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VOL .8 NO.21 PAGES 68

Market Rising above neglect Management Gearing up for the future Pharma Life Dr Vinod Prakash Sharma receives Gujar Mal Modi Award 1-15 SEPTEMBER 2013, ` 40

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VOL 8. NO. 21 SEPTEMBER 1-15, 2013


Chairman of the Board Viveck Goenka


Editor Viveka Roychowdhury*

Raise your game - Expand your horizons


in the Indian OTC market

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


RESEARCH Novartis receives FDA breakthrough therapy

Bangalore Neelam M Kachhap

designation to BYM338 for sIBM PAGE 30

Delhi Shalini Gupta

Bypassing immune rejection in stem cell-


based therapies PAGE 30

Deputy General Manager Harit Mohanty

Family history of diabetes increases the risk

Senior Manager Rajesh Bhatkal

of prediabetes by 26 per cent PAGE 31

PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Sr. Executive- Scheduling & Coordination Rohan Thakkar Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Photo Editor Sandeep Patil


In January last year, 13 pharmaceutical companies alongwith with the US, the UK and the UAE governments; Bill & Melinda Gates Foundation; World Bank; and other partners signed the London Declaration, renewing their commitments to accelerate progress for neglected tropical diseases. Much remains to be done, analyses Shalini Gupta

US FDA approves GlaxoSmithKline’s HIV drug Tivicay PAGE 31 FDA rejects Merck insomnia drug, seeks lower-dose


PHARMA ALLY ‘We are investing heavily this year to broaden our resource base in India’ PAGE 33 Pall Corporation opens expanded SLS Technical Support Centre in Bangalore PAGE 34 Thermo Fisher Scientific introduces high

Layout Rakesh Sharma

performance gas chromatograph


C I R C U L AT I O N Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208,TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

September 1-15, 2013

PHARMA LIFE Hiring activity in pharma sector rebounds in July-13


Dr Vinod Prakash Sharma receives Gujar Mal

MARKET Jubilant Biosys files IND with US-based Endo Pharmaceuticals PG 13

Modi Award PAGE 64

DoP extends excise duty exemption on formulations under DPCO 2013 PG 14 Ranbaxy allocates site for greenfield manufacturing facility in Malaysia 2013 PG 15 Biocon introduces novel biologic, ALZUMAb for psoriasis in India 2013 PG 16 Lex Witness to organise 2nd Annual Pharma Legal & Compliance Summit 2013 PG 19 IPM witnesses growth of 9.4 per cent in July ‘13 PG 20 IPA organises clinical research conference PG 22



EDITOR’S NOTE From price-led to IP-led innovation


India’s 66th Independence Day was overshadowed by

School of Pharmacy who has co-authored a recent

political bickering and economic turmoil as the

report, ‘Health and Health Care in India: national

rupee’s valuation to the dollar and other major

opportunities, global impacts’ was in the country

currencies like the British pound plunged. Growth in

to launch this report and made a very pertinent

all emerging nations is slowing, perhaps a sign of the

point when he said that for policy makers, the

inevitable maturing of these markets. The US, the UK

short term overwhelms the long term, especially

and the EU economies appear to be stabilising though

with an election around the corner. The cover story

they are not out of the woods as yet.

in this issue, 'Gearing up for future' gauges the

But looking to India’s next I-Day, when we will

reactions of industry stalwarts to these policy

have another set of leaders at the centre, can we

changes. The mood may not be upbeat but Ranjit

expect them to do a better job? Pre-election, there is

Shahani, Vice Chairman & Managing Director,



Novartis India sums it up best when he says,

stakeholders, with a spate of promises. Post election,

“There is too much at stake to give up the future

the promises turn to dust. Therefore, the best time for

for the present.”







a nation’s citizenry to test the worth of its politicians

Among other conclusions, the UCL report suggests that half a century after the 1970 Patents Act,

is in the pre-elections wooing period. Thus, we have a golden opportunity to re-set

a 're-modernised approach to intellectual property

political priorities and one of these is to catapult

(IP) law might mark the beginnings of the country's

healthcare to the top of the political agenda. If US

rise as a post transitional community.' This might be

President Obama will always be judged by the

a tough transition to make right now, with posturing

success of healthcare reforms, so much so that it has

taking precedence over clear thinking. For India, IP at


present is a black or white issue, with no shades of






politicians from championing this cause in India? Healthcare






pharmaceuticals, hospitals and medical devices,

grey. The pendulum seems to have swung from one extreme to the next, and fears of a backlash subdue the saner voices urging an equilibrium.

have not captured the imagination of our political

But extending this argument, Indian Pharma Inc

bigwigs. It is only when the policy paralysis is

already seems to be moving away from competing

perceived to impact global sentiment that the Prime

on price alone. The generics-only model of growth

Minister steps in; the most recent example being

is waning as countries like Sri Lanka and others in

when he cleared Mylan Inc’s takeover of Agila

South Africa designate medicines as 'priority import

Specialities, overriding fears of the Department of

substitution' sectors. As our traditional customers



for affordable generics climb the same ladder that

manufacturing facilities of crucial drugs should

India has ascended in the past decades, Indian

remain under Indian ownership. But, there is still a

pharma companies should graduate to the next

huge question mark on foreign direct investment

level: from price-led to IP-led innovations. Some of

(FDI) in brownfield pharma facilities.

them do have their own molecules in various stages





In fact as India ages, these sectors will become even more critical. Prof David Taylor, of the UCL

of R&D but how many more I-Days will we have to wait for this tryst with destiny. Viveka Roychowdhury


September 1-15, 2013

VISIT Join pharma professionals from all over the world to network and do business with pharma machinery, equipment and technology suppliers @ P-MEC India 2013!

Pharma Machinery, Equipment & Technology

3-5 December 2013 Bombay Exhibition Centre, Mumbai, India P-MEC India is part of the largest and most comprehensive pharmaceutical industry event in South Asia. Focused on pharmaceutical machinery, equipment, ingredients, outsourcing and bio-solutions, this is your ultimate one stop pharma shop! As the pharma industry is increasingly looking towards India to source low cost, high quality pharma solutions, P-MEC India and co-located events provide the perfect place to initiate and explore partnerships with key pharma companies from India and abroad.

CPhI - Halls 1, 2 & 3 P-MEC - Halls 6, 7, 8, 5 & Open Bay Area of Hall 5

P-MEC is an excellent platform to see the latest products in action. Most of us would like to see the machine performance live and P-MEC is the best place to see the product and thus facilitates the decision making process. Hitesh Doshi, Indeus Life Sciences Pvt. Ltd.

This event is an excellent opportunity to keep abreast with new developments in the pharma industry. Dr Prakash U.Tahiliani, Prime Ever Ayurvedic Research Laboratories

Co-located with:

Organised By:



Jubilant Biosys files IND with US-based Endo Pharmaceuticals PG 13 DoP extends excise duty exemption on formulations under DPCO 2013 PG 14 Ranbaxy allocates site for greenfield manufacturing facility in Malaysia 2013 PG 15 Biocon introduces novel biologic, ALZUMAb for psoriasis in India 2013 PG 16


In January last year, 13 pharmaceutical companies alongwith the US, the UK and the UAE governments; Bill & Melinda Gates Foundation; World Bank; and other partners signed the London Declaration, renewing their commitments to accelerate progress for neglected tropical diseases. Much remains to be done, analyses Shalini Gupta

Lex Witness to organise 2nd Annual Pharma Legal & Compliance Summit 2013 PG 19 IPM witnesses growth of 9.4 per cent in July ‘13 PG 20 IPA organises clinical research conference PG 22





A A study by Medicine Sans Frontiers and Drugs for Neglected Diseases (DNDi) published in December last year reveals that even as neglected diseases account for roughly 11 per cent of the world's global disease burden, a meagre four per cent of the world's new therapies and 1.2 per cent of new chemical entities (NCEs) were developed for them in the last decade. Clearly disease burden does not seem to be a criteria for new drug development for Neglected Tropical Diseases (NTDs). These diseases affect 1.4 billion of the world’s population, mostly the poorest of the poor even in countries such as the US and the UK and result in roughly 26 million DALYS (Disabilityadjusted life years) lost (as published in Lancet 2012, if one were to go by the core group of 17 NTDs). However, momentum is building up, if the London declaration is anything to go by.

Moving beyond MDA Mass


Administration (MDA) has so far been a tried and tested method utlised as a strategy to combat NTDs and as many as 13 pharmaceutical companies have pledged to amp up their efforts in January last year by donating preventive chemotherapy, an intervention that allows the regular and coordinated administration of quality-assured, safe, single dose medicines on a large scale for the treatment of foodborne trematode infections, lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminthiases and trachoma. “Many individual countries have success stories to share about the control and elimination of several NTDs achieved through NTD plans, scaled-up MDA and remarkable political will. Highlights include onchocerciasis elimination in Colombia; LF elimination in China and the Republic of Korea and blinding trachoma elimination in Ghana and Mexico,” chips in Peter Hotez, Dean, National School of Tropical Medicine



Dean, National School of Tropical Medicine at Baylor College of Medicine and President, Sabin Vaccine Institute

Senior Research Fellow, Tufts Center for the Study of Drug Development

The concept of ‘tool ready vs. 'tool deficient’ diseases is no longer valid. Ultimately, almost all of the NTDs will require new drugs and vaccines to overcome resistance and water, sanitation and hygiene challenges. We also need new diagnostics to better quantify the number and severity of NTD infections in people

Anti-malarial combination products with new formulations have improved health outcomes. The Coartem story is a good illustration of this. It is a fixed dose combination product approved in 2002. New formulations of the product, including a cherry-flavoured drink for children, have improved adherence tremendously in malariaendemic countries, such as Ghana

at Baylor College of Medicine and President, Sabin Vaccine Institute. However, although such programmes have been running for a decade now and are riding on a success wave, expanding further, there's much more to it than just doling out free, low cost medicines to the poor. They must also be continually assessed with respect to the

effect they are having on the ground. Margaret Chan, directorgeneral of the WHO, in her foreword to the WHO report“Sustaining the Drive to Overcome the Global Impact of Neglected Tropical Diseases” emphasised precisely this, when she said: “As more programmes approach their milestones and targets, new tools and

Statistics ❖


In India, the most prevalent NTDs are soil-transmitted helminths (STH), which include hookworm, roundworm (ascariasis), and whipworm (trichuriasis); lymphatic filariasis (LF); dengue; visceral leishmaniasis; rabies; and leprosy. India accounts for 27 per cent of the world’s STH burden, with over 240 million Indian


children in need of deworming medicine that can reduce the severe anaemia, malnutrition and accompanying lethargy caused by intestinal worms. India also represents more than 40 per cent of the global population at risk of LF, a debilitating parasitic infection transmitted to humans by mosquitoes that can lead to

massive swelling of the limbs and genitals; 600 million people in India currently live in LF-endemic areas. Chronic LF patients in India may lose as much as 11 years of productivity, at $50 lost per year or 15 per cent of an individual’s income. Chronic hookworm infection reduces future wage earning by 40 per cent

Outside India, African nations face high burdens of schistosomiasis, Latin American nations must confront widespread incidences of Chagas disease and East Asian nations encounter extensive cases of foodborne trematode infections.

September 1-15, 2013


protocols are needed to assess the intensity of transmission, support decision-making about when mass drug administration can be stopped, and then to verify interruption of transmission.” The report has set down a target of eliminating rabies and yaws by 2020, the latter through an oral antibiotic treatment which would replace the one in use since 1950s (mainly centered on delivering injections of benzathine benzylpenicillin). Take for instance dengue, ranked as the fastest spreading vector-borne viral disease in 2012, with an epidemic potential in the world, registering a 30-fold increase in disease incidence over the past 50 years which is yet to have an effective treatment. “Most of the 17 major NTDs can be treated by available drugs, but for diseases such as leishmaniasis, Chagas Disease and HAT (Human African trypanosomiasis ), these medicines can be highly toxic. The con-

September 1-15, 2013

NTDs globally ranked by DALYS (Disability-adjusted life years) Disease



3.3 mln

Hookworm infection

3.2 mln

Lymphatic filariasis

2.8 mln

Food-born trematode infections

1.8 mln


1.4 mln


0.8 mln


0.6 mln

Chagas disease, Sleeping Sickness, Cysticercosis (tapeworm) and Onchocerciasis

0.5 mln

cept of 'tool ready' vs. 'tool deficient' diseases is no longer valid. Ultimately, almost all of the NTDs will require new drugs and vaccines to overcome resistance and water, sanitation and hygiene challenges. We also need new diagnostics to better quantify the number and severity of NTD infections in people,” adds Hotez.

Not only novel drugs, but coming up with formulations and combinations to help reduce the time of treatment and increase adherence is also important. “Anti-malarial combination products with new formulations have improved health outcomes. The Coartem story is a good illustration of this. It is a fixed dose combi-

nation product approved in 2002. New formulations of the product, including a cherry-flavoured drink for children, have improved adherence tremendously in malaria-endemic countries, such as Ghana,” informs Joshua Cohen, Senior Research Fellow, Tufts Center for the Study of Drug Development.




