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Long way to go for AYUSH The proposal to set up a separate arm of the CDSCO to scruitinise applications meeting AYUSH specifications has received mixed reactions from the AYUSH players. Usha Sharma examines some reactions...... See Page 32

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Contents

E|X|P|R|E|S|S

Pharma VOL 7. NO. 23 OCTOBER 1-15, 2012 Chairman of the Board Viveck Goenka

quote

Editor Viveka Roychowdhury* Photo Editor Sandeep Patil BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta

Japanese consumers are traditionally wary of foreign brands. Some of these concerns about the quality of generics have legitimate origin, as only recently have active pharma ingredients manufactured outside Japan been subject to on-site plant inspections by Japanese regulators Michael Glessner Pharmaceutical Research Analyst Thomson Reuters Page 15

MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Production Manager Bhadresh Valia Asst. Manager - Scheduling & Coordination Arvind Mane

The setting up of Drug Control cell at the Centre will strengthen the executive structure for the department of AYUSH. The Drug Control cell would be responsible for framing regulations and policies for the entire industry Dr Vijendra Prakash, Senior Manager—Regulatory Affairs The Himalaya Drug Company

DCGI to make consent forms in regional languages mandatory With the objective of making volunteers on clinical trials more aware of the risks involved, the Drugs Controller General of India (DCGI) plans to make it mandatory to have informed consent forms in regional languages. This rule could be in place by the end of this year Page 18

Asst. Art Director

Page 34

Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma C I R C U L AT I O N Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2010-12 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021)

*Responsible for selection of news under the PRB Act. Copyright @ 2011

Doctor factor Pernicious osteoporosis

interview ‘Currently, we have more than 100 active sites in India’ With offices in Gurgaon, Ahmedabad, Gandhinagar and Mumbai, INC Research supports broad worldwide clinical trial strategies and services, including data services, functional services, alliance partnerships, strategic and regulatory consulting, and trial services. In an email interaction with Usha Sharma, Shabbir Rangwala, Regional General Manager – India, Sri Lanka, Pakistan and Bangladesh, INC Research and Kelvin Logan, President, INC Research, Asia Pacific share their company's plans for the future

Express Pharma, in association with Majestic MRSS, gives an idea about the awareness level about osteoporosis among the medical fraternity and patients and the myths related to it Page 36

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Editor’s Note

IPR, public health, policy reform at tipping point in India

nder threat of an interim order from the Supreme Court, the Group of Ministers (GoM) tasked with framing India's drug pricing policy finally plumbed for a market-based policy, fixing the prices of all formulations of the 348 bulk drugs in the National List of Essential Medicines 2011

by taking the weighted average price of all brands having at least one per cent or more market share by volume. The method may not be what the pharmaceutical industry hoped for, but there is some relief that the confusion will soon end. The decision of September 27 still needs the Cabinet's nod for approval but no one would like to come in the line of fire of the Supreme Court, which called the eight year delay a “slur on the face of all stake-holders”. This decision comes after the Court wondered if the members of the GoM were “meditating” or “deliberating” during the meetings as the letter pertaining to the deliberations did not have any details, leading the Bench to ask if the meeting was a silent one! On other fronts as well, the wheels of policy change finally seem to be moving in India. The Government's recent policy push which resulted in the Cabinet approving FDI in multi-brand retail, among other long overdue decisions, is good news and the pharma sector hopes it is next in line for FDI reforms. On the IPR front, India's regulators have so far stuck to their stance that policy must be framed to protect public health. There has been no rollback since India introduced such safeguards like Section 3d in its patent laws. In fact, countries like the Philippines, Taiwan, China and Argentina have followed India's example. September saw two landmark legal decisions which have earned their place in the history of the pharma industry in India, while final arguments in a third case are still being heard. Legal experts comment that these recent decisions (the Natco-Bayer case, the Cipla-Roche case) were resolved without undue postponements unlike in the past. Novartis too hopes to have a verdict in the Glivec case before year end. But industry does have a valid grouse that the Government has been dragging its feet on other important legislature. Once the pricing policy is in place, it’s time for the authorities to put in place a policy on unfair marketing practices. On the clinical trials front, guidelines on compensation need to be framed. The draft guidelines on biotechnology (released in June this year) as well as those on stem cell research (released in March this year) too need to go to the next stage. This criticism only serves to once again highlight the risks that the life sciences industry in India presents today. During a recent webinar hosted by Metro Atlanta Chamber and FDA Smart, with Express Pharma as the media partner, Vishal Gandhi, Managing Partner & CEO, BioRx Venture Advisors cautioned that the higher than expected pricing pressures, lack of predictable IPR policy resulting in increased risk of litigation and multiple window clearance could mar the India story for global pharma and biotech firms looking at the country for partnerships. Will these concerns be sorted out sooner rather than later? Hopefully, the September 27 decision of the GoM will clear the table for more such decisions. The push from India's highest judicial authority combined with an economist-Prime Minister who finally seems to have the OK from his party's high command to forge ahead with economic reforms, irrespective of the support of alliance partners could mean that all the pieces will finally fall in place for the pharma industry. Even if these are precursors to the campaign for the 2014 elections, we promise not to quibble. Viveka Roychowdhury viveka.r@expressindia.com

8 EXPRESS PHARMA

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Market

THE BUSINESS OF PHARMACEUTICALS

UPFRONT

‘Currently we have more than 100 active sites in India’ Sanofi and TB Alliance announce collaboration anofi and the Global Alliance for TB Drug Development (TB Alliance) have signed a research collaboration agreement to accelerate the discovery and development of novel compounds against tuberculosis (TB). Under the agreement, Sanofi and TB Alliance will collaborate to further optimise and develop several novel compounds in Sanofi’s library that have demonstrated activity against Mycobacterium tuberculosis, the bacterium that causes TB. This includes in-depth research of lead compounds based upon identified chemical derivatives of natural products, which have promising potential to treat all forms of TB, and the chemical optimisation of other series of compounds that have been identified as hits through high-throughput screening. Elias Zerhouni, MD, President, Global R&D, Sanofi said, “Sanofi’s long-standing commitment to delivering treatments for people living with TB including the discovery of rifampicin, the gold-standard drug for TB treatment, as well as the manufacture of TB treatments - continues with this collaboration. By continuing our excellent partnership with the TB Alliance and leveraging our joint resources, we hope to find together new options to fight this dreaded global disease.” “In working with Sanofi, we seek a common goal - to give patients and physicians significantly more effective treatments for TB and drug-resistant TB. Without new regimens, we cannot stop this global pandemic,” said Mel Spigelman, President and CEO, TB Alliance. EP News Bureau

October 1-15, 2012

With offices in Gurgaon, Ahmedabad, Gandhinagar and Mumbai, INC Research supports broad worldwide clinical trial strategies and services, including data services, functional services, alliance partnerships, strategic and regulatory consulting, and trial services. In an email interaction with Usha Sharma, Shabbir Rangwala, Regional General Manager – India, Sri Lanka, Pakistan and Bangladesh, INC Research and Kelvin Logan, President, INC Research, Asia Pacific share their company's plans for the future

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M|A|R|K|E|T hen Pfizer and Mylan, two of the world’s biggest pharma companies join hands to market drugs in a country, there should be no guesses to its potential. The country in focus is Japan, the second largest market in the world after the US, hugely untapped by foreign pharma due to various factors. But with an increasing ageing population, numerous impending drug patent expiries, a broad array of government initiatives aimed at reducing healthcare expenditures, and a rising demand for high quality generics it is not only becoming attractive for big pharma plagued by static sales in the US and European price cuts, but others too. The recent move by India to ask Japan to remove non-tariff barriers, might be the trigger for Indian pharma companies to increase their share in this growing market. While only a few have managed a footprint, we take a look at what makes the country attractive yet unexplored and the potential for India.

A growing generics market The Japanese pharmaceutical market was estimated to be worth ~JPY 9690 billion ($125 billion) in 2011. Growing at a CAGR (2010-2015) of ~ 3.5 per cent, it is expected to reach JPY 12220 billion ($145.5 billion) by 2015. The growth rate is slightly lower than those of the previous five years reflecting biennial price cuts scheduled for 2012, 2014, and 2016. The market consists of three broad segments –generics, non-generics (all patent protected and non-protected drugs excluding generics) and other products (OTC and other unclassified products). For the year 2011, the generics market stood at ~ JPY 520 billion ($6.7 billion), nongenerics at ~JPY 7430 billion ($95 billion) and the other products segment at ~JPY 1740 billion ($22.4 billion). The generics segment is the highest growing of all with a reported CAGR of ~14 per cent (2010-2015). According to new calculations based on IMS data released by the Japan Generic Medicines Association (JGMA), generic drugs sales accounted for fewer than 10 per cent of pharma sales by value and nearly a quarter of pharma sales by volume in 2011 and are expected to reach a figure of 12.8 per cent by 2015. This was up from 8.5 per cent (FY 2010) and just 5.7 per cent five years ago. However, Japan’s share of global pharma spending is expected to remain at roughly 10 per cent through 2016. Drug stores, hospitals and clinics hold the largest demand for pharma with prescription drugs accounting for the largest share(~90 per cent). This market grew by 7 per cent to JPY 9,481.6 billion ($120.5 billion) in 2011 despite the

HITESH GAJARIA

VINOD DHAWAN

Partner, KPMG

President, AAMLA & Business Development(Lupin)

Revising the generic dispensing fees for the benefit of pharmacists, lowering of generic price ceilings and a new rule that requires new generics to be made and registered in all strengths of the originator products, are some of new initiatives that might help encourage foreign companies

Having gained expertise in the market, regulatory is no longer an issue for us. Japan contributes $250million to our revenues currently and we see the figure increasing to $650 million by March 2017 alongwith filing 8-10 new products every year. We along with our subsidiary Kyowa Pharma, aim to be in the top four in the next few years and have put in the requisite sales force to match our operations

March earthquake, tsunami and nuclear crisis, driven in large part by increasing sales in the oncology, diabetes, and vaccines sectors. The Japanese market is not nearly as fragmented as the Indian market. Domestic pharma companies such as Takeda, Daiichi Sankyo, Mitsubishi Tanabe and Astellas hold a majority of market share(~26 per cent) with only four foreign companies ranking in the top ten (Pfizer, Roche (Chugai), Novartis and Merck). Most domestic companies derive close to 40 per cent of their revenues from exports. Takeda is the largest Japanese pharma manufacturer in terms of sales. At 5.6 per cent market share, Pfizer comes a close second with Roche and Novartis tied in fifth place with 4.4 per cent and Merck at ninth. As far as the therapeutic areas are concerned, oncology, CNS and immunology are some of the areas targeted for R&D by domestic firms. While the country has comparatively low rates of breast, ovarian, lung and colon cancers, their prevalence rates are rising rapidly, while rates for other cancers (such as gastric cancer) are already high

by international standards. The country is the third largest market for chronic myeloid leukaemia (CML). “The prevalence of heart disease in Japan in both men and women is among the lowest world-wide due to low obesity levels. It also has low incidence of Alzheimer's disease, despite its ageing population, although dementia levels are on a par with equivalent populations. Chronic Hepatitis C virus (HCV) infection levels are high. The country has one of the highest male smoking rates(~25 per cent). Drugs in areas such as cardio-vascular, oncology, gastroenteric, neurological and anti-infectives have the maximum therapeutic potential in Japan,” says Hitesh Gajaria, Partner KPMG.

Challenges and opportunities Despite being the second largest pharma market and the sixth largest generic retail prescription market worldwide, generic penetration (by volume) in Japan is still to rise beyond 23 per cent(~70 per cent in the US). One reason has been the country's resistance to generics medicines owing to concern

Top domestic pharma companies in Japan by sales Company

Total sales(2011) JPY

Domestic Sales(2011) JPY

Takeda

1509 bn

721bn

Astellas

970 bn

558bn

Daiichi Sankyo

939 bn

490bn

Eisai

648 bn

400bn

Source: KPMG compilation from Market Intelligence

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October 1-15, 2012

M|A|R|K|E|T over safety and quality as compared to their branded counterparts. Says, Michael Glessner, Pharmaceutical Research Analyst, Thomson Reuters, “Japanese consumers are traditionally wary of foreign brands. Some of these concerns about the quality of generics have legitimate origin, as only recently have active pharma ingredients manufactured outside Japan been subject to on-site plant inspections by Japanese regulators.” Drugs are prescribed by physicians, who have discouraged long-term availability of generic medicines with innovator companies wielding more power and retaining significant market share even after losing patent protection. Generic manufacturers thus are left to withdraw older products from the market due to reduced sales or lower reimbursement fees. Pharmacies too opt to stock the branded original instead of stocking multiple generic versions of a drug. New drugs currently reach Japan almost five years after their launch in other markets. Burdensome clinical data requirements and lengthy approval times further add to it. “There is no direct access to pharma and Medical Devices Agency (PMDA) and should be routed through in country caretaker. This leads to delay in getting regulatory information. Periodic GMP manual inspections of voluminous data is also arduous,” adds PV Appaji, DG, Pharmexcil. However, for all the glitches, there

October 1-15, 2012

remain windows of opportunity, for those seeking to tap them. With the Japanese government having set an ambitious target of increasing the generics share to 30 per cent of sales by volume by the end of 2012, a lot of reforms are underway. “Revising the generic dispensing fees for the benefit of pharmacists, lowering of generic price ceilings and a new rule that requires new generics to be made and registered in all strengths of the originator products, are some of new initiatives that might help encourage foreign companies,” opines Gajaria. The Japanese Government launched the public incentive programme in April this year as a part of which municipal governments, in their capacity as insurers, now actively promote the use of generics among their members. The Japanese Ministry of Health, Labour and Welfare (MHLW) is increasingly accepting non-Japanese Asian data as part of the regulatory approval process. To encourage pharmacists to prescribe generics, they are paid JPY40 ($ 0.45) per prescription if generic drugs account for at least 30 per cent of dispensed medicines over a three-month period. Prescription forms now contain a box where a physician must sign if he/she does not consent to generic substitution. The country is also trying to adopt a more liberal approach to the acceptance of foreign clinical data. The future thus looks bright for generics in Japan.

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PV APPAJI Director General, Pharmexcil

Pharmexcil is negotiating a MoU with Japan’s pharma producers/generic association for exchange of information, which could help our exporters to prepare and approach their market in a well planned manner The road ahead Although Indian companies have been able to ride the generic bandwagon in the US, the Japanese market has been a tough nut to crack. “As of March 2012, Indian companies have filed 112 Japanese DMFs and have launched over

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M|A|R|K|E|T 650 products in Japan,â&#x20AC;? states Glessner. Ranbaxy (now wholly-owned by Daiichi Sankyo) was one of the first companies to enter Japan in 2002 by acquiring 50 per cent stake in Nihon Pharmaceutical Industry (a subsidiary of Nippon Chemifar). After this relationship ended in 2009, the company today is back and much better armed, thanks to its Japanese parentâ&#x20AC;&#x201D;Daiichi-Sankyo. Ranbaxy and Daiichi in 2010 set up

Daiichi Sankyo Espha, to sell generics as well as long-listing drugs (off-patent branded drugs) in Japan. In 2011, Dr Reddyâ&#x20AC;&#x2122;s Laboratories announced its entry into Japan by signing a joint venture with Fujifilm Corporation banking on its expertise in cost competitive production technologies for active pharmaceutical ingredients and formulations and Fujjfilm's advanced quality control technologies to

deliver high quality generic drugs. Zydus Cadila has been present in the Japanese market since 2007 after it acquired Nippon Universal Pharma in Japan. Though only one per cent of its revenues comes from Japan, the company is bullish on the country and has filed four new products and received three approvals in the first quarter of 2012. The above examples clearly indicate that partnering with a local compa-

Drugs losing patent protection in Japan (2012-2015) Year

2012

Active Ingredients topotecan hydrochloride

mycophenolate mofetil

ivermectin

azelnidipine

zoledronic acid

2013

biapenem

nifekalant hydrochloride

oxaliplatin

finasteride

adenosine

inulin

follitropin beta

miglitol

bepotastine besilate

danaparoid sodium

basiliximab

capecitabine

pitavastatin calcium

efavirenz

trastuzumab

tolterodine tartrate

clopidogrel bisulfate

sivelestat sodium

letrozole

desmopressin acetate

tenofovir disoproxil fumarate

adefovir dipivoxil

pazufloxacin methanesulfonate

moxifloxacin hydrochloride

cetrorelix acetate

follitropin alfa

sertraline hydrochloride

verteporfin

imatinib mesylate

gabapentin

octocog alfa

voriconazole

pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein)

insulin lispro recombinant

ropinirole hydrochloride

insulin glargine

aripiprazole

zolmitriptan

valganciclovir hydrochloride

peginterferon alfa-2b

2014

fosamprenavir calcium

2015

baclofen

tiotropium bromide

bosentan

topiramate

dienogest

tadalafil

emtricitabine

imiquimod

entacapone

insulin detemir

eplerenone

landiolol hydrochloride

etanercept

monteplase

ezetimibe

palivizumab

ferucarbotran

pemetrexed disodium

fondaparinux sodium

rocuronium bromide

gefitinib

tamibarotene

Source: Thomson Reuters

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October 1-15, 2012

M|A|R|K|E|T MICHAEL GLESSNER Pharmaceutical Research Analyst, Thomson Reuters

development, Lupin. This strategy would come in handy for Indian companies looking for strategic partners in Japan. The company recently partnered with l'rom, which has significant presence in hospitals under the DPC (Diagnosis Procedure Combination) scheme that extensively use generics to cut costs. However, Indian pharma needs to rise upto the chal-

lenge. Informs Gajaria, “Japanese imports of India’s drugs, pharma and fine chemicals have been the lowest so far ($ 65 million)”. The grass does look greener since its not only the Japanese government which is taking steps to remove hurdles for foreign firms penetrating the market but the Indian govenemnt has also upped the ante. The recent request to remove numerous non-tariff barriers

like tedious registration process and language that have so far been a deterrent for the domestic pharma industry to ramp up trade with Japan, is a step in the right direction. This would help both countries take full advantage of the Comprehensive Economic Partnership Agreement (CEPA) signed in mid 2011 as a part of which the Japanese government would accord no less favourable treatment

to the applications of Indian companies than it accords to the applications of its own persons for drug registration. Although drug exports to Japan have increased, India only accounts a tiny share of less less than 1 per cent of total Japanese pharma market. We hope this figure would soon reflect the potential that the Japanese pharma market holds for Indian pharma. shalini g@expressindia.com

ny is a key to success in the Japanese market, since they have sufficient know-how and expertise of the regulatory hurdles. The most succesful example of the same is Lupin. With 12 per cent of its revenues coming from Japan, Lupin's alliance with Kyowa, a 50-year-old Japanese drug company (a 100 per cent subsidiary now) in 2007, is a point in case where Lupin develops and manufactures the drugs and Kyowa conducts regulatory testing, obtains approvals and markets the drugs in Japan. “Having gained expertise in the market, regulatory is no longer an issue for us. Japan contributes $250 million to our revenues currently and we see the figure increasing to $650 million by March 2017 alongwith filing 8-10 new products every year. We along with our subsidiary Kyowa Pharma, aim to be in the top four in the next few years and have put in the requisite sales force to match our operations,” informs Vinod Dhawan, Group President, AsiaPacific, Africa, Middle East, Latin America (AAMLA) and business October 1-15, 2012

