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Reversing the trend Despite its role in maintaining health, the antibiotics market has seen considerable downturn over the last few decades.

Sachin Jagdale analyses the reasons behind this negative phase and possible approaches to revamp the global antibiotic market See Page 15

95 per cent of the Fortune 50 pharma and medical device companies partner with Rockwell Automation Rajesh Vedak, ISM – Life Sciences, Rockwell Automation elaborates about the growing automation in the pharma industry, trends in automation, challenges hindering its growth and the benefits to be accrued through automation in an interaction with Express Pharma See Page 50

Effective packaging solutions for parenteral drugs Safe guarding parenteral drugs is not an easy job; however, pharma packaging solution providers have done this successfully with their innovative solutions.

Sachin Jagdale reports on how the packaging industry is set to tackle challenges that parenteral drug manufacturers may throw at them in future

See Page 56

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Contents

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

Pharma VOL 7. NO. 24 OCTOBER 16-31, 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

Since last few decades, the well known American and European pharma companies have been ignoring their antibiotic portfolios Sharad Dahatonde General Manager, Biotechnology, Elder Pharmaceuticals

Neelam M Kachhap

Page 16

Delhi Shalini Gupta MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal

B R Tipnis Production Manager

Sanofi announces new results from ORIGIN trial

Ranjit Shahani Vice Chairman and Managing Director Novartis India

Bhadresh Valia Asst. Manager - Scheduling & Coordination Arvind Mane

Page 36

Asst. Art Director 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

Anand Sharma, Minister for Commerce, Industry and Textile Government of India has recently conducted a sectoral meeting with all Indian pharma industry stakeholders to discuss the formation of an innovative pharma cluster scheme focused on shared R&D facilities Page 18

The new proposal will have an impact on industry as the span of price controls will now increase to cover around 30 per cent of the pharma market

PRODUCTION General Manager

GoI to introduce innovative R&D focused pharma cluster scheme

interview ‘Culturally, India has demonstrated strong doctor–patient relationships’ Denzil Benjamin, Senior Director, Clinical Trial Management, Asia Pacific for ICON, talks about the importance of Electronic Data Capture (EDC) in data management in clinical trial sector, with Sachin Jagdale Page 43

Sanofi announced new results from the landmark ORIGIN (Outcome Reduction with Initial Glargine INtervention) trial showing treatment with Lantus (insulin glargine) was approximately three-fold more likely (p<0.001) to achieve and maintain target glycemic levels, defined as HbA1C < 6.5 per cent in this analysis, vs standard care in individuals with pre-diabetes or early type II diabetes at high cardiovascular (CV) risk Page 40

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 The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole

95 per cent of the Fortune 50 pharma and medical device companies partner with Rockwell Automation Rajesh Vedak, ISM – Life Sciences, Rockwell Automation elaborates about the growing automation in the pharma industry, trends in automation, challenges hindering its growth and the benefits to be accrued through automation in an interaction with Express Pharma

or in part, without prior written permission is prohibited.

October 16-31, 2012

www.expresspharmaonline.com

Page 50

EXPRESS PHARMA

11

Editor’s Note

The ‘supreme’ authority

W

ith the Supreme Court closely tracking policy makers, both on the drug pricing and clinical trials front, will the pharmaceutical industry in India finally find a balance between patients and profits?

India is not the only country where the clinical trial sector is facing a backlash. A 'new low' is

the recent instance when Toshiba recently put out casting adverts for a new reality show, to be called 'Human Guinea Pigs', where participants would be egged on and rewarded to try out experimental drugs.

Worried that such a show might negatively impact recruitment rates, the Association for Clinical Research Organisation (ACRO) has strongly protested this moniker, stating that in fact volunteers for clinical trials are actually "medical heroes, not test monkeys".

In India too, industry associations like the Indian Society for Clinical Research (ISCR), with CROs like Quintiles, are engaging all stakeholders, not least the media, in order to tell their side of the story.

Suddenly, it’s a lot easier to get through to spokespersons of big pharma and big CROs. The effort is to blame the goof ups on 'black sheep; and the lack of clear guidelines, faulty implementation and poor enforcement.

Hospitals like the Apollo Group, which are the sites of some trials, are also talking about the need for more ethical oversight. This issue (dated October 16-31, 2012) of Express Pharma features a detailed interview with Dr Ranjit Roy Chaudhury, Chairman Task Force for Research, Apollo Hospitals Educational & Research Foundation (AHERF) who is pushing for accreditation of ethics committees and a host of other measures.

Obviously corporate hospitals want to distance themselves from the likes of Indore-based Maharaja Yashwantrao Hospital where 32 people have died in the past five years, thanks to unauthorised clinical trials.

We have to thank brave hearts like Dr Anand Rai of Maharaja Yashwantrao Hospital who first blew the lid of these trials, as well as NGOs like Swasthya Adhikar Manch in Indore and the Delhi-based Jan Swasthya Abhiyan which is at the forefront of the drug pricing policy campaign, for keeping these issues live.

But, will this last? And is this new-found transparency just a smokescreen? It seems that the clinical trial industry is on trial, and like any drug trial, currently operating under scrutiny, as per approved protocols. What happens when the oversight reduces? Will the lessons lead to long lasting changes?

Hopefully the supreme authority will keep up the pressure.

Viveka Roychowdhury viveka.r@expressindia.com

12 EXPRESS PHARMA

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October 16-31, 2012

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Market

THE BUSINESS OF PHARMACEUTICALS

UPFRONT ABLE, WBBA sign MOU to support discoveries for better healthcare solutions he Association of Biotechnology Led Enterprises (ABLE), and USbased Washington Biotechnology & Biomedical Association (WBBA) have signed a MoU for broad ranging co-operation in the field of biotechnology to support breakthrough discoveries in healthcare, agriculture and clean energy in the country.

According to this MoU, both ABLE and WBBA will undertake activities to further their respective mandates by providing each othersâ&#x20AC;&#x2122; members opportunities to co-operate and invest in the State of Washington and in India in the field of biotech. Among others, the activities could be concerned with technical knowledge, market research, inputs for policy making, internships, exhibitions, workshops, seminars, capacity building, collaborations, Investment and business partnering. Dr PM Murali, President, ABLE said, "The collaboration aims to achieve breakthrough discoveries to provide affordable solutions for critical diseases, important challenges in agriculture and energy on mutually agreed topics."

Chris Rivera, President, WBBA said, "We see India as the growth engine of tomorrow and one of the fastest growing economies in the world. This collaboration with ABLE in India is significant to WBBA to facilitate best of research in biotechnology from both the countries."

Chris Gregoire, Governor of Washington State, who was present for signing this MoU said that, "Washington State has always promoted technology innovation and biotech has been one of our areas of focus for research and development. This exciting partnership will spur progress in this sector in India and Washington, growing jobs in both regions. We know that this collaboration, over time, will pay dividends in improved public health and economic development."

EP News Bureau

T

October 16-31, 2012

GoI to introduce innovative R&D focused pharma cluster scheme Anand Sharma, Minister for Commerce, Industry and Textile Government of India has recently conducted a sectoral meeting with all Indian pharma industry stakeholders to discuss the formation of an innovative pharma cluster scheme focused on shared R&D facilities. The Government has tentatively allocated funds of around Rs 200 crore for this scheme and could launch it by end 2012

Page 18

www.expresspharmaonline.com

EXPRESS PHARMA

15

M|A|R|K|E|T lexander Fleming’s discovery of penicillin, more than eight decades ago paved the way for many more discoveries of antibiotics.

The wave of revolution that Fleming started continued for a few more decades with new antibiotics adding to the global medicine market. However, the enthusiasm surrounding new antibiotics started to wane as market conditions changed over the years. The antibiotic business was not adding too much to the balance sheets of antibiotic producers and so, antibiotics further climbed down the priority lists of pharma companies. Though pharma companies have shown depleting interest in the business of antibiotics, on the other hand, need of antibiotics for consumer remained the same.

A

SHARAD DAHATONDE

DR GIRISH MAHAJAN

General Manager, Biotechnology, Elder Pharmaceuticals

Senior Group Leader, Anti-infective Discovery-Natural Products, Piramal Life Sciences

Since last few decades, the well known American and European pharma companies have been ignoring their antibiotic portfolios

New approaches are required to be developed to further exploit microbial resources and their biosynthetic potential as an untapped source of novel metabolites

of nature as a source of new lead molecules. Globally, the microbiologist today is recognised as a key player in the drug discovery programme. The microbial products have been a phenomenal success for the past seven decades. Disease management has undergone a sea change since the discovery of antibiotics.”

He adds, “29 antibacterial medication were licensed between 1980 and 1989. The number fell to nine between 2000 and 2009. Over the past 30 years, only two truly novel classes of antibiotics have entered the market: the oxazolidinones (linezolid) and cyclic lipopeptides (daptomycin), and resistance has been documented for both of these compounds.”

According to Mahajan, besides multi-drug resistant bacteria, economic and regulatory factors are also responsible for the shrinking antibiotic pipeline.

nies should believe firmly that there is need for new antibiotic discovery and it is profitable. Since the safety requirements today are more stringent than perhaps few decades ago, there should be enough leads available to to clinical phases through IND. Microbiologically in order to counter to the current challenge of discovering novel antibiotics, new approaches are required to be developed to further exploit microbial resources and their biosynthetic potential as an untapped source of novel metabolites.”

He informs, “Among the latest efforts to remedy the antibiotic problem is the Food and Drug Administration’s Antibacterial Drug Development Task Force. On September 24, the FDA announced the creation of the panel, which will consist of 19 clinicians and scientists who are part of the FDA Center for Drug Evaluation and Research.

According to Dahatonde, big pharma’s participation will be necessary to resuscitate antibiotic drug discovery. He insists, “There is an urgent need to provide incentives for drugmakers to induce them to develop new antibiotics to treat antibiotic-resistant bacteria.

These incentives should include a priority review of new antibiotics by the FDA and an obligation by the agency to act on applications for approval no later than six months after submission. Also, allow new antibiotics to be eligible for the FDA fast-track approval programme, and companies would be granted five additional years of market exclusivity for newly approved drugs.”

According to Dahatonde, a major focus should be towards the formation of non-profit, public-private partnerships (PPPs) between government agencies and private entities with the primary goal of quickly advancing promising new antibiotics to approved products. “PPP advocates contend that by

Market slump Many pharma companies have decided to do away with the antibiotic business and they have their own justification to support their action. Though for around eight decades antibiotics helped mankind keep diseases at bay, overuse or wrong administration of antibiotics has also made different bacteria resistant to many antibiotics.

Currently, multi-drug resistant superbugs are giving a hard time to scientists.

“Since the last few decades, well known American and European pharma companies have been seen ignoring their antibiotic portfolios. Moreover, many of them have closed their antibacterial departments. The situation is worsened by recent merger and acquisition activity,whereby one new pharma company can come to represent the cumulative assets of up to six formerly independent firms. These mergers tend to be accompanied by stagnation or disappearance of the merged companies’ antibiotic portfolios, reflecting the new corporate entity’s lack of interest in antibacterials,” says, Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals.

Though generic competition is also widely blamed as the reason behind antibiotic crisis, according to Dahatonde, poor returns on the investment has also turned out to be the biggest culprit. For many companies reinvestment into antibiotics research programmes might have proved a wrong move due to lower sales and eroding profits.

Dr Girish Mahajan, Senior Group Leader, Anti-infective Discovery-Natural Products, Piramal Life Sciences, says, “The discovery of antibiotics like penicillin in 1928 and that of streptomycin in 1943, has been pivotal to the exploration

Is the crisis reversible?

Though, arguably, pharma industry is the origin of the antibiotic crisis, according to industry experts, the industry itself is capable of coming out of this uncomfortable situation. However, as problem is critical, the solution is also bound to be very demanding.

Mahajan suggests, “The first thing required is that the big pharma compa-

The enthusiasm surrounding new antibiotics started to wane as market conditions changed over the years.The antibiotic business was not adding too much to the balance sheets of antibiotic producers and so, antibiotics further climbed down the priority lists of pharma companies 16

EXPRESS PHARMA

www.expresspharmaonline.com

October 16-31, 2012

M|A|R|K|E|T removing the profit motive from the equation, novel new antibiotics can be developed regardless of market size and commercialisation potential. PPPs would be funded by both public money and private capital,” Dahatonde explains.

A consultant biologist with Mumbaibased Kohinoor Hospital says, “The R&D crisis can be slowed down by putting obligations on pharma companies to have actual R&D rather than having these only on paper. The companies should be given some benefits like terms of taxation if they show obvious results.”

Government should step in According to pharma players, developing new antibiotics is costly procedure and also less profitable. However, looking at the importance of antibiotics for public health, should Government offer some help to pharma companies?

Survival of any industry is largely determined by the Government, which monitors that particular region and pharma industry is also not an exception.

“Of course, developing new antibiotics is very costly process. Strong industry-academia collaborations with brain storming strategies, technical meetings are to be worked out to set new antibiotics discovery ways and set antibiotic policies in the country. This matter should be taken very seriously, the way the pulse polio campaign is

October 16-31, 2012

being followed. It will not only generate huge revenue but also ensure win against resistant bugs,” says Mahajan.

Even if any pharma company decides to develop new antibiotic, the time required to launch new molecule will be lengthy. So, no sudden positive development is expected as far as launch of new antibiotics is concerned.

There is also a general belief among pharma experts that policy makers and Government haven't yet understood the antibiotic crisis fully. Such an approach would perhaps make the situation even tougher to handle. Though the Government’s approval for higher prices of new antibiotics would make pharma companies feel more secure, the Government is unlikely to entertain such requests.

Market forecast Though there is a need for antibiotics, financial insecurity is making pharma companies' attitude hostile towards antibiotics. With even big players showing a thumbs down to the antibiotics business, the future of domestic and global antibiotic market appears uncertain. Efforts should also be directed towards finding out cost effective alternatives to modern day antibiotics.

Dahatonde explains overall market scenario for antibiotics by providing figures published by Global Research and Data Services, which is a leading international publisher of market research

www.expresspharmaonline.com

reports “Global demand for antibiotics is forecast to reach 34.1 billion euros in 2016. The market has been expanding with an average annual growth of 6.6 per cent between 2005 and 2011. The market expansion is expected to slow to 4.6 per cent in the coming years.

Currently, the industry is dominated by product group other antibiotics (includes e.g. aminoglycoside antibiotics) which covers 79 per cent of the demand while penicillins has 8 per cent, erythromycin 7 per cent, tetracyclines 4 per cent, chloramphenicol 1 per cent and streptomycins 1 per cent share of the market.”

Mahajan feels that, though the growth conditions are not 100 per cent favourable, but nevertheless it is very obvious that there is heavy demand for new scaffolds. Mahajan acknowledges the fact that it is becoming difficult to get new leads satisfying the desired criteria. “The return of trust in natural products, especially microbial should again bring back the era of antibiotics to reduce burden of diseases due to resistance bugs. The task force created at US FDA is indicative that there will be huge market for new antibiotics in future. If natural products are considered as a parallel way to synthetic chemistry to get new leads I think India will be a hub for new antibiotics as it harbours huge biodiversity. The biodiversity will be assets for giving novel antibiotics for future,” signs off, Mahajan. sachin.jagdale@expressindia.com

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M|A|R|K|E|T

GoI to introduce innovative R&D focused pharma cluster scheme Targeted to attract Indian R&D professionals to return & start up in India Usha Sharma Madrid, Spain nand Sharma, Minister for Commerce, Industry and Textile Government of India has recently conducted a sectoral meeting with all Indian pharma industry stakeholders to discuss the formation of an innovative pharma cluster scheme focussed on shared R&D facilities. The Government has tentatively allocated funds of around Rs 200 crore for this scheme and could launch it by end 2012.

Speaking exclusively to Express Pharma on the sidelines of CPhI Worldwide Madrid, S R Rao, Commerce Secretary, Ministry of Commerce and Industry Department of Commerce, Government of India, said, “Today, India’s generic drug exports to the US and EU accounts for 20-24 per cent. To encourage mid- and small-sized pharma

A

companies we have announced a scheme for innovative pharma cluster for R&D. It will help these companies to get better business not only in the domestic market but also in the non-regulated market.

Since the discussion is in its early stage, we have planned to set aside Rs 200 crores initially, which may get changed.

This scheme is likely to be launched by end 2012.”

Giving more details of the scheme JS Deepak, Additional Secretary, Department of Commerce and Industry mentioned, “We have plans to bring this new scheme under the five year plan.

This scheme will provide a common facility for companies on a fee-based approach. This scheme will help R&D professionals eager to return from multinational pharma companies and desire to start their own companies. These professionals can easily relocate to India and become a part of the cluster.”

This scheme will also support entrepreneurs who want to set up innovation clusters in their region.

Highlighting the benefits of the above mentioned scheme, Deepak said, “With the help of this scheme, scientists can carry out their research as a part of this cluster on a fee-based approach and later on they can file patents on their own innovation. This will help the Indian pharma industry to grow much faster.”

He continued that the Government also wants to set up funds for mid sized and small sized pharma companies.

Rajeev Kher, Additional Secretary, Department of Commerce commented on the Free Trade Agreement between India and EU saying, “We are in the process of finalising it and hopefully we will be able to sign the free trade agreement by end of this year.” u.sharma@expressindia.com

Ranbaxy launches authorised generic of Evoxac in US healthcare market Cevimeline hydrochloride is indicated for the treatment of symptoms of dry mouth associated with Sjogren’s syndrome anbaxy Pharmaceuticals Inc (RPI), a wholly-owned subsidiary of Ranbaxy Laboratories (Ranbaxy), has launched the authorised generic cevimeline hydrochloride 30 mg. capsules in the US market, under an agreement with Daiichi Sankyo.

Cevimeline hydrochloride is indicated for the treatment of symptoms of dry mouth associated with Sjogren’s syndrome, an autoimmune disorder affecting the moisture-producing glands, and is presently distributed by Daiichi Sankyo, under the brand name Evoxac. Evoxac generated total annualised sales of $62.4 million in the US (IMS – MAT June 2012).

Bill Winter, Vice President, Trade Sales and Distribution, North America, Ranbaxy said, “Ranbaxy is pleased to

R

announce the launch of cevimeline hydrochloride in 30 mg. capsules, as the authorised generic of Evoxac in the US. This launch further underscores Ranbaxy’s resolve to bring high quality, affordable generic medicines to the US healthcare system to meet the growing needs of patients and prescribers.”

Regarding the launch, Arun Sawhney, CEO and Managing Director, Ranbaxy, said, “We welcome the opportunity to launch cevimeline hydrochloride in the US market. This authorised generic form of Evoxac is an excellent example of optimising operational synergies that exists between Ranbaxy and Daiichi Sankyo, while accelerating our global business efforts. We see a continuing opportunity to leverage our combined strengths of

innovation and the manufacture and marketing of affordable, high quality, generic medicines through this collaboration.”

Commenting on the launch of an authorised generic of Evoxac, Dr Tsutomu Une, Chairman, Ranbaxy, said, “We refer to the strategy of optimising the diverse assets of both companies as our hybrid business model, that will allow both organisations to effectively seize opportunities across the full pharmaceutical value chain and product life-cycle, by leveraging the R&D and manufacturing of both Daiichi Sankyo and Ranbaxy. As such, we will continue to reinforce our respective business platforms over the longer term through this hybrid strategy.”

EP News Bureau

WHO prequalifies Cipla’s ‘MEFLIAM Plus’ for treatment of malaria MEFLIAM Plus, an Artesunate-Mefloquine fixed-dose combination to be rolled out throughout Asia umbai-based Cipla, along with the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) announced the prequalification of the fixed dose combination (FDC) of Artesunate (AS) and Mefloquine (MQ) – ASMQ FDC – by the World Health Organization (WHO).

This Cipla-manufactured ASMQ FDC available in India under the brand name ‘MEFLIAM Plus’ is the first Artesunate-Mefloquine FDC to be prequalified by WHO and is recommended for the treatment of malaria.

“The prequalification announcement is recognition that MEFLIAM Plus meets WHO’s high quality standards and we aim to make this treatment

M

18

EXPRESS PHARMA

widely available throughout Asia,” commented Dr Jaideep Gogtay, Medical Director, Cipla.

