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Market Biosimilars: The yellow brick road? Packaging Special Schott Kaisha: A ‘Glass’ical experience

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V O L 8 . N O . 1 2 A PR I L 1 6 - 3 0 , 2 0 1 3

CONTENTS

Chairman of the Board Viveck Goenka

MANAGEMENT

Editor Viveka Roychowdhury*

Towards sustainable CSR

BUREAUS

PAGE 28

SC verdict on Glivec: an IP milestone

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

PAGE 31

Sustainability reporting in the pharmaceutical sector: Prescription for pharma

Bangalore Neelam M Kachhap

PAGE 34

The case of market-based pricing

Delhi Shalini Gupta

PAGE 39

PACKAGING SPECIAL

MARKETING

Schott Kaisha: A ‘Glass’ical

Deputy General Manager Harit Mohanty

Experience PAGE 41

Senior Manager Rajesh Bhatkal

‘We will try to have more JVs between IPMMA and Pharmexcil’

PRODUCTION

PAGE 44

‘PaxPharma access to users anywhere in

General Manager B R Tipnis

world, in a secure fashion’

Production Manager Bhadresh Valia

PAGE 45

‘Govt is taking steps to introduce braille

Asst. Manager - Scheduling & Coordination Arvind Mane

script for pharma packaging’

Asst. Art Director Surajit Patro

PAGE 46

RESEARCH

Chief Designer Pravin Temble

GPU-accelerated software:

Senior Graphic Designer Rushikesh Konka

Aiding AIDS control

Photo Editor Sandeep Patil

PHARMA ALLY

Layout Rakesh Sharma

Two Thermo Fisher Scientific facilities

PAGE 84

achieve ISO 13485 Certification

PAGE 85

C I R C U L AT I O N Circulation Team Mohan Varadkar

PHARMA LIFE

MARKET

Express Pharma article on TB

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 & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act.

Biosimilars: The yellow brick road?

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.

IDMA to organise seminar and panel discussion at iPHEX 2013

April 16-30, 2013

PAGE 15

bags award

M&A activity in pharma sector focuses on expanding market presence during March 2013

PAGE 18

PAGE 89

Sinhgad College of Pharmacy hosts a series of state level seminars

Government of Puducherry partners with Abbott

PAGE 90

PAGE 20

Merck Serono collaborates with BioMed X Innovation Center in Heidelberg, Germany

PAGE 21

Piramal Enterprise launches anti-ageing cream

PAGE 22

Government College of Pharmacy, Bangalore to celebrate Golden Jubilee

PAGE 23

PAGE 25

Green ChemisTree Foundation organises seminar and exhibition for pharmaceutical industry

PAGE 26

Goa gets its first clinical research centre

PAGE 27

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EXPRESS PHARMA

EDITOR’S NOTE

From Glivec to Januvia and the Indo-EU FTA

BE IT PHARMA PATENTS OR TRADE AGREEMENTS, INDIA SEEMS DESTINED TO BE THE WORLD'S BATTLEGROUND

The world had barely digested and dissected the Supreme Court (SC) verdict on Novartis' Glivec when Glenmark fired another salvo by launching generic versions of Merck's Januvia and Janumet. Riding on the sentiments of the SC verdict against Glivec, the Delhi High Court (HC) refused interim relief to Merck. The HC allowed the MNC to proceed with its infringement case and set the date for July 16. Glenmark's challenge expands the patent battle from expensive anti-retrovirals and anti-cancer drugs to the much more modestly priced anti-diabetes segment. Its peers have restrained themselves from tilting at this windmill for two main reasons. Firstly, the public interest angle might not work in this case as the Glenmark's versions, Zita and Zita Met, offer at best a 30 per cent savings. Secondly, the US is the biggest market for Indian generic companies and many would have been anxious not to antagonise this nation any more. It is also interesting to note that one of Glenmark's peers, Sun Pharma, is a co-plaintiff in the case against Glenmark, because it has a license from Merck to sell these drugs as its brands Istavel and Istamet. Some industry observers also foresee a renewed demand from MNCs to link patent grants with marketing approvals as a reaction to this case. For all these reasons, the progress of the Glenmark-Merck tussle for the rights to sitagliptin phosphate will be closely followed by both generic and innovator companies. If Glenmark wins, then it could open the floodgates to many more such challenges as it could mean that the courts are willing to concede public interest even if the price difference is not too much. In fact, Merck's counsel quoted the SC verdict on Novartis to underline this fact. However, Glenmark is not arguing the case on just the pricing and public interest front. Its counsel has argued that its products do not infringe the innovator's product as Merck's patent is for sitagliptin hydrochloride only and not for sitagliptin phosphate. Quoting Paras 139 and 156 of the SC verdict on Novartis/Glivec, Glenmark argued that “coverage in a patent cannot be permitted to go much beyond the disclosure made by the patentee”. Merck's counterargument was that since sitagliptin was the invention and sitagliptin phosphate was merely a derivative, it wasn’t eligible for patent protection under Section 3(d). On this argument, it seems piquant that Glenmark seems to be using Novartis' argument that its salt of imatinib mesylate was a different compound from the original and therefore deserved a separate patent. Section 3(d) is the cornerstone of these debates and industry observers are hoping that a similar safeguard can be inserted into the Indo-EU Free Trade Agreement (FTA) as well. Non-profit organisations involved in supplying affordable

medicines and patient groups, both in India as well as globally, are protesting the haste with which the current Indian government wants to seal the deal. The Bilateral Trade and Investment Agreement (BTIA), between the EU and India, has been in discussion since 2007 but has consistently been delayed due to mounting opposition. Leaked drafts of the FTA have alarmed agencies like Oxfam, Médecins Sans Frontières (MSF), the Stop AIDS Campaign, Health Action International (HAI) Europe and Act-Up Paris because the EU seeks to impose stricter IP regimes in developing nations. While clauses related to counterfeiting were dropped after worldwide protests, other contentious clauses remain. For example, a HAI statement points out that the FTA still includes provisions that could block the production and export of generic medicines from India, allow medicines to be delayed, seized, detained and destroyed. Similarly, measures on investment could see the Indian government—as well as third parties, like treatment providers such as MSF—sued by MNCs if national laws, policies, court decisions, or other actions are perceived to interfere with their investments. For example, the recent SC verdict against Novartis too could invite such legal action from aggrieved MNCs once India signs the FTA in its current form. The last hope seems to be India's very vocal Left parties, like the CPI(M) which has released a strong statement accusing the government of rushing through the FTA without discussion. and the ruling UPA-2 is worried that if it cannot push it through this month, it will lose the opportunity. The CPI(M) statement argues that the agreement is likely to worsen the already burgeoning current account deficit and trade deficit. They also cite the agreement with Singapore as evidence that trade agreements further worsen the country’s trade deficit, converting a trade surplus into a deficit after the signing of the FTA. It was thanks to the efforts of the Left that section 3(d) came into existence in March 2005 as the UPA1 needed its support to push it through within the deadline. With the UPA-2's allies getting shriller by the day, they seem to realise that they will have to move into election mode post June and hence the haste to push the FTA through this month. The Left parties, combined with pressure from patient groups and global aid organisations, will have to create enough noise so that the FTA is delayed or the clauses dropped. Luckily, the pharma industry is not the only affected industry; the agriculture and dairy sectors too are worried that subsidies on EU goods could wipe them out. As this battle plays out, it's clear that if it were not for coalition politics we would not have had room for debate. One more reason to end monopolies; both in politics as well as industry. Viveka Roychowdhury viveka.r@expressindia.com

12 EXPRESS PHARMA

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April 16-30, 2013

MARKET

W H AT â&#x20AC;&#x2122; S INSIDE

THE BUSINESS OF PHARMACEUTICALS

M&A activity in pharma sector focuses on expanding market presence during March 2013 PG 18 Government of Puducherry partners with Abbott PG 20 Merck Serono collaborates with BioMed X Innovation Center in Heidelberg, Germany PG 21 Piramal Enterprise launches anti-ageing cream PG 22 Government College of Pharmacy, Bangalore to celebrate Golden Jubilee PG 23 IDMA to organise seminar and panel discussion at iPHEX 2013 PG 25 Green ChemisTree Foundation organises seminar and exhibition for pharmaceutical industry PG 26 Goa gets its first clinical research centre PG 27

MANAGEMENT 28 PHARMA PACKAGING 41 RESEARCH 84 PHARMA ALLY 85 PHARMA LIFE 86 April 16-30, 2013

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M|A|R|K|E|T ANDREW MERRON

As Richard Ridinger, the Chief Executive Officer of Lonza mulls his chances of reviewing its investment with Israel-based Teva group, one thing is clear, development of biosimilars is no longer a low risk, high reward game, instead it is for those who have the heart to take risks, because that will determine the reward. In this case, a market with promising returns for those who are in for the long haul. The global biosimilar market stood at $2 billion in 2012 and is expected to reach $2.7 billion by 2013, with a projected $19.4 billion by 2018, exhibiting a CAGR of 36.6 per cent over 2009-2018, informs Mahadevan Narayanamoni, Partner and National Leader, Healthcare and Life-sciences Advisory, Grant Thornton India LLP. Rising healthcare costs, drugs worth $60 billion going off patent and slow pace of development of generics are some of the factors that have fuelled this surge.

The market India, which ranks thirdlargest in the Asia-Pacific region, after Australia and China has more than 30 biosimilar companies like Dr Reddy’s Laboratories, Wockhardt, Lupin, Cipla, Reliance Life sciences, Avesthagen, Biocon, and Zydus Cadilla with products in their pipeline under various stages of development. Insulin accounts for a big chunk of the market followed by erythropoietin and GCSF. Interferon alpha, thrombolytics, plasma proteins, vaccines, and others form the rest. Europe commands 80 per cent of the market share with 13 approved biosimilar products (as opposed to none in the US). Human growth hormones (hGHs), erythropoiesisstimulating agents (ESAs), and granulocyte colony-stimulat-

EXPRESS PHARMA

Director of the Biosimilars Advisory Service, Decision Resources Group

MAHADEVAN NARAYANAMONI Partner & National Leader, Healthcare and Life-sciences Advisory, Grant Thornton India LLP

DR PM MURALI President, Association of Biotechnology Led Enterprises

“Many of the countries outside the G7 segment have embraced non-innovator versions of biologics over the last 10 years”

“Selection of the molecule, would be the most important factor with the cost of development being high as compared to a generic, followed by building the right infrastructure and processes”

“For Indian biosimilar growth story to sustain itself, it has to cross five bridges, all of them equally important. They are: affordability, assets, approvability, acceptability, and availability”

ing factors (G-CSFs) were the three main product classes driving sales in 2012. Biosimilar ESAs are expected to dominate half of the market in 2013 despite the expected launch of the first biosimilar filgrastim in Japan in Q2 2013, according to Andrew Merron, Director of the Biosimilars Advisory Service at Decision Resources Group. There will be no biosimilars available in new classes of biologics during this time, but this is slated to pick up pace towards 2015, such that by 2020, biosimilars will be able to garner 30 per cent of the share of biologics, he adds. This might be the year, by when biosimilar versions of major biologic blockbuster drugs appear on the horizon (Rituxan, Herceptin, Avastin, Enbrel, and Humira). India, is confident of capturing 20-25

per cent of the market share globally in the next five years growing at a CAGR of 30 per cent as per PM Murali, President, Association of Biotechnology Led Enterprises (ABLE). The Indian market boasts of sales worth $380 million in 2012 with a projected figure of $680 million for 2015. Out of 40 biologicals marketed in India, 25 are biosimilars. The upcoming oncology market is one of the prime targeted areas for many companies. Dr Reddy’s Reditux, a biosimilar monoclonal antibody registered as a copy version of Roche’s Mabthera/Rituxan and sold at less than 50 per cent of the innovator drug has demonstrated how biosimilars can improve access to expensive biologics in developing countries. So much so, that the par-

ent company tied up with Emcure to grab a piece of the growing market. As Dr Reddy’s plans to enter global markets and expand its presence, it would need comparability data with the original brand with the barriers getting higher given the uncertain regulatory environment in the US and the stringent standards in Europe, the two biggest markets. Figuring out its way will help pave the way for others in the fray.

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Two steps forward, one step back However, the changing regulatory landscape especially in the US, means that companies need to navigate through choppy waters. This has led them into rethinking their strategies, revising business models and launching spin offs in order to tackle the

April 16-30, 2013

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rising challenge. So even as Rituxan, one of the first biologics faces patent expiry this year in Europe, efforts to develop a biosimilar of the same have been met with hurdles with both Teva and Samsung halting their clinical trials late last year. While Novartis’ generic arm Sandoz,

April 16-30, 2013

Boehringer Ingelheim, Stada Arzneimittel and Gedeon Richter, are reportedly working on biosimilar versions of the drug, they refuse to indicate the timeline by which it would be in the market. In fact, Sandoz’s Global Head, Jeff George even went on to say last month that the intro-

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duction of Sandoz’s product may be delayed until 2016. It is not difficult to comprehend why. Even though biosimilar development costs less than their biologic counterparts, it is higher than what was estimated earlier, ranging from $75 million to $375 million per molecule. Not only this, slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute. Hence, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Hence manufacturing challenges will also be different, depending on whether a firm is an innovating biologics firm, switching to biosimilars, or a traditional generics manufacturer, entering into biologics production for the first time. “Innovative firms would need to develop strategies to transform expensive development and manufacturing processes into lean analogs reducing the cost per unit dose

and make the same amount of drug with fewer batches through higher fermentation titres, higher purification recoveries, and longer shelflife formulations. The expertise to reverse-engineer the biologic, develop a stable, therapeutically active cell line along with manufacturing processes that meet specifications, predictably and consistently while applying specialised analytical tools would be required,” adds Murali. Given the unpredictability of the enterprise and the hurdles therein, it is not surprising then that analysts are coming to believe that only those companies that are willing to absorb the costs and risks of development, registration and commercialisation will emerge as competitors. Result: the battleground seems to be heating up with biotech giants copying each other drugs rather than opening them to competition from less established firms. The latest to enter the bandwagon is Amgen, which has recently announced its plans Continued on Pg 19

EXPRESS PHARMA

M|A|R|K|E|T DEAL TRACKER

M&A activity in pharma sector focuses on expanding market presence during March 2013

&A activity in the pharmaceutical sector in March 2013 was focused on diversification of product pipelines, in order to expand market presence. In line with the above trend, Canada-based Valeant Pharmaceuticals agreed to acquire Obagi Medical, a US-based specialty pharma company, for approximately $360 million. This transaction will strengthen and diversify Valeant’s dispensed portfolio and also expand its market presence, focusing on dermatologists and plastic surgeons. The acquisition of Obagi will be a valuable supplement to Valeant’s current dermatology portfolio and will further build upon their growing aesthetics franchise. With this acquisition, Valeant will gain access to dermatology brands including Obagi Nu-Derm, Condition and Enhance, Obagi-C Rx, ELASTIDerm and CLENZIDerm. In another key deal, Ireland-based Shire agreed to acquire SARcode Bioscience, a US-based biopharmaceutical company, for approximately $160 million. This transaction will help Shire to focus on building research and development pipeline with innovative, well-differentiated assets. This transaction will also help Shire to expand its presence in the ophthalmology therapeutic category. With this acquisition, Shire will gain access to LIFITEGRAST, a phase III compound currently under development for the signs and symptoms of dry eye disease. M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of previous six months’ (September 2012–February 2013). According to Datamonitor’s Medtrack database, the pharma sector recorded 28 M&A transactions in March 2013, against the previous six months’ average of 35.8 transactions. In value terms, the sector recorded deals worth $1 billion against the previous six months’ average of $3.1 billion. The Indian pharma sector witnessed one deal during March 2013, against the average of zero deals over the previous six months in which Mauritius-based ChrysCapital acquired approximately four per cent stake in Ipca Laboratories, a pharma company, for $40 million.

Witnesses one deal in March

Top M&A deals (March 2013) Rank

Date

Acquirer

Deal value ($m)

03/20/13 Obagi Medical Products, Inc. (US)

Target

Valeant Pharmaceuticals International, Inc. (CA)

360

03/06/13 Althea Technologies, Inc. (US)

Ajinomoto Co., Inc. (JP)

175

03/25/13 SARcode Bioscience, Inc. (US)

Shire plc (IE)

160

03/12/13 Chiatai Qingchunbao Pharmaceutical Co., Ltd. (CN)

Shanghai Pharmaceuticals Holding, Co., Ltd. (CN)

70.84

03/07/13 PTC Therapeutics, Inc. (US)

Brookside Capital Partners Fund, L.P.; Adage Capital 60 Management L.P.; Jennison Associates LLC; Longwood Fund; Credit Suisse First Boston Equity Partners, L.P.; HBM Healthcare Investments Ltd; Vulcan Capital; Celgene Corporation; Delphi Ventures; Novo A/S; The Column Group

03/04/13 Progenika Biopharma, S.A. (ES) Grifols, S.A. (ES)

48.18

03/25/13 Ipca Laboratories Limited (IN)

ChrysCapital (MU)

03/26/13 Novartis AG - Cardioxane (CH)

Clinigen Group plc (GB)

03/14/13 MedVend, LLC (US)

Medbox, Inc. (US)

5.15

Venture funding Companies in the pharma sector raised $55 million during March 2013, against the previous six months’ average of $350.9 million. In terms of volume, the sector recorded 14 venture funded deals, compared to the previous six months’ average of 25.8 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 developmental benchmarking. For more information, visit www.medtrack.com

Source:

Top venture financing deals (March 2013) Rank Date

Target

Investors

Deal value ($m)

03/13/13

NABsys, Inc. (US)

Bay City Capital LLC; Point Judith Capital; Stata Venture Partners LLC

03/25/13

Theraclone ARCH Venture Partners; Canaan Partners; 8 Sciences, Inc. (US) MPM Capital; HealthCare Ventures LLC; Alexandria Real Estate Equities, Inc.; Amgen Ventures; Versant Venture Management LLC; Zenyaku Kogyo Co., Ltd.

03/20/13

Savara, Inc. (US)

Tech Coast Angels; Keiretsu Forum; Central Texas Angel Network; North Texas Angel Network; Undisclosed Investors

7.4

03/21/13

OriGene Technologies, Inc. (US)

Qiming Venture Partners; Kleiner Perkins Caufield & Byers China; IDG-Accel Capital Partners

6.38

03/25/13

Theraclone MidCap Financial LLC; Silicon Valley Bank Sciences, Inc. (US)

Source:

EXPRESS PHARMA

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April 16-30, 2013

M|A|R|K|E|T

Biosimilars: The yellow... Continued from Pg 17 to enter the space and launch six biosimilars beginning 2017. AstraZeneca is also pontificating its strategy. Which brings us to how can India make its presence felt amidst all the chaos.

Addressing the concerns

folio of filgrastim, peg-filgrastim, rituximab and darbepeotin alfa, which have commercial presence in 13 emerging countries. Cipla has also acquired facilities in India and China to develop biosimilars. Wockhardt is among the early entrants and has developed insulin and analogue,

Lupin is now on its way and plans to soon launch its first of two biosimilar drugs for oncology in India by the end of this year. The company currently has a total of 10 proteins in different stages of development. Avesthagen and Reliance Lifesciences are also strong contenders.

But it remains to be seen if they will be able to rough it out in the more regulated markets even as they are charting out their strategy in emerging markets. Finally Murali offers words of advice the for the Indian industry. “For Indian biosimilar growth story to sustain itself, it has to cross five

bridges, all of them equally important. They are: affordability, assets, approvability, acceptability, and availability. The ability to safely cross over this span will determine the level of success we are likely to see in the Indian biosimilar industry,” he concludes. shalini.g@expressindia.com

“Many of the countries outside the G7 segment have embraced non-innovator versions of biologics over the last 10 years, but the majority of these biologics cannot be considered true biosimilars owing to the absence of a biosimilars regulatory pathway and/or robust demonstration of comparable quality, safety and efficacy compared to a specified reference brand,” pitches in Merron. However, the emergence of biosimilar guidelines late last year by Indian Department of Biotechnology, along with the drug regulator outlined specific requirements for pre-marketing and postmarketing data, apart from guidelines for pre-clinical and clinical trials for biosimilars. The move is aimed at upgrading and maintaining the quality of Indian biosimilar products, although it is strongly felt that there should be a independent regulatory pathway for biosimilars with the DCGI currently looking after both generics and biologics. Else, doubts about the quality of Indian biosimilars may persist. Licensing agreements and alliances would be the key to gaining access to regulated markets and riding the obstacles. “Selection of the molecule, would be the most important factor with the cost of development being high as compared to a generic, followed by building the right infrastructure and processes, access to market and funding, when it comes to a forging an alliance,” reiterates Narayanmoni. Even after the demonstration of biosimilarity, companies need to work on the quality of the product, price, positioning, perceived trust, and adoption of targeted marketing campaigns, adds Merron. With the patent expiry of products like Herceptin, Humira and Rituxan, mAbs (monoclonal antibodies) are in the pipeline for many Indian players. Meanwhile Indian companies are on the move. Dr Reddy’s Laboratories has already launched a few of its significant biosimilars in emerging markets with a portApril 16-30, 2013

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M|A|R|K|E|T

COMPANY WATCH Government of Puducherry partners with Abbott Puducherry to be a model state in care and treatment of non-communicable diseases he Government of Puducherry and Abbott have signed a three-year agreement to improve awareness of Non-Communicable Diseases (NCDs) like diabetes, hypertension and dyslipidaemia (cholesterol related disorders) and thyroid disorders; and implement initiatives to fight them and record their prevalence in the Union Territory of Puducherry. The partnership programme will reach out to the Union Territory’s citizens and screen/monitor over seven lakh people, which is the general population of Puducherry who are 30 years or above. It will also build the skills of local healthcare providers through continued medical education. This partnership for integrated health management is the first of its kind to be initiated by a government in India to capture and assess reliable population level screening / monitoring data. This data will help to create health risk maps to forecast the burden of these non-communicable diseases, facilitate early interven-

tion, and ultimately help reduce disease burden in the Union Territory of Puducherry. The Government of Puducherry will provide the infrastructure and the necessary permissions and logistical arrangements in the Union Territory to run the project, while Abbott will provide subsidised diagnostics, educational support to healthcare providers, patient awareness material and will conduct diet guidance camps. Abbott will also provide NCD management kits (including supplies to measure blood pressure, body mass index and blood glucose) and 150,000 glucose test strips free of cost to support monitoring of diabetes, as well as access to a unique internationally-recognised, evidence-based disease risk and health assessment tool. The health assessment tool will help the Puducherry Governments’ healthcare providers to assess each individual’s health risks and support the public health ecosystem to create a personalised care plan to drive better health outcomes for patients and increase the focus of preventive care. The assessment of population-level data of diabetes, hypertension, choles-

terol and thyroid disorders will project the likely disease pattern over a period of three years, thereby enabling a targeted approach to reduce the Union Territory’s disease burden and also favourably impact the associated social and economic burden. The partnership aims to focus on diseases with a significant, and often growing, impact in India. With an estimated 61.3 million people living with diabetes, India currently accounts for almost 17 per cent of the global diabetic population. A further 77.2 million people in India are at risk of developing diabetes. Over a period of time, diabetes can damage the heart, blood vessels, eyes, kidneys, and nerves. The overall risk of dying among people with diabetes is at least double the risk of their peers without diabetes. An Indian Council of Medical Research (ICMR) study suggests that the country’s incidence rate for dyslipidaemia is estimated to be 37.5 per cent amongst adults aged between 15-64 years. Thyroid disorders in India are characterised by a high prevalence (approx. 11 per cent of adult population), minimal diagnosis, low awareness and low

involvement of doctors in treatment. N Rangaswamy, Chief Minister, Puducherry said, “The partnership with Abbott is one of the first in the country for a state or Union Territory to build awareness, provide treatment and better manage chronic diseases for its citizens, using its existing public health infrastructure. This partnership will not only improve patient outcomes, but also help address the growing disease burden and the associated economic burden of Puducherry.” He added, “Leveraging its diversified healthcare expertise in areas such as diagnostics and pharma therapies, Abbott is uniquely positioned to be the right partner for this integrated health management solution.” Vivek Mohan, Senior Director, Global Integrated Health, Abbott said, “Combating non-communicable diseases (NCDs) is a shared commitment in building a healthy society. Partnerships like these with government will help to prevent and manage these diseases effectively, in particular by strengthening the health care systems addressing NCDs.” EP News Bureau-Mumbai

