Modern Pharmaceuticals - October 201 by Infomedia18

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Editorial

FDI policy for Indian pharma: A healthy road ahead? he government’s hibernation over Foreign Direct Investment (FDI) in pharma industry seems to be finally over. After protracted ‘suspense’ on whether the government will put a cap of 49 per cent FDI in a pharmaceutical company’s equity, the latest news of allowing 100 per cent FDI in green-field projects may have come as a breather. However, their brown-field cousins have to seek go-ahead from the Foreign Investment Promotion Board and the Competition Commission of India (CCI). Further as reported, the latter would have specific rules in place for the healthcare sector besides the existing ones that oversee M&As in the country.

Now, the question that arises here is if it is a retrograde step? Will it take the industry back to the days of license raj? While it is good to have rising valuation of pharma firms, it is also essential to ensure affordable healthcare especially for financially weaker sections in India along with other developing countries. In this backdrop, it is important to analyse the transformation of sorts that the Indian pharma industry has undergone in the recent years. In fact the pace of change from a predominantly reverse-engineering and protection driven market to a global and innovation driven one has been fairly quicker. Thanks to the increasing competition from the multinational firms among other factors, Indian pharma companies have emerged more value-adding, agile and cost-effective over their peers in the emerging economies.

Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair

That said, one can neither discount nor promote the recent spate of M&As resulting in a sharply reduced number of domestic big pharma companies operating in India. While no one is contesting the reality of global collaboration and consolidation as perhaps the next successful strategy for Indian pharma, there needs to be ample room for meeting the country’s growing healthcare needs based on two broad parameters viz, accessibility and affordability. Perhaps the time is now ripe to have a clear pharma strategy road map with adequate facilitating measures at the national level. Needless to add that there has to be a well-defined long-term vision embedded in it as well as plenty of provisions to drive the change in a healthy manner.

IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Manas R Bastia manas@infomedia18.in

October 2011 I Modern Pharmaceuticals

Contents FE AT URES 28

LEADERS SPEAK 'What is needed in India to improve access to healthcare is political leadership' ...says John J Castellani, President & CEO, Pharmaceutical Research and Manufacturers of America (PhRMA)

ROUNDTABLE EC’s new draft guidelines: Will it benefit the Indian pharma industry?

FACILITY VISIT Bafna Pharmaceuticals Ltd: Turning a new leaf in the regulated market

INDUSTRY UPDATE Pharma manufacturing: Cost saving with optimal utilisation

SPOTLIGHT Regulatory approvals and denials: Things pharma companies should be concerned about

INTERFACE

52 54

'The Indian pharma industry has evolved into a mature & integrated industry’ ...says Bhavesh Patel, MD, Marck Biosciences Ltd 'The per capita consumption of medicine in India is negligible when compared to other countries’ ...says Subhash Chandra Sehgal, CMD, Ozone Pharmaceuticals Ltd

MARKET TRENDS Automation for pharma: Robotic applications ushering in a change

SME CORNER IT penetration in pharma SMEs: Yet to click

CASE STUDY Inspecting labelling errors: New accuracy levels achieved Didier Lacroix, Senior Vice President, Worldwide Sales & Marketing, Cognex Inc

INDUSTRY INSIGHTS Hepatitis A preventive vaccines: Driven by increased tourism Courtesy: GlobalData

REPORT

78 80 82

LEGAL EDGE Pharmaceutical patents: The curious case in India Anuradha Salhotra, Managing Partner, Lall Lahiri & Salhotra

Pharmac India 2011: A platform aiding future goal setting

REGUL A R SEC TIONS Editorial ...........................................................9 National News ................................................14 World News ....................................................20 Tech Updates .................................................24 Events Calendar .............................................75 Product Update .............................................85 Product Index ................................................91 Advertisers’ List .............................................92

Workshop on ‘Future Supply Chain Strategies – the way ahead’: Of communion and concrete ideas 2nd Annual BIO India International Partnering Conference: Exploring opportunities in Indian biotech

Highlights of Next Edition: Special Focus Pharma machinery

Details on page no.

12, 47, 77

Insight & Outlook Pharma raw materials Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

October 2011 I Modern Pharmaceuticals

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October 2011 I Modern Pharmaceuticals

National News Jubilant, Cipla honoured at International trade awards Jubilant Life Sciences Ltd & Asahi Songwon Colors Ltd were felicitated with the ‘Outstanding Exporter Of The Year – Chemicals’ & Cipla Ltd was commended with the‘Outstanding Exporter Of The Year - Pharmaceuticals, Healthcare and Life sciences’ at DHL and CNBC–TV18 ‘The International Trade Awards 2011’’ organised for the ﬁrst time in India. These awards aim at recognising the innovations and excellence of the Indian

importers and exporters at the International Trade facilitation in India. Shri R P N Singh, Minister of State for Corporate Aﬀairs presided over the awards held in the city recently. Adi Godrej, Chairman, Godrej Group was the Guest of Honour on the occasion. Speaking on the occasion, Anil Uniyal, CEO, CNBC-TV18 and CNBC AWAAZ said, “We are proud to partner with DHL for the fourth edition of International

Boehringer and Eli Lilly sign India alliance pact

Boehringer Ingelheim India and Eli Lilly India (Lilly) announced that they have entered into an agreement speciﬁc to India to co-promote a portfolio of diabetes compounds currently either in late-stage development or on the market. The collaboration includes Boehringer Ingelheim’s oral anti-diabetic agent, Linagliptin, not yet approved for marketing in India and Lilly’s insulin analogue, Humalog™ (Lispro), which is already on the Indian market. “India is clearly a market with great need and huge potential for the treatment of diabetes,”

said Jacques Tapiero, President, Emerging Markets Business Area, Eli Lilly and Company. Linagliptin discovered by Boehringer Ingelheim and developed as an oral once-daily single dose tablet for type 2 diabetes. It is already approved in the US, the EU and Japan, among other countries. A greater number of healthcare providers across India will now have access to the Humalog™ range of products. “India is a key strategic market for Boehringer Ingelheim and this co-operation will give Boehringer Ingelheim and Lilly in India the combined beneﬁts of Lilly’s expertise in the diabetes market as well as Boehringer Ingelheim’s rich and innovative late-stage pipeline”, said Philipp von Lattorﬀ, Head, Emerging Markets, Boehringer Ingelheim.

Trade Awards 2011. The awards will represent the ﬁnest of the International Trading Community and highlight their extraordinary achievements. As we continue to honour and recognise innovation and excellence showcased by the Indian entrepreneurs on a global platform, we feel equally privileged in watching the custodians of ‘Brand India’ being rewarded for making their mark globally.”

Signet, FMC & Roquette conduct technical seminars across the country Signet, the Mumbai-based ‘excipients’ specialist, together with its major partners FMC & Roquette, organised technical seminars on various topics in Mumbai, Hyderabad, Bangalore, Ahmedabad & Delhi. R&D, manufacturing & QA personnel L-R: Dr Carlin & Dr Simon from several pharma majors attended the workshops. In the seminars, Dr Brian Carlin provided an insight on several topics such as Quality by Design (QbD), Controlled release and New Excipients from the FMC portfolio. Under QbD, he said “The more science demonstrated in product development, the greater the regulatory freedom for Operational Excellence post approval. QbD requires understanding of the impact of excipient variability on finished product quality. Such understanding requires knowledge of the true excipient variability, beyond the pharmacopoeial specification and Certificate of Analysis. Access to such knowledge and data requires early discussion with the excipient suppliers. McKinsey estimates that as much as $ 20-30 billion in potential savings can be realised by QbD/OE.” In the seminar, Dr Denis Simon gave insight on new excipients for coating and oro-dispersible tablet applications and his talk also provided new techniques in solubilisation with cyclodextrins.

Sproxil in pact with Greenlife and Bliss GVS Pharma Ltd to protect LONART DS from counterfeiting Sproxil, a US-based company that provides world-class brand protection in emerging markets through software and services that work anywhere there are mobile phones, announced the establishment of an alliance with Greenlife Pharmaceutical Ltd, a Nigeria-based distributor for prescription medications, and Bliss GVS Pharma Ltd, an India-based pharmaceutical manufacturing company. Providing protection for the popular anti-malarial drug LONART, the partnership marks Sproxil’s ﬁrst cross-national collaboration between India and Nigeria, allowing Nigerians to verify the authenticity of a crucial anti-malaria drug. To maintain the integrity of the LONART Brand, Greenlife Pharmaceuticals and LONART manufacturer Bliss GVS Pharma have instituted a mobile authentication service (MAS) to provide

customers a way to verify the authenticity of their product at the point of purchase. Powered by Sproxil advanced technology, the same anti-counterfeiting services were launched by NAFDAC in Lagos last year. Sproxil’s Mobile Product Authentication™ (MPA) technology capitalises on technologies that already exist and are readily accessible and easily understood by all levels of society – namely cellular phone SMS capabilities and scratch-oﬀ lotterystyle labels. The company’s services allow end consumers to verify with a simple free text message that they are not purchasing counterfeit medication. “I am quite pleased that Greenlife Pharmaceuticals and Bliss GVS Pharma chose to protect not just their product, but Nigerians as well,” stated, Tomi Davies, Director, Sproxil.

Modern Pharmaceuticals I October 2011

National News OPPI honours scientists & young scientists The winners of the fourth OPPI Scientists & Young Scientists Awards 2011 in collaboration with Council of Scientiﬁc & Industrial Research (CSIR) and National Institute of Pharmaceutical Education and Research (NIPER), were announced on the sidelines of the Annual General Meeting of Organisation of Pharmaceutical Producers of India in Mumbai. On the occasion, Tapan Ray, Director General, OPPI said, “Every year OPPI presents awards of excellence to scientists and young scientists of the country to recognise, honour and encourage innovation in the

pharmaceutical sector of India. Such encouragement has the capacity to unleash the innovative potential of the Indian scientists, which could play the role of a game changer to catapult Indian Pharmaceutical Industry to greater heights of success, meeting the unmet needs of ailing patients.” The winners were honored with a memento, citation and a cash prize of ` 1, 00,000/, by Andrew Witty, Global CEO, GlaxoSmithKline. Dr Srinivas Kolupula, Assistant Professor, Dept of Medicinal Chemistry, NIPER,Hyderabad was recognised for his outstanding research work in the ﬁeld of

Pharmaceutical Chemistry. While some of the other winners include Dr Kulbhushan Tikoo, Professor, Dept of Pharmacology & Toxicology, NIPER, Mohali; Dr Sanjay Kumar, Senior Group Leader, Dept of Medicinal Chemistry, Piramal Life Sciences Ltd, Mumbai and many more. As a part of the Public Private Partnership (PPP) initiative in the area of pharmaceutical R&D, OPPI invited nominations across the country and the winners were decided by an independent board of eminent juries. The scope of the awards covers pharmaceutical chemistry, pharmaceutics, pharmacology, pharmaceutical biotechnology/ nanotechnology and pharmacognosy & phytochemistry.

Dr Reddy’s terminates Rx business deal in Russia

Glenmark’s zolmitriptan gets USFDA approval

Dr Reddy’s Laboratories has announced that the proposed business deal to acquire the pharmaceutical prescription portfolio of JB Chemicals & Pharmaceuticals in Russia and other CIS countries has been mutually terminated in the overall business interest of both parties. Dr Reddy’s and JBCPL had entered into an agreement on July 22, 2011. Russia is one of Dr Reddy’s focus markets where we continue to improve our market ranks and are committed to expanding our presence in the region.

Glenmark Generics Inc, USA, the US subsidiary of Glenmark Generics Ltd, announced that the USFDA has granted tentative approval for their generic version of IPR’s migraine treatment Zomig® 2.5 mg and 5 mg tablets. Glenmark believes there are no first to file applicants for zolmitriptan tablets and therefore the company would commence marketing and distribution of their zolmitriptan product upon patent expiration in May 2013. Product launch is dependent upon receipt of final approval of its ANDA from the USFDA. IMS Health has reported sales for the same for the 12 month period ending June 2011 as $ 141 million.

Merck Millipore hosts conference on ‘the web of process and regulatory trends’ Biopharm Process Solutions of Merck Millipore India creates a platform for the Pharma and Biopharm industry by hosting an event for and by the industry, ‘the web of process and regulatory trends’ once every two years to discuss and deliberate on the ‘current and emerging process and regulatory trends’. Through this conference Merck Millipore and the industry work together in achieving their common goal of improving the quality of life through innovation. This years conference the 5t in the series was held on the 15t and 16t of September at Hotel Sheraton, Bengaluru, India. The conference this year was uniquely structured in bringing the professionals from pharma, BioPharma, consultants and the regulators on to one stage to discuss, deliberate and understand the trends in processes, technology and regulations. There was an overwhelming

October 2011 I Modern Pharmaceuticals

Glimpses of the inauguration

response from the industry and 145 senior and middle management professionals from various departments of companies like Biocon, Lupin, Intas, Dr Reddy’s, Hospira, Gland Pharma, Strides, Matrix, Promed Research Centre, Cipla, Serum Institute, Kemwell and Indian Immunologicals were a part of the event. Dr Jagashetty, The Drugs Controller of Karnataka, the guest of honour for the

event, inaugurated the event by lighting the lamp and addressed the gathering. In his address he reinforced the importance of risk management to the industry. Dr Gregory S Blank, former Director Late Stage Puriﬁcation, Genentech delivered a guest lecture on ‘Process Design Considerations for mAb Puriﬁcation’. Dr Ralf Gleixner, Director Quality by Design, Merck Serono SA, Switzerland delivered a lecture on “Applying enhanced QbD approach to manufacture of Biopharmaceuticals’. Lectures were delivered by 22 eminent professionals of the industry from India and abroad on 22 topics related to current trends, processes and regulations related to the pharma and biotech industry. Dr Kurt Brorson from CDER/US FDA delivered a guest lecture to the delegates through a live video conference.

National News Franklin Templeton invests ` 5 crore in Symbiotec

Strides gets USFDA approval for anti-bacterial injection

Franklin Templeton Private Equity Strategy (‘FTPES’), a private equity portfolio managed by Franklin Templeton Asset Management (India) Pvt Ltd, and advised by Darby Asia Investors (India) Ltd (‘Darby India’) the private equity affiliate within Franklin Templeton Investments group has invested ` 45 crore in Symbiotec Pharmalab Ltd (‘Symbiotec’). Transaction details were not disclosed. The funds raised from FTPES will be applied towards backward integration by setting up fermentation facilities, which is expected to improve the Company’s competitive positioning and profitability. This also is expected to help the company to attract customers from highly regulated markets such as the US, Europe and Japan. Anil Satwani, Managing Director, Symbiotec Pharmalab Pvt Ltd, said, “We at Symbiotec look forward to benefiting from Franklin Templeton’s global experience and achieving the common goal of transforming Symbiotec into an integrated steroids solution provider to the global pharmaceuticals industry.” Deepa Sankaran, Managing Director, Darby India, said, “Symbiotec has established itself as a leading player in APIs for niche segments in India. Our investment recommendation was based on the strong platform built by Symbiotec to capture the high growth potential in this space given the huge export opportunity”

Drug ﬁrm Strides Arcolab has recieved US health regulator’s approval to market injectable clindamycin USP, used in the treatment of bacterial infections, in the American market. The product will be available in three singledose vial sizes and in pharmacy bulk packaging, Strides Arcolab said in a statement. “The product is expected to be launched in early 2012,” it said, adding that the company received approval for its clindamycin USP from the US Food and Drug Administration (USFDA). According to IMS data, the size of the US market for injectable Clindamycin stood at $ 65 million (including bags) in 2011. Clindamycin is the twelfth product approved under a marketing tie-up between Strides and US-based Sagent Pharmaceuticals. As per the agreement, Strides will develop and supply more than 25 injectable products for the US market, which will be marketed by Sagent.

Pharmexcil Patents National Award 2010-11 won by Green Chem The herbal extracts manufacturing company Green Chem has won Pharmexcil Patents National Award 2010-11. The company has bagged this award for the third consecutive year since 2008-09. Kiran Kumar Reddy, Chief Minister - Andhra Pradesh, conferred the award at an India–Latin American Country (LAC) Pharma Business Meet at Hyderabad. The company exports its entire herbal extracts for nutraceuticals and it also runs organic farms for the cultivation of several important herbs. There are more than 150 herbs being oﬀered by the company. These products are related to slimming, joint pain relieving, male and female libido increasing, improvement blood circulation, skin care, wound healing, natural minerals supplement, memory power improving, natural vitamins supplement and antioxidant. At present, these products are being exported to the countries such as Germany, Austria, US, Australia, Korea, South Africa, Canada, Brazil, Mexico, New Zealand, Norway, China and many others.