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M|A|R|K|E|T INTERVIEW

‘Currently, we have more than 100 active sites in India’ With offices in Gurgaon, Ahmedabad, Gandhinagar and Mumbai, INC Research supports broad worldwide clinical trial strategies and services, including data services, functional services, alliance partnerships, strategic and regulatory consulting, and trial services. In an email interaction with Usha Sharma, Shabbir Rangwala, Regional General Manager – India, Sri Lanka, Pakistan and Bangladesh, INC Research and Kelvin Logan, President, INC Research, Asia Pacific share their company's plans for the future

Shabbir Rangwala, Regional General Manager – India, Sri Lanka, Pakistan and Bangladesh, INC Research

Kelvin Logan President Asia Pacific INC Research

Brief us about INC Research’s ongoing activities in India? Rangwala: INC Research provides the full spectrum of clinical research services for phase II to IV clinical trials in India. With offices in Gurgaon, Ahmedabad, Gandhinagar and Mumbai, we’re able to support broad worldwide clinical trial strategies and services, including data services, functional services, alliance partnerships, strategic and regulatory consulting, and trial services. We’re also looking to expand our research expertise in Biosimilars. Our Indian hub serves as a centre for our Contracts and Functional Services group, providing global site contract management, regulatory document (eTMF) processing and site payment administration. Additionally, we’ve set up a dedicated biometrics team to help sponsors determine the most efficient way of enhancing their studies using the latest biometrics technologies. We’ve also developed an internationally recognised electronic data collection and organisation system that streamlines data handling. Presently, INC Research performs phase II to phase IV clinical trials. Do you have any plans to conduct clinical trials on phase I? Rangwala: We have not conducted any phase I trials in India to date, as current Indian regulations do not permit them at this time. However, as a leading global CRO, INC Research has the capabilities to provide the full range of phase I to IV clinical development services across six continents. The company has its centre in the SEZ in Ahmedabad-Gandhinagar. What made you choose the SEZ? Rangwala: We have a dedicated operations centre in the SEZ of Ahmedabad-Gandhinagar Knowledge Corridor, which allows us to rapidly increase staffing to match spikes in demand. Additionally, INC Research has several IT-enabled services in India that fit into the SEZ. We wanted to leverage these services to support future capacity and also set up a back-end operations centre for data management, pharmacovigilance, biostatistics, analytical work, medical writing and clinical research support services. Globally, which country has the large number of patient pool and why? Logan: In terms of disease rate per 100,000 residents of a particular country, China has the largest patient pool, but it’s closely followed by India. With a population set to exceed China’s by 2035, India has more than 1.3 billion potential patients and is anticipated to be one of the top three pharmaceutical markets by 2020. This huge population means an incredibly diverse disease base of most major diseases as well as rare diseases,

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including an endless variety of disease areas from tropical infections to degenerative diseases. While we see huge patient recruitment potential for clinical trials in India we have to recognise that the bulk of clinical trials in the world in 2012 are still conducted in North American and European patients where Good Clinical Practice (GCP) and the pool of scientific and medical expertise are long established. This is certainly changing rapidly, but the local media comment about over excessive use of India patients in clinical trials is much overstated today. INC Research is committed to working closely with DCGI and other authorities in India to ensure that the highest standards of GCP and patient ethics are adhered to in all our studies in India. In India, INC mainly conducts research on diabetes, HIV, neurology, oncology and psychiatry. Tell us the reason behind this? Which are the therapeutic areas that INC Research has an expertise in? How will this expertise be deployed in India? Rangwala: We’ve conducted a lot of research in diabetes, HIV, neurology, oncology and psychiatry because of India’s spectrum of disease, which includes 10 million people with HIV, eight million epileptics, three million cancer patients, and 34 million diabetics. In fact, India is known as the diabetes capital of the world, having the highest number of diabetes patients. It is also estimated that India will have a 500 per cent growth spurt in the number of cancer cases within the next two decades. In fact, the Indian cancer registry data suggests that one in every 10 Indians will develop cancer in his/her lifetime. INC Research conducts clinical trials in these and numerous other therapeutic areas. In addition to the ones mentioned above, we’ve conducted trials in India for rheumatology, cardiology, infectious disease, general medicine, ophthalmology, dermatology, pulmonology, gastrology and pain. Which are the other therapeutics segments that have growth potential and why? Rangwala: With a huge population and diverse disease base, both major and rare diseases are prevalent in India. The most dominant therapy areas in terms of potential patient volume and clinical research investment are infectious diseases and women’s health. In addition to the therapeutic areas mentioned above, we also see a lot of potential in the areas of the reproductive and urology disorders. Indian regulators are trying to make the existing law more stringent in this scenario. How will this move affect you? Rangwala: Industry would welcome refinement of existing laws as long as implementation follows a regulatory mechanism. The establishment of 12

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New Drug Approval Committees (NDAC), which advise on clinical trial approvals of new drugs, has increased the overall approval timelines compared with past processes, but the changing regulatory environment has made study approval rates still difficult to predict. Our close relationships with local regulatory authorities is a major reason why more pharma companies are turning to CRO partners like INC Research, because we’re able to help sponsors navigate this volatile system and unlock the potential profitability to be gained from conducting clinical research in India. Tell us how INC Research regulatory team in Gurgaon is helping the New Drug Advisory Committee and its subsidiaries? Rangwala: Our regulatory team in Gurgaon maintains close relationships with the NDAC and its subsidiaries, enabling us to keep abreast of India’s continual regulatory updates. As an applicant, INC Research is required to submit proposals to the committee, which reviews it independently. Typically, CROs and sponsors are allowed to present their trials for approval by explaining scientific, logistics and administrative strategy to conduct the study in India. The Committee then independently weighs the merits of the proposed study and grants approval. According to INC Research, what are the regulated elements that should be considered by an Indian biopharmaceutical company before finalising its CRO selection. How important is it? Rangwala: Indian biopharmaceutical companies should look for CRO partners that can assist them in complying with complex regulatory requirements and provide them with lower costs and access to new patient samples. When selecting an outsourcing vendor, most biopharma companies today are interested in developing long-term strategic relationships as opposed to simply maintaining a transactional arrangement and Indian biopharma companies are no exception. The most important characteristics to look for when selecting a CRO partner are local experience, the ability to provide consistent quality, high fidelity, superior service, and an extensive network of regional offices. Recently, CDSCO has drafted the guidelines on quantum of financial compensation to be paid in case of clinical trials related injury or death? What is your comment on same? Logan: With support from the industry, most countries are starting to address this issue. Draft guidelines are evolving and while this is a good start, most in the industry expect some unresolved issues around causality/relatedness/worsening of underlying diseases to remain. INC October 1-15, 2012

M|A|R|K|E|T Research is committed to complying with the emerging CDSCO guidelines on financial compensation for patients that are negatively impacted through participation in clinical trials. It should be acknowledged however that patients in late phase clinical trials are, by definition, suffering from an illness and often a series of illnesses from which they may suffer adverse conditions during the time they are participating in a clinical trial, but which have no relation to the trial itself. There are longstanding international medical standards for assessing drug or trial-related serious adverse events that have been adopted in all countries of the world. There is a concern by patient groups and the industry in India that extending financial compensation to all adverse events, even those unrelated to the drug or clinical trial in question, will have a serious impact on the availability of new medicines to patients in India. What are the differences that exist in India when it comes to domestic vs. multi-national CRO scenario? Rangwala: Indian pharma companies previously conducted the majority of their research within India because local CROs provided a costcompetitive advantage. However, their desire to reach a more global market has led to international CROs becoming more attractive. While global CROs are able to offer services on a larger scale, the pharma industry is constantly seeking new ways to drive down drug development costs, meaning opportunities still exist for local CROs in India to grow. However, they must continue to distinguish themselves as leaders in their areas of specialty through high-quality services. In the past, monitoring was a key focus in India for the CRO industry. Now CROs provide a full spectrum of services at different stages of drug development, including project management, medical affairs, regulatory affairs, quality assurance, data management and statistical analysis. This trend has brought large-scale outsourcing business to the country, particularly in the area of data management and statistical analysis. Which countries have more friendly regulations? Logan: The US, Australia, Canada, Western Europe and other countries in Asia such as Korea and Japan have more evolved regulatory expertise, October 1-15, 2012

and therefore offer more clear-cut pathways in terms of their regulations. Australia, in particular, offers an extremely time-efficient regulatory process. The Australian government also recently introduced R&D tax incentives for its local entities, as does the government in France. Eastern Europe has also evolved more clear guidelines and processes, which has led to an increase in clinical development. Until recently India clinical trial regulations

were considered to be relatively straightforward, marking the country as an equal for running clinical trials with the aforementioned countries. Recent guidelines, however, have caused some consternation and confusion within the industry that has had a negative impact on some companyâ&#x20AC;&#x2122;s decisions to bring new medicines for trial in India. How many sites does INC Research have and how many are in the pipeline?

Rangwala: Currently we have more than 100 active sites in India and we will activate 70 more sites in the next few months. How many trials are currently going on and in which therapeutic areas? Rangwala: INC Research is currently involved in approximately 18 clinical studies in areas such as CNS, infectious diseases, oncology, endocrinology and pain management.

Overall, how many people have been employed in INC Research in India? Do you have plans to increase the number of employees? Logan: INC Research currently employees approximately 140 clinical research professionals in India and we anticipate substantial further growth over the coming three to five years, subject to government support of clinical trial regulations in the country. u.sharma@expressindia.com

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DCGI to make consent forms in regional languages mandatory Rule could be in place by the end of this year Usha Sharma Mumbai ith the objective of making volunteers on clinical trials more aware of the risks involved, the Drugs Controller General of India (DCGI) plans to make it mandatory to have informed consent forms in regional languages. This rule could be in place by the end of this year. Talking exclusively with Express Pharma, GN Singh, DCGI said, “As it is difficult to make rules without understanding the ground realities, I am making surprise visits to different clinical trial sites. On these visits, I have realised that all subjects enrolled in trials were not fully informed of the possible risks and related side effects of participating in clinical trials. I feel that the language barrier is the key reason for this information gap as most of the subjects enrolled in clinical trials tend to belong to the economically deprived sections of society and enrol themselves in trials due to lack of money. As a regulator, our primary concern is the health of the human volunteers enrolled in

clinical trials. I feel it is my responsibility to address this issue and make them aware of the pros and cons of participating in clinical trials by ensuring that the informed consent form is in languages that they can read.” He also highlighted that enforcing this rule will ensure that no sponsor or CRO violates this rule, and if they do, the regulator may need to take strict action against them and maybe even stop the trial. In an effort to ensure that the subject has access to all the information on the trial, the CDCSO has recently defined 14 essential elements that have to be incorporated into informed consent documents. These include: a statement that the study involves research and explanation of the purpose of the research; expected duration of the subject's participation; a description of the procedures to be followed, including all invasive procedures; a description of any reasonably foreseeable risks or discomforts to the subject; a description of any benefits to the subject (if no benefits are expected, the subjected should be made aware of

this); information on appropriate alternative procedures or therapies available to the subject; a statement describing the extent to which confidentiality about the subject's records would be maintained; information on the trial's treatment schedule and the possibility of random assignment of each treatment (in case of randomised trials); information on compensation and/or treatments available to the subject in the event of a trial-related injury; information on whom to contact for trial-related queries and rights of a subject, especially in case of a trial-related injury; information on the payment, if any, to the subject for participating in the trial; and a statement that participation is voluntary and that the subject can withdraw at any time while clarifying that withdrawal from the trial will not involve any penalty or less of benefits to which the subject is otherwise entitled. DCGI has also requested that all subjects participating in clinical trials go through this information in the informed consent form carefully before enrolling themselves in the trial. u.sharma@expressindia.com

MHRA to launch 'Good Clinical Practice Guide' in the UK Will cover the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK he Medicines and Healthcare products Regulatory Agency (MHRA) will launch a brand new publication— the ‘Good Clinical Practice Guide’ which will cover the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK. Written and produced by the MHRA, this is the only guide on GCP produced by a regulatory authority that is available within Europe. The ‘Good Clinical Practice Guide’ will be beneficial for any individual or organisation involved in conducting clinical trials with medicines in the UK. This includes both commercial and non-commercial sponsors and hosts of clinical trials, as well as contract research organisations, clinical research consultants and other niche providers. As the guide references European legislation and guidance as well as international standards, it will also be relevant to organisations conducting clinical trials across Europe and beyond. It is intended that this guide will complement currently available legislation and guidance and provide practical advice about implementing the principles of Good Clinical Practice (GCP) across the wide range of trials conducted in the UK, within the context of the clinical trial regulatory framework in

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the European Union. The guide will cover all the different areas of clinical trials, for example sponsor oversight, applying for authorisation for the trial to the MHRA and obtaining an opinion from an Ethics Committee. It will also cover the conduct and management of clinical trials in chapters covering the investigational medicinal product, documentation, management of data, safety reporting and quality systems. Specialist topics such as advanced therapies and technologies for managing drug supplies are

also included. Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA said, “It was recognised that there was a need to provide additional information to those involved with GCP and therefore this guide has been produced. While this guide does not replace existing documents on the subject, it does offer valuable practical guidance on GCP and how it is possible to comply within the existing legal framework.” EP News Bureau

DRL launches generic amoxicillin tabs, caps The Amoxil brand and generic tablets (875 mg) has US sales of approximately $22.2 million r Reddy’s Laboratories (DRL) recently launched its bioequivalent generic version of Amoxil (Amoxicillin) tablets, capsules, and oral suspension in the US market on September 17. Amoxicillin tablets (500 mg and 875 mg), capsules (250 mg and 500 mg), and oral suspension (125 mg/5 ml, 200 mg/5 ml, 250 mg/5 ml, and 400 mg/5 ml) are approved by the United States Food and Drug Administration (US FDA). The Amoxil brand and generic tablets (875 mg) has US sales of approximately $22.2 million, while capsules had US sales of approximately $67.2 million, and oral suspension clocked US sales of approximately $89.5 million, all for the most recent 12 months ending June 2012 according to IMS Health. EP News Bureau

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October 1-15, 2012

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US FDA approves new multiple sclerosis treatment Aubagio Most common side effects of Aubagio experienced by patients in clinical trials include diarrhoea, abnormal liver tests, nausea and hair loss he US Food and Drug Administration (US FDA) has approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). Russell Katz, Director of the Division of Neurology Products in the FDA’s Centre for Drug Evaluation and Research said, “In a clinical trial, the relapse rate for patients using Aubagio was about 30 per cent lower than the rate for those taking a placebo. Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.” MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline. The most common side effects of Aubagio experienced by patients in clinical trials include diarrhoea, abnormal liver tests, nausea and hair loss. The drug contains a Boxed Warning to

alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treat-

ment. Also included in the Boxed Warning is an alert noting that, based on animal studies, the drug may cause fetal harm. For this reason, Aubagio is labelled as Pregnancy Category X,

which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment. Aubagio will be dispensed with a patient

Medication Guide that provides important instructions on its use and drug safety information. Aubagio is made by Bridgewater, NJ-based Sanofi Aventis. EP News Bureau

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risk of liver problems, including death, and a risk of birth defects

October 1-15, 2012

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India. Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA office : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com

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Glenmark Pharmaceuticals initiates phase II study of GBR 500 for ulcerative colitis The trial is part of a strategic global collaboration between Glenmark and Sanofi lenmark Pharmaceuticals, a wholly owned subsidiary of Glenmark Pharmaceuticals (GPL) announced that GBR 500 has entered phase II clinical development. This phase II clinical trial is part of a strategic global collaboration between Glenmark and Sanofi to investigate GBR 500 for the treatment of chronic inflammatory disorders. The study is a randomised, double-

blind, placebo-controlled, multi-centre study designed to investigate the efficacy and safety of GBR 500 in patients with moderate to severe ulcerative colitis (UC). The trial will be conducted at multiple clinical sites in North America and Europe, and is expected to include approximately 84 patients. Individuals participating in the study will receive multiple doses of either GBR 500 or placebo, administered over a period of