Venus Remedies launches first OTC product ‘Ezenus’ First anti stress herbal product in easy to use candy form

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enus Remedies, a research-based global pharmaceutical company announced the launch of its first OTC product ‘Ezenus’, a stress reliever. Dr Manu Chaudhary, Joint Managing Director, Venus Remedies said, “Ezenus is a unique medical nutrition product which is absolutely safe, zero calorie, non–addictive, herbal candy, with clinically proven antistress activity. It is world’s first anti stress product launched in

easy to use candy form even suitable for diabetic patients. It is highly safe in acute stress management such as exam stress in children and in chronic stress like in alcoholic and smoking population, without change in life style by continuous detoxification and strong antioxidant activity.” Ezenus is a patent-protected herbal, anti-stress formulation based on German technology. It is a strong detoxifier candy free from side effects, with strong antioxidant, hepato-protective, and immune boosting activity which reduces stress without altering the physiological functions of the body. Chaudhary further added that Ezenus reduced more than 60 per cent stress within 30 days without change in life www.expresspharmaonline.com

style and significantly improves the quality of life in terms of physical, social, emotional and functional wellbeing. This breakthrough innovative product is suitable for all ages with safety established upto 10 times of advised dose i.e. two to three tablets per day. Ezenus is the outcome of continuous research, latest technology and thorough screening for safety and efficacy of more than five years. Pawan Chaudhary, Chairman cum Managing Director, Venus Remedies said, “With launch of Ezenus, a stress relieving candy, Venus is entering into the OTC segment for the first time. It is a moment of pride for all of us who have contributed towards this achievement. We are hopeful that this novel

research product Ezenus will acquire five per cent of the $100 million direct market of stress segment in India, other than lifestyle disorders, within three years of its launch.” The company has plans to make Ezenus available panIndia within this calendar year to contribute in the reduction of stress in society thereby helping people in bringing balance to life. The company will use its existing network of 50,000 pharmacists to distribute this product on pan-India basis. Further, an aggressive promotional campaign will be undertaken for broadening its reach. It will also be available for online purchase on its website wherein a toll free number would be available for customer queries. EP News Bureau-Mumbai April 16-30, 2013

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Merck Serono collaborates with BioMed X Innovation Center in Heidelberg, Germany Constitution of a new class of innovation model to leverage external resources to contribute to Merck Serono’s research efforts erck Serono, a division of Merck, Darmstadt, Germany, announced a collaboration to start innovation projects under the roof of an innovation centre operated by BioMed X. This new research laboratory will establish a new way of fostering innovation. With the support of BioMed X, it will allow Merck Serono to run research projects with interdisciplinary project teams of young talented scientists, coached by a supervisor at Merck Serono and an experienced academic in an open-innovation laboratory facility in Heidelberg. The new innovation concept has been co-developed by Merck Serono and BioMed X. Top young talent from leading academic institutions world-wide will be selected through assessment centres based on their scientific expertise, creative energy, and passion for product-oriented pre-clinical research and development. Interdisciplinary project teams will collaborate with guidance of experienced mentors while expanding their scientific network and receiving an intensive entrepreneurship and leadership training. The laboratory will be placed at a global innovation hotspot, the life science campus of the University of Heidelberg, providing access to a broad academic network and a creative environment. Under the terms of the agreement, Merck Serono will run its own research projects in the biomedical research lab in Heidelberg operated by BioMed X. The projects will be funded by Merck Serono. The project teams will work on new approaches for the therapy of cancer. Further details of the agreement and financial terms were not disclosed. “Our goal is to seed and boost early stage research projects by placing them into a vibrant environment, bringing in top young talent to work at the interface between industry and academia in one of the top European research hubs in Heidelberg. We expect this concept can result in a constant flow of innovative projects and creative talent into Merck Serono,” said Bernhard Kirschbaum, Head of Global

April 16-30, 2013

Research and Early Development at Merck Serono. Merck Serono is commit-

ted to providing guidance and coaching and to ensuring the highest industry quality standards. Furthermore, participants will have access to Merck Serono’s technical expertise and research infrastructure. In addition to operating the innovation centre, BioMed X will be responsible

for world-wide recruiting of young talents, providing education to teams and securing access to academic research infrastructure in Heidelberg. Christian Tidona, Founder and Managing Director, BioMed X said, “I believe forming teams of top life science talents from around the

world and providing experienced mentors from academia and industry is a critical step to success. Our strength lies in embedding these teams in a strong local network and leveraging the opportunities of an innovation hotspot such as Heidelberg.” EP News Bureau-Mumbai

33-year history of partnership with leading pharma companies

TELMISARTAN TELMISART AN GREEN Non-Infringing Process

active pharmaceutical ingredients & its intermediates* Commercial scale Antitubercular Pyrazinamide# * Isoniazid # *

Antimalarial Artesunate Arteether Artemether# * Dihydroartemisinin Lumefantrine# * Piperaquine

Macrolides

Antihypertensive

Azithromycin Clarithromycin Erythromycin base # # Erythromycin estolate Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #

Irbesartan # Losartan potassium Telmisartan Valsartan

Antihistaminic Cetirizine dihydrochloride # Hydroxyzine diydrochlorid + Meclizine diydrochlorid

Alendronate sodium Zoledronic acid

Sedative, Hypnotic Zopiclone

Antifungal Flucytosine #

Antiosteoporotic

Antiepileptic Valproic acid

Antidepressant Venlafaxine hydrochloride

Under Development Antiretroviral

Antidiabetic

Hypnotic

Antithrombotic

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Linagliptin Vildagliptin

Eszopiclone

Clopidogrel bisulphate

* WHO APIMF

CEP / COS

*The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility rests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction. Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India. Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com "Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

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Global Coalition of TB Activists launched, aims to put communities affected by TB at the centre of decision making TB patients and survivors, members of affected communities and TB activists working across the world are invited to join the GCTA through its Google Group group of activists launched the Global Coalition of TB Activists (GCTA), a new network that aims to put communities affected by tuberculosis (TB) at the centre of decision making in the fight against TB. “TB knows no borders, neither should the response to fight the disease and its inherent social inequalities,” said TB activist Alberto Colorado. “I hope the GCTA will unite us all with the vision of a TB free world.” The GCTA is the product of a meeting of community activists hosted by the Stop TB Partnership in February. The activists present at the meeting recommended that the Community Task Force, a group formed of advocates serving on various Stop TB Partnership Working Groups,

should be restructured into a broader global coalition to represent communities affected by TB, multi drug-resistant TB and TB/HIV. “We welcome the creation of this coalition of TB activists from implementing countries where communities are heavily affected by TB and TB/HIV,” said Dr Mark Dybul, Executive Director of the Global Fund to Fight AIDS, TB and Malaria. “Coverage and access to TB services must increase for everyone but especially for vulnerable and stigmatised groups, and this is impossible without the involvement of communities and activists.” The objectives of the GCTA are to: Act as a community representation body at local, state, national and international levels; provide input to the two representa tives of communities affected by TB on the Stop TB Partnership Board, and to community representatives on other Global Health Initiatives; Build the capacity of activists and encourage

their involvement in global health initiatives and establish TB advocacy forums at different levels; create a platform where different stakeholders such as affected communities, activists, civil society organisations and government allies can come together and lobby with policy makers to develop rightsbased and patient-centered TB policies and strategies; build a pool of well-informed and confident activists and advocates to share their experiences with other groups. “TB activists have struggled to be heard and get a foothold into global decisions affecting patients at ground level. I believe the GCTA will be the platform for activists to speak, be heard and valued,” said Blessi Kumar, Vice-Chair of the Stop TB Partnership Coordinating Board and Board Representative for Communities affected by TB. TB patients and survivors, members of affected communities and TB activists working across the world are invit-

ed to join the GCTA through its Google Group. Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership welcomed the launch of the new coalition. “In the fight against TB, the bottom line is that our efforts must translate into healthier lives for all people,” she said. “Unless we work together with people affected by TB, representatives of affected communities and civil society, this will never happen. We look forward to working together to increase funding, attention and support for TB at the national and global level, and ensure that this results in better health for all.” TB activist Pervaiz Tufail said that communities and TB patients are the missing link in efforts to stop TB. “I am excited about the launch of this new global coalition and hope that it will act as a community and patient representative body to raise TB high on the political and social agenda,” he said. EP News Bureau-Mumbai

Piramal Enterprise launches anti-ageing cream Lacto Calamine RENEU has been manufactured using globally patented ULMAe technology iramal Enterprises, the flagship company of Piramal Group has launched an anti-aging cream ‘Lacto Calamine RENEU, with globally patented ULMAe technology, under its OTC segment. Dr Swati Piramal, Vice Chairperson, Piramal Enterprises unveiled the antiaging cream at recently held press conference in Mumbai. The RENEU [ACTION] 3 FORMULA is a unique combination of three ingredients. It has Ultra Low Molecular Aminoglycan Extract (ULMAe), nine natural nourishing organic extracts and Natural Anti Melanin (NAM). The Lacto Calamine RENEU is available in glass jars of 50 gm and each jar comes with three proof strips. Underlining the need for an effective anti-ageing cream, in India, Piramal said, “In today’s time, stress,

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tedious lifestyles and pollution contributes to skin ageing, and consumers are seeking anti-aging products which not only promises great results but also delivers on them. The product is an outcome of an extensive research and study conducted by our team. Lacto Calamine RENEU with the unique combination of three ingredients, Ultra Low Molecular Aminoglycan Extract (ULMAe), 9 Natural Nourishing Organic Extracts and Natural Anti Melamin (NAM) marries science with nature resulting in 83 per cent reduction of wrinkles and 70 per cent improvement in skin smoothness.” Nandini Piramal, Executive Director, Piramal Enterprises said, “The consumer is facing ample choices while selecting her anti ageing cream as the category has number of players. Through intensive consumer contact programmes; we recognised the need to forwww.expresspharmaonline.com

mulate a product which would help women, measure its benefits so they can believe in it. It is the only anti-ageing

cream available in Indian market with such technology to measure the improvement over the eight weeks.” EP News Bureau-Mumbai April 16-30, 2013

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PRE EVENT Government College of Pharmacy, Bangalore to celebrate Golden Jubilee Event to be held in Bangalore on June 1 and 2, 2013

will have apart from honouring the retired professionals and faculty members of the college, addresses and group discussions led by the distin-

guished alumni of the college. It will also involve talks about how professional pharmacists can serve the patients and consumers better.

he Government College of Pharmacy (GCP), Bangalore will celebrate the 50 years of beginning of pharmacy education in the state of Karnataka. The celebrations will he held on June 1 and 2, 2013, at Bangalore, and will continue throughout the year. A local organising committee has been formed with Professor S Shashidhara, Principal of the college, Shiva Hiremath, President of the Alumni association,

“I am looking forward to these celebrations,” said Dr Jaga Shetty, Drugs Controller of Karnataka, under whose department

the college has successfully operated and attained a unique position in the country. EP News Bureau - Mumbai

An Investment in Drug Protection

IT WILL ALSO INVOLVE TALKS ABOUT HOW PROFESSIONAL PHARMACISTS CAN SERVE THE PATIENTS AND CONSUMERS BETTER GCP, and KP Ravindra, President of American Association of GCP Alumnae, US. Dr S Ramachandra Shetty, professor in the college is the organising secretary. Sessions will be held on – Remembering 50 Golden Years (Reminiscence); Pharmacists: Professional Challenges for better service to patients; Challenging Technologies — with moving times; and Bridging the Generation Gap: Present and Past in pharmacy. ‘GCP: 50 Glorious years in shaping talented pharmacy professionals’ will be the slogan for the Suvarna Sambhrama (Golden Jubilee). GCP has nurtured pharmacy professionals and its alumni occupy high positions to day in FDA, US, Vice-Chancellors of the universities, lead many pharmacy colleges as principals and faculty, scientists in the pharma industry and also hold positions of drug controllers. The two-day celebrations April 16-30, 2013

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EVENT BRIEF iPHEX 2013 Date: April 24-26, 2013 Venue: Bombay Exhibition Centre Summary: Pharmaceuticals Export Promotion Council of India (Pharmexcil), has announced the launch of iPHEX 2013, India’s own pharmaceutical show under the support of Ministry of Commerce and Industry, Department of Commerce, and Government of India. Over 400 leading Indian companies are expected to showcase the best of pharma products at the event. The organisers claim that iPHEX 2013 will see the presence of 5,000 business visitors including overseas buyers and drug regulators. Huge business opportunities are expected to emerge during the event. Further, the presence of large number of drug regulators from overseas market is expected to help Pharmexcil and its members to promote the quality and affordability aspect as envisaged in ‘Brand India’ pharma campaign. The campaign has been initiated by Ministry of Commerce and executed by Pharmexcil in association with IBEF. Contact details: Sanika Patil ProjectManager – IPHEX 2013 Tel: 91.11.23324288 M: 91.9582758812 E-mail: sanika@falconmail.com

PHARMA Pro&Pack 2013 Date: April 24—26, 2013 Venue: Mumbai Exhibition Centre, Goregaon Summary: PPPE 2013 is an initiative of the Indian Pharma Machinery Manufacturers’ Association (IPMMA), jointly with GPE Expo. The event will offer a single platform for more than 200 exhibiting companies from India and across the world to showcase their products.

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Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380015, Gujarat Tel: +91 79-2687 1390 +91 79-4000 8253 +91 79-4000 8233 Email: contact@pharmapropack.com

gies for effective time management. Contact details: Tel: (022) 61727001 Email: conferencesindia@ubm.com (Promo Code: EXP-DISC10) Website: http://www.pharmaprojectmanagement.com?utm_campaign=MEDIAPARTNER &utm_medium=EVENTLISTING&utm_source=EXPRESS PHARMA

Pharma Project Management conference Date: May 8-10, 2013

RDD Europe 2013

Venue: Mumbai

Date: May 21-24, 2013

Summary: CPhI in association with PMI India will hold Pharma Project Management conference, customised specifically for pharmaceutical industry’s high end project needs around cost, quality and time. This strategic conference aims on discussing best practice strategies to implement project management from the leaders of the industry who have successfully handled complex projects themselves. This distinctive conference has received a lot of interest and has already confirmed industry leaders to present including Sanjit Singh Lamba, Managing Director India, President, Global Brands Business Unit Eisai Knowledge Centre; Swaminathan Srinivasan, Director Project Management, Dr Reddy’s Laboratories (UK); Sanjay Bhanushali, Director International Operations, Cipla; Mohan Pandey, Director R&D operations, Bristol-Myers Squibb; Dr Varada Bapat, Head-Project Management, Wockhardt and many more. The event will feature indepth discussions on streamlining end-to-end product life cycle management, minimising project risk management, overcoming application challenges in R&D, clinical research, engineering, SCM and manufacturing. It will also help in understanding application of theory of constraints specific to complex pharma projects, best strategies for critical path identification and innovative strate-

Venue: Intercontinental Hotel, Berlin, Germany Summary: The Respiratory Drug Delivery (RDD) Europe 2013 scientific conference will welcome pulmonary and nasal drug delivery experts from all over the world to Berlin, May 21-24, 2013. The three-day interactive symposium of the highest level will begin with a plenary lecture titled “Biomarkers and Targeted Treatments for Small Airways Diseases – The Past, Present and Future”. The symposium will also focus on drug development – new drugs, targets and formulations, weighing the evidence in support of bioequivalence, orphan drugs – opportunities, regulatory and clinical challenges, harmonising the clinical requirements for lab / ICS combinations in the US and Europe, designing devices for the marketplace, optimising formulation and device partnerships. RDD Europe conferences highlight innovative research contributions through podium and scientific poster sessions. These are enhanced by 12 technical interactive workshops from vendors and service providers in the industry. In all sessions, the latest technological advances related to nasal and pulmonary drug development will be presented. Contact Details: Marion Baschet VernetLondon, Great Britain Tel: +44 (0)797 609 41 00 Email: mbvernet@gmail.com www.expresspharmaonline.com

Drug Delivery & Complex Generics Conference Date: May 28-30, 2013 Venue: Mumbai Summary: With the patent cliff reaching its peak, complex generics and innovations in drug delivery present huge opportunities for the pharmaceutical industry to gain the first mover advantage. Visitors will be able to delve deeper into innovative formulation and manufacturing techniques and latest drug delivery systems orals, injectibles, nasal, transdermal and opthalmics by attending the conference. Latest case studies on controlled release formulations, HME and spray drying techniques, depot injections, nanoparticle technology will be discussed. A workshop will be held on how to ensure smooth scale-up of complex generics that will address all critical scale-up issues - from concept to commercialisation. Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://www.drugdelivery-complexgenerics.com?utm_campaign=MEDIAPARTNER&ut m_medium=EVENTLISTING&utm_source=EXPRESS PHARMA

Pharma Quality by Design Date: June 12-14, 2013 Venue: Mumbai Summary: The 2nd Annual Pharm QbD Forum will have case study sessions on various dosage forms (pulsatile drugs, solid oral dosage, lyophilised products), on API synthesis and scale up, on various analytical sciences and development. Workshop on DOE covering all the basic statistical approach all supported with different case studies will be held. Speakers who have been implementing and working on the QbD principles for their respective organisations like Dr Reddys Laboratory, Emcure, Lupin, Jubilant Life

science, Teva Pharmaceuticals, BristolMyers Squibb, Orchid Pharmaceuticals will attend the event. Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://pharmaqbd.com/?utm_campaign=ME DIAPARTNER&utm_medium=EVENTLISTING&utm_so urce=EXPRESSPHARMA

Govt. College of Pharmacy, Bangalore (Golden Jubilee Celebrations) Date: June 1-2, 2013 Venue: Government College of Pharmacy (GCP), Bangalore Summary: The Government College of Pharmacy (GCP), Bangalore will celebrate the 50 years of beginning of pharmacy education in the state of Karnataka.A local organising committee has been formed with Professor S Shashidhara, Principal of the college, Shiva Hiremath, President of the Alumni association, GCP, and KP Ravindra, President of American Association of GCP Alumnae, US. Dr S Ramachandra Shetty, professor in the college is the organising secretary. Sessions will be held on – Remembering 50 Golden Years (Reminiscence); Pharmacists: Professional Challenges for better service to patients; Challenging Technologies – with moving times; and Bridging the Generation Gap: Present and Past in pharmacy. Apart from honouring the retired professionals and faculty members of the college, the two-day celebrations will have group discussions led by the distinguished alumni of the college. It will also involve talks about how professional pharmacists can serve the patients and consumers better. Contact details: Email: goldengcp@gmail.com

April 16-30, 2013

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PRE EVENT IDMA to organise seminar and panel discussion at iPHEX 2013 Event to be held on April 24 and 25, 2013 ndian Drug Manufacturers Association (IDMA) is supporting Pharmexcil’s iPHEX 2013 inaugural event and is organising a seminar on ‘India: Destination of Choice for Quality Medicines’ at iPHEX 2013 on April 24 and 25, 2013. The event is planned to attract the entire Indian pharma industry, as also the participation of about 400 foreign buyers and regulators from many countries. A panel discussion on ‘Hassle Free Exports’ based on the Seminar theme will be held on the first day with industry stalwarts such as Smitesh Shah, Chairman and Managing Director, Calyx Chemicals and Pharmaceuticals, Dr Milind Joshi, President, Global Regulatory Management, JB Chemicals and

THIS SEMINAR WILL ENSURE DELEGATES TAKE HOME THE SKILLS TO ENABLE THEM AND THEIR TEAMS TO PERFORM TO THE PEAK OF THEIR ABILITIES Pharmaceuticals, Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting, Dr Raja Smarta, Managing Director, Interlink Marketing Consulting and other experts as panellists. Utkarsh Palnitkar, Partner (Head of Transactions and Restructuring), KPMG India will moderate the panel discussion. The second day will have an interesting presentation on ‘Pharma Branding’ by Sudarshan Jain, Managing Director, Healthcare Solutions, Abbott Healthcare, ‘Success Stories of Indian companies in Exports’ by Sriram Shrinivasan, Partner, Life Sciences, Accenture India, and others on relevant topics such as ‘Biosimilars – April 16-30, 2013

‘Look before you Leap‘, ‘Financing Pharma Exports ‘ etc. An interactive session with overseas Regulators is

also scheduled on the second day, wherein they will be requested to highlight their regulatory framework and how they can help in easing

import of from India. This seminar delegates take skills to enable

medicines will ensure home the them and

their teams to perform to the peak of their abilities, and build ‘Made in India’ pharma brands for global markets. EP News Bureau-Mumbai

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POST EVENT Green ChemisTree Foundation organises seminar and exhibition for pharmaceutical industry Event held in Hyderabad was attended by 108 representatives from pharmal companies across the country seminar and exhibition on ‘Green Chemistry and Engineering for Pharma-ceutical Industry’, was recently held in Hyderabad. Organised by the Green ChemisTree Foundation in partnership with Andhra Pradesh Pollution Control Board (APPCB), Bulk Drugs Manufacturers’ Association (BDMA) and Ministry of Environment and Forests (MoEF), the event was attended by 108 representatives from pharma companies across India. The industry partners were Newreka Green Synth Technologies; Aurobindo Pharma; Dr Reddy’s Laboratories and Natco Pharma. The media partner for the event was Express Pharma. The objective of the seminar and exhibition was to bring together the pharma industry, especially the API and API intermediate manufacturers in and around Hyderabad region, to create awareness on the various opportunities of implementing green chemistry and engineering practices to address environmental challenges in their respective manufacturing units. It als helped to connect the techni-

cal representatives (R&D, Plant/Operations and EHS) with the potential environmental solution providers to facilitate collaboration for implementing green chemistry and engineeringbased solutions in their respective firms. The event was inaugurated by key representatives from partnering organisations comprising Shiva Reddy, Sr Environment Engineer, APPCB; Arun Kumar, Chief Environment Engineer, APPCB; Madhsudan Rao, Joint. Chief Environment Engineer, APPCB; Dr Vilas Dhanukar, Global Process R&D Head,

THE OBJECTIVE OF THE SEMINAR AND EXHIBITION WAS TO BRING TOGETHER THE PHARMA INDUSTRY, ESPECIALLY THE API AND API INTERMEDIATE MANUFACTURERS IN AND AROUND HYDERABAD,TO CREATE AWARENESS ON THE VARIOUS OPPORTUNITIES OF IMPLEMENTING GREEN CHEMISTRY AND ENGINEERING PRACTICES TO ADDRESS ENVIRONMENTAL CHALLENGES IN THEIR RESPECTIVE MANUFACTURING UNITS 26

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Dr Reddy’s Laboratories; Anil Jain, President Operations (API division) Aurobindo Pharma; Radha Krishna Murthy, Advisor, BDMA and Nitesh Mehta, Founder Director, Newreka Green Synth Technologies and Green ChemisTree Foundation. The event comprised two sessions and the first one consisted of presentations aimed to orient the participants on the overall context of implementing green chemistry and engineering, highlight the environmental challenges; deliberate on the emerging trends in regulations; and the profit-centric approach in ‘managing’ effluents. A panel discussion on the theme of ‘Barriers to implement green chemistry and potential strategies’ with presentations on successful case-studies by pharma companies and learn from experience sharing, ended the session. The second session was the ‘Technology Showcase’ which consisted of presentations by six technology solution provider companies. They shared details of their products, services and technologies and demonstrated how these technologies can be be commercially evaluated for their implementation to address some of the immediate and mid-term environ-

mental challenges in the areas of green process alternatives; bio-based ‘greener’ alternative catalysts; solvent recovery solutions; recyclingat-source technologies for reducing the e-factor (i.e.: kgs of waste generated behind per kg of production); zero liquid effluents discharge facilities; green engineering through homogeneous and micro-reactor technologies. Speakers at the seminar and exhibition also included Dr Dhileep Krishnamurthy, Vice President and Head of R&D - API Services, Piramal Enterprises; Dr N Lingaiah, Indian Institute of Chemical Technology; Dr Kushal Manudhane, Manager, Process Engineering, Dr Reddy's Laboratories; Dr Naveen Kolla, DGM – R&D, Mylan Pharmaceuticals; Sandeep Bijamwar, Business Head API, Advanced Enzymes Technologies; Shailesh Dhume, Manager - Process lead, Bayer Technologies Services; Dr Sanjiv Bachal, Managing Partner, Equinox Services, Dr Raghu Palle, Business Partner, Ecologic Technologies; Dr Komal Maheshwari Joshi, Green R&D Manager, Newreka Green Synth Technologies; Amit Udgirkar and Senior Manager – Environmental Engineering, Praj Industries. EP News Bureau-Mumbai April 16-30, 2013