Sun Pharma’s US arm resolves issues with health regulator Sun Pharmaceutical Industries Ltd has said that its US arm has resolved issues raised by the country’s health regulator regarding violation of manufacturing standards. “The US Food and Drug Administration (USFDA) has informed Sun Pharmaceutical Industries, Inc that after a June, 2011, re-inspection of its Cranbury, New Jersey, US manufacturing facility, the site has an acceptable regulatory status,” Sun Pharma said in a statement. Therefore, the issues noted in the USFDA’s August 25, 2010, warning letter are considered to be resolved, it said. The USFDA had pulled up the US arm of Sun Pharma

for violation of manufacturing standards, such as its inability to produce batches of consistent quality and lack of suﬃcient corrective actions. Sun Pharma, however, said its other USbased subsidiary, Caraco, is yet to resolve

similar issues. “Caraco, now wholly owned by Sun Pharma, continues to work with consultants to resolve issues raised by the USFDA at its Detroit plant,” the company said. In June, 2009, USFDA oﬃcials had seized 33 drugs manufactured at Caraco’s Detroit unit and temporarily stopped all manufacturing activities. The regulator had also seized all drugs manufactured by Caraco, including raw materials and active pharmaceutical ingredients.Since then the health regulator had stopped the ﬁrm from further distributing them until the company complied with good manufacturing requirements.

Modern Pharmaceuticals I October 2011

National News National Consultation on developing methodology for study on spurious drugs To create data uniformity and combat sale of spurious drugs, a national consultation meet was held in the capital to build consensus on the methodology needed to study the volume of spurious and substandard drugs prevalent in the country. Participants included key government oﬃcials, regulatory bodies and civil society groups. Expressing grave concern on the conﬂicting data on sale of spurious drugs in developing countries such as India, the stakeholders stressed on the need to develop a common framework under which such drugs can be studied in detail. The meet took cognizance of the fact that increased used of the Internet worldwide was indeed providing an anonymous marketplace for criminal counterfeiters trading and advertising spurious medicine. It was also alleged that a few countries were illegally using brand India to market such drugs overseas in their own interest.

Dr Praful Naik, CEO, Bilcare Research with Dr Kalam

Acknowledging that the laws in India were adequate to deal with counterfeiters, oﬃcials were of the view that the regulators and industry needed to work in tandem to safeguard public health by availing latest technologies. Dr D Roy, Dy Drug Controller General of India, said, “No doubt technology can play a major role to track and trace the menace

Sparsha Pharma launches new generation transdermal patches Sparsha Pharma International Pvt Ltd, has launched India’s first WHO certified Fentanyl two new-generation transdermal patches meant for effective pain management. Chief Guest D L Ravindra Reddy, Hon’ble Medical & Health Minister of Andhra Pradesh, unveiled Artho-Touch TM and Diclo-Touch TM transdermal patches. Speaking at the launch, Dr Dange, said, “Sparsha Pharma’s transdermal patches Artho-Touch and Diclo-Touch have advanced designs. Also, these are aesthetically acceptable

and are capable of delivering sustained dosing of active compounds. These products will tremendously benefit patients who have developed painful conditions such as Myalgia, shoulder pain, neck pain, etc owing to their poor lifestyle habits.”Both these products have long-lasting application and do not lead to any kind of gastric irritation or systemic side-effects of drugs taken orally. They are so designed to effectively deliver the drug directly into the wearer’s bloodstream/tissue.

Ipca Laboratories plans Indonesian acquisition Ipca Laboratories Ltd plans to acquire a pharmaceutical company in Indonesia with a view to enter the largest South-East Asian market. “We are scouting for an Indonesian company, especially with a generic product marketing licence,” said S Sugumaran, Regional Manager, Ipca. The company has put together a $ 20 million war-chest for the

acquisition, to be made within the next few months, said Kuala Lumpur-based Sugumaran, adding that a number of companies have been shortlisted. “We need good access to the Indonesian market and an established pharmaceutical company would be a good vehicle to market Indian pharma products in Indonesia,” he added.

of spurious drugs but the need of the hour is to evolve a more holistic approach that ensures involvement of all stakeholders in the supply chain.” Citing the importance of having suﬃcient checks, Dr APJ Abdul Kalam, Former President of India, said, “The menace has to get eliminated from the root cause and the best organisations and persons who can play the role are public/private hospitals, nursing homes, clinics and medical practitioners, who should immediately report any kind of incidence caused due to spurious or sub standard medicines in the public domain and ensure preventive actions are taken before it becomes a major public health disaster.” Dr Prof HS Rissam, Member Board of Governors - Medical Council of India & Wajahat Habibullah, Former Chief Information Commissioner to the Govt of India, also spoke about providing a credible direction to tackle the menace of spurious and sub standard medicines in India.

India to be among top 10 pharma markets by 2015: E&Y Emerging markets India and China will ﬁgure in the top 10 pharma markets of the world by 2015, an Ernst & Young report has said. The report has identiﬁed India as the preferred choice for outsourcing in the area of late stage drug discovery, shared services and complex manufacturing, while China has been the preferred market for building blocks and intermediates. The other major emerging markets are likely to be Brazil, Russia, Venezuela, Turkey and Korea, according to OPPI & Ernst & Young’s latest report on ‘India emerging: Pharma’s evolving business models’. Ajit Mahadevan, Partner - Life Sciences Practice, Ernst & Young, added, “Global MNCs that have entered India have developed a deep understanding of their target customers. They have broadened the range of their products, adopted unconventional partnership models to increase access and tested new pricing and marketing approaches.”According to the report, although Indian companies were able to launch most products in the pre-2005 era, the enforcement of the product patent regime has led to fewer on patent drug launches (21 per cent of on-patent product launches in 2005–2010 compared to 55 per cent in 2000–2005). While a few MNC companies have expressed their apprehension on enforcement of the patent regime in India, others have successfully launched patented products in the country’s market.

Modern Pharmaceuticals I October 2011

World News Waters gives the Center of Innovation recognition “His fondness for idea generation and bringing Waters Corporation recently welcomed the University ideas to fruition continues to inspire those he of Minnesota’s Mass Spectrometry Laboratory into its collaborates with giving us great pleasure to Centers of Innovation programme and honoured the recognise Dr Dalluge and support his laboratories Mass Spectrometry Laboratory under the direction of ongoing research through our Center of Innovation Joseph Dalluge, PhD for his research into diagnostic programme,” said Tim Riley, VP-Strategic marker assay development relevant to cystic ﬁbrosis and Innovation, Waters Division & Program Director, other diseases. He is also honoured for his research as a Waters Centers of Innovation programme. collaborating member of the Universities newly created Joseph Dalluge “I am honoured to be a part of the Centers Center for Bioanalysis of Molecular Signaling. The Dalluge Mass Spectrometry laboratory is part of the Department of Innovation Program and for what it means to us as we conduct of Chemistry within the University’s College of Science and leading-edge research. I regard Waters as more than just an instrument vendor of choice. They are a research partner,” said Dalluge. Engineering.

Exco InTouch secures growth investment

Novozymes in pact with ConjuChem

Leading growth equity and venture capital group Scottish Equity Partners (SEP) has led an initial £3 million pound investment in Exco InTouch, the leading provider of mobile patient communication and management solutions for the pharmaceutical and healthcare sector. Exco InTouch has developed an innovative suite of patient focussed services, which are delivered using a cell phone and Internet technology. Used in clinical trials, the companies’ services beneﬁt both patients and pharmaceutical clients. SEP has taken a minority stake in the company, which will use the funds to accelerate its expansion, enabling it to take advantage of signiﬁcant growth opportunities in the clinical technology sector, particularly in the emerging mobile patient communication market. Demand for its services is growing exponentially as pharmaceutical companies are increasingly adopting smart technology to optimise clinical trial execution.

Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, recently announced that it has concluded an exclusive supply agreement with ConjuChem LLC of Los Angeles, California and would be supplying its recombinant human albumin, Recombumin®, for use in the development of a new GLP-1 analog in phase 2 testing for type 2 diabetes. The use of Recombumin in the development of the product significantly reduces dosing frequency, allowing patients to self-inject once per week instead of once or twice daily. “This supply agreement is a great example of using Novozymes’ Recombumin as a vehicle for extending the half-life of peptides in drug delivery applications. Also the agreement for this new drug will potentially pave the way for the use of Recombumin in other peptide based therapies,” said Thomas Videbæk, Executive Vice President, Novozymes’ BioBusiness. Recombumin is the only commercially available, animal-free recombinant human albumin approved for use in human therapeutics. It is compliant with United States Pharmacopeia (USP) National Formulary (NF) standards and supported by a strongly documented safety package and drug master file. Patrick Soon-Shiong, Managing Director & CEO, ConjuChem, said, “The Recombumin technology, and the strong commitment from Novozymes, will be key as we develop next generation treatment for a disease affecting more than 360 million people worldwide.”

PPD expands clinical microbiology laboratory services globally PPD Inc recently announced that they have expanded its clinical microbiology laboratory to strengthen its laboratory testing services in infectious diseases as it is one of the largest therapeutic areas for clinical research and development. This expansion will oﬀer a range of microbiology testing services such as bacteriology, mycobacteriology and testing of microbioterrorism pathogens. “Microbiology is an important component of laboratory testing for infectious diseases. Strengthening our microbiology capabilities demonstrates PPDs’ commitment to deliver a full range of high quality global central laboratory services and builds on our fully integrated clinical research and development expertise across all areas of infectious diseases,” said Elena Logan, Senior Vice President, Global Central Labs, PPD. This merge would also provide extensive virology testing, including real-time polymerase chain reaction, viral load, genotyping and single nucleotide polymorphism analysis.

Modern Pharmaceuticals I October 2011

World News AstraZeneca to build $ 200 million centre in China AstraZeneca PLC, one of the world’s leading pharmaceutical companies, said it would invest $ 200 million to launch a new manufacturing facility in China to meet growing demand, including in rural areas, according to a press release. Construction work on the project, in the China Medical City in Taizhou of East China’s Jiangsu province, is scheduled for completion by the end of 2013, creating approximately 600 jobs. This will be London-based AstraZeneca’s largest single investment in a manufacturing facility globally. The new plant will produce intravenous and oral solid products, the company said. “The new facility will signiﬁcantly enhance our capacity

and allow us to meet the growing healthcare demand of the Chinese population, and help us expand into the 900 million (rural) people outside of the big cities and hospitals,” said Mark Mallon, President of AstraZeneca China. “It will also allow us to free up some capacity at our existing manufacturing facility in Wuxi, Jiangsu, to bring on more new innovative products that will be launched over the next few years,” he added. The Chinese pharmaceutical market grew from $ 10 billion in 2004 to $ 41 billion in 2010, according to market research agency IMS Health Inc, and it is expected to reach $ 102 billion by 2015.

Karen Horn, Lead Director of Eli Lilly, joins NACD Board of Directors Continuing to advance the highest levels of board professionalism, The National Association of Corporate Directors (NACD) has elected Karen Horn to its esteemed Board of Directors. Horn is the Lead Director and Chair of the compensation committee for Eli Lilly, and she is the Chair of the nominating and corporate governance

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committee for Simon Property Group. She also serves as a Director for Norfolk Southern Corporation and T Rowe Price Mutual Funds; the US-Russia Foundation; and the National Bureau of Economic Research. Horn holds a BA from Pomona College and a PhD in Economics from Johns Hopkins University.

“I am proud to be a part of an organisation as dedicated to director education programmes and director professionalism as NACD,” said Horn. “Over the past 30 years, NACD has been a proven leader in furthering exemplary board leadership, and I am honoured to be a part of this ﬁne organisation.”

World News Merck sells its interest in J&J-Merck consumer pharmaceuticals Merck recently announced that the company has sold its 50 per cent interest in the Johnson & Johnson Merck Consumer Pharmaceuticals Co joint venture ( JJMCP) to Johnson & Johnson ( J&J). The venture between Merck and J&J was formed in 1989 to develop, manufacture, market and distribute certain over-the-counter (OTC) consumer products in the US and Canada. Under the agreement, Merck will receive a one-time payment of $ 175 million. Mercks’ rights to the Pepcid brand outside US and Canada will not be aﬀected by this transaction

Sanofi unveils 150 million Sanofi’s Gemzyme unit has inaugurated a 150 million expansion at its biotechnology campus in Waterford. The site, which employs 500 people, has seen capital investment of 500 million euros since Genzyme’s arrival in Ireland 10 years ago. The latest spend has increased capacity at the company’s manufacturing operation, and added development capability, laboratory facilities and administration offices. Christopher Viehbacher, Chief Executive Officer, Sanofi, which acquired Genzyme earlier this year for $ 20.1 billion plus addons, said, “Waterford is a strategic site and products

Irish facility expansion from this location make a great diﬀerence in the lives of patients in more than 70 countries.” Richard Bruton, Minister for Jobs,Enterprise and Innovation, Ireland, noted, “Biotechnology and pharmaceuticals have been major parts of the success of multinational investment in Ireland in recent years. If we are to get out of the crisis we are in, we must continuously build on these strengths.” He added, “We must continually encourage companies in these sectors to locate more important parts of their operations in Ireland and create the jobs.”

and would give Merck greater freedom to operate in the OTC consumer sector and will allowing Merck to fully exploit its pipeline of Rx-to-OTC switches as well as actively pursue OTC licensing activities in the US and Canada. Following the transaction, J&J will own the ventures’ assets, which include the exclusive rights to market OTC Pepcid, Mylanta, Mylicon and other local OTC brands where they are currently sold in the US and Canada. The partnership assets include a manufacturing facility in Lancaster, PA.

Synexus expands its business UK-based Synexus dedicated to the recruitment of patients and running of clinical trials at its own dedicated research centres across the world. They have expanded their therapeutic offering to its global pharma and CROs clients and further strengthened its board. “In order to keep pace with this reputation we work hard to ensure we stay abreast of market changes and have developed a number of new offerings. We broadened our therapeutic offering into CNS and ophthalmology and conditions such as asthma and COPD and have combined this with our extended geographical reach and the delivery of quality data on time,” said Christophe Berthoux, CEO, Synexus. Synexus also announced that Alan Pilgrim (retired as CEO of Europes’ largest diagnostic imaging services company, Alliance Medical) would be joining the board as Chairman. Andrew Aylwin, Director and Shareholder, Synexus commented, “We, at Lyceum, are committed to being part of a business which is shaping the future of the industry. Synexus has huge potential and we look forward to helping them realise that over the next few years.”

Evotec and UCB form drug discovery collaboration Germany-based Evotec has formed a second multiyear, multi-target integrated drug discovery collaboration with Belgium-based biopharmaceutical ﬁrm UCB in the ﬁeld of immunology. Under the collaboration, Evotec will apply its integrated drug discovery expertise and technologies to identify interesting small molecules against a selected number of targets. The molecules will be further optimised and progressed through lead

optimisation to a pre clinical candidate. It will receive research funding based on the resource allocated over the projects and will be rewarded on achieving the goals of the research collaboration with early stage discovery, preclinical and clinical milestones. “We are extremely pleased that UCB has again selected Evotec to collaborate on this second signiﬁcant drug discovery

collaboration. This integrated drug discovery deal showcases our broad target class expertise coupled with our industry leading platform. We look forward to a fruitful collaboration with our scientiﬁc colleagues and friends at UCB,” said, Werner Lanthaler, CEO, Evotec. Adding to this Ismail Kola, President, UCB NewMedicines, said, “Evotec is the ideal partner to provide the resource bandwidth and drug-hunting expertise to complement our internal eﬀorts to progress this strategically important programme.” Modern Pharmaceuticals I October 2011

World News MedImmune signs in-licensing deal with Pfizer

MedImmune,the worldwide biologics business for AstraZeneca, has signed an in-licensing agreement with Pfizer’s Tremelimumab. Under the terms of the deal, MedImmune will assume global development rights to Tremelimumab and Pfizer will retain the rights to use Tremelimumab with specified types of combination therapies. It is also planning to explore Tremelimumab in a number of potential cancer indications According to the company, tremelimumab is a fully human monoclonal antibody which binds to the protein CTLA-4, expressed on the surface of activated T

lymphocytes. “Adding another immunotherapeutic approach to our oncology pipeline, one which may employ the immune system itself to fight cancer,exemplifies our continued commitment to embracing this new era of cancer care,” said Bahija Jallal, Executive Vice President, R&D, MedImmune. With new antibody and biologic technologies, the MedImmune oncology pipeline is focussing on developing new therapies to eliminate cancer cells in more effective and targeted ways. Anders Ekblom, Executive Vice President, Global Medicines Development, AstraZeneca, said, “This project to further explore and advance tremelimumab showcases our synergies in marrying world-class biologics expertise with global development and commercialisation capabilities in oncology.”

