfalls of 2010-2013 were created by change of direction in the finance ministry due to frequent changes of the portfolio between various ministers of the previous Government. The previous Government did not have the majority and the political will to roll over minor bumps in the road-map created by states with vested interests. Having a clear majority, it will be easier for the current Government to clear those without much internal and external resistance.”

Implementation of GST will bring better transparency and efficiency to the system, because as Anand explains, “Simplifying the distribution network and merging smaller warehouses to regional centres will result in economies of scale being generated where the location will no longer need to be fixed depending upon Central Sales Tax (CST) constraints but can be decided based on demand and supply patterns, centre of gravity, long-term logistical and real estate considerations. I.e. cost to serve basis.”

Arora points out that since the cycle of implementation to actual increase Government’s revenue and other benefits will take two-three years to reap, it is also in the current Government’s interest to target implementation at the earliest so that they can reap full benefits before it

MANAGEMENT tent advantage of the implementation of GST will be that in the following years it will lead to enhancement of revenue by not only enhancing the flow of goods and services, it will also disenfranchise the parallel economy and bring the entire trade rev-

enues into the mainstream. It, however, needs to be simplified to the maximum and implemented to perfection as post-independence this is the biggest change in the way our economy works. With automation and eimplementation in most of the

state departments being complete, I don’t think it will be a big challenge.”

If the right decision is taken at the right time, then the final outcome will be beneficial in the long run. Considering the future growth potential of the pharma

industry in India, GST is sure to help the industry grow. Thus all eyes are on the Modi Government in the hopes that the long awaited GST regime will finally see the light of day. u.sharma@expressindia.com

Vikas Anand Managing Director, DHL Supply Chain India

hits the elections again in 2019.

Moving into the fast lane In today's technology age, several IT-enabled companies have systems like track and trace technologies, etc. to monitor supply chain integrity and such tools should be actively employed. Similarly, bar coding, radio-frequency identification (RFID), anti-counterfeiting devices, temperature indicators and new packaging materials are also now available.

“While these may appear little expensive initially, ROI from the point of view of product quality and integrity makes its consideration worthwhile. Stockists and C&F agents should also be encouraged to invest in IT systems to increase supply chain efficiency. This will also improve the number of days of inventory holding and also loss of sales due to stock outs,” suggests Dangi.

Commenting on the implementation of GST and its positive impact on the pharma industry, Anand notes, “Large scale shared facilities with multiple users will set the platform for consolidation in the post GST scenario. GST will make large regional warehouses economically viable as opposed to the multiple small ones set up to deal with the current tax structure.”

Arora anticipates, “The la-

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MANAGEMENT LOGISTICS SPECIAL

Falling in Line It has been a year since the new EU GDP guidelines came into force. As the industry moves towards an increased focus on quality, much is needed to ensure proper compliance

BY SHALINI GUPTA

42 EXPRESS PHARMA June 16-30, 2014

MANAGEMENT

O

n March 7, 2013, the revised “Guidelines on Good Distribution Practice for Medicinal Products for Human Use” were published by the European Union (EU) authorities. These guidelines describe the requirements for procuring, holding, supplying and exporting prescription-based and prescription-free medicinal products. They apply the known principles of Good Manufacturing Practices (GMPs) from pharmaceutical manufacturing to the transport of medication to a greater degree.

It has been universally recognised by the pharma industry that these are much needed to ensure transport quality. While globally the standardisation of temperature-controlled transportation of pharma products is developing, the knowledge of smaller non-specialist forwarders, in particular, could still be improved. Pharma manufacturers themselves are getting more proactive about improving their logistics processes. Global MNCs have in-house guidelines to ensure stringent implementation of the worldwide GDP requirements such as the WHO and the EU GDP along with regular audits of the quality management system and the process documentation of their logistics contractors.

Ensuring compliance It is an undeniable fact that globalisation has had a significant impact on the supply chains of medicinal products.

Not only are they getting longer, but are more susceptible to seasonal variations during the storage, transport and distribution of goods. The availability of expertise, infrastructure and equipment for temperature-controlled storage, transport and distribution can differ significantly between countries and continents. These new variables

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increase quality and safety risks for medicinal products in the supply chain. This is where the guidelines come in as they help prevent adulterations, mix-ups and temperature deviations of products, even reducing theft and falsified medicines entering the supply chain.

Taking about the regulations a spokesperson from Marken, a global clinical supply chain provider, explains that the new guidelines place more emphasis on risk assessment, the role of the named or responsible person, and the heightened scrutiny on transportation requirements. The

temperature controlled portion is directly linked to cool chain and even temperatures outside the typical cool chain environment (+15°C to +25°C) are included in the guidelines.

In view of these, becoming and remaining compliant is, of course, a big challenge and undertaking. Not only do all

steps, components and actions need be in compliance with the outlined procedures, but it all needs to be verifiable, with documents and proof of shipments and procedures performed. This becomes imperative since GDP inspectors are now carrying out, or are about to carry out,

MANAGEMENT inspections according to the new GDP guidelines. It is critical that the processes are already in place, he adds.

Companies are now reviewing their existing supply chain processes and contractual agreements to ensure compliance and have also updated their SOPs that detail transport conditions depending on product, supplier and season. Based on a transportation and storage validation performed by their quality teams, it ensures that products are transported and handled according to GDP requirements, chips in a spokesperson from Dr Reddy's Laboratories (DRL).