“The availability of ASMQ FDC will have a direct impact on patients, especially in Asia. It addresses an important public health need in the region as it forms part of the malaria treatment arsenal necessary to control the disease,” said Bernard Pécoul, Executive Director, DNDi. This combination of AS and MQ is one of five Artemisinin Combination Therapies (ACTs) currently recommended by WHO for the treatment of uncomplicated P falciparum malaria, and is the first-line treatment in a number of South East Asian countries.

www.expresspharmaonline.com

ASMQ FDC was registered in India in 2011 and in Malaysia in early 2012. In India, about 18,000 adult patients have already been treated with MEFLIAM Plus.

ASMQ FDC was originally developed by DNDi and the Brazilian government-owned pharma company Farmanguinhos/Fiocruz and was registered in Brazil in 2008. A South-South technology transfer between Farmanguinhos and Cipla was achieved in 2010 to facilitate the implementation of ASMQ FDC in Asia. Prequalification is a major milestone, as it indicates that ASMQ FDC meets WHO standards of quality, safety, and efficacy.

EP News Bureau October 16-31, 2012

M|A|R|K|E|T

ABLE and WBBA sign MOU to support breakthrough discoveries for better healthcare solutions Join hands for co-operation and investment in the field of biotechnology he Association of Biotechnology Led Enterprises (ABLE), the apex body of the biotech sector in India and US-based Washington Biotechnology & Biomedical Association (WBBA) have signed a Memorandum of Understanding (MoU) in New Delhi for broad ranging cooperation in the field of biotechnology to support breakthrough discoveries in healthcare, agriculture and clean energy in the country.

According to this MoU, both ABLE and WBBA will undertake activities to further their respective mandates by providing each others’ members opportunities to co-operate and invest in the State of Washington and in India in the field of biotech. These activities could be the current ones that both associations are engaged in or future ones that both may decide to do individually or jointly. Among others, the activities could be concerned with technical knowledge, market research, inputs for policy making, internships, exhibitions, workshops, seminars, capacity building, collaborations, Investment and business partnering. Speaking on this occasion, Dr PM Murali, President, ABLE said, “We are pleased to partner with WBBA to support and provide each other with cutting edge research in biotech. The collaboration aims to achieve breakthrough discoveries to provide affordable solutions for critical diseases, important challenges in agriculture and energy on mutually agreed topics.”

Chris Rivera, President, WBBA said, “We see India as the growth engine of tomorrow and one of the fastest growing economies in the world. This collaboration with ABLE in India is significant to WBBA to facilitate best of research in biotechnology from both the countries.”

Chris Gregoire, Governor of Washington State, who was present for signing this MoU said that, “Washington State has always promoted technology innovation and biotech has been one of our areas of focus for research and development. This exciting partnership will spur progress in this sector in India and Washington, growing jobs in both regions. We know that this collaboration, over time, will pay dividends

T

October 16-31, 2012

in improved public health and economic development.”

This partnership will enable both WBBA and ABLE to recognise each other as the preferred knowledge partner for the biotechn industry.

This will encourage individual industry member repre-

sentatives or industry organisations wishing to consider investing or doing business in the State of Washington or India to come through ABLE /WBBA so that the views can be harmonised and vetted by WBBA /ABLE experts. This would enable a more efficient

and effective mechanism of interaction between WBBA/ABLE and the private biotech industry in India and in the State of Washington.

Both associations will provide inputs on various issues related to the healthcare, food, agriculture, bio-energy, clean-

tech and nutritional field and facilitate opportunities in research, technologies, drug development, education, human resources, manufacturing, marketing, services, business, trade, capacity building.

EP News Bureau

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

Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India.

Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com "Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

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EXPRESS PHARMA

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Takeda and Advinus initiate multi-year drug discovery collaboration To focus on novel targets for major therapeutic areas, including inflammation, CNS, and metabolic diseases akeda Pharmaceutical and Advinus Therapeutics have entered into an agreement to initiate a three-year discovery collaboration focused on novel targets for major therapeutic areas, including inflammation, CNS, and metabolic diseases. In this collaboration, Advinus is responsible for leading the programmes to create optimal IND ready compounds for pre-defined targets.

Advinus is a research-based pharmaceutical company, which creates longterm value through internal and collaborative innovative drug discovery, and is building on a strong track record of efficient solutions to address some of the key challenges facing biopharma industry’s R&D productivity. Advinus’ proprietary pipeline demonstrates its ability to create a timely and sustainable flow of IND candidates. The multi-year collaboration will be built upon this foundation, with the goal to develop INDs for both pre-existing and novel targets.

Under the terms of the agreement, Takeda will receive worldwide commer-

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cial rights to drug candidates emerging from this alliance. Advinus will receive guaranteed research funding of $36 million over the term of the collaboration, $9 million in milestones leading to candidate selection, and is eligible to receive future clinical and regulatory milestone payments of up to $45 million per product, plus royalties on product sales worldwide.

“Collaboration with Advinus is one of our initiatives to enhance our research productivity. We are very excited to partner with Advinus as they have innovative approaches to efficiently generate INDs that will further strengthen Takeda’s drug discovery capabilities, while also enhancing our pipeline,” said Dr Paul Chapman, General Manager of the Pharmaceutical Research Division, Takeda.

“Advinus team is delighted that its biggest ever collaboration has been made possible by Takeda's visionary leadership, and their confidence in the founding principles that aim to create

these new R&D opportunities. Takeda and Advinus teams together will advance globally networked innovation for addressing key Pharma R&D issue – R&D productivity for better return on R&D investments,” added Dr Rashmi Barbhaiya, Chief Executive Officer, Advinus.

Dr Ajay Kumar Sharma, Associate Director - Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East said, “This is a good start as largely the Indian CRO's were considered for their costs for chemistry process involving drug manufacturing. The prediscovery or the biology processing was largely absent in outsourcing deals.

Advinus has been focussing on developing its own drug candidates for quite some time and now with the support of Takeda coming in there would be no surprise if the world sees some blockbuster drugs coming out of their arsenal in the next decade. This move will also increase the confidence for other big pharma's to re-think their strategies.”

MSF launches Patent Opposition Database in developing countries Database aims to boost access to medicines hit by high drug prices new online resource for civil society and patient groups in developing countries to challenge unwarranted drug patents was launched by Médecins Sans Frontières (MSF). The Patent Opposition Database comes as many developing countries face dramatically high drug prices because patents block the production of lower-cost generic versions. The Patent Opposition Database is accessible at patentoppositions.org “Drug companies routinely apply for patents or are granted monopolies on medicines even when these aren’t actually deserved. It’s a myth that every patent application that is filed is valid. When you look closely, a patent application may fail one or more of the legal tests it needs to pass. The idea behind this database is to help civil society and patient groups stop unwarranted patents from blocking people’s access to more affordable medicines,” said Michelle Childs, Director of Policy Advocacy for MSF’s Access Campaign.

A ‘patent opposition’ is allowed under international trade rules as a way to keep checks and balances on pharma patenting. In countries where they are allowed, like Thailand, Brazil or India, patent oppositions have successfully prevented undeserved patent monopolies from being granted and allowed generic competition to bring the price of medicines down.

“Successful patent oppositions by

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civil society in India have enabled us to use more affordable generic versions of key HIV medicines in our treatment programmes,” said Dr Esther C Casas, MSF HIV/TB Specialist for Zimbabwe.

“Due to the volume of applications, local patent examiners can miss information and grant unjustified patents. Just putting two or three separate pills into one, or using known industry practices to formulate a drug, should not be considered innovative enough to warrant a new 20-year patent, for example. By filing patent oppositions, we can highlight this information and the possibility of invalid patents being granted is reduced,” explains Vikas Ahuja, President, Delhi Network of Positive People.

Successful examples include the opposition by Indian groups to GlaxoSmithKline's patent application in India on the HIV fixed-dose-combination zidovudine/lamivudine, on the grounds that it was not a 'new invention', but simply the combination of two existing drugs. This combination is now widely used in HIV treatment in developing countries. A pre-grant opposition filed by the Cancer Patient Aid Association was also the spur for the rejection of Novartis's patent application on the salt form of imatinib, on the basis that the medicine was merely a new form of an old medicine. The move – which is now the subject of a challenge before the Supreme Court - opened up generic com-

www.expresspharmaonline.com

petition on the drug used in the treatment chronic myeloid leukaemia and brought the price down by 92 per cent from over $2158 per month to $174 per month.

Childs said, “An unwarranted patent not only delays the entry of price-lowering competition, it also undermines the drive for genuine innovation. With very few innovative new drugs in their product pipelines, pharma companies desperately want to stave off generic competition by trying to get more patents on old molecules, or on processes that are not new.”

The Patent Opposition Database aims to guide civil society groups through the process of challenging an unjustified patent. It will allow organisations to forge new alliances and share vital specialist knowledge, as a patent application can often be challenged in different countries on the same basis. It contains a searchable listing of 45 patent oppositions relating to key medicines and over 200 other supporting documents that will aid in the building of future patent oppositions. The resource will grow as more data is added.

The launch of the database marks the 10-year anniversary of the first time a patent opposition filed by a patient group - Thailand’s AIDS Access Foundation successfully overturned an unfair patent on the HIV drug didanosine in the Thai courts.

EP News Bureau October 16-31, 2012

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

Sep’12 clocked decreased pharma M&A activity in both volume and value terms MedTRACK recorded 25 M&A transactions in September 2012, against the previous six months’ average of 41.5 transactions M&A (including private equity) trend analysis

Mergers and acquisitions &A activity in the pharmaceutical market was focused on increasing product offerings through complementary product portfolios, as the companies were looking for long-term growth.

In line with the above trend, Canada-based Valeant Pharmaceuticals agreed to acquire Medicis Pharmaceutical, a US-based specialty pharma company for approximately $2.6 billion. This acquisition is a strategic fit and will help the company to drive long-term growth.

With this transaction, Valeant will gain access to Medicis’ complementary portfolio of branded products Solodyn, Restylane, Perlane, Ziana, Dysport and Zyclara.

The transaction will strengthen Valeant's presence in acne, actinic keratosis, aesthetic injectables and anti-viral markets.

In another key deal, Mallinckrodt, the pharmaceuticals business of Covidien agreed to acquire CNS Therapeutics, a US-based specialty pharma company for approximately $100 million. With this acquisition, Mallinckrodt will gain access to CNS Therapeutics’ marketed product line, which complements its branded portfolio.

The M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of previous six months (Mar 2012–Aug 2012).

According to Datamonitor's Medtrack database, the pharma sector recorded 25 M&A transactions in September 2012, against the previous six months’ average of 41.5 transactions. In value terms, the sector recorded deals worth $3.6 billion against the previous six months’ average of $10.3 billion.

The Indian pharma sector witnessed two deals during September 2012, against the average of 0.8 deals over the previous six months. Among them, Japan-based Mitsui’s announcement for acquisition of 25 per cent stake in Arch Pharmalabs, a manufacturer and seller of active pharmaceutical ingredients for $69.32 million, is notable.

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Source:

Top M&A deals (Sep 2012) Rank

Date

Target

Acquirer

Deal value ($m)

1

Sep 3, 2012

Medicis Pharmaceutical Corporation (US)

Valeant harmaceuticals International, Inc. (CA)

2600.00

2

Sep 12, 2012

3SBio, Inc. (DE)

CPEChina Fund, L.P.; Dr. Jing Lou

337.00

3

Sep 24, 2012

QLT, Inc. - Visudyne (CA)

Valeant Pharmaceuticals International, Inc. (CA)

132.50

4

Sep 17, 2012

Complete Genomics, Inc. (US)

Beijing Genomics Institute (CN)

117.60

5

Sep 27, 2012

China Nuokang Bio-Pharmaceutical, Inc. (CN)

Kingbird Investment, Inc. (US)

112.00

6

Sep 24, 2012

CNS Therapeutics, Inc. (US)

Mallinckrodt, Inc. (US)

100.00

7

Sep 17, 2012

Arch Pharmalabs, Ltd. (IN)

Mitsui & Co., Ltd. (JP)

69.32

8

Sep 6, 2012

Triplex Biosciences Company, Ltd. (CN)

RRJ Capital (HK)

50.00

9

Sep 27, 2012

NeuroSearch A/S - Huntexil (DK)

Teva Pharmaceutical Industries, Ltd. (IL)

25.90

10

Sep 27, 2012

BioLineRx, Ltd. (IL)

Lincoln Park Capital Fund, LLC (US)

15.00

Source:

Venture financing trend analysis

Venture funding Companies in the pharma sector raised $304.1 million during September 2012, against the previous six months’ average of $247.6 million. In terms of volume, the sector recorded 18 venture funded deals, compared to the previous six months’ average of 21.1 transactions.

Notes and Definitions

Source:

Top venture financing deals (Sep 2012) Rank

Date

Target

Investors

Deal value ($m)

1

Sep 18, 2012

CureVac GmbH (DE)

dievini Hopp BioTech holding GmbH & Co. KG

104.95

2

Sep 20, 2012

Foundation Medicine, Inc. (US)

Deerfield Management Company L.P; Casdin Capital, LLC; Redmile Group, LLC; Roche Venture Fund; WuXi Corporate Venture Fund; Third Rock Ventures, LLC ; Google Ventures; Kleiner Perkins Caufield & Byers ; Undisclosed Fund ; Undisclosed Investors

42.50

MedTRACK is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. MedTRACK’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. Inhouse analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

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

Definitions

3

Sep 20, 2012

MyoKardia (US)

Third Rock Ventures, LLC

38.00

4

Sep 5, 2012

F2G Ltd (GB)

Advent Life Sciences Fund; Novartis BioVenture Fund; Merifin Capital ; Sunstone Capital A/S; Astellas Venture Fund I (AVF I) ; K Nominees

30.00

5

Sep 19, 2012

Selexys Pharmaceuticals Corporation (US)

MPM Capital

23.00

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

2. Trend analysis excludes rumoured and terminated deals.

3. Value and volume analysis excludes private equity exits.

Source:

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www.expresspharmaonline.com

October 16-31, 2012

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

Chromatographic Society of India to organise symposium Symposium on ‘Evolution of Gas Chromatography in India—Past, Present and Future’ to be held in Mumbai on November 23 and 24 hromatographic Society of India (CSI), a non-profit organisation committed to education of chromatography and mass spectrometry to interested students and chemistry professionals, will organise a symposium on ‘Evolution of Gas Chromatography in India—Past, Present and Future’. The symposium will be held at Training School Hostel Auditorium, BARC, Anushakti Nagar, Mumbai on November 23 and 24, 2012.

The symposium will bring together all those connected with gas chromatography. There will be only invited talks from the experts in various fields of GC application such as petrochemicals, natural gas, perfumeries, flavours, pharma, forensic, doping, synthetic chemistry, natural products, etc. It will provide a platform to recognise the scientists, companies and the people who have helped in placing India on the international map of chromatography.

The delegates of this symposium are expected to be the users of GC from the industry, researchers as well as teachers and students from the academic institutions and national research centres. The representatives from the analytical instruments industry are also expected to participate.

On this occasion, CSI is planning to bring out a special commemorative souvenir covering the history of gas chromatography developments in India, the profiles of companies that have helped in bringing up this industry and the profiles of the selected individuals, who have devoted a major part of their career in contributing towards this industry and education of this technique.

It is expected that this volume will be a 'Collector's Item' by those who are interested in analytical instrumentation in general and chromatography in particular. It is proposed to have an exhibition of both local and imported GC suppliers, accessories and consumables during this symposium for the benefits of the delegates and visitors.

The exhibition will help them to decide on their future purchases. The symposium is intended to be a common

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October 16-31, 2012

meeting point of researchers, students, teachers, chemical industry personnel and the analytical industry representatives.

Speakers at the event are: Annaji Rao, retired scientist from BARC, Mumbai; B Sitharaman, Director of

Thermo Fisher Scientific, Nashik; Rodney Cheng, Analytical Measurements, Singapore; Dr Sangita D Kumar, ACD, BARC, Mumbai; Ambarish Anjaria, Reliance Industries, Hazira; Dr L Kalyanaraman, Dr Reddy’s Laboratories, Hyderabad; Dr

M Vairamani, SRM College, Chennai; Dr SY Pandey, JRF, Vapi; Dr K Sundararajan, International Flavour & Fragrances, Chennai; Dr ND Gangal, NOCIL, Mumbai; Dr MK Malve, Forensic Science Laboratory, Mumbai; Dr Alka Bheotra, National

Dope Testing Laboratory, Delhi; Dr Ajit Datar and Dr G Ramakrishnan, CSI, Mumbai.

The concluding remarks will be given by Dr Tulsi Mukherjee, Director, Chemistry Group, BARC. EP News Bureau

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API China Date: November 7-9, 2012 Venue: International Conference & Exhibition Center, Xiamen, China Summary: China’s leading exhibition for the pharmaceutical manufacturing sector will cover the complete spectrum of products from raw material, fine chemical, intermediate, ingredients, processing machinery and packaging machinery. It is an event for international buyers to meet Asian sellers especially Chinese ingredients manufacturers. The event will attract over 1,400 manufacturers and 30,000 professional visitors.

Contact details: Exhibitor Services Tan Zhen API China Team E-mail: zhen.tan@reedsinopharm.com Tel: 0086-10-84556693 Visitor & Media Services Shell Zhao API China Team E-mail : weilin.zhao@reedsinopharm.com Tel : 0086-10-84556692

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

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Symposium on Evolution of Gas Chromatography in India - Past, Present and Future Date: November 23-24, 2012 Venue: BARC Training School Hostel at Anushakti Nagar, Trombay, Mumbai.

Summary: The symposium will bring together all those connected with gas chromatography. Experts will speak on various fields of GC application such as petrochemicals, natural gas, perfumeries, flavours, pharma, forensic, doping, synthetic chemistry, natural products, etc. It will provide a platform to recognise the scientists, companies and the people who have helped in placing India on the international map of chromatography.

Contact details: Dr G Ramakrishnan Convener of the Symposium, Chromatographic Society of India C-1203 Synchronicity, Nahar Amrit Shakti Road, Chandivali, Mumbai - 400072.

Mobile: +91-98200 93260 E-mail: ramakrishnan.g@ chromsocindia.org Website: www.chromsocindia.org

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, gamechanging strategies and relevant application of the knowledgeintelligence 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 bioeconomy 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

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

October 16-31, 2012

Watson India goes live with SAP BusinessObjects Dashboards for their Organization wide MIS & Business Analytics for India & Europe Our Delivery Teams are based in multiple locations in India and draw upon strategic relationships and alliance across Europe, Middle East, Africa and the USA markets.

For more information please visit www.prisminfoglobal.com or email us on info.in@prisminfoglobal.com

Watson India and Prism makes successful implementation of Business Analytics

Consulting & Implementation Partner: PRISM Informatics Ltd.

Overview

Performance on a Go..

Watson Pharmaceuticals, Inc. (NYSE: WPI) is a leading integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic, brand and biologic pharmaceutical products. Watson is among the top five pharmaceutical companies in the United States, and among the top 4 generic companies in the world, based on total prescriptions

¡ Easy integration with the existing ERP

Situation Watson India's management committee chaired by its Managing Director reviews month and year to date performance (vis a vis Budget/Forecast) alongwith Functional Heads and Unit Heads. This monthly review encompasses both the financial and operational metrices. The performance dashboards are shared with the Global Operations Head, Global Finance Head and other Global Leadership teams.

Solution SAP BusinessObjects has been implemented to facilitate KPI based dashboards through a system based approach with leveraging SAP BW as an enterprise Data Warehouse.

Implementation Covers ¡ Manufacturing Analytics ¡ Sales Analytics ¡ Financial Analytics ¡ R & D Projects Analytics ¡ Quality Compliance Analytics

system, SAP, without deploying any additional tool to extract the data. ¡ Extraction of relevant information from

the ERP system with less custom development. ¡ Easy integration for accessing the data

from non SAP system and also direct upload from excel. ¡ Automated the data collection process ¡ Reduced duplication of efforts

About Watson Watson Pharma Private Limited, India is a stepdown subsidiary of its parent organization in US, namely Watson Pharmaceuticals Inc. Watson Pharmaceutical Inc, (NYSE: WPI), headquartered in Parsippany, New Jersey, is a leading integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic, brand and biologic pharmaceutical products

¡ Potential reduction of human errors ¡ Repository of data / information at one

central place accessible to stakeholders

About Prism

Dashboards comprised of ¡ Location wise KPIs ¡ Month and year to date financials. ¡ Operations performance metrics of

various functional areas including, Manufacturing, Quality Assurance, Human Resources, Regulatory Affairs, Supply Chain (SC), Finance and Shared Services. ¡ Graphical and tabular presentation of

Unit wise and function wise KPIs, along with highlights for the month, challenges for the next quarter and forecast for the year.