Parexel fuels Asian CR talent with Singapore University tie-up

US-based bio pharmaceutical services organisation Parexel International is setting up an academic programme in Singapore through an alliance with the island states National University to underpin the rapid expansion of clinical research in Asia. The partnership is between Parexel Academy and the National University of Singapore Academy of GxP Excellence (NUSAGE), which oﬀers career entry and advancement pathways for professionals, managers, executives and technicians with degrees

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in health and basic sciences, engineering or other relevant fields, equipping them with the specialised knowledge and advanced technical skills to meet evolving global regulatory standards. “The Singapore location of the first Parexel Academy in Asia will give students access to a significant business centre for the Asia/Pacific region, while supporting regional growth in clinical development,” commented Dr Albert Siu, Vice President, Parexel International. To this Kevin Lai, Deputy Director, Biomedical Sciences, Singapore Economic Development Board added, “For companies looking to advance their interests in the rapidly emerging Asian biopharmaceutical sector, Singapore offers a vantage point in Asia, from which they can develop the requisite international and multidisciplinary talent to support their growth.”

EU toughens its plans on prescription drug information The European Commission has adopted revised proposals clarifying the information that drugmakers may supply to the public on prescription-only medicines. The new proposals, which amend those put forward by the Commission in 2008 and respond to requests from the European Parliament, would maintain the current advertising ban on prescription medicines.”The revised proposals put rights, interests and safety of patients ﬁrst,” said John Dalli, European Commissioner for Health and Consumer Policy. He added, “They oblige industry to provide certain key information to patients and set clear rules for additional voluntary information on prescription medicines. And they further strengthen the control of authorised medicines.” The European Public Health Alliance (EPHA), which had dismissed the Commission’s previous proposal said, “It cautiously welcomed the new version, describing it as controversial and longawaited.”

Indian pharma to gain from the proposed GCC- India free trade agreement: Doha Bank CEO The Indian pharma and chemicals industry will be among the biggest beneﬁciaries of a free trade agreement between the GCC and India, said R Seetharaman, Group CEO, Doha Bank. The Indian pharmaceutical and chemical companies will be able to export their products to the lucrative GCC region. The senior banker and economist were speaking at the second World Tamil Conference, which concluded in Dubai recently. “The GCC - India trade exceeded $ 80 billion for during the three quarters

ending December 2010 and can exceed $ 100 billion for the year 2010-11. It could exceed $ 130 billion by 201314,” said Seetharaman. There are several potential sectors for investments by Indian entrepreneurs in the GCC, including IT, education, healthcare services, tourism and hotel industry, banking, oil, gas and petrochemicals, electricity, housing, road and rail network. “The GCC investment in India has signiﬁcantly increased in the last two years and is now estimated at more than $ 125 billion,” he added.

Tech Updates Waters introduces TruView LCMS certified vials

LCMS Certiﬁed Vials

Waters Corporation has recently introduced TruView™ LCMS certified vials, a new line of low-adsorption sample vials certified for LC/MS/ MS analyses where analyte concentrations are on the order of ng/mL or pg/mL and where analytical sensitivity and accuracy are critical. “As LC/MS/MS technology evolves and levels of detection approach or exceed the part-pertrillion range, our customers are demanding low adsorption vials that will not compromise their results,” said Mike Yelle, Senior Director, Chemistry Commercial Operations, Waters Division. “Our TruView glass vials are manufactured and certified to perform better than any commercially available glass auto sampler vial.” TruView vials are manufactured under tight controls using a proprietary process that limits the concentration of free ions on the surface of the glass dramatically lowering analyte adsorption. During the manufacture of glass vials, free ions are deposited on the surface. Problems occur when the ions are freed from surface and enter the sample raising the pH and exposing ion exchange sites on the glass to sample analytes that can bind to glass. The longer a vial awaits aspiration and injection of its contents, the greater the analyte adsorption.

MetaMap® Tox - a novel technology for early safety enablement The Drug Safety Executive Council (DSEC), an industry membership run by Cambridge Healthtech Associates (CHA), together with Metanomics Health GmbH, a BASF Group company, and leader in offering targeted and non-targeted metabolite profiling recently announced the results of the technology assessment of MetaMap® Tox conducted by DSEC’s technology evaluation consortium. “We are pleased with the success of the evaluation of the MetaMap® Tox solution. The platform provides pharmaceutical companies the opportunity to identify safety risks early in compound development and to address options to diminish those risks,” said Ernie Bush, Vice President Collaborative Projects, DSEC. Dr Tim Bölke, MD, Metanomics Health GmbH, said, “We are pleased that MetaMap® Tox is recognised as a high value solution for early safety enablement in pharma research. The precompetitive DSEC platform offered us a unique opportunity for close interaction with several leading biopharma companies.”

Robotic technology packs patients’ drugs Robotic technology, installed by Quality Compliance Solutions, part of the County Durham-based Norchem Group, dispenses individual prescriptions into their own unique blister packaging. The Chilton company, which supplies prescription drugs to patients, pharmacies, commented that it would make it easier for the patient to identify the tablet and understand clearly when to administer it. Peter Batty, Chief Executive, Norchem, said, “This technology

means that we can bring the best possible service to our clients. It creates a reliable, accurate, portable and safe way to package medication for patients, which is clearly and correctly labelled.” The machine aims to store the medicines in cassettes. When the prescription is entered into the system the correct drugs are dispensed into individual pouches and simply labelled. Further, a photographic system checks the pre-packed doses in accordance to the prescription.

Santaris Pharma A/S showcases microRNA and mRNA research advancements Santaris Pharma A/S, a clinical stage biopharma company, focussed on the R&D of mRNA and microRNA targeted therapies, recently announced advancements from the company’s RNA-targeted research programmes utilising its proprietary Locked Nucleic Acid (LNA) drug platform. The LNA drug platform and drug discovery engine developed by Santaris Pharma A/S combines the company’s proprietary LNA chemistry with its highly specialised and targeted drug development capabilities in order to deliver potent single-stranded LNA-based drug candidates that can

selectively inhibit mRNA and microRNA targets for a range of diseases including metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders. “Santaris Pharma A/S is pleased to have the OTS hold its annual meeting here in Denmark this year as it recognises the groundbreaking RNA-targeted R&D being conducted in Denmark from companies such as Santaris Pharma A/S as well as public institutions and research centres,” said Henrik Oerum, Vice President & Chief Scientific Officer, Santaris Pharma A/S.

Modern Pharmaceuticals I October 2011

Tech Updates Quantum Materials Corp and Nanoaxis announce technology alliance Quantum Materials Corp and Nanoaxis, LLC recently announced the formation of a technology alliance combining Quantum Materials tetrapod quantum dot mass production technology with Nanoaxis advanced research expertise and intellectual property in gene therapy biomedical nanotechnology. The aim of the alliance is to develop tetrapod quantum dot based cancer diagnostic kits and applications including Alzheimer’s, type 1 and type 2 diabetes, breast cancer. Quantum Materials Corporation will develop specialised

quantum dots for Nanoaxis to functionalise with their proprietary biomedical nanomaterials for a multiplexing drug delivery platform for drug/gene therapy and diagnostic medical devices technology. The technology alliance allows these technologies to be developed rapidly due to Quantum Materials’ ability to create the highest quality quantum dots in quantities necessary to support multiple projects with timely deliveries. All products will include QMC quantum dots.

Zebra Technologies launches the ZXP Series 3 Direct-to-Card Desktop Printers Zebra Technologies Corporation, a recognised global leader in enabling technologies that extend visibility into operations, recently announced the availability of its new full-featured compact ZXP Series 3 printer Andrew Tay for low-to-medium card printing in Asia Pacific. Featuring enhanced capabilities for more robust, cost-efficient customer services and access control across retail and services, healthcare, manufacturing and transportation sectors, the ZXP Series 3 extends Zebra’s industry leading card printer product line with a new model that combines performance and affordability suited for most smart card printing and encoding applications.

The ZXP Series 3 is unique to the card printing market, employing several advanced features that provide best-in-class performance at an attractive price point. The ZXP Release 3 ZRaster host-based image processing technology takes advantage of the increased processing power of today’s PCs to significantly optimise image and print quality without sacrificing printer speed or adding cost. “Card usage by businesses is getting more sophisticated. Businesses are concerned about the print speed, complexity of design and enhanced security protection, especially in the printing of ID Cards,” explains Andrew Tay, President of Asia Pacific at Zebra Technologies. “The ZXP Series 3 is our answer to better quality print, secured card issuance and ease of use for small to medium enterprises, particularly for those in the financial and retail sectors.”

Fighting against counterfeiting An African non-proﬁt social enterprise, mPedigree, together with HP Labs as the technology provider recently launched a project to track and authenticate a range of lifesaving drugs in Nigeria and Ghana. A similar service is being rolled out in India because of the growth in the country’s pharma industry as well as the parallel counterfeit drug market. A similar service is being rolled out in India due to the phenomenal growth in the country’s pharma industry as well as the parallel counterfeit drug market. Once the products are registered, its drug packs will have the code, instructions and the number to which the SMS should be sent. This technology not only provides commercial beneﬁts to clients, but also helps to save lives.

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Malvern launches Mastersizer 3000 particle size analyzer

The new Mastersizer 3000 particle size analyser delivers rapid, precise particle size distributions for both wet and dry dispersions. Working over the millimetre, micrometre and nanometre particle size ranges, it packs exceptional performance into the smallest of footprints, bringing operator-independent measurements that every user can rely on. The new Mastersizer 3000 utilises Malvern’s experience and expertise. Easily conﬁgured to meet individual application requirements, it generates robust, reproducible particle sizing data with the minimum of fuss. A new optical core concentrates the best ever Mastersizer performance into minimum bench space and brings precise resolution across a wide size range, for wet and dries samples. Further, novel dispersion accessories ensure optimal sample preparation, for every material type.

Tech Updates Bosch offers cutting edge technology for manufacturing

The sterile process technology of Bosch includes systems for the fabrication, storage and distribution of pure medias, as well as fermenters, sterilisers and complete biotechnology systems. With the products of Hüttlin and Manesty, Bosch offers cutting edge technologies in the manufacturing of powders and special systems for drying and granulation; including complete solutions. Bosch is a competent and reliable partner to mid-sized and international companies. Due to the global presence with production, distribution and service providers in several key markets, our customers benefit from proximity, profound competence and proximity. In the field of sterile fill and finish, Bosch offers best-in-class solutions for the processing of ampoules, ready-to-use syringes, cylindrical cartridges, injection and infusion bottles as well as drop and spray solution bottles. Regarding solid dosages Bosch services its customers with a comprehensive offering for processing of pharmaceutical powders for capsules and tablets including coating.

Edwards launches new range of dry pumps Edwards, a global leader in vacuum and abatement technologies, has recently launched a new range of dry pumps that delivers exceptional vacuum performance in harsh pharmaceutical, chemical and petrochemical processes. The easy-to-use CXS pumps feature cutting edge tapered screw technology, have excellent reliability, are simple to install, environmentally friendly and give improved liquid and solids handling. As a result, they are economic to run and users can optimise their vacuum processes and minimise overall cost of ownership. CXS pumps enable users to minimise their environmental impact. They are robust and reliable even in harsh pumping environments and have excellent liquid and solids handling capability, with the ability to pump up to one liter of liquid per minute continuously and up to 25 litre slugs without stopping.

Wyatt Technology’s FFF-MALS provides efficient liposome characterisation

Wyatt Technology Corporation, the world leader in instrumentation for absolute macromolecular characterisation and software, recently announced that its Field Flow Fractionation (FFF) technology combined with Multi-Angle Light Scattering (MALS) and QuasiElastic Light Scattering (QELS) enables

rapid measurements of particle size, size distribution, particle count, as well as structure. The combined system performs the most diﬃcult sizing tasks in key areas of research and development in molecular biology and nanotechnology analyses, including the separation and characterization of liposomes and nanoparticles. The FFF system oﬀers a number of distinct advantages over column separation techniques for many applications. The method is robust and easy to use, involving minimal shearing and enabling a broad separation range, from small proteins (nm) to large particles (μm).

Bio-Rad’s PCR supermix for improved HRM performance Bio-Rad Laboratories, Inc’s new precision melt supermix delivers robust High Resolution Melt (HRM) performance for sensitive and accurate detection of Single Nucleotide Polymorphisms (SNP) and CpG methylation for epigenetic studies. The PCR reagent is compatible with all HRM-capable thermal cyclers. Further, traditional genotyping methods, such as denaturing high-pressure liquid chromatography (dHPLC) and single-strand conformation polymorphism (SSCP), involve lengthy protocols and require multiple days for completion. Probe-based genotyping can be expensive, especially for large numbers of SNPs. HRM is a simple, rapid, and inexpensive alternative for studying genetic variation. Precision Melt Supermix is optimised speciﬁcally for accurate, robust, and reproducible HRM discrimination. By

employing the saturating EvaGreen dye, which is required for detection of class III/IV SNPs, the supermix discriminates all four SNP classes across a broad range of amplicons. This allows for any genomic region to be studied, regardless of amplicon length and GC content. The supermix is also fully compatible with bisulﬁte-converted DNA and allows for accurate detection of CpG methylation status. Furthermore, Precision Melt Supermix’s room temperature stability allows researchers to screen thousands of samples using Bio-Rad’s CFX96 Touch™ or CFX384 Touch™ real-time PCR systems with the CFX automation system for high-throughput HRM analysis. Precision Melt Supermix is part of Bio-Rad’s suite of HRM analysis products, including Precision Melt Analysis™software and the CFX96 Touch and CFX384 Touch real-time PCR systems.

Modern Pharmaceuticals I October 2011

Leaders Speak

‘What is needed in India to improve access to healthcare is political leadership’ …says John J Castellani, President & Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA). Named as one of the 100 most influential people in corporate governance by a leading magazine, Castellani enlists the various vital aspects India needs to focus on to become the innovation hub of the world, while highlighting the focus on investments in innovation made by US companies. Arshia Khan

Modern Modern Pharmaceuticals Pharmaceuticals I October 2011

Leaders Speak

astellani joined PhRMA in August 2010, and is the leader of the organisation that represents America’s leading pharmaceutical research and biotechnology companies. These companies directly employ more than 6,00,000 employees. In assuming his new responsibilities, Castellani has pledged that PhRMA will continue to lead efforts to find patientcentred solutions to healthcare challenges in USA and around the globe. In particular, PhRMA will focus on helping to successfully implement and improve the healthcare reform law and will work to build a dynamic environment in the US that promotes and rewards medical innovation. Before joining PhRMA, he was the President and Chief Executive Officer of Business Roundtable (BRT), the most influential chief executive lobbying group in the US. Castellani is frequently sought by the news media for his expert insights on business and public policy issues, appearing on such programs as NBC’s ‘Meet the Press’, PBS’ ’The NewsHour with Jim Lehrer’; Fox News Channel’s ‘Special Report’; CNBC’s ‘Street Signs’. Prior to the BRT, Castellani was the Executive Vice President of Tenneco Inc and part of the senior management team that led the transformation of the ailing conglomerate into seven strong companies. Castellani’s Washington experience includes serving as Vice President for Resources and Technology with the National Association of Manufacturers, and as Vice President of State, Federal and International Government Relations for TRW Inc. He started his career at General Electric (GE) as an environmental scientist and strategic planner. In 2007, Castellani was named one of the 100 most influential people in corporate governance by Directorship Magazine. A graduate of Union College in Schenectady, NY, Castellani now serves on its board of trustees. He is also an Ethics Resource Center Executive fellow and a member of the Advisory Council of the Business Roundtable Institute for Corporate Ethics, in addition to being a member of The Economic Club of Washington. He and his wife, Terry, reside in Washington and have two sons.

What does PhRMA advocate? PhRMA comprises America’s leading biopharmaceutical research companies that today lead the world in research and development of innovative medicines and treatments to ﬁght disease, and help patients to live longer, healthier lives. PhRMA advocates for public policies in the US and around the globe that promote health, patient access to the medicines they need and for an economic, regulatory, scientiﬁc and trade environment needed to encourage and reward the continued discovery of innovative new medicines, cures and treatments.

What have been the developments at PhRMA since you have taken over as the CEO? PhRMA has increasingly focussed on several issues of particular interest to the

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international community. For example, today PhRMA is engaged in the eﬀort to raise global public awareness of the growing problem of non-communicable diseases (NCDs), especially in the developing world. We understand that conditions like heart disease, diabetes and other diseases related to changing lifestyles are becoming major healthcare concerns. Our Global Health Progress initiative, in particular, has helped to highlight the importance of ﬁnding solutions to better address NCDs around the globe.