Each organisation thus needs to embark on a riskbased approach. This involves answering questions such as: What are the various points in their logistics and transportation processes where they need to evaluate the storage, temperature ranges, documentation, validation of processes? How is the stability of the product evaluated and checked at various points to ensure there have been no temperature excursions along the way? Outside temperatures, political changes in the country affecting infrastructures such as roads, blockages, delays, etc all need discussion and back up plans put into place. This is where providers like Marken come in with their IT systems for managing inventory, tracking, and temperature control management as well as proven models to ensure adherence .

KEY POINTS OF EU GDP GUIDELINES ◗ Introduction of a quality management system for wholesalers including brokers (which includes management reviews, change controls, CAPA and quality risk management) ◗ Full time availability of a responsible person ◗ Temperature mapping of storage areas and transport vehicles ◗ Equipment calibrations and computerised system qualifications ◗ Qualification of suppliers and customers ◗ Use of First Expired First Out (FEFO) instead of FIFO (First-In-First-Out) ◗ Complaints / recall handling ◗ Transportation and training of drivers ◗ Storage controls at hubs prior to changeover

Ironing out the roadblocks Management of subcontractors transporting temperature controlled shipment and required packaging is one of the challenges including making sure that the entire supply chain is covered as per GDP requirements, says the DRL spokesperson. The reality however also is that even though companies might be willing to comply with the international guidelines, many are already managing a range of logistics services and providers who may or may not be in compliance themselves.

44 EXPRESS PHARMA June 16-30, 2014

This means that every pharma company needs to strive for operational efficiency to be able to supply patients with products on time.

According to Luc Huybreghts, Senior Quality Assurance Consultant Pharma Services at Pauwels Consulting, companies need to address this by visualising different parts of the transport

process - various modes of transport, storage, and transport handover points. For each part of the transport process, the variables that affect the transport must be described and a risk assessment must be carried out. These include product-related variables (type of product and its stability) on one hand and the process-related factors (out-

side temperatures in different parts of the supply chain) on another.

Taking into account all the variables that could influence the probability of a risk such as stability data, weather conditions, transport mode and protective packaging while not limiting its severity to patient risk; regulatory risk and business continuity, cannot be

missed out. By multiplying the probability scores with the severity scores, a risk score for a certain product or product group for a specific transport route can be obtained.

Risk scores could then influence the transport strategy of a company as well as define the selection of the right distribution and logistics partners or the optimal packaging design of the shipping containers. A good transport strategy must include risk identification and risk mitigation. From the design phase onwards, risks must be under control as much as possible.

The GDP guidelines are perfectly timed for today’s pharma and cool chain management because the industry is increasingly focused on patient-centric improvements striving to bring products to market quickly, but more importantly, safely. These requirements ensure that all organisations are working towards the same goals of patient safety by utilising the right packaging, ensuring the right temperature is maintained for product stability, and making improvements to benefit all of us.

The guidelines are just as sustainable as other regulations (GCP, GLP, GMP); their impact however, will depend on the results of the inspections – how many pharma organisations are ready, prepared, in compliance? If they are not, remedies will need to be put into place, which can of course take more time and effort. However, if organisations are now compliant, the new guidelines are clear and will certainly improve processes that should continue to be refined going forward.

The supply chain was probably the weakest link and now will operate at the same or higher standards than other parts of the industry, concludes the spokesperson from Marken. It’s likely that changes and improvements will continue to evolve as the focus continues to be on improving product and patient safety in the future. shalini.g@expressindia.com

MANAGEMENT REPORTS

Product launches and patent expiries to push MDD treatment market by 2023: GlobalData MDD treatment market achieved sales of approximately $9.3 billion in 2013 THE THERAPEUTICS market for Major Depressive Disorder (MDD) will face a dynamic phase up until the end of 2023, thanks to the potential launch of new treatments following the patent expirations of top-selling products, says a new report from research and consulting firm GlobalData.

According to the company’s latest report, the MDD treatment market achieved sales of approximately $9.3 billion in 2013 across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) and Australia. These sales will witness minimal growth by the end of 2023, reaching an estimated $9.7 billion, at a Compound Annual Growth Rate (CAGR) of

0.39 per cent.

However, GlobalData forecasts that the market value will first undergo a decline until 2017, with sales dropping to $7.3 billion. This can be attributed mainly to the expirations of patents for Eli Lilly’s Cymbalta, Otsuka Pharmaceutical/BMS’ Abilify and AstraZeneca’s Seroquel XR. Toli Koutsokeras, Senior Analyst, GlobalData covering neurology says, “Additionally, there are a number of significant needs in the depression therapeutics market that are yet to be addressed. These include the requirement for products that demonstrate improved efficacy, more favourable safety profiles and a rapid onset of antidepressant

GlobalData states that there are already seven products in the late-stage pipeline that could enter the MDD market during the forecast period

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effects. Ample opportunity therefore exists for players looking to develop and potentially introduce therapies, which can address these unmet needs, into this arena.”

GlobalData states that there are already seven products in the late-stage pipeline that could enter the MDD market during the forecast period. These include adjunctive therapies, such as Otsuka/Lundbeck’s brexpiprazole, Forest (Actavis)/Gedeon Richter/Mitsubishi Tanabe Pharma’s cariprazine, Alkermes’s ALKS5461 and Naurex’s GLYX-13, along with antidepressant therapies, including Euthymics Bioscience’s amitifadine, Lundbeck/Takeda’s tedatioxetine and e-Therapeutics’ ETS6103.

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Koutsokeras continues, “All seven of these pipeline drugs show promise as safer and more efficacious treatments for MDD patients, while GLYX-13 and ETS6103 in particular boast the potential to provide rapid antidepressant effects. With their ability to address some of the MDD treatment market’s key unmet needs, we believe that these products’ launches could well spark its return to growth in 2018. Other driving factors behind the reversal in its decline will be the increasing uptake of Lundbeck/Takeda’s Brintellix, combined with the expanding number of MDD prevalent cases that we expect to see by the end of 2023.”