The trial will be conducted at multiple clinical sites in North America and Europe, and is expected to include approximately 84 patients

several weeks. “Despite treatment advances in recent years, UC remains a debilitating condition for many individuals, and represents an area of substantial unmet medical need. We are pleased with the continued progress of our partnership with Sanofi and excited about the commencement of this trial,” said Dr Michael Buschle, Chief Scientific Officer, Glenmark Pharmaceuticals.” GBR 500 is an antagonist of the VLA2 (alpha2-beta1) integrin. It is a first-inclass therapeutic monoclonal antibody for chronic autoimmune disorders. Glenmark has completed phase I of GBR 500 in the US. Sanofi has licensed the rights to all therapeutic indications and is conducting the clinical development program including this trial. EP News Bureau

Evolva reaches first milestone in Roquette collaboration The objective of the collaboration is the development of novel and optimised biosynthetic production routes for an ingredient with important applications in food products volva Holding announced that Roquette Frères (Roquette) has confirmed that Evolva has achieved the first milestone in their collaboration that was announced in January 2012. The ultimate objective of the collaboration is the development of novel and optimised biosynthetic production routes for an ingredient with important applications in food products. Several targets have been defined to measure the progress of the project, including yield and production hosts. As the first major target in this project has been achieved, Roquette will make a mile-

The ultimate objective of the collaboration is the development of novel and optimised biosynthetic production routes for an ingredient with important applications in food products stone payment to Evolva. The milestone payment does not change Evolva’s cash flow guidance for 2012. Thierry Marcel, Corporate Research and Development Director, Roquette. “This is already the second milestone

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we have achieved for a food ingredient project within the last few months. It is clear that Evolva’s technology is delivering on its promise to provide innovative and sustainable production methods for nutritional ingredients. We are looking forward to our next successes in this space." Marcel added, “We have been working with Evolva's team of scientists for nine months now and we are

impressed with their progress to date. It confirms our belief that Evolva’s technology will provide new impulses in our search for innovative products and improved production processes. Ultimately these efforts are aimed at strengthening our leading position in providing high quality ingredients in a sustainable manner from renewable resources.” EP News Bureau

Aurobindo Pharma receives US FDA tentative approval urobindo Pharma has received tentative approval from the US Food and Drug Administration (US FDA) for Pioglitazone Hydrochloride and Metformin hydrochloride tablets, 15mg (base)/500mg and 15mg (base)/850mg (ANDA 200823). The product will be eligible for final approval upon the expiration of 180-day generic drug exclusivity. Pioglitazone hydrochloride and metformin hydrochloride tablets, 15mg (base)/500mg and 15mg (base)/850mg are the generic equivalent of Takeda Global Research Development Center Inc’s actoplus met tablets, 15mg (base)/500mg and 15mg (base)/850mg. Pioglitazone Hydrochloride and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus when treatment with both pioglitazone and metformin is appropriate. The product has a market size of approximately $433 million for the 12 months ending March 2012 according to IMS. The product has been approved out of unit VII (SEZ) formulations facility in Hyderabad. Aurobindo now has a total of 159 ANDA approvals (134 final approvals including 1 from Aurolife Pharma LLC and 25 tentative approvals) from US FDA. EP News Bureau

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October 1-15, 2012

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Pharma Legal & Compliance Summit 2012 Date: October 5, 2012 Venue: Hotel Holiday Inn, Mumbai Summary: India’s first comprehensive discussion will deal with important issues affecting the industry on governance, ethics, compliance, contracts management, licensing agreements and developing a proactive legal strategy for patent litigation. The full-day convention aims to offer an opportunity to all stakeholders in the industry, including law firms, pharma and bio pharma firms, bio tech firms, copyright societies, regulatory and patent filing consultants to share their views on the grave concerns affecting their business. The expert speakers’ panel will feature more than twenty proficient speakers consisting Partner, VPs, functional heads, legal head, general counsel, general manager legal and compliance and company secretary of industry’s few best known companies. some of the key areas of debate will focus on Fraud and corruption management, legal and regulatory compliance of ethics for pharmaceutical and bio-pharma companies in India, legal risk management strategies for new product launches, current regulatory developments and implications of changes to regulatory framework, trends in patent opposition and litigation, recent developments in pre-grant and post-grant opposition, Settlement strategies, key elements of a compliance programme, recent changes in clinical trials documentation requirements in India, current legal issues in domestic and cross border site contracts and contracts, claims and counter claims and licensing agreements. Contact details: Bhupinder Kaur Special Initiatives Team Lex Witness Tel: +91.9654155065 Mobile: +91.11-43440010 B 1/6, Hauz Khas New Delhi – 110016 Email: bhupinder@witnesslive.in Website: www.witnesslive.in

CPhl India 2012, P—MEC India 2012 Date: November 21-23, 2012 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India into its sixth

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year, with its co-located events with more than 800 exhibitors, is the largest and most comprehensive pharma industry event in South Asia. CPhI India is a great gateway to meet with key decision makers in pharma industry from around the world including India, China, Japan, the US, the UK, Germany, France, Italy, etc. P-MEC India is South Asia’s number one pharma machinery and technology exhibition and will give those involved in pharma manufacturing an unprecedented insight into the future of mechanical equipment and machinery. The exhibition will highlight the latest knowledge and the newest trends within the industry. Contact details: Milind Dixit Director - Exhibitions UBM India Tel: + 91 22 66122600, Fax: + 91 22 66122626 Email: milind.dixit@ubm.com

64th Indian Pharmaceutical Congress (IPC) Date: December 7-9, 2012 Venue: SRM Institutions Campus, Chennai. Summary: Association of Pharmaceutical Teachers of India will host the 64th Indian Pharmaceutical Congress. Contact details Prof BG Shivananda Secretary-APTI Association Of Pharmaceutical Teachers of India HQ: Al-Ameen College of Pharmacy Opp Lalbagh Main gate, Hosur Main Road, Bangalore – 560027 Email: aptienquiry@gmail.com

BioAsia 2013 Date: January 28-30, 2013 Venue: Hyderabad Summary: Biotechnology being an emerging industry, game-changing strategies and relevant application of the knowledge-intelligence resource pool, drive the process of growth. BioAsia seeks to enhance, enrich and encourage newer innovations, path-breaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholders - Biotech & Biopharma companies, research

institutions, investors, service providers, policy makers, regulators and analysts. Contact details: BioAsia Secretariat 204, Imperial Apartments Greenlands Circle, Ameerpet Hyderabad 500016 Andhra Pradesh, India Tel: +91 40 6644 6477 +91 40 6644 6577 Web: info@bioasia.in

Bangalore INDIA BIO 2013 Date: February 6-8, 2013 Venue: Bangalore, India Summary: Bangalore INDIA BIO is an annual event organised by Department of Science & Technology Government of Karnataka, under the guidance of Vision Group of Biotechnology. Since 2001, Bangalore INDIA BIO has been promoting the Indian biotech industry to the outside world and is one of the biggest event on life sciences. Bangalore INDIA BIO 2013 will be an opportunity to get insights about the latest trends and biotech business opportunities in India. It will also deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bio-services, bioinformatics and agri-biotechnology in the light of the emerging bio economy. It will also discuss about collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio-economy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia. Event Highlights ● Multi-Track Conference ● International Trade Show ● BioPartnering India TM ● Vision Leadership Series ● CEO Conclave ● Poster Walkway of Discovery ● Bio Excellence Awards ● BioQuiz ● Workshops

Tel: +91 80 4113 1912 / 13 Fax: +91 80 4113 1914 enquiry@bangaloreindiabio.in

PHARMA Pro&Pack 2013 Date: April 24—26, 2013 Venue: Mumbai Exhibition Center, Goregaon (East), Mumbai Summary: Indian Pharma Machinery Manufacturers’ Association (IPMMA), will be organising PHARMA Pro&Pack Expo 2013 (PPPE 2013), an international exhibition to showcase the brand India pharma machineries and allied products/services. The event is an initiative of IPMMA and is being jointly organised by the IPMMA and and GPE Expo. The event will offer a single platform for more than 200 exhibiting companies from India and across the world to showcase their products/ services to entire pharma fraternity of India and neighbouring countries. Exhibitors’ profile includes pharma processing and packaging machinery and materials, API, bulk actives and pharma chemicals, lab instruments and consumables, utilities, biotechnology, research, consultants, trade associations and publications and related services. Top-notch professionals and decision makers, regulatory officials, etc. from across India and SAARC region, as well as Gulf region, African nations are expected to attend the event. Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows Bodakdev, Ahmedabad 380015 Gujarat Tel: +91 792687 1390 / 4000 8253 4000 8233 Email: contact@pharmapropack. com

Contact details: MM Activ #9, UNI Building, 1st Floor, Thimmaiah Road, Millers Tank Bed, Vasanthnagar, Bangalore - 560 052

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October 1-15, 2012

M|A|R|K|E|T PRE EVENTS

Pharmexcil to launch Brand India Pharma Campaign at CPhI Worldwide 2012 India is the focus country this year and Anand Sharma, Ministry of Commerce and Industry, Govt of India will be the Chief Guest at the inaugural Our News Bureau Mumbai harmaceuticals Export Promotion Council of India (Pharmexcil) is organising India Show in CPhI Worldwide 2012 at Madrid, Spain. Ministry of Commerce and Industry, Government of India has initiated a Brand India Pharma Campaign to position India as 'pharmacy of the world'. The campaign is being carried out by Pharmexcil in association with India Brand Equity Foundation (IBEF). As part of Brand India Pharma Campaign, this is the first time that Government of India has approved a pharma sector specific India show. Anand Sharma, Minister of Commerce, Industry and Textile, and top senior government officials are participating in the event. Drugs Controller General of India (DCGI) and other drug regulators from some states are also participating in India Show. Over 250 companies from India are participating in this global event. India

is the focus country during this edition of CPhI World Wide and Sharma will be the Chief Guest during the inaugural ceremony. Over the years, India has emerged as major exporters of generic pharmaceuticals products with a strong manufacturing base. In conjunction with the country's rich vendor base, India is also emerging as hub for contract research, bio-technology, clinical trials and clinical data management. The key objective is to bring global recognition to pharma developed and manufactured from India which are high quality, authentic, and safe, but also affordable. The need for such a strategy is strengthened further in view of reports in various market places about concerns on quality of pharma products sourced from India which affects the brand image of the Indian pharma industry. At the same time it calls for initiating sustained activities to challenge and dispel wrongly propagated ideas about Indian pharma mainly generics.

The key objective is to bring global recognition to pharma developed and manufactured from India which are high quality, authentic, and safe, but also affordable. Over 250 companies from India are participating in this global event

The campaign includes specific objectives such as: to raise the awareness of the Indian pharma success story and improve the credibility of the Indian pharma market; to create awareness that Indian generics are not counterfeits and are, in fact, genuine medicines of exceptional standards and quality; to position India as global pharmacy of world; to respond to dubious allegations about this market by vested interests; to highlight the growth drivers: government support, strong regulatory framework, cost efficiencies, and technical capabilities and to increase business on a sustainable basis and take it to the next orbit. A huge India pavilion and a theme pavilion has been constructed. Pharmexcil will organise the following activities during the event: Press Conference and media interviews highlighting India’s pharma sector and its strength; showcasing of products from India by Council’s members in India Pavilion; global buyer seller meetings in India theme pavilion; business seminar/panel discussions involving prominent Indian and global CEOs; FDA centre representing Indian and global regulators. Minister of Commerce, Industry and Textile will be hosting a dinner reception on October 10, 2012. An Indian cultural programme will also be organised on the same day during the reception. A large number of CEOs, buyers, distributors and other stake holders are expected to participate in the activities being organised by Pharmexcil and IBEF with the support from Ministry of Commerce, Govt of India. EP News Bureau

Lex Witness to organise Pharma Legal & Compliance Summit 2012 Summit to take place at Hotel Holiday Inn in Mumbai on October 5, 2012 ex Witness, India’s first magazine on legal and corporate affairs will be organising a first of its kind Pharma Legal and Compliance Summit (PLCS 2012) on October 5, 2012 at Hotel Holiday Inn in Mumbai. India’s first comprehensive discussion will deal with important issues affecting the industry on governance, ethics, compliance, contracts management, licensing agreements and developing a proactive legal strategy for patent litigations. A full-day convention, PLCS aims to offer an opportunity to all stakeholders in the industry, including law firms, pharma and bio pharma firms, bio tech firms, copyright societies, regulatory and patent filing consultants to share their views. The expert speakers’ panel will feature more than 20 speakers consisting of

October 1-15, 2012

legal practice Partner, VPs, functional heads, legal head, general counsel, general manager legal and compliance and company secretaries of industry’s few best known companies. Pharma giants like Biocon, Wockhardt Group, Cipla, Cadila Healthcare, Abbott India, Novartis India, GlaxoSmithKline Pharmaceuticals are going to take part in the event. Debate will focus on Fraud and Corruption Management, Legal and regulatory compliance of ethics for pharma and bio-pharma companies in India, legal risk management strategies for new product launches, current regulatory developments and implications of changes to regulatory framework, trends in patent opposition and litigation, recent developments in pre-grant and

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post-grant opposition, settlement strategies, key elements of a compliance programme, recent changes in clinical trials documentation requirements in India, current legal issues in domestic and cross border site contracts and contracts, claims and counter claims and licensing agreements. The PLCS 2012 initiative is sponsored by Legasis as Knowledge partner, TMT Law Practices and PSA as Silver partners, Laser GRC Solutions as Technology partner and Society of Indian Law Firms (SILF) as Supporting partner. The media partners to the summit include Express Pharma, India Law Journal, Lawyers Club India, Think Legal and National Bar Association of India. EP News Bureau EXPRESS PHARMA

M|A|R|K|E|T POST EVENT

3rd annual BIO India sees extensive review of policy issues The US and Indian biotech industry found common ground on key issues at the recently held two-day event. An Express Pharma report Our News Bureau Mumbai he 3rd annual BIO India conference, recently organised by Biotechnology Industry Organization (BIO) in partnership with Association of Biotechnology Led Enterprises (ABLE) saw the industry body addressing key issues in tandem with major industry players. At BIO India International Conference 2012, views were expressed on public policies that are intended to bring about innovation, collaboration and investment in the biotech sector, particularly strong intellectual property (IP) protections and regulatory mechanisms. The industry captains led by Kiran Mazumdar—Shaw, Chairman and MD, Biocon, H Thomas Watkins, Former President and CEO, Human Genome Sciences, along with industry organisation heads—Alan Eisenberg, Executive Vice-President, Emerging Companies and Business Development, BIO and PM Murali, President, ABLE laid thread bare issues like strong intellectual property as well as patent enforcement, strong tax and regulatory system, strong support for R&D, streamlined safety and efficacy testing and approval process. The participants agreed that they do not believe that the compulsory licensing of innovative products or technology generally is an effective means of promoting access or affordability of healthcare. Moreover, it undermines incentives for companies and individuals to innovate in India, since it creates uncertainty about receiving economic returns for their innovations, they said. Indiscriminate use of compulsory licenses would thus jeopardise India’s goal of developing a research-oriented biotechnology industry, and is unsound policy, according to participants. All participants agreed that the issuance of India’s Guidelines on Similar Biologics is a step in the right direction. “The guidelines recognise the scientific and regulatory complexities presented by the development and manufacture of biologic medicines. What follows next is industry collaboration in the implementation of these guidelines in a manner that continues to protect patient safety and ensure continued research and development of new cures and treatments,” said Alan Eisenberg. However, he pointed out that India needs to recognise scientific differences between small molecule therapeutics and biologics. The US industry represented by BIO urged the Government of India to include substantial non-patent data exclusivity in its policy and

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H Thomas Watkins, Former President and CEO, Human Genome Sciences

Kiran Mazumdar—Shaw, Chairman and MD, Biocon respect intellectual property and other legal rights. All participants agreed that there is scope for continued discussion and collaboration on these key issues. The two-day conference saw both large and small biotech companies engage in partnering discussions with biotech leaders from around the world. It also featured a fireside chat on the future of development and production of vaccines in India with Dr Cyrus Poonawalla. BIO, in partnership with ABLE and the Confederation of Indian Industries (CII) held a roundtable to discuss ways that US and Indian industry can work together to facilitate the development of new biotechnology products and commercialisation. Participants in the roundtable representing US and Indian industry, academia, and government shared their views on critical issues important to the development of the Indian biotechnology sector, including intellectual property, R&D collaboration, and regulation of biotechnology products. A joint statement encapsulated key findings of the round table, focusing on R&D collaboration, biosimilars regulations and intellectual property.