Prism Informatics Ltd. (BSE: 505530), a leading Software Development and IT Business consulting services provider, has delivered unmatched value benefits to many Pharmaceutical & Chemical companies and has partnered them in their quest of scaling untenable heights of success.

Prism, with its deep knowledge of the Pharmaceutical and Chemical industry and supplemented with a large number of functional domain specialists has delivered several successful SAP implementations.

Our Delivery Teams are based in multiple locations in India and draw upon strategic relationships and alliance across Europe, Middle East, Africa and the USA markets.

¡ Supply chain & Inventory AnalyticsC o s t

Analytics

Contact: Mr. Kavan Shah kavan.shah@prisminfoglobal.com +91 9819957770 | +91-22-65724261

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

Lex Witness hosts Pharma Legal & Compliance Summit 2012 in Mumbai Summit provided an ideal platform to all business experts and stakeholders to come together and discuss issues ex Witness, a magazine focussed on legal and corporate affairs recently hosted Pharma Legal & Compliance Summit (PLCS 2012) in Mumbai. An initiative undertaken for pharma companies, biopharma firms and medical device manufacturers, the summit provided an ideal platform to all business experts and stakeholders to come together and discuss issues relating to current regulatory developments, ethics and compliance issues, contract management, licensing agreements as well as develop a proactive legal strategy for patent litigations.

Speaking on the occasion, PBA Srinivasan, Editor-in-Chief, Lex Witness said, “The bio-pharmaceutical industry of India is in its emerging stage and hence, now is the time to revise the legal and compliance strategies concerned so as to ensure sustenance and future growth.

Marketing practices by pharma companies of pushing their products to foreign countries is against the medical ethics and MCI rules. The need of the hour is to bring into force a new code of conduct so as to knock down the doctor-pharmaceutical nexus running in the country.”

The day long discussion focussed 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 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

L

claims and licensing agreements.

The convention saw participation of various law firms, copyright societies, regulatory and patent filing consultants sharing their views and proficiency on the grave concerns affecting their territories.

The proficient speakers’ panel included Ajay Thomas, Registrar, LCIA India; Debolina Partap, Associate Vice President and Head Legal, Wockhardt Group India; Girish Gokhale, President Legal & Group General Counsel, JSW Group; KP Pradeep, Sr Manager Compliance, MSD; Marshall Mendonza, Vice President Legal & Company Secretary, Glenmark Pharmaceuticals; Milind Antani, Head, Pharma & Life Sciences Practice Group; Nishith Desai Associates, Nasser Kabir, Vice President Legal, Strides Arcolab; Priti Suri, Founder Partner, PSA; Rajeev Mukundan, General Counsel and Chief Compliance Officer, Mylan Laboratories; Suhas Tuljapurkar, Managing Partner, Legasis Partners & Director, Legasis Services and Vivek Mittal, Head Legal, Lupin Pharma.

Summing up the learning’s of the day Shyam Grover, Group Editor and CEO, Lex Witness said “Indian pharma industry is

escalating up the value chain and its future development demand that all the rules and regulations which guide, monitor and control the conducts of the contributors of the country’s healthcare system and also examine the means to bring them at par with international standards.

I am delighted that we took one small step towards progress by bringing together so many professionals of pharma sphere under one roof who made us see where we stand as of now and where we have to reach.”

The PLCS 2012 pioneering initiative was conceived by Lex Witness as part of a knowledge series and was sponsored by Legasis as Knowledge Partner, Nishith Desai Associates as Legal Partner, TMT Law Practices and PSA as Silver Partners, Laser GRC Solutions as Technology Partner. NMIMS Institute of Intellectual Property Studies supported the summit as Academic 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

Pharma Supply Chain Forum highlights growing demand of supply chain and logistics in pharma industry The theme for the forum was 'Agile, Efficient Supply Chain' he theme for the 2nd Edition of Pharma Supply Chain Forum was ‘Agile, Efficient Supply Chain’.

The forum recently held in Mumbai was a part of the 6th Express, Logistics & Supply Chain Conclave. The forum had a mix of panel discussion sessions and individual presentation sessions.

Prominent well known industry experts spoke on various subjects / topics.

Some of the eminent speakers who took part in the forum were SG Rao, Novartis; Thomas Lobo, Pfizer Pharmaceutical India; Ryan Viegas, Watson Pharmaceuticals; Srinivas Iyer, Thermo Fisher Scientific India; Rajiv Sharma, Panacea Biotec and

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Vikas Upadhyay, Carrier India; Olivier Brusle, Supply Chain Foundation; Monish Darda, Co-Founder & CTO, Icertis; Manas Sahoo, Fresenius Kabi India; A Jagannatha Reddy, Mylan Laboratories; Sukhendu M

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Patnaik, Truecare, Abbott Healthcare; Surendra Deodhar, Reliance Life Sciences; Chetan Kumria, Baxter (India); Dilip Kumar Sharma, Startrek Logistics.

The speakers discussed topics on 'Collaboration with strategic partners to manage your supply chain on a global level', 'JIT in Pharma SCM', 'Supply Chain Capability Building in the Pharmaceutical industry', 'Bringing the benefits of cloud to Transportation: Faster, Simpler, Better!'& 'Building an integrated supply chain network to achieve high level of accuracy in forecasting, sourcing and inventory management.'

EP News Bureau October 16-31, 2012

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IPA’s 3rd Technical Conference talks on Global Regulatory Compliance Challenges of APIs Event held in Mumbai saw august gathering with interactive sessions ndian Pharmaceuticals Association (IPA) recently organised 3rd Technical Conference in Mumbai. The main participants were from European Directorate for Quality of Medicine (EDQM) and WHO. The title of the conference was Global Regulatory Compliance Challenges of Active Pharmaceuticals Ingredients (APIs). Present on the occasion were SD Joag, General Secretary, IPA and Dr JAS Giri, President, IPA along with Dr Florence Benoit – Gubod - EDQM and Dr Milan Smid – WHO. An august audience comprising pharmaceutical technical personnel attended the meet.

Dr P Khadgapathi, Director and Chairman, Hetero Group, delivered the key note address pertaining to Quality Assurance and Manufacturers’ Perspectives of APIs. Following eminent speakers of the first session moderated by Dr Venugopal Somani, Deputy DCGI, spoke on assurance of API quality and its implication for the Global API manufacturers. Benoit spoke on 'Assurance of API Quality and its Implication for the Global API manufacturers'; Ian Thrussel – (WHO) – spoke on Application Quality By Design (QBD) Concept in Production of APIs. SM Mudda – Executive Director Technical and Operations –Micro Labs, conveyed his concerns on EU Falsified Medicine directives and implementing these directives will lead to protectionist measure possibilities by the EU regulators.

Mudda added, “The fact that key speakers from the major leading Regulatory Agencies such as UK MHRA, WHO, EDQM, French Regulatory Agency and US FDA participated actively and shared their expectations from the Indian industry confirmed that India is considered as one of the important global suppliers of API. However, the presentations made and the deliberations brought to the fore the concern that the Indian API industry has to adopt the quality systems and risk-based approaches to face the future regulatory challenges and remain in the state of ongoing compliance.”

Parallel sessions followed where Dr Nandkumar Chodankar moderated the session on GMP Compliance in Production of APIs along with Benoit and Thrussel. Dr Albinas D'sa -US FDA Country Manager spoke on inspections conducted by US FDA of API manufacturing sites in details where a lot of insights were highlighted.

Thrussel drew the audience to international collaboration of api programme and inspection aimed at arriving at successful quality global supply chain.

The second parallel programme was on Documentation of API Quality as required for regulatory purposes. This was moderated by Dr Jagashetty – Drug controller of State of Karnataka. The speakers were Dr Vishwanath MalkarConsultant. He Spoke on quality of the

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APIs followed by Dr Maryam Mehmandoust. She gave an authentic details of EU requirements on Quality of APIs Dr Anthony Fake – (WHO) discussed on API Documentation from the perspective of WHOPrequalification Programme.

The first session on the second day was an Update on Pharmacopoeia Development. This session was chaired

by Dr Ajit Dangi - President and CEO Danssen Consulting with Dr Pascale Poukens – Renwart; DrViany Nayak – President, Alembic Pharmaceuticals and Dr Anthony Fake -WHO. They all spoke

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and gave updates on European International and Indian Pharmacopoeias respectively.

Nayak highlighted the important areas in the Pharmacopoeal harmonisation and the initiatives taken and to be taken in the days to come.

The last session was on API Certification & Prequalification Scheme.

This session was moderated by Dr Devinder Pal- Head Catalyst Pharma. The session saw Dr Pascale Poukens and Dr Anthony Fake gave details about EDQM Certification and WHO programme respectively.

EP News Bureau October 16-31, 2012

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Highlights of a recent webinar organised by Metro Atlanta Chamber in partnership with FDASmart, which threw up interesting insights n September 26, 2012 a unique webinar was held by Metro Atlanta Chamber in partnership and collaboration with FDASmart, a USbased with India offices life sciences and pharmaceutical services firm. Express Pharma was the exclusive media partner to the 90-minute webinar, which focused on opportunities and challenges of life science Small, Medium Enterprises (SMEs) in the US- Atlanta region seeking possible Indian collaboration or partnering.

US speakers included an HIV vaccine early stage developer in Atlanta and a brief, but comprehensive snapshot of Atlanta as a life sciences hub in the US South East by Metro Atlanta Chamber while Indian webinar speakers addressed India’s CRAMs and CMO market leader possibilities beyond small molecules and generics plus financing life science ventures in today’s globally strapped economic and investment scenario.

Highlighting Atlanta's advantages, David Hartnett, VP-Bioscience and Healthcare IT, Metro Atlanta Chamber mentioned that tech majors from India like Wipro, Mahindra and Mahindra, Tata, and L&T were already in the arena. He indicated that consultations were on with Indian companies in the biosciences arena as well. A key attraction for Indian companies could be features like the 85,000 sq feet of shared bioscience incubator space available in the Innovation Crescent, a collection of 13 communities in close proximity to Atlanta.

Robert McNally, President and CEO, GeoVax Labs talked about the HIV/AIDS vaccine being developed by his company and his intention to partner with Indian pharma and biotech companies for

O

the development of the Clade C version which would be suitable for Indian populations.

Satish Nagaraj, Global Business Development, Syngene International spoke about converging disease patterns in the developing and developed worlds, which is increasing the need for partnerships between the US and India. According to him, India makes a very good value proposition for USbased big pharma and biopharma players not just on the cost front but also for its scientific talent pool, diverse genetic profile, attention to quality as well as government initiatives like biotech parks, etc.

Rounding off the India perspective, Vishal Gandhi, Managing Partner and CEO, BioRx Venture Advisors gave a perspective about the financial ecosystem, commenting that while the Indian Government is committed to take the biotech segment to the next level, there is a huge scope for PPPs. While 70 per cent of PE funds in India want to invest in pharma and biotech industries, the lack of a clear exit strategy could be a threatening factor.

Based on the success of the first webinar with Metro Atlanta Chamber, Ram Balani, CEOFounder, FDASmart indicated there would be more future life sciences webinars to come. According to him, “These unique webinars address a big gap which customary trade delegations cannot bridge, i.e. bringing together (virtually at first) start-up, small innovative life sciences companies from both Atlanta and India that will hopefully foster partnering or new business developments beneficial to both the US and Indian life sciences industry sector.”

EP News Bureau

15th IDMA - PAC 2012 focusses on ‘Conformance to Emerging Global Quality Standards’ Event sees more than 200 participants ndian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) recently organised the 15th Pharmaceutical Analysts’ Convention (PAC) 2012 in Mumbai. The main theme of this year’s convention was 'Conformance to Emerging Global Quality Standards'.

The two-day event saw more than 200 participants including exhibitors from across the country. Officials from US FDA, IPC and past presidents and executive committee members from IDMA participated in the event.

The convention was inaugurated by Dr Kamal Sharma, Managing Director, Lupin, who was the chief guest accompanied by Dr Nitya Anand, First Chairman – SB IPC, Co-Chairman, IPC and ExDirector, CDRI. During the PAC, the ‘Young Pharmaceutical Analyst Award 2012’ was presented to Dr Wahajuddin, who is a scientist at Pharmacokinetics and Metabolism Division, CSIR, Central Drug Research Institute, Lucknow. “The Outstanding Pharmaceutical Analyst Award 2012” was presented to S Somasundaram, who is working as Head,

I

Visit www.agilent.com/chem/usp-232-233 for the Agilent pharma primer, Elemental Impurity Analysis in Regulated Pharmaceutical Laboratories

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Quality Management, for API Division, MSN Group, Hyderabad.

On the first day of the convention, delegates and speakers visited Piramal Healthcare & Life Sciences.

The delegates were received by Dr H Sivaramakrishnan, President, Research & Development, Piramal Healthcare & Life Sciences.

The exhibitors interacted with speakers, invitees and delegates at the special interaction session organised on the first day of the convention.

In his concluding remarks, Daara Patel, Secretary-General, IDMA, appreciated the presentations made by all the eminent speakers.

EP News Bureau October 16-31, 2012

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Pharmexcil launches EU leg of Brand India Pharma Campaign at CPhI Worldwide Madrid Buyer Seller meet and India pavilion get good response Usha Sharma Madrid, Spain he Europe launch of Brand India Pharma Campaign was recently held at CPhI worldwide 2012 at Feria de Madrid, Spain. The three-day event by Pharmaceuticals Export Promotion Council of India (Pharmexcil) saw a huge number of visitors and exhibitors from across the world. Ministry of Commerce and Industry, Government of India has initiated the Brand India Pharma Campaign to position India as ‘pharmacy of the world.’

The Europe launch of Brand India Pharma Campaign follows the launch at CPhI Japan, this March 21–23, 2012 and CPhI South East Asian in May. The India Pavilion was inaugurated by lighting the lamp by S R Rao, Commerce Secretary, Ministry for Commerce and Industry, Government of India; Rajeev Kher, Additional Secretary, Department of Commerce, Ministry of Commerce and Industry; J S Deepak, Additional Secretary Department of Commerce, Ministry of Commerce and Industry,

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Sunil Lal, Ambassador of India to Spain and N R Munjal, Chairman, Pharmexcil.

Lal said, “Given the huge size of India, it enables us to remain profitable and at the same time promote inclusive growth. It is a known fact that India is able to produce quality medicines at a very low cost. In other words, the more you buy from India, the less you spend.”

Rao mentioned, “The Government of India has supported the ‘Brand India Pharma Campaign’ to reiterate that Indian pharma market is known for its credible, affordable and sustainable healthcare. It is meant to raise an awareness of the success stories in the Indian pharma industry.”

On the second day, Pharmexcil organised a business seminar on ‘Generics from India: Quality and Affordability.’ This seminar, which saw huge participation, began with opening remarks by Lal. He revealed details of the fast track approval process in Spain. Rao gave the keynote address and mentioned that today 50 per cent of the patients get medicines from India.

“The Indian pharma market has registered a CAGR of 15 per cent over the past five years and it is a matter of pride that over 70 per cent of patients in 87 countries get ARVs from India. As the generic segment gains more traction, there is more competition and at the same time makes it a low-margin business. There is a need to develop competencies that will drive the growth of the Indian pharma market beyond 2013,” added Rao. Dr S Eswara Reddy, Deputy Drugs Controller (lndia), CDSCO, explained how the regulatory system works in the Indian pharma industry. Realising that there have been many improvements in the overall quality of the products in the Indian pharma market over the past few years, there is a strong October 16-31, 2012

need to convey these changes to the global audience. Reddy also made a presentation where he spoke on the regulatory framework of India in the pharma sector.

While concluding the first part of the session, Munjal emphasised, “There is a need to maintain a balance between profitability and to heal the global ailing human society.”.

In continuation to the above agenda, panel discussions followed later in the session. Key dignitaries from the Indian pharma industry who shared the dias were Dr Y K Hamied, Chairman and Managing Director, Cipla; Dr B Hari Babu, Acting CEO and Executive Director, Mylan Laboratories; Ajit Singh, Chairman, ACG Worldwide; Anuj Reddy, Vice President Business Development, Wockhardt and Brian Tambi, Former CEO, Morton Grove Pharmaceutical. The panel discussion was moderated by Venkat Jasti, Past Chairman, Pharmexcil.

The opening remarks of the panel discussion started by Rajeev Kher, Additional Secretary, Department of Commerce. He shared the initiatives been formulated by the Government for the Indian pharma industry. “With the Government of India contemplating to institutionalise production in the Indian pharma sector, recognising that tier-II (mid-sized) and tier-III (small-sized) markets, generic companies are operating on lower margins and require government funding. Institutionalising a programme will aim at tying up access to the new export markets,” said Kher, adding that the track and trace mechanism developed by the Indian Government for the Indian pharma industry will further improve the perception about the quality of Indian products.

“92 per cent of the total drugs used in the treatment of HIV are from India, which shows the strong position of the country. If the Indian pharma industry is in confidence, we will surpass the Government target of $25 billion pharma exports by 2015,” said Hamied.

Largely agreeing to the points made by the panel so far, Babu stressed on the fact that there is a need to promote that India has a capability to produce the best quality medicines across the globe.

“The industry needs to support the government in a big way to make the track and trace system a successful proposition for the industry,” said Singh.

The day ended with an Indian cultural programme organised by Pharmexcil.

Raghuveer Kini, Executive Director, Pharmexcil said, “We have received better response in the Buyer Seller meeting at CPhI Worldwide 2012. This year we have managed to conclude around 100 meetings on a positive note.

Around 65 exhibitors participated through Pharmexcil’s India Pavilion this year.”

Kini added, “As a part of the Brand India Pharma Campaign led by Pharmexcil and initiated by the Ministry of Commerce & Industry, Govt of India, top officials from the Ministry have graced the global pharma event, CPhI Worldwide. They also interacted with the Indian exhibitors participating outside the India Pavilion during the threeday event. The support from the Indian government officials has been very well appreciated by all the Indian participants. We thank the Commerce Secretary, Additional Secretaries, the entire Indian pharma industry and all the participants for the success of this event.”

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Management

INSIGHT FOR MANAGING PHARMA

‘Unless an ethics committee is accredited, it should not function’ In a high level meeting held at the Apollo Group of Hospitals, Delhi, experts from various institutions, deliberated on the need for quality and ethical practices in clinical trials by ethics committees. Dr Ranjit Roy Chaudhury, Chairman Task Force for Research, Apollo Hospitals Educational & Research Foundation (AHERF) who also chaired the various sessions, gives an overview of the key points in a chat with Shalini Gupta

Page 38

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October 16-31, 2012

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he Group of Ministers (GoM) finalised its recommendations on India's pharmaceutical pricing policy on September 27, 2012; which proposes that all 348 drugs under the National List of Essential Medicines (NLEM) will come under price control. These proposal will now be sent to the union cabinet for a final approval.

The GoM, who were given the task to decide on the modalities of drug price control, is recommending a ‘market based’ mechanism. As per the GoM's recommendation, the price cap for these drugs will be calculated as the weighted average price (WAP) of all the brands having market share of more than one per cent. Players selling any of these drugs at prices higher than WAP will have to lower their prices and the combinations will be kept out of price controls.

The Supreme Court does not think this mechanism will keep prices in check and has therefore issued a directive to the Government not to change the existing mechanism, ie. to stick to the cost-based method, while including all essential drugs so that the prices of medicines can become affordable. The Supreme Court had responded to a PIL filed by the All India Drug Action Network (AIDAN) which argued that drug prices in India are a major cause for catastrophic medical expenses and that they need to be brought under control. The PIL argued that keeping only 74 bulk drugs and their formulations under the span of price control of the Drugs Prices Control Order, 1995 (DPCO'95) did not really serve the purpose of making medicines affordable as many many essential medicines were actually out of price control.