EP News Bureau-Mumbai

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RESEARCH

FDAsets approval Higher doses of statins path for Prosensa linked to diabetes risk muscle disorder drug RESEARCH UPDATES

The first major statin trial was published in 1994, but researchers did not suspect a link with diabetes until 2008 New York PEOPLE WITH heart problems who were started on cholesterol-lowering statins were more likely to develop diabetes if they were prescribed stronger versions of the drugs, a new study finds. “This is not about stopping statins,” lead author Colin R. Dormuth, from the University of British Columbia in Vancouver, said.

“These patients should be on a statin, the question is, should they be on a higher or a lower dose?”

Dormuth and his coauthors analysed data on 137,000 patients from Canada, the US and the UK. The patients were all prescribed statins after being hospitalised for a stroke, heart attack or other major heart problem between 1997 and 2011. None of them had diabetes. The researchers considered rosuvastatin (brand name Crestor) prescribed at 10 milligrams or more per day, atorvastatin (Lipitor) at 20 mg or more and simvastatin (Zocor) at 40 mg or more to be higher-potency statins. All other dosages were considered lower potency.

About 3,600 of the patients were diagnosed with diabetes within two years of starting the drugs, according to results published in BMJ. Those prescribed a higher-potency statin were 15 per cent more likely to be diagnosed with diabetes than those given lower dosages. Previous studies have found that taking higher doses of statins reduces the risk of having another serious heart problem by the same amount

46 EXPRESS PHARMA June 16-30, 2014

about 15 per cent compared to taking lower doses.

“Physicians need to weigh the small increase in benefit against the increase in diabetes risk,” Dormuth said. In other trials, rates of death among patients taking lowdose and high-dose statins have been the same. That means higher-dose statins do not extend life more than the low-dose versions, he said.

The higher dose may still be necessary for some patients, for example those with genetic conditions leading to very high cholesterol, he said. The first major statin trial was published in 1994, but researchers did not suspect a link with diabetes until 2008, said David Preiss. He has studied statins and diabetes at the University of Glasgow in Scotland and was not part of the new study. After that, two major trials were published which found that taking a statin puts people at slightly higher risk of developing diabetes and taking a stronger statin puts them at slightly higher risk than taking a weaker statin, he said.

“Commonly used statins, such as simvastatin, atorvastatin and rosuvastatin, taken at a lower dose probably puts one at 10 per cent higher risk of developing diabetes,” Preiss said. “Taking

these same statins at high doses probably pushes this up to about 20 per cent.”

However, it’s still not clear what explains the extra risk, researchers said. The BMJ study is based on a review of the records of patients treated in day-to-day practice by doctors who individualised treatment for each patient, Preiss noted.

“In other words, there were inevitably differences between patients that were treated one way and those treated another way - and this limits the ability of such studies to be able to look at cause and effect,” Preiss said. Statins have been linked to other health problems beyond diabetes, including kidney injury and rhabdomyolysis, or rapid loss of muscle tissue, Dormuth noted.

“It’s not as simple as comparing a small increase in diabetes to a small increase in heart protection,” he said.

The new findings are important for doctors to consider when prescribing statins, but they shouldn’t change anything patients are doing, he said. “If patients are worried they should talk to their doctors,” he said.

Reuters Health

PROSENSA HOLDING NV said the US Food and Drug Administration had outlined an accelerated regulatory approval path for its most advanced drug, aimed at treating a muscle disorder.

The Netherlands-based company said it planned to conduct two more studies, and file for US marketing approval later this year.

Prosensa said it would file for European approval in the near future.

Like Sarepta Therapeutics's eteplirsen, Prosensa's drug to treat Duchenne muscular dystrophy (DMD) will probably win US approval in 2015 at the earliest, leaving each with about half of the market, said Jan De Kerpel, an analyst at KBC Securities in Brussels. De Kerpel expects the drug to generate peak global sales of 1 billion euros ($1.36 billion) by the end of the decade, and estimates it will cost about 200,000 euros a year per patient.

Prosensa's treatment will likely fare better than Sarepta's in Europe as it holds a patent advantage in the region, he said. Drisapersen, like eteplirsen, is designed to enhance the production of a protein called dystrophin, the lack of which causes DMD. DMD drugs-indevelopment have received encouraging signals from regulators in recent months.

The FDA indicated an alternate path for approval to Sarepta's eteplirsen in April, while European regulators recommended conditional approval for PTC Therapeu-

Drisapersen, like eteplirsen, is designed to enhance the production of a protein called dystrophin, the lack of which causes DMD tics Inc's Translarna. Prosensa said in January it would pursue the development of drisapersen despite its failure in a late-stage trial, after additional data showed its use could slow disease's progression. Earlier that month, partner GlaxoSmithKline Plc returned the rights to the drug to Prosensa, terminating a 2009 collaboration deal to develop it.

Accelerated approval is usually granted to drugs for serious diseases with no treatment options, based on data from initial trials. However, a company still needs to conduct larger trials to bolster its initial findings. DMD is a degenerative disorder that hampers muscle movement. It affects one in 3,600 newborn boys, who usually succumb to the disease by the age of 30.