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On the R&D collaboration, the statement reiterated that success in biotechnology collaboration requires shared risk, shared incentives and shared rewards. Importantly, in collaborations involving US and Indian partners, there should be a balance of risks and rewards by both sides, recognising that each provides key contributions to the partnership, and each wishes to minimise risks while maximising rewards. To enable R&D collaborations, it is necessary to have a legal framework for translating discoveries into products and creating incentives for those who are willing to take on the necessary risks. Commenting on India's recently issued new guidelines for biosimilars regulations, the statement urged that while these guidelines are generally accepted to be well-crafted and sciencebased, they need continued refinement over time. Industry and other stakeholders should provide feedback to the Indian government in its application of these regulations. The statement also recommended that regulations should not be so onerous as to make innovative products or biosimilars unaffordable to Indian October 1-15, 2012

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(L-R) Thomas Watkins, Kiran Mazumdar-Shaw, Alan Eisenberg and PM Murali at BIO India 2012 patients and urged that a first priority is to streamline and rationalise the necessary clearances in order to eliminate unnecessary processing delays. On the Intellectual Property front, the statement commented that recent legal developments in the India have raised key questions that will impact the biotechnology industry, particularly the development of new, innovative products for Indian consumers. It was pointed out that biotech product R&D and commercialisation is a capitalintensive endeavour, which requires both incentives such as intellectual

Pharma Ingredients & Services

property rights to develop these needed products and a system for providing them to those who need them. The second day focused on stem cells, featuring a session ‘Commercialising Stem Cell Therapies and Regenerative Medicine’ with BN Manohar, MD and CEO, Stempeutics Research, Virender Sangwan, Associate Director, LV Prasad Eye Institute (LVPEI) and Chandra Viswanathan, Head of Regenerative Medicines Group, Reliance Life Sciences as panelists. A keynote and plenary luncheon on ‘Strategies for Success: India’s Global

Role in Innovation’ had Achin Gupta, Director, Strategic Planning, Abbott Laboratories, Phil Kearney, Director, External Scientific Affairs, Worldwide Licensing, Merck, Chaitanya Saxena, CEO, Shantani Proteome Analytics, Renu Swarup, Adviser, Department of Biotechnology, Ministry of Science & Technology, Government of India and Holly Vineyard, Deputy Assistant Secretary for Africa, the Middle East, and South Asia, US Department of Commerce, International Trade Administration as panelists. EP News Bureau

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M|A|R|K|E|T POST EVENTS

ISCR, IDMA, ACRO meet to discuss on clinical research in India The discussion focussed on the existing issues related to the clinical research industry, the CROs and the media were urged to work together towards tackling the issues Usha Sharma Mumbai hree leading industry associations Indian Society of Clinical Research (ISCR), Indian Drug Manufacturers Association (IDMA), Association of Contract Research Organisations (India) (ACRO) came on a common platform and discussed issues related to the clinical research industry at a recently held panel discussion in Mumbai. The Medical Subcommittee of IDMA in collaboration with ACRO and ISCR organised a panel discussion on 'Clinical Research in India—Where are we heading? In his opening remarks, Dr Rashmi Barbhaiya, CEO, Advinus Therapeutics explained the hitches during the approval process in India. To make his point clear he highlighted that the overall time consumption in the different stages of the approval process in India is long than in other developed countries. While showing his concern towards the clinical research industry, he highlighted that in 2008-09, 246 clinical trials were conducted in India whereas in Korea 397 were conducted. The size of the Indian population in 2008-09 was estimated at 1.210 million and Korea had a population of just 48 million. He projected that the number of clinical trials in India from the current year will go further down. Investigator—Ethics Committee Members, NGO, Industry and Media were part of the panel discussion. Dr VR Joshi, Director of Research, PD Hinduja Hospital chaired the session and Dr Arun Bhatt, President, ClinInvent moderated it. Panelists who took part in the discussion were Dr Ashok Vaidya, Research Director, Kasturba Health Society Director and Director, Clinical Pharmacology, BSES MG Hospital; Dr Purvish Parikh, VP and MD, AmeriCares India (NGO) and Chairperson Ethics Committee—Wadia Group of Hospitals; Dr Mohandas Mallath, Consultant, Digestive Oncologist and Ex—HOD Digestive Oncology, Tata Memorial Hospital. Industry panelists included Dr Kiran Marthak, Vice Chairman Medical Sub Committee (IDMA) and Head Global Clinical Development – Lambda, Apurva Shah-Chairman, ACRO (India) and Dr Kratish Bopanna, President, ISCR. The panel discussion started with the existing issues related to the clinical research industry in India and lack of attention from the regulatory body. Heated discussions followed where the role of media was raised and it was accused of showcasing half-baked stories rather than figuring out the root cause. On the other hand, the media personnel argued that the news provided by them are sourced from authorised persons. Shah spoke about compensation guidelines like strengthening the link between industry, associations and regulatory bodies, grading the CROs capabili-

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ties and judging them on that ground before making an act on it. Panelists also highlighted that it is wrongly believed that only those clinical trials are being conducted in India, which could not have been conducted in developed countries. They also informed that trials in India have sufficient insur-

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ance coverage for negligence and deaths which occur due to the clinical trials and today even the regulation is being put in place with respect to proportion in which compensation is to be paid for any drug-related adverse event/death. The panelists urged that these points needs to be highlighted by the media in October 1-15, 2012

M|A|R|K|E|T

a positive way so that the general public, NGOs and the concerned government officials can be updated of these facts. Another point that was emphasised is that no research is initiated unless the patient included is explained the nature of the study and now even the recording of this event is being agreed upon which itself speaks volumes of the earnestness of the research industry. “If clinical research is not encouraged then even the wonder drug aspirin would not have taken birth.” Bhatt said. Parikh mentioned that at times we do not follow the given guidelines not because we don't know it but we believe that if we follow the given or existing guidelines, we might end up losing the person who is part of the trial. The discussion was well hooked by both audience as well as panelists. It was a high energy debate between media experts and the industry. Dr Sanjay Agarwal, Head, Medical Department, Corona Remedies said, “It will be good for the industry if they and media work together. As such CRO conditions are very critical in India due to media exposure. We are not able to get subjects (patients) on whom we can conduct the trials. On the other hand, DCGI is not giving requisite permissions for conducting trials, even for the bioequivalance, and not only due to poor infrastructure of DCGI. I personally feel, they are taking more precautions in new drug approval committee (NDAC) as

October 1-15, 2012

more clinical doctors are involved in the process as compared to the past. While sharing his view, Shah said, “The challenges faced by the Indian clinical research industry in the form of regulatory stagnation since last year have brought various stakeholders together to collaborate and eliminate all negative perceptions regarding clinical research. I am pleased with the open and candid discussions we had today between the industry, NGOs, academia and the media on the challenges and the possible ways to overcome those challenges. ACRO has already drafted the Code of Conduct for our members as a proactive measure to ensure compliance of the Indian and global ethical and quality standards among its members. Besides this we are working on other measures to ensure safety of the volunteers on a national level. We welcome the government’s initiative to come out with the draft guidelines on compensation and registration of Independent Ethics Committees (IEC). This, along with, better enforcement of the laws by our regulators will help in eliminating a lot of issues and therefore lead to a more positive environment for clinical research in India.” Marthak suggested, “The prospering clinical research industry has suddenly taken a down turn due to various reasons including adverse publicity in media, irrational thinking by regulatory bodies, ad hoc changes in

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rules and regulations related to clinical research, tremendous delays in getting NOC for the clinical trials has dissuaded the companies to conduct clinical trials in India. There is a disconnect between what the health ministry thinks and the mode of implementation of the rules. If this continues for a long time, clinical research as a science will have a natural death in the country.” Mallath said, “India has joined the trials much later and hence there is acute shortage of trained investigators, Accredited Ethics Committees, experienced DCGI inspectors, as well as experienced CROs. If we work together and strengthen all the links, India could regain the lost glory. I do not think that the media alone will be able to save the situation.” While summing up the session, Bopanna said, “Clinical researchers do not want any shortcuts or concessions with respect to ethical or quality standard and are willing to match the best benchmarks that are suitable to the country. The clinical research industry would like to have a clean and transparent regulatory process and balanced reporting that makes scientific sense keeping in mind our social-economic environment. The clinical research industry has always been ready to work with the regulators to strengthen the process and plug the loopholes where applicable.” u.sharma@expressindia.com

EXPRESS PHARMA

M|A|R|K|E|T POST EVENT

OPPI’s 46th AGM focuses on ‘Improving Access to Health’ Excellence Awards presented to top scientists, study on 'Unlocking the potential of the pharmaceutical distribution channel' released he 46th Annual General Meeting (AGM) of the Organisation of Pharmaceutical Producers of India (OPPI) was recently held at The Taj Mahal Palace, Mumbai. The AGM saw stalwarts

(L to R) Tapan Ray, Sam Pitroda, Dilsher Singh Kalha, Ranjit Sahani, Chandra Prakash Singh

EXPRESS PHARMA

from the Government, regulatory authorities, overseas/local opinion leaders, heads of companies, senior managers of the pharma industry and other dignitaries come together and discuss key issues. More than 200 delegates participated in the AGM. The meeting was presided over by Ranjit Shahani, President, OPPI and Vice-Chairman and MD, Novartis India. Sam Pitroda, Advisor to the Prime Minister of India on Public Information Infrastructure and Innovations, released the OPPI and Ernst & Young study ‘Unlocking the potential of the pharma distribution channel.’ The study identified

the key concern areas such as loss of sales due to non-availability of products at the retailers end in the pharma distribution setup and lack of visibility of pharma companies into stock holding and stock movement in the post CFA (Carrying and Forwarding Agent) supply chain. Among the key dignitaries present on the occasion were Chandra Prakash Singh, Chairman, National Pharmaceutical Pricing Authority, Government of India; Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India and Sam Pitroda, Advisor to the Prime Minister of India, Public Information, Infrastructure and Innovations as the Guest of Honour. On the occasion, the 46th Annual Report was released, outlining the various initiatives undertaken by OPPI and highlights of the major events in 2011-2012. The report elucidates the pharmaceutical industry’s concerns and challenges in general as well as those of member companies by analysing implications of various issues related to the pharma industry. Placing Universal Healthcare (UHC) at the top of the agenda, OPPI's focus this year will be on ‘Improving Access to Health’ and enabling an environment that

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fosters research and innovation in the country. Expressing concern over the recent policy decision on FDI and pricing, Tapan Ray, Director General, OPPI said, “OPPI will continue to work in tandem with the government and other stakeholders to uphold high standards of governance in all areas that impact health and patients’ interest, including issues related to access to medicines, investments in the pharma sector, clinical trials, regulatory compliances and ethical promotion of medicines, just to name a few. OPPI member companies will continue to act responsibly and in close collaboration with all stakeholders towards achieving the common goal of ‘health for all’ as envisioned in Vision 2020.” OPPI also presented Excellence Awards to top scientists working in drug discovery and pharmacology, apart from releasing their various publications. Speaking on the prospects of the pharma industry, Shahani said, “Sustaining the growth of the pharma industry in the long term is a challenge due to various uncertainties prevailing in the country. Further, the absence of an ecosystem that fosters innovation will be to the long-term detriment of the patient if not addressed speedily.” EP News Bureau

October 1-15, 2012

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M|A|R|K|E|T POST EVENT

Good days ahead for India’s cosmetic industry Vibrant economy, growing middle class and young people will drive cosmetic industry in India he Indian Pharmaceutical Association (IPA)—Maharashtra State Branch and the Indian Society of Cosmetic Chemists, recently conducted a symposium on the topic,

Advanced instrumental techniques to measure various parameters, along with clinical assessment, can now be used to meet this requirement. Moreover, as India desires to export these products,

emphasised that product safety is the responsibility of the company making it. Shweta Purandare, a consultant, said, “In India, in the last two decades, there has been a steady shift to more

international regulations demand supporting data too. Dr Alain Khaiat, President, Seers Consulting, the first and only ‘Life-time achievement award’ recipient from the International Federation of Societies of Cosmetic Chemists (IFSCC), gave an account of the differences in regulations between cosmetics, drugs and OTC products. He talked about the roadmap for cosmetic safety assessment, as well as the responsibilities of raw material suppliers in ensuring the safety of the ingredients supplied. He explained about the ASEAN and EU safety guidelines. For cosmetic manufacturers, he

diverse, sophisticated and specialised products. Nowadays, international products are giving stiff competition to local products. There still remains ambiguity in terms of regulatory controls for products. Registration of imported cosmetics is yet to be implemented. Reform in cosmetic regulations is the need of the hour to embrace these changes and match the pace with which the Indian cosmetic market is evolving. The consumer has a right to safe, high quality and efficacious products, so companies need to market responsibly and the regulators need to monitor with efficient systems.” EP News Bureau

Dr Alain Khaiat, President, Seers Consulting 'To and Thru the skin' in Mumbai. The symposium was attended by both the pharmaceutical and the cosmetic industry and had eminent speakers from India, as well as from the overseas. Skin, being the largest organ of the body is attracting immense attention from both the pharma and the FMCG industry. A vibrant economy, over 50 per cent people under the age of 30, the growing middle class with increasing expending power, the influence of the glamour industry that makes each one wanting to ‘look good’, are just few of the factors that attract this industry. Priti Mohile, Managing Director, MediaMedic Communications, gave a perspective of how product developers could get consumer insights through digital and social media. She elucidated a case study on acne which evoked tremendous interest from the industry participants. Various regulatory challenges in the cosmetic industry were also discussed during the event. As marketers strive to present differentiated offerings for every customers need, the regulator is not far behind to demand proof for every claim.

EXPRESS PHARMA

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October 1-15, 2012

M|A|R|K|E|T

Goa Medical Council releases guidelines for prescription writing and handling of prescription medicines Stakeholders have drawn out guidelines based on legal implications, social and moral principals Sachin Jagdale Mumbai oa Medical Council recently published guidelines for prescription writing and handling of prescriptions and prescription medicines. The guidelines for prescription writing and

handling have been drafted based on existing laws. However, as the regulatory documents do not cover all the aspects, the stakeholders have drawn out guidelines based on legal implications, social and moral principals, and responsibilities of all those involved in prescription writ-

ing as well as prescription dispensing. Laxmikant Parsekar, Health Minister, Goa, was present to release the guidelines, besides a large number of medical fraternities and pharmacists. All the stake holders in Goa namely, Food and Drug Administration (FDA), Indian Pharmaceutical Association (IPA) Goa branch, The Chemist and Druggist Association, Goa, Voluntary Health Association, Goa Medical Council, Indian Medical A s s o c i a t i o n — M a rg a o branch, as well as the Private Medical Practitioner Association in Goa for the last two years had been involved in a series of deliberation to put in place a guideline document for all in respect of writing proper prescription. It will also ensure that the medical fraternity does not encourage patient in to purchase of drugs without prescription and also creating an awareness in the rationale use of drugs. Avoiding in-discriminate use of drugs is also one of the purposes to

set up these guidelines. Indiscrimate use of drugs lead to drug resistance and forcing doctors to prescribe the second and the third generation of drugs. Safety of these drugs can be real issues from the patient's safety point of view. Patient's safety is a widely discussed topic in the global arena. The General Medical Council, UK, changed its stated role from 'Registration of Doctors and Regulating Medical Education', to 'Protecting Patients and Guiding Doctors'. The UK now has National Safety Agency (NPSA). Australia has its Australian Patients Safety Foundation and India has established the National Institute for Patients Safety (NIPS). Salim Veljee, Director, FDA, Goa said, “This is the first of its kind initiative in the country, which documents a lot of guidelines of prescription writing.” “These guidelines will benefit the doctors in ensuring proper discipline, pharmacist in compliance to the Drugs & Cosmetics Rules 1945 and overall the patient in safe use of drugs,” asserts, Dr Shekhar Salkar, President, Goa Medical Council. sachin.jagdale@expressindia.com

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Quality in your hands

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Management

INSIGHT FOR MANAGING PHARMA

Page 36

oday, Ayurveda, Yoga, Unani, Siddha and Homoeopathy (AYUSH) are rationally recognised systems of medicine and have been integrated into the national health delivery system. India enjoys the distinction of having the largest network of traditional healthcare in the world. AYUSH is generating new interest among the people in the West as well. The major reason for the surge in demand for herbal drugs is that they have no adverse effects and are safe to use, in contrast to synthetic medicines which have long-term and short-term side effects.

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Additionally, herbal extracts and powders are comparatively cheaper than synthetic drugs and formulations and act as an alternative for the lower-income segments of the society who cannot afford allopathic drugs. India stands tall in this field due to a rich history and expertise of traditional medicine. Significant markets for AYUSH are Western Europe, the US, Japan and Southeast Asia with a sizeable potential for increase. Among the top 10 destinations of India’s herbal products, the US leads the list. US has imported herbal products worth ` 202 crore

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every year since 2007-08. In the US, as many as 42 per cent of people are adopting ‘complementary or alternative medicine’ (CAM) approaches to help meet their personal health problems. New surveys show that four in every 10 people in the US have used CAM in the last year. Organisations like the Food and Drug Administration (FDA) and American Medical Association and American Association of Medical Colleges are taking note of evidencebased CAM to curtail healthcare costs. In 2009, the market for AYUSH was estimated at ` 8,000 crore including drugs,

October 1-15, 2012

M|A|N|A|G|E|M|E|N|T

over-the-counter and wellness products, treatment and herbal extracts and it has been growing at 20 per cent yearon-year. The export of these products took a jump from ` 617.87 crore in 2005-06 to ` 1335.01 crore in the year 200910 and are expected to reach ` 16,250 crore in 2014. Total exports share is mostly in around 26 clusters pan India with over 20,000 ayurvedic proprietary formulations and 1,000 classical formulations. With 9,493 licensed manufacturing units (mostly micro and small), the significant herbal and AYUSH products according to 2009-10 list of India’s 30 top exports include medicaments of ayurvedic systems, Psyllium husk (isobgul husk), saps and extracts, senna leaves and pods, other plants and parts of plants used in pharmacy, insecticidal/fungicidal purpose, medicants of homoeopathic systems, Lactus and Lactus syrup containing 99 per cent or more Lactus , Vinca rosea (herbs), Zedovary roots, Cascara sagrada bark, kuth root, sarsaparilla, Tukmaria and medicants of bio-chemic systems. Recently, Union Minister for Health and Family Welfare, Ghulam Nabi Azad, mentioned in the Lok Sabha that Expenditure Finance Committee (EFC) chaired by Secretary (Expenditure) has approved a proposal on October 4, 2010 to create 40 posts in the proposed Central Drug Controller’s Office for (AYUSH), including 25 regular and 15 contractual/outsourced posts and to support engagement of 330 scientific manpower in the state drug testing laboratories. The Department of Expenditure has allocated ` 80 lakh in the annual plan 2012-13 for creating 40 posts in the proposed Central Drug Controller’s Office (AYUSH). Giving the background to this decision Dr Namyata Pathak, Integrative Ayurveda Physician and Research Associate, Kasturba Health Society - Medical Research Centre, ICMR Advanced Centre for Reverse Pharmacology in Traditional Medicine says, “AYUSH industry has a turnover of ` 10,000 crore of which ` 9,500 crore is patent and proprietary (P&P) products. The rest are all classical products which were not allowed to be branded until now. They have set up pharmacopeial standards, but have issues in implementing these due to many small to medium scale manufacturing houses. They were going to assist the process by setting up AYUSH October 1-15, 2012

clusters, where the smaller industries could get certificates of analysis from common testing labs.” She continues that I do not know how far that has been successful and whether this new proposal is an extension of that. Setting up regulatory posts is welcome, but the requisite process and minimal, optimal requirements need to be transparent. It literally is a 'jungle out there'. I only hope it does not provide more opportunity

for corruption by poorly paid, poorly informed 'drug controllers.'” Ranjit Anand Puranik, Executive Director, Shree Dhootapapeshwar and ExGeneral Secretary, Ayurvedic Drug Manufactures Association (ADMA) comments, “Currently, there are around 10,000 drug manufacturing units in India and nearly 9,000 AYUSH manufacturing units. I feel the budget allocated is very less in com-

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parison to the pharma sector. It is going to be a tough war between the AYUSH regulatory authority and Drugs Controller General of India (DCGI) because traditional medicines are extremely expensive and the cost involved in monitoring these are much higher.” As a science and as an alternative treatment option, ayurveda is gaining momentum. Herbal medicine is being researched and recommended

by doctors around the world. In India, the ayurvedic market size is touted to be at around ` 5,000 crore in India, as per recent reports. The Department of AYUSH has been promoting Ayurveda through various initiatives. A good example is the AROGYA expo, which is in its sixth year. Dr Vijendra Prakash, Senior Manager—Regulatory Affairs, The Himalaya Drug Company supports the move.