Even though the GoM has expanded

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October 16-31, 2012

the span of control from 74 to all the 348 drugs in the NLEM, patient activists groups and NGOs are not satisfied. Dr Amit Sengupta, co-convenor of Jan Swasthya Abhiyan (JSA) raises his concerns on the WAP being used as the method, saying, “In such a system the present prices of existing brands and their respective share in the entire market of a particular drug will be taken into account to compute the ceiling price. Such a method is entirely skewed, as the ceiling price fixed would largely reflect the price of the brand leaders. Generally two to three top selling brands – usually the most expensive or some of the more expensive brands - control a bulk of the market. So price control will do nothing to bring down drug prices, and in fact will encourage cheaper brands to start charging more and approach the high ceiling price.”

As the table shows, if WAP is calculated by discounting the price of the most expensive brand(s), WAP would be lower, but still significantly higher than the lowest price at which the particular drug is already available in the market.

The JSA analysis shows that if the ceiling price is calculated by the cost plus formula, it would tend to be similar to the minimum price as stated in the table (as the drugs mentioned in the table also make a profit). So the differential between WAP and the minimum price is a rough indicator of how much more expensive the ceiling price would be using WAP over a cost plus formula.

This situation has arisen because medicine prices in India have no relation to the actual cost of production, packaging and marketing. A study commissioned by the National Commission on

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Macroeconomics and Health showed that there is a very wide variation in the prices of drugs sold in retail and those sold in bulk through tenders to institutions. The price differences ranged from around 100 per cent to 5600 per cent. There is also a wide variance in prices of the same medicine sold under different brands by different companies. Moreover, the more expensive brands sell much more than the less expensive ones because big companies are able to promote their expensive brands by offering incentives to prescribers and chemists.

Industry relieved ...

Industry, on the other hand, seems to have accepted the GoM’s recommendations. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India comments, “We acknowledge the rights of the Government to make essential medicines available to the most vulnerable sections of society at affordable prices. The new proposal will have an impact on industry as the span of price controls will now increase to cover around 30 per cent of the pharma market. Still a market-based policy is a balanced formula and will help improve the availability of essential medicines for patients.”

Tapan J Ray, Director General, Organisation of Pharmaceutical Producers of India (OPPI) disagrees with his industry colleague and avers, “The new proposal will have adverse impact on the industry, as the span of price control will now cover around 30 per cent of the Indian pharma market with further squeeze in the margin.”

Doing a detailed analysis, DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) opines, “All formulations

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RANJIT SHAHANI

TAPAN J RAY

D G SHAH

Vice Chairman and Managing Director Novartis India

Director General Organisation of Pharmaceutical Producers of India

Secretary General Indian Pharmaceutical Alliance

The new proposal will have an impact on industry as the span of price controls will now increase to cover around 30 per cent of the pharma market

The proposal will have adverse impact on the industry, as the span of price control will now cover around 30 per cent of the Indian pharma market

The prices of these formulations will be fixed by taking weighted average price (WAP) of all brands having at least one per cent or more market share (MS) by volume

(654) of 348 bulk drugs specified in the NLEM 2011 are brought under price control. This will constitute about 30 per cent of the total pharma market. Currently, about 18 per cent of the market is under price control. The prices of these formulations will be fixed by taking weighted average price (WAP) of all brands having at least one per cent or more market share (MS) by volume. This will impact about 62 per cent of the NLEM market by value.

In other words, prices will be reduced for almost two-thirds of the sales value of NLEM medicines. The average price reduction will be about 11 per cent.

However, price reduction of some medicines for many large companies, both domestic and foreign, will be as high as up to 75 per cent. A study shows that prices of 60 per cent of NLEM medicines will be reduced by more than 20 per cent.

The average revenue loss to the industry is estimated at about 15 per cent to 17 per cent.”

Dr Ajay Kumar Sharma, Associate Director - Pharma and Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East thinks the WAP methodology preferred by the GoM over the current cost of production plus the

DR AJAY KUMAR SHARMA Associate Director - Pharma and Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East

The policy comes as a relief for the industry. The consumers are benefited because, the NLEM list has been increased from current 74 to 348

mark up policy will bring relief to the industry, saying, “The policy comes as a relief for the industry. The use of weighted average prices for all the drugs which have market share beyond one per cent preferred by the GoM as compared to few other methods proposed. Specifically being pursued for the 74 bulk drugs under NLEM comes as a big relief for the industry. “ He continues, “The consumers will benefit because, the NLEM list has been increased from current 74 to 348 (approx includes 750 formulations) which will reduce the prices for these drugs up to 20

Comparison of Prices – Weighted Average Price vs. Maximum and Minimum Price in the market today Drug

Therapeutic category

No. of Brands

Max price

Min price

WAP (total)

Times Costlier (WAP vs. min. price)

ATORVASTATIN 10 mg.

Cardiovascular

75

7.50

0.92

4.92

5.35

AMLODIPINE 5 mg.

Cardiovascular

61

6.40

0.15

1.84

12.27

LOSARTAN 50 mg.

Cardiovascular

39

5.58

0.93

3.76

4.04

CLOPIDOGREL 75 mg.

Cardiovascular

33

15.00

1.37

3.99

2.91

ATENOLOL 50 mg.

Cardiovascular

47

2.78

0.21

1.87

8.90

HUMAN INSULINS 40 IU vial

Anti-diabetic

49

151.20

95.40

127.3

1.33

METFORMIN 500 mg.

Anti-diabetic

78

3.10

0.37

1.41

3.81

GLIBENCLAMIDE 5 mg.

Anti-diabetic

13

0.84

0.20

0.76

3.80

CEFIXIME 200 mg.

Antibiotic

46

24.08

4.38

8.44

1.93

AZITHROMYCIN

Antibiotic

92

29.97

8.00

17.79

2.22

CIPROFLOXACIN 500 mg.

Antibiotic

76

7.65

1.80

4.93

2.74

AMOXY. & CLAV 500 mg+ 125 mg.

Antibiotic

64

15.49

4.48

7.72

1.72

ORS Satchet

Gastrointestinal

8

10.96

3.16

10.91

3.45

OMEPRAZOLE 20 mg.

Gastrointestinal

27

4.36

0.44

3.02

6.86

PANTOPRAZOLE 40 mg.

Gastrointestinal

108

17.55

0.87

4.25

4.89

ALPRAZOLAM 0.25 mg.

Sedative

106

1.22

0.23

0.71

3.09

PHENYTOIN 100 mg.

Anti-Convulsant

6

1.60

0.76

1.51

1.99

Source: Calculated from IMS, Health 2011, courtesy: Jan Swasthya Abhiyan

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October 16-31, 2012

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per cent. The grey area here is that, the specific drugs for specific strengths are only included in the current NLEM list.

Hence, it would be interesting to see how the industry looks at by-passing this regulation. On an overall basis this can be seen as a win-win situation for all.”

According to Rahul Sharma and Nishith Sanghvi, analysts at Karvy Stock Broking, “The companies which are in the premium pricing band would be impacted the most. MNCs, in particular which have a pure domestic play like GSK Pharma and Sanofi India, would be impacted the most, with contraction in EBDITA margins for the business as a whole. Indian companies not having very huge exposure to the domestic play would be insulated to some extent, but what we would be seeing is contraction in EDBITA margins for the domestic segment as a whole and hence impacting the profitability. Companies such as Dr Reddy’s, Sun Pharma, Lupin, Ranbaxy Labs and Cipla would be lesser impacted due to their presence in the exports space.”

Looking ahead, the analysts from Karvy believe the policy would take a minimum of six months to implement as problems would crop up on the inventory in the system, as it would need inventory recall once the policy is implemented, as the GoM will forward it to the Cabinet which would then pass it onto the Supreme Court. Delving deeper, the Karvy analysts say, “The stocks would face reprinting /repacking issues. The

other problem impacting the companies would be implementing the pricing on MRP regime, the price which both the AIOCD/IMS is capturing is based on the wholesale price to the retailer and it does not include the excise duty element, retailer margins and VAT. We spoke to a couple of pharma companies who were slightly disappointed as majority of them were expecting market share in excess of five per cent as the criteria. The inclusion of market share in excess of one per cent would cover a higher spectrum of companies which would have a lower price band.”

since combination drugs have been kept outside the purview of price control.

Then the span of price control will be about 30-40 per cent rather than 60 per cent.” The GoM has resisted pressure to finalise a cost-based pricing policy which is also incrementally positive as, for the first time, the policy will make drug prices market-determined. But this is being opposed by organisations like the JSA and the Supreme Court itself.

Parikh comments that the lower revenues for the industry will partially be set off by lower margins for the trade/retail channels due to lower prices. Preliminary estimates indicate that the hit to the overall industry will be approximately Rs 6080 billion i.e. approximately one year of growth. This is higher than the impact under the proposed National Pharma Pricing Policy (NPPP) of October 2011, which was estimated at Rs 25-30 billion.

Once cleared by the Cabinet, prices of 60 per cent of essential medicines (NLEM) will be reduced by over 20 per cent, while in certain cases the prices may come down by even 70 per cent. This implies that under the new proposals, the overall impact on the industry will be about twothree times of that proposed under the NPPP. The stage seems set for a tug of war, with the Supreme Court and JSA advocating a cost-based pricing mechanism, while the GoM, applauded by the industry, pushing for a market-based system. It remains to be seen what the final policy will look like.

… but also impacted The actual policy document is still not available but based on overall details, Rikesh Vinod Parikh, Vice-President Equities, Motilal Oswal Financial Services believes that “MNC players will have to take the maximum hit due to their premium pricing policy. Among Indian players, companies with high exposure to anti-infectives may get adversely impacted since such medicines account for 17 per cent of NLEM. In our coverage universe of Indian companies, Cipla, Cadila and Ranbaxy have high exposure to anti-infective segment. For the remaining companies, the impact is likely to be relatively moderate-to-low.

Actual impact on these companies may vary depending on their positioning/pricing policy for each drug.”

Parikh agrees, “The proposed policy is relatively better than general expectations

u.sharma@expressindia.com

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

â&#x20AC;&#x2DC;Unless an ethics committee is accredited, it should not functionâ&#x20AC;&#x2122; In a high level meeting held at the Apollo Group of Hospitals, Delhi, experts from various institutions, deliberated on the need for quality and ethical practices in clinical trials by ethics committees. Dr Ranjit Roy Chaudhury, Chairman Task Force for Research, Apollo Hospitals Educational & Research Foundation (AHERF) who also chaired the various sessions, gives an overview of the key points in a chat with Shalini Gupta imple direct consent forms: Currently information to the people is very technical. The translation made in Hindi is so stylised that the patient cannot understand its implication. It was recommended that for the lay people of the ethics committees or the patient, a simpler, more accurate version of the information sheet should be provided, that he/she can read in his/her mother tongue.

Consent of children and challenged patients: For children upto the age of 14 years, consent of a legal guardian is required, however, if the child understands the information in the form, he/she can also give assent.

In case of mentally challenged, schizophrenic patients, consent of a guardian can be taken into account.

Compensation: There is a proposal to put the decision on the quantum of compensation to be paid in the ambit of ethics committees. The group, while discussing this, felt that most ethics committees did not have the expertise to make the calculation for payment to participants of clinical trials in cases of unfortunate outcome.

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Should they look at how much pharma companies are paying per patient for trial? Should the institution conducting the trial be involved? How many clinical trials should one investigator handle at a time? The consensus was that there has to be a limit on the number

of clinical trials one investigator is handling.

Biobanking and ethics: In some cases tissues of patients are taken as part of the trial and may be banked for further studies or research such as to study the efficacy of a drug. However,

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if this tissue need to be used for any purpose other than the original one an informed consent of the person from whom the tissue is being taken should be agreed upon.

Ethics of international collaborative research: With an increasing number of collaborations in research, it is imperative that there are certain safeguards for the same. For instance, if a clinical trial is carried out in India, the resultant drug should be released here and not in the US. Also, the number of patients in India on whom the study is conducted needs to be sufficient enough to give an information as to how the drug functions in Indian patients. Conducting studies in 2-3 cases in India, is fairly insignificant.

Choosing clinical sites: The centres where clinical trials are conducted should be chosen by the Drug Controller General (India) (DCGI) on a randomised basis and not by pharmaceutical companies. This will bring in greater transparency and help avoid any conflict of interest. This was decided in the light of the latest report by the Parliamentary Standing Committee

October 16-31, 2012

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that exposed the nexus between pharma companies and those managing trial sites. An unbiased approach would only benefit everyone involved in the process.

Accreditation of ethics committee: The number of clinical trials are going down in India. While the country was a preferred destination for foreign MNCâ&#x20AC;&#x2122;s, China is now fast taking over. The falling credibility of clinical trials in India has led to drug regulatory centres not accepting results from India. An assessment body for ethics committees that accredits them would help bring in more standardisation. Such a body is envisaged in and may function under proposed National Council for Human Resources of Health, which will have a council for accreditation. Apart from this, institutes and investigators should also be accredited, it was felt.

Clinical trials of medical devices: Medical devices regulation remains a grey area due to the lack of a specialised regulatory body for the same and hence it was strongly recommended that a medical devices agency be set up. As opposed to drugs, devices need to be tested for the material which might react with the body, dissolve in it and hence proper research and investigation needs to be undertaken while conducting clinical trials of devices.

Stem cell treatments and ethics: Both clinicians and patients are eager to use stem cells for treatments of various disorders. However, as per regulations, only the use of hematopoietic stem cells is allowed for certain well established haemotological indications. All other types of stem cells therapy can be done only in an investigative mode. We need to find out if there is a legal way to give stem cell treatments to a patient with

spinal cord injury.

According to the Indian Council of Medical Research (ICMR), there is no proven evidence that stem cell treatment works. In the light of the above facts, it was recommended that a fund should be created that is run by government (ICMR) and anyone who wants to conduct a clinical trials for stem cell treatments should apply to it and if selected the study would be funded by

government research agency. The Indian patient has a right to know that stem cell treatement works.

At the same time, scientists have a duty to inform them on the same. Only when clinical trials are done using stem cells on patients, can we establish them as a suitable course of treatment.

Incentives for more involvement in clinical trials: Most of the members of ethics committees do not

read the forms carefully.

This includes lay members usually from civil society, academia, social work and the legal field. They need to be better informed about the ethical implications of trials (a part of ICMR guidelines) probably by giving them a background of the same.

This would help protect the patient from any doctor conducted trials.

Stop mushrooming of independent ethics commi-

tees: Currently there are 100-120 ethics committees in India. However, institutes which do not have ethics commitees get their trials approved by independent ethics committees. The registration and accreditation of ethics commitees will put a stop to this illegal practice.

It should be made mandatory that unless an ethics committee is accredited, it cannot function. shalini.g@expressindia.com

An assessment body for ethics committees that accredits them would help bring in more standardisation October 16-31, 2012

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Research

EXPERTISE FOR DRUG DEVELOPMENT

GSK’s pneumonia vaccine launched in Pakistan Pakistan has become the first country in South Asia to introduce a vaccine against the deadly pneumococcal disease in children, with GlaxoSmithKline’s Synflorix selected for the programme. Worldwide more than 1.3 million children under the age of five are killed each year by pneumonia and in Pakistan it accounts for almost 20 per cent of child deaths, according to the Global Alliance for Vaccines and Immunization (GAVI)

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Sanofi announces new results from ORIGIN trial Trial shows treatment with Lantus was approximately three-fold more likely to achieve and maintain target glycemic levels anofi announced new results from the landmark ORIGIN (Outcome Reduction with Initial Glargine INtervention) trial showing treatment with Lantus (insulin glargine) was approximately threefold more likely (p<0.001) to achieve and maintain target glycemic levels, defined as HbA1C < 6.5 per cent in this analysis, vs standard care in individuals with pre-diabetes or early type II diabetes at high cardiovascular (CV) risk.

Data presented at the European Association for the Study of Diabetes (EASD) 48th Annual Meeting showed that insulin glargine use was an independent predictor of maintaining mean yearly HbA1c <6.5 per cent target over five years, vs standard care. Similarly, a lower HbA1c baseline level was also found to predict reaching the same target.

ORIGIN was a six-year randomised clinical trial designed to assess the effects of treatment with insulin glargine vs standard care on

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CV outcomes and involved over 12,500 participants worldwide with pre-diabetes (impaired fasting glycemia or impaired glucose tolerance) or early type II diabetes (treated at most with one oral anti-diabetic) and high CV risk. Key results reported earlier this year at the American Diabetes Association Congress (June 2012) showed insulin glargine had a neutral effect on CV outcomes and significantly reduced progression from pre-diabetes to diabetes (secondary outcome) by 28 per cent (p=0.006).1 “This analysis shows that insulin glargine generally brought glycemic control to HbA1c <6.5 per cent, a commonly sought target, and sustained it over five years. Further study of the ORIGIN data is likely to provide further insights regarding the medical benefits or risks of this

approach to treatment,” stated Professor Matthew Riddle MD, Oregon Health and Science University, USA, lead author of this ORIGIN sub-analysis.

These new findings showed that insulin glargine was more effective than standard care at maintaining glycemic control in all subgroups assessed, including age, alcohol consumption, depression, baseline HbA1c, urine albumin:creatinine ratio (ACR), diabetes and particularly in individuals with abdominal obesity (p=0.011) and greater grip strength (p<0.001).

Dr Riccardo Perfetti, Vice President Medical Affairs, Global Diabetes, Sanofi, commented: “Contrary to conventional understanding that diabetes is a progressively worsening disease, these new results from this sub-study of ORIGIN

suggest that achieving and maintaining glycemic control early with insulin glargine might positively affect the natural history of the disease.”

Safety outcomes from the new ORIGIN sub-study were not included in the presentation at the EASD 48th Annual Meeting. Hypoglycemic events as observed in the ORIGIN main study were infrequent. In the insulin glargine arm, the rate of severe hypoglycemia was 0.01 episodes per patient-year of exposure versus 0.003 episodes per patientyear for standard care. Rates for overall hypoglycemia with insulin glargine were 16.7 patients with events per 100 patient-years of exposure versus 5.2 patients with events per 100 patient-years for standard care. In addition, weight gain was modest for participants in the insulin glargine arm, at an average of 3.5 pounds over the duration of the study.

EP News Bureau

Scientists find new way to up safety factor of stem cell therapy Causes contaminated cells to purge themselves luripotent stem cells show great potential in treating various debilitating diseases, but at a risk: during the process of reprogramming the cells so they will grow (differentiate) into the desired tissue, some of their DNA may be damaged causing them to develop into tumours. Researchers have been scrambling to find a way to overcome this huge drawback to an otherwise highly promising therapeutic candidate.

Now, researchers at the Mayo Clinic, Rochester, Minn, think they might have found an answer.

Reporting in the October issue of STEM CELLS Translational Medicine, they detail a low-cost, highly-effective way to detect and then purge at-risk cells during an early stage in the differentiation process.

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“Strategies to improve the safety of stem cell therapy have generally focused on separating or depleting damaged cells after the cells have differentiated. However, while this method was able to diminish the number of tumours formed as well as significantly reduce their size, the technical burdens and cost of specialised reagents and equipment needed to do so remain a challenge

for widespread clinical applications,” says lead investigator Timothy J Nelson. He directs the cell biology group within the clinic’s Regenerative Strategies team.

Instead, the Mayo team turned to a relatively simple protocol that involves pre-treating cultured stem cells with a genotoxin — an agent that sniffs out gene mutations or chromosomes changes in contaminated cells and kills them — after first priming the cells through the up-regulation of Puma protein, which can be activated to send a series of signals leading to cell suicide. They tested their theory using stem cells taken from a mouse model.

The results showed that not only did the contaminated cells die off, “At the same time, it didn’t affect the remaining healthy cells’

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capability to differentiate nor did it have any negative consequence on their genomic stability. And it worked on stem cells derived from both natural and bioengineered sources. This novel strategy, based on innate mechanisms of pluripotent stem cells, is primed for highthroughput and cost-effective clinical translation,” Nelson says.

“The potential for tumour formation has been a significant drawback to therapeutic use of certain cell populations. The strategy outlined in this manuscript shows promise for avoiding the risk of uncontrolled cell growth upon transplantation,” said Anthony Atala, Editor, STEM CELLS Translational Medicine and Director, Wake Forest Institute for Regenerative Medicine.

EP News Bureau October 16-31, 2012

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Parasite study suggests need for rethink on malaria treatments Fresh discoveries about how the malaria parasite responds to drugs could help inform strategies for treating infection cientists have shown for the first time that severe strains of the parasite, which cause the most harmful malarial infections, are harder to kill with treatment than less harmful strains. The research suggests that drugs may unintentionally encourage more harmful strains to evolve because the treatments are more effective at killing milder strains of the disease.