Reuters

US to test immunotherapy drugs on newly diagnosed brain tumors Researchers are already testing Bristol's nivolumab in patients with a glioblastoma US RESEARCHERS are finalizing plans to test two immunotherapy drugs made by Bristol-Myers Squibb Co on patients newly diagnosed with the most common form of deadly brain tumors in adults. Dr Mark Gilbert, a leading brain tumor researcher at University of Texas MD Anderson Cancer Center in Houston, said he got approval from the National Cancer Institute (NCI) to start designing the trial, likely to begin this fall, with the melanoma drug Yervoy and an experimental drug called nivolumab.

The trial will be run through the nonprofit NRG Oncology, an NCI sponsored cooperative group of cancer researchers. "We're really excited about them," said Gilbert, who spoke in an interview at the American Society of Clinical Oncology meeting in Chicago. The hope, he said, is that the drugs, which ramp up the immune system to fight cancer, will prove effective in treating the brain tumors known as glioblastomas. Researchers are already testing Bristol's nivolumab in patients with a glioblastoma that has come back after standard treatment, which involves surgery followed by radiation and chemotherapy. Michael Giordano, head of development for oncology and immunology at Bristol-Myers, said the company's trial in recurrent glioblastoma is part of its push to test the potential of immunotherpies in a broad range of cancers.

Gilbert said he has met with company officials, who still need to give written approval for their drugs to be used in the government-backed study.

Initially, the trial in newly diagnosed patients will test the safety of the drugs in some 42 patients, Gilbert said.

One concern is that bolstering the immune system in the brain could trigger an autoimmune reaction known as encephalitis, causing swelling and worsening patients' symptoms. But so far,

Glioblastomas are the most common and most deadly form of brain and nervous system tumors the studies in patients with recurrent tumors have not shown that to be a major issue, Gilbert said. "We have to take it slow. We want to understand what we're doing," he said.

What is challenging about brain tumors is getting active treatments through a protective membrane called the blood-brain barrier. A major study led by Gilbert, reported at last year's American Society of Clinical Oncology meeting, showed Roche's antibody drug Avastin failed to prolong life in patients with newly diagnosed disease.

But early studies of immunotherapy in melanoma showed the treatments did shrink tumors in patients whose cancer has spread to the brain, suggesting that immune system cells were reaching their target in the brain and raising hope for immunotherapy treatments.

Gilbert acknowledged that research on brain tumors has lagged some other fields, especially with new immune system therapies, but he sees that changing. Glioblastomas are the most common and most deadly form of brain and nervous system tumors, which affect an estimated 240,000 adults globally per year. With standard treatments, average survival is 15 to 17 months.

Reuters Health

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RESEARCH

US FDAapproves Biogen's hemophilia Adrug Eloctate Hemophilia A is a rare, inherited blood-clotting disorder that can lead to prolonged bleeding, bruising and joint and tissue damage Washington THE US Food and Drug Administration said it approved Biogen Idec's long-lasting hemophilia A drug, Eloctate, adding another product to the company's nascent portfolio of drugs for non-malignant blood disorders. Hemophilia A is a rare, inherited blood-clotting disorder that can lead to prolonged bleeding, bruising and joint and tissue damage. It is caused by deficient levels in the body of factor VIII, a protein needed to clot the blood.

The FDA's ruling followed its approval in March of Biogen's hemophilia B treatment, Alprolix. Biogen developed both drugs with Swedish Orphan Biovitrum AB, or Sobi, and expects the products to form the basis of a new non-malignant

blood disorder portfolio.

"We see Alprolix and Eloctate as the anchor tenants in a growing franchise," said Douglas Williams, Biogen's head of research and development.

"We're in this space to stay."

Biogen's biggest products are currently the multiple sclerosis drugs Avonex, Tecfidera and Tysabri.

Eloctate is expected to generate annual sales of $1.5 billion by 2019, according to the average estimate of six analysts polled by Thomson Reuters.

Sales of Alprolix are expected to generate annual sales of $286 million over the same time period. Current treatments for hemophilia B generate about $1 billion a year, according to Biogen, while the market for hemophilia A therapies is worth about $6 billion.

Hemophilia A is the more common form of the disease, affecting about 16,000 people in the US, Biogen said. Hemophilia B affected about 4,000 people. Hemophilia drugs must be infused two to three times a week to prevent bleeding episodes. Eloctate cuts the number of doses needed per

week to between three and five days. Biogen has not set a price for the drug, but Tony Kingsley, head of commercial operations, said the cost for patients who switch from a short-acting product to Biogen's longer-acting product should be roughly the same, even though they will be dosing themselves less frequently.

Last month, Weston, Massachusetts-based Biogen and Stockholm-based Sobi said they would donate hemophilia drugs for use in developing nations in quantities large enough to treat tens of thousands of patients over the next decade.

The drugs will primarily be used in those nations for emergency treatments rather than preventative care.

reality for managing malaria," Venter Institute researcher William Nierman added.

Viruses to be studied include: influenza from human, avian and swine sources, respiratory syncytial virus (RSV), rotavirus, West Nile virus and Eastern equine encephalitis virus. In the bacterial research, the program aims to perform genetic sequencing on more than 1,700 strains of three disease-causing types: klebsiella, acinetobacter and enterobacter.

OMEROS CORP said the US Food and Drug Administration had approved its drug for use in cataract and lens replacement surgeries, the first drug developed by the company to get marketing clearance from the regulator. Omeros, said it plans to launch the drug, Omidria, later this year in the US. Wedbush analyst Liana Moussatos said she expects the drug to be launched by September 30 and raised her price target on the company's stock to $44 from $37. The analyst estimated gross peak annual sales of about $500 million for Omidria in 2019.

The drug could cost $200$250 per bottle, Needham & Co analyst Serge Belanger said.