What will be your agenda at PhRMA for the next one year? PhRMA’s long-term agenda will remain very much the same. We will continue to focus on the value of medicines, how

improved access to medicines helps patients live longer, healthier lives, and the important role that medicines play as the ﬁrst line of treatment for a growing number of diseases. Additionally, PhRMA will also focus on the economic environment that our member companies operate in and increasing the understanding among policy makers, healthcare stakeholders and the media of the economic contribution that PhRMA member companies make to the economy, especially during these diﬃcult economic times. As an example, a recent study by the Battelle Technology Partnership Practice showed how America’s biopharmaceutical research sector supported nearly 6,75,000 direct jobs and a total of over 4 million direct, in-direct and induced jobs across America. These are high-value and well-paying jobs that are greatly needed in this country.

What are the key issues being faced by the global pharma industry? How can they be tackled? In most countries, governments are the major supporters of healthcare, and in this global economic environment, governments everywhere are facing severe cost constraints. Thus, the most important issue for PhRMA both here in the US and in the rest of the world is to enhance appreciation for the value of medicines, for example how these medicines improve the quality of healthcare. Medicines are increasingly the ﬁrst line of care that patients receive. Studies show that in the US improved access and better adherence to medicines can help reduce a patient’s use of more expensive healthcare services – such as hospitalisation and nursing care. This means a greater emphasis on quality care and meeting each patient’s individual healthcare needs. It also requires a domestic and global economic and investment environment that continues to provide incentives for new R&D, promotes drug discovery, rewards innovation, facilitates data protection and ﬁghts counterfeit medicines.

Leaders Speak What kinds of investments are being made by PhRMA member companies for R&D of new drug molecules? Which therapeutic areas are the US companies focussing on for research and why? PhRMA member companies invested an estimated $ 49.4 billion in new R&D during 2010. Industry-wide R&D investment reached a record $ 67.4 billion in 2010. R&D by PhRMA member companies covers many kinds of diseases and conditions. However, there are several R&D areas that are increasingly the focus of new research. Nearly 3,000 new medicines for a wide array of conditions including Alzheimer’s disease, arthritis, neurological disorders, HIV/AIDS, cancers, infectious and rare diseases are now in late-stage development, testing or being considered by the US Food and Drug Administration (US FDA) for approval for patient use. However, with the recent shift of the disease burden to NCDs, drug development for the treatment of ailments such as cancer, diabetes and heart strokes is being undertaken on a priority basis.

What are trends that differentiate the US pharma industry from rest of the world? One of the most important differentiations is the high level of investment in R&D by America’s biopharmaceutical companies. Last year alone, PhRMA member companies invested over $ 49 billion in new R&D projects. What is critical to note is that this investment took place in the midst of difficult economic times. The commitment of PhRMA member companies to investing in new R&D has helped keep the US biopharmaceutical sector the most innovative and productive in the world.

If the Indian industry wishes to become more innovative, then it needs to advocate for those policies that encourage innovation.

How far is the US pharma from launching a blockbuster drug? The R&D model for the biopharmaceutical research sector is evolving. It is important to understand that new technology and changing science are having an important effect both on work on target diseases and our industry’s approach to creating new, innovative medicines. Increasingly, R&D efforts are focussed on personalised medicine and how we can effectively and efficiently create new treatments that better meet the individual needs of each patient.

What are the growth drivers of the US pharma industry? R&D is one of the biggest growth drivers for the US biopharmaceutical industry. It is critical to creating new medicines, treatments and healthcare technologies needed to help patients around the world avoid disease, treat disease and live longer, healthier lives.

How serious is the issue of Intellectual Property (IP) protection in India? When it comes to access to health and medicine in India, IP protection is simply not a factor. The vast majority of medicines sold in India have no IP protection whatsoever. Less than one per cent of the market is under patent protection at the moment. Only a small number of medicines on India’s national list of essential medicines are patented. Furthermore, prices of medicines in India are among the lowest in the world. However, according to World Health Organization (WHO) statistics, approximately two-thirds of the Indian population cannot aﬀord even the most basic, essential medicines. Clearly the problem of access goes far beyond IP, and keeping IP laws weak will not address the problem. However, when one considers the situation of India’s local pharmaceutical market, IP is a topic of great concern.

By and large, the Indian pharmaceutical market is locked in a mode of imitation not innovation. Government policies and attitudes toward IP and investment are such that the incentives to conduct drug discovery in India for the beneﬁt of Indian patients do not exist. This is not an IP problem, but an innovation problem. We hope to engage the Indian government on this and related issues in the coming years.

Your agenda in India. Our agenda in India focusses on two areas: access to health and incentives for innovation. We believe strongly that India needs to focus on the problems of access to health for the average Indian. By investing in the health of its people, India will reap enormous economic and social benefits, from increased worker productivity to the millions of high-value jobs created in the healthcare industry.What is needed in India to improve access to healthcare is political leadership, reform of national health system financing, and a commitment of domestic financial resources for healthcare delivery and infrastructure. Our second priority is in the area of stimulating new innovation. We believe that current Indian policies regarding pharmaceuticals and healthcare deny proven incentives for local industry to become more innovative, and introduce new products for the benefit of the Indian people. India has aspirations to become an innovative economy. To realise those aspirations, political leaders and businessmen alike need to realise that proper government policies are needed, including, but not limited to, IP protections.

What should the Indian pharma industry focus on and why? India is home to the largest, most vibrant generic pharmaceutical industry in the world. Indeed, many of the medicines sold in this country are manufactured in India. India has many of the elements to act as a hub for investment in pharmaceutical R&D and make a major contribution to tackling health challenges both domestically and around the world. These include consistent growth, a highly educated workforce and a developing science base. If the Indian industry wishes to become more

Modern Pharmaceuticals I October 2011

Leaders Speak Quick Picks There are over 40 generic substitutes for cardiovascular drugs in India with no IP protection whatsoever. Although the lowest priced generics are readily available, a recent Lancet study revealed that 80 per cent of cardiovascular patients in India are not getting access to these very cheap but essential medicines. innovative, then it needs to advocate for those policies that encourage innovation.

How crucial is data exclusivity and what is your view on this with regard to India? Regulatory Data Protection (RDP) is an essential legal mechanism to protect, for a limited period, huge investments in data necessary to bring a medicine to market. There are literally billions of dollars being invested by companies at great risk, to generate the data that demonstrates the safety and eﬃcacy of a product and if this data is not protected it will go a long way towards discouraging that kind of investment in the future. The absence of RDP is a vital gap in India’s intellectual property regime to promote pharmaceutical innovation, particularly when compared to both developed economies and other emerging economies such as China and Russia. RDP is often misunderstood and misrepresented in the media. Contrary to how it is portrayed by certain groups, RDP is a complement to patents and not a means of extending patents. In most cases, patents and RDP run in parallel. In certain cases, depending on the jurisdiction and the methodology for determining the start date of RDP, it may continue to apply for a short period once a patent term has expired. In those instances, however, a generic manufacturer may prepare their own safety and eﬃcacy data to obtain marketing approval.

What is the mid-way between data protection and aﬀordable access to healthcare in poor and developing countries like Africa, India, etc? As I noted, IP protection, including regulatory data protection, should not be confused with accessibility. Accessibility is a broader issue that encompasses geographical, socio-economic and gender barriers with respect to resources. For example, there are over 40 generic substitutes for cardiovascular drugs in India with no IP protection whatsoever. Although the lowest priced generics are readily available, a recent Lancet study revealed that 80 per cent of cardiovascular patients in India are not getting access to these very cheap but essential medicines. We must all work to strengthen global healthcare infrastructures as well as better train healthcare professionals to help patients throughout the developing world gain improved access to the medicines they need. (arshia.khan@infomedia18.in)

October 2011 I Modern Pharmaceuticals

Roundtable

EC’s new draft guidelines

Will it benefit the Indian pharma industry? Guidelines for stability testing requirements for variations to a marketing authorisation after approval had last been released in 2005. In 2011, some amendments, particularly, providing more number of practical situations of post-approval variations are released. Experts discuss the pros and cons of the change. Chandreyee Bhaumik

he old European Medicine Agency (EMA) guidelines (CPMP/QWP/576/96 Rev 1) entitled ‘Stability testing for applications for variations to a marketing authorisation’ came into eﬀect in 2005. The new guidelines (EMA/CHMP/CVMP/QWP/441071/ 2011) under the same title has been issued in a draft form and is open for comments till December 31, 2011. Th e recent draft encompasses changes that were necessitated after introduction of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. While the 2005 and 2011 documents are similar in scope and stability testing requirements for Type I variations, the main change in the new draft document is with respect to increase in the number of practical situations of Type IB and Type II variations, which have gone up from three to nine. Considering that, the draft guideline only provides for stability testing requirements in more number of practical situations of post-approval variations. Will these revised guidelines help the Indian pharma companies to eﬃciently plan their stability study programmes? Experts voice out their perspective.

The change in the bill is asking for more detailing especially in the stability section. This indicates more documentation work. However, process of documentation varies from place to place/ country to country. While in the US there is strict detailing of documents, Europe requires relatively less number of details. So, these will be checked to see whether stability testing is done. As far as the negative aspects of the drafting of the new bill are concerned, an increase in paper work on the part of pharma companies will be a must. This would mean that they will have to do extensive work in order to prove the eﬃciency and safety of their products. Thus, there is a requirement to eﬃciently plan and manage the next actions. On a positive note, with more regulations there will be a possibility of the existence of an error-free system. The European Commission (EC) has updated the stability testing guidance in order to ensure that the variations or the

changes are submitted. The change can be in respect to the batch size for marketing authorisations and many other respects. These changes are required to be submitted. In the earlier version, three type II variations were detailed whereas the new document will list nine. Further, EC has also detailed a set of norms for active pharmaceutical ingredient (API) along with finished products. Thus, all these changes are expected to benefit the pharma industry as a whole.These procedures will ensure that the safety and efficacy of the products are maintained as we are dealing with life saving commodities in these cases. Dipta Chaudhury Senior Consultant, Pharma and Biotech Practice (South Asia and the Middle East), Frost & Sullivan Modern Pharmaceuticals I October 2011

Roundtable The trigger of the revision of the variation regulations was the EU initiative ‘Better regulation’ Commission policy, which is aiming to reduce bureaucracy in order to strengthen the European industry. The current revision has a great potential to contribute to the EU Commission’s objective in strengthening Europe’s economic power ensuring high quality medicinal products and being still affordable, their availability and continuous improvement. The main changes are the harmonisation of the EU variation systems and the work sharing procedures between EU member states, the shift from defining minor to major changes and immediate notifications, the introduction of the design space

concept, comparability protocols and regulatory agreements. But, there are some concerns even from the European member states as well as pharma. One point of concern is the extensive additional paper work that would be required for every small change in the processes. And the fees required for the paperwork will pose an additional burden that might be translated either on the proﬁts of the company or may be passed on the end user (customer) in the form of moderate pay hikes.

Pharma industry is governed by strict product quality, process and manufacturing guidelines, these guidelines have been evolved over the years to ensure enhanced product quality, efficacy and safety. The new EC amended guidelines are in line with these enhanced objectives and help reduce ambiguities that may have plagued the earlier guidelines. An example of this would be to view the amendments to the EC variation filing guidelines, they are a step forward in aiding companies to reduce their time to market especially on account of those variations, which are of an administrative nature. For the other types of variations, the clarity of the regulatory expectations articulated would ensure that timelines of the approval process would reduce/improve significantly. Most amendments clearly stress and put the onus of product quality and regulatory compliance on the product

license/marketing authorisation holder that forms the basis of risk assessment, mitigation plans and risk management. Selfcertiﬁcation scheme that is implemented for pharmacovigilance compliance obligations would in all probability be implemented for all other regulatory processes over the next few years. All these EC amendments are based on the success of pilot schemes like BROMI implemented by the MHRA earlier. We believe that these EC amendments would help industry to conform to stringent compliance obligations in logical and eﬀortless manner.

The statement under Preamble or Introduction, which reads as “The guideline provides a general indication on the requirement for stability testing, but leaves sufficient flexibility to encompass the variety of different practical situations required for specific scientific situations and characteristics of the material being evaluated” is same in old and new guidelines. The flexibility is uniformly offered to all the manufacturers, whether in India or abroad, and the same is built on scientific, rational and logical grounds. One can be sure that the manufacturers, in absence of specifics on several practical situations in old guidelines, still must have been taking the benefit from EMA by providing sufficient

justiﬁcation to the kind of stability studies pursued by them in case of a particular variation. What Indian manufacturers must do is to critically look into the draft document and if they have fruitful suggestions or even more instances of practical situations where they would like guidance to be included, the comments must be passed over to EMA, so that they are taken care of while ﬁnalising the guidance.

With EC’s drafting of new bill one can say that the department is deﬁnitely growing matured, rather to be precise, the stability section is getting more matured. In other words, it can be said that this kind of drafting of bill will ensure better and eﬃcient drug quality. There is a regular standard of allowing a period of six months for the stability check. Everything has its pros and the cons. This drafting might have its share of negative aspects. For example, if a new drug is going for combination with

a drug that is already established in the market, then practically there is no requirement to conduct a long term stability testing. Thus, this process of testing will become redundant.

Dr Mandar Kubal Consultant Infectious Disease and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC)

Nitin Bidikar Associate Director, KPMG

Dr Saranjit Singh Professor and Head, Department of Pharmaceutical Analysis, NIPER

T S Jaishankar Managing Director, Quest Life Sciences Pvt Ltd, Chairman, Confederation of Indian Pharmaceutical Industry (CIPI) Modern Pharmaceuticals I October 2011

Facility Visit

Bafna Pharmaceuticals Ltd

Awards

Turning a new leaf in the regulated market The pharma industry is known for its stringent quality policies and regulations. In an industry which leaves no scope for errors, Bafna Pharmaceuticals Ltd had emerged as a leader of sorts in the regulatory market and has made a prominent mark for itself. Jasleen Kaur Batra

he Indian pharmaceutical industry has expanded across the Indian market, and over a period of years, several companies have entered this space. Bafna Pharmaceuticals has entered the industry with a new model that has worked for their advantage. It entered the manufacturing industry as early as 1981 and became a public

limited company in 1995. It established their set up in Chennai and has been a part of the industry for more than twenty years now.

Initial days “I always wanted to enter the pharmaceutical industry; the drive within me was so strong that I started working for a pharma company called Kemkopharma. I worked there for four years to gain knowledge and understanding of the industry. After four years I gained an

Awarded the WHO GMP in 1995 The State Pharmaceutical Corporation of Sri Lanka awarded the ‘Best Supplier’ Award to Bafna Pharmaceuticals in 2005 Honoured with the Gold Quality Excellence award by Indian Drug Manufacturers’ Association (IDMA) in January 2011.

understanding of the way the industry functions and went ahead to set up my own company,” says Mahaveer Chand Bafna, Chairman & Managing Director. He continues, “The ﬁrst plant was set in Madhavaram in 1984. During inception our main focus was on generic products and contract manufacturing; we began our journey with manufacturing tablets and gradually made our way to capsules and syrups.”

Modern Pharmaceuticals I October 2011

Facility Visit Projects in pipeline Launching Raricap all over India in the coming months Working on 10 new products for the UK market- products under R&D Working on 50 new projects for the regulatory market Working on 30 products for the UK and Europe market Developing products for the SriLankan market Malaria Vaccine Initiative (MVI) for Malaria The urge to produce high quality products and services and enter into the innovation space has helped it leave a mark in the international market. Over the years it has emerged as one of the most proﬁcient players in the contract research as well as manufacturing of generic product market. “Our manufacturing strength, consistency in quality delivery

to the multinationals; we want to be a support to them. Hence, we are a contract manufacturing ﬁrm for the regulated markets. A company should either be too big or too small; if a company is in between there is possibility of it getting squashed,” avers Bafna. As for the other non-regulated markets, Bafna plans to create a brand name and supply products globally. The revenue it generates from the regulated market helps it expand its R&D and manufacturing unit, which further increases the amount of products as well as countries it exports its products to. “Entering the R&D and manufacturing space in the non-regulated market and leave a mark with our brands, which has now started to shape up, has been my goal” says Bafna. Today, the company provides contract manufacturing facilities and exports its products to countries such as Europe,

for contract manufacturing,” informs Bafna. These strategies are adopted strictly for the international market, as for the India market Bafna Pharmaceuticals has recently stepped into the local market. They strictly want to get into generic and branded generic products. “We are not very strong in the local market, domestically maybe no one knows us. Hence, we thought we should focus on the domestic market and we started our marketing set up in the North East. But fortunately we had the opportunity to acquire a product from J&J called ‘Raricap’. This product has been a part of the market since the past 40 years. At that time this drug was extremely popular, hence we thought we would enter the local market with this drug. We have barely spent two months into the market and are doing fairly well. We launched the product in June and this has brought a turning point for us in the domestic market,” avers Bafna.