Researchers say that this gives severe strains an advantage – they can survive better in the host and spread to mosquitoes, which pass on the infection

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to new hosts. Over time this could mean that people with malaria, when untreated, suffer more harm from their disease.

The research also found that a commonly used malaria drug called artemisinin reduces the advantage that severe strains have over mild strains.

Experts say that careful choice of drugs to treat malaria could minimise the spread of more severe parasite strains.

Dr Petra Schneider of the University of Edinburgh’s School of Biological Sciences said, “Drug treatment for

malaria infections is very important and our results suggest that careful choice of drugs and treatment regimens could minimise unexpected consequences.

The next step is to determine whether our findings in mice apply to malaria in humans.”

The study by the University of Edinburgh and Pennsylvania State University was carried out in mice and is published in Proceedings of the Royal Society B and is supported by the Wellcome Trust.

EP News Bureau

GSK’s pneumonia vaccine launched in Pakistan The introduction of Synflorix in Pakistan is possible due to GAVI’s advanced market commitment scheme akistan has become the first country in South Asia to introduce a vaccine against the deadly pneumococcal disease in children, with GlaxoSmithKline's Synflorix selected for the programme.

Worldwide more than 1.3 million children under the age of five are killed each year by pneumonia and in Pakistan it accounts for almost 20 per cent of child deaths, according to the Global Alliance for Vaccines and Immunization (GAVI).

The move comes at a time when healthcare experts are still struggling to get polio vaccination accepted in parts of Pakistan, one of the few countries where it is still endemic.

The introduction of Synflorix in Pakistan, which began recently, is possible due to GAVI's advanced market commitment scheme, which provides incentives for drug companies to produce large quantities of vaccines for poor countries at low cost.

“In Pakistan, with a successful rollout we can save tens of thousands of lives,” Seth Berkley, CEO, GAVI told reporters at a briefing at its Geneva headquarters. “It will make a dramatic difference in life expectancy in the country.”

GSK, Britain’s largest drugmaker, said it would provide a minimum of 480 million doses of Synflorix to GAVI

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for programmes against pneumococcal disease in 73 developing countries by 2023. GAVI also has a similar global deal with Pfizer for its rival pneumococcal vaccine Prevnar. The agency

Worldwide more than 1.3 million children under the age of five are killed each year by pneumonia and in Pakistan it accounts for almost 20 per cent of child deaths, according to GAVI chooses between the competing vaccines in each country.

GAVI is a public-private partnership backed by the Bill & Melinda Gates Foundation, the World Health

Organisation, the World Bank, UNICEF, international donor governments and others. It funds bulk-buy immunization campaigns for poorer nations that can’t afford vaccines at rich-world prices.

Berkley noted problems with Pakistan’s polio eradication effort, which has been hampered by mistrust and rejection among local people, but said he expected the introduction of the pneumococcal vaccine to be smoother, and potentially helpful to the polio campaign in the longer run.

“The government of Pakistan assures us they will do everything they can to roll out this product,” he said.

“This is a vaccine that families understand, (along with) the importance of this disease and children dying, so it actually may help the effort.”

Latest United Nations estimates show that pneumonia accounts for 18 per cent of child deaths globally. In Pakistan more than 352,000 children die before they reach their fifth birthday and almost one in five of those deaths are due to pneumonia.

GAVI said that while pneumococcal vaccines cannot prevent every case of pneumonia they can prevent a significant proportion and have the potential to protect tens of thousands of children from preventable sickness and death.

Reuters

Generic antidepressant not equivalent to original Wellbutrin: US FDA N ew data by the US Food and Drug Administration (US FDA) indicates that the generic version of the popular antidepressant Wellbutrin is not equivalent to the original drug manufactured by GlaxoSmithKline.

Budeprion XL 300 mg, or bupropion hydrochloride extended-release tablets, are manufactured by Impax

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Laboratories and marketed by Teva Pharmaceuticals USA. The FDA, in a notice posted on its website said it has changed the therapeutic equivalence rating for the product in the agency’s Approved Drug Products with Therapeutic Equivalence Evaluations to show that Budeprion XL 300 mg fails to demonstrate therapeu-

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tic equivalence to Wellbutrin XL 300 mg.

Impax has requested that the FDA withdraw approval of budeprion XL 300 mg extended-release tablets, the FDA said. Impax and Teva have stopped shipping the product, the agency said.

Reuters October 16-31, 2012

Pharma Ally INTERVIEW

‘Culturally, India has demonstrated strong doctor–patient relationships’ Denzil Benjamin, Senior Director, Clinical Trial Management, Asia Pacific for ICON, talks about the importance of Electronic Data Capture (EDC) in data management in clinical trial sector, with Sachin Jagdale Which are the current methods/technologies in use for data management in the clinical trial sector?

The contract research industry is increasingly adopting the use of technology to improve the process of data management. eClinical technologies, such as Electronic Data Capture (EDC), Interactive Voice or Web Response (IVR/IWR) Systems, Electronic Patient-Reported Outcomes (ePROs) and Electronic Imaging, provide a range of solutions to address the need for greater efficiency and productivity in the drug development process.

In what way would EDC fill the gap that seems to exist in current forms of data management?

The use of EDC opened the door to real time data processing, which has gained almost universal acceptance as the optimal way to collect and process data. The recent technology developments that enable rapid pooling of data across different data repositories coupled with the advances in portal technology have really revolutionised clinical drug development by making that same data available in an easy to understand manner so that decisions can be taken almost in realtime. This is now the ultimate goal of pharmaceutical companies – rapid access to data to enable real time decision making in order to shorten drug development timelines.

What are the India specific challenges as far as data management in the clinical trial industry is concerned?

I think the multiple data standards, platforms and databases with different vendors are the challenges for data management not only in India but globally. This can lead to problems with data sharing and comparability of trial results, e.g., imaging data – knowing which version of the data is the latest and which database holds the latest version. However, we believe the introduction of an information platform such as ICON’s ICONIK has the capability to overcome many of these challenges by standardising the data received and enabling the sponsor and CRO to have visibility of real time information across studies and programmes October 16-31, 2012

areas such as SAS programming and biostatistics as well as providing backend services in interactive technologies, medical safety services, data management and study feasibility assessment. ICON will continue to grow in providing these services out of India for the global market.

regardless of the type of source data.

What are ICON's solutions in the field of data management?

The ICON solution that meets the technology needs of the sponsor is ICONIK, a web-based information platform that enables the management, reporting, analysis and visualisation of all data relating to drug development. ICONIK can collect, manage and standardise study data from multiple sources, including EDC, patient diaries, central laboratories and imaging, to provide a single view of study information. ICONIK is a centralised, clinical development work environment for clinical programme teams, providing superior security, access control and chain of custody of not just the data but also the data cleaning, statistical programmes and study outputs. With ICONIK's in-built audit trail capabilities, sponsors can be assured of the transparency and integrity of all the data and clinical programming processes. In addition to managing clinical data, ICONIK can collect operational data, such as project management, CTMS and metric information. Investigator data, such as payments, site details and performance, can also be incorporated.

How are your solutions different from your competitors?

Data transparency and near realtime access to study information, enabling visualisation of study data, such as status, progress and trending from study startup to database lock is the core benefit. ICONIK enables quicker access to safety and efficacy data, allows sponsors' simple signal detection to identify any issues and provides a full 'audit trail', which shows who has done what and when.

This improves the quality and transparency of the data and the speed at which it is collected. One example of efficiency savings is the provision for creating a standard patient profile.

ICONIK makes this a quick and easy process compared with the current system whereby data from many different databases must be collated to produce one patient profile. ICONIK also allows for adaptive trial design whereby a sponsor can adapt a clinical trial based on the availability of near real-time data collected while the trial is ongoing. In addition, it can

have a positive impact on facilitating audit trails, data mining and combating malpractice. For a sponsor, this solution provides web-based access via a single portal. It enables study comparisons, quicker patient enrolment and data lock. Improved quality and speed of data collection will help the sponsor to achieve shorter time to market and lower drug development costs What are the factors in the Indian market that you think would help ICON to propel its growth in this part of the world?

Significantly lower operating costs than those typical of western countries and the relatively easy availability of patient and gene pools have facilitated a range of trials in India. The growth of the sector has also been driven by good medical expertise, an English-speaking work force, advanced capabilities in technology and a modern hospital infrastructure.

Its world-class laws on intellectual property rights have also boosted industry confidence. India’s status as one of the first countries in the AsiaPacific region to start a clinical trials registry (it is now mandatory to record all trials in the ‘central registry’ in India) has led to improved transparency and public accountability. Indian data is also accepted by the US FDA for drug approvals. Culturally, India has demonstrated strong doctor–patient relationships, with good treatment of and follow-up care for patients.

India is an important region for ICON, with staff strength of more than 850 employees across its offices in Bangalore, Chennai and Thiruvananthapuram.

ICON has tapped into the local talent pool in

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Can you tell us about your future plans for the Indian as well as global markets?

At a regional and country specific level, ICON India will continue to invest and grow our staff to ensure we are meeting our customers’ requirements. We will listen to our customers and their clinical development needs and how we can, as their CRO partner work together to support their goals.

For the global markets, operating under strategic partnership models continues to be one of ICON’s strengths. For example, in 2011, ICON announced strategic partnerships with Pfizer and Shire Pharmaceuticals and extended its Bristol-Myers Squibb partnership to incorporate early phase services.

ICON is building unparalleled informatics capabilities which provide full transparency of trial data and enable better and faster decision making while reducing costs. ICONIK, ICON’s integrated information platform, is being very well-received by strategic clients and is a real differentiator for ICON. ICON’s Firecrest investigator site support platform and Medical Imaging capabilities are also good examples of technology solutions where ICON leads the market.

ICON also continuously looks for suitable acquisitions or alliances that can either broaden the company’s service portfolio or add greater depth and scale to existing services. Asia Pacific is an increasingly important market and we plan to build our capabilities through acquisitions or alliances with key players in the region combined with organic growth.

For example, our alliance with ACRONET allows us to tap in to their extensive coverage and knowledge of Japan. While an example of strengthening our capability in Asia Pacific through acquisition is the acquisition of BeijingWits, which has strengthened our presence and service capabilities in China. sachin.jagdale@expressindia.com EXPRESS PHARMA

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

Goose launches Goose Proofreader Goose Proofreader compares and proofreads artwork files and leaflets and gives detailed report on the derived results yderabad-based Goose a specialist in providing pharmaceutical business re-engineering solutions has launched Goose Proofreader, a 21 CFR part 11 compliant solution that enables excellent review of printed materials.

Goose also announced two of the top pharma companies in India, Glenmark Pharmaceuticals and Aurobindo Pharma have begun to use Goose Proofreader.

The major challenge that the pharma industry faces today is to make the artwork error free. Goose Proofreader is engineered to deal with this challenge as it reduces the costly errors, increases accuracy and maximises productivity.

Making the announcement Deb Pattnaik, Founder and CEO, Goose said, “Our goal is to make Goose Proofreader as an industry standard. It is a completely new alternative to manage document proofreading task. Usage in our client location has tackled even the most complex tasks like evaluation of multilingual texts, comparison of images in different angles at the same time adhering to strict FDA regulations effortlessly.”

According to FDA enforcement report in 2012-(Medmarc- Foley & Lardner LLP), total product recalls for the year 2004-2011 have increased from 4670 to 9288 which includes class I, II & III recalls. Industry experts say that 35 to 40 per cent of pharma product recalls happen due to faulty packaging and mislabeling. From 2004-2012, there were 15 per cent class one drug recalls for mislabelling. Therefore, it is critical for companies to provide accurate printed mate-

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rial. This would mean that the printing components of the packaging workflow should work efficiently.

Goose Proofreader compares and proofreads artwork files and leaflets and gives detailed report on the derived results. The tool performs two types of comparison. These are: Pixel to Pixel (Compares images and texts) and Text Verification (Compares only texts).

The key features of Goose

Proofreader are: It identifies differences in the texts and images. It also compares scanned copy with system generated copy. Other features include image rotation, auto crop, flip, resize, angle suggestion, overlay etc. for evaluating files.

The solution generates detailed report for pixel to pixel comparison and has the ability to read Barcode and Pharmacode.

EP News Bureau

New evidence-based 3D cell culture web portal launched by Reinnervate Reinnervate will run a series of webinars describing detailed scientific data comparing 3D and 2D cell culture experiments einnervate, the developers of Alvetex Scaffold for 3D cell culture, launched a new 3D cell culture portal for scientists in the life science sector. The new resource brings together a wide variety of information, protocols, peer-reviewed papers and videos to help not only those who are considering the adoption of 3D cell culture but also those already using this approach to growing cells in vitro.

“We have created a central resource that will help scientist to learn why 3D cell culture may be beneficial, how they can evaluate 3D cell culture and how to pick the right type of Alvetex Scaffold format for their experiments. We are highlighting independent publications, testimonials from scientists already growing cells in 3D, validated protocols and videos showing how different 3D technologies stack up,” Barry Lynch, Marketing Manager, Reinnervate.

To support the launch of the new 3D cell culture resource, Reinnervate will run a series of webinars describing detailed scientific data comparing 3D and 2D cell culture experiments in the areas of; assessment of cancer cell cytotoxicity in a novel 3D culture assay; Formation of Mesenchymal tissues in Alvetex Scaffold derived from stem cells and other established cell lines and modelling cancer cell invasion using novel technology for 3D cell culture.

EP News Bureau

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October 16-31, 2012

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GGA Software Services launches open-source version of chemistry electronic lab notebook Receives exclusive license from a global pharma company to create and distribute the open-source version GA Software Services has released version 1.0 of Indigo ELN, the open-source version of the chemistry electronic lab notebook that was developed by one of the world's largest pharmaceutical companies.

GGA received the exclusive license from this global pharma company to create and distribute the open-source version, and it has been working to modify the pharma company's internal chemistry ELN for distribution as an open-source application. The system is now publically available for downloading at GGA's website (http://www.ggasoftware.com) under the open-source GNU General Public License, version 3.

“Indigo ELN represents a leading costeffective alternative to commercial ELN products: Users can upgrade their existing ELN with a proven and tested opensource platform, and they can do it at no charge,” said Richard Golob, President and CEO, GGA. Golob continued, “Through our own open-source cheminformatics initiative, GGA has been contributing software tools to the scientific community, and we regard this initiative with one of the world's largest pharma

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October 16-31, 2012

companies as a natural extension of our existing commitment to open-source technologies.”

Benefiting from the considerable investment by this global pharma company in its internal chemistry ELN, Indigo ELN provides scientists with a proven way to create, store, retrieve, and share electronic records of chemistry information in ways that meet all legal, regulatory, technical, and scientific requirements.

It allows scientists to prepare, plan, and analyse experiments, access relevant information, and develop new methods in the areas of synthetic chemistry, analytical chemistry, and process chemistry.

With Indigo ELN, users will be able to enjoy the functionality of an ELN platform that has been used by thousands of scientists in the global research and development organisation of GGA's partner,” according to Golob. Users will be able to perform functions including creating and setting up singleton experiments, running experiments and recording results, automatically registering and submitting batches, attaching related documents, and printing reports. In addition to this core package, users can integrate

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Indigo ELN with existing or new customer services, such as compound registration, structure verification, and analytical information services, as well as chemistry logistics systems.

Furthermore, users can integrate Indigo ELN with GGA's open source offerings, such as its Bingo molecular search engine for Oracle database, its Ketcher chemistry drawing tool, and its Indigo cheminformatics engine. GGA is offering broad support for Indigo ELN, including installation and configuration services, integration of the core Indigo ELN system into the user environment and with other services, creation of custom functionality, and support and maintenance.

“For several years, GGA has worked successfully as an outsourcing partner for the global pharma company that developed the chemistry ELN, and we are confident about GGA's capability to provide Indigo ELN users with the full range of services needed to make the Indigo ELN a successful application, from installation, customisation, and integration, to support and maintenance,” said Golob.

EP News Bureau

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Merck Millipore [India] kicks off ‘EMPROVE Seminar Series’ in Mumbai The inaugural seminar had a panel discussion on key issues in regulations erck Millipore [India], a division of Merck KGaA, Darmstadt, Germany, recently flagged off the ‘EMPROVE Seminar Series’ in Mumbai.

EMPROVE is a proprietary service from Merck Millipore which combines product quality with user-related documentation simplifying rigorous regulatory work for the pharmaceutical industry. The inaugural seminar on ‘Evolving Trends in Regulations in the US and EU’ consisted of a panel of eminent speakers of international repute.

Panelists who addressed key issues in regulations included Ajit Singh, Chairman, ACG Worldwide, who spoke on the ‘Current Trends in the Pharmaceutical Industry with respect to Indian and International Regulations’. Dr Bernd Renger, Chairman, European Qualified Persons Association addressed the seminar on ‘Challenges for Regulatory Compliance for the EU’. Leading pharma companies were present to exchange notes and have discussions on the evolving regulatory scenario and tools to expedite the complex process.

Introducing the seminar Peter Salazar, Head of the Pharm-Chem Solutions, Merck Millipore [India], said, “The regulatory landscape is changing and it is imperative for our industry to understand, interpret and prepare to meet the challenges of tomorrow. Merck Millipore has an extensive range of tools designed to support its clients during all stages of the drug manufacturing process from research to industrial-scale production and quality control. The EMPROVE

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Ajit Singh, Chairman, ACG Worldwide and Dr Bernd Renger, Chairman, European Qualified Persons Association light the traditional Indian lamp to inaugurate the ‘EMPROVE Seminar Series’ organised by Merck Millipore [India] in Mumbai, while Peter Salazar, Head of the Pharm-Chem Solutions, Merck Millipore [India] and Kashmira Billimoria, Merck Millipore [India] look on Seminar Series is an endeavour by Merck Millipore [India] to give back to the industry by bringing together under one roof experts from different fields to predict and better prepare for the future.”

Salazar further added, “With EMPROVE, we have established ourselves as leaders in quality and international regulatory compliance. The ever-increasing requirement for regulatory compliances often impacts the product costs. Merck Millipore’s customer-friendly EMPROVE offers benefits such as greater product safety, cost and time savings, and regulatory support through tailor-made documentation.”

EMPROVE offers comprehensive dossiers and documents needed for the intended usage of raw materials in three different product lines. Since its introduction in 2005, the EMPROVE portfolio is

continuously growing and consists of several hundred products. The EMPROVE seminar also saw reputed spokespersons like Chandrashekar Deo, Consultant – Quality and GMP who provided an overview of ‘The Changing Environment for Regulatory Compliance in the US’; P Manoj Kumar, Assistant Vice President R&D, Mylan Laboratories who spoke on ‘Developing Complex Parenteral Dosage Forms – A Generic Perspective’; Dr Sandeep Tiwari, Regional Technical Manager, South Asia, Colorcon Asia who spoke at length on ‘Examining the Impact of Excipient Variability on QbD’, and Dr Ulrich Reichert, Head of Regulatory Experts and Customer Audits, Merck Millipore who gave insights into ‘Elemental Impurities – Perspective as per ICH/EU/US’.

EP News Bureau

Square Pharmaceuticals signs contract with Telstar Global for development of pharma plants Plants to produce oral and parenteral products pain-based Telstar Global will direct the full execution of two new pharmaceutical plants for Bangladesh-based Square Pharmaceuticals. For the first project, Telstar will manage the construction of a plant for the production of oral solids consisting of a four-storeyed building of 32,000 square metre with seven fluidised bed granulation lines, 11 tablet lines, four lines for capsules, and 16 primary and secondary packaging lines, plus a second service building of 1,000 square metre.

The second project consists of a 20,000 square metre four-storeyed building for production of parenterals in small and large volume formats, including two lines for manufacturing Blow-Fill-Seal (BFS) bottles with two reactors of 20,000 litres each, a line for manufacturing glass bottles, one for bags, two for vials, two for preloaded syringes, one for

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lyophilised vials with two freeze-dryers and one topical aerosol production line.

Telstar performed the engineering for both plants and was the winning bidder for the full project administration and provision of the pharma architecture and the process equipment and critical installations; managing the coordination of local installers for the remaining installations. Start-up and qualification of these new plants is scheduled for the first half of 2013.