Omidria a formulation of the pupil-dilating agent, phenylephrine, and anti-inflamatory ketorolac works by maintaining pupil size and reducing post-operative pain in adult patients. The drug is the only FDA-approved product for this use in lens replacement surgeries, one of the most common surgeries in the US, Omeros said. About 3.8 million intraocular lens replacement procedures were performed in the US, and about 22 million worldwide, this year according to the company's website.

The company said it received the regulatory consent without any post-marketing commitments other than a previously agreed study of the drug's use in pediatric patients. The European Medicines Agency is reviewing the company's marketing application for Omidria, Omeros said.

Reuters

Reuters

Reuters

US backs new genetic research on infectious diseases Washington THE US National Institutes of Health has awarded $25 million to the J. Craig Venter Institute to back an initiative to study infectious diseases like malaria and influenza at the genetic level to help find better treatments and preventive measures. The institute, with offices in Maryland and California, will use the 5-year grant from NIH to establish the Genome Center for Infectious Diseases to study the genetic secrets of a wide range of bacteria, viruses and parasites, officials said.

48 EXPRESS PHARMA June 16-30, 2014

The effort will include genetic sequencing of a number of pathogens and research on genetic mechanisms behind the emergence of antibiotic resistance, they said. "It's a pretty big program," said Karen Nelson, president of the non-profit institute. Venter, the former NIH researcher who founded the institute, said in a statement that the new work will be aimed at "enabling a more in-depth understanding of pathogen biology and potentially aiding in better treatments and preventative measures against infectious disease."The parasite re-

search will focus on malaria, the mosquito-borne disease that every year kills more than 620,000 people - mostly African children, and also toxoplasmosis, which US health officials call a leading cause of death attributed to foodborne illness in the US, officials said.

"Malaria is a particularly high focus for the (NIH's) National Institute of Allergy and Infectious Diseases. The focus there is really on exploring approaches to come up with malaria vaccines, which are looking more and more like they're going to potentially be a

Eye drug wins first FDA approval for Omeros

PHARMA ALLY WHITE PAPER

VENDOR NEWS

Seven reasons to switch to vision sensors Didier Lacroix, Vice President, International Sales and Marketing, Cognex Corporation explains the benefit of vision sensors

Checker vision sensors can simplify inspections that would be troublesome for photoelectric sensors—such as the presence of tapped threads or weld nuts in an automotive assembly.

DIDIER LACROIX, Vice President, International Sales & Marketing, Cognex Corporation 2. No mechanical fixturing:

AS THE global manufacturing market continues to get more competitive, it is important to ensure that each factory is running at a peak level of efficiency.

Any downtime due to process related malfunctions is considered non value-added downtime, which directly affects the company’s profitability.

Robust yet easy-to-use, self-contained vision sensors perform automated inspections that previously required costly and complex vision systems. The vision sensors solve simple inspection applications, are easy to use, fast and provide a simple pass/fail or go/no-go result.

Machine vision is an area that if set up correctly can reduce process inefficiencies. If your facility uses machine vision as robot guidance or inspection, there is always an area of improvement that can be investigated.

The seven reasons 1. Identifies features photoelectric sensors cannot:

An object can be inspected in any position on the belt because the vision sensor is always looking for the part.

5. Set-up, edit and monitor inspections on a smart display or a PC: Operators can set up new parameters or adjust existing inspections on a PC. Vision sensor activity can be displayed on a touch screen monitor making it easy for operator interaction on the factory floor.

3. External triggers are not required: Vision sensors overcome imprecise part positioning using patented multi-image analysis to determine if a part is present.

6. Accessories optimise image contrast and minimise obscuring features: Vision sensors can be deployed with special lighting and filters to create better images and achieve more consistent and reliable results.

4. Inspects multiple part features: There is no limit to the number of part features that a single checker vision sensor can inspect. For example, a vision sensor can inspect for the presence of a straw and an insertion on a package of juice.

7. Requires fewer adjustments than photoelectric sensors: Unlike photoelectric sensors that require frequent adjustment, vision sensors can detect objects regardless of their speed and position on the line.

The vision sensors solve simple inspection applications, are easy to use, fast and provide a simple pass/fail or go/no-go result. Machine vision is an area that if set up correctly can reduce process inefficiencies

TÜVRheinland conducts ‘REACH’ awareness programme in Chennai The objective of this programme was to address issues relating to the awareness, registration, notification, and implementation of REACH in order to avoid rejection, penalties and legal consequences in EU in case of non-compliances TÜV RHEINLAND India, the Indian subsidiary of the German-based TÜV Rheinland Group, a leader in testing, training, inspection, consulting and certification; announced that it has recently conducted an awareness programme on ‘REACH-(Registration, Evaluation, Authorisation and Restriction of Chemical substances’) in Chennai.

REACH is a European Union (EU) Regulation that addresses the production and use of chemical substances and their potential impacts on both human health and the environment. The regulation is applicable to all product and chemical exporters in India whose market is the EU. The programme was attended by nearly 25 manufacturers and exporters who evinced keen interest.

“The objective of the Chennai awareness programme, conducted by our REACH consultant Shruthi Ravindranath, was to address issues relating to the awareness, registration, notification, and implementa-

tion of REACH in order to avoid rejection, penalties and legal consequences in EU in case of non-compliances, by early identification of the intrinsic properties of chemical substances right from the raw material stage till the final product,” said M Bhaskar, Director, TÜV Rheinland India.

“We have already conducted more than 100 such programmes not only for the benefit of the manufacturers and exporters but also as a CSR initiative to improve the protection of human health and the environment.” In India, TÜV Rheinland is spread over 100 locations and has 12 stateof-the-art laboratories and testing facilities. TÜV Rheinland India currently employs over 1000 highly skilled professionals.