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M|A|N|A|G|E|M|E|N|T DR NAMYATA PATHAK

RANJIT ANAND PURANIK

DR VIJENDRA PRAKASH,

Research Associate, Kasturba Health Society and Vaidya Scientist Fellow

Executive Director, Shree Dhootapapeshwar

Senior Manager—Regulatory Affairs, The Himalaya Drug Company

Setting up regulatory posts is welcome, but in the requisite process and minimal, optimal requirements need to be transparent

It is going to be a tough war between AYUSH regulatory authority and Drugs Controller General of India (DCGI) because traditional medicines are extremely expensive and cost involved in monitoring these are much higher.

He says, “The setting up of Drug Control cell at the Centre will strengthen the executive structure for the department of AYUSH. The Drug Control cell would be responsible for framing regulations and policies for the entire industry. The State Drug Licensing Authorities will oversee the implementation of these policies and regulations at the state-level. This structure will benefit the companies applying for product license and the licensing authorities.” He further stresses the point that the government needs to build awareness for ayurveda and promote its benefits, globally. Like the IT industry in India, the ayurvedic industry should also be promoted. The government should extend its support by giving subsidies and tax rebates to ayurvedic manufacturing companies in India. Prakash further says that stringent quality and product regulations need to be put in place within the framework of traditional medicine to ensure that wellresearched and scientifically validated drugs are reaching the market. The government should provide generous subsidies to small and medium enterprises (SMEs) in the ayurvedic sector. This will help SMEs to develop quality products that are both safe and efficacious, which can compete with drugs in the organised market.

on safety-efficacy of AYUSH are a matter of concern, which need to be addressed by elucidating authentic manufacturing procedures as described in the classical texts. Quality control and standardisation have been the thrust area in the manufacturing process. Good Manufacturing Practice (GMP) is a system to ensure that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in any pharma production that cannot be eliminated through testing the final product. There is a need to develop specific GMP guidelines for AYUSH products. GMP will cover all the steps of the manufacturing process starting form evaluation of raw materials, processing, validation of manufacturing process, standard operating procedures, evaluation of storage area, personnel, quality control, documentation etc. In an effort to make the complementary medicine manufacturing units to become GMP compliant, Department of AYUSH will be spending ` 26 crore towards quality control. The Health and Family Welfare ministry has made mandatory GMP compliance for licensing of AYUSH drugs. Many countries including the EU, US, Canada, Japan, etc. work on mutual recognition agreements with countries with equivalent levels of GMP and registration standards. India is not a signatory to many of these mutual recognition agreements hindering the exports of the country’s exports. Quality assurance is a significant demand of AYUSH importers and therefore, a GMP certification for AYUSH products exported from India would establish quality credentials of these products, and is strongly recommended. Apart from GMP compliance from industry, setting up of in-house quality control laboratories, development of common drug testing facilities for industry clusters of small and medium scale units etc will be instrumental in enhancing exports.

control procedures are completed for a formulation, it can be patented and the intellectual property rights of the product will be preserved so as to benefit the system to which it belongs. This will help protect the country from and give an edge over the other products which have not gone through such standardisation procedures. Such patented quality products will have national as well as international market.

Challenges to meet the global standards Arun Kedia, Managing Director, VAV Life Sciences emphasises, “In spite of India being recognised world over as source of alternate medicine source with a strong manufacturing base, the lack of globally accepted standards for AYUSH products and non-documentation of our traditional skills are the basic issues that need to be solved for India to be a world leader in AYUSH products.” He revealed that a recent study covering 90 traditional medicine manufacturers found that 62 per cent of them did not conduct any safety tests on their drugs while another eight per cent performed the tests on some products. Questions encountered

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IPR issues After standardisation and quality

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Clinical trials Clinical evaluation to assess the efficacy of a formulation will also help ensure global acceptance of AYUSH products. The efficacy of the said product can be tested jointly by traditional practitioners and modern physicians. Such clinical trials will increase the confidence of consumers in traditional medicines. The choice of investigating centres is also very important for carrying out such trials. Approval from institutional ethics committees is an important part of clinical trials. These trials can be merged with the safety and toxicological tests to ensure safety of the users in the long run. Equally important is evaluation of data generated by the clinical trials to validate the safety and efficacy. From a regulatory point of view, recommendation of the expert group to take the product forward to attract pharma companies is essential. Safe and effective products can be documented in suitable drug dossiers mentioning all method of preparation, good agricultural and collection practices, full description of the plant material as per modern scientific parameters preferably by a taxonomist, pharmacognosy, chemical finger printing, standardisation and quality control of the raw material, determination of microbial pesticides, heavy metals, production source of the finished product, batch to batch variation, stability study and shelf life. Thus, while the segment AYUSH is definitely growing there are lot of challenges that need to be tackled before it achieves its optimum potential and propels India into the big league. u.sharma@expressindia.com October 1-15, 2012

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M|A|N|A|G|E|M|E|N|T DOCTOR FACTOR

Pernicious osteoporosis Osteoporosis is a condition that results in loss of bone strength and density, causing bones to become more fragile and easily susceptible to fractures. In India, many people suffer from this disease, specially women, without any overt symptoms. Express Pharma, in association with Majestic MRSS, gives an idea about the awareness level about the deadly disease among the medical fraternity and patients and the myths related to it erived from a Greek word meaning porous bones, osteoporosis is known as the 'silent killer', that leads to disease of bones and to an increased risk of fracture. This silent progressive metabolic bone disease is widely prevalent among Indian women, where the patient suffers from a broken bone. According to Association of Spine Surgeons of India, currently there are about 28 million osteoporosis patients in India out of which 80 per cent are females. This number is expected to increase by five million in the next one year. According to World Health Organization (WHO), osteoporosis is second only to cardiovascular disease as a global healthcare problem and it is projected that one out of every three women will suffer from osteoporosis. A survey of 100 doctors was conducted across metros in India in order to gauge awareness levels among the medical fraternity about the condition.

porosis. Apart from fractures, other common symptoms are stoop posture

Causes According to the doctors surveyed, the main reason for a surge in osteoporosis in the country is due to dietary deficiency of calcium, which if prevalent from an young age, leads to a lower peak bone mass. Mal-absorption of calcium due to a subclinical deficiency of Vitamin D may also lead to osteoporosis. A gynaecologist in Delhi said, “Most women in their post menopause stage approach us with joint and back pain. They think that it is due to old age and they fail to understand that it may be due to osteopenia. Ostopenia is a condition where bone mineral density is lower than normal. It is considered by many doctors to be a precursor to osteo-

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and fatigue while undertaking day-today activities.”

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An orthopaedic surgeon in Mumbai said, “Osteoporosis is very common in females. People suffering from osteoporosis usually approach us when things become too late because they ignore the early symptoms.” According to the doctors surveyed, as one gets older, the body’s ability to restore bones and absorb calcium decreases, which causes the bones to take the structure of a honey comb. This results in weak bones specially in the hip areas. An orthopaedic surgeon in Kolkata said, “The fact is, we build bone density only till the age of 30, after which the calcium level depletes, which is precisely why a healthy diet and exercise is so important early in life.” According to an orthopaedic surgeon in Chennai, “In India both male and female within the age group of 50 to 60 suffer from osteoporosis whereas in the western countries this disease is found in people above the age of 70. Everything depends on the diet and lifestyle.” A gynaecologist in Delhi said, “It is quite disturbing to see that more young females are approaching us with the symptoms of osteoporosis. We need to teach school students about the importance of a healthy diet and life style, otherwise the number of patients suffering from osteoporosis would continue to increase.” According to all doctors who took part in the survey, unless the the population understands the importance of both calcium and vitamin D intake, it would be difficult to curb this problem. One of the most common factors which puts an individual at a higher risk of osteoporosis is menopause as the hormonal changes aggravate the problem. An orthopaedic surgeon in Delhi says October 1-15, 2012

M|A|N|A|G|E|M|E|N|T

that consumption of alcohol, smoking and leading a more sedentary lifestyle may lead to osteoporosis. This is the reason why doctors are seeing a larger number of young patients, analyses this doctor. Although certain medications can speed up the process their volume of contribution is not so much, as mentioned by a gyneacologist in Mumbai. In certain cases, religious beliefs could also play a role in the progress of osteoporosis, according to a GP from Delhi. He points out that women who need to always be veiled when they step out of their house could have vitamin D deficiency due to lack of exposure to sunlight. Most patients feel that intake of calcium and Vitamin D supplements would solve the problem this is not the case. Many doctors suggest hormonal treatment, but the cost and apprehension of side effects deter most patients. Physical exercise is also important to help strengthen the bones. Most commonly, doctors prescribe bisphosphonates and other steroid- based medications, but once again compliance plays a huge role in its success. A gynaecologist in Chennai mentioned, “Women have the worst compliance, they either forget or not willing to spend money on medication.” A Delhi-based gynaecologist pointed out that it is very important to educate

October 1-15, 2012

One of the most common factors which puts an individual at a higher risk of osteoporosis is menopause as the hormonal changes aggravate the problem. Consumption of alcohol, smoking and leading a more sedentary lifestyle may lead to osteoporosis school children about having proper diet and importance of treatment. The order of the day is to increase knowledge levels, by holding camps in schools and neighbourhoods for free testing and providing information about osteoporosis. Education should include early warning signs of osteopenia, and importance of regular resting for women. In most cases doctors have seen that although patients are aware about osteoporosis they do not understand the seriousness of the disease. As per a gynecologist in Mumbai,“In countries like the US, many companies have started support groups and forums on which people can come together and discuss their apprehensions questions etc. Something like this is needed in India.” The government needs to play a more active role before osteoporosis

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turns into an epidemic. It should be given an equal importance as diabetes and hypertension. The medical fraternity looks forward for better medication with lesser side effects. In the end, according to the doctors surveyed, prevention is better than treatment in order to make the future of women in India healthier and brighter. Disclaimer: Statements and opinions expressed in this article are those of 100 doctors (diabetologists, nutritionists) across urban cities (Delhi, Mumbai, Hyderabad, Chennai, Kolkata, and Bangalore). While every care has been taken in the compilation of this information, the authors will not be responsible for any claim, loss, damage or inconvenience caused as a result of any information within these pages.

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Research

EXPERTISE FOR DRUG DEVELOPMENT

2012 guidelines for stem cell research Dr BM Gandhi, Chief Executive Officer, Neo BioMed Services, and Former Advisor, Department of Biotechnology, Government of India, gives an insight about the draft guidelines for stem cell research released this March

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‘A multidisciplinary approach to Alzheimer’s’ This September marked the first global World Alzheimer’s Month. With treatments to prevent progression of Alzheimer’s disease (AD) still proving to be elusive, Prof Philippe Amouyel, Director, DISTALZ (DISruptive Thinking for ALZheimer’s disease), talks with Shalini Gupta about how research offers a new ray of hope What does DISTALZ aim to do? DISTALZ aims to explore new pathways involved in Alzheimer's pathophysiological processes, some being suggested by agnostic genomic approaches. New biological clues identified would then be developed as potential biomarkers and drug targets. Using a multidisciplinary approach, we will set up the clinical, social and ethical bases of new clinical trials to test promising new components in high-risk patients or individuals, identified thanks to a sophisticated battery of biomarkers, years before any conversion to AD. We will offer a common identity with a competitive critical mass in terms of researchers and research capacities, potentiating the existing international visibility of each individual team, significantly increasing their attractiveness, offering a unique setting for higher-education programmes, favouring translational medicine, technological transfers and public information, able to compete and collaborate with other centres of excellence in neurodegenerative disease around the world. What is the plan of action at DISTALZ? Its plan of action will be developed along four research axes: From gene to pathophysiological hypotheses: We will pursue the characterisation of the genetic component of Alzheimer's, decoding the missing heritability, performing a fine mapping of Alzheimer's genes to identify functional variants and fuelling the following axes with putative new pathophysiological hypotheses. From pathophysiological hypotheses to biological pathways: The impact of these genes and pathways would then be studied on amyloid and tau metabolisms in experimental models and in particular the mechanisms controlling the enzyme activities that modulate production/clearance of Abeta, the implication of recently described APP fragments, the roles of Tau and finally the protein aggregation and propagation. This will lead to the development of more comprehensive experimental models for biological drug screening tests.

From biological pathways to effective targets: Genetic and biological tests stemming from the results of axes 1 and 2 would then be studied. The necessary validation of the new biomarkers will be carried out in the framework of the epidemiological and clinical activities of our partners, taking into account the complex interactions with other neurodegenerative and cerebrovascular diseases and aiming ultimately at a personalised medicine approach. From effective targets to clinical trials: The new findings would then be translated to clinical activity by allowing access to precisely characterised patients at an early stage of the disease and by anticipating the psychological and social consequences of an early diagnosis, taking into account all ethical dimensions. What past approaches to develop an effective cure for Alzheimer’s have failed and why? Our understanding of Alzheimer's pathophysiological pathways has considerably evolved over the last 15 years, unmasking new tracks and offering opportunities for the development of new pharmacological targets and cellular/animal models. However, to date, most treatments directed towards these pathways have failed in slowing down the degenerative processes. One possible explanation might be related to the long standing process of brain damage and the delayed initiation of treatment at a stage where dementia is irremediably present, with no hope of resilience of the brain functions. Identifying the optimal time windows for intervention remains a major challenge for treatment here. In parallel, other solutions aiming at preventing or slowing-down neurodegeneration through risk factor modifications such as physical exercise and vascular risk treatment have been also proposed but not yet clinically validated. Is Alzheimer’s genetic or hereditary? What have been the findings of researchers at DISTALZ? As any complex chronic disease, Alzheimer's Disease results from interactions between environmental risk factors and a genetic susceptibili-

DISTALZ (DISruptive Thinking for ALZheimer’s disease) has been identified as one of six projects in Northern France Lille Region to be certified as “Laboratories of Excellence” by the French Government. It is part of the Alzheimer’s Plan of the European research strategy on neurodegenerative diseases, which is structured as a joint programming initiative involving 23 countries and intends to improve efficiency and effectiveness of funding in this area.

ty background. Some rare cases are hereditary characterised with the presence of a specific mutation in a specific gene, very often associated with an early age at onset, lower than 65 years (and sometimes less than 45). However, for the vast majority, we estimate that around 60 per cent is associated with a genetic susceptibility explained by multiple genes with minor effects. The characterisation of these genetic risk factors is essential for the identification of new causative pathways. Thanks to whole genome highthroughput techniques and the largest high quality collections of AD patients and controls from various countries which they have access to, DISTALZ partners systematically characterise the molecular bases of the genetic components. In the last three years, we have made progres in characterising AD genetic susceptibility using Genome Wide Association Studies (GWAS) to locate genes harbouring single nucleotide polymorphisms (SNP) associated with AD risk. The EADI consortium (European Alzheimer's Disease Initiative), gathering five countries, 6,322 cases and 10,373 controls, has made it possible to identify 10 new genes, alone or in collaboration with other consortia including the EADI, the Alzheimer’s Disease Genetics Consortium (ADGC), the Genetic and Environmental Risk in Alzheimer’s Disease (GERAD), the Cohorts for Heart and Aging in Genomic Epidemiology (CHARGE) and the International Genomics Alzheimer's Project (IGAP). shalini.g@expressindia.com

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R|E|S|E|A|R|C|H AWARD

On the cutting edge Nanotechnology might still be at its infant stage, but research in the field looks promising. Two scientists recently conferred with the Thomson Reuters India Citation Awards tell us how. A report by Shalini Gupta Area of research: Nanofluids, nanobiotechnology, heat and mass transfer, two phase flow, heat exchangers, fuel cells. Motivation: My general expertise is in heat and mass transfer and hence my preliminary choice was in the application areas like power and nuclear industries. However, I was amazed by the introduction of nanotechnology and biology and their integration into main stream engineering research. The pleasure of finding new things and revealing the secrets of nature, and utilising this towards serving mankind is what drives a researcher. Even today I work tirelessly and sleep for five hours a day.