Stepping up R&D Although pharma companies have stepped up their commitment to supply existing drugs, the R&D scenario on NTDs remains grim. An analysis by MSF and DNDi in December last year revealed that of the 850 new therapies and vaccines approved by the US Food and Drug Administration(US FDA), the European Medicines Agency and other agencies between 2000 and 2011, 37 focused on neglected diseases, with a mere four of them being NCEs. An earlier paper published in 2002 by members of the Drugs for Neglected Diseases Working Group, counted 1,393 new drug approvals—16 of which focused on neglected diseases—between 1975 and 1999 (Lancet 359, 2188–2194, 2002). 11 of those 16 drugs were NCEs. The numbers suggest that although the rate of approvals for drugs for neglected diseases has gone up, the rate of approvals for NCEs seems to have remained relatively flat. Recent analysis from the Tufts Center for the Study of Drug Development corroborates this further with statis-

tics showing that an average of 2.6 new drug products— including new molecular entities, vaccines, indications, combinations, and formulations were approved each year from 2000-2008 to combat neglected diseases. The number rose to five per year in 2009—12, however, annual R&D spending to treat neglected diseases has leveled off at $3 billion in total, after rising rapidly from 2000 to 2007, which is a cause of concern. “Our study only mentions the total (global) annual amount of funding, not solely by drug companies, but also PPPs and governments (mostly US),” clarifies Cohen. Rise in R&D funding by pharma companies might be a key to increased numbers of approvals targeting neglected diseases. Clearly, NTDs need to rank high on the priority. Partnerships then, have emerged as the route to new drugs, diagnostics and vaccines with non-profit product development partnerships with developing countries’ manufacturers. According to a survey by the International Federation of Pharmaceutical Manufacturers &

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HEAD OFFICE MUMBAI Rajesh Bhatkal Business Publications Division, The Indian Express Limited., 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : Branch Offices NEW DELHI Ambuj Kumar Business Publications Division, The Indian Express Limited, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail:

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Associations (IFPMA) 132 R&D programmes were under way in 2012, a 40 per cent increase over 2011, with 112 in partnerships with key pharma players. Just 15 per cent or 20 programmes, are being driven entirely by companies. However, public sector rules the roost when it comes to funding, supplying $2 billion of the $3.05 billion spent in 2011. Philanthropic groups contributed another $570 million, with pharma companies at the lowermost rung with $525 million. There might be a reason for that, argues a paper by the Maastricht School of Management which in turn advocates funding through 'push' and 'pull' mechanisms to create more attractive markets, lower uncertainty, and support return on investment, thereby stimu-

Dist - Howrah -711409 T No: 91- 33-66043842 Fax: +91 -33-66043825 Cell ; 09831182850 KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018 Tel: 2212157/2216718/2216732 E-mail:

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lating increased investment in R&D. Push funding in the early stages of scientific research should support translational research and academic-industry initiatives. As soon as the ‘proofof-concept’ has been established, however, performance-based mechanism should be activated like the Advanced Market Commitment (AMC) and Priority Review Voucher (PRV). The authors developed a ‘risk-investmentincentive’ model that calculates the size of funds needed to sufficiently reward the innovator(s). However till then, PPPs shall strive to fulfill the targets set by the London declaration, even as pharma companies try to get their act together.

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

September 1-15, 2013


COMPANY WATCH Jubilant Biosys files IND with US-based Endo Pharmaceuticals IND relates to a novel molecule targetting prostate cancer

engaluru-based Jubilant Biosys, a subsidiary of Jubilant Life Sciences, announced the US FDA acceptance of the Investigational New Drug (IND) filing for a novel molecule targetting prostate cancer with Endo Pharmaceuticals of the US. This molecule will now progress towards the next phase of development and is anticipated to go into clinical trials by late 2013. “We are pleased and elated with this successful outcome, which is the result


of excellent collaboration between the scientists at Endo and Jubilant Biosys. Being at the forefront of pharma, life sciences and healthcare innovation, Jubilant pursues its goal to enable affordable healthcare to patients worldwide,” said Dr Subir Kumar Basak, President, Global Drug Discovery Services, Jubilant Life Sciences. Dr Sandeep Gupta, Senior Vice President, Discovery & Early Development, Endo Pharmaceuticals, “I congrat-


ulate the Jubilant and Endo teams on achieving this important milestone. It was their outstanding collaborative work and ingenuity that enabled the successful filing and acceptance of an IND in less than three years. The IND filing and progression of the molecule to the next stage of development further validates Endo’s unique collaborative drug discovery approach which aims to address unmet medical needs and improve patient outcomes.”. EP News Bureau - Mumbai

34-year history of partnership with leading pharma companies

active pharmaceutical ingredients & its intermediates*

Commercial scale Macrolides


Pyrazinamide# * Isoniazid # *

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

Irbesartan # Losartan potassium Telmisartan Valsartan

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Sedative, Hypnotic



Linagliptin Vildagliptin


Flucytosine #


Antimalarial Artesunate Arteether Artemether # * Dihydroartemisinin Lumefantrine # * Piperaquine

Antiosteoporotic Alendronate sodium Zoledronic acid US DMF

Under Development






Cetirizine dihydrochloride # Hydroxyzine dihydrochloride Meclizine dihydrochloride+







Valproic acid





Clopidogrel bisulphate

Venlafaxine hydrochloride

CTD ling under process

*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 rest 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:, USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email:, Website : "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, the website of the BRLMs, i.e. PL Capital Markets Private Limited at and YES Bank Limited at and is also available on the website of the Company at 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”.

September 1-15, 2013




DoP extends excise duty exemption on formulations under DPCO 2013 No extension in the deadlines set for price revision

Usha Sharma – Mumbai ollowing the Department of Revenue's notification to exempt scheduled formulations impacted by Drugs and Price Control Order 2013 (DPCO) from excise duty if they are re-printed, relabelled, re-packed or re-stickered in premises other than those registered by the manufacturers, the Department of Pharmaceuticals (DoP) has decided to extend this exemption period by one month. The extended exemption period starts on July 29 for the first batch of ceiling price notifications announced on June 14. Formulations under subsequent ceiling price notifications (dated June 12, June 28 and July 5) will also get a similar 30-day exemption from excise duty post the end of the 45-day period. The DoP circular dated August 8 incorporates sugges-


tions from a meeting held in Mumbai, which was attended by around 50 pharma companies and associations' representatives in the presence of Dilsher Singh Kalha, Secretary, DoP; Chandra Prakash Singh, Chairman, NPPA and drug regulators from Gujarat and Maharashtra. The pharma industry finds itself grappling with the logistics of implementing the revised prices as per DPCO 2013 within the set deadline. Cipla and Alembic were the first companies to challenge the order in the Delhi and Gujarat High Courts respectively, following which a few other pharma companies and two associations namely Indian Drugs Manufacturers Associations (IDMA) and Confederation of Indian Pharmaceutical Industry (CIPI) also approached the courts. After hearing all the

filed petitions by the pharma companies and associations, the court has asked the DoP not to take coercive action against them. This aggressive stance of the pharma industry has resulted in top officials from NPPA and DoP taking these measures to resolve the ongoing issues related to deadlines and price mechanism. Discussing about the meeting's outcome, Singh said, “During the meeting we have come across many queries which were raised by various pharma companies on different issues. However, we mainly focused on relabelling and also issues related to the price fixation mechanism.” Commenting on the steps taken by the pharma companies on challenging the price mechanism, Singh replied, “So far, we have come across two cases of challenging the

price mechanism of and we have asked the respective companies to make individual presentations. If there are factual errors, we are ready to correct it, provided the companies give in writing about the factual errors.” He also mentioned that the matter is still sub judice in Delhi High Court and the court has not given a stay order to the companies nor to the associations. However, the Delhi High Court has instructed the pharma companies and associations to submit copies of the manufacturers, stockists and dealers (agents/supplier) and present quantitative details about the price notifications before and after. While signing off, Singh made it very clear that there will be no extension in the deadlines set for price revision.

World’s pharma development manufacturing base moving to India: IBEF Generics exports growth of nearly 30 per cent enabling greater research spend



he India Brand Equity Foundation (IBEF) has compiled its findings and released an overview of the current generics market in India. They predict that the Indian pharma market is now at the precipice of the next stage in its development, having seen manufacturing innovation and development technologies rise, thanks to the explosion in generics production. Over the last three years exports of pharma products (largely generics) have grown at over 21.5 per cent (CAGR) and now accounts for over $13 billion in annual sales. Highlighting India’s dominance, nearly 40 per cent of Abbreviated New Drug Applications (ANDA) received by the FDA in 2012 were from India, with a further 87 confirmed and another 25 already received between January and June 2013, according to an IBEF release. This huge growth in generics production has seen the country become a hotbed of manufacturing innovation – India has over 3000 DMFs registered with US FDA – which coupled with increased investments in R&D means India is now ready to challenge traditional big pharma and start producing more patented products. A natural evolution of the success of the generics market has been the


rise in supergenerics across India where much R&D spend is currently being invested (e.g. Lincoln Pharma’s patent for NDDS). With the world’s pharma development manufacturing base moving to India – there are 546 US FDA approved company sites, 23 companies holding 1100 authorisations with UK's MHRA, and 166 companies with Certificates of Suitability (CEPs) from EDQM – coupled with the rise in supergenerics, the country’s next natural step is to use its world leading development expertise for creation of new chemical entities. Recognising this opportunity, the Government of India is putting in place supportive initiatives with the goal of cementing the country’s position as the ‘pharmacy of the world’ and creating a global innovation hub. With generics predicted to rise to 35 per cent of global pharma market value by 2016 (some $400 billion+), and with an annual growth rate of 27 per cent amongst Indian generics exports (comparing very favourably with the global average of 10 per cent) the Government and Pharmexcil are forecasting much of this revenue will be reinvested across the country in new research- leading to a steady pipeline of future drug targets. In support of this, the Indian government has committed to

three schemes including a major multi-billion dollar initiative with 50 per cent public funding through a PPP model to harness India’s innovation capability. In addition, the Government has made taxbreaks available to the pharma sector and a weighted tax deduction of 150 per cent for any R&D expenditure incurred. Additionally, they have also introduced 19 dedicated SEZs to help stimulate pharma sector investment across the country. Steps have also been taken to streamline procedures covering development of new drug molecules and clinical research - including two schemes ‘New Millennium Indian Technology Leadership Initiative’ and the ‘Drugs and Pharmaceuticals Research Programme’, which has been specially targeted at drugs and pharma research. Already this year, Dr Reddy’s, Lupin Labs, Sun Pharma, Ranbaxy and Cipla have invested over $500 million in R&D, which is allowing increased innovation in manufacturing processes and will ultimately help to lower the cost of medicines production. “India, termed as the Pharmacy of the World, has a basket of wide spectrum of generics that are second to none in terms of quality. The industry is on the track to

expand its reach to newer markets, which makes it equally critical for the Indian pharma industry to keep its focus on quality, affordability and accessibility of medical solutions for the global pharma market. The country’s success in generics manufacturing is helping to keep our industry at the forefront of innovation and over the next few years we are lending our support to the R&D effort across the country so that we are leading in generics production and even developing new drugs out of India,” said Rajeev Kher, Additional Secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India. “Being a world leader in generics, India already has a huge presence in the highly regulated markets in terms of pharma exports. Almost two thirds of Indian generic exports are to the highly regulated markets (e.g. the US and Europe), which speaks volumes about the quality of Indian medicines. The Government of India is supporting Brand India Pharma campaign to reiterate that the Indian pharma market offers credible, affordable and sustainable healthcare solutions,” said Dr PV Appaji, Director General, Pharmexcil.. EP News Bureau - Mumbai September 1-15, 2013


Ranbaxy allocates site for greenfield manufacturing facility in Malaysia Agreement signed with Kulim Hi Tech Park anbaxy Malaysia has been allocated the site for setting up its greenfield manufacturing facility in Malaysia. The company signed a ‘letter of offer’ agreement with Kulim Hi Tech Park (KHTP), a wholly-owned state agency and industrial park that houses various other leading industries. KHTP is located at Kulim in the state of Kedah, Malaysia. The agreement was signed by T Jeyabalan Thangarajah, Managing Director, RMSB and Tuan Haji Muhammad Sobri, President, KHTP in the presence of representatives of the Ministry of Investment Development Authority (MIDA) and Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy. The Ranbaxy greenfield facility will be built on an area of around 15 acres with an investment of around $35 million providing employment to over 200 people. This will be Ranbaxy’s second manufacturing plant in Malaysia. Last year in September, the Government of Malaysia gave an approval to RMSB for setting up a greenfield manufacturing facility in Malaysia as an Entry Point Project (EPP).


Lanka, China and other select nations.” The RMSB new facility

would manufacture dosage forms including tablets and capsules primarily in the cardiovascular, anti diabetic, anti-

infective and gastrointestinal segments. Ranbaxy’s total output in Malaysia will be increased from one billion

doses/annum to three billion doses/annum when the new facility is fully operational. EP News Bureau - Mumbai

RANBAXY GREENFIELD FACILITY WILL BE BUILT WITH AN INVESTMENT OF AROUND $35 MILLION Commenting on the signing ceremony, Thangarajah said, “Ranbaxy established its foothold in Malaysia three decades back and since then has been offering high quality, affordable generic medicines to the Malaysian healthcare system. The new greenfield facility reinforces our long term commitment.” He further added, “In addition to serving the local market, the new facility will also export products to the ASEAN markets, Middle East, Europe, Sri September 1-15, 2013