Packing Line

Production Corridor Sampling Booth

and enormous production capacity is made possible by our two state-of-theart manufacturing facilities located on the outskirts of Chennai,” says Bafna.

Business model Bafna Pharmaceuticals has made a conscious decision to adopt a diﬀerent but eﬀective business model, which has helped them develop and expand its business to a great extent. “I always wanted to enter the regulated market. It is relatively easy to enter the non-regulated market like Sri Lanka but entering the regulated market is a big deal as there are a number of stringent procedures. We are too small to be a threat

October 2011 I Modern Pharmaceuticals

UK, Ghana, Nigeria, Sri Lanka, Ethiopia, Philippines, Vietnam Columbia, etc. Bafna Pharmaceuticals also provides strategic partnership and global research projects to a number of companies. Strategic partnership is when a company assigns the R&D, manufacturing, market authorisation as well as commercialisation of a drug to their partner. “We are medium players in the market; when it comes to focussing on the European market a lot of capital needs to be invested to gain market authorisation (licences). To be ﬁnancially strong it is important to enter contract manufacturing as well as strategic partnership space. We have tied up with a number of companies

Inspection Line

The company is now focussing purely on lifestyle and generic products. Their main focus would be on women wellness medicines, and they are working extensively towards it. “We want to go slow in the volume, and have just entered the branded generic market. We have 23 products in the market with the brand, which have fewer competitors,” says Bafna. It has also joined hands with the top pharma companies in India like Biocon, J&J, Cipla and would be providing contract manufacturing and export services to them. “We would be conducting contract manufacturing for Biocon for their renal products,” informs Bafna.

Facility Visit

Adopting a public private partnership (PPP) model would in no way benefit the industry as several restrictions would be imposed by the government. Mahaveer Chand Bafna Chairman & Managing Director, Bafna Pharmaceuticals

Impediments for the path breakers

Upcoming trends

The Indian market is diﬃcult to adapt to as it is harsh on its regulatory issues. Bafna Pharmaceuticals struggled to create its own path and hence had a number of hurdles, establishing a name in the international market was the biggest obstacle. “India has more than 35,000 thousand pharmaceutical companies out of which a minimum of 5,000 companies export. There are a few

India is an emerging market and has been attracting a number of MNCs. “MNCs today feel that if they do not enter the Indian market they can be in trouble. Today, a number of tie-ups are taking place between Indian companies and MNCs, and this is hampering the thought process of companies as their focus is purely on contract manufacturing

The pharma industry is highly capital intensive and needs a lot of investment in the initial stage. “On an average a minimum amount of ` 1520 crore is required for a small set up. After the set up the gestation time is of at least 3-4 years. So how is a company supposed to survive for so many years without sales or proﬁt? This is when the government should step and support the company and help them expand and utilise their resources to their optimal best,” says Bafna.

The tricks of the trade The amount of capital a pharma company invests in its plant is huge and needs a lot of investment on a periodical basis. “I started the company with ` 2,80,000. Our investment has been approximately ` 75 crore since we established the manufacturing set up. Maintenance has a huge cost bearing

Autocartonator Line Packing Line

quality problems that are faced with the Indian manufacturers due to lack of funds or use of cheap raw material. Hence, even if one Indian company does not deliver high quality products then the entire Indian market loses its reputation. It becomes extremely difficult to breakthrough the mindset of the other countries and definitely takes considerable time and effort,” expresses Bafna. Another problem that came their way was extensive competition and regulation. “There is stiff competition and regulation in the market and we faced problems as we were not equipped to handle them in the initial stage. Gradually, we have overseen all the regulated markets and have even entered the regulated market of Europe, Australia, UK, etc.”

Water Puriﬁcation System

and not innovation,” expresses Bafna. He adds, “The government needs to support these companies. To increase the productivity level of a company and promote innovation the government should help in terms of tax benefits, policies and flexible regulation.” He adds, “Adopting a public private partnership (PPP) model would in no way benefit the industry as several restrictions would be imposed by the government. The private sector needs to be encouraged to set up pharma companies with the support of the government, they should provide subsidies and support rather than impeaching hard rules and regulations, which further pull the industry down,” believes Bafna.

as well. The facility, human resource, machinery, raw material and all other things put together cost approximately ` 5-7 crore per annum,” explained Bafna. To cater to the international market high quality raw material as well as equipment need to be acquired and maintained. The company has set up a strong manufacturing and R&D set up which helps them produce top quality products. Bafna Pharmaceuticals can deﬁnitely be looked upon as a pharma company which has entered the innovation space with the business model that they have chosen to follow. The model is new and oﬀers huge scope in the industry. (jasleen.batra@infomedia18.in) Photos by: Anand Kumar Perumal

Modern Pharmaceuticals I October 2011

Industry Update

Pharma manufacturing

Cost saving with optimal utilisation The drug industry is estimated to waste more than $ 50 billion a year on manufacturing. Should money be pumped in to maintain the final pricing of drugs or other changes are required? Also, how far quality is a concern for Indian manufacturing units?

Titash Roy Choudhury

he domestic pharma industry ranks fourth globally in terms of volume and 13t in terms of value. “Driven by increased affordability and medical infrastructure expansion, the Indian pharma market is expected to triple by 2015,” says Dr Praveen Khullar, Senior Director, Goa Development Center, Sanofi. The pharma manufacturing sector in India is lucrative and is attracting a lot of participation from foreign countries too. “India offers a low cost high quality option for pharma manufacturing with highly skilled resources and proficiencies across the pharmaceutical value chain from R&D to active pharmaceutical ingredient (API) to formulations to contract manufacturing,” says Dr Amit Rangnekar, General Manager,

Centaur Pharmaceuticals. India is already recognised as a leading quality manufacturer of APIs, intermediates and the best manufacturer of quality generics the world over has also now emerged as a competitive outsourcing hub for manufacturing and R&D. “The Indian pharmaceutical outsourcing market is close to around $ 65 billion and its outsourcing market is expected to grow at a compounded annual growth rate (CAGR) of 12.6 per cent during ﬁnancial year 2010-12 to reach a size of around $ 85 billion as the innovator companies were expected to lose patent protection to an extent of around $ 97 billion over 2011-15 as compared to $ 73 billion over 2006-10 period,” says Alok Ghosh, President - Technical Operations, Lupin Ltd. The type of investments that are being done in setting up of manufacturing units is huge but does that investment aﬀect the pricing

of the drugs. There are reports of loss of money on manufacturing and at the end it is the cost of the ﬁnal product that matters to the patients. Can the price of drugs be reduced by manipulating the manufacturing cost? And also, with setting up of these manufacturing units quality becomes a great concern and adhering to the global standards imperative. Given this scenario, are the Indian manufacturing units complying with the laid quality standards or there are some loopholes to be ﬁxed?

India: An outsourcing destination Pharma manufacturing in India is presently not only meeting the demands of the country but also fulﬁlling the demands from other countries. India caters to the world demand of manufacturing by living up to global standards and compliance issues along with having a strong knowledge base and infrastructure. “Pharma manufacturing

Modern Pharmaceuticals I October 2011

Industry Update

India has the advantage of cost competitiveness, and therefore more and more global players are setting up development centres and manufacturing sites in the country. Dr Praveen Khullar Senior Director, Goa Development Center, Sanofi in India is quite elaborate and sufficient to meet the demands of the country. The manufacturing scenario at present is flexible and adoptable in the sense that we are capable of coping up with the changes,” Prasad Joshi, Manager - Corporate Affairs (Technical), Plethico Pharmaceuticals Ltd. According to Partha Mukherjee, VP - Sales, Anglo-French Drugs & Industries Ltd, “Most companies have selfowned manufacturing units for their own products especially the big brands. They have significant manufacturing division and pharma manufacturing is growing in this country looking at the growth of the pharma market. The requirement is huge and so is the need of manufacturing. India is definitely the hub of manufacturing, the advantage and facility of getting Chinese and Korean raw materials, procurement of chemicals is easier.” Many global generic players have set up their own manufacturing plants in India, while a larger number of firms have allied with Indian firms for contract manufacturing and/or formulations development. “Many Indian players also have their own operations in the US and other regulated markets. Centaur Pharma has a unique model wherein we undertake the entire gamut of activities from R&D, API development, clinical trials, formulations marketing to contract manufacturing,” says Dr Rangnekar. The pharma manufacturing sector in India is growing steadily and consistently with more MNCs coming to the country for manufacturing support. “Over the last few years, many large MNC pharmaceutical companies have entered into product supply alliances with Indian pharmaceutical companies. This has further strengthened India’s position

October 2011 I Modern Pharmaceuticals

Economies of scale can certainly result in minimising costs, or scaling up as per requirements and planned phases of growth is another approach to optimising manufacturing costs. Dr Amit Rangnekar General Manager, Centaur Pharmaceuticals

as a global leader in pharmaceutical API and formulations manufacturing,” informs KV Subramaniam, President & CEO, Reliance Life Sciences. “India has the advantage of cost competitiveness, and therefore more global players are setting up

Pharma manufacturing in India is presently not only meeting the demands of the country but also fulfilling the demands from other countries.

development centres and manufacturing sites in the country,” says Dr Khullar. The growth of Indian pharma industry has been fuelled by exports to global markets with a sizeable share in developed, highly regulated markets of the US, European Union (EU) and Japan. India has the largest number of US Food and Drug Administration (USFDA)-approved facilities besides US and the number of drug master files (DMFs) and abbreviated new drug application (ANDAs) filed by Indian companies is increasing every year. “For the past five years outsourcing of manufacturing has increased significantly. There have been prominent agreements in the last few years between international MNCs and Indian pharma companies, like the agreement between Daichi and

Ranbaxy, Pirmal and Abott agreement, Pfizer with Aurobindo and also Pfizer partnering with Biocon for API processing. These international companies prefer Indian pharma companies considering the availability of raw materials, the high capacity and scale of manufacturing and comparatively low labour cost than the regulated markets. And since India has become a preferred outsourcing destination quality becomes of utmost importance,” says Joshi. “We can easily term India as the hub of manufacturing since several MNCs are coming to this country for R&D outsourcing, manufacturing, and partnering with Indian companies for logistics facilities and CRAMS. We are poised at an attractive position for the pharma manufacturing sector worldwide and it may not be as good as China but it is notable. India has better technical talent, cheap and easy availability of raw materials, packaging materials and machinery” believes Joshi. Even Subramaniam is of the same opinion, “India has emerged as an attractive outsourcing destination for API and formulation manufacturing due to its competitive advantages, viz low development costs, complex synthesis capabilities, cGMP compliance and a large domestic market.” India being the preferred destination for manufacturing by other countries has given it an impetus, “The global pharma outsourcing market is estimated at close to around $ 65 billion while the Indian pharmaceutical outsourcing industry is predicted to offer a $ 2.5 billion opportunity to companies in 2012, due to the low cost of R&D,” says Ghosh. He also believes that, apart from the cost advantage, India offers several

Industry Update

Cost efficiencies can be achieved through several factors such as backward integration in manufacturing, operational efficiencies through long term strategy and energy conservation to name a few. Alok Ghosh President- Technical Operations, Lupin Ltd

other advantages for contract research outsourcing by pharma companies including process, analytical and research chemistry skills, good lab practice (GLP) compliant R&D facilities and a large talent pool of scientists. Many MNCs are outsourcing not just manufacturing but of late, research work to Indian players. Another advantage in India for outsourcing is that it is predominantly an English speaking country, which makes the process easier.

The manufacturing scenario at present is flexible and adoptable in the sense that we are capable of coping up with the changes. Prasad Joshi Manager - Corporate Aﬀairs (Technical), Plethico Pharmaceuticals Ltd

that have been put forward by the Indian government. Like there was Schedule M that was passed in 2002 along with GMP and GLP and the improvement is quite evident.” “Indian manufacturers have invested signiﬁcantly in high-quality GMP infrastructure over the last decade. This has resulted in obtaining the highest number of USFDA approvals for Indian manufacturing facilities,” says Subramaniam. But also the rules and regulations for quality are not that rigid

Meeting the quality standards? Poor quality and related compliance issues have cost the industry globally more than $ 700 million in ﬁnes since 2001. Says Joshi, “Considering the turnover of the global pharma market for the last 10 years the loss we are considering for manufacturing is very less. This kind of loss is seen in almost all sectors but along with that we should also look at the size of the market and how it is growing globally and domestically. When it comes to quality issues in manufacturing, upgradation is being done constantly both on the international and national level. There are two types of companies one that is a player in the domestic market only and other, which is a global player. The latter is highly quality conscious and routinely upgrades its standards of quality with compliance to the current good manufacturing practice (cGMP). Because if they want to expand their reach into more regulated countries and markets, then increase in the level of quality is essential. For the domestic players there have been regulations to comply with set standards

Quick Picks Poor quality and related compliance issues have cost the industry globally more than $ 700 million in ﬁnes since 2001. in this country, there are various approval or regulating bodies but implementation does not happen that rigidly. This is mainly because the Indian pharma market is huge and unregulated and there are not many stringent rules to regulate the quality of the products. “Today, the global pharma industry has to deal with increasingly stricter quality standards as well as greater regulatory scrutiny. As a result, in the recent past, there have been several instances where leading Indian pharmaceutical companies have been issued warning letters by USFDA. These incidents may have impacted the image of Indian manufacturers, but not necessarily their contract manufacturing business. This is due to the fact that India

still has several competitive advantages (manpower, capex costs, operational costs, etc) over its closest competitor like China,” says Subramaniam. Even Joshi believes that quality is not a concern for Indian pharma manufacturing and most of the units are well-equipped to practice cGMP. And with more regulatory bodies coming up internationally also compliance to quality standards has become mandatory. “Along with having rules, complying to them routinely is also important since there are internal audits along with external audit of system’s check up. Thus, as far as quality goes it is not an issue in India for the pharma manufacturing sector,” aﬃrms Joshi. Opines Dr Rangnekar, “Although quality and compliance issues have occurred in India, such issues are prevalent across every regulated and unregulated market, and every major global manufacturer has also faced these issues even in their home country. However, with experience such issues will substantially reduce in the near future in India.” “Further, this phenomenon (tighter regulatory scrutiny) is a global one and not only limited to India. Therefore, it may not severely impact outsourcing business in India,” says Subramaniam.