Nano enabled tumour ablation It was during my sabbatical at MIT, Cambridge USA as a visiting professor during 2007-08 when a paper on tumour ablation from Prof Sangeeta Bhatia of MIT â&#x20AC;&#x201C; Harvard combined institute (HST) came to my notice.

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Prof Sarit Kumar Das Department of Mechanical Engineering, IIT Madras

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Working with Geoffrey von Maltzahn, a student of hers, I started working towards an efficient way to ablate tumours. Infrared laser when used, results in cancerous tissues scattering the laser radiation more than they absorb thus damaging neighbouring tissues. In our experiments, we injected gold nanorods that accumulated in the tumour thus increasing the absorption of laser radiation significantly and ablating small tumours succesfully. A computer model to predict the parameters required for this therapy, like time and power of the laser for a given size of tumour and required amount of nano particles etc was also developed. This was a pathbreaking work which was published in Journal of Cancer Research and happens to be a very well referred article worldwide.

Targeted drug delivery Quite often in cancer patients undergoing chemotherapy, the drug

needs to be injected in higher dosage(hundreds of milligrams instead of couple of micrograms). After few such sessions, patients end up at a high risk of death due to destruction of the immune system. Our research is looking at delivering a drug in the right dosage at the right place. Gold particles are tagged with the drug alongwith a small stretch of DNA which is then inserted into the body. Cancer cells detect a protein that the gold particles are coated with and attach themselves. Once this happens, the temperature of the gold particle is raised externeally to 42 degrees, at which, the DNA melts and the drug is released. We have completed computational work and preliminary invitro experiments and now need to shift to in vivo experiments. Work on such nanoenabled drug delivery is still in nascent stage internationally and offers hope to those suffering from cancer in terms of better treatment options.

Commercialisation is not the only aim of research A researcher in technology aims to innovate his work so that it can be commercialised. However, commercialisation is not the only aim of research. There are many areas in which developing the knowledge is more important. For example, fuel cell has been known for more than half a century. Research in 70s and 80s did not produce a product in the market but paved the way for understanding and development. A multi-disciplinary approach along with sustained research will help create technological products of the future. It goes without saying that the infrastructure of research in this country, although improved in the last decade, is far below that of not only the advanced countries but also the countries like Korea, Taiwan and China. India needs to spend at least five times more in research to compete internationally.

Areas of work: Studying the the interface between inorganic nano materials and biological molecules (such as amino acids, proteins and DNA) and systems (microbes). Driven by curiosity: While I was at the National Chemical Laboratory(NCL) Pune, the field of nanotechnology was in its infancy. There were many gaps in understanding nano processes at a fundamental level that I wanted to address and contribute to and then use this knowledge to develop processes with commercial value. The opportunity to work at the intersection of physics, chemistry and biology was tremendously exciting and motivating. NCL provided the right environment to come into contact with scientists from diverse backgrounds that helped me come up with breakthrough ideas in my field of research.

Dr Murali Sastry Director Innovation Center DSM India

Tough times fuelled innovation I started my research career in India on returning from Italy in 1991. Those were tough times for young researchers and funding was difficult and hard to come by. That forced many of us to be more innovative and use infrastructure optimally. I believe it pushed me to ask deeper questions and be more innovative in my approach to research and indeed, the sort of problems to address. There is much merit in starting out the hard way, which I notice is becoming increasingly rare in the current scenario.

Low cost nano-based water purifier At Tata Chemicals, my research became more application oriented and I focused on using nanotechnology to address challenges related to safe drinking water and agriculture. Rice husk ash- a by-product of the combustion of rice husk during milling of rice is traditionally used in rural areas as a toothpowder and also as a water purifier. TCS was already working on a rice husk-based water purifier- a basic product called Sujal, which was used in disaster relief like the Bhuj earthquake and during the tsunami. However, Sujal could not be used for large scale rural or urban population since it could remove impurities but not microbial contamination, which is responsible for waterborne diseases caused due to pathogens. At Tata Chemicals, when we were asked to design a water purifier, we looked at nanotechnology to provide a solution. We inserted nano silver, a potent antimicrobial agent into rice husk to fur-

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ther enhance the purification by removing gram positive and gram negative bacteria and viruses to a certain extent. The product has been tested as per US Environmental Protection Agency guidelines and is completely chemical free. .

Inorganic nano particles using microorganisms Working with my students at National Chemical laboratory, Pune, I was involved in developing inorganic nanomaterials such as metals, metal sulphides and oxides using microorganisms such as bacteria, fungi. Termed as direct evolution, the process involves subjecting microorganisms to stress. A big â&#x20AC;&#x2DC;ahaâ&#x20AC;&#x2122; moment was when we serendipitously discovered a bacterium that could convert metal complexes to oxide nanoparticles. I am proud that we were the first group in the world to have done this sort of research. We also used plant extracts from tamarind leaves, lemon grass, neem etc. We created a new school of thought and put India on the world map in the area of nano biotechnology. For quite some time, my lab at NCL was ranked number 4 in the world and I was consistently ranked within three top 10 nano scientists globally (based on research output and citations). This is totally a green process unlike standard fermentation in industries. Although it has not found a commercial application yet, it is completely scalable. shalini.g@expressindia.com

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2012 Guidelines for stem cell research Dr BM Gandhi, Chief Executive Officer, Neo BioMed Services, Former Advisor, Department of Biotechnology, Government of India, gives an insight about the draft guidelines for stem cell research released this March he Draft Guidelines for Stem Cell Research 2012 were issued jointly by the Indian Council of Medical Research and the Department of Biotechnology in March 2012. They were developed against the backdrop of the

There is no any significant change in the areas being left out of research and applications except that more emphasis is given to basic research involving preclinical, clinical trials and clinical research to prove efficacy, safety and util-

ity of the cell types used. The Guidelines make it mandatory to run clinical trials for any use of stem cells for therapeutic applications even for types of cells prepared using standard established technologies and reagents.

Stem cells using standard technologies have been commercialised worldwide and are being used for therapeutic use for a variety of disease conditions. The implementation of the new Guidelines may pose an imminent threat

to commercial use as only very few of them have facilities for research and clinical trials. It would also give a set back to the established industry to re-establish to meet the stringent requirement under the Guidelines to generate pre-

perception that various clinics in India are offering largely unproven therapy, raising several ethical, legal and social issues and putting desperate patients at health and financial risks and that various studies in the West have shown that adult stem cells can cause severe complications. Apprehensions are raised that embryonic stem cells may cause further side effects in the form of cancer or tumours. It is further apprehended that in India, none of the treatment modalities have gone through rigorous clinical trials; there are no pre-clinical data on animal models available to ensure the safety of the treatments. Apprehensions are raised that embryonic stem cells may cause further side effects in the form of cancer or tumour. It is further apprehended that in India, none of the treatment modalities have gone through rigorous clinical trials; there are no pre-clinical data on animal models available to ensure the safety of the treatments. The significant difference the new Draft Guidelines presents is that there should be more emphasis on research and proof on concept before the stem cells are put to therapeutic applications. The Guidelines for Stem Cell Research and Therapy 2007 is now Stem Cell Research 2012. Guidelines prescribe strict procedures for sourcing and the use of stem cells by research institutions and provide ethical direction to scientists working in the field. October 1-15, 2012

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clinical information and clinical trial data before commercialisation. Given the present understanding, the strict compliance of the Guidelines would hold back thecommercial application of stem cells in India by another 7-10 years. It would also deny the beneficiaries the genuine treatment using the cell types prepared by standardised technologies. Most of the research in India is through public funding and restricted to major institutions doing basic research. They do not have much experience or capabilities of running clinical trials for which they are largely dependent on CROs/industry. Majority of members of the committees deciding on the fate of research and application of stem cell research in India are academicians with limited or no participation of industry. Finalisation of the Guidelines 2012 thus would require further debate with the industry. A committee set up by the government agency should also study the side effects in form of cancer or tumour and reasons thereto by use of embryonic stem cells and other type of cells and do the risk benefit analysis. Regenerative medicine industry should also collectively come on a common platform in the form of a consortium to put forth constructive suggestions to improve the Guidelines.

Legal measures The Draft Guidelines are still silent on how the absence of legal measures will be able to curb unethical stem cell medical practices. There is nothing in the Guidelines to outlaw, prohibit or punish those carrying out stem cell treatments. After the Guidelines are finalised, India will have a Bill to regulate stem cell practices. The Medical Council of India is supposed to regulate clinicians involved in unethical acts. The Ministry of Health has prepared draft rules for umbilical cord blood banking under the Drugs and Cosmetics Act, 1940 and has put them up for pubic consultation. The new rules will govern cord blood stem cells. Difference between the 2007 Guidelines and 2012 draft Guidelines: The proposed Guidelines issued by the Department of Health Research and

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the Department of Biotechnology 2012 is still a draft. Significant change from the previous Guidelines in 2007 (Guidelines for Stem Cell Research and Therapy) is that more emphasis is given to the research than therapy and hence the 2012 Guidelines are titled as 'Guidelines for Stem Cell Research.' Reasons cited for the above are issues related to the use of human embryos to create human embryonic stem (hES) cell lines, danger of exploitation of underprivileged people, and challenges related to prevention of human germ-line engineering and reproductive cloning, potential dangers of tumorigenicity in view of their potential for unlimited proliferation, possible genomic changes and immunological tissue incompatibility between individuals. To ensure safety and rights of those donating embryonic stem cells, additional basic and clinical research is suggested on foetal or adult stem cells to protect research participants from receiving unproven stem cell transplants. The scope of the Guidelines has been extended to all stakeholders involved with basic and clinical research on all types of stem cells from humans whether

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autologous or allogenic, embryonic or foetal or adult, with or without manipulation. General principles would follow biomedical research involving human participants. Specific guidelines unique for stem cells have been suggested in view of their potential for unlimited proliferation, differentiation to tissues and cells of germ layers and their involvement in preimplantation stages of human development in terms of procurement, regulated differentiation and pre-clinical and clinical research. The research on human subjects, including human embryos and foetuses should ensure safeguarding of human dignity, human rights and fundamental freedom and practices related to obtaining human tissues and cells for research, diagnosis and therapy, fundamental tenets of beneficence, non-malfeasance, justice and autonomy would be guided by the general principles laid down in the Ethical Guidelines for Biomedical Research on Human Subjects by the ICMR. Stem cells being unique, several specific scientific and ethical issues are to be addressed by the stakeholders by evolving specific principles to regulate stem cell research. Appropriate information needs to be provided to the potential donors while taking their consent of the invasiveness of the procedures, potential transmittable infections/diseases, possibilities of development of cell lines from their stem cells, banking and shared with others. They may also undergo genetic manipulation, and have potential for development of commercial products and that the intellectual property rights will not be of the donor. The stem cells few in number require processing in terms of enrichment or in vitro expansion etc to obtain them in sufficient numbers. For embryonic stem cells or induced pluripotent stem (iPS) cells targeted differentiation may be required to generate the appropriate cells of interest. Being a biological product special considerations are required while choosing appropriate reagents/ media for developing quality assurance, safety while maintaining their potency and efficacy. Special considerations are also required in terms of safety of the October 1-15, 2012

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lular structures that have the potential of developing into human organs and tissues, regardless of the method of its derivation, beyond 14 days or formation of primitive streak, whichever is earlier..

Basic research Since stem cells derived from various sources are extensively being used in basic research for the fundamental understanding of their multiplication, differentiation

to other cell types, drug discovery and screening research and clinical research/trials for human disease, a new chapter on basic research has been added to the Guidelines. Depending on the source of their derivation and their differentiation capabilities, stem cells are classified into adult stem cells (ASCs) and pluripotent stem cells (PSC). On the basis of their origin, these cells have been classified in to different groups.

For basic research, a new class of human stem cells, human iPS cells, has been added to the list which are derived from foetal or adult diploid somatic cells by forced expression of pluripotency inducing factors such as Sox2, c-Myc, Oct-4 and Klf-2. They are genetically reprogrammed PSCs and they exhibit properties similar to a typical ES-cell line. Guidelines are also provided on experiments requiring IEC/IC-SCR/IAEC clear-

ances. Details on derivation and characterisation and potential applications of human pluripotent stem cells for basic and clinical research are also listed. Other areas for basic research identified include modelling of human disease, drug development and derivation of a new hES cell line whether from spare embryos or embryos created for the purpose and necessary clear-

therapeutic products in view of the basic characteristics of stem cells of their potential for unlimited proliferation and ability to differentiate into a variety of cells and their ability to produce teratoma. The Guidelines expands to add responsibilities of conduct of stem cell research to the sponsors of research besides investigators and institutions. Sponsors shall need to take note of their responsibilities and liabilities under various statutes and regulations governing research and development in the area in-force in the country. Sponsors would need to give maximum importance to review of research in this field to ensure highest degree of scientific rigor and resolution of ethical concerns. The institutions would also need to ensure that the most current standards are applied for stem cell research and establish suitable mechanisms for creating awareness and communicating scientific evidences to the public. Institutional Committee for Stem Cell Research (IC-SCR) would have major responsibility to provide adequate support in view of limited expertise in the field. The physician/scientist engaged in stem cell research shall ensure that no hype or unrealistic expectations is created in the minds of subjects or public at large regarding stem cell therapy. The basic scientists engaged in stem cell research from human sources shall safeguard human rights and human dignity to the donors. The role of IC-SCR is expanded. Approval of IC-SCR would be necessary for creation of all new human pluripotent stem cell lines, irrespective of the source and methodology used; in-vitro studies on established pluripotent stem cell lines; in-vivo studies in experimental animals (other than primates) with established cell lines from any type of pluripotent stem cells; in-vivo studies on experimental animals (other than primates) using foetal/adult somatic stem cells; establishment of new hES cell lines from embryos left unutilised in IVF programme and deposited in a cell bank for use by others; establishment of umbilical cord stem cell bank following guidelines for collection, processing, and storage etc.; clinical trials with clinical grade cells processed as per National GLP/ GTP / GMP guidelines. Prohibited areas of research also include any invitro culture of intact human embryo, or any organised cel-

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Carbopol® Polymers High Performance Pharmaceutical Ingredients

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ances required for the same. A new chapter on preclinical and clinical trials and clinical research using stem cells has been added to the Guidelines. Guidelines are outlined for preclinical studies and clinical trials using stem cells for appropriate clinical applications involving the principles of clinical translation including ethical, social, clinical, scientific, and regulatory concerns and established standards of care for treatment. Details are provided preclinical study designs, approvals and monitoring, animal models, GCP/GLP; clinical research as laid down in the Schedule Y of Drugs and Cosmetic Act, GCP Guidelines of CDSCO and ICMR Ethical Guidelines, trial subjects, approval and monitoring, regulatory approvals, monitoring of clinical trials, potential use of stem cells for therapeutic purposes. The guidelines have introduced a new chapter for the first time on tissue engineering and scaffolds in stem cell research. This chapter describes the recommended specifications and characterisation of raw or starting materials of natural and synthetic origin or their combination and a set of properties, which a scaffold must satisfy during the tissue regeneration process. The properties of biocompatibility of the material biodegradation into non toxic products, malleability to complicated shapes with or without appropriate porosity, ability to support cell growth and proliferation, and appropriate mechanical properties are also described. The raw materials and finished products should also meet the requirements of physicochemical properties, such as chemical identity,

structure, topography, mechanical properties, thermal characteristics, sterilisability and biodegradation. The Guidelines outlined in detail the criteria for biological evaluation of tissue engineering scaffold; physicochemical evaluation as per the procedures of American Society for Testing and Materials; and biological evaluation in terms of chemical characteristics of materials and the nature, degree, frequency and duration of its exposure to the body. Scope of the Guidelines covers primarily the materials and scaffolds that are used or new ones being developed for the delivery and in vivo functions of stem cells. Representative examples of scaffolding materials and synthetic tissues and biological substitutes include synthetic materials including biodegradable and degradable polymers; natural materials such as chitosan, alginate, collagen, albumin, hyaluronic acid, fibrin, de-cellularised tissues and peptides; biological substitutes from the extracellular matrix of human or animal tissues. Another chapter has been included on defining the scope of banking standards of biological tissues, which included several models for banking of various biological tissues. Tissues of current interest in stem cell isolation and expansion are adipose tissues, Wharton’s jelly, dental pulp, endometrial tissues, placental tissues etc. The Guidelines define standards for banking of umbilical cord blood and other tissues. Researchers are advised to adhere to suggested guidelines in the document and international standards, and regulatory documents for

more information . Additional information is provided for banking and distribution of cell lines. Cell lines from various tissues being used by researchers include embryonic stem cells (both normal and parthenotic), neonatal tissues (Wharton’s Jelly ), iPS cell lines, adult stem cell lines derived from mesenchymal stem cells, fibroblasts, myoblasts etc. The guidelines specifically outlined banking and distribution of hESCs. New issues covered under the Guidelines are import / export of stem cells and public participation. The Guidelines referred extensively to the international practices, procedures and technologies for basic research and applications of stem cells and ISO standards for biocompatibility testing of materials used in medical devices.