As an independent body, TÜV Rheinland inspects, tests, certifies products, people, installations, processes and management systems for international standards.

EP News Bureau - Mumbai

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June 16-30, 2014

PHARMA ALLY

Romaco unveils new business model and corporate design at Interpack 2014 More than 300 guests attended the Romaco Kilian Event in Cologne THE ROMACO Group’s new business model and corporate design made a very successful début at this year’s Interpack under the motto beyond technology. The Romaco booth attracted a number of visitors and sales deals were sealed actually during the exhibition week.

More than 300 invited guests attended the Romaco Kilian Event in Cologne on the first day.

Romaco took the opportunity of Interpack 2014 to introduce its new business model and corporate design, which can be summed up under the heading beyond technology. Romaco customers profit from excellent value for money, deep application expertise and strong Romaco brands. The new brand identity and extended product portfolio were presented to an international audience on 600 square metres of floor space at

the Dusseldorf Exhibition Centre. The new KTP 420X high speed tablet press from Romaco Kilian, which won the iF Award 2014 for innovative design, met with considerable interest among visitors and was one of the Romaco machines to be sold directly at the event.

Paulo Alexandre, Chief Executive Officer, Romaco Group, said, “Crowds of visitors turned up at our Interpack stand every single day and we forged a lot of promising contacts. Our solutions evidently touched a nerve with our customers.”

On the trade fair’s first day, more than 300 industry players took part at the gala reception which was held at Romaco Kilian's facility in Cologne. The new Romaco motto beyond technology was brought to life at this special event hosted by the Romaco Group’s newest

The underlying aim is to establish Romaco as industry leader when it comes to operative performance with very short delivery times member.

Romaco Kilian staff demonstrated various high-tech innovations like the new KTP 420X high speed tablet press for pharma applications. Romaco Kilian is the first manufacturer worldwide to offer an in-line system that enables continuous weight control as the products are pressed. This highly efficient tabletting solution was also shown by Romaco in line with a

Romaco Siebler HM 1-230 heatsealing machine and FlexTrans FT servo-driven transfer unit as well as a Romaco Promatic P 91 intermittent motion cartoner.

At the same time, those present had a chance to see for themselves how Romaco is successfully optimising key processes such as stocking based on lean management principles. The underlying aim is to establish Romaco as industry leader

when it comes to operative performance with very short delivery times.

Following the tour of the Kilian plant, Alexandre outlined the Group’s new strategic approach. Romaco now goes beyond technology, offering far more than just the technological expertise embedded in its diverse brands. The company is currently extending its portfolio of products and services to meet customers’ increasingly differentiated specifications, with the emphasis on long-term partnerships. The objective is to achieve higher economic value added for end users throughout the operating lifespan of every Romaco solution. The new Romaco image film gave even greater emphasis to what Alexandre was saying.

EP News Bureau - Mumbai

GlobalSpace Technologies introduces GloEDGE platform Targeted at enhancing scientific interface between pharma industry and healthcare ecosystem MUMBAI-BASED GlobalSpace Technologies introduced GloEDGE platform on Windows Embedded operating system, in association with Microsoft for the Indian pharma industry. GloEDGE is an 'Enhanced Digital & Graphics Experience' enabling platform, which will enable pharma companies to improve the scientific information dissemination to healthcare ecosystem.

GloEDGE is one of the most evolved 360° marketing plat-

50 EXPRESS PHARMA June 16-30, 2014

forms which can be used as a one stop content management and analytics tool by pharma companies. It is way beyond the commonly known 'eDetailing' tool and will act as a strategic aid for the top management of pharma companies to manage their promotion and marketing strategies effectively and efficiently. “We are a technology solutions company in the mobility space, focusing mainly on developing integrated hardware, software and specially crafted services

which aim to deliver unprecedented business gains for large scale organisations. We have been pioneering this innovation for the last three years, deploying Tablet PCbased customer interface solutions at large scale pharma companies in India,” said Krishna Singh, Founder Director, GlobalSpace Technologies.

It will enable pharma frontline sales executives to have all the relevant scientific information on their fingertips. The information deck for a specific

audience has been prepared and organised in such a manner that the sales representative will be able to respond to a doctor’s query on real time basis, saving the latter’s precious time. The platform is designed to augment the capability of pharma sales representatives to perform their traditional primary role of scientific promotion of drugs, so that the physician can take a well- informed decision and customise it in the interest of a specific patient be-

fore prescribing the drug. Using Windows 8 live tile feature, the GloEDGE suite delivers excellent user experience and analytics capabilities.

“The platform has gone through numerous iterations based on real time effectiveness, utility, feasibility, feedback and simplicity of Man Machine Interface (MMI),” Siddhartha Xavier, Founder, Director GlobalSpace Technologies, further added.

EP News Bureau – Mumbai

PHARMA ALLY

Quintiles honoured for ITinnovation Award recognises Infosario Safety platform QUINTILES HAS been named to the 2014 CIO 100 for its transformational Quintiles Infosario Safety solution, a drug safety technology platform which is fully integrated with relevant regulatory agencies and future-proofed through a community development model.

“We are honored to be included in the CIO 100 for our work helping solve industry and customer challenges,” said Quintiles CIO Richard Thomas.

“Introduced in 2011, our award-winning Infosario solutions combine our deep scientific and operational expertise with industry-leading technology innovations that improve our customers’ probability of success at every step of the way.”

During development of Quintiles Infosario Safety, the company consolidated more than 35 individual drug safety systems and pooled a wide range of best practices and processes to create a highly optimised and efficient operating model to help its biopharmaceutical customers ensure that all regulatory requirements for drug safety management are met on a global basis.