The link between pricing & investment “Pharma manufacturing broadly involves following processes – manufacturing of chemical intermediates, APIs and manufacturing of ﬁnished dosage forms (FDF). Within each of these areas, several steps are involved in manufacturing process. Investments are required for

Modern Pharmaceuticals I October 2011

Industry Update

India is definitely the hub of manufacturing, the advantage and facility of getting Chinese and Korean raw materials, procurement of chemicals is easier. Partha Mukherjee VP - Sales, Anglo-French Drugs & Industries Ltd setting-up manufacturing facilities for APIs and FDFs. The investment amount would largely depend on any other type of chemical reactions to be handled in the API manufacturing process, scale of production and type of FDF,” says Subramaniam. Usually the investment of setting up of a manufacturing unit depends on a number of factors such as the type of product that is being manufactured, the number of products being produced and the volume of production, the location of the unit, the target of the company, logistics, etc. “Depending on all these factors it can vary from ` 25-30 crore for a single block to ` 150-200 crore,” says Joshi. The price of the finished products, ie, the drugs depend on various factors. “The cost of raw materials, packaging cost, manufacturing and operation cost, analytical cost, ie, the lab testing at factory level, maintenance cost and other costs. Out of all these manufacturing costs contribute may be only 10 to 15 per cent of the price of the final product. But if we are talking about biotech and biopharmaceutical products then the part played by manufacturing cost in determining the final price of the drugs increases to almost 40 per cent,” informs Joshi So there are other costs also that goes into determining the cost of the final products, especially if it is a new product. “Apart from manufacturing, drug distribution and sales and marketing costs, the key determinant for pricing would be the competitive scenario for that particular product. Manufacturing costs do not solely contribute to the cost of any pharmaceutical product, more so

Indian manufacturers have invested significantly in high-quality GMP infrastructure over the last decade. This has resulted in obtaining the highest number of USFDA approvals for Indian manufacturing facilities. KV Subramaniam President & CEO, Reliance Life Sciences

if the product is novel and not a generic,” says Subramaniam. In India there is Drug Pricing Control Order by which there is a cap ﬁxed by the government on the pricing of certain lifesaving drugs and this regulates the pricing of the drugs. But reduction of manufacturing cost can bring down the price of the drugs. It can be done by optimal utilisation

Quality of manufacturing is not an issue for Indian pharma companies since most of them are following cGMP with minor differences.

of the manufacturing unit. “If there is optimal utilisation of manufacturing operations then the price of the drugs can be reduced. And optimal utilisation can be achieved by having a competent technical team; the manufacturing unit should be planned according to the need of the product in the market and then only it can be fully utilised. Most of the times, it is poor planning that leads to such conditions; like when a manufacturing unit is established for the capacity of 10 lakh drugs but the market requirement is 6 lakh so that aﬀects the

pricing of the final drug. By and large, most big pharma companies are trying to achieve operational excellence,” says Mukherjee. Subramaniam avers, “It is definitely possible to reduce the manufacturing cost by increasing scale of operations, developing new vendors for raw materials thereby reducing costs of materials involved in production.” While Joshi adds that getting more automation and IT into manufacturing can bring better results and better operational excellence. “Economies of scale can certainly result in minimising costs, or scaling up as per requirements and planned phases of growth is another approach to optimising manufacturing costs. Third approach could be to have capabilities for a wider product mix,” informs Dr Rangnekar. “Cost efficiencies can be achieved through several factors such as backward integration in manufacturing, operational efficiencies through long term strategy and energy conservation to name a few. All these lead to increased profitability and market competiveness,” says Ghosh. Analysing these opinions, we can conclude that quality of manufacturing is not an issue for Indian pharma companies since most of them are following cGMP with minor differences. But on the whole quality cannot be termed as determinant to the pharma manufacturing industry, while as for the pricing of the drugs it can be operated on a manufacturing cost level. Achieving operational excellence has to be the motto of the pharma companies if they want to reduce the prices of their products. (titash.choudhury@infomedia18.in)

Modern Pharmaceuticals I October 2011

Spotlight

Regulatory approvals and denials

Things pharma companies should be concerned about For a growing pharma market like that of India, new manufacturing units and products being launched seek United States Food and Drug Administration (USFDA) approvals. Along with approvals, USFDA also issues warning letters to the Indian pharma companies for regulatory and manufacturing issues. The possible reasons and the way pharma market should equip itself in such situations are analysed. Titash Roy Choudhury

oday, India plays a pivotal role in the manufacturing of pharmaceuticals worldwide and can be termed as the hub of manufacturing. The Indian pharmaceutical market especially the outsourcing of contract research and contract manufacturing or CRAMS is growing at healthy rate.“The global pharma outsourcing market is estimated close to around $ 65 billion, while the Indian pharmaceutical outsourcing industry is predicted to oﬀer a $ 2.5 billion opportunity to companies by 2012, due to the low cost of R&D. The outsourcing market is expected to grow at compounded annual growth rate (CAGR) of 12.6 per cent during 2011-12,” says Alok Ghosh, President - Technical Operations, Lupin Ltd. And while exploiting this opportunity, India should also be cautious about the regulations and compliance issues. Today, with growing visibility of Indian pharma companies in the global forum, more companies are applying to USFDA for their products and for each product approval the USFDA comes down for inspection. USFDA approval weighs a lot in the pharma market globally and though each country has its own regulatory body, the authenticity and popularity of USFDA is at a higher level due to its stringent rules and strict adherence to quality. But as the number of applications to USFDA is increasing so are the risks of violating the rules leading

to adverse effects. There are some recent incidences of Indian pharmaceutical companies who have come under the USFDA scanner and though most of them have been solved or will be, the question is why should they arise in the first place? If such cases increase then the outsourcing market will be badly affected and also the credibility of the Indian pharma market would be imapcted on a larger scale.

Coming under the scanner There have been several Indian generic drug makers who are reported to be facing regulatory action by USFDA. Cadila is the latest among several Indian generic drug makers facing regulatory action in the US. Companies like Ranbaxy Laboratories Ltd, Dr Reddy’s Laboratories Ltd and Aurobindo Pharma Ltd have been warned, or in some cases banned from importing certain drugs to the US, over issues like quality of test data and manufacturing practices at their plants in India and abroad. India-based Sun Pharmaceutical Ind Ltd’s Cranbury, New Jersey manufacturing unit in US was given a warning by USFDA in August 25, 2010 and almost after a year in September 2011 it has been ﬁnally resolved. The USFDA had pulled up the US arm of Sun Pharma for violation of manufacturing standards, such as its inability to produce batches of consistent quality and lack of suﬃcient corrective actions. But even before this in the year 2009 USFDA had seized 33 drugs manufactured at Sun Pharma’s Caraco-

Modern Pharmaceuticals I October 2011

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Spotlight Steps to avoid regulatory mishaps

It is imperative that each manufacturer ensures that its techniques and facilities comply with the international quality regulatory bodies that it exports to. Alok Ghosh President- Technical Operations, Lupin Ltd Detroit unit and stopped all manufacturing activities there. This was reportedly owing to the company not complying to good manufacturing requirements and this has not been resolved yet. Ahmedabad-based Cadila Healthcare had also reportedly faced similar manufacturing issues with USFDA for its facility at Moraiya in Gujarat, which is meant for injectable drugs. According to the FDA’s website, the US drug regulator inspected the Cadila plant between January 17 and February 3, 2011 and identified ‘significant violations’ of manufacturing regulations, and reviewed the firm’s response to its observations on February 10, 2011, and noted that it lacks sufficient corrective actions. The company’s laboratory records reportedly fail to include complete data derived from all tests necessary to assure compliance with established specifications and standards. The USFDA cited the example of inability of the company’s microbiologists to identify microbial growth correctly. The health regulator noted that the firm was responsible for the accuracy and integrity of the data. Aurobindo Pharma also received a warning letter from USFDA on May 20, 2011 for its antibiotic manufacturing unit in Hyderabad. Indian generics maker Dr Reddy’s Laboratories has also received a warning letter from USFDA for its Mexican facility that is key to its operations in that country–and to its supplies for the US market. USFDA had inspected Dr Reddy’s active pharmaceutical ingredients (API) manufacturing plant in Morelos, Mexico in November 2010. The agency issued a warning letter to Dr Reddy’s on June 3, 2011 about those

manufacturing violations, saying that failure to correct them may prompt FDA to bar imports from that plant. The warning letter noted that the inspector found signiﬁcant cGMP deviations that, under the Federal Food, Drug, and Cosmetic Act, are considered to be product adulteration, and that Dr Reddy’s December 1, 2010, response letter did not adequately address the corrective actions required. Deviations reportedly included validation of analytical methods used to test APIs, incomplete cleaning validation of non-dedicated manufacturing

Isolated cases of regulatory and compliance issues may impact the outsourcing market in the long run.

equipment, a lack of full investigations for out-of-specification data, and irresponsibility in ensuring cGMP compliance with API manufacture. These are some of the cases that cropped up in the past two years. These cases may not impact the overall image of India as the quality providers of products, believes an industry expert, “These are individual cases which at large will not affect the Indian pharma market as much as their own company but it would definitely harm the image of the company.”

India is one country in addition to China that provides low cost manufacturing and has established itself as a low cost provider. Along with its re-engineering skills, which are well-known, Indian scientists are good at adaptation of new technology and innovation and for all these reasons India has become a preferred destination for manufacturing. But with such isolated cases of regulatory and compliance issues it may impact the outsourcing market in the long run. With progressive growth in the Indian pharma market every year more and more companies are applying to USFDA and thus making the competition more aggressive. But dealing with USFDA is not easy. “Largely what people follow is that before the companies know that USFDA will visit, they themselves get the unit audited by some external expert, but even then sometimes people think they can getaway without being noticed. When it comes to Indian regulatory authorities they are not as rigid as their foreign counterparts,” says Dr Ravi Sobti, Pharmaceutical professional. Outsourcing is growing at a phenomenal rate as far as India is considered. “If we look at the global scenario the total pharma market all over the world is $ 880 billion and it is growing approximately at 5 to 7 per cent. In India contract manufacturing or CRAMS is growing at 30 to 35 per cent,” informs Dr Sobti. Given this lucrative market scenario when India has become known for its manufacturing skill, such regulatory issues can make the situation grim. “There was a big discretion in the US Senate regarding the USFDA becoming more stringent for the material to be outsourced from India and China,” informs Dr Sobti. So now if Indian pharma companies want to be global players and if the outsourcing of manufacturing needs to grow at a steady rate, then companies should become more cautious and take necessary steps to follow the regulations of the USFDA. If a company is following the guidelines vehemently then these cases will not arise but if there is a minor slack from the company’s side and if it wishes

Modern Pharmaceuticals I October 2011

Spotlight to cut corners then it will come under the purview of the regulatory body, which will lead to further investments and hassles of solving it. And Indian pharma companies cannot aﬀord this lackadaisical attitude any more if they want global limelight. “It is imperative that each manufacturer ensures that its techniques and facilities comply with the international quality regulatory bodies that it exports to,” says Ghosh.

The road ahead The major problem that gives rise to such situation is the technical fault or lack of technical expertise from the company along with lack of stringent rules from Indian regulatory bodies. These issues may be company specific and are solved in the long run, but even coming under the scanner can put a scar on that company. With big names coming under the scanner of the USFDA, the outsourcing of manufacturing goods from India can be affected. The only difference is that USFDA is stricter in its action and will not allow a slight issue to go unnoticed.

October 2011 I Modern Pharmaceuticals

If we look at the global scenario the total pharma market all over the world is $ 880 billion and it is growing approximately at 5 to 7 per cent. In India contract manufacturing or CRAMS is growing at 30 to 35 per cent. Dr Ravi Sobti Pharmaceutical professional So if big pharma companies who are driving the growth of Indian pharmaceutical market cannot completely adhere to the rules and global manufacturing practices then it is time for both the companies and the Indian regulatory bodies to take notice and undertake the necessary steps. The Indian regulatory authorities need to be more rigid and stringent, USFDA can be considered one of the supreme regulatory bodies in the world pharma market and being under the scanner of this body will grossly reﬂect the competency of the respective companies. “Ensuring the technical competency of the unit

is very essential and crucial along with having better internal audit control and a stringent control from the company’s side,” says Dr Sobti. The guidelines are all formulated and tabulated but it is at the implementation level that we are seeing a major gap. Companies are not following these guidelines in full tandem. Regulatory bodies have to gear up along with individual companies who need to have a stronger adherence to rules and regulations of USFDA if they want to export their products to the international market. (titash.choudhry@infomedia18.in)

Interface

‘The Indian pharma industry has evolved into a mature & integrated industry right from fundamental research to clinical APIs, dossiers, finalising the product and manufacturing’

...is how Bhavesh Patel, Managing Director, Marck Biosciences Ltd, Ahmedabad, views the market. Being at the helm of the company for more than a decade now, Patel has put concerted efforts to bring Marck Biosciences Ltd at a far greater and prominent position in the world market. A graduate in Mechanical Engineering & Finance, he has recently been elected as the President of Pharmaceutical Form–Fill Seal Association of India (PFFSAI). Titash Roy Choudhry How has your journey with Marck Biosciences been and since establishment how far the company has grown? Marck Biosciences has moved from the image of a manufacturer to a preferred partner for many Indian as well as international pharma companies. When Marck started in 1997, it had just one small line for making IV solutions, whereas today it has 7 blow-ﬁll-seal (BFS) lines. Till 2005, we were not making small volume parenterals (SVP) and today Marck is among the top three companies in the country. We started

operations with only ﬂuid therapy; today, apart from ﬂuid therapy, we have a range of injection formulations, ophthalmics, other I Cap products, respiratory nebules, products for eye & wound irrigation. In addition, we have also developed a variety of packaging & drug delivery option. Its formulation & development is geared to match the market expectation and being a customised solution provider. The company aims to address and capture a larger market share both with Marck’s brand and through contract manufacturing. Marck Biosciences is among the few Indian pharma companies who have geared their

production facility to become a versatile manufacturer of 0.5 ml injectibles to 1,000 ml irrigation solutions. Not only that but Marck Biosciences has launched world’s ﬁrst ever Paracetamol IV in plastic pack. Is quality a concern for maintaining a manufacturing unit and do pharma companies adhere to quality standards? Quality is of prime concern and no compromises should be made in adhering to prescribed standards. The quality of a product to a great extent is right from the design stage of facility, what we normally call quality by design. As far as our case is concerned we are putting more emphasis on induction/training. Since all the manufacturing units are advised to follow the same regulatory standards, when all are adapting similar technology; the only critical variable is manpower. A good manufacturing facility must have good hardware, evolved systems & trained manpower. We have extensive 48 hours

Modern Pharmaceuticals I October 2011

Interface induction programme, 45 days on job training and evaluation of performance at various stages. With competition getting more aggressive by the day and stricter quality standards, I think that most pharma companies are adhering to quality standards – those that do not will ultimately lose their customers and brand equity. How is manufacturing of parenterals and injectables different from that of formulations? As far as quality is concerned, it does not and should not be different for different dosage forms. Quality has to be need and risk based. The only difference between injection and parenterals is that they are sterile dosage forms and the environment control and the water system, especially in case of large volume parenterals (LVP), is critical. Since these are sterile products and because of their bulky nature, post-manufacture challenges such as transportation, storage and multiple handling are the major issues.

October 2011 I Modern Pharmaceuticals

Manufacturing cost and drug prices, what is the link & what are the most promising markets for Marck? The cost of manufacturing is only going to be higher, because the API market is always volatile. With regulations getting more and more stringent there is generally an increase in price. We are working across six therapeutic segments. The market phenomenon would vary from segments to segments. For instance, we consider India as a promising market, as far as ﬂuid therapy is concerned. Your take on outsourcing of manufacturing. Pharma manufacturing holds the key to industry’s gradual progression towards sustained growth. Enhanced focus on manufacturing has resulted in India becoming a key global manufacturing hub. The Indian Pharma industry has evolved into a very mature & integrated industry right from fundamental research to clinical APIs, dossiers,

ﬁnalising the product and manufacturing. Indian pharma companies have the capability to captive across the entire value chain. It would be wrong to say that Indian pharma companies are manufacturing centric. For outsourcing, India has the cost advantage and this advantage is likely to remain the same for next 10 more years. Pharma outsourcing is a win-win situation and Indian researchers see healthy prospects for the outsourcing sector in terms of increasing presence. Moreover, Indian players pursuing innovation will focus on it anyways. As per industry estimates, outsourcing of activities such as manufacturing and R&D work to India leads to cost arbitrage of more than 50 per cent when compared to developed countries. As a fall-out of that, non-core activities such as manufacturing of APIs, dosage development and packaging have been outsourced to low-cost destinations such as India and China. (titash.choudhry@infomedia18.in)

Interface

‘The per capita consumption of medicine in India is negligible when compared to other countries’

...says Subhash Chandra Sehgal, Chairman & Managing Director, Ozone Pharmaceuticals Ltd. The mind behind Nomarks, Sehgal has been heading one of the growing pharmaceutical companies in India. He elaborates on his plans of coming out with a Skin Institute. Titash Roy Choudhury What triggered the establishment of Ozone Pharmaceuticals? I come from a family of academicians and Air Force. I started my career in the pharma sector with Glaxo and from there on I went on to assume the post of Managing Director at Seagull. During my journey I witnessed signiﬁcant changes taking place in the Indian pharma industry. Equipped

with all the experience and knowledge in this ﬁeld I ventured into my own business with the establishment of Ozone Pharmaceuticals. I started the company with 4 people and today the company employs directly and indirectly almost 2,000 people. So the journey since then has been quite challenging and enlightening that has given me enough scope to grow even as an individual. The main reason behind the establishment of the company was that I wanted to utilise the knowledge

and expertise that I had gained over the years from my experience in this field. And second, I knew that as and when the economy grows the first need of the person will be food and after food it is health followed by looks and in that succession; we addressed health first and then ventured into looks. This is one sector that affects people the most and as and when the economy would grow this sector would be among the first two to be reciprocating that growth. The per capita consumption of medicine in India is a fraction of what is there prevalent in other countries, so the scope of growing is larger in India and I believe it will be fully utilised in the coming years.