Square Pharmaceutical’s trust in Telstar as a technological partner is based on its know-how, experience and capability in the development of these types of large scope projects. Since 2003, Telstar has collaborated with Square on a number of high-complexity projects which involved the development of production installations and plants.

Outstanding examples include the new

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cephalosporin plant built in 2005, the new plant for sterile filling and bottling of pharma liquids with BFS technology in 2007, the new insulin production plant in 2010 (with the ability to produce up to 13 million vials of insulin per year) and, finally, the SVPO plant for production of small volume parenterals and ophthalmology products inaugurated in 2008 in Dhaka.

Square Pharmaceuticals is the largest manufacturer of pharma products in Bangladesh. The most prominent company of the Square Group since its founding in 1958, it has experienced solid growth leading it to its current leadership position in its country and in the Asian continent. With a market share of 16.43 per cent, Square Pharmaceuticals obtained a sales volume of approximately $164 million in 2010.

EP News Bureau October 16-31, 2012

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Quintiles, dabl team to advance cardiovascular safety assessment Quintiles’ customers worldwide will have access to dabl’s round-the-clock ABPM services abl, a provider of centralised ambulatory blood pressure measurement (ABPM) services, and Quintiles recently announced a strategic alliance that significantly enhances the latter’s suite of offerings in cardiovascular safety assessment.

Through the alliance, Quintiles’ customers worldwide will have access to dabl’s round-the-clock ABPM services to enhance the safety and efficacy of global clinical trials across the entire trial lifecycle. “dabl’s scientific leadership and data management techniques are setting new industry standards and complement Quintiles’ pioneering cardiac safety solutions. Together we can improve understanding of drug-induced blood pressure responses and help our customers improve trial participant safety, manage risk, and improve efficiency – all vital to meet the challenges of the New Health,” said Dr Deepa Desai, Executive Director, Cardiac Safety Services, Quintiles.

The US FDA and other regulatory agencies are requiring assessment of 24-hour blood pressure profiles for blood pressure-lowering drugs; there is also increased focus on how non-cardiovascular drugs affect blood pressure. The web-based dabl ABPM system automatically checks data in accordance with the study protocol; generates alerts about safety and enrollment issues; and provides real-time access to clinical data and progress reports.

Professor Eoin O’Brien, Medical Director, dabl, said, “Accuracy of circadian measurement, speed and excellence in interpreting data have never been more important in the clinical trial process. Biopharma companies will be able to make faster and more confident decisions about the cardiovascular effects of their compounds with the combination of Quintiles’ therapeutic expertise and dabl’s proprietary technology and excellence in providing haemodynamic profiles.”

WJ 'Bill' Rickard, CEO, dabl, said, “We welcome this alliance with Quintiles. It’s another milestone in our development, particularly in our rapidly growing Global Clinical Trial Division.”

EP News Bureau

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Avacta extends Pall Life Sciences’ Optim 1000 distribution agreement to include India Deal marks Avacta’s entry to the third largest Asia-Pacific biotech market vacta Analytical, a leading provider of analytical technologies, has signed a third distribution agreement with Pall Life Sciences – a global leader in filtration, separation and purification – appointing Pall as the Indian distributor for its market-leading Optim 1000 protein drug development tool.

The Optim 1000 is an innovative analytical instrument that provides biopharmaceutical developers with information about the viability of candidate drug molecules and formulations much earlier in the drug development process, avoiding costly end stage product failures. The latest collaboration extends the existing North America and South East Asia agreements, granting Pall exclusive marketing and distribution rights to the Optim 1000, to include India.

Alastair Smith, CEO, Avacta Group, commented, “Pall has proved an excellent partner for Avacta, and the success of our existing collaborations in North America and South East Asia was a major factor in the decision to appoint the company as the sole distributor for the Optim 1000 in India. The Indian biopharma industry is growing rapidly, offering exciting new opportunities, and we look forward to working with Pall in this new territory.”

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October 16-31, 2012

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Malvern Instruments launches Morphologi G3-ID to global markets alvern Instruments has launched the Morphologi G3-ID particle characterisation system to the global market. A live webinar held recently introduced participants to the unique capabilities of the system, which combines automated particle imaging with the chemical identification of individual particles using Raman spectroscopy. This fully automated system measures particle size, shape and chemical identity in a single platform.

The Morphologi G3-ID is ideally suited to solving complex particle characterisation problems where particle size and shape do not provide sufficient information. The recent early access programme has been designed to enable users to explore specific applications and to allow full optimisation of the product features.

Key applications for which it is proving especially valuable are in determining component-specific particle properties of mixtures and blends, such as the particle size of drug ingredients in nasal sprays and asthma inhalers, and in the identification of unknown or suspicious parti-

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cles in injectable or parenteral products, for example.

The Morphologi G3-ID has been designed to meet a wide variety of needs and to enable all users, from particle characterisation scientists with limited spectroscopy experience right through to experienced spectroscopists, to gain an in-depth understanding of particulate samples. Simple SOP operation takes the user from integrated sample dispersion for dry powders through to size, shape and chemical analysis, with automatic selection, targeting and chemical classification of thousands of individual particles. Measurements can be made on dry powders, suspensions and membrane filters.

Malvern’s moving laser diffraction from the laboratory into the production process n a new presentation from Malvern Instruments entitled ‘Moving laser diffraction from the laboratory into the production process’, Product Group Manager Dr Paul Kippax discussed the benefits and challenges of taking laboratory-based particle sizing out into the production process. The presentation is particularly tailored to the pharmaceutical industry but is generally relevant to all manufacturers considering an investment in on-plant real-time particle size measurement.

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Particle size information is used in the development and manufacture of a significant number of products, with laser diffraction now the analytical technique of choice across many industries. A key attraction of the method is the availability of process systems for real-time measurement that complement highly productive laboratory instruments. However, some still perceive the transition from lab to line as potentially problematic and consequently fail to fully exploit the potential of this powerful analytical method.

In the presentation Dr Kippax looks at how particle size information is used to understand and control product performance, and examines the application and benefits of both off- and online measurement. He reviews the primary requirements of a process analyser, which are to deliver relevant information, in a relevant timeframe, using an appropriately robust device and goes on to outline how laser diffraction process systems, as exemplified by Malvern’s Insitec range, meet these challenges, by combining rapid measurement with extremely high reliability. Installed in the process line or on an associated sampling loop, these systems deliver the real-time monitoring that underpins optimised, often automated, control, and can return substantial economic return. Throughout the presentation the focus is on how best to apply laser diffraction technology to meet requirements, whether in research, development, manufacture or QC, and how to ensure the successful application of the technique across the product lifecycle.

Zetasizer Nano ZSP by Malvern Instruments ew top-of-the-range dynamic light scattering system adds unique protein measurement and microrheology capabilities to market-leading family of instruments Malvern Instruments recently conducted the global launch of an exciting addition to its Zetasizer family, bringing unique protein measurement and novel microrheology capabilities to this established and market-leading range of dynamic light scattering (DLS) systems.

Introduced in the space of 24 hours, via a series of webcasts, to audiences around the world, the new high specification Zetasizer Nano ZSP delivers enhanced sensitivity and comes with advanced software that drives the two new measurement types.

Like other systems in the range, the Zetasizer Nano ZSP is a single, compact unit. It

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shares the simplicity and ease of use that have made Zetasizer Nano systems a firm favourite in industry and academia for almost a decade.

Where the Zetasizer Nano ZSP stands apart, however, is in its unique performance specifications for both size and zeta potential measurement. One of the most significant applications being the measurement of the zeta potential, or electrophoretic mobility, of proteins. This process is further simplified by the inclusion of a new protein mobility measurement type in the software that controls data acquisition, guiding the user through the measurement and assesses and reports on data quality. The protein mobility measurement package is included with the Zetasizer Nano ZSP instrument as standard.

As well as the suite of new protein-specific features, the new version of Zetasizer software, launched together with the Zetasizer Nano ZSP, enables a brand new type of measurement on the instrument – Microrheology. This DLS-based optical technique allows rheological characterisation of weakly-structured and highly strainsensitive materials using only microliter sample volumes. Amongst its applications are measuring the viscosity of polymer and protein solutions and determining the onset of protein aggregation.

Malvern’s extended Zetasizer family now

includes the full Zetasizer Nano range of systems for characterising size, molecular weight and zeta potential measurement; the Zetasizer APS for automated protein size measurements in multiwell plates; and the Zetasizer µV designed for protein size and molecular weight measurements in both cuvette and chromatography modes (for example, in combination with a GPC/SEC system).

Contact details: Soloni Gosalia Malvern Aimil Instruments Naimex House, BSEL Tech Park, B Wing – 906 Sector 30A Opp Vashi Railway Station, Vashi, Navi Mumbai 400 705, India Tel: + 91 22 3918 3596 Fax: +91 22 3918 3562 soloni.gosalia@malvernaimil.com

October 16-31, 2012

P|H|A|R|M|A| A|L|L|Y Schreiner MediPharm develops multi-functional Pharma-Tac Plus Label for infusion bottles

Thermo Fisher Scientific launches selection handbook on new chemical and reagents

chreiner MediPharm has launched Pharma-Tac Plus label, a new marking solution for infusion bottles that combines several functions. In addition to the hanger, the specialty label provides sufficient space for extensive product information and also makes it possible to document the medication that has been administered.

The Pharma-Tac Plus label combines the product marking function with an integrated hanger and detachable label parts. Due to its multi-layered design, the label can accommodate extensive product descriptions. After opening the top layer, additional information such as the current calendar date and expiration date can be entered by hand. This is important when the contents of the bottle are only usable for a limited period of time after removal from cold storage, such as in the case of blood plasma infusions. The hanger that is embedded in the bottom layer makes it possible to quickly and conveniently suspend the infusion bottle from the rack. To do so, the user simply separates the hanger from the bottom label, folds it and closes the top label again. The detachable label parts integrated into the Pharma-Tac Plus label are used for documentation. They are attached to the patient’s medical file and the medical facility’s blood transfusion records. This specialty solution also convinced the judging panel of this year’s FINAT competition. The Pharma-Tac Plus label was awarded a “highly commended” certificate in the “Innovation” category for functionality, printing quality and finish.

hermo Fisher Scientific launched its new Fisher Chemical and Fisher BioReagents Laboratory Reagents Handbook, an essential, easy-to-use reference guide for one-stop access to its comprehensive laboratory reagent ranges.

The new Fisher Chemical and Fisher BioReagents Laboratory Reagents Handbook features 250 new products, including an extended range of Optima liquid chromatography/mass spectrometry (LC/MS) solvents and high-purity acids for trace elemental analysis, microbiology media and modifying enzymes. In addition, the Laboratory Reagents Handbook includes more than 4,400 Fisher Chemical products and solutions dedicated to analytical applications and more than 1,000 Fisher BioReagents products for molecular biology research, biochemistry and cellular biology.

Designed to be easy to navigate, the Fisher Chemical and Fisher BioReagents Laboratory Reagents Handbook allows users to quickly access product information by application or product name. The handbook provides detailed specifications and GHS-compliant hazard symbols for all products, along with grade, application, physical, chemical and transportation information. With many different product grades available, there are products to suit every analytical and life science application.

Analytical reagents and solvents are produced in an ISO 9001:2000- and ISO 14001-compliant manufacturing site. All products feature innovative, environmentally friendly packaging that is designed for quality, safety and convenience.

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Contact details: Schreiner MediPharm, a business unit of Schreiner Group GmbH & Co. KG Bruckmannring 22, 85764 Oberschleissheim, Germany, Phone +49 89 31584-5400, Fax +49 89 31584-5422, info@schreiner-medipharm.com

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Pharma HEAD OFFICE MUMBAI Rajesh Bhatkal Business Publications Division, The Indian Express Limited., 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar Business Publications Division, The Indian Express Limited, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Vijay Kulkarni The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor, Whites Road, Royapettah, Chennai - 600 014 Tel: Board: 28543031/28543032/

October 16-31, 2012

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Contact details Media Contact Information: Sarah Perceval, Alto Marketing, +44 (0)1489 557672, sarahp@alto-marketing.com

28543033/28543034 Fax: 28543035 Cell: 09940047667 E-mail:vijay.kulkarni@expressindia.com BANGALORE Khaja Ali Business Publications Division, The Indian Express Ltd. 5th Floor, Devatha Plaza 131, Residency RoadBangalore - 560 025, INDIA Tel: 22231923/24/41/60 Fax: 22231925 Cell: 09741100008 E-mail: khaja.ali@expressindia.com HYDERABAD E. Mujahid The Indian Express Ltd. Business Publications Division, 6-3-885/7/B, Ground floor, V.V. Mansion, Somaji Guda, Hyderabad - 500082 Tel: 040 - 23418673/ 23418674/ 66631457 Telefax: 040 - 23418675 Mob: 09849039936 Email: e.mujahid@expressindia.com

Board No. +91-33-2213 8587, 2231 8879 / 80 Fax: +91-33-22138582 Cell: 09830130965 / 09831182580 Email: prasenjit.basu@expressindia.com ajanta.sengupta@expressindia.com KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: Kochi.bpd@expressindia.com raghu.pillai@expressindia.com COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018 Tel: 2212157/2216718/2216732

KOLKATA Prasenjit Basu / Ajanta Sengupta The Indian Express Limited Business Publications Division 5, Pannalal Banerjee Lane (Fancy Lane), 2nd Floor, Kolkata - 700 001 Tel No. (Direct) +91-33-2213 8567 / 8573

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Tel: (91-79) 26872481 / 82 / 83 Fax: (91-79) 26873950 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications.

We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

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Automation S P E C I A L INTERVIEWS

‘95 per cent of the Fortune 50 pharma and medical device companies partner with Rockwell Automation’ Rajesh Vedak, ISM – Life Sciences, Rockwell Automation elaborates about the growing automation in the pharma industry, trends in automation, challenges hindering its growth and the benefits to be accrued through automation in an interaction with Express Pharma What are the manufacturing challenges and trends in the pharmaceutical industry driving the move towards greater automation?

Traditionally, the pharma industry regularly faces challenges like compliance, standardisation, real time information, effective utilisation of capacities, frequent product change overs, production scheduling, packaging and logistics etc.

Automation is expected to achieve dynamic and stringent regulatory expectations and extensive validation documentation associated with it. Automation helps achieve better compliance and transparency by limiting manual interference. Apart from that, plant-wide automation, data management, centralised control over multiple manufacturing plants, efficiency improvement techniques like overall equipment effectiveness (OEE) and energy efficiency are other driving forces expected to bring ease of operations, better compliance and a healthy bottom line.

Also, more and more domestic companies are getting into tie-ups, mergers, acquisitions with global companies. Multinational companies expect local companies to have smart, safe and sustainable manufacturing with certain level of standardisation and transparency in their operations. That's where Rockwell Automation comes in.

Automation companies like Rockwell Automation can help all the plants to achieve effective plant management and better control .

Rising energy cost, irregular and insufficient power supplies are also leading to automation in the area of DG synchronisation, harmonics

reduction, priority load shedding, air-conditioning (HVAC CONTROLS) etc for effective management of power and energy.

Increasingly, pharma manufacturing companies are realising and acknowledging the benefits of automation and evaluating how it can be used effectively to overcome these challenges.

Rockwell Automation can help pharma companies to optimise process for validation and improve efficiency. As an automation and information partner, Rockwell can help companies achieve sustainable production across the entire product life cycle – from API to formulation.

Which are the common areas in a pharma plant's operations which benefit the most from automation? ◆ Process, utilities, environmental monitoring systems like AHUs etc, ◆ Dispensing, packaging, warehouse, OEMs machines/equipment etc. ◆ Quality assurance, compliance How up-to-date is the pharma industry in India when it comes to adopting new automation technologies?

Traditionally, domestic pharma companies are perceived as ‘slow‘ in adapting new technologies related to manufacturing vis a vis their international counterparts. This could be because of various factors like regulatory compliance, extensive change protocols and revalidation documentation etc. As the products are validated based on the processes, equipments, methodolo-

Pharma manufacturing companies are realising and acknowledging the benefits of automation and evaluating how it can be used effectively to overcome these challenges 50

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gy, location, plants etc, any change in the combination attracts revalidation. Of late there is an increase in awareness about the various automation solutions made available and many companies are checking the possibilities of implementing in their plants in the following areas. ◆ Increase product quality and consistency through PAT services and solutions ◆ Improve operational efficiency through compliant-ready systems and processes ◆ Reduce business risk with OEM-ready solutions ◆ Suppress counterfeiting with RFID enabled solutions Cost and user convenience could be the most common reasons given by pharma companies in India for not implementing automation systems, what are the others? Are these valid concerns?

And what can be done to settle these doubts?

Meeting today’s business challenges makes automation ever more important, especially for integration of islands of production automation for greater productivity and lower risk. But it is very natural to not disturb the current running plant for automation, if every thing is perceived to be running perfectly.

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Thus, the system exerts inertia to change, more so if there are immediate cost implications associated with it. It is important for companies to evaluate automation investment on the scale of direct benefits such as minimising manual interference, person independent systems, better compliance etc. and indirect benefits like easier validation, standardisation etc. This evaluation should give enough reasons to select and implement plant-wide automation philosophies. For example: benefits like shortened product release cycles with automation or Electronic Batch Recording (EBR), increase asset utilisation, lower compliance costs through integrated architecture can effectively reduce the return on investment time for the investors.

What are the hallmarks which pharma companies should look for when they are choosing automation systems and solutions?

Progressive life sciences companies are realising the importance of optimising clinical, commercial and contract manufacturing. However, many of these companies have found few vendors that understand manufacturing process and have in depth knowledge, have a broad solution of offerings, knowledge of system validation, and compliance solutions for regulations such as 21 CFR Part 11. Hence, choosing the right automation partner makes a lot of impact on realising the automation dream.

Rockwell Automation recognises that there are particular opportunities to uncover hidden efficiencies in the manufacturing arena and provide smarter, safer and sustainable solutions for manufacturing, as well as, the entire product life cycle.

That’s why 95 per cent of the Fortune 50 pharma and medical device companies partner with Rockwell Automation to improve quality, safety, financial performance and time to market.

October 16-31, 2012

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‘Automation will bring in more transparency and user friendliness’ Pradeep Karnik, Managing Director, OMRON India in an interaction with Usha Sharma, provides insight about the benefits of industrial automation to the pharma industry The need to save energy and improve efficiency, compliance with regulation, quality issues, avoiding/ minimising human error, sustaining competitive advantage, etc are challenges driving the move towards greater automation. Could you add to this list?

Apart from the above challenges, key pointers driving the move towards greater automation in the pharma industry are as follows: ◆ The major challenge is FDA approval (21 CFR and cGMP) ◆ Productivity considering India is well known for manufacturing generic drugs ◆ Consistent quality ◆ Energy efficiency ◆ Lack of skilled manpower What is OMRON's mantra when it comes to automation of pharma operations?

We at OMRON believe that industrial automation is the way forward. With the high demands in volumes from the pharma industry, as well as stringent quality checks, industrial automation has several benefits for a plant’s operation. The most important function in a production facility is the secondary section, which involves formulation, encapsulation and packaging.

Alongside, automation also helps bulk manufacturing in the primary section and tracking and tracing of medicines and drugs that are exported.

Compared to other industry sectors, how up-to-date is the pharma industry in India when it comes to adopting new automation technologies?

Overall the pharma industry is still at a very basic stage of automation, as processes like 21 CFR are rarely automated.

With full fledged SCADA, high level of automation, very less human intervention and solutions like RFID etc. we can make the pharma industry’s technology solutions up-to-date.

Cost and user convenience are key reasons for not implementing automation systems, what are the others? And how does OMRON meet these concerns?

Cost and user convenience are only

the limits; when we talk about the costs people consider only capital costs. However when the lifecycle cost is considered, the whole scenario changes.

As far as the user is concerned, automation will bring in more transparency and user friendliness. The most important aspect is that total cost of ownership must be considered.

Can you give case studies of successful implementation of automation systems in the pharma industry?

One of the relevant case studies we have in OMRON is about auto loading of syringes in a blister backing line.

Pharmaceutical manufacturing companies for medical devices like canulla, disposable syringes and high level sterility products posed a new challenge when changing from manual intervention of loading syringes to automation. This was becoming a requisite for the pharma companies as it could save them from many problems like hiring more manpower, keeping a check on quality issues and production and revenue loss.