Quintiles then developed an entire portfolio of safety applications, regulatory agency integrations and implementation accelerators virtualised and deployed in its private cloud, securely available 24 hours a day, seven days a week via web browser.

This success led to the introduction of a platform that provides customers with benefits including, but not limited to massive cost reductions versus legacy solutions, automated regulatory agency and partner integration, guaranteed information exchange, comprehensive safety capabilities and best-ofbreed processes, enhanced regulatory and operational reporting capabilities, enhanced compliance and a secure environment, guaranteeing patient privacy and pharma confidentiality.

“Patient safety is a top priority for us, just as it is for our customers. Infosario Safety helps conquer some of the complexity involved in safeguarding patients. We believe technology innovation must be focused on success in human measures, ” adds Thomas.

EP News Bureau - Mumbai

Waters ACQUITYUPLC TQD gets medical device nod in China WATERS CORPORATION announced that the Chinese Food and Drug Administration (CFDA) approved the registration of the ACQUITY UPLC TQD system for legal promotion and sale in China as a medical device for routine diagnostic applications and neonatal metabolites diseases screening. A continuation of Waters' commitment to China and to growing clinical LC-MS applications worldwide, this registration represents the second Waters' mass spectrometer approved for in vitro diagnostic (IVD) applications in China. In 2008, the CFDA (formerly known as the SFDA) approved a neonatal screening solution inclusive of the Waters Quattro micro mass spectrometer. "The approval by the CFDA of ACQUITY UPLC MS/MS system as a

medical device is significant for two reasons. First and most importantly, this registration opens the door for millions of Chinese citizens to benefit from the gold standard of LC-MS diagnostic analysis," said Dr Rohit Khanna, Vice President of Worldwide Marketing and Informatics. "Secondly, this commitment to China's analytical scientists and laboratories reinforces Waters' strategy of expanding applications of our core chromatography and mass spectrometry technologies throughout the world. As of this decision by the CFDA, the ACQUITY UPLC, MS/MS system is registered as a medical device in 29 countries plus the European Economic Area, which includes an additional 30 countries."

EP News Bureau - Mumbai

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June 16-30, 2014

PHARMA ALLY PRODUCTS

Cognex launches In-Sight 7010 and 7010C IN-SIGHT 7010 from Cognex is an entry-level smart camera vision system developed specifically for inspection tasks where vision sensors are too limited and the solutions available in the market may not be cost effective or may not suit the entire requirements. With the unique combination of hardware features and software tools, the In-Sight 7010 is the ideal out-of-the-box solution for many straightforward vision applications.

It is a self-contained vision system that includes autofocus optics and integrated lighting in a compact IP67 rated industrial housing. Applications can be configured very quickly using the intuitive EasyBuilder user interface. The vision library on the In-Sight 7010 has been simplified to focus on the tools most frequently used in straightforward vision

applications.

The Easybuilder software helps the user to quickly set up their application without programming knowledge.

Included in this are tools such as Pattern Matching, Edge, Blob, and Circle detection tools.

Additionally, the colour vision system model includes a Color ID tool for applications that require the ability to identify different colors. It has 800 x 600 (SVGA) resolution and takes 102 frames per second. It has an external light connector providing powers and strobe (requires Cognex light cable kit).

In-Sight 7010 has an integrated autofocus which helps with production situations requiring regular part changeovers, or applications that require the vision system to be placed in hard-to-reach spaces. The built-in autofocus capability of the In-Sight 7010

makes it ideal for production situations requiring regular part changes, or applications that require the vision system to be placed in hard-to-reach spaces where manual focus adjustment would be difficult.

With autofocus, users can simply set and save the focus values associated with the inspection of each part. Users can also fine-tune focus levels manually with the interactive software. The In-Sight 7010

autofocus system is available with five different lens options to match the working distance and field of view requirements of each application.

It also offer integrated, fieldreplaceable white lighting as well as four specific colour lights (red, green, blue and infrared) to highlight particular parts or features. The compact In-Sight 7010 features integrated white lighting that is suitable for most vision applications. If a specific

colour light is required to highlight particular parts or features, four optional coloured lights are available. The autofocus optics and integrated lighting developed for the InSight 7010 are also being deployed as options across the full In-Sight 7000 product range.

In-Sight 7010 features EasyBuilder and a selection of the key inspection, measurement, alignment and guidance vision tools found on other In-Sight vision systems.

With the unique combination of hardware features and software tools, the In-Sight 7010 is the ideal out- of-the-box solution for many straightforward vision applications.

Contact details Sunil Vaggu Cognex Sensors India info.in@cognex.com Mob: +91 988 146 6003

Sandilyam introduces Axicon 12700 2D/Linear Barcode Verifier SANDILYAM HAS launched the latest Axicon 12700 2D/Linear Barcode Verifier. An ideal solution for verifying popular 2D, as well as Linear Barcodes including the Datamatrix ECC 200.

The system is perfectly designed to meet the requirements for pharmaceutical manufacturers, packaging companies, and label printers. The verifier is simple to use and yet comprehensive.

Once interfaced to a PC via the USB2 and the software installed, the verifier presents a comprehensive range of facilities to meet user needs.