Biocon introduces novel biologic, ALZUMAb for psoriasis in India ALZUMAb is being introduced in India by Biocon's Immuno Therapy Division

iocon recently announced the launch of its ‘first in class’ novel biologic ALZUMAb (Itolizumab), reportedly the world’s first anti-CD6 monoclonal antibody to be introduced for treating patients with chronic plaque psoriasis in India. ALZUMAb with a unique Mechanism of Action (MoA) claims to offer superior safety and similar efficacy profile compared to other existing therapies, and has a long remission period with very low opportunistic infection rate. Psoriasis is a socially debilitating disease affecting two to three per cent of world population. The global



psoriasis market size is estimated to cross $8 billion by 2016. Commenting on this development, Kiran M a z u m d a r - S h aw, Chairperson and Managing Director, Biocon said, “Biocon’s ALZUMAb (Itolizumab) is the first antiCD6 monoclonal antibody to be commercialised, an outcome of path breaking research in India. This new line of treatment will usher in a paradigm shift in the management of psoriasis. We are proud that this will be the first instance of a breakthrough innovation from India with a potential to treat multiple autoimmune diseases and making a difference to a much larger patient population across the world.” Rakesh Bamzai, President-Marketing, Biocon said, “Biocon is committed to address the huge unmet need of patients suffering from psoriasis through its ‘first in class’ biologic ALZUMAb. Compared to existing therapies, ALZUMAb

offers better safety and efficacy profile to the patients with longer remission periods and lower infection rates that will lead to better patient compliance and overall reduction in the cost burden to the patient.” Indicated for the treatment of moderate-to-severe psoriasis, ALZUMAb is being introduced in India by Biocon's Immuno Therapy Division. Formulated as an infusion drug it is manufactured at Biocon's Biopharma manufacturing facility at Biocon Park, Asia’s largest biotech hub in Bangalore. Biocon is a front runner in introducing a biologic based on TH 17 pathway. According to the company's press release, ALZUMAb is the world’s first anti -CD6 biologic addressing the Th 17 pathway that has completed its ‘Lab to Market’ journey. Emerging data shows that in addition to Th 1, Th17 cells, play a critical role in autoimmune diseases, and Biocon is a front-runner in the race to develop biologics targeting

the Th17 pathway with ALZUMAb (Itolizumab). This differentiated MOA positions Itolizumab as a potentially 'best-in-class' treatment for psoriasis, and other autoimmune diseases. Itolizumab is a high potential biologic for a range of autoimmune diseases. ALZUMAb is an outcome of breakthrough innovation at Biocon which has the potential to transform the treatment options for several autoimmune diseases besides psoriasis like rheumatoid arthritis, multiple sclerosis and others. It is potentially a pipeline within a product. Its launch in India for psoriasis is the first milestone on a promising and exciting journey towards new treatment options for lifechanging autoimmune diseases, claims Biocon’s press release. The company intends to take ALZUMAb (Itolizumab) from India to patients worldwide with a global partner. EP News Bureau - Mumbai

West-Coast Pharmaceutical Works to foray into nutraceutical segment To launch the products in the western region of the country initially

hmedabad’s WestCoast Pharmaceutical Works plans to increase its product range by launching nutraceuticals products under the brand name, 'HealthVit'. Initially, the company has launched over 40 products categorised under fat reduction, hair growth, nutrition supple-



ments, skin care, under the brand name HealthVit. Its main focus is on weight management products, cardiac care products, immunity boosters, women’s health products. Initially, the company plans to launch the brand in the western region due to the established distribution

network there. It will target metros cities in the next phase of distribution expansion with more product range. There are plans to add more than 100 products under the category of fitness, vitamin, nutrition, child care, diabetic care.. EP News Bureau - Mumbai

Glenmark gets final ANDA approval for acamprosate Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence



lenmark Generics (GGI), a US subsidiary of the Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the US FDA for acamprosate calcium delayed release tablets, its generic version of Forest Laboratories’ Campral delayed release tablets.


Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence. Based on IMS Health sales data for the 12-month period ending March 2013, acamprosate garnered sales of $21 million. Glenmark’s current portfolio consists of 88 products authorised for distribution in the US


marketplace and 53 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio. EP News Bureau - Mumbai

September 1-15, 2013


Venus Pharma gets marketing authorisation approval from France Signs agreement with Mylan enus Pharma, a subsidiary of Venus Remedies, has bagged marketing authorisation (MA) approval from France for meropenem, a generic broad spectrum antibiotic injectable. It has signed a non-exclusive marketing rights deal with generic giant Mylan to sell meropenem in France, world's fifth largest pharma market with a market share of 3.8 per cent. Terming it as a major achievement, Ashutosh Jain, Executive Director-cum-Chief Operating Officer, Venus Pharma said, “We are proud of our drug regulatory capabilities which have enabled the company to emerge as a key player in the European Union (EU)markets. Driven by our MA grants, we are all set to grab the maximum share in the $270-million


meropenem market in the EU in the near future.” Meropenem is an offpatented generic broad spectrum anti-bacterial agent of carbapenem family, which fights diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children. “Currently, Venus is generating good revenue from the export of meropenem to EU markets. In 2012-13, we generated a business of about euro 5 million from meropenem exports. This figure is expected to double by the end of this financial year. We have plans to capture the meropenem share in other lucrative markets as well, including Australia, Spain, Switzerland, South Africa, Malaysia and Gulf Central Committee (GCC) countries where the registration process is in advanced

MEROPENEM IS AN OFFPATENTED GENERIC BROAD SPECTRUM ANTI-BACTERIAL AGENT OF CARBAPENEM FAMILY stages,” said Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies. Venus has already received MA for meropenem from the UK (Medicines and Healthcare products Regulatory Agency), Austria, Denmark, Finland, Ireland,

Germany, Netherlands, Poland, Slovenia, Slovakia, Sweden, Portugal, Czech Republic, Cyprus, New Zealand and Mexico. It has also achieved a major breakthrough in Balkan countries by getting marketing approvals from Bosnia and Herzegovina and Croatia. Meropenem sales, which are to the tune of $906 million across the globe, are expected to cross the $1,000million mark by the end of 2013. Besides, France accounts for a $36.76-billion share in the $962-billion global pharma market. Venus, in association with its partners, is already offering the best quality meropenem to 35 countries. It aims to penetrate the market in 15 more countries by the first quarter of 2014. EP News Bureau - Mumbai

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DPCO'13 impacts July growth But growth back to double digits for products still out of price control he ceiling prices announced on June 16 for the first batch of products falling under Drug Pricing Control Order (DPCO 2013) have already had an impact on several companies. Although the implementation date was from August 2 onwards for the first batch (45 days from June 16), the revised prices have also affected overall IPM growth in July, according to an analysis by market research firm AIOCD Pharmasofttech AWACS. According to Ameesh Masurekar, Director, AIOCD Pharmasofttech AWACS, for certain companies the impact of DPCO has been significantly higher – both due to percentage coverage of products under DPCO where ceiling price has been announced and due to their


products/brands being above the ceiling price. For example, Mankind Pharma, the DPCO products grew by 20.3 per cent, as almost all of them are below

the ceiling price, while for Ranbaxy, the DPCO products registered a de-growth of 28.1 per cent as most of them were above the ceiling price. Overall ceiling price has been already

declared for 10 per cent of the industry turnover. For another 7-8 per cent products, the ceiling price is expected in coming weeks. EP News Bureau - Mumbai

Below is the impact of ceiling price declared products basket vs. the balance portfolio – overall for the industry and for top companies

OVERALL CEILING PRICE HAS BEEN ALREADY DECLARED FOR 10 PER CENT OF THE INDUSTRY TURNOVER Below is the chart by therapy Area, along similar lines of bifurcation of products where DPCO Ceiling Prices have been declared, versus the rest of the portfolio



September 1-15, 2013


PRE EVENT Lex Witness to organise 2nd Annual Pharma Legal & Compliance Summit 2013 Summit to be held in Mumbai on September 27, 2013 ex Witness will present the 2nd Annual Pharma Legal & Compliance Summit 2013, which will be held in Mumbai on September 27, 2013. Pharma companies in India are facing a challenge of an increasing complex, demanding and fast-changing logistics and regulatory environment. Traditional approaches are being challenged by shorter market cycles, outsourced production, and increasing government regulations. Multinational pharma companies are increasing efforts to strengthen their presence in India through research investment, licensing deals, co-marketing arrangements, acquisitions, or other partnerships. 25 per cent of proposals received by FIPB are for pharma. On the other hand, approval timelines and over restrictive regulations are giving thoughts for Indiacentric pharma organisation for establishing base in countries offering transparent regulations. The recent changes in regulation and agencies involved in regulatory oversight means a catch up game to analyse business impact on short and long-term strategy for legal, regulatory, compliance and commercial professionals operating in the pharma space. With increasing management expectations on business strategy formulation from senior professionals,



especially in a complex regulatory environment, the 2nd edition of Pharma Legal and Compliance Summit is the best investment of time to analyse, interpret and strategise the current and future response to legal, regulatory and compliance challenges. Discussions will be held on: How to use compliance and ethical business practices as competitive business advantage?; Key elements of a compliance programme; Analysis of Legal and Regulatory Updates; Section 3d of Indian Patent Act; Patent Litigations: Recent Case Updates and Analysis; Grey areas of Competition Law; Uniform Code of Pharmaceutical Marketing Practices (UCPMP) and Pharma M&A Contract and FDI. The confirmed speakers for the summit are AS Kumar, General Counsel, Dr Reddy’s Laboratories; Abhayan Jawaharlal, Chief Legal Officer, Cipla; Ajay Thomas, Registrar, LCIA India; Ashok Bhuta, DGM (Legal & Secretarial) as Compliance Officer, Sun Pharma Industries; Atul Bonde, Regulatory Affairs, Cipla; Atul Moghe, Deputy General Manager - Regulatory Affairs, Mylan Laboratories; Darshini Bhatt, AGM IPR, Troikaa Pharmaceuticals; Debolina Partap, Associate Vice President & Head Legal, Wockhardt Group, India; Deepak S Pandya, VP (Legal) and Company Secretary, Dishman Pharmaceuticals & Chemicals; Durgesh Paliwal, Head – Legal, Abbott Laboratories; Ghanashyam Hegde, Senior Legal Counsel, Abbott India; Marshall Mendonza, Independent Legal Professional; Nilesh Shah, AGM- Legal, Alembic Pharmaceuticals; Rajeev Mukundan, General Counsel and Chief Compliance Officer, Mylan Laboratories; SP Date, Company Secretary and Compliance Officer, Elder Pharmaceuticals; Sheela Vadavalli, Vice President Legal and Compliance Officer, Mylan Pharmaceuticals; Susheela, Head IP, Biocon; Vivek Mittal, Head – Legal, Lupin; Yasmin Cama, Senior Director - Legal Affairs, Sanofi-Aventis Group, India. EP News Bureau-Mumbai




GROWTH TRACKER IPM witnesses growth of 9.4 per cent in July ’13 Six therapies have outgrown the IPM growth With Bonus Units at Full Value Val in Crs CORPORATE

Rank MAT

MAT July -13 MTH


Val (Cr)



Val (Cr)









IPM Abbott + Abbott HC + Novo









Sun Pharma


















Zydus + Biochem




































Alkem + Cachet + Indchemie









Pfizer + Wyeth




































Emcure + Zuventus


















Dr. Reddys









Sanofi-Aventis + Universal



























Micro + Bal


















Val in Crs


Super Group

MAT June13


Mth June13

















hile growth momentum in the domestic formulation industry slowed down in 2012-13 owing to a confluence of reasons, including the announcement of ceiling prices as per the DPCO 2013, July witnessed growth of 9.4 per cent with even the month’s Indian Pharma Market (IPM) value at ` 6453 crores, better than the previous month. For July 2013, amongst the top 10 corporates, Alkem registered growth of 23.4 per cent, Sun Pharma 15.6 and Cipla 14.7 per cent. 31 of the top 50 corporates crossed IPM growth in this month. Amongst the top 50 corporates, Biocon has the highest growth of 48.7 per cent followed by AstraZeneca at 45.5 per cent and Franco Indian at 23.5 per cent. Amongst the 11-20 ranked companies Aristo has shown a high growth of 22.8 per cent followed by Glenmark at 18.9 per cent and Torrent at 15.5 per cent. Amongst upcoming corporates Corona Remedies has grown at 135.5 per cent, Eris at 23 per cent and Akumentis at 22.9 per cent. Alkem has crossed ` 2500 crores and Wanbury ` 200 crores in the IPM. The overall bonus market grew by nine per cent. Certain molecules like AmoxyClavulanic grew by 16 per cent, Cefixime 19 per cent which are a part of DPCO 2013. From the therapy perspective, six therapies outgrew the IPM. The anti-infective market saw a growth of 14.6 per cent, while the respiratory market grew 27.6 per cent. The anti-diabetic market has grown at 2.8 per cent and cardiac at 7.2 per cent in chronic business. The anti-diabetic market felt the heat of the pioglitazone issue with these formulations down 74 per cent over July 12.


About PharmaTrac



















































PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.






Terminologies used






MAT – Moving Annual TotalMTH – MonthVal(Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage



























For more information, visit

September 1-15, 2013


EVENT BRIEF 2nd Annual Nutraceuticals 2013 Forum Date: August 28-30, 2013

Maharashtra Tel: +91-22-26003977, 26003978 E mail:

PHARMAbiotika 2013

Venue: Holiday Inn International Airport, Mumbai Date: September 16-18, 2013 Summary: UBM India will organise a strategic conference, 2nd Annual Nutraceuticals 2013 Forum, under Fi Brand by UBM.There will be a pre-conference regulatory seminar on August 28, 2013 focusing on domestic and global nutraceutical regulations. Contact details Shwetha Prabhu Tel: (022) 61727001 Email:

Pharmac India 2013 Date: September 5-7, 2013 Venue: Hitex, Hyderabad Summary: Pharmac India 2013 is 4th International pharma machinery, equipment, bulk drugs, API and material exhibition, which is going to be held in Hyderabad, Hitex. It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry. Pharmac India 2013 is jointly organised by Orbit Exhibitions and IDMA (GSB) and actively supported by BDMA and CIPI. Contact details Varsha Surve Manager - Operations Exhibitions Orbitz Exhibitions 402, Navyug Industrial Estate,TJ Road, Sewri (W), Mumbai 400 015. Tel: +91 22 2410 2801-03 | Fax: +91 22 2410 2805 | Cell: 09322037955. /

Pharma Pack 2013 Date: September 12-14, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: Intel Trade Fairs & Expositions will organise the 13th Edition of Intelpack-2013 will see 300+ exhibitors who will showcase the latest developments in packaging and processing on a floor space of over 1,40,000 sq ft. (14,000 sq. mtrs). Contact details Intel Trade Fairs & Expositions 113, New Sonal Link Industrial Estate, Building No.2, Link Road, Malad (W), Mumbai - 400 064 September 1-15, 2013

Venue: Mahatma Mandir Convention and Exhibition Centre, Gandhinagar, Gujarat Summary: PHARMAbiotika is an exhibition and conference revolving around emerging challenges and trends in pharma, allied and clinical research related industry.This is the first time in India that an exhibition on Medical Tourism will be co located with PHARMAbiotika 2013. Contact details Atanu Bhattacharya, Director Human Crayon Management Services C-28, Sector - 4,Noida - 201301, India Tel: (0120) 6528801 / (011) 65378800 Mob: 9810303916 (Delhi) / 9167280126 (Mumbai) Email: Website:

Master Class on Bio-entrepreneurship Date: September 20-23, 2013 Venue: National Institute of Immunology, New Delhi Summary: BIORx Venture Advisors (BIORx) has launched comprehensive Master Class on Bio-entrepreneurship with the theme 'Accelerating Innovations to marketplace – A small step towards strengthening India’s Bioeconomy.' Perceiving the acute need for enabling technologists to become successful business women/men in the life sciences sector, BIORx has designed this programme on bio-entrepreneurship. Contact details: Uttam Singh Negi Company Secretary BIORx Venture Advisors Tel: (0120) 6450521 Mob: 8130155022 Email:

Clinical Trials Asia Summit Date: September 26-27, 2013 Venue: Hyderabad Summary: Clinical Trials Asia Summit is a platform for key stake holders to engage and critically analyse the road map for further growth towards establishing sustainable




leadership of India in global clinical trials scenario. Contact details Tikenderjit Singh Makkar Dy Mktg Manager India Fleming Gulf 605, City Tower Boat Club Road Pune - 411001 Maharashtra (India) Tel: (020) 67276403 Fax: (020) 6607 0061 Email: Website: URL:

16th PAC-2013 Date: September 27 - 28, 2013 Venue: Hotel Hyatt Regency, Sahar Airport Road, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) have announced the 16th Pharmaceutical Analysts’ Convention (PAC) 2013.The main theme for this year’s convention is ‘Generics The Game Changer’. Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India New Delhi will be the Chief Guest. Contact details Prachi,Sr Manager Publications & PR,IDMA 102-B, ‘A’ Wing, Poonam Chambers

Dr Annie Besant Road, Worli Mumbai - 400018 Tel: (022) 24944624/ 24974308 (Extn. 103) Mob: 9867634383 Email: Website:

PharmaTech Expo 2013 Date: October 6-8, 2013 Venue: Brilliant Convention Centre, Indore Summary: PharmaTechnology and Indian Drug Manufacturers Association are jointly organising the second edition of PharmaTech Expo 2013 in association with Pharmexcil. Contact details Keena Shah 702, Corporate House, Opp. Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009. M: 09825698756 Ph.: 079-27541142 / 27540493 E-mail: Website:

6th Symposium on Nasal and Pulmonary Drug Delivery Date: October 24-25 Venue: Hotel Novotel, Juhu, Mumbai

Summary: The Indian Pharmaceutical Association announces the 6th Symposium on Nasal and Pulmonary Drug Delivery with a theme “Global Regulatory Trends”. This two-day scientific symposium is tailored specifically to nasal and pulmonary drug delivery and will welcome a panel of highly renowned scientists and technical experts for sharing knowledge about Orally Inhaled and Nasal Drug Products (OINDPs)

Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol,Andheri (East) Mumbai - 400 059 Tel: +91 22 61727162 Ph: +91 22 61727273 email:

Contact details SD Joag Indian Pharmaceutical Association Kalina, Santacruz (E) Mumbai-400 098 Phone No: 022 26671072 Telefax: 022 26670744 e-mail: website:

Summary: Indian Pharmacy Graduates’ Association will host the 65th IPC, 2013 from December 20-22 this year. Express Pharma has been chosen as the ‘Exclusive Official Media Partner’ for the 65th IPC, 2013.The event will be organised by Indian Pharmaceutical Congress Association.The academic partner for the event is Amity University, Noida.

CPhI India Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals.Take this opportunity to showcase your products and services while enhancing your brand at South Asia’s leading pharma industry event.

65th IPC, 2013 Date: December 20-22, 2013 Venue: Amity University, Noida

Contact details Dr Arun Garg General Secretary-IPGA Director-PDM College of Pharmacy, Bahadurgarh, Haryana Mob: 09416056213

Contact details Chaitali Patil UBM India Times Square

POST EVENT IPA organises clinical research conference Conference attended by more than 100 participants had the theme ‘Practical Solution to Challenges in Clinical Research’ ndian Pharmaceutical Association (IPA)-Delhi branch recently organised a one-day conference on clinical research in New Delhi. It had the theme on ‘Practical Solution to

I 22


Challenges in Clinical Research’. The knowledge partner for the conference was Excel Life Sciences – a US-based, India-focused provider of comprehensive clinical trial management services. Dr Naresh Sharma, Vice President, IPA (Delhi branch) and Assistant Drugs Controller (India), Central Drugs Standard Control Organization (CDSCO); and Dr Gaurav K Jain, Joint Secretary, IPA (Delhi

branch) were the main coordinators for the conference. Dr Farhan J Ahmad, President and Kalhan BazazSecretary, IPA (Delhi branch) were the co-coordinators. The conference was attended by more than 100 participants right from investigators (doctors), Clinical Research Organization (CRO) representatives and insurance companies’ representatives to regulatory consultants,

pharmacovigilance teams and Ethics Committee (EC) members. The conference had four interactive sessions on compensation guidelines, site inspection, EC registration and pharmacovigilance, which involved distinguished and experienced speakers from all spheres of the clinical research industry to give their perspectives on the above topics. EP News Bureau-Mumbai

September 1-15, 2013



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‘India’s pharma sector is currently undergoing unprecedented regulatory changes’

T ARUN SAWHNEY Chief Executive Officer and Managing Director, Ranbaxy Laboratories

he Indian regulations for pharmaceuticals are witnessing a transformation. There are several examples where small and big changes that have been proposed has the potential to impact the industry directly or indirectly. While any effective and meaningful measure to strengthen regulations should be considered positively by the industry, not all of such changes are being approached and implemented in a pragmatic and objective manner. Till the end of 2011, the new drug/clinical trial (CT) approval process was based on the letters from experts and scrutiny by Central Drugs Standard Control Organisation (CDSCO) officials. In the year, 2011, CDSCO constituted 11 New Drug Advisory Committees (NDAC), on par with United States Food and Drugs Administration (US FDA) to oversee the CT/new drug approval process. While this action strengthened the review/approval process, it has also led to significant stretching of product approval timelines, and consequently the number of new drug approvals has gone down with the advent of NDACs. This is primarily because NDAC often requests clinical trials on simple combinations that have been in use for decades in the country, thus duplicating efforts and delaying the process. Hence, the patient access to these medical benefits has been delayed or unmet. Since long, there has been introduction of newer fixed dosage combinations (FDCs) into the Indian pharma market, approved by state regulators based on therapeutic rationale, some of which were considered as irrational in view of them being not approved anywhere across the globe. On the other hand, in fact, such FDC’s in chronic care do improve patient compliance, and are widely prescribed by the 'Registered Medical Practitioner'. The Drugs Controller General of India (DCGI) vide circular dated Jan 15, 2013 introduced a proposal giving a chance to the industry to prove the safety and efficacy of such FDCs, which don’t yet have DCGI approval. This corrective measure will ensure availability of safe and effective FDCs with DCGI approval. However, the pharma industry is still seeking more clarity on data requirements and regulatory framework to fulfil the above criteria. For FDCs which are already in market for many years and have a good therapeutic record, some flexibility in additional data requirement through clinical trials should be considered. This regulatory directive will have an

impact on the medical community and patient convenience as many products will get discontinued for some time. Many initiatives have been undertaken by the DCGI for ensuring close monitoring of clinical trials. Some of these steps include registration of ethical committees and filing of Informed Consent Form (ICF) under video recording. This is a welcome step but greater support is needed to implement these requirements. India, like any other regulated country, is taking bold steps in banning of drugs in the interest of patient health and safety. Some of the recent examples include Nimesulide for under children of 12 years, formulations containing Phenylpropanolamine (PPA) and Sibutramine containing formulations. However, all above are based on the ban status in the innovator countries. It will be prudent to have our own database, specific to our own population that can form basis for proactive ban in India, obviating the need for dependency on international markets. While many changes have been undertaken by the government, there are still some areas that need improvement. A classic example is implementation of real time stability testing conditions in the Indian sub-continent. On one hand, there are the WHO recommendations for temperature and humidity of 30oC and 70 per cent RH respectively. On the other hand, Schedule – Y of the Drugs and Cosmetics (D&C) Act that recommends data generation at 30oC and 65 per cent RH leads to subjectivity in implementation. Amendments are needed in the D&C Act to strengthen data requirements for grant of manufacturing licenses at State level for new drugs post four years after DCGI approval. Also, the assignment of shelf-life for pharma products needs to be delinked from shelf-life for API, and should be based on the stability data of the drug product. India's pharma sector is currently undergoing unprecedented regulatory changes. While majority of changes are directed to improve accessibility and affordability of safe and effective medicines for the Indian Population, the industry would expect greater collaboration from the government in implementing these changes with more clarity on data requirements and implementation time frames. Perhaps a constitution of government - industry partnership could be an optimum solution to serve our ultimate stakeholder, the patients.

‘All the changes will lead to better and positive growth’

I DR JAYESH LELE, State Secretary, Indian Medical Association Maharashtra



n India, the pharma industry is fast changing with a new outlook at the healthcare sector. The changes are going to affect the prices as well as availability of medicines in India. There are many changes which shall affect the patients directly as they are the end user of the product. Many Indian pharma companies will soon have to bear the higher costs for sale of products in American markets, as the US health regulator FDA is hiking the fees for generic drug makers by up to 48 per cent from October 13. This shall reduce the export to US much more. At the same time, the drugs available in India shall cost more. The new drug price control list sees many new drugs added to it and it is going to help patients at one end, but there is a possibility of newer combinations coming into existence which may remain out of the price control. Pharma industry is taking a heavy toll, as many feel it is a political move to approach the forthcoming elections. As of today, clinical trial guidelines are more based on the available material from other countries and research work. It may be biased, but with the changes occurring now we expect them to be fairer and well documented. Good

manufacturing practices are being advised by US FDA and other government authorities, which will result in dual benefits. Patients will get a superior and well documented product. This again can turnout a bit costly but in today’s scenario wherein we are well exposed to legal issues, it is a better option. Another option now being thought about is the generic drug market. So far in India this has not picked up, but in near future it is going to be a key. Due to all round price hikes many shall opt for this method. We still do not have well regulated guidelines for this. The patient will be happy that the cost is reduced but how they would respond is not sure. Many still believe in brand value. Pharma industry on the other hand is increasing exports, with stricter control on various issues from manufacturing to packing as per the international standards. This will help all our Indian pharma giants to establish themselves in the international market. All the changes will lead to better and positive growth.

September 1-15, 2013


‘Recent regulatory changes are impacting the industry significantly’

P DR MILIND ANTANI Nishith Desai Associates, Legal and Tax Counseling Worldwide

ANAY SHUKLA Member, Pharma and Life Science team, Nishith Desai Associates

ricing of drugs: The Ministry of Chemicals and Fertilizers notified the DPCO 2013 on May 15, 2013 that replaced the old price control order. The DPCO has put forth a mechanism to control prices of essential drugs using an objective formula. Under the formula, ceiling price is derived by calculating the average of retail prices charged by manufacturers who occupy more than one per cent market share. The operation of the Order has brought down the prices of the essential drugs but has affected large portion of the industry which is involved in manufacturing essential drugs. The formula forces all the players in the essential drug market to match the low prices charged by some other players. An important factor which has been overlooked while preparing the DPCO is that the quality of raw material makes a big difference in pricing of drug. Thus, because of DPCO, a significant number of market players have been forced to cut necessary margins or reduce quality of the drug, which has naturally impacted their growth. Clinical trials: The Ministry of Health and Family Welfare notified the compensation related amendment to the Drugs and Cosmetics Rules, 1945 (Amendment) on January 30, 2013. In its present form, a sponsor is liable to pay for medical management of injury sustained by the trial subject even when the injury does not have any connection with the clinical trial. Further, the Amendment imposes a responsibility on the sponsor to pay compensation to the trial subject when the investigational drug does not produce the intended therapeutic effect. The regulators appear to have failed to understand that a clinical trial is an experimental trail, where in there is high likelihood that the investigational drug will not produce the intended therapeutic

effect. As a result, the amendment has multiplied the risk of liability relating to compensation faced by the sponsor, and this has deterred numerous pharma companies, both local and international, from conducting clinical trials in India. This would in turn lead to reduced number of new drugs in Indian market as conducting clinical trial in India is a pre- requisite for marketing of a new drug in India. Audio-Video recording of informed consent process is likely to affect stakeholders as an additional infrastructure needs to be set up. The Drug Technical Advisory Board (DTAB) has submitted recommendations to the authorities to the Government considering the above concerns raised by various stakeholders. Track and trade: The Director General of Foreign Trade, Department of Commerce enforced requirement of bar- coding on secondary level packaging of all exported pharma from January 1, 2013. The requirement to bar- code exported drugs is a welcome step since it enhances track and trace capability. However, the manner of its implementation has severely crippled small and medium size enterprises’ capacity to export pharma. The Government did not provide any relaxation or financial support to these cash- starved enterprises. Considering bar- coding equipment is costly, adhering to the requirement led to increase in packaging cost which in- turn eroded margins. Moreover, the requirement added procedural burden since existing label approved from the country of import had to be modified to accommodate the bar-code. This clearly demonstrates what was stated at the beginning, that recent regulatory changes are impacting the industry negatively.