Conclusion 1. Industry-sponsored stem cell research and therapy may not be subject to ICMR and DBT, when it is not funded by these organisations. 2. Separate body under DGCI, with academics and industry should be constituted, which will decide what should be done or not, keeping in mind the interest of public on the whole. 3. There are contradictions between perceptions of academia and industry . Since no patents are possible as a result, industry will not be able to get investors to fund stem cell research. The author can be contacted at dr.bmgandhi@yahoo.co.in and drbmgandhi@rediffmail.com

GlobalData analysts focus on early detection and prevention of Alzheimer’s Disease The prevalence of Alzheimer’s Disease is expected to quadruple by 2050 lobalData analysts explored the current Alzheimer’s disease research landscape and what can be expected in the year ahead to mark the World Alzheimer's day, which is observed on September 21 every year. There are 36 million people worldwide suffering from the often heartbreaking and debilitating effects of Alzheimer’s Disease (AD), while millions more make dramatic sacrifices to care for them. The US alone spends approximately $200 billion annually on AD patient care, with unpaid caregiver support estimated to value an additional $210 billion. Furthermore, due to an aging global population, the condition's prevalence is expected to quadruple by 2050. The medical community, however, is making positive strides in tackling this crippling disease. Rob Littlefield, GlobalData’s analyst covering medical devices, said, "2012 has been momentous for AD in terms of progressing research, guidelines for therapy, government funding and services." Littlefield continued, "Recent studies have dramatically changed both the diagnosis and treatment of AD, and the future promises significant advances in research and care related to prevention and early

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diagnosis of this degenerative disease." This year, high profile clinical trials of medications designed to reduce levels of harmful protein amyloid in the brain, such as bapineuzumab and solanezumab, were ultimately unsuccessful, but Littlefield believes this area of study still has potential. "It has been suggested that this approach would be more effective in impacting disease progression if implemented earlier, and to this end, three complementary prevention trials starting in the fall of 2012 will test whether antiamyloid treatments are effective in asymptomatic AD patients," said the analyst. Dr Sally Chege, GlobalData’s analyst covering neurology, echoes the growing industry consensus that the future of AD research may lie in early detection and prevention, rather than cure Chege said, "There are two major unmet needs that currently plague the field of Alzheimer’s. The lack of therapies that actually target and impact disease progression, and a dearth of early diagnostic biomarkers and imaging tools." Correspondingly, work has begun to develop biomarkers with the goal of aiding the identification of AD - vitally

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important work as current clinical diagnosis of the disease is inaccurate in about 15 per cent of cases, even among experienced investigators. The disease can progress for a number of years before symptoms become evident, so the ability to initiate treatment before symptoms arise could prove revolutionary. The upcoming year will see a UC Santa Barbara clinical trial attempt to trace AD to a specific genetic mutation, while investigations into anti-amyloid drugs, though unsuccessful to this point, will continue in optimistic mood thanks to Roche’s promising medication, gantenerumab. 2013 will also see further research into the long suspected link between AD and diabetes - a study with possibly massive implications as the global diabetes population continues to soar. Promising clinical developments, combined with continued support from organisations such as alzheimers.gov and legislation including the National Alzheimer’s Project Act (NAPA), may see the weeks and months between now and World Alzheimer’s Day 2013 celebrated as most successful yet in the fight against this tragic condition. EP News Bureau October 1-15, 2012

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Mice experiment may point to new ways to protect female fertility Although the experiments have only been in mice, researchers believe they have relevance for female cancer patients Hong Kong gg cells can repair themselves from damage caused by radiation far better than doctors ever thought, a finding researchers say gives fresh hope in protecting women undergoing cancer therapy from infertility. Although the experiments have only been in mice, researchers believe they have relevance for female cancer patients and women who suffer premature menopause, a condition that puts them at risk of early infertility, osteoporosis and heart disease. In a paper to be published in the November 9 issue of the journal Molecular Cell, scientists in Australia found that egg cells, or oocytes, are not killed by radiation, but by two proteins puma and noxa which snap into action

when they detect DNA damage to egg cells. In experiments using mice that did not carry these proteins, the scientists found that their eggs survived radiation and they went on to produce normal offspring. "This is very exciting. It means if you get rid of those proteins that kill, the oocytes or specialised egg cells can actually repair their DNA and that has never been known before," said lead author Clare Scott, an associate professor and oncologist at The Royal Melbourne and Royal Women's Hospitals. Between 50 to 80 per cent of eggs survived in these mice. “These were enough to result in normal fertility in those mice and they could produce normal pups. Those pups went on to be fertile themselves and lived a normal lifespan with no evidence of tumors or

other abnormalities,” she said. Scott's colleagues are conducting similar trials on human egg cells to see if the two proteins work in the same way. If all goes well, they hope a drug can be designed to block the two proteins from killing egg cells. “If that pans out well, then we would hope that a drug that could target (the protein) puma be provided as a therapy for three to six months during cancer therapy,” Scott said. Such a drug that blocks the action of the proteins could possibly prevent premature menopause or infertility, she added. “In a woman, premature menopause is caused by (early) death of specialised egg cells. And if you can get specialised egg cells to survive, then premature menopause won't occur.” Reuters

Regeneron eye drug Eylea wins US approval for new use With the approval, Eylea can now be used to treat the thickening of the eye macula that sometimes follow central retinal vein occlusion egeneron Pharmaceuticals announced that US health regulators approved the company's eye drug Eylea for a new use, potentially boosting the already soaring sales of the drug that treats a sight-robbing condition. With the approval, Eylea can now be used to treat the thickening of the macula of the eye that sometimes fol-

lows central retinal vein occlusion - a blockage of the veins that carry blood away from the eye. The macula is an area of the retina that is responsible for central vision and its thickening or swelling can lead to vision impairment. Over 100,000 people in the US are estimated to suffer from central retinal vein occlusion, the company said. Eylea won US approval last November

to treat age-related macular degeneration - the leading cause of blindness in the elderly. Since its launch, Eylea has surpassed Wall Street expectations for its sales. The strong numbers have also prompted Regeneron to raise its forecast for the drug's sales for the third time this year to between $700 million and $750 million in 2012. Reuters

Bayer seeks EU approval for birth control patch Bayer, is one of the largest players in the $8 billion global market for hormonal birth-control pills Frankfurt erman drugmaker Bayer requested European approval for a contraceptive skin patch as it seeks to broaden its birth-control business and challenge Johnson & Johnson’s Evra patch. The hormonal contraceptive, to be produced for Bayer by Swiss company Acino, was shown to be effective with a good safety profile in clinical trials involving 4,200 women, Bayer said. It added that detailed results will be presented at the FIGO World Congress of Gynecology and Obstetrics in Rome in October. The transparent patch, which Bayer says could generate annual sales of 250-500 million euros ($325-$650 million), is applied once a week either to the abdomen, buttocks or outer upper arm, where it

October 1-15, 2012

The hormonal contraceptive, to be produced for Bayer by Swiss company Acino, was shown to be effective with a good safety profile delivers a steady dose of hormones through the skin. If successful, Bayer's product would offer an alternative to J&J's Ortho Evra birth control patch, which is approved in North America

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and Europe. US drug advisers have, however, recommended that the label of Ortho Evra patch be simplified to better explain the risk of blood clots. A spokeswoman said Bayer was in talks with the Food and Drug Administration (FDA) over a possible filing also in the US. Bayer, is one of the largest players in the $8 billion global market for hormonal birth-control pills, competing with J&J, Teva's Barr Pharmaceuticals and Ireland-based Warner Chilcott. Its main oral contraceptive brand Yasmin has also been subject to controversy over health risks. Bayer has agreed to pay a combined $400 million to settle almost one third of about 6,000 legal claims in the US that Yasmin caused blood clots. Reuters EXPRESS PHARMA

Pharma Ally POST EVENT

BD organises annual seminar series, ‘Technovation’ Technovation will help customers stay informed of the latest developments in the industry ith more biopharmaceutical companies coming into the market it is evident that prefilled devices are becoming more prevalent. As they become more widely accepted by customers and patients, their packaging and form becomes equally critical for easy and safe administration and treatment adherence. In keeping with this trend, BD, a leader in the field of prefilliable syringe systems, invited pharma, biotechnology and vaccine manufacturers to offer them a glimpse of the latest innovations in packaging of parenteral delivery devices in its third edition of Technovation in India. This year the event was held in Mumbai and Hyderabad. The parenteral industry has grown in recent years with the development of new treatments and formulations to treat a wide range of acute and chronic conditions. In tandem with this growth, there has been increased sophistication of the packaging for parenteral drugs, including prefilled syringes and disposable injection devices. Murli Sundrani, Director, BD Medical-Pharmaceutical Systems in India, said, “Today as pharma companies continue to enable their consumers identify genuine products in the market, we believe a knowledge seminar like Technovation can help our customers stay informed of the latest developments in the industry. It also helps them to make informed decisions while investing in

resources and technological interventions.” The seminar had invited 'Packaging Connections', a packaging consultancy based out of Gurgaon, Haryana, which illustrated how newer packaging inventions have revolutionised the product categories and given the marketers a winning edge. As disposable drug delivery devices continue to grow in popularity, it is natural that an intelligent design can also address concerns such as environmental footprint reduction. In an era when prefills are

driving the growth of biotech and vaccine industries because of their economic and safety aspects, it is through innovations and processes that BD wants to make the latest products that are being used worldwide available to Indian manufacturers. Technovation also focused on the importance of safety and how manufacturers can move up the value chain of safety to help prevent needlestick injuries. Healthcare workers face many risks in their daily duties, including accidental needle-

stick and exposure to bloodborne pathogens. BD uses a design approach in which patient inputs are considered from the very early stages of the product development and through launch. At BD, sustainable packaging provides many essential benefits, such as sterility of instruments and protection from damage during transport. BD is working to reduce the amount of packaging it uses and to find effective materials not made from fossil fuels that are easily recyclable and reusable. EP News Bureau

VENDOR NEWS

Quintiles unveils next generation of Quintiles Infosario New role-based navigation and actionable insights at a study, programme and portfolio level uintiles launched its interactive, role-based navigation as part of the next generation of Quintiles Infosario Reporting & Analytics Platform. Quintiles Infosario is an award-winning solution that seamlessly integrates data, systems, processes and Quintiles’ therapeutic expertise to unlock faster, better-informed decisions from clinical trial planning and design, to trial execution services, through post-market outcome studies.

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The new navigation introduces templates that allow users to create dashboards to view the most relevant data and visualisations for their specific, day-to-day needs. It also offers transparency into critical data at the study, programme and portfolio levels - unlocking valuable insights that enable customers to tackle key challenges, such as realtime oversight, risk mitigation, patient safety, productivity and time to market. With Quintiles Infosario clinical

programme managers can view the overall status of trials in a specific region in near real-time, enabling quick and deliberate decisions to ensure trial success. Pharmacovigilance scientists and medical monitors can easily focus on safety-specific data, enabling subtle but important signal detections for improved patient safety. Site start-up specialists can seamlessly monitor patient enrollment at specific sites to forecast, benchmark and optimise the patient recruitment processes.

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Thomas Grundstrom, Vice President, Integrated Processes and Technologies, Quintiles said, "Historically, our customers have experienced gaps in the availability of integrated, continuously updated data necessary to manage their studies. With the next generation of Quintiles Infosario, users can easily view data according to their specific needs and make better-informed decisions to run more efficient clinical trials and accelerate time to market." EP News Bureau October 1-15, 2012

P|H|A|R|M|A| A|L|L|Y

Waters selects Metabolomics Laboratory at Univ of North Texas for Center of Innovation Prog New laboratory directed by Prof Vladimir Shulaev recognised for metabolomics and metabolic signalling pathway research and teaching t a ceremony officiated by University of North Texas (UNT) Provost Warren Burggren, Waters Corporation welcomed UNT’s Metabolomics and Metabolic Signaling Pathway Research Laboratory into the Waters Centers of Innovation Programme. The laboratory directed by Professor Vladimir Shulaev is known worldwide for research in the field of metabolomics, the study of all cellular metabolites produced by living organisms. His laboratory is part of UNT's Plant Signaling Cluster, a team of researchers who collaborate to improve the understanding of cellular communication in plants to find solutions related to energy, agriculture, nutrition and medicine. In addressing an audience of students, faculty and staff, UNT Provost Warren Burggren, a biologist, said, "I’m really proud to be representing UNT here to celebrate the opening of this Center of Innovation. This is a university-corporate partnership at its very best. To use a biology metaphor, we look forward to a long, close symbiotic relationship between UNT and Waters. It is a natural fit, a really natural fit, and we’ll each benefit tremendously." Addressing the audience, John Gebler, General Manager, Centers of Innovation Programme, said, "Waters wants to put technology in the hands of individuals who are going to be really successful with it. Our hope for you is that your discoveries may help improve your lives and the lives of the next generation that comes along. For Waters to be successful, we have to partner with individuals who can take our technology and make the best out of it." Vladimir Shulaev said, "Two years ago, when I first arrived on campus, the idea of a state-of-the art metabolomics laboratory at UNT was a dream. With the hard work, enthusiasm, and belief by a lot of people we have seen that dream come true. And it is investments in the development of new instrumentation by companies like Waters that drives science to the cutting edge. Our new Metabolomics and Metabolic Signaling Pathway Research Laboratory will put UNT on the map in metabolomics research and create a facility for everyone to be proud of." "Advanced liquid chromatography combined with mass spectrometry is, in many ways, what makes metabolomics possible," Shulaev noted. Shulaev refers to the laboratory’s Waters SYNAPT G2 system as "the workhorse of our highthroughput metabolite profiling." Also, like many leading laboratories around the world, Shulaev’s laboratory has recently taken delivery of a Waters ACQUITY UltraPerformance Convergence Chromatography (UPC2) system, which will be used primarily for lipidomics research. "Lipidomics is a large focus of the lab now "studying the structural lipids, as well as signalling lipids involved in a variety of signalling networks in plants and animals," he explained. Convergence chromatography is a new category of separation science which promises to rival liquid chromatography (LC) and gas chromatography (GC) in importance for the analytical laboratory. Compressed carbon dioxide (CO2), the primary mobile phase for convergence chromatography, offers numerous major advantages over liquid mobile phases or carrier gases that are used with LC and GC. For one, CO2 alone, or in combination with a co-solvent, is a low viscosity mobile phase that achieves higher diffusion rates and enhanced mass transfer than HPLC liquids. For another, when compared to GC, CO2 allows separations to occur at a much lower temperature. For institutions and laboratories with sustainability goals to meet, CO2 replaces toxic and volatile organic solvents that are very expensive to purchase and dispose. For Shulaev, teaching the use of analytical instruments is another critical part of his work. "It is very important to train the next generation of scientists, especially in mass spectrometry, which is one of the big deficiencies now. We need to have a big pool of people who understand mass spectrometry and technology and not just understand it in theory, but in practice." EP News Bureau

October 1-15, 2012

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P|H|A|R|M|A| A|L|L|Y PRODUCTS

BD Biosciences launches BD FACSJazz cell sorting system

D Biosciences, a segment of BD (Becton, Dickinson and Company), launched BD FACSJazz Cell Sorting System, a next-generation flow cytometer that simplifies cellular isolation and analysis for researchers requiring high sample integrity. Occupying 20” x 20” (51 cm x 51 cm) of benchtop space, the new sorter features high sensitivity to identify and isolate target cells for up to eight parameters. The new BD FACSJazz Cell Sorting System will have broad utility for next-generation genomic studies. The system is capable of identifying, characterizing and isolating single or multiple cells and depositing them in 96 and 384 well plates with precision, accuracy and rapidity. The BD FACSJazz Cell Sorting System incorporates customer input from a 2011 global early access programme. As a result, refinements were made to enhance usability and ease of use. In addition, a violet laser and pulse processing were added to the offering to enhance live dead cell discrimination and cell cycle analysis. The system has many innovative features that simplify sorting such as digital controls and factory-optimized settings for the precise isolation of cells. In addition, the intuitive BD FACS Sortware was developed explicitly for cell sorting to simplify workflow to isolate cells into tubes, or plates as single or multiple cells. The BD FACSJazz Cell Sorting System can be configured to support up to six colours with eight parameters. This system includes a standard blue laser but can be additionally configured with an optional red and/or a violet laser. It is also available with an optional, custom-designed biological safety cabinet. The custom enclosure has been verified by Baker Company to meet personnel and product protection standards for both a Class II Type A2 biosafety cabinet and National Sanitation Foundation International Standard 49.

Contact details: Sunit Trivedi – BD Biosciences Signature Tower-B, South City 1, Gurgaon, Haryana 122001 tel: +91 124 2383566, fax: +91 124 2383224/5/6 email: Sunit_trivedi@bd.com

Contact details: Dr Armin Bruck Managing Director 130, Pandurang Budhkar Marg, Worli, Mumbai - 400 018. Tel: (022) 3967 7000, Fax: (022) 3967 7500

Phenomenex introduces Kinetex™ Core-Shell Technology HPLC / UHPLC Columns that delivers improved results on any LC instrument

PikoReal Real-Time PCR Systems by Thermo Fisher Scientific

henomenex, a global leader in the research and manufacture of advanced technologies for the separation sciences, has launched Kinetex Core-Shell Technology chromatography column line in India. The Kinetex core-shell products, which have been extremely well received worldwide, meet researchers’ need to improve results and increase productivity without large capital expenditures. Phenomenex opened an office in Hyderabad last year. With the addition of the new 5 µm particle size, HPLC and PREP LC analysts now have a simple-to-use solution for improved performance. By delivering significant gains in speed and separation efficiency over traditional fully porous columns, Kinetex columns enable chromatographers to get improved results and performance on any LC instrument platform. Now chromatographic methods in India can be completed at a fraction of the time previously required, without sacrificing performance and with potential reduction in solvent usage. Researchers who have already invested in UHPLC instrumentation can also see substantial performance gains with the Kinetex 2.6, 1.7, and 1.3 µm particles. With traditional, fully porous particles, efficiency decreases as flow rate increases, resulting in loss of resolution and sensitivity, which slows the overall analysis time. Kinetex Core-Shell Technology enables high resolution and sensitivity over an extended linear velocity without generating excessive back pressure, along with significantly lower limits of detection and quantitation. Kinetex CoreShell Technology is ideal for a wide range of applications, including food testing, environmental analysis, drug discovery and clinical research. Kinetex core-shell columns are available in four particle sizes, from 1.3 to 5 µm, and six phases. Method transfer challenges, common with traditional sub-2 µm products, are eliminated with Kinetex. Methods developed with Kinetex columns are scalable and can be transferred to any LC system.