More manpower was required as there would be four operators necessary to load the syringes and two operators were made to check the orientation of the syringes loaded. As per GMP norms, syringes needed to be sterile and therefore extra precaution had to be taken for no contamination, but on several occasions, operators had to manually adjust syringes correctly.

All of this added up to production and revenue loss as operators often stopped the line to adjust/reload syringes manually thereby increasing downtime of machine.

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OMRON proposed a mechanism of auto loading syringes which could save both the production losses and reduce the manpower being used at the factory.

The solution involved using two vision cameras at the point where the conveyor of packing machine picks the syringes which will help in checking the orientation of syringes before they are loaded into the packing machine. The Two G-Series Servo Systems along with

Automation helps bulk manufacturing in the primary section and tracking and tracing of medicines and drugs that are exported

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High-Speed CJ2 Plc’s are used to get OK or NG command from camera and turn the orientation of syringes.

Mechanical arrangements were made for auto loading of syringes into the blister packing machine conveyor. Instead of one blister packing machine it is connected to two blister packing machines, hence one autoloader will feed syringes to two packing machines.

Key Benefits to the customer by using the OMRON solution:●

Return of Investment (ROI) :Our customer intends to get back the money invested in 2-4 months as the volumes of production have gone up considerably.

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Quality improvement :By making the process fully automated and enabled with automatic correction, the need of manual intervention/touching has been eliminated, thereby making the syringes fully sanitised and contamination-free.

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Reduced manpower :By offering this solution to our customer, OMRON has helped them reduce manpower in the plant thereby reducing the overall cost of manufacturing.

Any advice to pharma companies when choosing automation systems and solutions?

Pharma companies should be looking for completely integrated automation systems with a clear visibility right up to the shop floor and working on the common platform including field devices, automation systems, MES and ERP. u.sharma@expressindia.com

October 16-31, 2012

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A|U|T|O|M|A|T|I|O|N| S|P|E|C|I|A|L INSIGHT

Automation trends in pharma and biotech industry Rajkumar Gupta, Managing Director, Perfect Pharmaceutical Consultant and Director Global Institute of Regulatory affairs, Pune, provides an insight about automation, its various applications in the pharma industry and its myriad benefits oday, the pharmaceutical industry in Europe, the US and Japan is becoming more and more automated. However, the Asian countries are lagging much behind in automation. China is commanding huge production of drugs but the entire industry is still labour intensive and lacks automation.

Comparatively, the Indian pharma sector is looking forward to more and more automation. Use of computerised and automated systems are becoming very common with all new projects.

The major reasons given by pharma companies in Asia for not implementing automation are: lack of knowledge, lack of innovation, underdeveloped economy.

Currently bio products such as vaccines, antisera, monoclonal antibodies and tissue culture derived drugs are commanding more automation than synthetic drug products. In synthetic drugs, hormones, anti cancer products have achieved the maximum automation.

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The potential advantages which are driving the pharma industry towards greater automation are firstly, that automation optimises the energy consumption and thus saves energy. It also ensures higher productivity, superior quality of end product, efficient usage of energy and raw materials and improved safety in working conditions.

It address compliance with regulation as required by FDA. The automated systems are normally backed with detailed systematic recording of all the operation and inprocess controls; It avoid quality issues. The precision, accuracy and repeatibility of the operations are excellent. It minimises human error as very few people are required to run the automated manufacturing sites.

Automation also ensures 24x7 production. The continous and quantum production reduces the production cost while maintaining the quality. This helps to sustain competition. It ensure convenience in manufacturing operations as once all operations are automated, there are no human errors and no human dependancy. It also ensures continuous operation and thus reduces downtimes.

IT ensures interconnectivity between different machines and operations.

Automation also ensures stream flow of material from start to finish and avoids mix-ups. Automated systems communicate faster than human beings in case of trouble shooting. It ensures safety as the operations are performed untouched by human. It can accommodate large number of product variations and thus improves capacity utilisation to the maximum. It reduces changeover time/connecting time while dramatically reducing material losses during operation. Almost 100 per cent yield is possible with automated operations. The automated operations require less startup time and ensures streamlined material flow while preventing mix-ups and EXPRESS PHARMA

Top 100 automation systems currently used in pharma and biotech industry ▲

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reducing errors. Automation ensures great saving on space as automated systems require less than 50 per cent space than manual operations. Automation greatly reduces training cost as human beings are required only to handle the system as there are no manual operations. This makes for easier integration of operations.

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Automatic inspection system to capture images for particles, fibres and other contaminants in pharma liquid products Integrated regulatory compliant electronic batch reporting system Computerised inventory control and audit system for raw materials and finished products and other consumable items.

Automatic colour matching system for colour blends in tablet coating area Automated high speed (18000 vials per hour) micro dosing system for sterile powders into vials. The product dosing, nitrogen flushing before/during/post filling is done automatically in dehumidified are under vertical laminar flow.

High speed, very compact Inline plastic bottle leak tester.

The device is very useful after blow moulding and before filling the moulded containers.

X-ray based and spinning less in-line foreign particle detection system which can detect glass, metal and many other particles Automated laser operated Braille verification workstation to scan, read and evaluate embossed and screen printed Braille on cartons, labels or any type of packaging.

Automated highly functional and space saving robotic strip/blister packaging system for wide range of products Automated artwork, graphic, text, fonts and colour shades matching system for the labels Automated data acquisition , visualisation, data recording and qualification, data recording and rule 21 CFR part 11 compliance system for clean room monitoring Automated labelling ,cartooning and bundling machines SCADA integrated compounding vessel with attached chemical analysers Automated power backup facility for stability chambers Automated NIR-based residual moisture measurement system Automated system for displaying and recording the vacuum inside a lyophilised drug vials

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using laser absorption spectroscopy.

Automatic in-line leak detection system based on force sensor technology for flexible IV bags (capacity 1000 bags per hour) Automated X-ray-based particle detection system in liquid products Automated in-line leak detecting system for blisters and pouches based on the force sensor technology Automated in-line leak testing system based on the principle of both pressure and vacuum for ampoules.

Automated in-line foreign particle detection system for suspension and clear liquid formulations.

Automated non-visible needle damages detection system for pre-filled syringes Automated detection system for damaged rubber stoppers, chipped glass rims underneath the aluminum cap on vials Automated (SCADA based) inline leak detection system (up to 3 micron.) for blister packs. The machine indicates which blister pack and which cavity is leaking.

Automated video surveillance round the clock Auto smoke alarms for prevention of fire Automatic wireless displayer of room conditions such as temperature, humidity, noise scale, illumination levels PLC /Computer system for remote control of manufacturing operations Vacuum transfer of solids and liquids to remote processing areas Auto loaders and un-loaders for raw ,in process and finished materials Automated control on changes in electronic records Access control system for computers/machines/equipments/i nstruments and manufacturing areas Automated product review systems for quality assurance Auto street shoe covering system while entering into clean rooms Automated guided vehicles for weighing and delivery of raw materials at appropriate production points Auto lifts for just-in-time delivery of allocated raw materials and packaging materials to the manufacturing/packaging lines Auto washing of reactors/storage vessels through CIP technology Automated Process Control and Monitoring System (PMS) October 16-31, 2012

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Automated Manufacturing Management System (MMS) Automatic supervisory control and data acquisition systems for process control (SCADA) Load cell technology for accurate charging of raw materials/intermediates in reaction/process vessels Automated cGMP training systems Automated mobile system to view all site activities at any remote place Remote operable HVAC/AHU/ Freeze drying system Auto run HPLC systems for process control Auto analysers for analysing individual heavy metal impurity/amino acids Automated continuous production lines for orals, ointments, capsules and injectable manufacturing Automated continuous production lines for API manufacturing Robotic manufacturing of anticancer drugs and biological products Automated system to control conductivity of purified water Automated air showers at the entrance of production area Automated eye wash stations in production areas involving high dusting e.g. blending areas, granulation areas, micronisation areas, bulk powder packaging areas Automated metal detectors in production line Fully-automatic intelligent empty bottles as well as filled bottles inspection machines in liquid oral lines Automatic dropout system for defective/unfilled containers on packaging lines e.g. ointment filling lines, dry powder filling lines, liquid filling lines Automated product tracking system in cold chain Automated identification system for active ingredients in dosage forms on production line using near IR technology Automated dry heat sterilisation of glass containers using intelligent tunnels for dry heat sterilisation FFS aseptic system for injectables and eye drops Automated changeover system for electricity supply (Regular electricity supply to Gen set and from Genset to Regular electric supply) Dedicated training room with GMP Video on demand Automated spoken communication recording systems Auto calibration systems for instruments Audit trail facility in computer system Electronic system for issuing, verifying and checking batch manufacturing and packaging records Electronic system to display/print SOPs on demand

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Electronic colour matching system for inks used for printing on capsules Electronic visitor tracking system Computerised raw material and finished product tracking system Automated training reminders for employees Automated noise/sound control system in critical areas Automated system to control equipments including FBD, high pressure reactors, Autoclaves PLC/Computer controlled device for high pressure/high temperature reactions Use of a state-of-the-art laser operated device for critical biological processes e.g. aseptic egg opening for production of egg derived vaccines Automatic handling of explosive dusts and asphyxiating chemicals untouched by human hands Auto code verification system for cartoner and labels The electronic counting, inspection, deleting non confirming products and filling system for tablet packaging into bottles Sequential coding and 2D data matrix bar-coding for security against counterfeiting Radio frequency identification (RFID) technology for full traceability throughout the supply chain Modeling/isometric designing of entire piping system using software such as such as AutoPLANT or ISOGEN. Interdiscipline sharing the project design using software such as XREF SAP system for documentation and inventory management Automated artwork generation technology which delivers ready to print art work for multilingual labeling of pharmaceutical products.

Computerised electricity, diesel, steam and water production and consumption audit system Automated proofreading system to ensure content integrity of the labels and brochures.

Automated laser detection system for detecting deviations in blister films during blister packaging.

Automated system for cleaning, drying, sterilisation, filling, lyophillisation and sealing of filled vials.

Calibration management software having various features such as : ● Maintenance and calibration controls schedules / SOP’s / Drawings / Safety sheets / Loops diagrams / Seamless data transfer Automated high performance, wireless, data logging system which offers the ability to monitor temperature, humidity or pressure Automated robotic system for viral culture for viral based vac-

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cines.

The clean rooms with electronic access control systems Automatic window blind control system to control glare, heat and cold in processing area. The blind operates automatically to protect the area from excessive glare, heat and cold.

Automated air conditioning system to save energy. The system automatically configured to suitable mode depending on environmental conditions’ Use of specialised softwares' which integrates smart security and regulatory capabilities including an audit trail log for all security levels, data encryption, electronic signatures, enhanced password protection and administrative security options Software system to create, review, edit, approve, distribute and retire and manage SOPs throughout the lifecycle Automated and electronic proofreading solutions for ensuring the integrity of SPL/PIM or PDF submissions to external bodies Automated system for top surface sterilisation of rubber stopper fixed on sterile vials by ebeam (beta-irradiation at 25 kGray) Automated drug injecting system in pre-sterilised vials capped with sterile rubber closure.

Automated low energy laser resealing of the punctured rubber closures 24/7 accessible web based system to review critical manufacturing/QC-QA data for investigation, remediation and planning of proactive compliance Automated notification and distribution system for effective distribution and rapid notification of document changes and approvals Automated 'Read and Understood' marking system to ensure accountability throughout the organisation Comprehensive audit trail for wide range of regulatory documents including DMF/Dossier/CMC reports

Summary Today automation has become the hallmark for quality and regulatory compliance for pharma and biotech products. The computerised and robotic systems are very largely utilised to ensure mass production of pharmaceuticals.

FDA has already placed GAMP guidelines to encourage and control the automated systems used by the industry.

Today’s watch word for the industry is 'automate or perish'.

The author of this article is a free lancer consultant for US DMF, COS, ANDA, ACTD, CTD, eCTD and other regulatory submissions. This article has been solely written by him to guide to illustrate current automation status of pharmaceutical industry. He can be contacted at guptarmg1952@gmail.com.

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MES- A harbinger of manufacturing excellence in Indian Life Sciences industry Rajesh Vedak, ISM – Life Sciences, Rockwell Automation gives an insight into the workings and benefits offered by its new generation of life sciences MES software called FactoryTalk Pharma Suite he pharmaceutical industry has a little secret: Even as it invents futuristic new drugs, its manufacturing techniques lag far behind those of potato-chip and laundry-soap makers."

September 3, 2003 issue of The Wall Street Journal Most of us would agree that Indian pharma industry shares the same open secret by and large.

Over a last decade and half, we have seen a lot of investments in state-of-theart pharma – biotech facilities with unit operations to match in India. But till late, it had a very limited focus on investing in the technologies that would improve operational excellence or using the technologies that would help to give a real time visibility into the plant floor. The reasons could be various like it was never expected or mandated by any regulation or guideline nor did its large volume or capacity force us to think in this direction.

During the same period or so, some of the progressive pharma companies started realising the need of real time plant level visibility and initiated steps towards having a unified source to get consolidated data as a source of information.

Various ERP companies showed promise in understanding the challenge of delivering manufacturing-related information to the decision makers to help them take the right decision at the right time.

Subsequently, during this time a lot of investments were made on ERP systems by various small and big pharma companies in India. Organisations had success or failure, proportionate to their initial clarity of ‘what to expect from an ERP system’.

One thing that came out prominently from all these processes is that traditional ERP systems can be only effectively used to integrate data from functions like procurement, ware house, planning, sales, deliveries etc. They are not equipped to take data directly from the plant level as they don't cover production as a function.

Traditionally, ERP would not communicate with plant level devices and vice versa. The data which comes from the plant level needs to be fed in the ERP system by an operator. Thus it is a manual process which is prone to human errors like any any other manual process. It not only challenged the basic idea of having uninterrupted real time data available to decision makers but also failed to give

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seamless, error-free data. By the time the information reached the decision makers it would already be stale and a lot more information would have already been generated by the system.

As this gap was prominent, organisations started realising that ERP alone cannot have access to huge plant level data and there is a need for a system which can connect and bilaterally communicate to the plant and business systems like ERP to generate real time visibility at the plant level.

Manufacturing Execution Systems (MES) predominantly bridges this gap between plant level and business level.

What MES does …

MES primarily delivers information, enabling the optimisation of production activities from order launch to finished goods. Using current and accurate data, MES guides, initiates, responds to, and reports on plant activities as they occur.

The resulting rapid response to changing conditions, coupled with a focus on reducing non-value-added activities, drives effective plant operations and processes. MES improves the return on operational assets as well as on-time delivery, inventory turns, gross margin, and cash flow performance. It also provides mission-critical information about production activities across the enterprise and supply chain via bi-directional communications.

MES and compliance The most important outcome of implementing MES is helping achieve faster compliance to various regulatory bodies. Transparent information flow obviously leads to better compliance.

Production efficiency is affected by quality assurance requirements, out-of-date manufacturing systems and a shortage of capacity. Also, quality checks and quarantine time account for 50 per cent of manufacturing cycle times.

In spite of this, organisations' response to MES kind of technologies is very cautious due to some inherent challenges such as It was never driven by any regulatory bodies neither suggested ▲ Need and expectations for and from MES is not clearly defined and set ▲ Clarity of business is objective of a MES implementation ▲ Potential documentation and validation challenges ▲ Process harmonisation with automation and IT ▲ Implementation time lines and return on investment clarity Rockwell Automation recognises the importance of MES technology and its role in creating smart, safe and sustainable manufacturing environment and is

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focussed on bringing the technology to the end user, especially to fast growing industries like life sciences, consumer product goods, and automotives etc.

The recent Value Forum 2012, event in Pune on August 28, was one such effort to bring more companies closer to the technology by sharing the experiences of those who have actually implemented these technologies. The interaction was focussed on key cGMP principals like quality, equipment facility, production, change control, documentation etc. of Rockwell Automation’s Pharma MES solutions FactoryTalk Pharma suite. It also shared features like ‘management by exception’ which minimises review time by earlier visibilities to exceptions and improves first time approval rate of batch records where reduction in non-value added documentation.

Progressive life sciences companies are realising the importance of optimising clinical, commercial and contract manufacturing. However, many of these companies have found few vendors that understand manufacturing, have a broad solution of offerings, knowledge of system validation, and compliance solutions for government regulations such as 21 CFR Part 11.

Rockwell acknowledges and emphasises the specific needs of the life sciences customers for implementing MES such as ● Need of domain knowledge: talk the same language, understand the specific needs of an production in a regulated environment ● Proven implementation strategies: will balance the magic triangle between costs, scope and timeline ● Unique validation capabilities: lowers your burden of compliance A foundation of a comprehensive functional offering tailored to customer needs ● Partner up with a reliable vendor that understands the industry trends and values the uniqueness of the LS industry and drives their roadmap out of your input For more than 15 years, Rockwell Automation has been the MES vendor of choice for pharma companies worldwide, delivering superior products and services. Combining Rockwell’s experience and deep expertise with state-ofthe-art technology, industry standards and innovation, was the recipe for success when creating FactoryTalk Pharma Suite, a new generation of Life Sciences MES software.

(The author can be contacted at rcvedak@ra.rockwell.com) For more details please contact Rockwell Automation, India October 16-31, 2012

Packaging S P E C I A L

he pharma industry is known to deal with most sensitive products that directly decide life and death of the consumer. Therefore there is zero tolerance for any changes in the appearance or characteristics for a pharma product. Over the years, drugs have evolved a great deal and so have the complexities associated with them. The parenteral drugs category is perhaps the most sensitive product category in the pharma industry. To deliver parenteral drugs to the final consumer, with intact product quality has remained a prime concern for every parenteral drug manufacturer. However, much to the satisfaction of the pharma industry, the packaging sector has been successfully producing effective packaging solutions for parenteral drugs. With new innovations parenteral drugs pose increased challenges for packaging service providers. It will be interesting to see if the packaging industry can also keep pace with these new discoveries.

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Evolution of parenteral drug packaging Requirements of product purity, activity and

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shelf life order high standards for parenteral drug packaging. As said, parenteral drug packaging is among the toughest jobs that packaging service providers will have to do. However, industry experts do feel that the packaging sector proved itself competent while providing packaging solutions for parenteral drugs.

Manav Soni, CGM & Plant Head, Venus Remedies, opines, “Earlier, the requirements of pharma packaging focused exclusively on preserving the quality of enclosed medication. Now, they are extended to cover such criteria as prevention of product tampering and counterfeiting, assurance of product dispensing accuracy and promotion of patient compliance with product dosage schedules. Therefore, we have a variety of packaging available which includes glass, PET bottles, strip and blister packs, injectables, ampoules, bulk packs etc.”

Murli Sundrani, Business Director – BD Medical-Pharmaceutical Systems, India, echoes Soni's views. BD is a leading global medical technology company that develops, manufactures

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and sells medical devices, instrument systems and reagents. He says, “Surely, we have better, safer and user friendly packaging and devices for delivery of parenteral drugs. Pre fillable syringes, self-administered pen injections, auto injectors are efforts in this direction.”

Side effects Packaging in pharma industry is a serious business as it protects the products during shelf life, meets the legal compliances, provides convenience to customers and explains the route of administration. Soni lists the possible side effects of faulty packaging of parenteral drugs. He says, “A poorly designed packaging can expose the patients to a risk of serious adverse effects. Any fault in primary packaging can lead to decrease in tonicity and potency of the drug, presence of impurities, microbial contamination, exposure to gases or light or water vapour and so on, thereby causing adverse side effects. For example, sterile powders for injections must be protected from exposure to water vapours, else it will end

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up disturbing the chemical nature of the drug thereby reducing its potency. While secondary packaging faults can create problems in transportation of the drugs, delay in regulatory compliances, misguide the end user and so on.”

He adds, “In other words, the unique requirements of pharma products ask for special considerations on the quality of drug at the time of delivery and ways to increase the shelf life while designing the packaging for products.”