Modern Pharmaceuticals I October 2011

Interface What are the major verticals that Ozone is working on? Our company has two broad verticals that it caters to; allopathy and ayurveda. Under these two verticals there are again few subdivisions and segmentations. I think this is the time when a company should try to focus on some specialised area and excel there. And with that mindset we are creating specialty verticals even in pharma business. For allopathy, we are into branded formulations where the research is not conducted by us but we look into innovative delivery systems under our brand name. Under this vertical we have three specific segments that I consider requires special attention. We have cardiac-diabetes section that has high demand today then we have gynac problems related segment and in orthopaedic. In the ayurvedic segment, we have our own R&D for original formulations and products like Nomarks. Along with our presence in the pharma sector we also have products for personal care like Nomarks, which are in-house developed formulations. Recently, we have also launched Ozone Professional range that is designed for use in beauty parlours by professionals. Nomarks has introduced new, unique and more logical age specific skin care concept with strong communication at all levels, wherein it has specific skin care product(s) for specific age group. It comes in three categories, for teen, for youth, and for 25+.

What was the idea behind integrating both allopathy and ayurveda under one brand name? I believe that each science has its own strength and if we are focussing on one science only, then we cannot provide the true benefits to humanity, and thus we should also use the strength of other sciences to bring about effective solutions. While ayurveda is safe for long term usage, allopathy is good from immediate perspective. In some cases if allopathy is not working we should go for ayurveda, or the method which is more effective. So we will be equally respectful to both

sciences and we would like to work with equal passion and intensity.

Your take on the present R&D scenario in India. There is immense scope for R&D in India. However, what we need is an investment push. The kind of money that is required for investing in R&D runs into billions and India at present does not have that strength but seeing the rate at which the economy is growing it is a matter of few years before we see investment in R&D in India. Besides, the huge skilled talented population works on our side too. There are many talented Indian scientists and researchers who are working abroad. It is the money required for conducting them that needs to be allocated and along

While ayurveda is safe for long term usage, allopathy is good from immediate perspective.

with the growth of the economy it will happen gradually. In addition it will be more cost-eﬀective in India considering the lower costs of skilled professionals and it would also provide a good environment for the multi-nationals to research in India.

Elaborate on the leading products in the market. Ozone has launched many products. Some of them have become market leaders while some figure in the top five brands. Like we have a product for varicose vein named Osil. The brand commands No. 1 rank in the segment as per ORG IMS’ of January 09. Our pain relieving gel named DFO gel is among the top five brands in this segment in this country. We have a product called Tranostat meant for stopping bleeding

and we are among the top four brands in the country. So our products portfolio is varied and among the top brands. We are planning to expand the product range by introducing eyedrops. We will be shortly coming up with eyedrops for treating diabetic retinopathy and cataract. We are the ﬁrst company in the country to study the role of calcium dobesilate in cataract and prevention of diabetic retinopathy. We ﬁled the patent three years ago and are awaiting the results.

Your expansion plans. During the next five years time, we are aiming at achieving a turnover of ` 1000 crore from our present turnover of ` 150 crore. Ozone will be coming out with Oscar Skin Institute where we will be conducting lot of research for skin-related products for skin condition management. The company will be coming up with this 35 crore institute near Gurgaon where scientists will be working to study the skin and managing overall disease through the skin. Skin is the largest organ on human body so anything that happens in the body is reflected in the skin. So in case one studies skin very closely he/she will be able to study the total disease factor and in case one manages to find a way to give medicines through skin by getting the medicine into the bloodstream then we can have the medicine delivered without side-effects. This route of disease management can be very effective because it will be devoid of any side-effects. The construction work for the same has started and most probably it will be operating from next year. As of now the company has three manufacturing units in Himachal Pradesh and two in Guwahati along with many CNF agents across the country. In the international domain, we are looking at strengthening our distribution and reaching more places with more products. We have been aggressively marketing our products in the Middle East and UK and we are looking towards adding more countries to the list. (titash.choudhury@infomedia18.in)

Modern Pharmaceuticals I October 2011

Market Trends

Automation for pharma

Robotic applications ushering in a change While other forms of automation seem to have established a strong foothold across industries, robotic automation is still to pick up pace. With the cost of manpower gradually increasing, robotic automation may soon become a common trend in the pharma sector. Chandreyee Bhaumik

utomation is the use of control systems and information technologies to reduce the need for human work in the production of goods and services. In the scope of industrialisation, automation is a step beyond mechanisation. Mechanisation provides human operators with machinery to assist them with the muscular requirements of work, and automation greatly decreases the need for human sensory and mental requirements as well.

Why acquire automation? Automation has had a notable impact

in a wide range of industries beyond manufacturing (where it began). With time, automation started gaining prominence in daily activities. Gradually, medical processes such as primary screening in electrocardiography or radiography and laboratory analysis of human genes, sera, cells and tissues are carried out at much greater speed and accuracy by automated systems. In general, automation has been responsible for the shift in the world economy from industrial jobs to service jobs in the 20tď&#x2DC;ˇ and 21st centuries. Developments in sensory perception technologies for robots have increased the safety standards for robots and coworkers in industrial automation. The earliest applications are in material

handling, spot welding and spray painting. However, extensive research shows development within the robotics industry in terms to technology, R&D and application markets. According to Frost & Sullivan reports, small and medium-sized enterprises (SMEs) and consumer markets such as pharmaceuticals and food & beverage, hold huge reports for robotics in material handling. These traditionally conservative industries anticipate that their products will reduce the labour costs and thereby handle and manage the product line changes with ďŹ&#x201A;uctuating volume. The booming packaging segment of the pharma industry especially in reference to the consumer market oďŹ&#x20AC;ers immense potential for robotics. Changing product types and varying product volumes necessiate felxible automation. Manufacturers in consumer markets are opening up to the idea of investing in robots to reduce costs and maintain the

Modern Pharmaceuticals I October 2011

Market Trends efficacy, thereby increasing sales of robots in the packaging segment. However, most SMEs cannot afford the heavy investments in flexible automation although the need for flexibility is the greatest among the SMEs. Thus, the manufacturers will have to cope up with the increasing costs so that they can benefit the end users. Therefore, the success of robot manufacturers depend on the efforts to offer reliable and inexpensive robotic solutions to SMEs. Again, niche participants should have immense technical knowhow, successful pricing strategies and experience in competing with the global generalised participants. And the end users should focus on their efforts of taking their performance to a higher level especially for the SMEs who have huge potential.

What robotic automation brings? Robotics is the branch of technology that deals with the design,construction,operation, structural disposition, manufacture and application of robots. It is related to the science of electronics, engineering, mechanics and software. While most of the industries and their varied verticals are touched upon robotic automation, pharma sector is not far behind. Drug makers primarily rely on automated equipment. Yet unlike the food and semiconductor industries, the pharma industry has been slow to adopt one particular form of automation: robots. Sometimes it is the lack of expertise, the perceived high initial cost of robotics, and the misperception that robotic systems are too complex and require complicated programming. But current computer and peripheral systems have increased the capabilities and flexibility of robot technology, and some automation experts predict robots soon could be critical to drug manufacturers’ efforts to reduce costs, ensure consistent product quality and increase efficiency. Pradeep Shoran, AGM, Marketing, Kuka Robotics (India) Pvt Ltd, avers, “Robotic automation is primarily popular in the automotive sector. Gradually it went towards the metal industry. There are medical robots that aid in operating tumours. As far as pharma is concerned, the use of robotics has been negligible.”

October 2011 I Modern Pharmaceuticals

These machines are capable of giving similar results every time. The human element of fatigue is also absent in this form of automation. Due to consistency, productivity is also huge. Pradeep Shoran AGM, Marketing, Kuka Robotics (India) Pvt Ltd Robots have the capacity to improve product quality. Processes are performed with precision and high repeatability every time. This level of consistency is hard to achieve any other way. Further, with robots, throughput speeds increase has direct eﬀects on production. Thus, robots have the ability to work at a constant speed without pausing for breaks usually taken by human beings. As a result, robotic automation has the obvious potential to produce and oﬀer more than a human worker. Commenting on the relevance and the utility of the robotic automation, Shoran discusses, “These machines are capable of giving similar results every time. The human element of fatigue is also absent in this form of automation.” Further, robotics can function even in harsh environments where dust and fumes are fuming out. He adds, “Due to consistency, productivity is also huge.”

Indian scenario Robotics cannot be installed in isolation. The raw materials involved in this form of automation have to follow a particular pattern. Explaining this, Shoran mentions, “The raw materials that are being used have to be in par with the automation. These components are required to have consistency in them, otherwise functioning becomes impossible. Thus, if the system is not according to the robotics, then there is a dire need to upgrade the process system.” As far as robotic automation is concerned, India does not occupy a prominent position on the global map. India does not have a local manufacturing unit of robotic. Discussing the oft-noticed trends in India and the position that the country occupies, Shoran explains, “India

does not occupy a very strong position as far as robotics is concerned. Japan is leading in the world followed by Europe, Germany and the US. China is also ahead.” However, the situation is not all gloomy. He describes optimistically, “The situation is not all grim. In the last ﬁve years, it has deﬁnitely improved. However, the pharma and food industries seem to be lacking behind. Across other verticals, robotic automation is gradually picking up pace.” It is extremely important to have the entire process streamlined and also the production level has to be at par with the investment pattern. Therefore, the volume of production should justify the investment made. But, it is not about the quantity only. Quality is also an essential criterion for choosing robotic automation. Discussing the position that India occupies Vikram Gupta, Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd, avers, “As far as pharma is concerned, US utilises automation to the fullest. Drug dispensing is done through robotic automation.” While elaborating on the fact why robotic automation has not picked up much in Indian pharma scenario, Gupta explains, “In India, the availability of manpower is extremely cheap. Thus, it is easier to incorporate 10 people for the same work rather than taking an initiative in robotic automation. Therefore, most of the Indian companies are quite easily adopting the wait and watch attitude.”

Investment pattern With time it has become a stated fact that with automation comes quantity and quality with precision. Explaining the investment on robotic automation, Shoran avers, “In pharma robotic automation is a one-time investment. And in the

Market Trends

In India, the availability of manpower is extremely cheap. Thus, it is easier to incorporate 10 people for the same work rather than taking an initiative in robotic automation. Vikram Gupta Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd

next 2-3 years the investment is paid oﬀ.” However, he adds that it should be remembered that there are 300 variants of robots, and robots is one of the many components of robotic automation. He shares, “The range of the cost is between ` 15-30 lakh. However, since there are various types, one can easily say that this is a customised product.” Elaborating on the investment pattern of this form of automation, he says, “Heavy investment is required for high-end medicine like injectibles. Further, work with injectibles compared to capsules can only take place

in stringent environment with minimum of human intervention.”

Tech next According to Shoran educating and creating awareness is a big challenge. He emphasises,“Usually, in our country, players are more interested in the immediate eﬀect of a particular thing. However, they have to look at the long run.” There are also other disadvantages. All these machines are imported. Shoran says that some of the companies have to pay import charges, which may make the entire process

an expensive one. He highlights, “In China too, there is no manufacturing unit. But considering the fact that China does not have to pay the duty, the whole affair does not become very expensive.” Elaborating on the progress and the future of robotic automation, he avers, “In the next few years there will be a jump. There will be 20-30 per cent growth year on year. However, to give a generalised view is not fair. A particular year may not be progressive like 2009. But overall, a progress can be seen.” There are several other important issues that have not facilitated the growth of robotic automation. Gupta mentions, “Robotic automation needs a very definite skill set. One is required to have a combination of skills for this.” He signs off saying, “Manpower cost is increasing in India. Huge attrition and high amount of training is required. Thus, in this way the situation of robotic automation will surely improve in pharma.” (chandreyee.bhaumik@infomedia18.in)

Manas Bastia Senior Editor Infomedia 18 Limited ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W) Mumbai 400 028 India

D +91 22 3003 4669 T +91 22 3024 5000 F +91 22 3003 4499 E manas@infomedia18.in W www.infomedia18.in

Modern Pharmaceuticals I October 2011

SME Corner

IT enables smooth functioning and error-free productivity in all industries. And pharma is not an exception. Several processes in pharma SMEs involve the use of IT, but are they equipped to invest as much is required for utilising this technology to the fullest? Chandreyee Bhaumik

mall and medium-sized enterprise (SMEs) play an important role in the economic development of a country. Several theories have tried to decode the connection between IT and pharma SMEs and almost all have agreed on the acceptance, though a bit late, of IT in the pharma sector. IT indeed has a deep impact in most of the industries and in all aspects of economy. And, pharma SMEs play the game with no exceptions. SMEs are attracting considerable attention in developed and developing countries as well as transition countries. However, the question whether there is enough investment in the system that can aﬀord the inclusion of IT, keeps lingering around.

Solving pre-production matters IT assumes an integral part in the entire pharma value chain. The process of production planning becomes much easier

with IT. Usually it is difficult to combine the last moment status information from department and combine to plan future production and again manually it is error prone to calculate the exact needs of material requirement for achieving the plan. Thus, software keeps a track of market demand, capacity of production, profitability between different plans, availability of materials, etc and help in creating different plans & selects the best production plan, scheduling it date wise. It also creates purchase request for purchase department to meet the finalised plan. IT also takes care of the purchase department of the sector. Challenges such as maintaining the list of quality assurance (QA)-approved vendors for each different material and to inquire for the latest available offer for the required quality as per the Program Portfolio Management Certification (PPMC) department. Additionally, there are challenges to compile the entire offer and then decide the

best option. To create the purchase order manually and send and track the same until material is received and money is paid to the vendor, is very difficult without the aid of IT. Suketu Shah, Director, Soham Computers, IT solution provider to IT companies, opines, “It becomes easy as the request from PPMC comes automatically. One can send the inquiry to the concerned vendor just in one click. It is easy to feed the offer received and the software analyses the different offer received and guides about where the purchase orders can be placed. It also creates the purchase order and sends the same from the system through e-mail, fax and SMS. It is very easy to track the issued purchased order on a daily basis.”

Varied uses For vision entry, separate book is to be maintained where the entry of guest and its purpose is written. This is mostly not very legible and there is no auditing of the gate book on a regular basis. One cannot store picture of the visitor in manual system. Shah avers, “It is easy to create an online gate pass with concerned oﬃcer’s name who are responsible to attend the visitor with date, time, purpose with the visitors pictures and can be stored through web

Modern Pharmaceuticals I October 2011

SME Corner

Software automatically does all the necessary arithmetical calculation and creates the paper work in necessary formats so there is nearly no chance for any errors or omissions. Suketu Shah Director, Soham Computers

cam. This information can be utilised for further analysis as the information now can be available date wise, officer wise, purpose wise, visitor wise, along with time spent in company wise, etc.” Further, sometimes, only vehicle numbers and few other items are recorded when goods are received in the company. And the same information is not utilised for further entry. IT has a solution for this too. The information that is entered on the gate will be utilised for further detailed entry in the store, thus duplication of work and omission of work is controlled and we have double check on the vehicles coming for the delivery. In the material store there are about 10 to 15 types of different inward and outward transactions that happen in the material stores. Store keeper has to keep different formats for each transaction and compile them into different registers for the need of stock keeping and to comply with many regulations. In this case, with appropriate software the only work that the store keeper has to do is to enter inward and outward information about the material into software. The quality control (QC)/QA being the most important department of the pharmaceutical formulator unit, it has stringent procedure to follow for sample collection. Protocol to test them, declaring the result in the specific format to the concerned department is very important. Therefore, checking and rechecking becomes stressful and one single mistake may result in product batch fail, which calls for major monetary and good will loss. With the help of software all the procedures are fixed and

October 2011 I Modern Pharmaceuticals

IDMA is in touch with the government and it has promised to help with several schemes focussing on capital subsidy and many others. Daara Patel Secretary-General, Indian Drug Manufacturers’ Association (IDMA)

only the authorised users are allowed to do important decision-making activity. Software automatically does all the necessary arithmetical calculation and creates the paper work in necessary formats so there is nearly no chance for any errors or omissions. Information is sent to the concerned department and saves the time of the department. In the production unit all the listed activities are to be minutely recorded in the document named batch manufacturing

SMEs are attracting considerable attention in developed and developing countries as well as transition countries.

record (BMR); the paper work becomes stressful. Here, through software, creating BMR becomes very simple and there are rare chances of any errors. Auto co-ordination between the QC department is managed with the use of software. All the necessary documents in the required formats are generated automatically and hence gives release of stress to the concerned staﬀ, thus better quality of production is achieved.