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Goa gets its first clinical research centre VerGo Clinicals at Corlim, near Panjim is spread across 40, 000 sq ft area Sachin Jagdale Goa erGo Pharma Research has launched Goa’s first clinical research centre, VerGo Clinicals, located at Corlim, near Panjim. The facility was inaugurated by internationally renowned neuro surgeon, Dr Premanand Ramani. Speaking at the event Ramani stressed on the requirement of having more such facilities in Goa. The facility is spread across 40, 000 sq ft on a total plot size of 3.5 acres in a private industrial park. The 100-bed unit has departments of bioanalytical, clinical research, regulatory affairs, pharmacovigilance and data management, a fully functional ICU and pathological testing centre for conducting Bio Equivalence and Bio Availability (BABE) studies. Dr Nitin Borkar, Founder Partner and Chief Executive Officer, VerGo Pharma Research said, “Complete

April 16-30, 2013

development solution, from concept to approval can be provided with VerGo Clinicals.” Clinical trials are one of the most critical steps in the expensive drug discovery programmes and also helps generic pharma companies establish bio-equivalence with innovator products. The data generated from the study would determine the future regulatory approval for their drug or formulation. High speed, high quality data and accessibility to the required quantum of sample size are of prime importance for any CRO. It is crucial to have the GxP compliant facility, qualified experienced staff and the right volunteer pool. VerGo Clinicals has team members with versatile experience, having national and international regulatory environment exposure. VerGo Clinicals has already started its operations. The facility has diverse volunteer database, with a capacity for catering upto six to nine BABE projects a month and also take up late phase clinical

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studies. VerGo Clinicals is targeting compliance to global regulatory agencies like US

FDA, UK MHRA, MCC and TGA. sachin.jagdale@expressindia.com

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W H AT ’ S INSIDE

MANAGEMENT INSIGHT FOR MANAGING PHARMA

SC verdict on Glivec: An IP milestone PG 31 Sustainability reporting in the pharmaceutical sector: Prescription for pharma PG 34 The case of marketbased pricing PG 39

PHARMA PACKAGING 41 RESEARCH 84 PHARMA ALLY 85 PHARMA LIFE 86 28

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April 16-30, 2013

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First compulsory licensing, and now compulsory CSR? The Companies Bill 2012, passed by the Lok Sabha last December, mandates that certain companies will have to spend at least two per cent of the average net profits of the three immediate preceding years on activities related to corporate social responsibilities (CSR), every year. The companies to be impacted by this norm are those with a net worth of Rs 500 crore or turnover of Rs 1,000 crore or an average net profit of Rs 5 crore in last three financial years. Various reports estimate that at least 30-odd Indian pharma companies would fall into this category and around Rs 300350 crore would have to be set aside for CSR annually. Surya Bansal, Program Manager, Sustainability, Manufacturing & Process Consulting, Frost & Sullivan agrees that there is a huge investment that will have to be earmarked in the name of CSR. What remains to be seen, she opines, is whether CSR and sustainability initiatives need to be brought under the same umbrella so that in the end, an organisation invests in bettering society and is simultaneously able to work towards more sustainability. The Bill is expected to be tabled in the Rajya Sabha in the upcoming monsoon session and will also need the Presidential nod before it is passed. Granted that the more-than-half-a-century-old Companies Act, 1956 needed an extensive overhaul and was way past its 'use by' date. But given the other regulatory salvoes being fired on the pricing and other fronts, how are these Indian pharmaceutical companies viewing this added expenditure? It is still too early to look for reactions from pharma companies to this provision, April 16-30, 2013

PARESH PARASNIS

SURYA BANSAL

CHAITANYA KALIA

Head Piramal Foundation Piramal Enterprises

Program Manager Sustainability, Manufacturing & Process Consulting Frost & Sullivan

Partner Climate Change and Sustainability Services Ernst & Young

Professional organisations do not just focus on the inputs and investments in CSR. A large part of the effort is in measurement of the outputs â&#x20AC;&#x201C; generally referred to as Impact Assessment.

There is a huge investment that will have to be earmarked in the name of CSR

What is unique about the Indian situation is that a specific target amount has been mentioned. While governments urge companies to invest in CSR, no where in the world has any figure been specified

opines Hitesh Sharma, Tax Partner & National Leader â&#x20AC;&#x201C; Life Sciences Services, Ernst & Young. Companies which have CSR programmes are doing so irrespective of such provisions but he concedes that the provision might get them to look at CSR more seriously. The move is in line with most countries in the world, points out Chaitanya Kalia, Partner, Climate Change and Sustainability Services, Ernst & Young; where corporates and industry are being asked to contribute to the development of the country/society by providing employment, to achieve Millennium Development Goals, etc. But the Indian authorities seem to have gone one step further. What is unique about the Indian situation is that a specific target amount has been mentioned. While governments urge companies to invest in CSR, no where in the world has any figure been specified, says Kalia. The intentions of the Government of India (GoI) are indeed laudable in the light of the 'jobless recoveries' being seen in major economies like the US and the sluggish growth rates in India as well. But will such a stipulation do the trick? Analysts are not holding their breath on this one

because it could remain a toothless provision. Kalia points out that since there is no penalty provision, which means that companies cannot be penalised for not implementing this provision, it could result in a delay/time lag before companies actually start implementing this. However, he feels that most companies will do so to meet corporate governance (norms) and concedes that it is a starting point.

dominantly voluntary, with the steadily increasing importance that it is gaining globally, companies (in India) will have to start reporting on the impact they have on the economy, the environment, society and the organisation itself. There is no doubt that current spends on CSR by Indian pharma companies will have to be increased because they are much lower than the target of two per cent of profits mandated by the Companies Bill 2012. Secondly, says Kalia, companies which already had CSR programmes will maybe have to re-look/ re-structure them to be in line with the provision because Schedule 7 of the Companies Bill 2012 specifies six-seven areas where the CSR needs to be done. Commenting on GoI's intention, Bansal comments that Indian pharma companies are beginning their journey towards sustainability while global pharma companies are already far ahead. Analysing the difference in approach, she reasons that the latter have taken sustainability through their strategy and have defined the road-map. Given the GoI's recent initiatives, pharma companies, along with other industries, will

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Laggards so far When it comes to CSR and environment, social and governance disclosures, pharma companies lag behind the rest of India Inc. A joint report by Deutsche Gesellschaft fur Internationale Zusammenarbit (GIZ), Global Reporting Initiative (GRI) Focal Point India and Thought Arbitrage Research Institute (TARI) released last August, showed that only around 10 per cent of the firms in the BSE 200 bring out sustainability reports. This fact is borne out by the latest TARI report, 'Sustainability Reporting in the Pharmaceutical Sector: Prescription for Pharma' (see pages 34-38 in this issue) where the authors make the point that while reporting on sustainability metrics is pre-

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soon have to do the same.

Good intentions In the past few years, the GoI has taken some stern steps to make CSR and sustainable development initiatives mandatory for Indian companies. For instance, the Department of Public Enterprises has mandated that public sector units should invest 0.5 per cent to five per cent of their net profit on CSR activities. Way back in July 2011, the Ministry of Corporate Affairs released a booklet, titled 'National Voluntary Guidelines on Social, Environmental and Economical Responsibilities of Business', aimed at strengthening the Indian tradition of involvement of businesses in social welfare and development. The then Union Minister for Corporate Affairs in the Ministry of Corporate Affairs, Murli Deora had commented on how Indian businessmen followed the traditional practice of spending surplus profits on philanthropy and how many were inspired by Mahatma Gandhi to do so. But have Indian businesses moved beyond charity towards responsibility? As Bansal puts it, the challenge now is for companies, across sectors, to take CSR through the strategic route. The need of the hour is to be able to identify the business risks and opportunities (both short term and long term) and plan these CSR investments in such a way that the whole process itself is sustainable, she avers.

Pharma CSR in India Some of the biggies of Indian Pharma Inc already have well documented CSR activities. As head of Piramal Foundation, Paresh Parasnis makes the point that the Foundation has been operational over the last five years in the specific areas of education, and empowerment, with projects in each of these areas across a large geographic area in India. For example, Piramal Swasthya, has around 100 mobile health vans across six states (Rajasthan, Andhra Pradesh, Maharashtra, Assam, Orissa, Karnataka). Parasnis indicates that the scale has been growing over time and the funding plans have been drawn up considering the current plans and

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focus of these projects – as such, the increase in funding will not be attributable to the CSR requirements of the Companies Bill, but more on the requirements and expansion of each of the projects. Another long term contributor is Lupin Human Welfare & Research Foundation (LHWRF), which was set up almost 25 years ago in October 1988 with the objective of providing an alternative model for rural development in the country. Dr Reddy’s Laboratories set up Dr Reddy's Foundation in 1996, while Ranbaxy set up Ranbaxy Sanjeevan Swasthya Sewa in 2010. Among the other noteworthy CSR initiatives are those from Biocon and Cadila Healthcare. Sustainability and CSR go hand-in-hand as both are measures of a company's management policy to be a responsible corporate citizen. Bansal adds that Jubilant Lifesciences has been one of the first few Indian pharma companies to publish a sustainability report but on the whole, the approach to sustainability has been in bits and pieces by other companies, e.g. certain companies are focusing only on their social activities while some have started the process by preparing an internal sustainability report and few are talking of its environmental impacts. Parasnis reveals that Piramal Enterprises is currently working on their first Sustainability Report which they expect to release this year.

Protecting future markets The history of CSR in India has many examples of philanthropy evolving from individuals' charity or philanthropy to CSR, corporate citizenship and responsible business. But in most companies, CSR still equals philanthropy and is therefore done in an arbitrary manner. Hopefully the new norms in the Companies Bill 2012 will push companies to take it more seriously. What are the driving goals or rationale for CSR in today's world? The title of a 2008 white paper released by KPMG says it all: 'Corporate Social Responsibility: Towards a Sustainable Future'. But will a regulatory push do the trick and open the eyes of the corporate world to the rationale behind CSR? In www.expresspharmaonline.com

HITESH SHARMA

KAUSHIK DATTA

Tax Partner & National Leader – Life Sciences Services Ernst & Young

Director and Founding Member Thought Arbitrage Research Institute (TARI)

Companies which have CSR programmes are doing so irrespective of such provisions but the provision might get companies to look at CSR more seriously

CSR will be left to the discretionary goodness of those managing a corporation if a direct linkage of profits with environmental and social objectives are not established

a white paper titled, 'Governance Beyond the Corporate Veil', Kaushik Datta, director and founding member of TARI points out that unless the direct link between profits, and environmental and social objectives is established, CSR will be left to the discretionary goodness of those managing a corporation. Citing the millions spent by Bill Gates and Microsoft on AIDS and education, he makes the point that investment in development is a business protection and sustainability cost and this belief will channel resources from private enterprises towards holistic development of people and nations. It also protects and sustains their markets of the future – the youthhe says, also citing the Tata Group and initiatives like the ITC's eChoupal, which could drive prosperity among farmers in the future. Hopefully, the new norms will force companies to track their CSR programmes more closely because it is being funded by their own profits. Parasnis hopes that companies take a strategic view of this opportunity to ensure that the projects they support are in a position to expand their scale of operation (over time and across geographies) and become sustainable – both, from a financial standpoint as also the robustness of the solution implemented.

Impact assessment on various parameters will also have to be a key part of a corporate's strategy to gauge the effectiveness of a programme. “Professional organisations do not just focus on the inputs and investments in CSR/socially relevant projects,” says Parasnis. “A large part of the effort is in measurement of the outputs – generally referred to as impact assessment. The idea behind an impact assessment is to measure if the programme is leading to measurable change in the indicators – for example, reduction in infant and maternal mortality, improvements in disposable incomes, increase in rate of savings, improvement in student learning outcomes, reduction in school dropout rate etc. Any positive change in indicators of human development (that are targeted by any programme) would be compared with the base line data/targeted level of improvement to measure the success (or otherwise) of a programme,”he explains. Obviously, we will need to wait a couple of years to judge the impact of the new provisions proposed in the Companies Bill 2012 but by all indications, Indian Pharma Inc seems to be gearing up to earn its stripes as a more responsible corporate citizen. viveka.r@expressindia.com April 16-30, 2013

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INSIGHT SC verdict on Glivec: An IP milestone Experts stress that the verdict should not be seen as a case of weak IP rights. An Express Pharma report n April 1, In a 112page judgment, the Supreme Court of India upheld the refusal by the Patent Office to grant a patent to Novartis for the ßpolymorphic form of imatinib mesylate. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India saw this ruling as a setback for patients that will hinder medical progress for diseases without effective treatment options. “We strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation especially for unmet medical needs,” he said explaining that the company brought this case because they strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. When asked if the company would appeal the judgment or consider any further legal recourse, he said he needed to analyse the judgment completely before commenting on such action. For the same reason, he refused to comment on the implications of the judgment (Para. 195, page 96) which mentions that the appeals filed by Novartis “are dismissed with cost.” When quizzed on the larger impact of today's judgment on other MNC pharma, he predicted, “No MNC will invest in R&D in India after this judgement. R&D investment will move to places which have an ecosystem which protects intellectual property. For instance, China has seen an inflow of such investment in the past few years while India has not,” he pointed out. Though Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon agreed that the Supreme Court ruling on patent grant to Novartis for Glivec is certainly very disappointing for Novartis, she analysed that it is not a sur-

April 16-30, 2013

prise as it was a borderline case that was based on a decision related to recognising incremental innovation, which the Indian Patent Law does not favour. She, however, opined that this decision should not be confused with the subject of patentability of original innovation. “India is a signatory to WTO, TRIPS and must respect intellectual property associated with original innovation. India needs to be seen as actively encouraging innovation and creating an enabling ecosystem that delivers affordable innovation in order to find solutions to meet the burgeoning healthcare needs of Indian patients.” Criticising the Indian Government and the pharma industry in India (both global and local companies), she said, “The Indian government has abdicated its responsibility to provide life saving drugs to its patients, which has led to frivolous compulsory licensing issues jeopardising India’s image as a country that safeguards IP and encourages innovation. However, MNCs must also address access and affordability by engaging with the Indian Government to evolve a pricing mechanism that is linked to purchasing parity.” Also in the same vein, Dr Swati Piramal, Vice Chairperson, Piramal Enterprise, commented that the Supreme Court judgment should be seen on the merits of one case rather than viewing it as weak IP rights in a country. She points out that even the US Supreme Court is debating patent rights on a diagnostic gene assay for breast cancer.

Legal eagles dissect the order Hailing this as a landmark judgment, DG Shah. secretary general, Indian Pharmaceutical Alliance, commented that it will serve to set at rest the controversy that was raised regarding the scope of section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the www.expresspharmaonline.com

availability of affordable generic versions. Shah pointed out that imatinib is on the National List of Essential Medicines and is an important drug in the treatment of several cancers such as certain blood and stomach cancers. The decision of the Supreme Court will come as a relief to patients suffering from these dreadful diseases as several Indian companies including Cipla, Ranbaxy and Natco can continue marketing imatinib at a fraction of the cost of the Novartis product. Quoting Justice Chinnappa Reddy (in Para. 27, 28 and Para 159), Dr Gopakumar G Nair, Gopakumar Nair Associates pointed out how the Learned Bench emphasises “9. … A

may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.” Such observations will hopefully minimise the frivolous and costly litigations being undertaken by MNCs in India, he opined. In conclusion, he commented that the fact that the Novartis appeal have been rejected with COSTS, speaks volumes for the finality in the matter.

One up for Indian Pharma Inc

statute is best understood if we know the reason for it. The reason for a statute is the safest guide to its interpretation.” and “A statute is best interpreted when we know why it was enacted.” Nair commented that the order has adopted an excellent techno-legal approach to dissect the disputed Gleevec Patent application of 1998 via-a-vis the prior art Zimmerman patent of 1994 to expose lack of novelty and inventive step and consequent non-patentability, and opines that “the Supreme Court has hit the last nail on the decade-long debate on constitutional validity on Sec. 3(d) and on the patent abuse practices by “evergreening.” Putting forth an example of the “many beautiful gems of wisdom” in the order, Nair quoted: “We certainly do not wish the law of patent in this country to develop on lines where there

Initial responses from Indian pharmaceutical majors have hailed the verdict as an affirmative action, pending a more detailed analysis of the 112-page judgment document. As one of the companies directly benefiting from this decision, Dr P Bhaskara Narayana, Director and Chief Financial Officer, Natco Pharma welcomed this judgement and underlined that ”the uniqueness of this judgement is that it has attempted to distinguish between a “genuine” invention and a “non-genuine invention” which does not increase the efficacy of the drug.” Commenting on the judgment, Dr Y K Hamied, Founder and Chairman, Cipla said, “The judgment in the Novartis case is a victory for patients both in India and around the world. We are pleased with the judgment which prevents the use of frivolous patents to deny access to medicines for patients. India, being the Pharmacy Capital of the World can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines. This judgement will not only benefit patients in India, but patients around the world. EXPRESS PHARMA

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We will review the judgment in detail before commenting further. Likewise Leena Menghaney, Médecins Sans Frontières Access Campaign Manager, India said that the verdict appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines. “Novartis' attacks on the elements of India's patent law that protect public health have failed. The Supreme Court's decision prevents companies from abusing the patent system to get unwarranted patents on existing medicines, to block pricebusting generic competition on HIV and other essential medicines. This confirms that all patent offices in India have to use this interpretation and the law is now clear and must be strictly applied,” she concluded. Welcoming the judgement, Daara Patel, Secretary General, Indian Drug Manufacturers Association (IDMA) said, "IDMA has all along fought the vested interests in getting the Section 3(d) strengthened in the Patents Act and our stand is vindicated by the Supreme Court. Section 3(d) ensures that ‘ever-greening’ of patents by mere discoveries and frivolous improvements are denied. This landmark judgement will give the much needed boost to Indian generics and our poor patients will be benefited by faster availability of competitive generic medicines at affordable prices This judgement is also a warning to Western pharmaceutical firms that are increasingly focusing on India just to drive their sales thru exorbitant prices. The judgement will also help secure the supply of affordable medicines for millions of the world’s poorest."

Way forward for Novartis Speaking at a press meet soon after the SC verdict was announced, at Novartis India's Mumbai head office, Shahani said that though they were disappointed with the decision, they would continue with the full donation programmes, through which the company provides Glivec free of charge to 95 per cent of patients prescribed the drug in India, currently more than 16,000 patients. The remaining five

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per cent of patients are either reimbursed, insured, or participate in a very generous co-pay programme. Since Novartis began its first donation programme in 2002, the company has provided more than $1.7 billion worth of Glivec to patients in India. When quizzed on how this verdict would impact profits of the company, Shahani said that they do not break out profits or revenues for separate products but underlined that in India, “we do not make any profits from Glivec.” “We believe that Glivec is a breakthrough drug which has changed the way cancer research will be done globally. We will continue to invest in India but on a more cautious note.” Hoping that the ecosystem for patents in India will improve, he stressed,”It (the protracted legal battle) was not just about Glivec. It was about getting clarifications You have to test the system. In addition to seeking a patent for Glivec, the company filed the case to help clarify these unique aspects (Sections 3(d) and 3(b)) of the patent law. We will continue to apply for product patents in the future as well. We understand the value of generics. But without patented drugs, there will be no generics pipeline in the future.” Dr Ajaykumar Sharma, Associate Director, Pharma & Biotech, Healthcare Practice, Frost & Sullivan, opined, "The direct impact (of this judgement) on Glivec (on Novartis) is negligible as the generics were already selling in the market and the patient assistance programme launched by Novartis is a phenomenal success in increasing its access among Chronic Myeloid Leukaemia (CML) patients. But the long term and future prospects of its various molecules which it intended to launch in the Indian market with improved physicochemical properties will not get patent protection in future.

Strategy change Clearly, the Glivec verdict will impact the India strategies of pharma MNCs. Dwelling on the impact on other MNC pharma companies, Sharma predicted, "They will now try to get their product patented first. If it doesn't happen then they may opt to not launch www.expresspharmaonline.com

the same or else they may look at technology transfer to Indian companies or partners in India to manufacture and sell across the developing countries. Also evergreening strategy will definitely be out of the drawing board for India." Giving his take, Amit Backliwal, Managing Director, South Asia, IMS Health Information and Consulting Services India said, “Indian market opportunity is quite large to be ignored by any major pharma company today and going forward. However, for any company now to play in India, business models have to be adapted and aligned to the prevailing regulatory and market conditions that exist. Larger play involving alternative funding, market access, patient access programmes would becoAll healthcare stakeholders (pharma/payer/provider) need to start looking at middle and bottom of pyramid as well with innovative solutions to address overall access to healthcare concerns that exist.”me more important now than ever as clearly, the market is moving towards a more volume and price sensitive area." Speaking from the Indian generics side of the fence, Sharma of Frost & Sullivan reasoned, "The recent cases of Pfizer's Sutent, Roche's Pegasys will not be opened as the 3(d) definition analysed by Supreme Court will not grant a patent status to these drugs in India. Indian generics can freely manufacture and sell these drugs across India and other developing nations." Sharma predicts that there will be many more patent challenges coming to India in the near future which will move from lifesaving drugs to even chronic therapy medications. In fact, Glenmark is the first Indian pharma off the block on this prediction, when it launched a cheaper generic version of Merck’s blockbuster anti-diabetes drug Januvia (sitagliptin phosphate) a few days after the SC verdict on Novartis. Merck filed a patent infringement lawsuit against Glenmark in the Delhi High court but in line with the Glivec verdict, was refused interim relief.

Second filter for patenting The verdict will continue

t be analysed and will guide future judgements as well. As TC James, Consultant Research and Information System for Developing Countries (RIS), analysed, “The court rightly said that it was second filter for patenting. This implies that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant is not patentable. It goes on to clarify that, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers etc will be treated as the same substance unless they differ significantly in properties with regard to efficacy.” In his opinion, the intention of this provision is to ensure that only genuine inventions get patents and not frivolous or minor improvements. The section, though not specific to pharmaceuticals, has special relevance for that sector, since most of the applications for ever greening are in drugs and chemicals. In fact, the transnational pharma companies were challenging that provision, without realising that the portion they were challenging was an enabling and clarificatory section. James believes that the Hon’ble Supreme Court has now finally settled the interpretation by stating that patent applicants have to satisfy the criterion of substantial improvement of efficacy, the term has already been interpreted by the Madras High Court as therapeutic efficacy. This will greatly help the generic industry in India who were lately finding the going tough. He also highlights that the court also rightfully highlighted the public interest angle. This has already been stated in Articles 7 and 8 of the Agreement on Trade Related aspects of Intellectual Property Rights as well as in section 83 of the Patents Act. What is now required is a very strict application of section 3(d) to all patent applications by the Patent Office. That would April 16-30, 2013

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definitely improve the quality of patents granted in India and also help in the rapid industrialisation of the country.Other countries who were contemplating introducing section 3(d) like provisions in their patent law can also now move forward with more confidence, concluded James.

A victory for public health Weighing in on the public health angle, Sakthivel Selvaraj, Senior Health Economist, Public Health Foundation of India, New Delhi summarised that the verdict restricts patents for therapeutically breakthrough drugs, but utilises current safeguards available to developing countries. Calling it a landmark judgement, he listed the several aspects why this is the case. The landmark judgement is expected to improve affordability of some patented medicines to patients in India as well as in other developing countries. These are considered essential and life-saving, such as, Glivec in this case. India’s move towards a stringent product patent regime since 2005, has put several life-saving drugs out of reach of common man. This will continue to hold true. However, if the latest verdict were to be in favour of Novartis, it would have allowed a plethora of known molecules to be patented, called as evergreening, making drugs unaffordable to a large segment of India’s population. To Novartis’ complaint that the patent environment in India is not favourable to them and hence will scale down or stop investing in R&D in India, he said, “The fact is except for few, none of the Big Pharma has ever invested significantly in the pharma sector in India in the past. Novartis’ R&D expenses in 2012 in India are a paltry 0.03 percent of its overall expenses. Even in terms of production, drug transnational corporations act more as trading agents, than actually producing in their plan. Largely, drug multinationals either outsource their production to Indian companies or import it from their own country. Even foreign investment has been insignificant, as less than two per cent of overall foreign investment went into pharma sector in the past two decades. Much of last four-five years’ forApril 16-30, 2013

eign investments were of ‘brown-field’ investment category buying up Indian companies rather than investing in plants, called ‘green-field’ investment.” He pointed out that India, a global pharmacy, supplying good quality essential and life-saving drugs is able to do so at a fraction of what Big Pharma offers. This is true of anti-retroviral drugs, cancer medicines and other life saving drugs. The annual cost of treatment of leukaemia per patient offered by Novartis for Glivec is over Rs. 15 lakhs while the same is offered by Indian generic companies at a price of Rs. 10,000. Last year, Indian generic drug maker, Natco obtained compulsory licenses to sell it at Rs. 8800, while the same is being sold by Cipla at less than Rs. 7000. On the other hand, Bayer, whose Sorafenib tosylate was under question, was selling at that time for Rs. 2.8 lakhs per patient per month. In conclusion, Selvaraj said, “It is clear that the current patent system makes essential drugs unaffordable and therefore, there is a need to not only restrict patents for therapeutically breakthrough drugs, but utilise current safeguards available to developing countries, such as, compulsory licensing for patients’ advantage.”