MURLI SUNDRANI

MANAV SONI

Business Director – BD MedicalPharmaceutical Systems, India

CGM & Plant Head Venus Remedies

Putting drugs in packaging which is safe, convenient and easy to use while ensuring that the drug retains its effectiveness is the recent trend in the packaging of parenteral drugs

Nanotechnology, the science of very small materials, is poised to have a big impact in pharma packaging and will enable it to bring innovative and new generation packaging solutions to market

the near future and so is the pharma packaging industry. Soni provides the statistics, “It is estimated that the world pharma packaging demand is to increase 6.3 per cent annually to $62.3 billion in 2013. In India, the parenteral drug packaging market is around Rs 1,500 crore which is growing steadily at around 15 per cent per annum and is expected to follow an upward trend in global medication consumption.”

er dominates the market as this involves both primary and secondary packaging.

Even Soni puts a positive picture for the packaging sector. He says, “Global medication consumption is speculated to expand at a strong pace because of the ageing demographic patterns that are leading to increasing number of diseases and disorders. Besides this, the antibiotic segment of the industry is facing a downfall because of the growing dry drug pipelines and increasing resistance for antibiotics against the deadly infections.”

The pharma industry across the world is poised for growth and packaging being an intrinsic part of the industry will definitely grow at the same pace too.

As India is already on the radar of many big pharma players across the globe, it is widely speculated that India will be the key partner in the growth of not just the pharma industry but also allied sectors like packaging in the future.

Recent trends Sundrani feels that putting drugs in packaging which is safe, convenient and easy to use while ensuring that the drug retains its effectiveness is the recent trend in the packaging of parenteral drugs. As discussed the parenteral drug segment is enjoying a boom around the globe and so is its packaging. The clinical efficacies, high value and price tags demand high level of awareness in primary as well as secondary packaging.

According to Soni, with the advancement in technologies, new material has come to surface due to their better technical and material properties.

“Nanotechnology, the science of very small materials, is poised to have a big impact in pharma packaging and will enable it to bring innovative and new generation packaging solutions to the market. Increasing demand for drug delivery devices and blister packaging will also boost the growth of pharma packaging industry,” opines Soni.

Packaging market in India With the boom in the parenteral drug market, the packaging market is also enjoying a remarkable growth. The approach of pharma companies have changed over time. “Now, they have the same approach towards the science and risk-based packaging material as they do with molecule development entering the clinical stage. Drugs firms have trained, professional packaging staff of their own to ensure the smooth and successful transition of drugs from the lab to market,” says Soni.

With the rising demand for better and effective drugs, the pharma industry is poised to grow tremendously well in

Future perfect Pharma industry has hardly lost its momentum over the years. As parenteral drugs is the buzz word in the global pharma industry, it is a given that more opportunities will be lining up for packaging service providers in this particular category of medicines.

According to Sundrani, the future would be for packaging which is lighter, safer and easy to use and discard and convenient / intuitive to use. However, there is no data available on which play-

sachin.jagdale@expressindia.com

Guidelines recommended in The International Pharmacopoeia for drug packaging that cover quality of packaging, material used and set standards of labels.

The quality of the packaging of pharma products plays a very important role in the quality of such products. It must: ❖ protect against all adverse external influences that can alter the properties of the product, e.g. moisture, light, oxygen and temperature variations; ❖ protect against biological contamination; ❖ protect against physical damage; ❖ carry the correct information and identification of the product.

The kind of packaging and the materials used must be chosen in such a way that: ❖ the packaging itself does not have an adverse effect on the product (e.g. through chemical reactions, leaching of packaging materials or absorption); ❖ the product does not have an adverse effect on the packaging, ❖ changing its properties or affecting its protective function.

Apart from this, the most important part of packaging is 'its label'. All finished drug products should be identified by labelling, as required by the national legislation, bearing at least the following information: ❖ the name of the drug product; ❖ the batch number assigned by the manufacturer; ❖ the expiry date in an uncoded form; ❖ any special storage conditions or handling precautions that may be necessary; ❖ the directions for use, and any warnings and precautions that may be necessary; ❖ the name and address of the manufacturer or the company or person responsible for placing the product on the market.

Source: Manav Soni, CGM & Plant Head, Venus Remedies

October 16-31, 2012

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Packaging of parenteral drugs – Evolution of pre fillable systems Murli Sundrani, Business Director - BD Medical - Pharmaceutical Systems and Santosh Das – Manager, Customer Quality Assurance and Technical Services, BD Medical give an insight on packaging trends for parenteral drugs arenteral routes of drug administration such as intramuscular (IM), subcutaneous, intra venous (IV) and intra dermal (ID) are a means of introducing a drug into the body through injection, for quicker absorption by the body and these routes have the highest bioavailability and are not subject to first-pass metabolism or harsh gastrointestinal environments. Parenteral administration is also used for treatment of unconscious patients and under circumstances where a rapid onset of action is required. Parenteral administration provides the most control over the actual dose of drug delivered to the body.

When we talk about packaging of parenteral drugs, the responsibility is many fold. The objective of the packaging systems is to protect the formulation from external environment and vice versa, protect and retain the efficacy with maximum possible shelf life, maintain the sterility with adequate packaging integrity, help administering the right dose accurately with safe disposal after usage. Historically, packaging and drug delivery devices were different but now the trend is that both are integrated. For example, the use of vials is common but provides challenges to the user. Like, the health care professional needs a syringe to prepare the injection and deliver the required dose. In an integrated system such as a pre fill syringe, it not only contains and protects the drug product but also act as a delivery device.

Using syringe/ vial for injection involves 10-12 steps whereas pre fill involves two to three steps. So it minimises response time during emergency and increases patient compliance and reduces chances of administration errors In the traditional method the overfill volume need to be given in vial/ ampule and then again for syringe. In pre fill delivery system there is only syringe dead space. Apparently as compared to vial (over fill volume is 20 per cent – 25 per cent), pre fillable system requires much lesser overfill volume (2-5 per cent). When this is for expensive biotech products and vaccines, it can save substantial amount of money and valuable drug which can be used for many more patients.

Less preparation steps, less delivery steps, fewer materials, easier storage and disposal reduces overall cost of healthcare.

Prefill delivery systems enhance safety with less particulate matter , reduced risk of bacteriological contamination, reduced risk of medication error, reduced risk of misidentification and improper dosage delivery, reduced risk of injury and exposure to drug. the world wide pre fillable market is foreseen to grow at CAGR 7.8 per cent from 2010-2016 and then 5.5 per cent

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Murli Sundrani, Business Director - BD Medical Pharmaceutical Systems

Santosh Das – Manager, Customer Quality Assurance and Technical Services, BD Medical

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from 2017-2022 (source visiongain in 2012).

Way back in 1954, BD produced the first single use glass pre fillable syringe, BD Hypak in the immunisation campaign against polio by Dr Jonas Salk.

Since then the pre fill drug delivery systems have evolved significantly and is enriched with experience and expertise of many years. There is ever increasing demand, stringent regulatory requirement, more sensitive drug in pipeline and need for increased patient compliance, which will drive growth for pre fillable syringes Significant development has happened to make the injection experience

as comfortable as possible. One of the critical aspects of user experience is pain perception. Three main combined factors drive lower perception of pain and needle penetration force: a) Gauge of the needle: Moving to a thinner needle : ■ 25 Gauge to 27 gauge for IM injection (vaccines) ■ 27 Gauge to 29 Gauge for SC injection ( biotech) Thinner needles also provide better internal diameter so that the drug flow is not compromised. b) Needle point design and point quality ■ Moving to a sharper needle : 3 bevels to 5 bevels c) Needle shield material ■ Moving to a less abrasive NS material: rubber to TPE Considering the above factors BD has developed a prefill syringe BD Physiolis to make the injection experience more comfortable (less pain and less penetration force). This range of prefillable syringes are popular where multiple injections are required over a period of time such as multiple sclerosis.

New biologics drugs are increasingly complex (protein based) and interactions with primary container (tungsten, silicone oil) is a key issue.

Some emerging key expectations Patients are becoming more empowered, demanding safe, convenient, and easy-to-use drug delivery with injection convenience (strong preference for autoinjectors) and injection comfort (reduced pain, short injection time);

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Regulatory agencies have significantly increased their expectations and emphasising more on human factors requirement to asses when integrating drug product with a container and device apart from providing data regarding drug/container compatibility.

It requires substantial amount of investment in research to come up with advance product fulfilling these requirements.

In 2005, BD first became aware that tungsten can cause protein aggregation.

Tungsten in aqueous solution combines with a variety of chelating agent offering oxygen, sulfur, nitrogen as donor atoms.

With tungsten as a central ion in a chelate ring the following systems have been reported: O-W-O,O-W-S,O-W-N,S-W-S,S-W-N Potentially all amino acids are donor atoms and especially cysteine and methionine if we consider sulfur.

(Cysteine and methionine are both powerful antioxidants, and they both contain the health-promoting substance sulfur).

The source of tungsten is identified as the forming pin used to form the barrel tip of pre fill syringe. BD has developed expertise on the tungsten issue and developed process to offer low tungsten barrels. Combining this experience along with the other needs of biotech drugs, BD has developed Hypak for biotech.

Intra muscular and subcutaneous route of administration are more popular form of injection. Among the common vaccine delivery routes, notably for flu vaccine immunisation, intradermal injection (ID) has recently undergone clinical investigation and has reported an improved immune response resulting in

decreased antigen dose requirements relative to standard IM immunisation. The challenge with delivery through intradermal route is injection technique and availability of an appropriate device to ensure the accuracy in terms of dose and site of injection.

BD Soluvia – Microinjection system is a proven, easy-to-use, intuitive and reliable method of intradermal delivery, which integrates a 1.5 mm length BD microneedle (in pic above). The tiny micro-needle penetrates 1.5mm into the skin from the outer skin surface to deliver a volume upto 250 µL. The ideal October 16-31, 2012

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injection volume is drug dependent and would be determined by the pharma company. Intradermal route of admin-

istartion can save significant amount of active drug as compared to intramuscular route of administartion. The injection system has an integral mechanism that covers the needle after injection, protecting the user against inadvertent needle stick injury.

Another key feature of the BD Uniject is its auto disable feature or its difficulty to re-use.

This format of delivery system can be very good options for mass vaccination and injections in public health sector.

blood borne pathogens from (i) patient to patient, (ii) patients to health personnel, (iii) patients to the community at large.

As per Occupational Safety and Health Administration (OSHA), hospitalbased health care workers experience some 800,000 needle stick injuries each year in the US (Jagger, 1990). About 2 per cent or approximately 16,000 of these are likely to be contaminated by

HIV (American Hospital Association, 1992). Needle stick injuries account for up to 80 per cent of all accidental exposures to blood. (Jagger, 1988).

Based on various studies, researchers have documented that needle stick injuries are under reported by healthcare workers and the number of exposures could potentially be much higher.

So regulatory requirements are becoming more stringent around the need for a safety integrated system which can prevent Needle Stick Injuries (NSI).

When a needle of choice has to be used along with the syringe, a safety needle is desirable to prevent needle stick injuries. The BD SafetyGlide is a sterile, detachable hypodermic needle that connects to any conventional or prefilled luer syringes. It can be activated by single finger stroke and helps prevent needlestick injuries by allowing easy and secure shielding of the needle tip immediately after injection.

The BD Eclipse shielding hypodermic needle is one of BD’s latest innovations, further expanding the broadest and most comprehensive array of safety-engineered medical devices in the industry.

Self injection system Growing needs for injectable drug delivery and customised differentiated delivery systems are increasing the size of the self-injection market. Large aging populations with chronic diseases, healthcare cost pressures, and trend toward patient education and empowerment are increasing demand for selfinjection systems. BD can offer a wide range of self injection systems to meet the needs of pharma companies, patients, healthcare professionals and other important healthcare stakeholders.

Self injection systems can be syringe based or cartridge based. Also, it can be reusable or disposable and variable or fixed dose depending upon the requirement. The platform can range from a simple single dose disposable system to sophisticated systems with digital display and electronic controlled.

Auto injectors are used in therapeutic category like multiple sclerosis, rheumatoid arthritis, osteoporosis, anemia, neutropenia, CNS, hormones.

Disposable and reusable pens are used in therapeutic categories like dia-

betes, fertility, growth hormones, osteoporosis, other hormonal therapies, cancer management, Parkinson’s disease and sexual dysfunction.

Parenteral packaging and delivery systems are going through an exciting phase. As far as innovation in drug delivery is concerned, BD is always in the forefront to bring innovative and clinically proven product and solutions. With over 100 years of expertise in manufacturing and processing technology for parenteral drug delivery systems, BD has developed a strong understanding of how to help meet the pharma industry’s delivery requirements for injectable medications.

The authors can be reached at murli_sundrani@bd.com and santosh_das@bd.com

Safety Safety is a major concern today for patients and healthcare workers. The protection against unsafe injection practices can lead to the transmission of

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October 16-31, 2012

Express Pharma Business Avenues

October 16-31, 2012

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OSWORLD QUIZ

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Disclaimer: Quiz reproduced by Osworld from various sources. Any errors regretted. Advertisement inserted to enthuse readers.

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Plastic Containers (HDPE, LDPE) Rubber Closures, Glass Containers Medical Articles & Packaging Materials Testing as per USP, EP&JP Biological

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October 16-31, 2012

Pharmexcil felicitates leading pharma players The Pharmaceuticals Export Promotion Council of India (Pharmexcil) recently organised the India-Asia-Pacific Pharma Business Meet and the Annual General Body meeting of the Council wherein Pharmexcil awarded several pharma companies for their significant contributions to the sector

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JOB TRENDS

Hiring activity in pharma sector dips 3 months in a row Hiring levels for September 2012 is 6 per cent lower than what it was in August 2012 n September 2012 there has been no action in the recruitment front for the pharmaceutical sector. However, what is worrying is the fact that hiring has been consecutively dipping for the past two months. Hiring levels for September 2012 is 6 per cent lower than what it was in August 2012 and 8 per cent lower than July 2012.

The first half of the year had been upbeat for the sector with recruitment activities taking place on full swing. Hiring activity for the pharma sector in September 2012 is 10 per cent lower than February 2012.

Methodology: The Naukri Job Speak index is on the basis of job listings added to the site every month. To calculate the index, job listings added to the site in July 2008 have been taken as 1,000.

The subsequent months have been indexed with data of July 2008. The monthly report shows hiring trends across industry sectors, geography and functional areas. There might be high volatility

I

The Naukri job speak index for the pharma sector is a monthly report that indicates hiring trends across industry sectors, geographies and functional areas for certain fringe cases like smaller cities, niche industries etc. owing to a small base, but more

than 42000 clients using Naukri.com leads to high reliability of the data.

Jobs from Naukri.com Post: Sr. Executive - Finance

Post: Sr.manager- Engineering Purchase

Company: Acebright (India) Pharma Pvt Ltd Exp: 5-10 Location: Bengaluru/Bangalore Email: murali@acebright.in Job ID: 230812003485

Company: Macleods Pharmaceuticals Ltd. Exp: 8-13 Location: Mumbai Email: jobs@macleodspharma.com Job ID: 290912002259

Post: Assistant Manager Finance & Accounts

Post: Asstt Drug Regulatory Affair Manager

Company: Allergan India Pvt Ltd Exp: 2-4 Location: Bengaluru/Bangalore Email: roy_somnath@allergan.com Job ID: 260912001532

Company: Amol Pharmaceuticals Private Limited Exp: 2-7 Location: Jaipur Email: girishmaheshwari1960@gmail.com Job ID: 290912001585

Post: Research Associate Analytical Method Validation Company: IPCA Laboratories Ltd. Exp: 3-5 Location: Mumbai Email: adl.mumbai@ipca.com Job ID: 260912001476

Post: Q.c.analyst Company: Spansules Pharmatech (P) Ltd Exp: 8-10 Location: Hyderabad / Secunderabad Email: hrd@spansulespharma.com Job ID: 270912000868

Post: Manager-pharma Sales Training Company: Unichem Laboratories Ltd Exp: 2-7 Location: Mumbai Email: hrd@unichemlabs.com Job ID: 31012000247

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

Pharmexcil felicitates leading pharma players The awards recognised significant contributions by pharma players in various categories he Pharmaceuticals Export Promotion Council of India (Pharmexcil) recently organised the India-Asia-Pacific Pharma Business Meet and the Annual General Body meeting of the Council wherein Pharmexcil awarded several pharma companies for their significant contributions to the sector.

The event witnessed the presence of various successful companies who came together to share and recognise their achievements of securing patents in the pharma sector in 2011-12. Held in Hyderabad, the event was conferred by Raja Shekhar, IAS, Joint Secretary Department of Pharmaceuticals, Ministry of Chemicals & Fertilisers and RP Thakur, DGDC, AP. Some of the winners are as

T

follows: Venus Remedies who received four patents in this fiscal year with two patents each for Sulbactomax and Vancoplus won the Patent Award in Silver category for the year 2011-12. Hyderabad-based Bharat Biotech also received the Silver Patent Award for the year 2011-12 in recognition of commendable contribution in biotech products and research. The‘Outstanding Export Performance Award’ for the year 2011-2012 went to Calyx Chemicals and Pharmaceuticals, recognising the company’s performance as a supplier of excellent quality products and reliability.The winners were buoyant after receiving the awards.

Dheeraj Aggarwal, CFO, Venus

Remedies after receiving the award at the ceremony said, “Getting such a prestigious award for the second year in a row for our commendable contributions towards research and development, demonstrated by patent grants in 2011-12, is indeed a matter of pride and great honour.”

Dr Krishna Ella, Chairman and MD, Bharat Biotech stated, "We thank Phamexcil for recognising innovation at Bharat Biotech and the credit goes to the Bharat Biotech Team, who have worked relentlessly to make this happen."

The Pharmexcil jury recommended and selected winners based on the guidelines framed for selection.

EP News Bureau

NEW COURSE

FICCI announces online IPR course on pharma R&D The six-month course will have five modules ederation of Indian Chambers of Commerce and Industry (FICCI) will start an online certificate course on IPR and pharmaceutical R&D (CCIPR) from November 2012 to April 2013. The objective of the course is to provide a platform to understand the working of pharmaceutical industry, its business models, research, regulatory aspects and its relevance with respect to intellectual property rights.

This is a first of its kind of course

F

introduced with specific focus on the interlinking between the pharma industry and IPR. The course is of six months duration and consists of five modules i.e. pharma business, pharma research and development, intellectual property rights: introduction, IPR - with specific reference to pharmaceuticals, IPR Indian patent scenario and a case paper to be prepared by the participant.

Students in pharmacy/ pharmaceutical sciences or industry persons work-

ing in the pharma sector, willing to enter pharma R&D, formulations, generics, NDDS, regulatory affairs, drug discovery, clinical research, toxicology, international business, business strategy, strategic planning and the like, can join the course. Features like online FORUM for query resolution and weekly updates on IPR are available for the course. The last date for registration is October 25, 2012.

EP News Bureau

NOMINATION INVITED

AmeriCares India to host 4th edition of Spirit of Humanity Awards Americares India, through these awards, would felicitate individuals and organisations working to improve the health of the underprivileged and disadvantaged sections of the country meriCares India will be hosting the fourth edition of the ‘Spirit of Humanity Awards’ on April 6, 2013 in Mumbai. This is the premier award function of its kind for individuals and organisations working in the healthcare space among the underprivileged and disadvantaged sections of the country.

The event will be held a day prior to the WHO declared World Health Day. Individuals and organisations doing exemplary work in the healthcare space among the underprivileged in India will be facilitated in various categories like Women’s Health, Child Nutrition, Oncology and a special Jury’s Choice Award. The objective of the Spirit of Humanity Awards is also to showcase the best practices undertaken by these organisations/individuals while working in various corners of the country.

The Winners of the Spirit of Humanity

A

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Individuals and organisations doing exemplary work in the healthcare space among the underprivileged in India will be facilitated in various categories Award 2012 were El Shaddai Charitable Trust (Child Nutrition), Programme for

www.expresspharmaonline.com

Human Development (Infection), The Research Society for the Care, Treatment & Training of Children In need of Special Care (Neurology/ Mental Health), Muni Seva Ashram (Oncology Service),Dr Kunnambath Ramadas (Oncology Research), Prasad Chikitsa (Women's Health), Ambulance Access for All (Jury’s Choice Award) & Salaam Bombay (Jury’s Choice Award) Individuals and organisations from all across the country working in the healthcare space among the underprivileged can apply. Winners will receive a donation of Rs 1 lakh for a charity of their choice along with a trophy and a Certificate of Excellence. For additional information and to download the nomination form visit AmeriCares India Foundation at www.americaresindia.org EP News Bureau October 16-31, 2012

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