‘The drugs control dept in almost every state needs a revamp’


ABHAY KUMAR President, Indian Pharmacist Association

n the recent past, the pharma Industry has seen a tremendous development after the IT revolution in India though there have been a concern in the matter of hike in new drug patent fees, clinical trial guidelines, new drug price control order and lack of proper functioning of drugs control department. To cope with the ever challenging demand from this industry the concerned authorities have been compelled to make a better regulatory mechanism. At present, the CDSCO and the FDA in some states are looking up to the cause, which is highly insufficient. Moreover the Drugs and Cosmetic Act & Rules 1948 and Pharmacy Act 1950 needs comprehensive amendments owing to which the Government of India (GoI) has plans to introduce the Drugs and Cosmetics (Amendment) Bill, 2013, which seeks to create the Central Drug Authority (CDA) as a centralised licensing authority for drugs during the current session. As recommended by the Mashelkar Committee, a CDA needs to be set up. This authority would review the issuance of licenses for manufacture and sale of drugs. Once this authority is in place, suitable strengthening of its infrastructure and laboratories would be done. The government would mandate that labels

on drugs and food fully disclose all its ingredients. There are several drugs which come under Schedule-H and have been used in the OTC products/drugs. Some of these drugs are to be suitably shifted to some other Schedule. In the context of misuse/drug abuse and marketing of spurious drugs in the market, the present scenario of drugs control department/unit in almost every state needs a revamp. Unless and until there is a strong regulatory authority, it is very difficult to control and penalise the defaulter. The pharmacist can play a very vital role in the healthcare sector in India viz the regulatory authority in the capacity of drugs inspector to drugs controller. If such a setup is being established in every state it would create ample opportunities for the aspiring graduate pharmacist who at present has a very low scope job opportunity in government organisation. The utmost beneficiary will be the common people who thrive on good government policies. And if the regulatory reforms are implemented in a precise manner, the Indian pharma sector will become much more cleaner and stronger and this will have a positive impact in the overall development of the healthcare sector in India.

‘I believe that beginning 2014 will see a change in the landscape’ APURVA SHAH, Group Managing Director, Veeda Clinical Research

September 1-15, 2013


feel that the recent changes in the filling requirement for abbreviated new drug applications brought about by the FDA will have a very strong impact on the small and medium companies because it not only increases cost but also stretches the time for filing. All their already stretched resources will be stretched further and that might lead to some

companies selling off or merging in order to survive. This will surely have a negative effect on the CROs that serve that market. Only the very best will survive because the sponsors will not want to take any chances on the delivery from the CROs. I believe that the 4-6 quarters beginning 2014 will see a change in the landscape. EXPRESS PHARMA



‘Indian regulatory scenario is far from rosy at these times’


DR GOPAKUMAR G NAIR Founder, Gopakumar Nair Associates

have been a firm believer and a positive thinker on Indian pharma industry and its capabilities and strengths to scale the global technological and turnover tables and stables since the 1970s. In tandem with the strategies of the Indian government in the 70's and 80's, the Indian pharma industry picked up the gauntlet, stood up to the challenges and proved their might beyond doubt with the excellent growth, both in quality standards and in global generic pharma dominance, which commenced in early 1970s' and is continuing in the post-2005 product-patent era. During the 1970's, the deliberations leading to the then famous “Hathi Committee Report”, which laid the foundation for the growth of the pharma industry, was held by the government intently and intensely with the representatives of the Indian pharma industry. It was conducted with mutual trust and sense of partnership for growth. This trusted partnership continued upto the finalisation of the 1978 Drug Policy. Then active members of Parliament along with even the Minister for Chemicals (in-charge of pharma) used to join brainstorming sessions to finalise the Drug Policy of 1978 which laid the road map for growth of India’s basic drugs and formulation industry. The 1986 Drug Policy was substantially guided by the Indian pharma industry with full co-operation, participation and stewardship from the Chemical and Fertiliser Ministry as well as the Indian parliament. After the liberalisation in the 1995 Drug Policy, the National Pharmaceutical Pricing Authority (NPPA), the defunct proposal of National Drug Authority (NDA) became mired due to the extremely gross (mis)interpretations of Drug Price Equalisation Account (DPEA) and demands thereof, on the Indian pharma industry. Some of these doubtful and quaintly calculated demands led to sickness among smaller companies and a general mutual mistrust between government and the industry. The national pharma industry, led by Indian Drug Manufacturers’ Association (IDMA) under a united umbrella until then, started splintering, working at cross purposes and started voicing confusingly differing opinions and views. The government who was looking forward to dominate the industry, took this opportunity to divide the industry and the Associations to their advantage. This turn of events, along with strong emergence of the pharma NGO lobby, has started weakening the post-2000 Indian pharma industry. Pharmaceuticals Export Promotion Council (Pharmexcil), born in mid-2000 as a result of persistent efforts of IDMA, has attained an eminent stature in shortest time. The services rendered by IDMA in last fifty years and Pharmexcil in last few years have really helped Indian pharma industry to become the 'Pharmacy of the World'. Some noteworthy changes in the pharma sector are:

are becoming extremely delayed and non-uniform on the patent regulatory front.

Trademarks On the trademark side, there have been considerable clearing of backlog and cleaning up of the system. There is a need to keep the momentum going forward. The Central Drugs Standard Control Organization (CDSCO, office of the DCGI), in the meantime, discontinued granting new product approvals with brand names. This controversy has been settled favourably by clarifying that approved generic drugs can be branded thereafter.

The ISA, IPEA and Madrid Protocol India has become International Search Authority (ISA) and International Preliminary Examining Authority (IPEA ) on the patent front. However, much need to be done to create the infrastructure and logistics required to put this in place. Even though the notifications announcing ISA and IPEA are already announced, there is an urgent need to recruit, train and empower the needful manpower. All this and streamlining the patent office, requires funds and logistic support. If government will use the funds rightly and in a result-oriented manner, the proposed increase in patent fees is justified. India has joined the Madrid Treaty and Protocol, opening up filing of a single Trade Mark Application to all specifically elected countries of the world with an effective date of July 8, 2013. While there are few hundred applications filed from overseas designating India, only a couple of applications have been filed from India designating overseas contracting parties. This move will substantially help Indian generic pharma to build its pharma brands globally through the “Brand India Pharma Campaign” programme, sponsored by Pharmexcil.

The Pharma policy 2013 epilogue An eagerness to depart from the past, not only in the pharma policy (which is monitored and pushed by the Supreme Court of India). by enlarging the basket, but also in the procedures, such as the new 45 days limit for price-cuts, have put the success of the much awaited New Pharma Policy on the wire and in the air. The lack of unity in the pharma industry has also negatively impacted the hitherto strong voice of the national pharma industry. The going looks tough for Indian pharma both on the domestic front as well as in the international arena. Even though, there are provisions and opportunities in the new Pharma Policy 2013 to encourage innovation, the current stalemate in “new drug” approvals and the deadlock on clinical trials, clearly close this gate even before opining it. Delays in patenting, as stated elsewhere, add to the misery.

Patents The Indian Patent and Trademarks Office, which was down in the dumps till mid-2000, got a boost with the appointment of an upright Controller General. The IP Regulatory atmosphere in the country made notable strides thereafter. The provisions of the Patents Act, 1970 as amended up to 2005 and the procedures under the Patent Rules 2003, as amended up to 2006, started getting implemented in letter and spirit. There is an increasing trend for transparency with occasional ground for despondency. The various office actions



The clinical trial quagmire The pharma regulatory scenario in India has never been so dismal, it is reported that National Institutes of Health (NIH) of US recently scrapped nearly 40 chemical trials in India. Clinical trials of drugs have plummeted steeply in 2013. From nearly 500, the figures have slipped to nearly 200 in 2013. Simple approvals for novel drug delivery systems of widely used active pharma ingredients are also held up in this quagmire. India is in the forefront of rational combination therapy in the world. This strength must be taken forward. The new drug delivery systems must be given clearance through fast track, while the debate on advanced CTs for new chemical entities and the dosage forms thereof goes on. The new stringent norms on CTs appears to be driving the Indian pharma industry’s growth going down south. A strong leadership from a united Indian pharma industry and a joint national approach by the Ministries and departments of health, pharma, commerce and others (such as Environment, Industry etc.) alone can salvage the loss of “place of pride” of Indian pharma industry in the global community. September 1-15, 2013


‘Let this be the tipping point, but in a way that is to the benefit of all stakeholders’


year ago the impending Drug Prices Control Order (DPCO) was a key topic for debate. One year down the line the new DPCO has been announced and continues to be a hot topic for debate! And it is not just the DPCO but the environment in which the pharma industry operates in India at present leaves much to be desired. The main issues here seem to be lack of transparency, a limited understanding surrounding clinical trials (CTs) and intellectual property rights, and finally, a misplaced belief of what is good and right for the ultimate beneficiary – the patient.

Let us look at each of these issues as they stand today

RANJIT SHAHANI President OPPI and Vice Chairman and Managing Director, Novartis India

The new DPCO has been announced but the complexities of its implementation were not fully thought through. The logistics involved in recalling and stickering drugs is a complicated manoeuvre not to mention the challenges related to medicines that have special storage conditions. We are now well past the original deadline of 45 days but there is as yet no clarity. Some companies and associations have gone to Court. All stakeholders need to come together to ensure that the patient continues to stay well. India is a recent entrant to CTs. For a long time we were content consuming medicines that had never been tested on India’s genetic pool. Now we have global CTs taking place in the country but a lot of misguided information and policies that are not fully formulated. The Ministry of Health needs to ensure speedy formation of the Central Drug Authority. With that, industry hopes that the regulatory environment for not just CTs but also drugs and medical devices will be greatly improved.

Patient safety is of paramount importance We, as an industry, are more than willing to walk the talk to ensure that we comply with the regulations in letter and spirit. Global companies have norms that they must comply with, with regard to pharmacovigilance, and this needs to be fully in place here as well for the pharma industry as a whole. It is important to have good pharmacovigilance so that safety profiles for drugs used on Indians are enhanced. As always, it is all about the interest of the patient. Intellectual property rights continue to be a hot topic for debate – there are what are seen as patient rights on the one hand and the ability to continue to invest in research and development on the other hand, all to the benefit of the patient in the long term. Recent cases are not suggestive of an environment that fosters innovation no matter which way you look at it. Patents are granted then revoked. Patents are granted then violated with impunity. Patents are not granted citing specious arguments. Perhaps the time is right for not only raising awareness by collaborating with patent offices in other parts of the world but the time has also come to set up fast track courts to decide patent cases. Clearly for patents to be of any value to the innovator time is of the essence. We live in different times. The Indian pharma industry has come a long way. Let this be the tipping point but in a way that is to the benefit of all stakeholders keeping in mind the interest of the patient and the need to challenge unmet medical needs. Let the debate end.

‘Game cards need to be played with lot of concentration and long-term vision’



here is definitely a transformation seen in the Indian pharma industry. Indian pharma industry is a long term player in the global scenario. The industry is divided into the organised and unorganised sector. Things are looking up where reforms are concerned. Over the last few years, competition has pushed pricing so low that people have taken a casual approach, which has led to the industry compromising in various areas. This is evident from the warning letters being issued to many companies by various regulatory bodies. In the changing scenario, game cards need to be played with lot of concentration and longterm vision. DPCO impact: To an extent it has impacted the industry but there is a positive side also to be witnessed. Eventually

this has taken away cost-based regime and there is a professional approach from the government with regards to market pricing. The impact would probably be more on the MNCs than the Indian players or those who had high price regime. Clinical trial norms are being laid and it should be a welcome move, as volunteers/study subjects will not be exposed to unwarranted risks. New guidelines would ensure that fair trials have been conducted on the Indian population which in turn will ensure efficacy of products on our population. With respect to all the changes that are happening it will regularise the Indian pharma industry. However, it is important to review and implement new guidelines at regular intervals to make sure that health is not compromised while availability and affordability remains at the top.

Vice President-International Marketing, Bal Pharma

Conclusion The regulatory reforms in the Indian pharma industry may upset pharma entrepreneurs in the short term but is likely to be beneficial in the long term. However, it seems that India is following the steps of western countries and accordingly bringing changes in the system. The US FDA is hiking fees for generic drug makers up to 48 per cent from October 2013 which would impact exports to the US. At the same time thanks to DPCO 2013 the prices of 348 medicines will be reduced which will impact

September 1-15, 2013

the sales in the domestic market. Similarly, in India the patent office has drafted a gazette notification aiming to promote e-filing patent applications in India and proposed to hike patent fees. Post DPCO 2013, pharma companies and associations realised the danger of revenue loss and inorder to get alternate solutions both have come together and discussed the issue in depth. Despite the recent discussions and collaboration for a common goal, friction exists as was evident when the Department of Pharmaceutical (DoP) and NPPA requested the industry to share their products details and the

pharma companies were not pleased by this demand and failed to respond favourably. Beside this there are many more drafts guidelines and notifications which are still lying in the Government offices and are likely to come into effect shortly. It is upto the pharma companies to foresee these changes and their repercussions so that they are ready to meet them head on and play their role in maintaining the truce between the government and the industry players.




INSIGHT Raise your game - Expand your horizons in the Indian OTC market Sreedevi Yallamrazu, Sr Strategic Analyst, CubeX, provides a snapshot of the dynamics of the Indian OTC market and various opportunities, which Rx brands can take advantage of icholas Hall's 24th European OTC Conference & Action Workshop held earlier this year in London was yet again another spectacular performance in terms of the presentations made by the distinguished speakers from diverse backgrounds. The theme this year, 'Raise Your Game - Expand Your Horizons', focused on improved marketing, shopper insights and inspirational OTC advertising to stay ahead of competition. This theme is also apt in the context of the current situation in the pharma industry in India. The new pharma pricing policy is being perceived as a dampener by the industry with concerns regarding erosion of profitability. Reports are already pouring in regarding wholesalers’ refusal to stock essential medicines due to lower margins, although the policy has been touted to be beneficial from consumers’ / patients’ point of view. The industry is already plagued with challenges of market saturation and lack of new molecules to offer to healthcare professionals. In this scenario, sustaining brand growth is difficult, prodding the need for alternate avenues for increasing a brand’s market share. Since the battle will eventually become a level playing field as far as pricing is concerned and consumers are evidently wielding more power, Indian pharma marketers may have to shape their business models in light of this power shift. Indian marketers would have to now put the consumer at the centre and explore OTx/OTC strategies, thus expanding the horizon beyond Rx.


ed modest growth of four per cent (Source: Nicholas Hall's DB6 Global OTC Database). Emerging markets, chiefly BRIC nations, were the key contributors to the overall growth of the global OTC market. The Indian OTC market recorded sales of $ 2.3 billion

in 2012, having recorded growth of 13 per cent over 2011 (Source: Nicholas Hall's DB6 Global OTC Database). The Indian OTC market has maintained its momentum of double-digit growth over the last few years. Vitamins, minerals and supplements (VMS) and

Gastrointestinals (GI) together contributed nearly half (49 per cent) the total sales to the total Indian OTC market. In terms of growth drivers, apart from VMS, analgesics and dermatologicals too posted over $ 50 million incremental sales in 2012 (over 2011). However, the contribution from the major





Lifestyle OTCs



Vitamin, minerals and supplements




Cough, cold, allergy



CAGR: 12%






Dynamics of the Indian OTC Market The global OTC market has been valued at $ 121 billion at the end of 2012, having record-








September 1-15, 2013


categories has been constant.