Contact details: Kris Chu Global Marketing Manager, Phenomenex, 411 Madrid Avenue, Torrance, CA 90501, Tel: 310.212.0555 Ext. 3213, Fax: 310.328.7768 Email: krischu@phenomenex.com, Web: http://www.phenomenex.com

Siemens launches Sitrans FC430

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iemens has launched Sitrans FC430, the first of its kind flow solution, which is suitable for any liquid or gas application within the process industry. This latest offering from Siemens ensures high accuracy, low pressure loss, increased flexibility that is ideal for the chemical and pharmaceutical industry. The digitally based flow solution Sitrans FC430 with short build-in-length is suitable for any liquid or gas application within the process industry. The new device is capable of optimising a wide range of processes for increased productivity in industries like chemical and pharma sector. Sitrans FC430 is ideal for multiparameter measurement and can be used in applications like fast filling, batch control, blending and dosing as well as for measurement of gases or fluids. Sitrans FC430 features market-leading compactness, very high accuracy of 0.1 per cent, low pressure loss, extremely stable zero point and best-in-class data update with 100 Hertz high-speed signal transfer. Innovative user-friendly support tools provide direct access to all operational and functional data, certificates and audit trails. Sitrans FC430 is amongst the first Coriolis flowmeters to offer SIL (Safety Integrity Level) 2 and 3 approval in hardware and software respectively, enabling maximum redundancy meeting the highest standards of safety and reliability. The highly automated production of the Sitrans FC430 ensures a flexible supply chain for rapid responses to customer inquiries. Very short lead times for tailor-made solutions are guaranteed by assembly robots guided by sophisticated 3 D vision laser systems.

hermo Fisher Scientific has introduced its Thermo Scientific PikoReal Real-Time PCR Systems, which complete its molecular biology workflow. Available in 24- and 96-well formats, the PikoReal offers outstanding performance in a small bench-top footprint. The unique heating block design of PikoReal systems maintains excellent temperature uniformity and fast heating and cooling for optimal amplification. The proprietary ultra-thin wall (UTW) Piko PCR plates minimise running costs, plastics waste and energy consumption. Although these plates are a quarter the size of standard plates, their well volumes and spacing ensures compatibility with multichannel pipettes and liquid handling instrumentation. Finally, PikoReal systems use half the power of typical real-time PCR instruments and consume less reagent, providing a cost-effective and environmentally friendly option for personal bench-top or field use. The combination of the unique heating block and UTW Piko consumables ensures data uniformity for more reliable and repeatable results. The built-in optical system of the PikoReal contains five channels, pre-calibrated for the most common dyes, so users can perform multiplexing with four dyes while dedicating the fifth channel to SYBR Green and HRM experiments. The instruments are controlled by PikoReal software, which enables absolute and relative quantification, melting curve analysis and genotyping. Systems can also be used as stand-alone by transferring an amplification protocol from PikoReal Software to the instrument using a USB stick. The software also uses a Virtual Pipetting Tool that guides users through plate setup.

Contact details: Meenal Shinde Sr Executive - MarCom Laboratory Products - India Thermo Fisher Scientific India 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai. Mumbai - 400 076, India. Tel: +91 22 6716 2200 Direct No: +91 22 6716 2259, Fax: +91 22 6716 2244 www.thermofisher.com or www.thermo.com

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P|H|A|R|M|A| A|L|L|Y INSIGHT

Preferred vendor partnership: Emerging trend in analytical development Sarabjeet Singh Sharad, Senior Research Analyst, Beroe Consulting, talks about new CROs which focusses on pharma analytical testing, predominantly for clinical and other biological samples “Drug companies are looking into CROs/Lab that will service the analytical needs in rapid and accurate manner” Ranil Fernando VP of Operations BioScreen Testing Services arly 1990 there were only limited contract research organisations (CROs) committed to serving the pharmaceutical industry. Several of the laboratories commenced either during or after the environmental ‘boom’ of the 1970s linked predominantly to environmental testing. Due to the decline in government capital of environmental monitoring, these laboratories started looking for new markets and customers. With the fast expanding LC/MS technology, from the early to mid-1990s new CROs began to emerge which focussed in pharma analytical testing, predominantly for clinical and other biological samples. These CROs/laboratories have increased in number and some have expanded to sizes which rival the innovator pharma industries. Today, for e.g., Covance, Wuxi App Tec. CROs/Lab etc have strategic “preferred vendor partnerships” with large and

small pharma companies expanding to multinational sites globally. Several of these supposed “boutique” laboratories, with specialities ranging such as extractable/leachable testing, inorganic analysis, and analysis of clinical/biological samples by LC/MS, have made strategic partnerships in analytical development.

Why are pharma companies looking for outsourcing to preferred vendors? Drug companies nowadays consider outsourcing analytical development as a business model, an operation tactic rather than ad hoc service for additional analytical assignment. Many pharma companies are employing strategic partnerships with /boutique providers by establishing preferred vendor relationships that can deliver a broad range of pharma development services, including analytical testing. Drug companies are continuing to look for long terms allies who will ensure expert staff and also comply with glob-

Analytical development annual spending ($ millions) Bio/Pharma In-house

CDMO In-house

Contract Lab/CDMO lab only

190 164 664 Note: Annual spending on analytical development and testing for small molecule drug product Source: Primary Expert

al quality standards for analytical development.

What are the benefits of outsourcing analytical service? In-house laboratory functions are characterised by relatively high fixed costs capital investment and associated benefits and salaries. Assets and manpower are usually under-utilised in the in-house laboratories. Outsourcing will eliminate the rising lab costs and under-utilisation rates as well as reduce or rationalise the operation. Innovator drug companies have now started to organise better internally for outsourcing, mostly with committed outsourcing groups. Drug companies have recognised that commoditised testing services like “routine testing” need to be outsourced as it will mainly include dosage form stability testing, release testing, and analysis of clinical and biological samples.

What will be the major outsourcing change in the analytical landscape? A lot of companies are demanding biologics support testing, such as RNA sequencing, gene expression analysis, micro RNA profiling and multiplex protein profiling. Companies with the experience and platforms to deliver these services will continue to realise growth in ana-

Global spending on analytical development and testing for large-molecule drug substances by analytical activity ($ millions) Batch Release

Stability

Methods

Viral Clearance

Microbiology

Characterisation

103

134

221

Companies and investigators in diverse regions are gradually adhering to global regulatory standards, which will create additional growth through offshore providers of analytical testing. Source: Pharmaceutical Product Development

lytical development. In the near future, companies with cluster computing tools and bioinformatics data analysis capabilities will be more desired as these speciality technologies that are emerging in the biologics testing space will continue to add value to drug innovators.

What are the analytical development initiatives undertaken by preferred vendors? Recently, there has been implementation of totally validated “Laboratory Information and Management Systems” that permit CROs/lab suppliers to enter the results straight into client data handling systems, along with consistent data attainment. This application softwares' functions make outsourcing both an efficient and attractive proposition for future analytical development. Analytical service providers have improved regulatory compliance to cGMP and cGLP procedures and maintain the essential certified standards for analytical development. The upsurge in proportions of CROs, has led to increased competition for analytical development services, therefore the service providers have now started positioning themselves as one-stop shop for the full range of analytical testing facilities required for the drug companies.

Some of these service providers and their initiatives are:PPD, one of the prominent global contract research organisations, have recently extended their presence in Europe for analytical testing services Catalentpharma has stretched its geographical reach with the opening of their European Development and Clinical Services Laboratory in UK Wuxi App Tec has recently opened the largest “Toxicology testing Centre of Excellence in Suzhou which will provide safety testing and related services for drug development Charles River is providing analytical services for vaccines as drug companies are concentrating across the development process in vaccine.

Conclusion Over the next five years there will strong growth in the preferred vendor partnership model where mutual interest in continuous analytical improvement will lead to cost and time benefits that can be shared between the sponsor and vendor as a tool to manage R&D effectively. North America and Europe will lead this preferred partnership for analytical development due to well-developed infrastructure while in Asia it would be mainly due to low operational costs and rising talent pool of skilled analytical professionals. The author can be contacted at sarabjeet.singh@beroe-inc.com

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Processing technology expertise from granulation to tableting

 Fluid bed systems for drying,

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EXPRESS PHARMA

www.expresspharmaonline.com

October 1-15, 2012

Express Pharma Business Avenues

October 1-15, 2012

www.expresspharmaonline.com

EXPRESS PHARMA

Aarti Industries elevates Rajendra V Gogri as CMD Also appoints Rashesh C Gogri as the Vice Chairman and MD and Renil R Gogri as the Whole-Time Director

Page 74

INTERVIEW

‘Piramal Healthcare scientists have been the recipients of this award for three consecutive years’ Dr Girish Mahajan, Senior Group Leader—Anti-infective Discovery-Natural Products, Piramal Life Sciences was one of the scientists whose work was recognised at the recently held 46th Annual General Meeting of the Organisation of Pharmaceutical Producers of India (OPPI). He has been honoured with the OPPI Scientist Award 2012. He shares his experience after receiving the award with Usha Sharma What was your reaction when you were informed that OPPI will honour you for outstanding research in drug discovery? It was a splendid feeling. This is not only because I have been honoured with the the most prestigious pharmaceutical research related award. One reason is that Piramal Healthcare scientists are recipients of this award for the three consecutive years, including this year. It means that our drug discovery wing is persistent in discovering new ways to reduce disease burden of the globe and trying to meet unmet medical needs. Another reason for this splendid feeling is that this year the award has been given to me, a scientist who is discovering new drugs from natural resources, especially microbial resources. As the area of natural product antibacterial discovery from natural products has contracted, especially in the US and Europe over the past 10 years, it is important that the continued pursuit of natural products in other avenues, especially the burgeoning scientific arena of India, has to be fostered through recognition of Indian scientists in the field. With whom did you share this news first and why? I shared this news first with my direct team of scientists and senior management. Even though the award is individual, the drug discovery can never be a one man’s army. It is possible only with the help of a hard-working, talented and skilled team as well as a visionary senior management. The citation of the Scientist Award states that you have received this award for 'outstanding research work in the area of Drug Discovery Research'. Can you give us details of this work/project? I have been a keen believer of the continued usefulness of microbial products as a resource for new antibiOctober 1-15, 2012

Dr Girish Mahajan receiving the award otics and applications to reduce the burden of resistant bugs on the globe. I have patented, published, presented and mentored broadly in the area, nationally and internationally and have two pre-IND antibiotics in the pipeline. These new antibiotics have been products of microbes isolated from very unique ecological areas. How will this award help you to further enhance your career? What are the goals that you have set for the future? It is difficult to predict how this award will help in enhancing my career. Nevertheless, at least I can speculate that the pharma industry in India and abroad will definitely start rethinking about investing more in natural products and exploit the rich microbial diversity in India for getting new drugs for the masses. I am sure India will be looked upon as a prime hub of natural resources. Scientifically, my goal as such would be to promote the message to investors that microbes are the sustained sources of new drugs and other bioactive compounds. What credit would you like to give Piramal Healthcare for boosting your career? It is the vision of Dr Piramal and Dr Somesh Sharma to continue to work in natural products area with modern, advanced tools and to exploit unexploited natural resources to capture

novel curative ways. This vision has boosted our ways to look upon at this classical resource with modern tools. Perhaps that is why we have been more unique as compared to others. Tell us about the formal procedure which OPPI follows while selecting the right candidates for this award category? Based on my current experience, OPPI sends an alert call for nominations for this award. The individual organisation shortlists the candidate based on their internal assessment for that year. OPPI has very unique international standard format for providing application forms. The candidate has to put their data in that format. The organisation of the candidate sends the nominations (application+CV) to OPPI. Through OPPI the copies of these are sent to expert panel of judges. Opinions of all judges are pooled and then the final awardees are decided. Overall, how much time did you take on the drug research project for which you got this Award? Please share your success story with us. Technically, drug discovery is a journey as there is continuous need for new drugs to combat against resistant bugs and infections in immune-compromised patients. Especially, if you consider a microbial source as an example, it may take about two to

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three years to decide and confirm the novelty of the drug and to establish that it is a good project to take ahead for preclinical development. Looking at the climatic and geographical diversity in India, I feel there is huge scope to explore more and more least-explored types of microbes for drug discovery. Many scientific experts in India have showed the potential of this resource but there is need to completely characterise and screen the compounds in an exhaustive way. That will really give a way for the discovery of new scaffolds. Perhaps due to this strategy our R&D has been successful in getting novel potent bioactive compounds from microbial resources. How is your research work going to help the industry? I have been demonstrating successfully that natural products, especially actinomycetes and myxobacteria, are still sustained goldmines of new bioactive leads to reduce the burden of disease globally. Two new compounds are in preclinical development. The work could confirm that extreme niches yield microbes which can give novel leads in various therapeutic areas. Moreover our work unanimously proved that India harbours great biodiversity of microorganisms which can be explored effectively for finding new drugs to reduce the disease burden. So these drugs can be considered for semi synthetic modifications to improve their properties towards drugability. Besides this latest recognition, which other awards have you won? Besides this latest OPPI award, some of my other latest national level recognitions and awards are Awards for Excellence ‘ISCB AWARD OF APPRECIATION FOR INDUSTRY SCIENTIST -2012, in the area of Drug Research’ by the Indian Society of Chemists and Biologists (ISCB) at ISCB Conference-2012. u.sharma@expressindia.com EXPRESS PHARMA

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

Aarti Industries elevates Rajendra V Gogri as CMD Also appoints Rashesh C Gogri as the Vice Chairman and MD and Renil R Gogri as the Whole-Time Director ajendra V Gogri has been elevated to the post of Chairman and MD of Aarti Industries. Gogri was holding the office of Vice Chairman and MD and has been appointed as CMD in line with succession plan earlier approved by the company. Gogri holds a Masters Degree in Chemical Engineering from the US and is a rank holder in Bachelor of Chemical Engineering from UDCT. He has been with the company since its inception and was later on appointed as the MD in 1993 and Vice Chairman and MD in 2003. He has worked shoulder to shoulder with Chandrakant V Gogri to help the company achieve its present height and stature. He is a key reason for development of export of the company and has been handling the portfolios of marketing, purchase and other commercial

Rajendra V Gogri

CAMPUS BEAT

matters. Rajendra V Gogri is succeeding Chandrakant V Gogri, who retired as the Chairman. On request of the Board, Chandrakant Gogri has accepted the post of Chairman Emeritus for his invaluable guidance and support. Rashesh C Gogri, Whole-Time Director, has been appointed as the Vice Chairman and MD of the company. He has been an Executive Director with the company for more than 18 years and has handled various strategic business units of the company. He is an industrial engineer and holds diploma in business management and has been playing the crucial role in pharma operations of the company which have turned around during the year 2011-12 with expectation of better opportunities for growth. Under his supervision, the company

has successfully implemented SAP and has taken significant steps in automation of various internal MIS and administration related processes. Renil R Gogri has been appointed as the Whole-Time Director of the company. Renil R Gogri is a BTech (Mech) from IIT, Mumbai, 2008. He has worked as a Whole-Time Director with an associate company known as Anushakti Chemicals and Drugs, since April, 2010 and has been appointed as Whole-time Director of the company from August 16, 2012. He has worked with Deutsche Bank prior to joining the company. He handles the portfolios of Systems Developments / Improvements in Operations, Adoption of IT Advancements into Operations and Project Execution. EP News Bureau

Sinhgad College of Pharmacy, Pune conducts one-day joint seminar with MJ Export Around 110 students and faculty from different colleges attended the workshop inhgad Technical Education Society’s Sinhgad College of Pharmacy (SCOP) Vadgaon (Bk) recently organised a one-day joint seminar with MJ Export on 'Advancement in Texture analysis with various pharmaceutical Applications.' The welcome speech was given by Dr KN Gujar, Principal, Sinhgad College of Pharmacy. Around 110 students and faculty from different colleges attended the workshop. Christopher Freeman, Product Manager, Brookfield, UK and Nilay

CSR

Dr KN Gujar, Principal, Sinhgad felicitating Christopher Freeman, Product Manager, Brookfield

Shah, Marketing Manager, Brookfield, India conducted an informative session on Application of Texture Analyser in Pharmaceuticals by sharing various videos for the same. This was followed by demonstration of Brookfield’s Texture Analyser. The workshop was co-ordinated by Dr AM Avachat, Professor, Pharmaceutics, Sinhgad College of Pharmacy. The valedictory speech was given by SN Shrotriya, Assistant Professor, SCOP. EP News Bureau

Biogen Idec observes ‘Care Deeply’ week Organises donation drive, cleaning up of surroundings and spending time with children iogen Idec as part of its corporate social responsibility (CSR) initiative recently observed ‘Care Deeply’ week in Gurgaon. Some of the

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initiatives run during the ‘Care Deeply’ week were a donation drive for Assam Rahat in partnership with ‘Goonj’, where employees donated clothes, accessories, and utility items for bringing relief for Assam floods victims and Akshaya Patra supporting the mid-day meal for children and reducing hunger by promoting primary education. The ‘Day of Service’ was designed to increase the role of employee volunteerism with focus on patients, science education and local communities. Employees took a day off to spend a day with disabled children of Khushboo Welfare Society as part of its CSR

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besides cleaning their surroundings and spending time with children to spread a smile. As part of the service, employees cleared water-logged areas in Gurgaon that flooded annually during the rains. Biogen Idec also offered logistic support and interacted with the disabled children suffering from various neurological disorders and disabilities. On the occasion, Sameer Savkur, MD, Biogen Idec said, “This offers an opportunity to give back to the communities in which we live and work. We truly believe this is a great opportunity for us to not only contribute to our local communities but also help employees imbibe the quintessence of responsible citizenship.” EP News Bureau October 1-15, 2012

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2010-12, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. AT IND.EXP.PSO.

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