Protecting the ‘pharmacy of the world’ “This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF," said Dr Unni Karunakara, MSF International President. “The Supreme Court's decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.” Underlining this issue, Menghaney says, “Patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected.” (With inputs from Shalini Gupta, Usha Sharma and Viveka Roychowdhury) www.expresspharmaonline.com

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REPORT Sustainability reporting in the pharmaceutical sector: Prescription for pharma Sustainable development is vital to not only improving a company's commitment to its stakeholders but also in reducing costs through efficient use of scarce resources and processes. Kshama V Kaushik and Rosanna M Vetticad, in this sustainability report, conducts a study about top 10 Indian pharmaceutical companies and present a prescription for the indsutry ustainable development is vital to not only improving a companyâ&#x20AC;&#x2122;s commitment to its stakeholders but also in reducing costs through efficient use of scarce resources and processes. The pharmaceutical industry consumes large quantities of economic, natural and human resources. The Indian pharma industry is one of the largest in the world in terms of volume. It has been growing at a rapid pace post the liberalisation of the 1990s and changes in the Indian patent laws in 2005. In order to maintain and grow this stature, the industry will have to demonstrate commitment to sustainable development by use of innovative approaches to manufacturing processes and developing cleaner technologies. Sharing sustainable practices through the supply chain is also crucial as a symbiotic relationship exists between a company and its stakeholders including cus-

Kshama V Kaushik

Rosanna M M Vetticad

tomers and suppliers.

Indian pharma industry background The Department of Pharmaceuticals (DoP) administers the Indian pharma industry set up under the Ministry of Chemicals and Fertilisers in 2008, with a vision to make India the largest global provider of quality medicines at reasonable prices1. According to the DoP, the Indian pharma industry ranks third globally in terms of volume and 14th in terms of value. This represents around 10 per cent of the total global production and also 20 per cent of the total volume of global generics. Thus every fifth tablet, capsule and injectable in generics drugs consumed anywhere in the world is manufactured in India2. From a $1 billion industry in 1990 it has grown to an over $20 billion industry in 2010 (40 per cent of which are exports). The Indian industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing technologies. India is the only country with the largest number of US FDA compliant plants (more than 100) outside US, 793 WHOGMP approved plants, and 153 European Directorate of Quality Medicines (EDQM)

Table 1: Projected growth (Rs crores)

approved plants with modern state of art technology.

Financial performance and growth The industry has witnessed robust growth since the beginning of the 11th Plan in 2007 and continues to grow rapidly3. The Annual Report of the DoP forecasts a 14 per cent increase in revenue in 201112 vis-Ă -vis 2010-11. This increase is driven primarily by export oriented companies as the sharp depreciation of the rupee is expected to result in higher export realisation. The DoP projects the industry to grow to ` 288,000 crores by 2016-17 and ` 481,000 by 2019-20.

Fragmented industry The Indian pharma industry is a large and fragmented one. It comprises of approximately 10,500 units, most of which are in the unorganised sector. 300-400 of these fall in the medium to large organised sector. It is interesting to note that 36.5 per cent of the total market share is contributed by the top 10 manufacturers. The medium and large domestic companies in fact

have been the drivers of growth, contributing 75 per cent of domestic sales and over 90 per cent of exports4. However, only two per cent of units in India are ` 500+ crore generating units, whereas 70 per cent of all the units have turnovers of only up to ` 10 crores5. With blockbuster drugs getting off-patented and resultant rising R&D costs it is becoming increasingly difficult for global companies to maintain their bottom-lines. In order to save costs therefore they have resorted to outsourcing R&D and manufacturing activities. A research cited by the working group set up by the planning commission suggests that this segment is expected to grow by 30-35 per cent6.

Sustainability reporting requirements The pharma sector does not have any specific sustainability reporting requirements in India or globally, whether mandatory or recommendatory in nature. However globally accepted reporting frameworks applicable to all sectors can also be used by the pharma

Table 2: Turnover-wise distribution of units Turnover (` crores)

per cent distribution

0-10 crore

70 per cent

10-50 crore

20 per cent

50-100 crore

5 per cent

Year

2010-11

2016-17*

2019-2020*

100-500 crore

3 per cent

Turnover

1,04,944

288,000

481,000

500 + crore

2 per cent

*projections

*Export numbers are provisional

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Table 3: Sample of Indian companies Company

Net Sales (Rs Crores)

Ranbaxy Laboratories Ltd

7,687

Cipla Limited

6,978

Dr. Reddy's Laboratories Ltd

6,686

Lupin Ltd

5,364

Aurobindo Pharma Ltd

4,285

Sun Pharmaceutical Industries Ltd

4,016

Cadila Healthcare Ltd

3,152

Jubilant Life Sciences Ltd

2,641

Wockhardt Ltd

2,560

Ipca Laboratories Ltd

2,353

*No specific framework followed

Table 4: Sample of global companies Rank

Company

Country

Sales

Pfizer

United States

$67.4 B

Novartis

Switzerland

$58.6 B

Sanofi

France

$43.2 B

Merck & Co

United States

$48 B

103

Roche Holding

Switzerland

$45.3 B

119

GlaxoSmithKline

United Kingdom

$42.5 B

127

Abbott Laboratories

United States

$38.9 B

142

AstraZeneca

United Kingdom

$32.4 B

208

Eli Lilly & Co

United States

$24.3 B

217

Bristol-Myers Squibb

United States

$21.2 B

per their latest available annual reports7. As indicated above, these companies only form part of the two per cent group of all the pharma units in the country, whereas a majority of the units fall in the significantly smaller revenue segments (Refer SectionFragmented Industry). The top 10 global pharma companies (based on sales) have been selected from Forbes’ ninth annual list of Global 2000 companies published in April 20128.

Quality of sustainability/CSR reporting of Indian companies Of the 10 Indian companies in our sample only two have detailed sustainability reports, also observed in a joint research study conducted by the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) India, the Global Reporting Initiative (GRI) Focal Point India, and Thought Arbitrage Research Institute (TARI)– “Sustainability Reporting Practices and Trends in India 2012.” According to the report, considering the large manufacturing base in

India, the pharma sector lags considerably behind in reporting on sustainability9. Both the companies mentioned above used the GRI reporting framework, however only one company, viz Jubilant Life Sciences has a published report that is self-declared, externally assured, with a GRI checked application level of A+. This means that it has made all profile disclosures, all disclosures on management approach and applied all core performance indicators set out in the GRI framework under each of the economic, environmental and social categories, or provided reasons for omission of any indicator10. The company has been publishing its sustainability performance since 2003; this report covers the period April 1, 2011 to March 31, 2012 and was prepared under the GRIG3.1 reporting guidelines. The second company referred to above (viz. Dr Reddy's Laboratories) has been reporting on its environment, economic and social performance for several years now, the eighth report being for the two-year period April 1, 2010 to March 31, 2012. The report has been prepared in

sector. These are: ● Environment impact assessment ● UN Global Compact (UNGC) and Communication on progress ● Carbon disclosure project ● Global Reporting Initiative (GRI) framework ● Business Responsibility Report (BRR) and National Voluntary Guidelines (NVG) issued by SEBI and ministry of corporate affairs

Companies in the sample (Indian/global) For the purpose of this report we have selected the top 10 Indian pharma companies based on net sales as April 16-30, 2013

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accordance with the GRI G3 reporting framework11. Six of the remaining eight companies have discussed corporate social responsibility (CSR) activities and/or various aspects of their environment, economic and social performance either through disclosures in their annual reports or on their websites or both. No specific reporting framework has been adopted and the degree and extent of disclosures vary from company to company. The two remaining companies, viz. Sun Pharmaceuticals and Wockhardt do not mention any aspect of sustainability or CSR activities either in their annual report or on their websites. In fact, the annual report of Sun Pharmaceuticals for the year 2011-12 is not available on the company website; the annual report for 2010-11 simply makes the following statement –“At the close of a relatively event-free, disaster-free year, your company persisted with participation in activities at the local, grassroots level across health and education. In the past, support has been offered towards disaster relief as well as participation in the facilitation of civic utilities around the plants / research centers. Your company remains interested in these contributions12.” In contrast with the above, although the extent of reporting may vary, all global corporations in our selection have published Sustainability Reports – whether separately or on their websites.

are - Capacity Planning and Optimisation, R&D Effectiveness and Portfolio & Mix: Customer and Product Concentration. Thus complete correlation does not exist between risks identified in the two reports. Dr. Reddy’s Sustainability Report does not discuss any risks.

Risks identified by Indian vis-à-vis global companies In addition to the above risks that have been identified by Indian companies, global corporations identify two additional risks, risks related to information technology and alliances and acquisitions. The risks associated with information technology are the risk of exposing critical information or sensitive data regarding business due to information security systems and risk of losing information from cyber or hacker

attacks. Alliances and acquisitions related risks are the risks associated with acquiring other businesses or disposing businesses. It is interesting to note the difference in coverage between Indian and global companies when it comes to environment health and safety related risks. While the 60 per cent of the global companies in our sample have identified it as a risk, only 20 per cent of the Indian companies have.

CSR/Sustainability matters reported by companies in the sample Here we discuss the CSR initiatives taken by the companies in our sample. As two companies have published sustainability reports and two companies do not discuss CSR either in their annual reports or the websites, the discussion below is limited to the matters reported by the remaining

six companies. The extent and quality of discussions varies from report to report. Matters discussed include:

Environment: Four of the six companies covered in Figure 7 have included a discussion on their environment management or environment health and safety systems. Although, as indicated above, hardly any of the companies have identified any environment related risks. There is no discussion either bio-hazards. Three companies have discussed management of effluents and reduction of their carbon footprint, as well as measures for recycling waste water. It is no surprise that all six companies have made disclosures related to conservation of energy and the measures undertaken to achieve this, as such a disclosure is a statutory requirement under the

Risks identified/ risks reported by Indian companies The risks identified the Indian companies in their annual / sustainability reports are shown in Figure 5: Risk Disclosures. Jubilant Life Sciences which has a GRI checked A+ application level sustainability report has discussed its key risks in the Sustainability and Annual Reports. Key risks identified in the Sustainability Report and not mentioned in the MDA of the Annual Report are- Business Interruption Due To Force Majeure and Third Party Liability Risks. Additional risks discussed in Annual report not included in the Sustainability Report

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companies Act, 1956. The two companies excluded from the chart have also made these disclosures (related to conservation of energy).

Social: Almost all companies have undertaken community development work which has been discussed in the annual reports. This includes low cost sanitation and housing, installation of drinking water huts, economic development of communities including skills upgradation, etc. four out of six were engaged in providing education in the rural areas in which they operate, providing scholarships to deserving students, helping local schools with stationery, carpets, etc. Similarly four of the six companies provided information on occupational health and safety and measures taken to achieve this. Only two companies discussed their quality systems, safety trainings and health care initiatives like rural health camps, healthcare education, palliative care, price reduction in select drugs.

Jubilant Life Sciences merely touches upon the subject. Their sustainability report mentions that they have a “Green Supply Chain Policy” which also includes ensuring human rights. Under this policy, the supply chain management division is required to ensure that “human rights and related

commitments are obtained from the contractors and suppliers” in the contracts signed with them. None of the remaining eight companies discusses this subject in their annual reports or their websites.

Counterfeiting: Counterfeiting is a major

risk in the pharma industry world-over. World Health Organisation (WHO) defines counterfeit medical products as ones that are “deliberately and fraudulently mislabeled with respect to identity and / or source” (WHO/IFPMA, 1992)13. Unlike substandard medicines where there are

Supply chain management: Considering that contract manufacturing is a growing element in the pharma industry, none of the companies barring one has had a detailed discussion on their suppliers and how they ensure sustainable practices at the supplier end. Dr Reddy’s has a rather extensive discussion in their sustainability report on ‘sustainable sourcing.’ It recognises that every action by individual business associates has the potential to impact the sustainability of every other associate they interact with. For this purpose they have embedded good sustainable practices among all business partners by mentoring each member of the supply chain. Best practices on safety related aspects are also shared with vendors. The company holds bi-annual meets with business partners to focus on quality with periodic training on quality and all new vendors are mandatorily required to undergo a supplier induction training to sensitise them to the company’s business processes and culture. April 16-30, 2013

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problems with the manufacturing process by a known manufacturer, spurious / falsely-labelled /falsified /counterfeit medicines are made by people with the intent to mislead 14. Any kind of counterfeiting therefore has far reaching consequences in terms of social impacts as it affects public health and safety standards thereby threatening human life. Developing countries like India are particularly vulnerable due to weak regulatory control and enforcement. The problem is further exacerbated by factors like scarcity and/or erratic supply of basic medicines, uncontrolled distribution chains, large price differentials between genuine and counterfeit medicines, lack of effective intellectual property rights protection, etc15. A report prepared by TARI for FICCI Committee Against Smuggling and Counterfeiting Activities Destroying the Economy (CASCADE) makes an estimate of the total loss to the industry. According to this report, this is the only sector in India where the Ministry of the Government of India has acknowledged that a counterfeiting market exists, the size of which is 4.95 per cent16. The Planning Commission has estimated a domestic market size including imports at ` 66,437 crores in 2010. Using a compounded annual growth rate of 14 per cent17, the size of the market has been estimated at ` 75, 738 for 2012. Considering a grey market of 5 per cent, the estimated loss to the industry stands at approximately ` 4, 274 crores 18. Estimates made by different agencies vary drastically. Irrespective of the variance in estimates, the analysis above clearly indicates the magnitude of the problem. It would however be pertinent to note that in the sample selected for this report, none of the companies has identified counterfeiting as a risk inherent to the industry. In fact most of the companies have not even discussed the issue even briefly. While three companies (Ranbaxy, Dr, Reddy’s and Cadila) have briefly mentioned the initiatives taken by them to prevent counterfeiting either in their annual reports or sustain-

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ability report, seven have made no mention of counterfeiting at all.

Biohazards and the environment The Indian pharma industry evolved around industrial development clusters set up by various state governments at a time when there was no stringent of environment laws. International customers from developed nations however insist on compliance with local environmental standards which is a big challenge for the industry particularly the small scale units19. In order to see its vision of promoting environmentally sustainable development of the pharma industry come to fruition the DoP has to play a pivotal role in providing financial and technical assistance to improve the financial sustainability of SMEs on one hand and also safeguard the environment from the hazards associated with unplanned growth. Our analysis above shows that

reporting practices. Although reporting on sustainability metrics is predominantly voluntary, with the steadily increasing importance that it is gaining globally, companies will have to start reporting on the impact they have on the economy, the environment, society and the organisation itself. In the Indian context specifically companies across industries will have to gear up to comply with the recently introduced regulatory requirements viz. Business Responsibility Reports (BRRs) and section 135 of the new Companies Bill. BRRs are already applicable from FY 2012-13 to BSE 100 companies. As on March 26, 2013, only Ranbaxy Laboratories (from among our sample for this report) is part of the BSE 100. Based on the information provided above, it is quite clear that Ranbaxy appears to be far from ready to comply with this new requirement. Section 135, shortly expected to become

A REPORT PREPARED BY TARI FOR FICCI COMMITTEE AGAINST SMUGGLING AND COUNTERFEITING ACTIVITIES DESTROYING THE ECONOMY (CASCADE) MAKES AN ESTIMATE OF THE TOTAL LOSS TO THE INDUSTRY. ACCORDING TO THIS REPORT,THIS IS THE ONLY SECTOR IN INDIA WHERE THE MINISTRY OF THE GOVERNMENT OF INDIA HAS ACKNOWLEDGED THAT A COUNTERFEITING MARKET EXISTS,THE SIZE OF WHICH IS 4.95 PER CENT hardly any of the companies has made any disclosures in this risk or even identified it as a significant risk.

Way forward Sustainability reporting in India is still in an early stage across all sectors and only a limited number of organisations exhibit a continued commitment for disclosures. The analysis above clearly shows that the pharma industry in India is way behind in its sustainability www.expresspharmaonline.com

the law, requires companies, among other things, to spend, in every financial year, at least two per cent of the average net profits of the company made during the three immediately preceding financial years to achieve the programs set out in its Corporate Social Responsibility Policy. Indian companies appear far from ready to address the minimum requirements of regulation. The recent Supreme

Court judgement on the Novartis patent for the cancer drug Glivec is likely to give a boost to the industry, both for the manufacturers of generic drugs and research. India exports about $10 billion worth of generic medicines every year, more than any other country; this ruling will therefore be a boon for the industry particularly for the significantly large number of mid-cap and small companies. It will also help India maintain its role as the world's most important provider of affordable medicines, which is critical in the global fight against HIV/AIDS and other diseases. Glivec for instance can cost as much as $70,000 per year, while Indian generic versions cost a mere 4 per cent of that, about $2,500 year 20. While upholding the validity of Section 3(d) of the Indian Patent Act, the court held that the amended portion of this section was meant only for genuine inventions. This section states that inventions that are mere "discovery" of a "new form" of a "known substance" and do not result in increased efficacy of that substance are not patentable implying that Indian law does not support patents for ‘ever-greening’ existing patented drugs. Although the judgment has caused impassioned debates on affordability versus innovation, Indian pharmaceutical companies will have to come up with solutions that provide fair compensation to innovation while ensuring that the growth of the industry is not stymied. Solutions for growth of the pharmaceutical industry in India will have to ensure sustainable growth for all stakeholders including researchers, consumers and producers. A beginning has to be made by disclosing and reporting on all aspects of economic, environment and social parameters.

About TARI Thought Arbitrage Research Institute (TARI) is a not for profit organisation set up under Section 25 of the Indian Companies Act. Founded by Kaushik Dutta and Kshama V Kaushik, TARI is one of the few privately-funded, independent and non-partisan Indian think-tanks on corporate governance, sustainability, economics and public policy. April 16-30, 2013

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LEGAL EAGLE The case of market-based pricing Normative practice of pricing patented articles including medicines dictates a perfect use of TRIPs flexibilities via CL. This should not be compromised for MBP of patented medicines unless they are ensured to be lower than the price any company would offer under CL. Milind Sathe, founder of an online discussion group on CL, gives an insight ricing of patented medicines is a burning issue especially for fragile economies planning heavy expenditure on healthcare. It provides possibly the last chance to sovereign to guard its domain in the onslaught of lopsided version of IPR. Normative practice of pricing patented articles including medicines dictates a perfect use of Trade-Related Aspects of Intellectual Property Rights (TRIPs) flexibilities via Compulsory Licensing (CL). This should not be compromised for market-based pricing of patented medicines unless market-based price is ensured to be lower than the price that any other company would offer under CL. “Essential medicines are not a luxury whose availability can be left to private market forces only, but an essential component of the fulfillment of the right to health.”1 The price of medicines is a critical issue in rich countries like the UK and the US, as well as in developing countries (DCs) and least developed countries (LDCs).

Vigilant pricing strategy for patented medicines Big financially powerful pharma companies, a major class of patentees seek complete freedom of operation to enforce their patent rights even against sovereign priorities. Their invincible command over politics and political leaders in their parent country exert tremendous influence in determining rules of the IPR-based global trade. Their collective market capitalisation is greater than the sum of economies of DCs from Africa or from Latin America or South East Asia. It enables them to create suitable political and legal frames to support their business within any nation and globally. Unrestricted freedom given to a big patentee is a direct manifestation of shrinking soverApril 16-30, 2013

eign domain and identity diffusion2. Sure and predictable end of omitting sovereign expression in determining internal policies is, loss of control over national economy, debilitated indigenous industries and political chaos leading to loss of social tranquility, uprooted sustainable development and permanent political instability. Pricing of patented medicines is a volatile issue for all nations including developed nations for several reasons. It discloses sovereign abilities to guard its domain and extent to which IPR per se is understood, by members of apex institutes and the subject population. The relationship between some unique aspects of patented medicines and evolving global trend of expanding government subsidised health care leads to some critical issues that have a powerful long lasting impact on economy and industrial abilities of the nation. (A) Unique aspects of patented medicines ● These are marketed in developed nations first ● Being medicines, they have to conform to regulatory requirements of the nation where these are intended to be marketed ● Its prices are always dictated by the patentee in developed nations without disclosure of costs incurred ● These may involve some new technologies ● Active ingredients and to a great extent formulation can be produced by non-patentees if patentee exhibits adamant behaviour and domestic government invokes CL either for internal use or under DOHA declaration ● Patented medicines have been priced higher in DCs and LDCs than prevailing in developed world, sometimes ● Free samples provided in the initial stages are higher whereas at the later stage in the life cycle of the patented medicine, less number of free samples are provided. (B) Metamorphosis of global healthcare scene ● In many DCs and LDCs, medical expenses are through private pockets ● All nations of the globe are bulging their healthcare budgets ● Bigger volumes or a large www.expresspharmaonline.com

portion of subject population in each country is targeted to be covered by subsidised health care schemes ● In future governments of DCs and LDCs would be spending HUGE on medicines. ● Which patented medicines are essential for DCs and LDCs is a critical issue and provides scope for miscalculations and wrong conclusions. ● Patented medicines will be included in subsidised healthcare schemes ● Patented medicines are costly as their prices are practically not controlled by any government for whatever reason. ● There is awareness that prices of patented medicines should be controlled.

Issues emerging from (A) and (B) Why to control the prices of patented medicines? What happens if prices of patented medicines are not controlled? Which patented medicines should be included in government-aided healthcare schemes? At what price the government should purchase these? Is pricing of patented medicines an avenue to boost industrial progress, distribution and redistribution of wealth, internalisation of essential technologies? Is the issue closely related to sectors of vital importance? Is price control mechanism an effective tool to prevent the misuse and abuse of IPR and patents in specific? Should patentee be given unrestricted freedom and allowed to fix the price or the nation should take positive efforts to assess the cost of materials and allow prevailing mark ups to arrive at the price? Does this issue need a vigilant scrutiny to confirm if the nation has right IP laws in place and if these are appropriately enforced? Is the government machinery well coordinated and oriented to interpret and use the laws for the benefit of the nation? In IPR dominated knowledge economy, should price control bodies antagonise IPR/patent laws or should reinforce them for effective price control and to ensure fulfillment of sovereign objectives? And so on…

Eye opening facts of MBP of patented medicines Normally a country regu-

lates prices of patented medicines, through fixed cost-plus prices policy3 and review mechanisms. Albeit MBP is the easiest approach to price patented medicines, it is not based on the factual production and marketing costs. MBP simply takes into account prices of the same medicine in developed countries. These countries exhibit glaring disparity as compared to DCs and LDCs in several economy indices besides per capita income and gross national income. The most interesting fact is that patentee never divulges factual cost details to any reference governments. The main strength of developed economies is that they can afford sky high prices albeit. People voice that the prices of patented medicines are exorbitantly high. In these nations public opinion about the reputation of pharma industry is far from satisfactory primarily because of lack of transparency and perceived priority given by pharma companies to their financial success over social responsibility.