Battle of illness and wellness The growth of the Indian OTC market has been driven by sub-categories which fall under the 'illness' domain. Majority of these sub-categories were from dermatologicals, followed closely by gastrointestinals and cough, cold and allergy. Topical as well as systemic analgesics, both recorded higher growth, as compared to the total Indian OTC market. Since the prime focus of most companies is catering to illness needs, it is a highly competitive segment. However, brands positioned on the wellness platform are likely to witness long-term sustenance as consumers are looking out for products that enhance health and wellness. There is a clear trend towards health and prevention in developed markets as well.

Treasure of hidden OTC gems Over 60 per cent of the sales of the Indian OTC market has been contributed by deemed OTC brands. Huge untapped opportunities exist for these brands to extend their life-cycle as well as to expand their respective markets. Heritage Rx brands like Revital and Crocin have cashed upon their doctor equity and con-

sumer popularity to reap success in the OTC market. Latest addition to the list includes Otrivin (topical decongestant), growing at CAGR of 22 per cent over the past five years (20082012). Rx to OTC switches (ingredients as well as promotional switches) are expected to drive the global OTC market, providing the much-needed boost to the market growth. In the Indian pharma market too, immense opportunities exist for promotional switches.

Domination of natural remedies Ayurvedic formulations or brands registered as ayurvedic products (like Vicks and Eno) dominate the list of star OTC brands. Seven of the top ten OTC brands are ayurvedic in nature - a strong indication of consumer preferences for natural products. In case of Volini, (parent brand has Diclofanac as its active ingredient), a herbal variant, Volini Activ, too has been launched. Globally as well, the benefits of natural products are being recognised. Higher demands are being voiced for 'made by nature' remedies and thus products like nasal saline could witness new niches such as preventive therapy for environmental or seasonal changes, non-medicated adjunct therapy or as lifestyle therapy to be used by frequent fliers, who could be prone to higher tendency for nasal congestion. This puts us in an advantageous position, considering our rich heritage in Ayurveda. Indian marketers can benefit from in-licensing innovative products while outlicensing natural remedies. However, concerns in terms of safety profile need to be alleviated through well-defined quality protocols.

Line extensions adding to brand saliency In the Indian OTC market, a notable trend has been the launch of line extensions of existing brands, as compared to absolutely new brands. The line extensions have largely revolved around expansion of usage occasions (Moov spray, Hajmola) and indication adjacencies (Crocin n’ Flu, Crocin Pain Relief, D’cold). Although hardly any extensions have surpassed the performance of the parent brand, they add significant value to the overall brand’s saliency. This is evident from ENO’s success, which has recorded CAGR over 30 per cent, attributable to the September 1-15, 2013

excitement created by the new flavours. Post the buzz created by ENO’s cola flavour, Nimbu Shikanji is the latest flavour which is a combination of lemon and jeera flavours, both highly appealing in terms of preference for gastric ailments. The brand’s has also been extended into tablets and liquids, which are likely to be visible in the market very soon.

Changing competitive landscape Key players like Emami (Boroplus and Zandu balm), Dabur (Dabur Chyawanprash and Hajmola), Ranbaxy (Revital and Volini) and Reckitt Benckiser (Dettol and Moov) have two brands each in the list of top ten leading OTC brands. However, with the increasing focus of FMCG companies on health and wellness, competitive landscape is widening. FMCG/FMHG companies are making a mark steadily, by introducing novel concepts and positioning the products based on deep understanding of consumer behaviour. Pharma companies have the upper hand due to their focus on scientific backing and formulations that provide the required therapeutic or prophylactic doses.

Opportunities for Indian marketers India is expected to emerge as the world's largest consumer market with aggregate spending of $13 trillion by 2030, surpassing the likes of China and the US, according to Deloitte. Different consumer segments are evolving, each at varying stages of health awareness and approaches, presenting unique health needs. The key strategy would be to 'catch’em young' and offer effective solutions in convenient formats, using multi-media approach to find captive audience. Demographic segmentation has not been widely practiced in India. In fact, one of the 10 watch outs for the decade ahead as listed by Nicholas Hall was demographic segmentation. It is evidently emerging that we need to change the myopic lens with which we have been viewing men's (sexual health) and women's needs (reproductive health). CubeX has identified almost 25 needs of women, half of which at least are white spaces, yet to be explored by marketers. In today’s highly connected world, consumers and patients are connected with doctors in myriad ways, thanks to infor-

mation technology advancements. In markets like India, consumers are adopting social networking as quickly as they become online (Source: BCG, March 2012). In emerging markets like India, while Internet penetration is low <40 per cent, social networking penetration is approx. 80-90 per cent among Internet users (Source: Economist Intelligence Unit), indicating the saliency and need for social media presence. Globally, marketers are using social media for building brand awareness and believe that it is integral to business strategy. Valuable marketing insights shared by members of online communities can be utilised for co-creation of content Gamification is emerging as an interesting way to engage consumers with their own health. The power of social media can be leveraged at a fraction of the cost, as compared to conventional media, with measurable outcomes through ‘social media listening tools’. While the environment throws challenges in terms of stricter regulations, the need of the hour is innovative business strategies to maximise profits. Pharma companies need to change the focus of their lens from products to consumer needs to leverage the opportunities. It is important to understand the patients’/consumers’ journey as well their perceptions and behaviour in order to improve health outcomes through right product choices and better adherence. Rx to OTC promotional switches, innovative OTC products, home-use devices and even products, promoted through OTx strategies that meet consumers’ needs could be opportune areas that drive growth. If you always do what you always did, you will always get what you always got. [Albert Einstein] CubeX is the Strategic Consulting and Business Intelligence division of Sorento Healthcare Communications with expertise in the Consumer Healthcare and Wellness domain. To know more about reports from CubeX, you can write to Nicholas Hall's DB6 Global OTC Database, the only global OTC database, is a comprehensive business planning tool which provides strategic review of the OTC market, India being one of the key markets included in the database. CubeX is the exclusive network partner for Nicholas Hall & Company in India. EXPRESS PHARMA



Family history of diabetes increases the risk of prediabetes by 26 per cent PG 31 FDA rejects Merck insomnia drug, seeks lower-dose PG 32

RESEARCH CLINICAL UPDATE Novartis receives FDA breakthrough therapy designation to BYM338 for sIBM Designation highlights potential of BYM338 to address an unmet medical need in a serious disease. If approved, BYM338 has the potential to be the first treatment for sIBM patients Basel ovartis announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to BYM338 for sporadic inclusion body myositis (sIBM). Breakthrough therapy designation was created by the FDA to expedite the development and review of new drugs for serious or life-threatening conditions. This designation is based on the results of a phase II proof-of-concept study that showed BYM338 substantially benefited patients with sIBM compared to placebo. The results of this study will be presented at the American Neurological Association meeting on October 14 and is expected to be published in a major medical journal later this year. sIBM is a rare yet potentially life-threatening muscle-


wasting condition. Patients who have the disease can gradually lose the ability to walk, experience falls and injuries, lose hand function, and have swallowing difficulties1. There are no currently approved, (or established), treatment options for sIBM2. “BYM338 is the third example this year of Novartis’ leadership in bringing breakthrough therapies to patients reinforcing our commitment to innovation addressing significant unmet medical needs and enhancing the lives of patients,” said Timothy Wright, Global Head of Development, Novartis Pharmaceuticals. “With no effective therapies currently available for sIBM, bimagrumab has the potential to be the first real option for patients with this condition." BYM338 (bimagrumab) is a novel, fully human monoclonal antibody developed to treat pathological muscle loss

and weakness. BYM338 was developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with Morphosys, whose HuCAL library was used to identify the antibody. BYM338 binds with high affinity to type II activin receptors, preventing natural ligands from binding, including myostatin and activin. BYM338 stimulates muscle growth by blocking signaling from these inhibitory molecules. In addition to being developed for sIBM, BYM338 is in clinical development for chronic obstructive pulmonary disease (COPD), cancer cachexia, sarcopenia and in mechanically ventilated patients. BYM338 is administered by intravenous infusion. According to the FDA, breakthrough therapy designation is intended to expedite the development and review of drugs that treat serious or lifethreatening conditions. The designation requires preliminary clinical evidence that demonstrates substantial improvement over currently available therapy. The designation includes all of the fast track program features, as well

as more intensive FDA interaction and guidance. The breakthrough therapy designation is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met. sIBM is a rare disease, yet it is the most common degenerative disease of muscle in adults older than 65 years. It is characterised by a slowly progressive, asymmetric, atrophy and weakness of muscles. Commonly, patients become wheelchair bound within 10 to 15 years of onset. Death may occur due to injurious falls, infection (aspiration pneumonia), or malnutrition. Bimagrumab also was granted orphan drug designation in sIBM in both the US and Europe in 2012.

References [1] Engel & Askanas, Inclusion-body myositis: Clinical, diagnostic, and pathologic aspects, Neurology 2006;66(Suppl 1):S20-S29 [2] Griggs, The current status of treatment for inclusionbody myositis, Neurology 2006;66 (Suppl 1):S30-S32

RESEARCH UPDATE Bypassing immune rejection in stem cell-based therapies Durham, NC n an article featured in the latest issue of STEM CELLS, a research group from Stanford University describes a novel regimen for quashing the immunologic barrier a short-course treatment with two costimlation-adhesion blockade agents, allowing engraftment of transplanted differentiated stem cells and their prolonged survival in tissue. The scientific community has held tremendous hope




for the eventual emergence of stem cell transplantation as a broadly applicable and highly effective therapeutic strategy. However, the realisation of this hope has been plagued by the indomitable immune response to the transplantation of human embryonic stem cell (hESC) derivatives, which prevents the engraftment and long-term survival necessary for functional recovery or preservation of the host tissue. “Inducing immune tolerance to human embryonic

stem cell graft is critical for the clinical success of regenerative medicine,” commented Dr Joseph Wu, Professor of Medicine and Radiology, Stanford University School of Medicine. “We have realised, however, that traditional immunosuppressive therapies used to prevent solid organ rejection, such as calcineurin inhibitors and corticosteroids, are insufficient to prevent human embryonic stem cell rejection following transplantation.” In the study, hESCs were

made to express enhanced green fluorescent protein (eGFP), differentiated to endothelial cells and cardiomyocytes, and transplanted into mouse hindlimbs as well as into both healthy and ischemic mouse myocardia. A novel costimulation-adhesion blockade method was then used alongside a more traditional therapy involving cyclosporine to induce immunosuppression. Detection of eGFP in the tissues allowed the team to track the engraftment and September 1-15, 2013


longevity of the transplanted cells over time. The costimulation-adhesion method yielded vastly superior results to the cyclosporine treatment, not only showing significantly improved engraftment and survival of the cells in the tissues but ultimately showing the effective preservation of cardiac function following stem cell transplantation in an induced myocardial infarction model, as shown through MRI. “Here we demonstrate that a short-course, dualagent regimen that prevents optimal T cell activation is

sufficient to promote the robust and long-term survival of embryonic stem cell derivatives in both healthy and injured tissues in mouse models,” Wu explained. The authors indicate that the superior response of the transplanted cells to the costimulation-adhesion therapy may be attributed to its repression of both adaptive and innate immunity, which is likely to aid in mitigating the tissues’ rejection of these characteristically immunogenic cells. The researchers’ method led to both local and systemic upregulation of T cell immunoglobulin and

mucin domain 3 (TIM3), a Th-1-specific cell surface protein, in addition to an overall reduction of pro-inflammatory cytokines. “Application of hESC and iPSC-derived cells holds great promise for cell replacement therapies in man, with clinical trials already ongoing in the US/Europe and soon in Japan,” noted Majlinda Lako, Associate Editor for STEM CELLS and Professor, Stem Cell Science at the Institute of Genetic Medicine, Newcastle University. “This current study brings us a step closer to overcoming immunological barriers that have ham-

pered these clinical promises and addresses important issues that must be tackled before successful realisation of pluripotent stem cell therapies can take place in humans.” Speaking on behalf of his research team, Wu stated, “We are excited by these findings and about their implications for the field. This work demonstrates a simple, effective approach to overcome the immunologic barrier of using human embryonic stem cell derivatives that is far superior to conventional agents currently in use clinically.”