The verifier uses its high resolution camera-based optics to capture the information contained in the grid of the ECC 200 Datamatrix code. The verifier software provides to the

52 EXPRESS PHARMA June 16-30, 2014

CHARACTERISTICS ◗ ISO / ANSI / GS1 veri?cation standards ◗ Variable automatic aperture setting, with manual over-ride option ◗ Wide range of print and reporting options ◗ Meets ISO 15415, and ISO 15426-2 and a range of other standards ◗ Suitable for a range of retail level LINEAR as well as 2D barcode symbologies ◗ Provided with WINDOWS based PC-side software with upgrade facility ◗ Ease in operation and intuitive navigation and display of analysis

user also a camera image of the barcode during verification and measures a whole host of parameters optically for accurate and details analysis.

The Axicon 12700 2D/Linear verifier meets standards of ISO/IEC 15415 and ISO/IEC 16022. It is itself in full compliance to ISO 15426-2

verifier conformance standards.

Precision engineered for complete repeatability, rugged housing and camera-optic provide the ideal and prescribed conditions for verification. Using the fixed imaging unit needs no focus or alignment, and the verification process very simple.

Every 12700 verifier is factory calibrated and traceable to NIST standards.

The Axicon 12700 verifier can be supplied with accessories including: ● PQ: An integral part of many ISO 9000 systems , Performance Qualification is a process of establishing evidence that provides a high degree of assurance that your QA system accomplishes its intended requirements. ● Our solution provides

technical guidance and instruction on calibration, checking for industry standards, standards training, tips to ensure traceability of your verification ● activity.

The PQ documentation can be purchased separately along with the test kit. All Axicon Performance Cards are traceable to international standards.

Contact details Sandilyam Automation Systems # 203, Money Chambers, 6 KH Road, Bangalore 560 027 Phone- +91 80 6598 8333, 2211 0520 Telefax +91 80 4153 1655 E-mail: masters@barcodeglobal.com W-site:www.barcodeglobal.com

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PEARLITOL® FLASH offers excellent chemical inertness, needs a minimum of lubricant and makes tablet formulation surprisingly simple.

What’s more, it offers the consumer a uniquely pleasing taste experience.

Pearlitol® Flash We deliver !

ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

www.roquettepharma.com For your local contact : Roquette India Pvt Ltd Email : pharmabiz.india@roquette.com - Tel : +91 22 2570 6775 Our local Distributor : Signet Chemical Corp. Pvt Ltd - Email : sales@signetchem.com

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AVAILABLE DIRECTLY FROM THE MANUFACTURER AT HIGHLY COMPETITIVE PRICES < Ortho / Para Anisic Acid < Ortho / Para Cyano Phenol < 2 – Ethoxy Benzoic Acid < 1 / 6 – Hydroxy – 2 – Napthoic Acid < 3 / 4 / 5 – Methyl Salicylic Acid & Ester < 3 / 4 / 5 – Chloro Salicylic Acid < 3 / 4 / 5 – Amino Salicylic Acid < 6 – Methoxy – Naphthaldehyde < All types of Paraben & Mixtures thereof.

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Sieve Shakers & Air Jet Sieving Machine

If you are looking for a complete line of products for particle analysis, look no further than RETSCH. n Widest range of sieve shakers in the market n High-quality test sieves and evaluation software n Fast, reproducible results every time

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m-VROC is the leading small sample viscometer in biopharmaceutical applications used routinely by the leading biopharmaceutical companies at multiple locations globally. m-VROC is the ultimate viscometer for small sample protein therapeutics as little as 20 microliter and high shear rate viscosity measurement up to 1,400,000 s -1.

m-VROC Overview : Accuracy: 2% of readings Repeatability: 0.5% of the range Viscosity range: 0.2 ~ 100,000 m-Pas Shear rate range: 0.5 ~ 1,400,000 s -1 Sample volume: 20 microliter +

SpeciďŹ cation : : Accurate, Precise and top-of-the-line viscometer for R&D application : : 20 Îźl Repeatability Min sample volume : : 1 Maximum shear rate, s-1 0.5 ~ 1,400,000 Temperature sensor : : 2 Viscosity range, mPa-s (cP) 0.2 ~ 100,000 Software : : Temperature range* 4~70 oC Non-Newtonians ? : No Portable Temperature sweep : : : Accuracy 2% of Reading Shear rate sweep Description

ROSALINA

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0.5% of full scale Built-in Included Yes Yes Yes

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For your Pharma export consignments, to assist you with your Good Distribution Practices (GDP) A Single Use Sub Zero to Low Temperature Monitoring Device

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Accurately monitors sub zero to low temperatures

•

Starts logging temperatures at set intervals as soon as it is activated

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Can log as many as 6000 readings in transit

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Excellent battery life depending on the Transaction Days set and the frequency of temperature logging ie the intervals

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Allows a number of parameters to be set by the user e.g. Transaction Days, Lower and Higher TTI Time, Min and Max Alarm Limits, Start Delay, etc...

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Logged data can be downloaded by the importer when the consignment reaches them

Business Avenues

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The same data can be uploaded by them to the Enviro website, with a unique device ID, which in turn can be accessed by the exporter

Please Contact:

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Report and Graph with Mean Kinetic Temperature (MKT) calculation in 21 CFR part 11 compliant PDF format Report and Graph with Time Temperature Integration (TTI) calculation, as per USP Chapter 1118

■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Yuvaraj Murali 09710022999

Enviro also offers effective solutions for the monitoring of environmental parameters, suitable for Pharma Clean Rooms and Warehouses.

Enviro Technologies for Accurate, Tamper Proof and therefore Authentic and Reliable monitoring of environmental parameters and analytical reports.

Enviro Technologies 308, Puranik Capitol, Opp Hyper city mall, Ghodbunder Road, Kasarvadavali, Thane (W) 400 607 Tel: +91 - 22 – 64646500 Website: www.enviroworld.in E-mail: enquiry@enviroworld.in

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■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

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REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.