Data on pricing of patented medicines in general Indicative price structure of patented medicines suggests R&D costs to be about 15±2 per cent. Manufacturing and labour costs about 26±2 per cent, marketing costs about 35±2 per cent and 24±2 per cent is said to be net profit. By this logic, prices of generic drugs should be only 15±2 per cent lower than patented medicines as rest are all costs. If we neglect/delete (which is never the case), generics should be priced at 100 per cent – (15±2 per cent+24±2 per cent) = 61±4 per cent of patented drug. But that is not the case. After patent expiry, prices collapse far more than 35 per cent, to about 90 per cent to about 96 per cent, sometimes in less than a month. It means that the realistic cost of patented medicine is not above four per cent. Some reports say that patented/ branded medicines are priced 100+ to 300 times costlier than generic medicines. By this logic the realistic cost of patented medicines is far below four per cent. So, EXPRESS PHARMA

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alternatively, when prices are to be fixed by negotiation, the price of patented medicine must be discounted to arrive at a price anywhere between the lowest price in reference markets divided by 300 to lowest price in reference market discounted by about 96 per cent, which ever lower. Logic dictates to opt for the lowermost price among the price offered by patentee, and the prices calculated using factor of 300 or discounting by 96 per cent or the price offered by domestic pharmaceutical company. Despite doing this exercise, a negotiated price may not be reasonably affordable price because patentees are capable of lifting prices in reference markets by virtue of their influence. Therefore relying on MBP is always a risk. It will dent the economy of DC or LDC. It is surely and certainly not reasonably affordable price. This is because MBP neglects riders of domestic factors such as cheap manpower, expertise in cost effective procurements of other factors of production which make this land a global outsourcing destination, differences in gross national income, and the inherent structure of economy. These riders are given fulleffect in cost-based pricing and provides a very effective option for negotiating price. Refer to Korean experience in price negotiations. A body constituted by Apex Institute of any nation is expected to work for the subject population, a sovereign primacy. France planned to cut over 500 million euro primarily by efficient control over prices of patented/branded medicines. EU nations are creating several barriers to restrict price rise and to ensure huge savings. Germany, insists for proof of the new drug’s superiority over other available treatments. Chinese pricing authority exercises tighter controls over the pricing of foreign pharmaceuticals and was exhibited when prices of medicines produced by several multinational non Chinese companies received an average price cut of 19 per cent, in 2011. National Development and Reform Commission (NDRC) of China routinely conducts drug price investigations and have audited about 1000 products and their pricing. China reduced prices of drugs 20 times in 12 years. Besides promoting generic medicines, Japan uses a biannual price cut system.

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Russian regulation allows the government to decide on maximum mark-up prices for drugs. It enables the government to slash prices to make them affordable. In knowledge economy price control mechanisms to control prices of patented madicines should aid IPR laws to prevent misuse and abuse of IPR and to facilitate sovereign expression within the nation. Sane pricing mechanisms and regulatory framework should never intersect or contradict IPR laws in any nation but should enhance effectiveness of IPR laws, by aiding their enforcement by clarifying ambiguities created by complex international agreements and unworthy interpretations suggested by unfaithful patentees.

Role of regulatory bodies Regulatory body of the nation should grant permission to patentee to trade in patented medicine in the country only if the patentee promises to produce in approved domestic facility where it intends to produce. Failure of the patentee to substantiate his application by his domestic capabilities to manufacture and market the patented medicine should result into delay or refusal. A regulatory refusal keeps the issue of pricing beyond the reach of patentee. Refusal should automatically open the patent for CL. Patentee’s inability to procure the license to manufacture the same in the country and his inability to work the patent in three years after grant justifies CL in most TRIPs signataries. Failure of the patentee to obtain license because of his failure to conform to regulatory requirement should be published by regulatory wing. This is yet another manner to ensure working of patents and collection of realistic cost data. This approach supports and ensures achievement of sovereign priorities without compromising its domain power.

Break down of product costs Besides research costs elements of cost in case of patented medicines, are costs incurred in a) inputs: active ingredient, excipients, manpower, machines, and cost of finance. The cost of active ingredient is the only product specific element. Rest all factors such as excipients, machines, manpower are similar to other products produced and therefore can be www.expresspharmaonline.com

factorised. A liability free company does not incur cost of finance. b) conversion: are governed by guidelines related to price control orders and mechanisms prevailing in the country. c) distribution: Data available about distribution costs in case of domestic companies can be used to assess distribution costs. In fact distribution costs in case of government supplies, government hospitals and health care subsidy schemes will be considerably less as several agents and multiple agencies are not involved in distribution. Information which NDRC of China collects from manufacturers is exemplary in this regard. d) marketing and advertisement:In case of monopoly products these may be company and product specific but need to be deliberated and questioned. So, the cost of active ingredient is the main component in the costing of patented medicines. Estimations of remaining elements of costs is a matter of routine work for any pharma company and patentee need not be relied upon if he quotes exaggerated costs. Excessive costs are to be attributed to his inherent inefficiencies. However, if he quotes lower costs, then price fixing body should review and correct their data and system to have lower costs. These costs are also available across the industry. Therefore higher costs fixed by price fixing body should be audited and appropriate effect given.

Pricing of imported vis-a-viz domestically produced patented medicine If price determining body is unable to adopt the approach stated above, they may have to resolve the issue of pricing imported patented medicines because patentee successfully overrides sovereign and refuses domestic production. The price of imported patented medicine will be different than when produced domestically for the reasons sated above. A price lower among the two should be selected for negotiation. Should only imports be allowed? In India Section 83(b) states that “patents are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article”. Article 5(A)(1)4 of Paris convention suggests a remedy short of forfeiture in case of importation. Nation should interpret that remedy to be CL to “manner

conducive to social and economic welfare, and to a balance of rights and obligations” i.e. Section 83(c) and Section 83 (a) to (e) and (g) in India and TRIPs Article 7, Objectives. Only import arrests socio-economic and technological development, and is not good for sectors of vital importance. Where patented medicines are produced in a country and exported to developed nations, then a critical study of differences in invoicing prices of drugs exported and the price at which the same are sold in that market will give a fair idea about how to account for cost of labour and profits. Invoicing price includes the mark ups of the company producing the drug formulation. Absence of such data will indicate the lack of coordination in different departments How should patented medicine of patentee be priced if he is only importing it? It is a matter of national prestige as to how a nation is going to treat patentee who in daylight contradicts law of the land. Should such patentee be given special privilege which is not offered to subject population of this land? It is matter closely related sovereign identity, sovereign duties and ability of the sovereign to retain and protect its domains. Carelessness in this regard will manifest dissolving sovereign identity, intellectual void, diminishing patriotism pushing an alleged independent nation in-d-pendant. (Views expressed in this article are personal views of author)

References 1 TRIPS, R&D AND ACCESS TO MEDICINES: A GUIDE TO THE POST 2005 WORLD External briefing document, February 2005, Médecins Sans Frontières (MSF) Campaign for Access to Essential Medicines Based on a January 18th 2005 presentation to Members of European Parliament by Ellen ‘t Hoen http://www.msfaccess.org/sites/default/ files/MSF_assets/Access/Docs/ACCESS_ briefing_GuideToTRIPS_ENG_2005.pdf Last accessed on 25th March 2013. 2 Compulsory Licensing in Knowledge Economy - it is NOW or NEVER - What, Why and When about CL – by Milind Sathe Chapter 3.18.1 Identity Crisis: Identity diffusion and identity loss 3. Page 5/6, Access to Essential Medicines in Developing Countries: Does the WTO TRIPS Agreement Hinder It?- Jayashree Watal 4. (1) Importation by the patentee into the country where the patent has been granted of articles manufactured in any of the countries of the Union shall not entail forfeiture of the patent April 16-30, 2013

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'We will try to have more JVs between IPMMA and Pharmexcil' PG 44 'PaxPharma access to users anywhere in world, in a secure fashion' PG 45 'Govt is taking steps to introduce braille script for pharma packaging' PG 46 'Our business is driven by a huge effort on new product development' PG 47 Child resistant and senior friendly packs... PG 48 DIA to host conference... PG 52 Barcoding on pharmaceutical products: Getting it right PG 53

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SPOTLIGHT Schott Kaisha: A ‘Glass’ical experience With the launch of India’s first completely automated pharmaceutical packaging plant in Jambusar, Schott Kaisha has increased its production capacity by 50 per cent to around 2.4 billion ampoules and vials per year. Sachin Jagdale writes about the key features of the Jambusar plant and how the company sees its growth prospects in India ver the years the Indian pharmaceutical industry has emerged as one of the key pillars of the global pharma economy. However, the credit for this achievement should also be attributed to the players from the allied sectors that have stood by the Indian pharma industry during its testing times. A giant from the pharma glass packaging manufacturing industry, Schott Kaisha, is one such contributor to the success story of the Indian pharma industry. Kaisha Manufacturers started in 1991 as a 50:50 partnership between Shapoor Mistry and Kairus Dadachanji. The company began its operations with just four machines in a small facility in Daman with an initial annual output of 30 million ampoules. Later, products like vials, cartridges and sterile glass syringes were added to the portfolio. The Schott Kaisha joint venture (JV) started in 2008 when Kaisha Manufacturers joined hands with the international technology group Schott. “Today we are the leading suppliers to the pharma industry in India offering a one-stop shop for the entire range of parenteral packaging like ampoules, vials, cartridges and sterile pre-fillable syringes. Since the inception of our first facility in Daman, we have constantly improved our infrastructure and technological setup to ensure total customer satisfaction and appreciation. In February this year, we inaugurated our new state-of-the-art Jambusar plant in Gujarat,” informs Kairus Dadachanji, Managing Director, Schott Kaisha.

Jambusar plant Schott Kaisha’s recently opened Jambusar facility in Gujarat’s Bharuch district is the first-of-its-kind facility in India. “Schott Kaisha’s state-ofthe-art facility enables us to

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help Indian pharma companies to meet increasingly sophisticated market demands in India in terms of quality, innovation and differentiation. The new facility in Jambusar is India’s first completely automated pharma packaging plant,” informs Dadachanji. One of the foremost features of this facility is that it uses high-end robotic feeding technology for tube-loading, fully in-line automatic process and high-precision camera inspection systems. This high-end technology is not available with any other company operating in this product category. Such technology guarantees an extremely efficient and reliable production process of consistent quality, underlining company’s commitment to the international good manufacturing practice (GMP) standards. . “India’s pharma market enjoys sustained, strong growth which is directly proportionate to the demand for locally manufactured primary packaging. By steadily advancing with the Indian pharma industry and therefore understanding the specific needs and challenges of the Indian market, we have already emerged as one of the leading pharma packaging companies in India,” says Dadachanji. The new facility enables Schott Kaisha to help customers achieve their own growth and quality objectives in India. The Jambusar plant will benefit the company in multiple ways. This greenfield investment increases Schott Kaisha production capacity by 50 per cent to around 2.4 billion ampoules and vials per year. India is already among the top 20 pharma exporting countries and the exports have grown significantly. India is the supplier of low cost drugs to many nations across the globe. Technologically, advanced product packaging would help Indian pharma companies to further strengthen their base in the global market. Drugs manufactured in India are delivered to more than 200 countries including the US, the UK and countries of the EU. The industry is boosted by global exports from India’s state-of-the-art www.expresspharmaonline.com

pharma manufacturers. Schott Kaisha is keen to support the nation’s success with state-of-the-art packaging solutions. All this sets new standards in India and enhances Schott Kaisha’s competitive advantage substantially. Almost all big pharma players are clients of Schott Kaisha and they want to continue with Schott Kaisha’s service. Schott Kaisha invested more than `136 crores in this facility. The plant in Jambusar has 20 production lines for ampoules and 16 for vials, with scope for further expansion. The facility is housed in an area of 20 acres with ample room to construct further production modules in parallel with the increasing demand of customers. Dadachanji informs, “The growing importance of this market is the reason why we are already planning to expand the plant in the near future. We are currently working on the exact timing of the next investment phases and scope of expansion. For other products too, we are closely monitoring market conditions. If there is appropriate requirement we will certainly invest.”

Synergising skills with JV The Indian packaging industry is traditionally not considered equal to their foreign counterparts, as far as the use of advanced technology is concerned. However, Schott Kaisha’s Jambusar plant has proved this assumption wrong. On being asked whether Indian packaging companies are still dependant on their foreign counterparts for the high-end technology, Dadachanji says, “As far as our JV is concerned, it is not a question of being dependant on our foreign counterparts, but of synergising our skills and talents to be able to implement latest changes and upgrades constantly taking place globally in India. Together, we combined German high-tech engineering with Indian market know-how to provide a unique value proposition to satisfy the ever-changing demands of our customers in India.” He adds, “It is encouraging to see the Indo-German partnership growing to

KAIRUS DADACHANJI Managing Director Schott Kaisha

“We continuously monitor market dynamics for our entire product portfolio and I am confident that with our combined robust expertise we will exceed customers’ expectations” improve service and product standards in Indian companies. Recently, Schott’s competitive expertise was recognised by the Bureau of Indian Standards (BIS). As a new member, Schott is supporting BIS to ensure that glass products manufactured in India are safe, reliable and of the highest quality.” The Schott Kaisha JV is indeed an excellent example of a German-Indian partnership standardising product quality and manufacturing processes in India for primary pharma packaging.

India is the priority With the launch of its Jambusar facility, Schott Kaisha’s production capacity has increased manifold. So will increased production be used for exports as well? Dadachanji has a very patriotic view on this. “Schott Kaisha is an Indian JV and will therefore cater primarily to the Indian market,” says Dadachanji. He adds, “We are part of the international network of Schott Pharmaceutical Systems. As one of the world leading suppliers of parenteral packaging for the pharma industry, Schott has almost 800 production lines in 14 countries worldwide producing nine billion syringes, vials, ampoules, cartridges and special articles of glass tubing April 16-30, 2013

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or polymer. Schott is steadily investing and advancing its global footprint.”

Challenges for the packaging industry India’s growing pharma industry has also given a package of challenges and opportunities to the pharma packaging industry. Pharma packaging industry is responding positively to the changing Indian pharma scenario, however, there are a few things where co-operation from other allied industries is also required. “The biggest challenge we face is to keep up with the extraordinary demand of the market. As India’s pharma

April 16-30, 2013

market grows in size, the demand for better packaging is growing. This is also a major reason why we have set up an extra plant with considerable expansion plans to grow in parallel to the demand,” says Dadachanji. He adds, “Due to the sheer size of the country, logistic challenges cannot be overlooked. That is why the plant in Jambusar is situated right next to Schott’s tubing facility in order to ensure timely and efficient supply of the most important base material- SCHOTT FIOLAX tubes. In addition to this, we have an excellent Indian team and our back-up possibilities offered by our production

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sites situated all over the world, provide flexibility, reliability and security to our partners in India.”

Future plans for the Indian market As already discussed, Schott Kaisha primarily produces in India for the Indian market. Schott Kaisha’s turnover has increased almost threefold since 2008. This represents an average growth of 25 per cent per annum. Schott Kaisha is confident of exceeding the overall market growth also in the future. The Jambusar plant is a major milestone for the company. However, on the other hand, this has also increased

the expectations from Schott Kaisha. The company’s future offerings will be expected to be even more advanced than what they have developed in Jambusar plant. “The rapidly evolving Indian pharma industry creates a challenging yet an exciting space for us. As we see a steady growth in demand, we are building further manufacturing lines in Jambusar. We continuously monitor market dynamics for our entire product portfolio and I am confident that with our combined robust expertise we will exceed our customers’ expectations,” concludes Dadachanji. sachin.jagdale@expressindia.com

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'We will try to have more JVs between IPMMA and Pharmexcil' Being the President of IPMMA, Rajesh Shah, reveals the opportunities and challenges of Pharma Pro Pack Expo, with Usha Sharma and explains the importance of having such events for the Indian pharmaceutical industry

INTERVIEW

Pharma Pro Pack Expo(PPPE) 2013 will be organised by Indian Pharma Machinery Manufacturers Association (IPMMA) under the Brand India Pharma Campaign. Tell us the reason behind this? The basic reason is to promote ‘Brand India.’ Indian pharmaceutical machinery manufacturers have earned the reputation of being the hub for low-cost manufacturing of machines. The reasons behind this is the availability of cost-efficient man power, highly skilled and experienced engineers and low capital investment on plant and machinery. India has also shown remarkable progress in the growth in up-gradation and advancement of technology in machinery. Today, the country is in the forefront to offer value added engineering with integration of new technologies. Many foreign companies find it cost effective to work in the form of collaborative ventures with Indian partners. The number of joint ventures (JVs) between international and Indian machinery manufacturers is a proof of the fact that the Indian manufactures of machineries understands the stringent needs of pharma industry. Indian manufacturers can now produce international quality at affordable prices. It is significant to note that India is making machines which are 10-20 times less expensive than machines produced in the US and Europe. Now the time has come to unleash ‘Brand India’ so that all small, medium and big Indian machinery manufacturers can further consolidate their position in the world market. This year the expo is colocated with Indian Pharmaceuticals and Healthcare Expo (iPHEX) 2013. How will the participants benefit from this? Cooperation in any venture brings in benefits for all the stakeholders. By co-locating the iPHEX within the Pharma Pro&Pack Expo 2013 there will be several benefits not only for IPMMA and iPHEX2013 but for all the par-

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ticipants, exhibitors, visitors, business delegates and all others associated with the pharma industry. In this modern fast paced world, time is money and when you save time you save money. By co-locating exhibitions, everybody is going to save on time and money. Also in the coming days, we will try to have more such cooperation and JVs between IPMMA and Pharmexcil. What will be the agenda for this year? The agenda for this year’s Pharma Pro&Pack Expo 2013 can be summed up in just two words – Promote Brand India. We are hopeful and optimistic that PHARMA Pro&Pack Expo 2013 will provide an ideal platform to all small, medium and big pharma machinery manufacturers of India who have beyond doubt proved to be the backbone of the growth witnessed by the pharma industry in India and across the world. Very fortunately the Indian pharma machinery manufacturers have a unique advantage. Not only do they have to cater to the needs of the rapidly growing pharma industry at home but they also have to supply their machineries to the expanding pharma markets of the world. How many exhibitors are expected? Which sectors will be associating with the event and how beneficial will it be? The exhibition, PHARMA Pro&Pack Expo 2013, will be a mega platform where more than 4,000 products and services will be displayed on total pharma manufacturing by more than 200 exhibiting companies of all segments from 16 countries. PHARMA Pro&Pack Expo 2013 exhibition will be offering unparalleled opportunity for live demo of machineries and latest technologies and also at the same time, an outstanding business networking environment to establish and revise the business relationships. Truly, the PPPE 2013 provides the best opportunity to meet existing customers, revive industry contacts and also for exploring new prospects through business meetings. Almost all the sectors of the Indian pharma industry are associated with this event. Exhibitors’ profile of the PHARMA Pro&Pack Expo2013, Mumbai exhibiwww.expresspharmaonline.com

tion includes manufacturers, exporters and suppliers of pharma processing and packaging machineries and materials, utility products and services, analytical lab equipments and consumables, environment control products and services, water management, and consultants and turnkey contractors. The large scale participation from different sectors is evidence to the fact that such expos do help in almost all sort of business activities and add value to participating and visiting individuals, companies, corporations and business houses. Such expos lead to consolidation of the market, widen geographic reach of products and services and also strengthen distribution network and enhances knowledge of technological advancements undertaken in different sectors. Being the president of the event what are your responsibilities? As the president I can only say that today the Indian pharma machinery manufacturers provides the pharma industry, machineries at a price almost one third or one fourth of the imported technology for the same products and same capacity, which is a basic advantage. Hence, people look at Indian market for machineries. The pharma machinery industry is growing 15-20 per cent annually. The manufacturing facilities in India are being upgraded to the International standards of the regulated markets. Today, India has the highest number of FDA approved facilities outside US. So my responsibility is to ensure that the Indian pharma machinery manufacturers become the agents of 'Brand India' in true sense of the word. Time has come for India to leverage on its strength and I think this just not my responsibility but a collective responsibility of all of us. What are the challenges you faced while organising the event? IPMMA has a very dedicated team of office bearers who are prepared to burn the midnight oil when the demand arises. A large number of people have worked round the clock to make a success of the event.All of them deserve equal credit for converting a dream of this magnitude into reality. As far as the challenges are con-

cerned, we can only say that there is no challenge more challenging than the challenge to improve yourself. Tell us more about the conference and why do you think participants would be eager to attend it? As global pharma companies’ scout and scan for new growth and development opportunities over the next one decade, a realisation seems to have dawned that perhaps the most promising of the opportunities, openings and prospects are to be found not in the developed nations but in the emerging economies of the world. It is in this scenario that the conference gets added significance. And it is also because of the rising stature and importance of India in the world that the participants from across the globe have shown their eagerness in the right earnest to attend this ‘must attend’ meet. What message would you like to share with the industry? My only message to the industry is to seize the opportunity. The growth in advancement and up-gradation of technology in machinery has been faster in India. With almost low technology offerings in the initial stage, the Indian machinery today is considered as one that can offer value added engineering with integration of new technologies. Various international companies have found it cost effective to work with Indian partners in the form of collaborative ventures. The increasing number of JVs between foreign and Indian machinery manufacturers is a testimony to the fact that the Indian machinery industry understands the stringent need of pharma industry and that it can produce international quality at affordable prices. Indian pharma machine makers and their Western counterparts increasingly are exploring collaborations and partnerships with each other to innovate or share new technology. Together, they are targeting more price conscious developing countries. I can only end with this that the Indian pharma machinery manufacturers are standing at a cusp where a challenge is an opportunity to prove your ability to yourself and others. u.sharma@expressindia.com April 16-30, 2013

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'PaxPharma access to users anywhere in world, in a secure fashion' Recently Persistent Systems launched PaxPharma, which helps pharma companies to automate their entire product lifecycle – from new product introduction, to financial planning, bills of materials management, artwork and labelling management and label change management from pharmacovigilance. Ram Pazhayannur, Vice President, Paxpro Business Unit, Persistent Systems, reveals its features and shares its growth prospects in India in a chat with Usha Sharma

INTERVIEW

Tell us about Persistent Systems' expertise in various business arenas and how successfully it has grown over the period? Persistent Systems is a global company established in 1990, specialising in software product and technology services. For more than two decades, Persistent has been an innovation partner for the world’s largest technology brands, enterprises and pioneering start-ups. With a global team of more than 6,000 employees, Persistent has 300 customers spread across North America, Europe, and Asia. Today, Persistent focuses on developing best-in-class solutions in four key next-generation technology areas: cloud computing, mobility, analytics and collaboration, for telecommunications, life sciences, consumer packaged goods, banking and financial services and healthcare verticals. Thanks to our extensive technology product expertise, today our customers also turn to us for technology strategy and consulting services. Persistent’s customers benefit from our deep knowledge of next-generation cloud, BI and Analytics, collaboration as well as mobility-based computing platforms. By leveraging our strategic technology partnerships, IP-based accelerators, and agile development processes companies can successfully navigate increasing time-to-market pressures and deliver the highest quality solutions, faster and more cost effectively. Recently, Persistent has introduced PaxPharma in the US market. Could you tell us about the product and its importance in the pharma industry? PaxPharma is a solution that helps pharma companies automate their entire product lifecycle – from new product introduction, to financial planning, bills of materials

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management, artwork and labelling management and label change management from Pharmacovigilance. This is important to the pharma companies in many ways, the first being the ability to manage compliances. FDA and other regulatory authorities mandate what to say on labels, how to say it, and where to say it. These rules are very complex and pharma companies rely heavily on the expertise of specific individuals to ensure compliances to these rules. By using PaxPharma, the enforcement and inspection of these rules could be automated, thereby reducing errors and bringing efficiencies across the organisation. Data shows that packaging recall due to errors account to as much as three per cent of revenues, which is a huge saving, if done correctly the first time around. The other advantage is the improved speed to market. Pharma companies today are feeling the same kind of pressures consumer packaged goods (CPG) companies felt few years ago in releasing products to market, faster, at lower costs and in multiple variants. This coupled with compliances that are an order of magnitude higher than CPG industries, results in lengthened review cycles, across multiple departments, thus making the whole product development cycle just that much longer and difficult to manage without automation. One of our customers mentioned that they could triple their product releases with zero increase in headcount across departments just by implementing Paxpro – as they now have better control of their entire process, automation to replace manual review and inspection tasks, greater collaboration through online tools, and one “system of records” through integration with other systems of theirs. Reduced costs are another mentionable advantage. Our solutions are built on some of the best technologies in the industry and are complaint with the pharma security requirements. What role did Paxpro play in designing and launching the product in the market? PaxPharma has been built with significant inputs from our customers and partners. Inputs for PaxPharma have also come in from our internal innovation and product www.expresspharmaonline.com

teams, however, they were additionally validated by the customers and key advisors. Tell us why did Persistent System introduced PaxPharma first in the US market? Which other countries are you planning to launch the product and by when? Also when are going to launch it in the Indian market and how beneficial will it be for Indian pharma companies? We announced PaxPharma in the US first. For the global markets, PaxPharma being delivered as a SaaS solution, geography isn’t an issue. Our sales teams globally are actively marketing PaxPharma. In addition, several of our customers have global operations and use the solution across their offices worldwide. That is one of the key value propositions of PaxPharma – access to users anywhere in world, in a secure fashion. In India, we are currently in discussions with a few companies. What unique features does PaxPharma have? PaxPharma delivers an enhanced user experience through a fully integrated solution with secure data transfer across modules that significantly helps reduce human error, ensure regulatory compliance, and improve time to market. PaxPharma includes a unique FDA rules database module that manages the rules and regulations set by the FDA for each product type, from OTC drug to cosmetics. This module automatically selects several of the FDA rules based on product attributes specified by the labelling specialist – greatly reducing errors and providing significant time savings. Near print-ready drug fact templates (DFT’s) and labelling documents can be produced using this module allowing marketing managers to have better control of their artwork and labelling assets while reducing dependency on graphic artists and post production iterations. PaxPharma modules include: NPI/NPD; BOM/SKU; FDA rules database for accurate and compliance-based product labelling; Artwork lifecycle management; Document Lifecycle management for pharmacovigilance; Real time reports; Project Management.