Family history of diabetes increases the risk of prediabetes by 26 per cent study involving more than 8,000 participants has shown that people with a family history of diabetes see their risk of prediabetes increase by 26 per cent. The research is published in Diabetologia, the journal of the European Association for the Study of Diabetes, and is by Dr Andreas Fritsche and colleagues from the German Center for Diabetes Research. Prediabetes is a condition most often described as the ‘state between normal blood sugar control and full diabetes’, and indeed prediabetes progresses to full blown diabetes in up to 20 per cent of individuals affected per year. Prediabetes can


take two forms: impaired fasting glycaemia (IFG), whereby levels of glucose in the fast state are higher than normal but not high enough to be classed as diabetes; and also impaired glucose tolerance (IGT), where blood sugar levels are abnormal due to increased insulin resistance. While it is known that a family history of type 2 diabetes increases the risk of full blown diabetes, research has not yet explored whether such a family history increases the risk of prediabetes in either form. In this study Fritsche and colleagues analysed 8,106 non-diabetic individuals of European origin collected from the study centres of the German Center for Diabetes

Research. Of these, 5,482 had normal glucose tolerance, and 2,624 had IFG and/or IGT n=2,624. They analysed whether having at least one first degree relative with diabetes is associated with prediabetes. A family history of diabetes was found to increase the crude, unadjusted risk for prediabetes (IFG and/or IGT) by 40 per cent. This increased risk fell to 26 per cent when the analysis took account of age, sex, and BMI of participants. When different types of prediabetes were considered, family history increased the risk of isolated IFG by 37 per cent, of isolated IGT by 25 per cent, and the two combined by 64 per cent. However overall, when

adjusted for BMI, the association between family history and prediabetes was seen only in non-obese individuals (BMI<30 kg/m2). The authors say: “Our data suggest that a family history of diabetes is associated with prediabetes in non-obese rather than in obese individuals. This might indicate the effect of family history on prediabetes becomes readily measurable only when not overshadowed by strong risk factors such as obesity.” They conclude, “We found that family history is an important risk factor for prediabetes, especially for combined IGT and IFG. Its relevance seems to be more evident in the non-obese.” EP News Bureau-Mumbai

US FDA approves GlaxoSmithKline’s HIV drug Tivicay Washington he US Food and Drug Administration has approved GlaxoSmithKline’s drug Tivicay to treat the most common strain of HIV, the virus that causes AIDS. The oncedaily drug, known generically as dolutegravir, belongs to a novel class known as integrase inhibitors that block the virus from entering cells. Tivicay is owned by ViiV Healthcare, an HIV joint venture between GSK, Pfizer and Shionogi in which GSK is the largest shareholder, with a 76.5 per cent stake. Tivicay can be used to treat infected adults who have been treated with other drugs or are new to treatment. The FDA also approved the drug for use in children aged 12 years and over, who weigh at least 40 kg (88 lbs) and who


September 1-15, 2013

have not received treatment with a drug that has the same mechanism of action. About 50,000 people in the US are infected with HIV each year and about 15,500 died in 2010, according to the Centers for Disease Control and Prevention. Common side effects of Tivicay in clinical trials included insomnia and headache. Serious side effects included allergic reactions and abnormal liver function in patients who were also infected with

hepatitis B or C. Pa t i e n t s received either Tivicay or Merck & Co's Isentress in combination with other HIV drugs; or they received Atripla, a fixed-dose combination of three HIV drugs made by Gilead Sciences. A fifth trial evaluated the safety of the drug in children. Last week the FDA approved Alere’s HIV test which is designed to diagnose HIV infection earlier.” Reuters EXPRESS PHARMA



FDA rejects Merck insomnia drug, seeks lower-dose US health regulators have rejected Merck & Coâ&#x20AC;&#x2122;s new insomnia drug application but opened the door to approving a lower-dose version of the medication



erck has received a complete response letter from the US Food and Drug Administration saying that the agency could consider a 10 milligram starting dose of suvorexant for most patients, but that the company would have to have that dosage ready before it could be approved. The FDA in its letter said 15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective, Merck said. ISI Group analyst Mark Schoenebaum said the manufacturing study could lead to about a one-year delay in approval, especially if the FDA asks for long-term stability testing of the lower dose version. Merck declined to discuss the timeline or potential length of delay as a result of the FDA response. Merck had proposed that elderly patients start by taking 15 milligrams of the drug and increase that to 30 if necessary, and had recommended that non-elderly adults start


on 20 milligrams and increase to 40 milligrams if needed. In its letter, the FDA determined that doses of 30 mg and 40 mg were not safe for approval, Merck said. Merck said it doesn't see the need for further clinical studies to move forward with a 10 mg dose, but would require manufacturing studies to move ahead. Such manufacturing studies typically involve development of standard manufacturing and operational procedures to demonstrate that the pill can be manufactured in a stable and reproducible form. It

could also require demonstrating that the medicine has a durable shelf life. "We know how to do this. We do this all the time," Merck spokesman Steven Cragle said. ISI's Schoenebaum, who forecast annual suvorexant sales of $700 million by 2018, in a research note estimated a modest impact to Merck from the delay, and found a silver lining in that "suvorexant at 15 mg and 20 mg doses appears to the FDA to be approvable." He said a one-year delay

lowers ISI's 2018 Merck EPS estimate by only 0.25 per cent to 0.6 per cent. Merck also said it will discuss with the FDA whether additional studies will be required to support a 5 mg dose for certain patients. Suvorexant belongs to a new class of insomnia medicines called orexin receptor antagonists and would be the first such medicine on the market if approved. It is designed to facilitate sleep by blocking neurotransmitters in the brain that help to keep a person awake. Reuters

EU approves Novartis eye drug for new use Zurich wiss drugmaker Novartisâ&#x20AC;&#x2122; eye drug Lucentis has been approved as a treatment for a further condition related to worsening eyesight by the European Union, adding to three other conditions for which it is already approved. The Basel-based drugmaker said the European Commission had granted approval for Lucentis to treat patients with visual impairment due to choroidal neovascu-


larization (CNV) secondary to pathologic myopia. Lucentis, which was first launched in 2006, is an important product for Novartis and had sales of $2.4 billion in 2012. The drug is already approved in the EU to treat wet agerelated macular degeneration, visual impairment due to diabetic macular edema, and visual impairment due to macular edema secondary to retinal vein occlusion. Reuters

September 1-15, 2013

PHARMA ALLY ‘We are investing heavily this year to broaden our resource base in India’ Paul Mimnagh, International Product Manager (Pharmaceutical), IMCD Group, speaks with Sachin Jagdale about the company's marketing strategies for India, Australia, Russia and New Zealand Can you give us an overview of your business model in the India, Australia, Russia and New Zealand markets? The IMCD business model is based upon the identification, development and motivation of high calibre individuals within a culture of freedom and accountability. This model has seen IMCD grow into Europe's number one supplier of speciality pharmaceutical ingredients. Our success is based upon the 80+ pharma focused technical sales experts we employ. These highly knowledgeable people carry vast experience in the pharma industry and are challenged to continually grow their knowledge and experience through value added collaboration with our clients and within IMCD’s own network of formulation laboratories. Whilst our pharma model is relatively young with respect to the Indian and Russian markets, it has already gained significant traction with our clients. We aspire to work with our clients from early phase research and development through to final formulation and manufacture, offering them best in class service through the highest quality GDP standard supply chains. September 1-15, 2013

Our goal is to emulate our European position as the number one pharma ingredients supplier in these markets. With respect to Australia and New Zealand, IMCD is presently the leading speciality chemical supplier. However, we believe that we don’t have to be bad to be better! We have invested in strengthening our value proposition to the pharma industry in ANZ. This is today manifested in the deployment of one of the group’s core pharma experts to commit time and support to ANZ customers, in areas such as formulation and regulatory support. In 2014, it is our aim for example to hold our first programme of formulator workshops and seminars. Furthermore, despite this being a mature market fighting against manufacturing moving offshore rapidly we remain committed to expansion, having recently completed the acquisition of Capitol Ingredients. Patent expiries and the global economic slowdown have seen big pharma companies struggle to balance the books. How do you generate business out of such companies who are themselves trying to cut down on expenses? Pharmaceutical companies are indeed coming under increasing pressure to cut down on expenses. Furthermore it is becoming clearer to many of our clients that cutting expenses has to be approached in a much more holistic manner than the simple targeting of the purchase order price. If we look at the cost breakdown of a pharma formulation, the relative contribution of excipients for example, is in fact small, however, the cost of a


break in supply of any ingredient can be business critical. At IMCD, we offer a bespoke strategy for our larger pharma clients, this in some cases involves global service level agreements, vendor managed inventory initiatives, force majeure contingency initiatives, QA cost reduction and quality agreement programmes and many others. Essentially we try to encourage a ‘white paper approach’ from our larger clients. If we do not add value we do not survive in the supply chain, and have no right to do so. What challenges do you face for doing business in developing markets in Asia as compared to developed markets of Europe and Australia? And, how do you overcome them? Every market we operate in has its own dynamic and nuances. To succeed, IMCD must be able to navigate the terrain of any market, so while we have a strong governance of our pharma business plan in general, for an organisation our size we have a relatively light touch with respect to local or regional business management. Our IMCD sister

panies all conduct their business in line with company policy and guidelines however they also have the freedom to operate in their environments in the manner that is required. Understanding the dynamic of our market is key, the success of our business locally cannot survive solely by strong knowledge of our chosen industries; it must be complemented with strong local market knowledge. This matrix of industry focus and local knowledge is fundamental to our success. Have you noticed any India specific business challenges while distributing your products to the pharma industry here? The sheer size and geography of India in itself presents a challenge. We are investing heavily this year to broaden our resource base to reflect this. As we have grown in recent years we have been aware that our structure has been too central, thus we have already added a highly experienced resource to cover Gujarat and the North and will add two more this year to ensure we have the right blend of experience and knowledge deployed in all regions of the country. Another challenge which we are particularly aware of in India is keeping good resources. This is a concern for every company in every market, however, we are resolute in our determination to keep our staff happy and motivated, this is especially important in India where we see a particularly strong attraction for good people when presented an opportunity to leave distribution and work for the ingredient manufacturers. We keep our good people as they are so core to our business and as our business develops and grows in India, we keep a


Pall Corporation opens expanded SLS Technical Support Centre in Bangalore PG 34 Thermo Fisher Scientific introduces high performance gas chromatograph PG 35 Phenomenex extends Phree Phospholipid Removal sorbent family to tube format PG 36



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watchful eye that our new team members feel a part of the broader IMCD ethos. Also of particular relevance to India is the requirement to maintain a senior level of contact with the key decision makers in the client base. It is important that our senior business managers locally support the team effort by maintaining a somewhat statesman like relationship with their counterparts in our client base. What percentage of your revenue comes from the Indian market? It’s approximately five per cent of our global pharma revenue presently. Our aspiration is that this share will grow considerably based on ambitious but realistic plans for organic growth and targeted acquisition. Who are your major clients in India? We work with most of the leading manufacturers within the regulated pharma

sector. We also have quite a strong business in manufacturing for the domestic consumption sector. You would find suppliers from India supplying quality products that too at much cheaper rates. How do you handle such competition? The competitive threat from cheaper sources, where quality is or has improved markedly in recent years is not an issue restricted to the Indian market by any means. Irrespective of the market we are in, this is a threat we compete with day in, day out across our business. The suppliers who we partner with, and want to partner with us are leading in their respective fields. For our partners we excel in competing against these challenges, maintaining a profitable market share. Our clients for the most part appreciate that value does not solely equate to price, and as I said unit price is an area in excipients particularly, which has a limited poten-

tial to deliver cost reduction. Truly valuable ingredients are those that are supported by the supplier in such a manner as to help our clients meet challenges and opportunities, for example information and product bundles to assist in QbD submissions, or improved functionality to assist production efficiencies, bioavailability enhancement or even to assist in patent applications. The pharma industry has not nor never will be built on the basis of the cheapest sources for the cheapest drugs. What is going to be your growth model for India in the future? We are going to do what we and our partners do best. Bring a high value supply and service model to the Indian pharma manufacturing sector. This year we will add three new technical sales resources to our existing pharma team of five, strengthening our geographic coverage in India consider-

ably and allowing us to offer our core supply partners a credible IMCD Indian vehicle to drive the tried and tested business plan we have successfully implemented throughout the rest of our partnership. We are also reviewing the feasibility of adding to our pharma formulation laboratory network, a formulation lab in India is a possibility. This is core to driving a high value offering to the market by way of ensuring we have the best trained and most practically and conceptually knowledgeable people in the market. We will also continue on the acquisition trail. We wish to further add to our excipients and synthesis business in India in the short term. Ultimately our goal is to emulate the position we hold in our core markets today and to be able to justifiably say we are the leading pharmaceutical ingredients supplier in India.

VENDOR NEWS Pall Corporation opens expanded SLS Technical Support Centre in Bangalore To further enhances Pall’s capability to support the process development needs of its customers across various industries



all India has inaugurated its expanded Scientific Laboratory Services (SLS) technical support centre in Bangalore, which now has more than 60 per cent enhanced validation and testing capacity. Established in 2006, expansion of this SLS Technical Support Centre further enhances Pall’s capability to support the process development needs of its customers across various industries. The move also reinforces Pall Corporation’s dedication to


the growing bio pharmaceutical industry in India. Naresh Narasimhan, Managing Director, Pall India said, “Investment in this SLS Technical Support Centre to establish a premier filter validation facility represents a strong commitment from Pall Corporation towards solving the diverse and complex filtration and separation challenges of our customers in the South Asia region. It caters to both life sciences and industrial businesses, providing our customers with

advanced scientific support for their application needs. The expanded facility also houses a state-of-the-art training centre.” The Pall India SLS Technical Support Centre offers customised solutions through Pall products and technologies, filtration and validation packages, and optimisation of customer applications and processes. This expanded facility provides a validated clean room for microbiology, a validated lab capable of handling cytotoxic materials, a unique validated cold room to facilitate low temperature testing and houses new technologies for protein purification and characterisation. Sachin Indane, Director, BioPharmaceuticals division of Pall India emphasised, “With an increasing number of Indian pharmaceutical companies venturing into regulated markets, a need for reliable and speedy support in validation studies is eminent. We are excited to pledge our support to the growing

needs of this industry.” In addition, the SLS Technical Support Centre is focused on providing customers with wet laboratory training using specialised resources in the fields of filtration, biotech and vaccine process development, protein purification, process characterisation and optimisation. Training courses are fully customisable to Pall’s offering in primary separation, sterilizing filtration of liquids and gases, tangential flow filtration and ultrafiltration, chromatography, filtration validation studies and regulatory requirements, filter integrity testing and singleuse systems. Pall also hosted senior industry leaders for a symposium on 'Current Regulations and Inspection Trends for Filtration and Filling in Aseptic Processing,' which was led by Jerold Martin, Sr Vice President for Global Scientific Affairs for Pall Corporation. EP News Bureau-Mumbai September 1-15, 2013


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PRODUCTS Phenomenex extends Phree Phospholipid Removal sorbent family to tube format henomenex has announced the addition of a tube format in its Phree Phospholipid Removal sorbent line. First offered in 96-well plates for automated applications, the Phree sorbent in 1 mL tubes is ideal for users with lower throughput needs as well as for labs who do not have the ability to automate. Phree delivers fast cleanup of plas-


ma samples in pharmaceutical and clinical research laboratories. Phree in tube format can be used with a vacuum manifold, a positive pressure system or with a centrifuge. In one step, Phree removes both proteins and phospholipids, including 99.0 to 100 percent of lysophosphatidyl and phosphatidyl cholines, which are not removed

when a simple protein precipitation is performed. Successful chromatographic analysis of plasma samples requires the removal of both proteins and phospholipids, which can clog HPLC/UHPLC columns. Phospholipids can also cause ion suppression and over time will reduce sensitivity due to buildup on the mass spectrometry

source. Phree Phospholipid Removal products provide high recoveries of acids, bases and neutrals without the need for method development.

Contact details Erica Pike, Phenomenex Phone: (310) 212-0555 Ext. 3301 e-mail:

TerraSpray Rinse Station from Cole-Parmer ole-Parmer offers TerraSpray Rinse Station – an alternative to expensive automated systems or manual cleaning. Its compact design fits in small spaces or on laboratory benchtops and keeps water restricted, eliminating wet floors and slippery hazards from laboratories and workshops The Cole-Parmer Rinse Station is a cost-effective choice for cleaning all styles


of vessels and carboys up to 200 litres. The station connects directly to water inlet and drain—no electricity needed. Select from countertop or floor models. The countertop model cleans vessels up to 38.1 cm (15”) in diameter. Rinse is turned on and off by a hand-controlled valve on the side of the unit. The floor model cleans vessels up to 48.3 cm (19”) in diameter. A foot-controlled

valve on the bottom platform turns rinse on and off. Both models are easy to use with quick set-up. The units are crafted of a roto-molded polyethylene top panel and fabricated polyethylene base and legs. Valves are made of polypropylene with Viton elastomers and a Kynar coated stainless steel spring. Spray head is manufactured with PVDF. The inlet water connection is 1/2" NPT (F);

drain connection is 1 1/2" NPT(F).

Contact details Cole-Parmer India 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai Mumbai - 400 076, India Tel: +91-22-67162209 / 2222 Fax: +91-22-67162211 e-mail id:

Rockwell Automation extends agility, versatility and flexibility of Rockwell Software PharmaSuite System ockwell Automation has released Rockwell Software PharmaSuite v5.0 system for pharmaceutical and biotech production, setting new standards for manufacturing execution system (MES) performance in automation, risk management, cost reduction and regulatory compliance. The new version delivers a single MES solution with the agility to integrate and streamline pro-




duction not only across multiple production areas and product lines, but also from line to site level. Automation-layer integration – The PharmaSuite v5.0 system includes improved integration with production equipment – including premier integration to the Logix control platform – and automated batch processing using the PharmaSuite Recipe Designer. The system automatically collects data directly from production equipment, provides automation set points, monitors automation events, and integrates process information into the electronic batch record to reduce the risk for human error that can result from manual data collection. The PharmaSuite Recipe Designer now supports a greater number of production processes. Its enhanced information-flow design enables access to both definition and run-time information across the entire recipe to give users

added insight into real-time production information. The new data types within the expression editor enable users to deploy more sophisticated conditions, rules and calculations so they can more easily customise functionality to meet their needs. Equipment modelling– The PharmaSuite v5.0 system uses a new equipment modeler to define the underlying model and optimise integration across the range of manufacturing types, including biological, secondary, active, discrete assembly, weigh and dispense, and packaging. This allows users to define the automation interface, maintain equipment descriptions and specifications, and use the new equipment modeler as the foundation for GMP-compliance tracking and automation-integration scenarios. The user interface provides quick access to production information and is optimised to maintain and analyse massive amounts of

equipment-related data. Nonorder work-flow management–The PharmaSuite v5.0 system redefines assembling and supporting nonorder-related work flows that traditionally require custom programming by a systems integrator. Using S88-recipe design principles, the PharmaSuite v5.0 system enables the on-site end user or recipe author to create new work flows on their own, in just minutes, by reusing existing building blocks. By creating and managing these back-end tasks on their own, manufacturers can reduce overall production costs to help accelerate the return on investment.

Contact details website: e-sciences/ email: September 1-15, 2013

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We care for your family . . .

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

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Express Pharma Business Avenues World Class Bottle Packaging line solution from Countec, Korea New!!! 200 Bottles/minute Tablet-Capsule Bottle Packaging Line

Twice the speed, half the space!!!



Verification Counting Machine DMC CQ2


Bench Top Counter DMC 4


Electronic Tablet Counting Model DMC120T/DMC200

High Speed Rotary Screw Capper with Servo Motor Control CT-RC-120/200

Our range of packaging systems include 60BPM, 120BPM & 200BPM container packing line · ·

Mono block unscrambler with air jet cleaner Sachet desiccant inserter

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Servo controlled Retorquer Self adhesive labeler


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Cotton wool inserting machine


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ULTRA CENTRIFUGAL MILL ZM 200 ■ Grind size down to 40 microns, defined by the aperture size of the sieve used ■ Extremely fast process, with minimal temperature rise of the product ■ Powerdrive for high sample throughput ■ Easy cleaning through cassette and push-fit rotor ■ Various collection systems for batches up to 5 l ■ Grinding kit for small volumes up to 25 ml ■ Vibratory Feeder for automatic feeding process RETSCH INDIA PVT LTD | 1-2-45/1, 2nd Floor, Street No: 2, Kakatiya Nagar Colony, Habsiguda | 500 007 Hyderabad, India Phone: +91 40 2717 2431 | Fax: +91 40 2715 4686 E-mail: | Web:



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AWARD Novartis to hold annual healthcare entrepreneur competition 60 selected students from leading international universities will attend to explore science and innovation at Novartis headquarters in Basel



ovartis has invited 60 selected students from leading international universities in 21 countries to its headquarters in Switzerland for the International Biotechnology Leadership Camp (BioCamp). Over the course of three days, students will gain first-hand experience of starting a biotechnology company as well as developing and launching an innovative healthcare product. This year's BioCamp focuses on the company's innovation efforts in new business approaches to the healthcare industry. "With the aging population and increases in chronic disease around the world, demand for healthcare will continue to grow, well into the future. This will require innovative solutions as more healthcare systems focus on


improving patient outcomes. As Novartis innovates in healthcare, BioCamp underscores our commitment to creating a unique learning environment for young entrepreneurs. This programme enables us to forge ties between the healthcare industry and young talent from top universities. We believe this fosters the fresh thinking required to develop truly differentiated products and services with real-world outcomes," comments Joseph Jimenez, Chief Executive Officer, Novartis. Some of the company's leading outcome-based business models include collaborations with payors on pricing arrangements, patient compliance programmes as well as online support and education. For example, the company looks at innovative business models that go beyond tradi-

tional philanthropic and commercial efforts to reach patients today and those of future generations. The Novartis Arogya Parivar (Healthy Family) project is one such social healthcare business model involving a deeprooted outreach programme that trains local health educators and offers medicines in smaller, affordable packaging. Through this programme, Novartis has reached 42 million people in 33,000 villages in India. BioCamp is part of the Novartis commitment to supporting the exchange of ideas and thoughts between young talents in science and business and the company. Top students will meet with leading scientists and members of top management at Novartis including, among others, Rolf M. Zinkernagel, a Nobel Laureate and member of the

Novartis AG Board of Directors, and Prof Susan Gasser, Director, Friedrich Miescher Institute for Biomedical Research. BioCamp students also interact with Novartis scientists and executives who lead the company's approach to drug development and learn about new breakthrough medicines to address patients' unmet medical needs. The programme is designed to help students understand trends and challenges in the biotechnology and life science sectors as well as gain firsthand experience about starting and running a biotech company. BioCamp has helped forge ties with local communities and build connections to aid future innovative collaborations in research and clinical development. EP News Bureau-Mumbai

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JOB TRENDS Hiring activity in pharma sector rebounds in July-13 Is 24 per cent higher than what it was a month ago

he hiring activity in the pharma sector has rebounded in July-13 and is 24 per cent higher than what it was a month ago. Hiring activity has picked up in cities like Mumbai, Bengaluru and Hyderabad which are the prime job creators for the sector. Tracking the hiring levels for the past six months one can clearly witness that July has been a good


month in terms of recruitment with the job index going up to 1603.

About, Indiaâ&#x20AC;&#x2122;s No. 1 job site and the flagship brand of Info Edge introduced the concept of e-recruitment in India. Since its inception in 1997, has seen continued growth while outperforming its competitors in

every sphere. Info Edge was the first internet company to be listed in India. The site enjoys a traffic share consistently over 60 per cent as per the Comscore data. is a recruitment platform that provides hiring-related services to Corporates/ recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like Resume

Database Access, listings and Response Management Tools. With 230000 jobs live at any point and over 33 million CVâ&#x20AC;&#x2122;s, serviced over 48000 corporate clients in 2012-2013. The company has over 2500 people operating through 57 offices in 36 cities in India and overseas offices in Dubai, Riyadh, Abu Dhabi and Bahrain.

Jobs from Regional Sales Manager Company: Exp: Location: Job Id:

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Biocon 2-3 Bengaluru/Bangalore 060713002536

Naprod Life Science 3-5 Mumbai 221012002380




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AWARD Dr Vinod Prakash Sharma receives Gujar Mal Modi Award Receives award for his outstanding achievements in malaria research, control and prevention, including other vector borne diseases

r Vinod Prakash Sharma has been awarded with Gujar Mal Modi Award for Innovative Science & Technology 2013’ for his outstanding achievements in malaria research, control and prevention, including other vector borne diseases. The award was announced during a ceremony held at Shri Sathya Sai Auditorium in New Delhi. The scientist received a cash prize of ` 2 lakhs and one thousand, a scroll of honour and a silver shield. Sharma is known for his path-breaking work and contribution in the field of basic and applied research of malaria and vector biology. He is spearheading the 'Safe Water' campaign of the National Academy of


Sciences, India launched during the Year of Science. His work on popularisation of science, creating awareness and science education programmes of NASI, including in very remote areas, are widely appreciated . SK Modi, President, GM

Modi Foundation, said, “A malariologist like Dr Sharma is to be credited for bringing the nation at the frontier of the international scientific community. We, at The Gujar Mal Modi Science Foundation, feel delighted and proud to recognise such

invaluable research of our distinguished scientists, and will continue to be committed to carrying forward our efforts and dedication on bringing to light such achievements.” EP News Bureau-Mumbai

APPOINTMENTS USP appoints Michael D Maves as Senior Vice President of Development Previously served on USP’s Board of Trustees he US Pharmacopeial Convention (USP) has appointed Michael D Maves, as the Senior Vice President of Development. Maves brings indepth medical, global health and management experience to this newly-created position at USP, which is designed to extend the organisation’s standards-setting expertise into the worldwide philanthropic arena. He previously served on USP’s Board of Trustees,


Roger L Williams, Chief Executive Officer, USP said, “Mike Maves is uniquely qualified to lead USP’s initiatives in development, and in the execution of capacitybuilding activities in resource-constrained parts of the world. His understanding of USP’s mission as a global standards-setting organisation from his time on our Board builds on his extensive experience as a physician, teacher, global health leader and visionary executive.” Maves, a board-certified surgeon, served most recent-

ly as the Executive Vice President of Project HOPE, a global non-profit health education and humanitarian assistance organisation. Prior to that, he was the Executive Vice President and Chief Executive Officer of the American Medical Association (AMA). Maves has also served as President of the Consumer Healthcare Products Association. Earlier in his career, he led the American Academy of Otolaryngology – Head and Neck Surgery; chaired the Department of

Otolaryngology at the Saint Louis University College of Medicine; and served as professor and leader of medical departments at several universities and military divisions. Maves has served on numerous Boards of Trustees, and has published extensively. He is recognised as a leader in the medical and healthcare fields, and was elected to Alpha Omega Alpha, the national medical honour society. EP News Bureau-Mumbai

DIA names Barbara Lopez Kunz as Global Chief Executive Worldwide life sciences business leader to bring new vision and momentum to DIA arbara Lopez Kunz has been named as the Global Chief Executive, DIA. Kunz brings exceptional leadership experience to DIA as former president of the Global Health and Life Sciences business at Battelle, an international science and technology nonprofit organisation. Minnie Baylor-Henry, President, DIA said, “Barbara has a remarkably successful




track record of growing businesses that are based on innovation in science and technology and implementing globally effective strategies, and we are looking forward to her leadership and guidance.” In her role with Battelle, Kunz transformed the Global Health and Life Sciences through strategic investments, alliance development and technology commercialisation, increasing the number of research collaborations with

al, government and academic sponsors. She has also held senior roles at Thermo Fisher Scientific, Croda International, DuPont and PPG Industries, after starting her career as a research scientist. She has presided over the board of The Ohio State University Wexner Medical Centre and is a trustee of the Nationwide Children’s Hospital Research Institute and BioOhio. Kunz is a member of the Healthcare

Businesswomen’s Association Ohio chapter advisory board. “I look forward to continuing to advance innovation worldwide as I lead DIA into its 50th year. The foundation is in place to use my global knowledge of patient needs and the healthcare community to fortify DIA’s significant role in transferring vital information across the globe,” Kunz said. EP News Bureau-Mumbai September 1-15, 2013



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Express Pharma September 1-15, 2013  

Gearing Up For The Future Usha Sharma seeks the views of industry stalwarts on the recent upheavals in the Indian pharma regulatory system a...