PaxPharma is a complete solution as it is compliancebased, Design to Print (D2P) automation solution, what all qualities it addresses to the regulatory? PaxPharma is compliant with CFR 21 Part 11 guidelines and comes with all the necessary features such as audit trails, eSignatures, document control, user access control, label rules database, to name a few. Does this product have a trace and track feature as well? No, PaxPharma doesn’t currently have track and trace capabilities. PaxPharma, however, integrates with 3rd party Track and Trace systems and manages all the artwork related attributes (SR#, artwork changes, etc.) resulting from Track and Trace implementations. What is the USP of PaxPharma? Our main USP is offering one solution to manage your entire product lifecycle in a compliant manner; a solution that is simple to use, easy to onboard and that can scale to thousands of users in a controlled and secure manner. Do you think PaxPharma is a cost effective solution for the pharma industry? What special features it has in comparison to other competitors? The typical ROI for most companies from using PaxPharma is less than one year, this is purely from labour savings, not to mention recalls due to packaging errors, which could run into several millions of dollars. The FDA label rules module is the first of its kind in the industry and is unique to PaxPharma. Our automated proofing and inspection tools are also one of the best in the industry and comes loaded with a host of features for the pharma industry. PaxPharma includes a unique FDA rule database module which is in line with the FDA rules and regulations set by the FDA for each product type, from OTC drug to cosmetics. What all regulation has been followed by before launching the product in the market? There are several Continued on Pg 47 EXPRESS PHARMA

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‘Govt is taking steps to introduce braille script for pharma packaging’ Making information available to blind people is an important responsibility of the pharmaceutical packaging sector. Ajit Singh, Chairman, ACG Worldwide explains the importance of Braille scripting in pharma packaging and its implementation in conversation with Usha Sharma

INTERVIEW

What is the population of blind persons globally and in India? Worldwide, the visual impaired population is 285 million as per statistics available. Of these, 39 million are blind and 246 million have weak vision. Nearly 90 per cent of the visually impaired live in developing countries. India accounts for a staggering 20 per cent of the world’s blind population, which is approximately 7.8 million. Why is Braille script essential for pharmaceutical packaging? Packaging is an essential source of information on the content besides serving the purpose of brand recognition and anti-counterfeiting. Information such as name, strength, quantity, directions of use, cautionary statements, storage instructions, date of dispensing, period of use, etc., are important. Realising the need to get this information in the hands of over 39 million visually impaired (totally blind) people across the world, the European Union (EU) issued a directive in 2005 for pharmaceutical and packaging companies. The legislation (Article 56(a) of council directive 2001/83/EC) requires that the product name, strength and dosage appear in braille on all pharma packaging. ACG adds another dimension to this by adding the expiry date of the product on the pack, which is absolutely critical. What made the pharma companies adopt Braille script and which issues need to be addressed before implementing it? The EU regulation has been the guiding factor for pharma companies to introduce Braille for “any medical product for human use.” The directive defines this as “any substance or combination of substances presented as having properties for treating or preventing disease in human beings.” This regulation has since led the

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way, with other countries quickly following suit. All EU legislation relating to pharma products is covered under the EEA Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) have also implemented this directive. Even countries like Brazil, the US and Canada have implemented a mandate for braille labelling on all pharma packaging. The challenges for braille on pharma packaging are three-fold. Firstly, there is an additional cost in upgrading the packaging machinery and be Braille compliant. Secondly, the Braille dots need to be high enough to be easily read, but not too high that it perforates the packaging. Also, the manufacturer must ensure that Braille dots are not malformed or missing, while ensuring accurate spacing. And lastly, quality control is extremely critical in Braille pharma packaging; for one misplaced dot could lead to costly lawsuits, high product recalls and tarnish brand image. What are the measured being implemented to deploy braille at your company? The R&D team at ACG and SciTech Centre is in constant search for new ideas

All are important when it’s a matter of health and safety. Marburg Medium should be used as the preferred braille font for pharma packaging, as recommended by the European Commission and other agencies worldwide. Also, specifying dot diameter, dot spacing, character and line spacing makes it easier for manufacturers of vision inspection systems to develop readers that automatically interpret the dots. Is this technology cost effective? Braille-compliant features call for pharma companies to upgrade their packaging lines. There are modifications that need to be made on cartoning machines, but optimallypriced solutions are available in India. An important aspect that may require attention is to ensure that each blister is in a unit carton. Loose blisters are sold in India and adding Braille on blisters is a challenge. However, if unit cartons for every product are mandated, then it is an achievable goal. In India, how many pharma companies are offering this service? There are very few pharma companies that offer

CURRENTLY,THERE ARE MANY ISSUES THAT PLAGUE PHARMA COMPANIES WHILE IMPLEMENTING BRAILLE ON PACKAGING.TO BEGIN WITH,THERE ARE VERY FEW BLIND PEOPLE WHO CAN ACTUALLY READ BRAILLE and concepts. Currently, ACG Pampac - a member company that produces efficient, customised and costeffective blister packing, cartoning machines and packaging solutions is developing a new additional feature on cartoning machines. This will help emboss product expiry dates in braille script along with normal embossing. It appears that this feature will be the first to help print expiry dates in braille type. For which therapeutic area, does Braille script require much attention and why? www.expresspharmaonline.com

Braille on its packaging. In India, few pharma companies are adopting this technology. If at all, they are doing so mainly for exports, why is it so? Yes, there are very few pharma companies that are looking at adopting this technology. Braille on pharma packaging is not a government mandate. The export markets like EU and North America have braillecompliant pharma packaging, in line with EU mandate (2005) and Can-Am Braille (2009) respectively. What are the government

initiatives taken to promote and enhance this technology? The Indian government is taking many gradual steps towards introducing Braille script on pharma packaging through government and non-government bodies. But since Braille script on pharma packaging is not a mandate in India, the technology advancement in this sector has been minimal. What are the issues while implementing this technology and what solutions do you recommend? Currently, there are many issues that plague pharma companies while implementing Braille on packaging. To begin with, there are very few blind people who can actually read braille. Despite this, pharma companies that go ahead and implement this technology find it difficult because each European country has its own Braille code. However, there are occasions when the Braille translation can be used in more than one country. An increasing number of government and non-government organisations around the world are working towards making blind people literate in Braille. They are also working towards implementing and adopting a unified system of braille. In addition, many companies are choosing to use a standard font for artwork and then asking their manufacturers to meet the Marburg Medium specification. What is your forecast on this technology in India? Necessity is the mother of all invention. Although the Braille script technology is gaining widespread usage in developed countries, it still remains to be seen how it will develop in a high visionimpaired population country like India. We also have to wait for some mandate for Braille on pharma packaging. Once there is a directive from the government, the technology will develop further, making it easily accessible and cost effective. As mentioned earlier, the Indian government can set a global example by leading the introduction of expiry dates in Braille, something that is not mandated anywhere else in the world. u.sharma@expressindia.com April 16-30, 2013

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'Our business is driven by a huge effort on new product development' Piramal Glass is known for its glass bottles, used for packaging in the pharmaceutical sector. Vijay Shah, Managing Director, Piramal Glass talks to Usha Sharma about the company's products, the market for glass vials in the pharma industry and the strategies for the company's growth

INTERVIEW

Tell us about Piramal Glass and its current activities? Piramal Glass is into manufacturing of container glass which essentially acts as a primary packaging medium for cosmetics and perfumery products, pharma, food, liquor and beverages. We have a vision ‘To be among the top three flacconage companies globally’. Piramal Glass primarily manufactures three types of glass: Type III soda lime (alkaline in nature) amber glass— brown coloured glass commonly used for pharma products (syrups, tablets), chemical products (acids, solvents) and beer – basically products requiring protection from UV rays. Type III soda lime (alkaline in nature) flint glass - plain white coloured glass commonly used for cosmetics and perfumery products, pharma vials, food jars/bottles and Type I Neutral Glass (both flint and amber) - The glass is used for injectibles/life saving medicines where the contents should not have a reaction due to glass contact. Piramal Glass, besides a strong presence in domestic market, exports glass containers to close to 53 countries. The company has an active presence in two different sectors; namely, pharmaceuticals and perfumery. Is there any similarity between these verticals? The pharma and perfumery segments have dif-

ferent characteristics. While the pharma segment requires all the above three types of glass based on application, perfumery segment requires Type III soda lime Flint glass. The pharma bottle is sold to the customer as plain glass, while perfumery customers buy value added bottles with decoration (like coating, printing, foiling etc.). The perfumery segment is predominantly ‘made to order’ and the number of SKU (different shapes, sizes, decoration variants) is very large. This business is driven by a huge effort on new product development (NPD), while the pharma segment (whether Type I or Type III) is predominantly ‘made to stock’ with longer production run (compared to C&P) and more standard design bottles. Who are your clients? Some of our key clients are Cipla, Nitin Life Sciences, Macleods Pharma, Ranbaxy Laboratories, Merck in India. What is the USP of your products? How does it differentiate you from others? In the domestic pharma industry, Piramal Glass is recognised for its quality. The bottles in terms of design and packaging are common more like a commodity, and the key success criteria is to supply good quality bottles free of contamination, promptly to the customer because they are ‘made to stock’. As per the company's official website it has grown inorganically. Kindly comment on this. Piramal Glass has presence in Sri Lanka and the

US. Ceylon Glass Company listed on Colombo stock exchange was acquired in 1999. Renamed as Piramal Glass Ceylon PLC, it is the only glass container plant in Sri Lanka, with close to 95 per cent domestic market share and a substantial part of its turnover coming from exports to India, Africa, Australia etc. Piramal Glass US, erstwhile part of the Glass Group was a Chapter 11 company acquired in 2005. It is a wholly-owned subsidiary of Piramal Glass. We have turned around the performance of both these subsidiaries, within few years of the acquisition. How many manufacturing sites does the company have? Do you plan to upgrade, expand or set up new facilities? We have four manufacturing locations. Piramal Glass in India has two plant locations in Gujarat – Kosamba and Jambusar, where we have a total of nine furnaces. During the past one year, Piramal Glass has added one new furnace at Jambusar, and increased the capacity of one furnace through brown field expansion at Kosamba. Piramal Glass Ceylon PLC has one large furnace at Horana, while Piramal Glass US has two furnaces in Flat River, Missouri. Does your manufacturing site meet the regulatory norms? Do you receive regulatory approvals? Our manufacturing locations in India are certified for quality management system, safety management and social accountability. Our pharma customers conduct strict audits of our manufacturing sites, validat-

ing various aspects like the production process, chemical composition of the glass, glass bottle packaging and quality system. Tell us about the issues that need to be addressed by pharma glass manufacturing companies? What are the problems faced by the industry? In the amber bottle segment, there is a continuous shift from glass to PET, resulting in a good capacity build up in India. In the flint segment, which is essentially pharma vials, there are imports from China, as well as a substitute option from Type III tubular vials. The glass container industry, which is a high energy consuming industry, is also facing the challenge of rapid increase in the natural gas price in India. How large is your international presence? Do you plan to expand your geographical presence? As mentioned earlier, besides India we have two international manufacturing locations. We export to 54 countries globally, and have warehousing facility globally in countries like US, Brazil, UK, France, Germany and Sri Lanka to effectively serve our key customers. Tell us about the company's corporate strategic plans. Our corporate strategy hinges on growing the premium and select business in the cosmetics and perfumery segment. As far as the pharma business is concerned, we want to grow in the TypeI glass segment and improve our operating efficiencies in the Type III segment. u.sharma@expressindia.com

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lines, etc.

guidelines that the product must meet before it can be declared safe for release to the market – drug safety guidelines as mandated by the clinical trials requirements, drug safety declarations as mandated by the label rules, manufacturing processes as outlined by GMP processes, adverse effects management as governed by the pharmacovigilance guide-

Whom do you consider as a competitor and why? Incumbents in this market (not pharma in particular, but D2P in general), are providers such as Esko Webcenter, Shawk Blue and Kodal D2L. New entrants are PLM provides such as Dassault Enovia, Oracle Agile, Siemens TeamCenter. With the help of PaxPharma how much business do you www.expresspharmaonline.com

plan to generate for the US market and in India? This would not be the right time for us to disclose the financial of PaxPharma, however, we are confident of the product and the benefits it provides the users, so we definitely see a good growth trajectory. Presently, how many people are associated with the Persistent System? We are over 6000 employ-

ees globally at Persistent Systems at present. What are your corporate plans for the Indian market? As I mentioned earlier, with PaxPharma, we see it as a global product that can be used by anyone anywhere. In the Indian market, we are already in talks with companies and now have to wait and watch how it takes off. u.sharma@expressindia.com EXPRESS PHARMA

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WHITE PAPER Child resistant and senior friendly packs for pharma packaging — A total contradiction? Dr Erwin Pasbrig, Director, R&D, Ansapack, in a white paper analyses the varying regulations governing child resistant and senior friendly packaging for prescription drugs pproximately 140,000 to 160,000 small children poison themselves – unintentionally – every year in Germany, approximately 20,000 of who need to be treated. Unfortunately, every year there are 30 to 50 fatal poisoning accidents with children in Germany (related to household cleaner, poisoning plants, fertiliser, cosmetic products and pharma products) – deaths that could be prevented. The Pharmaceutical Association of Great Britain (PAGB) has been investigating accidents at home for years (HASS data) and has found that – poisoning accidents of children during the period 1982 until 1998 have been constantly decreasing: by 33 per cent for all children, by more than 50 per cent for children under five years of age. In the same period the proportion of non-reclosable pharma packages has increased tremendously.1 Only from the age of three are many children able to understand rational reasons about the dangers involved or at least are willing to accept a ‘no’ and follow educational measures and thus simple safety rules. From this point onwards-educational measures become

increasingly important. This is why around 90 per cent of all accidents involving swallowing of alien substances happen with small children at the age between 10 months and 4.5 years of age (approx 90 per cent), with a significant peak for children aged one to 2.5. Hazardous substances for poisoning are: household cleaning agents, pharmaceuticals, stimulants, poisonous plants, fertiliser, cosmetics and oils. Leading substances for poisoning are pharma (37 per cent) followed by tobacco (20 per cent) and cleaning agents.2, 3 Children are familiar with blister packs containing sweets or chewing gum (Blister A). Thus they associate blisters with something positive. The same holds true for shapes and colours of tablets (pharma products are marked by an arrow) (Picture 1). The history of childresistant packages started in the US with the Code of Federal Regulations Part 1700 to 1750, subchapter E: Poison Prevention Packaging Act (PPPA), 1970 regulation. This was the introduction of the concept of having packages tested by children and adults. An American study shows that since the introduction of child-resistant packages for prescription drugs (tablets) the mortality rate due to poisoning has been decreasing significantly. According to this analysis, approximately 460 fatal

accidents were prevented due to this protective measure; in other words a reduction by 45 per cent.4 After the start by the US there were more countries that introduced standards and legislation with regard to child-resistant packages (reclosable and non-reclosable). With the British standard BS 8404 and the European standard (for members of the CEN) it is for the first time that tests with children and adults are requested in Europe (CR/SF packages). As the first country in Asia, Korea have implemented the request for CR/SF in 2007.

A CR/SF package is defined as: “Package designed and developed which is difficult to be opened by small children within an appropriate time but not difficult to be handled by adults”5. According to EN 14375: “Package which complicates

opening (respectively access to the content) for small children but facilitate appropriate usage by adults.” A target range is defined which can be checked in the course of the test (maximum ‘n’ per cent children may open the package and at least ‘n’ per cent of the adults must be able to open the package) in a given time. The test is carried out with children and adults of a certain age group and gender. Depending on the opening performance the package meets the target (target range) or fails. The necessity for CR/SF packages for pharma packages is reflected by the population development in Europe and the US (Table 1). The ratio children/adults (older than 65 years) and the life expectancy vary but the trend in all countries is the same: increasing life expectancy and decreasing birth rates. In Europe more than 80

Country-wise regulations on child resistant packages US

1970

Canada

1975

Germany, DIN 55559

1979

Italy (only regulation, no standard)

1984

Australia

1985

The Netherlands follow DIN

1985

United Kingdom, BS 7236 CoP

1989

UK, BS8404

2003

EN 14375

2003

Korea

2007

Picture 1: Blister packaging for sweets and pharmaceuticals

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Table 1: Social and demographic indications Country

Population

Life expectancy (years)

Under 15 years (%)

Over 65 years

Women

Men

Europe

17.8 % (135 Mio.)

14.5% (110 Mio)

71 - 83

66 - 79

21 % (61.7 Mio.)

12 % (35.2 Mio.)

per cent of solid pharma are packed in blisters, in the UK approximately 60 per cent. The main reasons for this are as follows: high degree of protection of each individual dose, higher shelf life; patient compliance; hygienic storing (only individual dose is removed); safe against manipulation (tamper evidence); only one dose can be removed per opening.

Variation in regulations between Europe and the US Europe

Bottom material

Product should not be seen (e.g. opaque, dark colour)

no regulation

Toxicity

No Max eight products per blister can be removed

Type testing

Yes

April 16-30, 2013

Table 2: Test criteria for CR/SF

CR/SF in Europe and in the US – Two distinct worlds Regulations as to the design of CR/SF packages and the tests to be carried out vary considerably between Europe and the US. Shape and colour of pharma products are marketing factors. The patient is supposed to remember the product. Thus in the US the bottom material is transparent if cold form foil (CFF; alu-alu, Panblok) is not the material of choice. Thus there is the risk that children mistake the drug for sweets. In Europe mostly opaque coloured thermoform able film or Formpack is used. Each product which is listed or for which there is a risk that children might poison themselves by swallowing the drug has to be packed in a CR/SF package. In the US, pharmaceuticals are traditionally packed in bottles but the proportion of blisters is constantly increasing. Irrespective of the fact whether a pharma company has (a) product(s) in CR/SF on the market a test has to be carried out for a new or different amount of active substance. The criteria for the selection of test persons and test results are defined in the regulations/standards (Table 2). PPPA is applicable for the following products (without details and restrictions, original page 614 - 617 of PPA ):8 Aspirin, methyl salicylate, controlled drugs, iron containing drugs, dietary supplements with iron, acetaminophen, diphenhydramine. Prescription drugs, apart from nitroglycerin, isosorbide dinitrate, anhydrous cholestyramine, pancrelipase preparations, prednisone in tablet form, mebendazole in tablet form, colestipol in powder form, conjugated

Yes Limitation of the number of removable products depends on toxicity

PPPA (1970)

EN 14375

Children (months)

30% 42 – 44 40% 45 – 48 30% 49 - 51

42 – 51; max. 200 same number per age group and gender

Adults (years)

25 of 50 – 54 (since 1997) 25 of 55 – 50 50 of 60 - 70

25 25 50 30

Testing period children Testing period adults

2 x 5 minutes 1 x 5 minutes

2 x 5 minutes 5 minutes preparation 1 minute test

Criteria for target achievement Children

According to stipulation

Adults

> 90

< 15% more than 8 individual doses within 5 minutes without demonstration; < 20% more than 8 individual doses within 10 minutes with demonstration; > 90

estrogens tablets, norethindrone acetate tablets, erythromycin ethylsuccinate granules and tablets, cyclically administrated oral contraceptives sodium fluoride drug preparations,betamethasone tablets, all unit dose forms of potassium supplements, methylprednisolone in tablet form.

US Most frequently used solutions for CR/SF blisters are as follows: ● Tear-open package with notch; ASTM Type VIIIE; Semi-rigid blister with tear-open notch and instruction to use scissors for opening of the package (2 x 3 = 6 cavities); Test result adults: 0.942, tested by 2 x 100 adults. 84 per cent of the adults said that the package was easy to open ● Peelable opening ● Peel-push opening ASTM Type VIIID; Semirigid blister with peel-push opening (3 x 4 = 12 cavities) Test result adults: 0.961, tested by 100 adults. 81 per cent of the adults said that the package was easy to open; www.expresspharmaonline.com

As to pouches opening is carried out by means of hidden tear notches ● ASTM Type IVA; Pouch with internal (hidden) tear notch Test result adults: 0.981, tested by the first 100 of total 400 adults. 80.5 per cent of the adults said that the package was easy to open; ● ASTM Type IVC as ASTM Type IVA with instruction to use scissors for opening of the package. Test result adults: 1,000 tested by the first 100 adults. 99 per cent of the adults said that the package was easy to open. For all packaging solutions at least two steps are required to remove the product. Thus these blisters always have a cross perforation. As the children are asked during the test to take the blister into their mouths there is always a plastic film integrated on the outside. This renders the option of biting the package through more difficult. I do not know of any pharmaceutical in a pushthrough package on the US-

of 50 – 54 of 55 – 50 of 60 – 70 male, 70 female

American market which would be in compliance with the Fortschreibungsliste (list published by the German Federal Board of Health) and was tested as CR/SF. New solutions for CR/SF use blisters that are integrated in a cardboard package (blister cards). In this case access to the product is achieved by manipulation (pushing, turning) and subsequently the product is pushed through the lidding foil.

Europe In Europe the standard EN 14375 has been in effect since the end of 2003. This was agreed upon by the CEN member states. Members of the CEN (Comité Européen de Normalisation, Geneva) are: Belgium, Denmark, Germany, Finland, France, Greece, Ireland, Iceland, Italy, Malta, Luxembourg, Austria, The Netherlands, Norway, Portugal, Sweden, Switzerland, Slovakia, Spain, Czech Republic, Hungary, the UK. This European standard has to be changed by the individual member states into a national standard to EXPRESS PHARMA

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become effective. In Germany the EN 14375 has the status of a DIN. The peel-push opening that is frequently used in the US has not found a market in Europe. According to the opinion of the pharma companies no opening feature, which is unknown to the user, is to be offered. These companies fear that this would lead to a competitive disadvantage and market shares might be lost. Furthermore, the blister for a peel or peel push version becomes larger (perforation and tear-open tab = unsealed area). This causes a decreased machine output and increased requirement for packaging material, thus it is more expensive than a pushthrough package complying with the Fortschreibungsliste (Picture 2).

Presently, the development of a mechanical test, which would result in as little involvement of children in the tests as possible, is being discussed. Nevertheless, the test has to reflect reality and has to be validated.

Germany The Arzneimittelgesetz (German Medicines Law) stipulates the products which have to be packed in a childresistant package. According to the regulation of an edition according § 28 Arzneimittelgesetz (Childresistant packages for pharmaceuticals) dated February 12, 19829 and September 17, 198410 the formulations listed hereunder may only be sold in the following containers: a. Push-through packages (blister packages) with individual dose packaging under

exclusive use of opaque or dark coloured material, or b. Sealed strip packages with individual dose packaging under exclusive use of opaque or dark coloured material, or c. Container with safety closure (closure system with combined features (e.g. push and twist at the same time) which complicate opening by children. d. For pharmaceutical such as unit dose powders or granulates single dose envelopes or single dose

pouches are sufficient. e. As to liquid pharmaceuticals these containers comply with the regulation if they have inserts that cannot be removed by children without destroying the container. After the package has been opened and shaken, squeezed or tampered with once not more than 0.5 ml of the liquid may flow out if the liquid drug has to be taken in drops. In other cases not more than 2 ml may flow out. The containers mentioned under a, b and c have

Picture 2: Blister with peel-push opening

Table 3: Fortschreibungsliste (type testing) for child-resistant blisters BAFArM No.

Lidding foil

Bottom (1)

Remark

9 (1980)

lacquer/Al 25 µm soft/HSL

cross perforation, 0.7 mm width of perforation

14 (19981) 30 (1985)

50 g/m² coated paper/Al 9 µm/HSL

250 µm PVC 250 µm PVC/PVDC

15 (1981) 30 (1985)

35 g/m² glassine paper/Al 9 µm/HSL

250 µm PVC 250 µm PVC/PVDC

17 (1981) 30 (1985)

lacquer/ Al 30 µm/HSL

250 µm PVC 250 µm PVC/PVDC

pyramid-shaped embossing design

23 (1982) 30 (1985)

lacquer/Al 25 µm soft/HSL

250 µm PVC 250 µm PVC/PVDC

cross perforation, 1.1 mm width of perforation

31 (1985)

50 g/m² paper/Al 7 µm /HSL

250 µm PVC

42 (1991)

50 g/m² paper/Al 7 µm /HSL

300 µm PP

43 (1991)

40 g/m² paper/Al 7 µm /HSL

300 µm PP

48 (1996)

23 µm PET/Al 20 µm /HSL

25 oPA/60 Al/60 PP

49 (1993)

70 – 100 µm Purelay-Lid

300 µm PP

52 (1999)

50 g/m² paper/Al 9 µm /HSL (PVC)

250 µm PVC/51 µm Aclar

Peel-push

(1) = dark coloured or opaque;

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to comply with DIN 55559. Standards stipulate test procedures but not what the package needs to looks like. Packaging solutions, which have been tested successfully, were registered at the BFArM (Bundesinstitut für Arzneimittel und Medizinprodukte, German Institute for Pharmaceuticals and Medical Products) and are then entered in the Fo r t s c h r e i b u n g s l i s t e (Table 3). This list does not have to be complete as only those items are listed which are registered by pharmaceutical companies or packaging manufacturers. Material combinations past test according to the previous DIN 55559 still have to be tested according to the adult test in order to be compliant to DIN EN 14375. Type testing (Fortschreibungsliste) is valid for the tested package and in a sense for the product packed. Nevertheless there is no such regulation that the tests have to be repeated dependant of the geometry of the filling good. BS 8404 accepts the material combinations approved by the DIN standard. Changes of the material combination (e.g. 25 µm Al soft and COC, cross perforation) ask for a new test. Reason for this is mainly the distinct stiffness of bottom materials. For example for reclosable containers the largest and the smallest are

Abilities/Difficulties of children and adults Abilities

Difficulties

Children Clamping, pressing, biting, tearing, hitting, do it with perseverance, eager to learn, imitation, experimenting with pleasure, visual preferences, fundamental positive attitude

Combining, execute simultaneous and complex motions,reading, writing, strong force, semantic experience, finemotoric motions

Adult

Loss of force, weak vision, low contrast perception, low comprehension of new technical subjects, uncontrollablefinemotoric motions, loss of memory, mental block,typically negative approach to new thinks.

Combining, simultaneous motions, reading, writing, pressing, clamping, biting, tearing, pulling, hitting, semantic experience, understanding, taste preferences.

tested and it is assumed that the intermediate sizes will also comply with the criteria for CR/SF if it passes the tests. Reason for type testing: the number of children who have to participate in the tests is decreased.

Australia In Australia the Therapeutic Goods Act 1989 is effective, Therapeutic Goods Order No. 65 “ChildResistant Packaging for Therapeutic Goods” (nonreclosable and reclosable packages). In this regulation also the therapeutic goods are stipulated which have to be packed in a child-resistant package. As to non-reclosable packages blisters or other single unit dose packages listed it is stipulated which specific material requirements have to be fulfilled. Test procedures are defined in AS 19281982. In the protocol of 1996 it is described that approved

packages from Canada, the US or the UK will also be approved in Australia if an appropriate test certificate is provided.

India The Indian standard IS 14233 (1995) “Packaging – Pharmaceutical Products – Child Resistant Tamper-Proof Packaging for Solid Dosage Forms – Code of Practice” is similar to BS 7236 and describes blisters and strip packs. The test of the package is not carried out with children but is a mechanical test.

Japan In Japan there is no regulation/standard as to CR/SF. It is up to the pharma company whether and how to pack the pharmaceuticals with protection for children.

Canada Here the Canadian stan-

dard CSA 276 C: Drugs I is effective. According to this standard a package is childresistant when compliant with CSA 276 (1992 last edition concerning non-reclosable packages), reclosable packages (1995), UK Standard BS 5321 and PPPA.

New Zealand In New Zealand the standard NZS 5825 (non-reclosable and reclosable packages) is effective. Approval is granted by the Department of Health. Packages which are approved in Europe, US or Australia as child-resistant are also approved in New Zealand. Development and test of new solutions for CR/SF The pharma industry is looking for new packaging solutions for CR/SF. Some of the existing materials have been on the market for more than 20 years. The abilities of

Table 4: Values of Barrier properties of Lidding Foils for CR/SF

April 16-30, 2013

BAFArM No.

Lidding foil

MVTR (g/m² x d) ASTM F 1249-90 25°C; 100%r.H.

OTR (cm³/m² x d x bar) ASTM D 3985-81 25°C; 50% r.H.

14 (19981) 30 (1985

50 g/m² coated paper/Al 9 µm/HSL

(1)

(2)

15 (1981) 30 (1985)

35 g/m² glassine paper/Al 9 µm/HSL

(1)

(2)

17 (1981) 30 (1985)

lacquer/ Al 30 µm/HSL (embossed)

< 0.01

< 0.005

23 (1982) 30 (1985)

lacquer/Al 25 µm soft/HSL

< 0.01

< 0.005

31 (1985)

50 g/m² paper/Al 7 µm /HSL (PVC)

(1)

(2)

42 (1991)

50 g/m² paper/Al 7 µm /HSL (PP)

(1)

(2)

43 (1991)

40 g/m² paper/Al 7 µm /HSL (PP)

(1)

(2)

52 (1999)

50 g/m² paper/Al 9 µm /HSL (PVC)

(1)

(2)

35 g/m² Kraft paper/Al 9 µm /HSL (PVC)

(1)

(2)

protective lacquer/Al 20 µm, rigid/15 µm PVC

< 0.01

< 0.005

protective lacquer /Al 20 µm, rigid/30 µm PVC

< 0.01

< 0.005

protective lacquer /Al 20 µm, rigid/30 µm PP

< 0.01

< 0.005

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today’s children have evolved too and thus new solutions are required. In addition to new technical solutions there is the requirement to maintain the same for the same processability while producing low costs. The development of a package is influenced by the age specific abilities and difficulties of the user. The abilities of children and adults respectively the difficulties they have to cope with are reciprocal. This complicates the possibility to offer complex solutions. The more difficult it is for an adult to open the package the more likely it becomes that the package remains opened, or that the content is filled into a package which is not CR/SF. In order to check the probability for compliance of the newly developed solutions with the CR/SF test according to EN 14375 all materials can be checked as to their puncture resistance or burst strength. The test device is fixed in a machine for check of tensile strength and the strength, which the plug needs to puncture the lidding foil from the inside is measured. The heatseal lacquer can be replaced by a plastic film: 1. protective lacquer /Al 20 µm, rigid/15 µm PVC 2. protective lacquer /Al 20 µm, rigid/25 µm PVC 3. protective lacquer /Al 20 µm, rigid/30 µm PVC 4. protective lacquer /Al 20 µm, rigid/40 µm PVC 5. protective lacquer /Al 20 µm, rigid/30 µm PP Other solution, tested successful, is the lamination of paper to the 20 µm hard

tempered aluminium:- paper 40 g/m²/Al 20 µm, rigid/HSL. Advantage of this structure is that the inner side, contact to the product, remains unchanged. The test results in comparison to the existing specifications of CR push-through foil according to the Fortschreibungsliste are listed in Table 4. Standard pushthrough foil 20 µm rigid is also depicted as a comparable value with 100 per cent. Based on the results the lidding foils 1, 2 and 5 were checked at the IfKiV in Hamburg (Institute for Childresistant Packages) as to compliance with EN 14375 and BS 8404 with respect to CR/SF. All materials passed the tests and thus can be used for packaging of products that require CR/SF features. Processing of these new solutions for CR/SF can be carried out on existing blister lines, analogous to the paper laminates. A preheating station for high speed blister lines or increased angle of contact of the sealing roller is recommendable. A topic to be discussed is always the barrier properties of the lidding foils (Table 4) in relation to diffusion of water vapour (MVTR) and oxygen (OTR). A 20 µm thick aluminium foil is technically pinhole-free (max. 0.5 pinholes/m²; average: 0.1 pinholes/m²) and thus impermeable for gases and water vapour. A study published in the Schweizer Aluminium Rundschau 12(1) (Swiss Aluminium Review) has shown that only unconverted aluminium foil of 7 respec-

tively 9 µm thickness results in a higher water vapour transmissibility than detection limit and depends on the number of pinholes. The values measured which resulted from lacquered and laminated aluminium foils were lower. The main amount of humidity diffuses through the thermoformed bottom foil. Results of the oxygen transmissibility rate (OTR) (2) are not available. Nevertheless the same holds true as was stated in connection with the moisture vapour transmissibility rate (MVTR). Ansapack is producing following structures and selling under name Panchild1: - 35 g/m² glassine paper/Al 9 µm/HSL - 35 g/m² Kraft paper/Al 9 µm /HSL (PVC) - protective lacquer/Al 20 µm, rigid/15 µm PVC - protective lacquer /Al 20 µm, rigid/30 µm PVC They were given to the German test institute IfKiV and tested successful (certificates available).

Conclusion The application of CR/SF for non-reclosable packages is constantly increasing. Thus pharma companies, which sell their products to countries with respective regulations/standards have to process appropriate packages. Manufacturers of flexible packaging materials are requested to develop appropriate solutions. Ansapack has contributed to this request with the lidding foils mentioned. With Korea started to implement CR/SF regulations it is foreseen that other countries in Asia will

follow. Nevertheless, with regard to all solutions for CR/SF it must be self-evident that child-resistant packages are only the last measure of a whole range of protective measures and they do not assume the responsibility for parents and guardians; it is still their obligation to store pharmaceuticals out of the reach of children.14

Rerefences 1. Tassilo Korab, presentation TATAL Exhibition Birmingham, March 2004 2.www.aponet.de 3.www.vitanet.de 4.www.optipage.de 5. Guidance on Compliance with the Medicines (Child Safety), Regulation 2003, MHRA; John Trepper, VP Perrit Labs „Blister and Harmonisation“ May 2000 6. DSW-datenreport “Weltbevölkerung 2004” (World Population 2004), Weltbevölkerungsbericht 2004 (Report: World Population 2004) 7. Panblok is trade mark for cold form laminate from company Ansapack 8. Consumer Product Safety Commission 16 CFR Ch. II (1-1-90 edition) 9. Banz No. 36 dd. February 23, 1982, p. 1 10. Banz No. 178 dd. September 20, 1984, p. 10683 11.www.bfarm.de/de/Arz neimittel/am_sicher/stufenpl/KISIP-Aufst.pdf 12. “Schweizer Aluminium Rundschau” High Quality Converter Foils and Laminates with Maximum Barrier Properties - 1981 13. Panchild is trade name of M/s Ansapack

PRE EVENT DIA to host conference on ‘Technological Advances in meeting Regulatory Challenges’ Event to be held at Mumbai Exhibition Centre IA India is organising a one-day conference on ‘Technological Advances in meeting Regulatory Challenges’ on April 25, 2013 at Mumbai Exhibition Centre. This is in keeping with the objective of bringing quality programmes on a continuous basis. DIA is an exclusive conference part-

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ner of Indian Pharmaceutical Machinery Manufacturers’ Association (IPMMA) who are having an exhibition of Machinery and Equipment ‘Pharma Pro&Pack Expo 2013’ at the same venue from April 24 – 26, 2013. The conference will highlight on understanding of the technological advancements in facility design, lean validation concepts — a new trend, www.expresspharmaonline.com

ensuring automation in meeting global regulatory challenges, in-depth view of qualification and validation of facilities, equipment, and utilities. It will be an excellent platform to interact and network with like minded professionals in addition to interacting and listening to experts on varied subjects. The objective of the conference is to understand the

type of technological advancements available in the current scenario, get insight into lean validation concepts in performing the qualifications, gather update on automation challenges, assess regulatory overview of qualification and validations and get an oversight of design considerations for new facilities. EP News Bureau- Mumbai April 16-30, 2013

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INSIGHT Barcoding on pharmaceutical products: Getting it right Siva Nagarajan, Executive Director, Sandilyam Automation Systems, gives an insight about 2D Datamatrix, which enables identification of a product covering its article number, batch of origin, date of manufacture and if required even an itemised serial number oday, healthcare and pharmaceutical industries globally, are actively investing in accurate traceability, as a deterrent against counterfeiting apart from benefits of tracking and supply chain automation. This has grown in the last few years to become a legislative compliance requirement, and spreading fast across many countries. India has also clearly laid down steps for the legislation for all exports to begin with. The preferred data carrier to achieve this is two-dimensional 2D barcoding, chosen over other comparable technologies, like RFID for numerous reasons. Datamatrix is a very efficient, 2D barcode symbology that uses a small area of square modules with a unique perimeter pattern, which helps the barcode scanner determine cell locations and decode the symbol. Characters, numbers, text and actual bytes of data may be encoded, including unicode characters and photos. The Datamatrix ECC 200 is the most suitable format given its very robust nature and small footprint. The ECC 200 provides redundancy

April 16-30, 2013

through error checking and correction which is particularly relevant for scanning the symbol under challenging circumstances, particularly online. Amongst the countries who have pioneered in adopting barcoding on pharma products for traceability, very successfully, is the French pharma industry. This has become a benchmark for other countries in the world to follow, given its success. The legislation in French, CIP-13, requires every pharma item to incorporate a 2D Data Matrix barcode consisting of product code, batch number and expiry date. The gathering momentum globally requires all pharma manufacturers to gear up to the challenges of this upcoming legislative requirement and be able to print and verify this barcode symbols on their products, before supplying them into the supply chain network. The printing techniques to generate these 2D Datamatrix barcodes could cover thermal inkjet, thermal transfer, print-and-apply and, drop-on-demand systems depending on the particular application requirements. In view of the criticality of the task on hand, and traceability upto the point of consumption of the drug, it is an obligation of pharma manufacturers to be able to assure reliable and correct data content and barcode print quality, since much

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depends on this, for any track and trace system to work. Maintaining acceptable barcode quality is an important task and basic requirement. To check this, using a

fixed-mount scanner or a hand-held reader to see if it reads, the code is very insufficient. The symbolâ&#x20AC;&#x2122;s reading quality cannot be established. The specialised

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testing equipment and assessment procedure are already laid down, to be adopted, in conformance to ISO/IEC standards, and GS1 general specifications, that have been created for assessing and defining barcode quality. Barcode verifiers are therefore used to verify these 2D Datamatrix barcodes and they perform a detailed analysis of defined parameter as per ISO IEC 15415. The global standards body – GS1 which is also the issuing agency for the linear EAN/UPC family of barcodes, developed 'Calibration Conformance Standards Text Chart' for the Datamatrix barcodes as well. This makes it a very definitive parameter check of the data quality generated by the barcode verifiers. The printer or the pharma company has to therefore use the data structure of GS1 general specifications in handling the Datamatrix barcodes for their products. The ISO/IEC 15415 standard specifies the methodologies for measuring, evaluating, and grading 2D symbol characteristics in order to indicate the quality of the mark. In addition, the standard identifies possible causes for symbol degradation. Users with less than optimal symbols due to problems with marking methods or substrate inconsistencies can use this information to correct and improve their marks and achieve better symbol quality In printing of the

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Datamatrix 2D barcodes there are always potential areas of problems and challenges that need to be carefully considered. Important among this is the structure of the symbol identified by a perimeter where scanners begin their attempt to read the encoded data. This finder pattern is 'L'-shaped and the opposite two adjacent sides consist of a dark and light clockpattern. Some of the critical elements of ISO/IEC 15415 in assessing the quality of the printed Datamatrix code include: ● Axial non-uniformity ● Fixed pattern damage ● Grid non-uniformity ● Modulation ● Symbol contrast ● Decode ● Unused error correction ● Reflectance margin ● Quiet zones ● Transition ratios Not to confuse scanning or camera-based reading with verification as this is a very critical link, within control and scope of the pharma manufacturer. No scanning system will be able to reliably assess and measure barcode quality as defined by ISO/IEC with repeatability and consistency, to be able to therefore assure scanability in any other scanning environment further down the supply chain. It is important that ‘verification’ has to be performed using the right optics and correct wave length of light source while reading the barcodes under test.

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Furthermore, during verification the symbol is also checked for encodation, right usage of the GS1 application identifiers (AI) mistakes of which, often go undetected otherwise. It is very important to be able to measure this quality conformance, since simply put, we can’t control what we can’t measure. Drawing a parallel from the retail and FMCG industries, we have seen as a global phenomenon that even with linear barcodes more and more, larger retailers and distributors globally are imposing fines on suppliers when they deliver goods with poor or low quality barcodes. We have seen these include the likes of TESCO, Walmart, Woolworth, and more, in retail supply chain operations. Logically, barcode quality and assured scanability assumes greater importance and criticality in a health and

ing operation for their facility. This is going to stay and grow, and getting it right is critical for all. Recently in the US, The Healthcare Distribution Management Association (HDMA) has just updated their guide for formatting, encoding, and placing bar codes on pharma products. Their aim is the safe and efficient distribution of healthcare products and services. Some significant changes now done include: ● The addition of a unique serial number in the GS1128 product identification bar code to product case labels ● A recommendation to add an optional 2D GS1 DataMatrix bar code symbol to drug packages and product cases ● A reduction in the bar code dimensions, thus freeing up space on labels for serial numbers

THESE STANDARDS OF BARCODE QUALITY COMPLIANCE ARE EXPECTED FROM MOST EUROPEAN, INCLUDING TURKEY, AND AMERICAN PHARMA MARKETS AS WELL pharma environment. The most effective method of supervising the Datamatrix barcode quality would be to use standalone verifiers which allow a comprehensive assessment on every single aspect of the Datamatrix quality. Any online scanning system would be motivated from a data collection perspective, and can never do the job to define the barcode quality. In selection of a barcode verifier, care must be taken that it meets the standards of ISO/IEC 15415 and ISO/IEC 16022. Secondly, the verifier must be capable of consistent performance in any environment. The verifier’s camera pixel size apart from wave length of light should be in conformance to the symbology specification and the GS1 requirements respectively. An important element of Datamatrix verification also includes operation training and calibration as per standards. Care and attention to these above parameters will ensure that manufacturers get the right product and knowledge to implement a successful Datamatrix printApril 16-31, 2013

●

New information on standardised numerical identifiers (SNIs) The goal in adding the 2D GS1 Data-Matrix symbol— which duplicates exactly all of the primary GS1-128 symbol data (GTIN) plus the data encoded in the secondary GS1-128 bar code — is to populate the supply chain with efficiently scannable 2D symbols to complement and enhance scanning efficiency when camera-based (2D) scanning is implemented by distributors for case-level receiving, put-away, picking, and distribution. These standards of barcode quality compliance are expected from most European, including Turkey, and American pharma markets as well. So be it LINEAR barcodes or the 2D DATAMATRIX symbols, verifying the symbols as per clearly laid down global standards, is not only a serious obligation, but also necessary from an engineering and quality assurance perspective. The proof of quality traceability being the verification report.

Powder Blender

Manual Capsule Filling Machine

Preformed Blister Sealing Machine

Trituration & Homogenization of Ointments Turboemulsifier Mixer

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Liquid Filling Machine with PLC

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Express Pharma Business Avenues We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

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Express Pharma Business Avenues CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

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GOA ANTIBIOTICS & PHARMACEUTICALS LTD (Goa Government Enterprise) CONTRACT MANUFACTURING Goa Antibiotics & Pharmaceuticals Ltd. (GAPL) a State Public Sector Enterprise and has a state of the art manufacturing plant at Tuem Pernem, Goa, conforming with cGMP standards. GAPL’s manufacturing facilities have been upgraded to meet Schedule ‘M’ GMP standards and has been accredited with WHO-GMP certification for manufacture of dosage forms in the category of Powder Injections(Cephalosporin range), Tablets (General), General Capsules, Liquid Orals and ß-Lactum Capsules. The Company has excellent manufacturing track record and has been associated with companies in organized sector (Multinationals and Public Sector Undertakings). Emphasis is given to quality service to meet the requirements of the customers in the area of product quality, productivity and delivery schedules. Proposals are invited from reputed Companies for Loan License, Turnkey or P to P business and also from Contract Manufacturing Agencies who can arrange business from Government Institutions/Companies along with required input materials as per above arrangements. Interested parties may send their proposals within 15 days to: The Managing Director, Goa Antibiotics & Pharmaceuticals Ltd. Near Tuem Industrial Estate, Tuem, Pernem Goa – 403 512. Tel: (0832) 2201419, 2201256, FAX:0832-2201278 E-mail: gapl_goa@bsnl.in / web site: www.gaplgoa.com

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KLEPTOSE速 HPB KLEPTOSE速 HPB and HP comprise a range of accessible hydroxypropyl cyclodextrins used increasingly as formulation aids to solve difficulties with aqueous solubility, stability or taste. KLEPTOSE速 HPB and HP are available as compliant cGMP grades that are particularly useful for parenteral solutions, syrups and oral suspensions, as well as for dry formulations.

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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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START YOUR SECOND CAREER !!! INVEST ONLY YOUR TIME & EXPERIENCE Chennai based Nutraceutical company dealing in innovative products with high potential to meet the unmet medical needs for the past 15 years Offers SECOND CAREER to join as BUSINESS ASSOCIATE at various locations in INDIA. Profit will be shared based on the receivables. Our Associates current EARNING Rs.25,000/- to Rs.50,000/PM

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RESEARCH EXPERTISE FOR DRUG DEVELOPMENT

CASE STUDY GPU-accelerated software: Aiding AIDS control A case study analysing the use and benefits of graphics processing units (GPU) to provide stimulation for AIDS virus maturation IDS is a devastating disease that directly attacks and weakens the human immune system, making it vulnerable to a wide range of infections, and is responsible for the death and infection of millions of people around the world. AIDS is caused by the HIV virus. The action of a protein called ‘HIV protease’ is responsible for the initial step of the whole HIV virus maturation process, which is what enables the virus to become infectious. HIV protease acts like a pair of scissors, cutting the long chain of connected proteins that form HIV into individual proteins that will form the infectious structure of new virions.

The solution Researchers at Bioinformaticians at IMIM (Instituto Hospital del Mar de Investigaciones Médicas) and UPF (Universidad Pompeu Fabra) in Barcelona used ACEMD, a GPU-accelerated molecular dynamics software, for the first time, to simulate the behaviour of the first crucial step in the HIV maturation process. This step revealed how the first HIV “scissors proteins” can cut themselves out from within the middle of these poly-protein chains, which initiates the whole HIV maturation process. They uncovered this major finding using GPUGRID.net, a voluntary distributed computing platform that provides the supercomputing power of thousands of

NVIDIA GPUs – 10 times the computational performance of CPU-based systems. Using NVIDIA GPU accelerators, researchers were able to run several highly complex computer simulations, each for hundreds of nanoseconds (billionths of a second) for a total of almost a millisecond, giving them a very high-probability that their simulation accurately represented realworld behaviors. The researchers are of the opinion that simulations of this length and complexity would have been practically unfeasible to achieve using a computing system based on CPUs alone. By leveraging a distributed network of computers with affordable, high-performance NVIDIA GPU accelerators, researchers achieved the needed level computational power that previously was only available on dedicated, multi-million dollar supercomputers.

The outcome This finding provides new visibility on the maturation of the HIV virons, specifically, how newly formed inert virus particles become infectious, which is essential in understanding how the virus replicates. By providing new visibility into how the HIV protease protein behaves, researchers can potentially design new antiretroviral drugs to halt the HIV maturation process and as a result, prevent it from becoming infectious. These findings have been published in the latest edition of Proceedings of the National Academy of Sciences of the United States of America (PNAS). Increased access to high-performance, affordable GPU-accelerated supercomputing, as was used in this research, promises to democratise computational science and potentially enable similar breakthroughs in other areas of science in the future.

UPDATES Piramal Enterprises and Tata Memorial Centre forge alliance To advance understanding of cancer biology and develop tools for personalised medicine iramal Enterprises and Tata Memorial Centre will collaborate to enable the development of valuable tools to better understand disease biology and predict responses to various treatments for cancer patients. The new alliance between the two organisations will focus on the development of preclinical cancer models to enhance the understanding of disease biology, treatment

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response/resistance and biomarkers as they relate to diagnosis, prognosis and response to drugs. These models will be based on tumour tissues from cancer patients and are predicted to have better translational relevance than the currently used human cancer cell line models. Scientists at both organisations hope to gain a better understanding of the mechanisms through which various drugs work on differwww.expresspharmaonline.com

ent cancers. This research could lead to new therapies and predict the medicine best suited to treat an individual cancer patient. “Our collaboration with Piramal Enterprises addresses a critical need in cancer care, which is widely accessible and cost effective personalised medicine for cancer patients,” said Dr Rajendra Badwe, Director, Tata Memorial Centre. Dr Swati Piramal, Vice Chairperson, Piramal Enterprises said, "We hope that the insights we gain from

this alliance will ultimately lead to new treatment options for cancer patients.” The New Chemical Entity Research division of Piramal Enterprises focuses on the discovery and development of innovative medicines to improve the lives of patients suffering from cancer, diabetes, metabolic disorders and inflammatory conditions. It has a state-of-the-art research centre in Mumbai and comprehensive capabilities spanning target identification all the way through clinical development. April 16-30, 2013

PHARMA ALLY VENDOR NEWS Two Thermo Fisher Scientific facilities achieve ISO 13485 Certification Distinction certifies facilities’ quality management system for medical devices hermo Fisher Scientific's facility in San Jose, Calif and its Franklin, Mass site have achieved ISO 13485 certification, an internationally recognised standard of quality management for the design and manufacture of medical

devices. The sites in Franklin and San Jose are the first of Thermo Fisher’s liquid chromatography and mass spectrometry sites to achieve ISO 13485 certification. Thermo Scientific TLX multiplexed HPLC (high performance liquid chromatogra-

phy) platforms and a number of Thermo Scientific mass spectrometry systems will be designed and manufactured under this standard, paving the way for CE-IVD device registration in Europe and Class-1 medical device listing in the United States, the company said. “This is a critical step in our ongoing initiative to develop LC-MS (liquid chro-

matography-mass spectrometry)-based devices for the clinical market,” said Dan Shine, President, Thermo Fisher’s chromatography and mass spectrometry business. “The medical community is expressing great interest in utilising LC-MS technology, and we’re aggressively developing tools to address this growing demand.” EP News Bureau-Mumbai

Sigma-Aldrich launches Vetec Brand in India New brand brings Sigma-Aldrich reliability to reagents for everyday use igma-Aldrich Corporation, a leading life science and high technology company, has introduced its new Vetec brand product line in India. The Vetec portfolio is aimed at meeting the everyday needs of scientists in India and consists of a growing collection of over 400 reliable-quality laboratory reagents, competitively priced to enable their use in

routine research. Vetec products are thoroughly tested to ensure they meet SigmaAldrich quality control standards for integrity, consistency and reliability and come with Certificates of Analysis, MSDS information and spec sheets. Vetec, backed by SigmaAldrich’s industry-leading quality and supply chain excellence, offers customers

a strong alternative to the brands that currently serve India’s 'everyday' research market and includes solvents, buffers, carbohydrates, detergents, inorganic salts and synthetic reagents. The brand is aimed at providing reliable, easy-toorder, readily available products for everyday laboratory use. “Sigma-Aldrich has been conducting business in India for more than 20 years. Our success will continue to be

based upon our capabilities and the ability to customise our offer to meet the demands of the local market,” said Jason Apter, Vice President and Managing Director, Asia Pacific. “In October, 2012, the Vetec brand was introduced in China. Its launch in India, and subsequently into other countries in the Asia Pacific region supports our company’s strategy of ‘international localisation’.” EP News Bureau-Mumbai

PRODUCTS Fisher Scientific launches Fisherbrand centrifuge tubes and serological pipettes F isher Scientific, a part of Thermo Fisher Scientific India has launched Fisherbrand centrifuge tubes and serological pipettes. The brands are set to represent quality, consistency and reliability. By introducing these products in the life science portfolio, Fisher Scientific hopes to offer its customers 'Convenience and Choice' to select from the existing premium brands like NUNC, Corning. The Fisherbrand centrifuge tubes and Serological Pipettes are

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Durable, chemical-resistant and clear polypropylene. Most styles and sizes are

available in all the range in individually wrapped foam racks or in bulk packs. Fisher Scientific offers a product portfolio that spans chemicals, life science and general laboratory supplies from leading product and supplier brands. By combining global supply chain expertise with customized product and service solutions, they provide choice and to make order processing easy.

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Contact details: Mrudula Joshi Sr Marcom Coordinator Research & Safety Division (RSD) Fisher Scientific (Part of Thermo Fisher Scientific) 403 - 404, B Wing, Delphi, Hiranandani Business Park, Powai, Mumbai - 400076. India Direct: +91 22 6680 3062 Fax: +91 22 66803001 / 02 Email: mrudula.joshi@thermofisher.com web: www.fishersci.com

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The number of pharma professionals donning the cap of an entrepreneur has increased with a speed like never before over the last one decade. Peter Drucker, renowned nanagement consultant, once said, “The entrepreneur always searches for change, responds to it, and exploits it as an opportunity.” This statement rightly describes the mentality of new breed of pharma entrepreneurs. In quest of new Chetan Tamhankar, Founder and Director, Zhi Holistic spent many years of his professional life in the CRO industry. India’s leading CRO, Siro Clinpharm, grew under Tamhankar’s able leadership. However, he left many of his industry colleagues surprised, not because he decided to leave Siro Clinpharm, but because he ventured into the health and wellness business. Tamhankar’s experience in CRO industry would have helped him in a great way had he started his own CRO, however, his foray into a completely new segment of the business increased the curiosity levels across the entire CRO industry. Tamhankar says, “Having contributed to building India’s pioneering CRO— SIRO Clinpharm in the first 16 years of my career, I thought of experimenting with a different idea. The new venture is in the health and wellness area, where I have put together several elements of health and wellness solutions - international standard spa service, yoga studio, treatment of chronic illnesses using ayurvedic and natural medicine, diet and nutrition consulting and laboratory services.” While explaining the rationale behind venturing into this business other than the CRO, he says, “My business in health and wellness service venture, while earlier work April 16-30, 2013

IVY LOUIS

VISHAL SHARMA

Founder and Director, Vienni Training and Consulting LLP

Challenges and risks are plenty in every field. The achievement of having set up an organisation grows when you find there are people who are willing to risk their standing and join you

The field of entrepreneurship is virgin in pharma and allied sectors, although biotechnology has a different story. “Many people hold themselves back and do not venture into being an entrepreneur simply because of fear, especially fear of failure

You may make business plans on excel spreadsheets, but real understanding will come after reviewing the way business shapes up. If one realises that the business does not deliver what it was expected to deliver, then one must be ready to take tough decisions as well

was with clinical research services. So, though the business offerings are different both are service businesses. Of course, SIRO Clinpharm was a B2B business, while the new project is in retail.” Vishal Sharma and Ivy Louis, Founder and Director, Vienni Training and Consulting LLP, spent many years in the pharma sector. Now they have their own consultancy for the pharma industry. “The training and consulting field in the biopharma and pharma has always been traditional in its approach. Breaking this barrier was the need of the hour and this prompted us in setting up a venture that deals with training and consulting,” informs Sharma. Louis says, “Vienni adds value directly and indirectly to pharma and biologic manufacturing organisations, in the area of training and development, six sigma implementation, statistical process control especially in the microbiology areas, terminal sterilisation, filtration

and sterilisation, QbD–QRMQMS, third party audits and technical due-diligence, review of microbiology activities.” Dr Nitin Borkar is a well known name in the global pharma industry for his expertise in R&D. After spending enormous time overseas and in India, handling different responsibilities in the pharma industry, he moved on to become an entrepreneur. Today, Borkar is the Founder Partner and Chief Executive Officer of Goa-based VerGo Pharma Research. His company is into CRO business. He had an ambition of becoming an entrepreneur. Today, VerGo is shaping up to become a leading CRO of India. “By nature, I have a drive to be an entrepreneur with an innovative bent of mind. In the past 30 years, R&D with emphasis on quality has been my passion. These were the two drivers, supported by luck which pushed me in this field of contract research,” says Borkar. Presently, VerGo has three divisions: Pharma

Research, Organics and Clinicals, involved in product development, custom synthesis and clinical research respectively. This unique CRO platform provides end-to-end service for all the development activities for the global healthcare industry. The company also has a joint venture with VerGo PharmAZet to provide all regulatory, distribution and quality services in Europe. Prakash Shanware, President and Chief Executive Officer, People First, spent more than three decades in the pharma industry and is hardly left with anything new to experiment with in his domain of expertise. “I had a long pending desire to do something on my own and hence switched from corporate to being an entrepreneur,” reveals Shanware. He adds, “I also realised that after reaching the highest level in your career, what you will continue to do will be what you have been doing in the past years and hence wanted to now start my second

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CHETAN TAMHANKAR Founder and Director, Zhi Holistic

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P|H|A|R|M|A| L|I|F|E

innings of being totally independent. I work in the human resources domain, from consulting, OD to training and coaching and also help organisations in carrying out senior leadership level talent acquisition, specifically for the pharma sector and life-sciences space.” Deepak Naik, was Managing Director with a leading pharma MNC. However, like other pharma professionals he too moved out to test his entrepreneurial skills. Today Naik is the Managing Director of his own company Health‘N’U Therapeutics. His company is engaged in importing and marketing pharma products in India. “I had decided that I should fulfill all my career objectives by the age of 45 and then turn entrepreneur,” he informs.

neering has given me the confidence to direct a CRO programme,” asserts Borkar. “Since a large part of my experience has been in the pharma sector, I understand the challenges and complexities of the sector,” says Shanware. Talking of the benefits that experienced individuals get, Shanware points out, “Experience enabled me to contribute more by identifying the right candidates for the company, keeping in mind the cultural aspects of the individual and company. For other areas in human resources, having

ent,” opines Naik. While describing technical challenges Borkar says, “The challenges are many but the major ones are acquiring land in a developed industrial park, getting electricity quota, and also timely approvals from government bodies. The two major risks were to correctly budget the financial layout and avoid execution overages and manage the influence of world economy and the monetary fluctuations.” Shanware explains a few more facets of challenging scenarios. He says, “You

DR NITIN BORKAR

PRAKASH SHANWARE

Founder Partner and CEO, VerGo Pharma Research

President and CEO, People First

Experience matters According to industry experts, experienced individuals are more likely to have the potential to become successful entrepreneurs and new entrepreneurs too endorse this fact. However, it should be mentioned that experience is not the norm. Tamhankar, who has ventured into a new business segment is hoping to apply his experience of scaling up businesses from bottom up, pushing profitability drivers to see if the same can be implemented in the new venture. According to Sharma, the domain expertise is a line that gives one a head-start, but as we progress, it will be the ingenuity and the out-ofbox thinking that nurtures the business, yet maintaining a fine balance between retaining the strengths of what was learnt and shedding what is not appropriate can put one into a tizzy. “Experience is helping me tremendously. Throughout my career I established, improved business, launched and developed brands for others. Now we are doing for it for ourselves,” states Naik. For Borkar, the exposure of working with MNC’s, generic and OTC companies in the US, India, China and Europe has given him the perspective and experience to handle all aspects of the business. “The exposure to R&D-driven allied fields such as regulatory, quality, manufacturing and pharma engi-

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The exposure to R&D driven allied fields such as regulatory, quality, manufacturing and pharma engineering has given me the confidence to direct a CRO programme

You need to be an expert juggler with regards to handling all jobs as they come to you. Be it certain administrative jobs, sending couriers, making your own presentations, anything that ends up on your table

first hand exposure with varied sectors like the pharma, agro chemical and even electronics, provide me with a deeper insight on all HR matters.”

need to be an expert juggler with regards to handling all jobs as they come to you. Be it certain administrative jobs, sending couriers, making your own presentations, anything that ends up on your table. Distributing your time into core and non-core operations is another challenge.” “Challenges and risks are plenty in every field. The achievement of having to set up an organisation grows when you find there are people who are willing to risk their standing and to join you,” asserts Louis. Sharma feels that the field of entrepreneurship is virgin in pharma and allied sectors, although biotechnology has a different story. “Many people hold themselves back and do not venture into

Not without challenges Working for an established organisation and establishing a business house by himself are two different things altogether. Responsibilities and liabilities increase many fold in the later scenario. Newly crowned entrepreneurs know that building a corporate house is not going to be a cakewalk. “The biggest challenge after becoming an entrepreneur is to live without the fancy of designation, perks and power. The next big challenge is capital and talwww.expresspharmaonline.com

being an entrepreneur simply because of fear, especially fear of failure,” criticises Sharma. As Tamhankar moved away from his field of expertise, for him, his new venture was altogether a new experience. Challenges are given for any new start up but for Tamhankar who is a newbie to health and wellness business, conditions are perhaps even more challenging. Tamhankar describes, “Getting new customers, differentiating, making sure you deliver consistent and high quality results to your customer, motivating teams are the key challenges. As mentioned earlier, the new venture is like an experiment for me, to see if a venture in retail is scalable, well differentiated model or not.” He adds, “You may make business plans on excel spreadsheets, but real understanding will come after reviewing the way business shapes up. If one realises the business does not deliver what it was expected to deliver, then one must be ready to take tough decisions as well.”

More to come The entrepreneurs mentioned in this article are just a small sample of the many in the industry. If these entrepreneurs themselves are to be believed, there is long queue of pharma professionals who are all set to take a dose of the medicine manufactured in their own factory. “This trend of entrepreneurship will certainly grow and allow a variety of business models to flourish. An entrepreneur will be willing to take this risk when he/she knows that their idea is worth pursuing and is unique in entirety,” says Sharma. “I am aware of many people getting into a new business and I guess it will continue,” informs Tamhankar. According to Shanware, although it is a tough call to move from a lucrative corporate job to an uncertain challenging transition, the tough people opt for it. Pharma professionals are trying to do something new and innovative. However, new moves and ideas should be backed by right strategies and accurate executions. After all, there is no use of wind if one doesn't know in which direction to sail. sachin.jagdale@expressindia.com April 16-30, 2013

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AWARDS Express Pharma article on TB bags award Media's role in TB control highlighted at REACH Lilly MDR-TB Partnership Media Awards

s in previous years, the REACH Lilly MDR-TB Partnership Media Awards 2013 recognised the best reporting on TB by Indian journalists, in English and all other languages. Viveka Roychowdhury, Editor, Express Pharma was one of the four recipients of this year's Awards. The award winning entry is her story, 'Beyond the Ban', published online in Express Pharma on June 29, 2012, as well as in the June16-30, 2012 issue. The article explored the complex world of TB diagnostics, the various stakeholders and their vastly differing interests and responsibilities. The other winner in the English category was Mumbai-based Prayaag Akbar, currently with the Sunday Guardian, for his meticulously researched, wide-ranging story ‘The Growing Tuberculosis Threat: Can India control drug-resistant tuberculosis?’ published in The Caravan last year,

drawing attention to the growing dangers of multidrug resistance and the longterm responsibility of both the state and private players in controlling TB. The award in the Local Language category went to Yasir Fayas of Mathrubhumi Aarogyamasika for his focus on ‘Childhood entrapped in TB’, describing the complexities of paediatric TB in Kerala and emphasising the urgent need to understand the linkages between adult and childhood TB, in terms of both prevention and care. Ranchi-based journalist Anupama Kumari of Tehelka was the other recipient in this category, for her story ‘TB via Bidi: Life in the shadow of Death’, describing the health consequences for bidi workers, particularly in terms of a growing vulnerability to TB. The award winners were felicitated by Dr Jagdish Prasad, Director General of Health Services, Ministry of Health & Family Welfare, Government of India in Delhi on March 22 in the run up to World TB Day on March 24. Congratulating the winners, Prasad said, “I congratulate all the winners. It is a pleasure to see REACH/Lilly MDR-TB Partnership adopt such an initiative in spreading awareness on TB. Despite TB being a curable disease people are unaware of its management and treatment. Media can play a vital role in raising awareness on the disease as well as help in reaching out to the patients and

educating the practitioners.” Bemoaning the fact that inspite of tuberculosis (TB) being curable and treatable, India is seeing increasing infection rates, Prasad emphasised media's crucial role in increasing awareness about the disease. Prasad used the occasion to outline some of the regulator's latest thinking on the public health problem posed by TB. He was in favour of continuing free medication for TB patients exclusively through the public health system and asked media to reach out to private practitioners to spread information about increasing drug resistance. The country needs an emergency for change to come, he said and media has to play its role in creating awareness. Speaking on the occasion, Dr Ashok Kumar, Deputy Director General, Central TB Division, Ministry of Health & Family Welfare, Government of India was the Guest of Honour spoke about the success of the Revised National Tuberculosis Control Programme (RNTCP), he underlined the purpose to hasten the decline in TB incidence and energising the movement. Other dignitaries who participated and spoke at the event included Melt Van Der Spuy, Managing Director, Lilly India; Dr Nalini Krishnan, Director, REACH; Dr Madhukar Pai, Professor, McGill University, Canada and Dr Jaya Shreedhar, Health Communications

Consultant. Speaking on the occasion, Spuy said “On behalf of the Lilly Foundation, I congratulate the winners of the fourth edition of these awards. Media plays a crucial role in educating masses about this daunting disease and it becomes imperative to reward their valuable contribution to this fight. At Lilly, we believe that TB and MDRTB are major health concerns that cannot be solved alone and we are therefore supporting the Lilly Foundation to work closely with various stakeholders including media professionals to address the challenges and barriers to its control.” “As India struggles with an increase in cases of multidrug resistant tuberculosis, rising public health costs and a lack of basic awareness of the disease, journalists have an even bigger role to play. We are delighted to be inviting applications for our first ever National Fellowship, open to any journalist from across India, who is keen to explore TB-related issues at the national, policy level,” said Krishnan. The event included a poster exhibition on the REACH Lilly MDR-TB Partnership Media Fellowship Programme, featuring the work of the 10 journalists who have taken up the Fellowship this year. The organisers also called for applications for the first ever National Fellowship for Reporting on TB.. EP News Bureau-Mumbai

Suresh G Kare receives ‘Udyog Shree Jeevan Guarav Sanman’ Receives award for his noteworthy contribution to S business and industry uresh G Kare, Executive Chairman, Indoco Remedies, was honoured with 'Udyog Shree Jeevan Gaurav Sanman’ (Lifetime Achievement Award) for his noteworthy contribution to business and industry. Udyog Shree Publication, a forum for Industries & Commerce, awarded Kare at a recently held event in Mumbai. The Udyog Shree Award was awarded to eleven other entrepreneurs. Manohar Parrikar, Chief

April 16-30, 2013

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Minister, Goa, handed over the award to Kare. Kare said, “This Lifetime Achievement Award belongs to my 5500 fellow Indocoiites. I faced tough times in my initial days, when Indoco was on the verge of closure and strived hard to bring it to the respectable position it has today. The company today is not only well established in India, but is also the most preferred partner for generic pharma companies across

the globe.” The Udyog Shree selection committee is headed by Subhash Dandekar, Chairman Emeritus of Camlin Kokuyo and also has Kumar Ketkar, Journalist, Madhu Mangesh Karnik, litterateur, Eknath Thakur, Chairman, Saraswat Bank, Kesari Patil, Founder Chairman, Kesari Tours and Bhimashankar Kathare, Editor, Udyogshree Magazine. EP News Bureau-Mumbai EXPRESS PHARMA

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CAMPUS BEAT Sinhgad College of Pharmacy hosts a series of state level seminars S the seminars were sponsored by University of Pune

inhgad Technical Education Society’s, Sinhgad College of Pharmacy (SCOP), Pune recently organised a series of seminars, which were sponsored by the University of Pune. A one-day state level seminar on 'Perspectives and challenges in implementation of credit system in the curriculum of UoP at post graduate level' was followed by a twoday national level seminar on 'Pharmacovigilance: Ensuring the Safe Use of Medicines.' The last seminar was on 'MDR/ XDR Tuberculosis: A healthcare menace to developing countries'. The seminar on 'Perspectives and challenges in implementation of credit system in the curriculum of UoP at post graduate level' was inaugurated by Dr Sampada Joshi, Controller of Examinations, University of Pune, who was also the guest of honour for the seminar. Experts from various institutions were invited to discuss the different aspects of credit system which is already part of some of the universities in India. It was attended by around 50 faculty and 115 PG students from different colleges. Dr KN Gujar, Principal, SCOP and Convener of the seminar emphasised on student-centric learning system. He added that higher education in India needs to improve to gain international competitiveness, mobility and employability of students. Dr Shirolkar S V, Professor DY Patil College of Pharmacy Pune; Dr Milind Wagh, Professor, NDMVP’s College of Pharmacy, Nasik and Professor Samreen Shaikh Allana College of Pharmacy elaborated on choice-based credit system. In the valedictory session, Dr MD Burande, Principal, Siddhant College of Pharmacy enlightened that the skill in a person will be highlighted by the credit system. The seminar was summarised by Dr NS Ranpise and the vote of thanks was proposed by Shilpa

EXPRESS PHARMA

Shrotriya, Coordinator the seminar.

Pharmacovigilance The two-day national level seminar on 'Pharmacovigilance: Ensuring the Safe Use of Medicines.' was held for creating awareness and providing knowledge of the pharmacovigilance to the budding pharmacists for monitoring adverse drug reactions and ensuring the safe use of medicines in the society. VM Shende, Co-ordinator of the seminar and Dr KN Gujar welcomed the delegates. Dr Padmakar Pandit, Professor and Head Department of Pharmacology, BJ Medical College, Pune inaugurated the seminar, explained basic concepts of pharmacovigilance and emphasised on the need of pharmacovigilance centres in India. He said physician and pharmacist as members of healthcare team are responsible for monitoring adverse drug reactions and ensuring the drug safety. Eminent speakers from BJ Medical College, DY Patil Medical College and professors from various pharmacy colleges were invited to deliver the lectures. Topic such as signal detection in pharmacovigilance and details of suspected adverse drug reactions form, risk-benefit assessment in pharmacovigilance, drug development and importance of pharmacovigilance, impact of drug and cosmetics (1st Amendment) Rules, 2013 on clinical research with respect www.expresspharmaonline.com

to pharmacovigilance and role of pharmacists in drug safety, were discussed in depth. RS Sahane, Assistant Professor, SCOP proposed the vote of thanks. Around 80 students representing state and national institutes were present. The seminar evoked a great response from the students, boosted the knowledge of pharmacovigilance and created awareness for monitoring adverse drug reactions and ensuring the safe use of medicines.

World TB Day In view of World TB Day and to take few initial steps towards the ‘Stop TB programme’, a three-day international seminar on 'MDR/ XDR Tuberculosis: A healthcare menace to developing countries' was held.Dr Gujar took the initiative to bring together all healthcare professionals on a common platform and e x c h a n g e the ideas to fight the problem together. Dr Dhiman Sarkar, Scientist from National Chemical Laboratory (NCL)

inaugurated the seminar and briefed about anti-tubercular research and drug discovery initiatives in India to overcome the problem of multidrug resistance (MDR) and extensive drug resistance (XDR). Eminent speakers from Indian Institute of Science education and Research (IISER), BJ Medical College, and professors from various institutions were invited to deliver the lectures. Topics such as new drug discovery, novel formulation approaches, microbiological aspects, diagnosis of TB, patient related issues, TB-HIV co-infection, causes, remedies of TB and how the menace can be stopped were discussed in depth. Priti Jamkar, Professor, SCOP and Coordinator of the programme proposed the vote of thanks. Around 100 students and faculty representing national and international institutes were present. The seminar created awareness amongst all the delegates as well as the invitees towards the ‘Stop TB’ mission. April 16-30, 2013

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