Post-production: A click away The packaging department of a pharma company is a site of several functions. Here, packing material is received from store, bulk product is received from production, packing the product in different packing as per the order, printing the tertiary labels as per the rules and send the goods. Thus, to check the quality and yield after each process and finally come out with bulk product is a task. Shah says, “Here one has to create batch packaging record (BPR) record and store it for long years. Smooth communication between Production and PPMC and Finished Goods (FG) store is difficult.” Thus, through software this is created as a part of the procedure without any extra effort by the users. In the FG store, recording maintenance is lengthy as it has to comply with many regulatory tools. With software this becomes easy as user just has to select from the menu and feed the data with the minimum key stroke and regulatory reports are generated automatically. In the marketing department, data collection from the field force is mostly difficult to get, and thus all the decision based on that are taken late, which in a way sometimes makes losses or less profitable than expected. Further, it is difficult to co-ordinate with market, PPMC and production department to avoid shortage of goods in market or excess storage at depot. Shah says, “Due to system integration with all the department coordination between market, PPMC, production and dispatch departement is smooth and on the tip of the fingers. It can use a bar chart and line chart to measure the gaps between each

SME Corner

In the future, the usual trend will become to pay for use of the license of the software. Gradually, the bigger companies are also trying to do so. Vikram Gupta Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd department and take measures to solve the issue. Further, data from the field force from all over the country becomes online. In the excise department, it often becomes too difficult and erroneous to maintain large books and documents that are mostly duplication of work. The figures should tally with each other at any given point of time. This is a real manual challenge for the staff members. Shah explains, “In software no special entry is done for creating this reports. Records are generated and made available in due course and does not involve even 10 per cent of the time compared with manual. And with the 100 per cent accuracy is obtained.” In the finance department with IT accounting can be accomplished in a systematic manner with the least man power and auditor can also audit computerised reports as they do not need to check the totals. Thus, VAT, TDS & Service Tax returns are compulsory to upload on net. He further comments, “In management department, software has the business intelligence tool that has the inbuilt capability to analyse volumes of data and provide single screen decisive data with graphs and charts for simpler decision making process and thereby comparison becomes easy.”

Adequate investment? Government is constantly helping the SMEs so that they can accept IT. APITCO, a business technical consultancy provides subsidy on Information and Communications Technology (ICT) up to 50 per cent in MSME Pharmaceutical at Madhya

More than financial investment what is required is the technical knowhow to operate and thereby help in the functioning of the industry. Dr Partho Gogoi Regional Director - Health & Family Welfare, North East State

Pradesh (Indore Cluster) & Uttrakhand (Dehradun Cluster). Further, MSME Development Institute provides different schemes for upgrading MSME in ICT in Gujarat. In spite of the several advantages rendered by the IT, inclusion of it becomes a challenge due to the investment required for it. Daara Patel, SecretaryGeneral, Indian Drug Manufacturers’ Association (IDMA), says, “As far as IT in pharma sector is concerned, the progressive ones will do a lot. In fact, IDMA is in touch with the government and it has promised to help with several schemes focussing on capital subsidy and many others. This will help in fuelling the progress from the SMEs. Further, IDMA also conducts Pharmaceutical Analysis Convention that aims to bring about solutions as far as the investments in pharma SMEs are concerned.” Shah however adds that for IT in pharma basic amount is required that can be easily financed by the company. Vikram Gupta, Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd, avers, “There are several IT solution providers who offer IT more as a service rather than as a product.” He adds that SMEs do not make fixed or capital investment for IT. They prefer to work on variable cost solution model. He says, “It pays for the usage of the software. Thus, the figures for the investment will only show the operating or the variable cost.” According to Gupta, within the sector the investment pattern for different verticals vary. Usually in pharma, the biotech and bioinformatics survive more on IT than manufacturing sector.

As far as return on investment is concerned, Gupta opines, “It is difficult to calculate financial data for this. There are lots of benefits that are an outcome of IT. But they are not reflected. The typical example is customer acquisition. Nobody attributes it to the development of IT. Thus, it is only in the input-output model that the development of IT can be seen rather calculated.”

Looking forward Due to the new rule of Directorate General of Foreign Trade (DGFT) Public Note no 59(RE-2010) / 2009-2014 dated 30th Jun 2011, it is impossible to export without implementing barcode technology and that is possible only through ICT. Signing off, Dr Partho Gogoi, Regional Director Health, Family Welfare, North East State, “IT is definitely growing and there are achievements such as telemedicine. There are adequate investments in order to capture the required IT setup. However, more than the financial investment what is required is the technical knowhow to operate and thereby help in the functioning of the industry.” Gupta believes, “In the future, the usual trend will become to pay for use of the license of the software. Gradually, the bigger companies are also trying to do so.” Overall, IT vendors can look into the trends that are following in pharma SMEs. They can essentially target their products based on the usage of this segment. To tackle the challenges faced for complete penetration in this segment, companies need to adapt smart and effiecient marketing ways. (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I October 2011

Legal Edge Section 3(a)

Pharmaceutical patents

The curious case in India With the advent of product patent regime, effective from January 1, 2005, India witnessed a surge of patent applications, in particular chemical and pharmaceutical patent applications. The future will be extremely promising with many more milestones to be conquered in the journey of the Indian pharmaceutical industry.

urrently, in India filing patent applications is on a rise. The number of drug applications filed between 2001 and 2004 was 2,728 and between 2004 and 2010 that number was 21,300. The patent amendment has acted as a major catalyst in this sharp growth and thus product patent regime, in consonance with international laws, has significantly impacted the Indian pharmaceutical industry. Despite the substantial changes incorporated in the Patent law, India’s patent system still differs in various aspects vis-a-vis other member countries. Given the fact that limited case laws are available in the field of patent, therefore, understanding of various aspects is essential for the applicant to avoid the various pitfalls associated with patent filing and prosecution in India. An overview into these areas will assist the applicant in formulating a robust strategy for smooth and economic pharmaceutical patent allowance in India. In India, intellectual property laws pertaining to pharmaceutical inventions are not resonant with the triple criteria of novelty, inventiveness and applicability alone. Some unique requirements exist in India.

Unique requirements of the Indian Patent System Indian Patent laws are in the process of evolution. On one hand the system complies with international obligations, yet it has some unique features for safeguarding national interests. Till the time there is more clarity, the applicant has to be judicious in ﬁling pharmaceutical patent application in India. While ﬁling pharmaceutical patents, some unique requirements may be considered to secure the allowance of patent in India. Currently, six sections of the Indian Patent Act are to be borne in mind before preparing and prosecuting pharmaceutical applications in India, ie, Section 3 (b), 3(c), 3(d), 3(e), 3(i) and 3 (j).

3(a) An invention which is frivolous or which claims anything obvious contrary to well established natural laws. eg, A drug capable of transforming a new born baby into adult within six months shall be considered frivolous, hence not patentable under Section 3(a) of the Indian Patent Act.

Section 3(b) An invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment. Recently, this provision has been held against patent of Swiss drug maker Novartis for cancer drug Glivec by Intellectual Property Appellate Board (IPAB), citing that the price quoted for the drug creates public disorder among other things, since Glivec costs ` 1.2 lakh per month, against the generic versions that cost ` 11,000. The pertinent part of the order reads as below “We are fully conscious of the Appellant’s benevolent GIPAP program for free distribution of GLEEVEC to certain cancer patients. But as per information furnished in its written counter–argument by R 3 that when the Appellant was holding the right as EMR on GLEEVEC it used to charge ` 1,20,000 per month for a required dose of the drug from a cancer patient, not disputed by the Appellant, which in our view is too unaffordable to the poor cancer patients in India. Thus, we also observe that a grant of product patent on this application can create a havoc to the lives of poor people and their families affected with the cancer for which this drug is effective. This will have disastrous effect on the society as well. Considering all the circumstances of the appeals before us, we observe that the Appellant’s alleged invention will not be worthy of a reward of any product patent on the basis of its impugned application for not

Modern Pharmaceuticals I October 2011

Legal Edge only for not satisfying the requirement of section 3(d) of the Act, but also for its possible disastrous consequences on such grant as stated above, which also is being attracted by the provisions of section 3(b) of the Act which prohibits grant of patent on inventions, exploitation of which could create public disorder among other things.” This decision has been challenged by Novartis AG before the Supreme Court of India. The patent rejection of Novartis key cancer drug, Glivec, under Section 3(b) of the Indian Patent Act was attributed its high price and was judged to be against ‘public order.’ However, on the other hand, Novartis has held that that Section 3(b) is not applicable to Glivec, citing that in no other country, price is bar for acknowledging the patentability of the invention. Novartis has argued that pricing of the drug must be independent of patentability criteria. In another matter, Roche vs. Cipla, for product Erlotinib – Tarceva (TM@), the Delhi High Court denied injunction to Patentee. The Court order reasoned that between the public interest in granting an injunction to affirm a patent during the pendency of an infringement action, as opposed to the public interest in access for the people to a life saving drug, the balance has to be tilted in favour of the latter. India being a developing nation, affordable drug availability to public is of prime importance. Therefore, in order to avoid rejection under Section 3(b), affordability of the drug by differential pricing option must be considered, although said section does not seem to have been interpreted in consonance with the essence of this Section.

Section 3(c) 3(c) The mere discovery of a scientiﬁc principle or the formulation of an abstract theory or discovery of any living thing or non-living substances occurring in nature. This section is of relevance for drug patents, including genetically engineered pharmaceutical products. The wording of the claims must indicate the substantial

October 2011 I Modern Pharmaceuticals

human intervention involved, so as to come out of the realm of discovery.

Section 3(d) 3(d) The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

In India, intellectual property laws pertaining to pharmaceutical inventions are not resonant with the triple criteria of novelty, inventiveness and applicability alone.

Section 3(d) has been drafted keeping in view the public health safeguard. This Section aims to block ‘ever greening’ of patent by acting a check valve against additional patents on insigniﬁcant improvements, thus paving way for introduction of generics on expiry of the original patent. In January 2006, the Patent Controller in Chennai refused to grant Novartis a patent, in view of being obvious, and being not patentable under section 3(d). Thereafter, Section 3(d) has drawn considerable attention of intellectual property attorneys, policy makers, academicians, pharmaceutical ﬁrms, non- governmental

organisations and has been in limelight ever since 2005. Novartis’ primary contention in its challenge to the constitutional validity of section 3(d) was that the use of the term ‘efficacy’ in Section 3(d) is vague and ambiguous, and therefore violates the equality provision (Article 14) of the Indian Constitution. The Government of India and other opponents argued that section 3(d) is not in violation of the equality provision of the Indian Constitution as the concept of efficacy is well-known to people in the pharmaceutical industry to mean ‘therapeutic efficacy’. Dismissing the petition, the Madras High Court held that “We have borne in mind the object which the Amending Act wanted to achieve namely, to prevent ever greening, to provide easy access to the citizens and therefore did not violate the Indian Constitution.” The Patent application was subsequently heard by IPAB and it rejected the application on the ground of providing insufficient data to show that beta crystalline form of imatinib mesylate exhibited enhanced therapeutic efficacy over known imatinib mesylate. This decision has been challenged in Supreme Court of India and is still pending. The Novartis’ Glivec matter has created an impression that because of Section 3(d), any kind of incremental innovations will not get patent in India, however, Section 3(d) has stood the test of time and many patents have been granted in recent past for innovation wherein the improvements were significant. The Indian Patent Office has uploaded on July 28, 2011, a detailed list of granted pharmaceutical patents on its website. The data provided therein clearly indicates during the last five years alone, the Indian Patent Office has granted 3,588 patents relating to pharmaceutical innovations rebutting the notion that Section 3(d) was against incremental innovations. Thus, Section 3(d) of the Patents Act is not a bar for patenting of significant incremental innovations, since the patents granted are not only for

Legal Edge new molecules but also for new processes as well as new uses, combinations and dosage forms. While many cases have been refused on the ground of insufficient data to show the increased efficacy of the claimed drug, however, many drugs have also been allowed after submitting sufficient data, eg, in the matter of Hoffmann La Roche AG vs Wockhardt & Sankalp Rehabilitation Trust, the Patent office has upheld the Hoffman patent. In this patent, the Controller has considered the experimental data which showed decreased antiviral activity and increased anti-proliferative activity of PEG conjugated interferon as ‘therapeutic effects’. Thus, a derivative of known compound having enhancement in known efficacy has been allowed. Similarly, other matters which received a favourable response in favour of the Plaintiff are Gilead Sciences vs. Cipla; Hoffman La Roche and Pfizer products vs. Cipla Ltd; Pfizer Ltd vs. Natco Pharma. As per Section 3(d) new forms of known substances are patentable, provided the enhanced therapeutic efficacy is established in comparison to known substance. As regard inventions related to pharmaceutical, incorporation of comparative data in the specification to show enhanced efficacy in terms of therapeutic effects will assist in securing the allowance of patent. Though it is not

essential to present final clinical trial data, details of initial laboratory data or test results of compound/composition in comparison to base/ known form of compound, which support the arguments for the enhanced therapeutic effect, must be disclosed in the specification.

Quick Picks Section 3(d) of the Patents Act is not a bar for patenting of signiﬁcant incremental innovations. Section 3(e) 3(e) A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance. In an Indian patent application, compositions claims should provide unique ratio or percentage of the components and should be supported by teaching of surprising eﬀect or synergy to prevent the rejection of claims under Section 3(e) on the ground of being admixture. To claim a composition, wherein no chemical reaction is taking place, it is imperative to show that combination of ingredients claimed is a synergistic composition exhibiting surprising or synergistic properties not

exhibited by components individually. In case of composition claims, at least two active components are required to claimed; mere addition of excipients and carriers is considered obvious by the examiner, resulting in rejection of composition claim. The claimed composition should show synergism in comparison to individual components, eg, an Indian Patent application was allowed as the claims related to a synergistic composition with proof of synergism in the examples including bio availability data and clinical data. On the other hand, another application was rejected in spite of description showing considerable increase in the therapeutic eﬀect, since data pertaining to the synergistic eﬀect of the combination and individual drug(s) was absent.

Section 3(i) 3(i) Any process for the medicinal, surgical, curative, prophylactic diagnostic therapeutic or other treatment of human being or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. In India, claims related to method of treatment and diagnosis per se are unpatentable. However, as per the practice followed in India, ‘in vitro’ methods are considered patentable, provided the method has industrial application. Also in

Comparisons of Indian Pharma patentability with other countries Invention subject matter

JPO

EPO

USPTO

Indian Patent Oﬃce

Chemical compounds

Allowed

New form of existing compounds

Allowed

Allowed, subject to furnishing of data

Comparative data with base compound to be submitted

Chemical composition

Allowed

Allowed, subject to furnishing of data

Data for showing synergistic eﬀect achieved by the composition in comparison to components take alone

New chemical process

Allowed

1st use claim

Allowed

Allowed, in form of medical treatment claim

Not Allowed

2nd use claim

Allowed

Allowed, in form of medical treatment claim

Not Allowed

Remarks for Indian Patent Oﬃce

Modern Pharmaceuticals I October 2011

Legal Edge general, claims directed to composition for treatment, medical devices and diagnostic kits per se are considered patentable. Reference is made to J N Mitra vs. Kesar medicaments for device for detection of antibodies to Hepatitis C, wherein Delhi High Court granted injunction, reasoned the order on the basis that the use of patent being limited, irretrievable prejudice will be caused to the plaintiff if interim orders are not granted. The balance of convenience lies in favour of the plaintiff as the plaintiff ’s patent cannot be permitted to be infringed. Thus, the applicant has the option of securing allowance of such matter by appropriately re-wording the claims as compounds, composition and applications claims, instead of treatment method per se. However, Swiss type claims or use claims worded as per current European practice are not allowed.

Section 3(j) Plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species

October 2011 I Modern Pharmaceuticals

and essentially biological processes for production or propagation of plants and animals. Microorganisms per se are patentable in India. Clones and new variety of plants/ animals are not patentable. However, process/method of preparing genetically modiﬁed organisms (GMO) are patentable subject matter. Recombinant proteins and method of preparation of such proteins are also patentable. In spite of limitations set forth by the Sections discussed above, the past few years have witnessed exponential rise in pharmaceutical patent ﬁling and grant of applications in this area. By keeping the few considerations in mind, applicants have been successful in securing allowance of pharmaceutical patents in India.

if enabling policies, including strong IPR regime are implemented, the pharmaceutical market is expected to touch the $ 55 billion in 2020 and has a further potential to reach $ 70 billion by 2020, if aggressive growth eﬀorts are embraced. Companies and investors from the pharmaceutical sector fully understand the value of intellectual property for commercialisation of their inventions in India due to its huge market potential. Despite certain ambiguities and unique requirements, the patent laws are inﬂuencing, encouraging and fostering growth of pharmaceutical research and development in India. (salhotra@lls.in)

Conclusion In the past few decades, pharmaceutical industry has made great strides in India. As per a report by IMS Health India, the Indian pharmaceutical market size in July 2010 was $10.04 billion. According to a new McKinsey & Company report,

Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra

Case Study

Inspecting labeling errors

New accuracy levels achieved

Courtesy: Cognex Inc

As a global player, AstraZeneca’s top production priority is to ensure the accuracy of label detection as well as the stability of the detection system. When AstraZeneca in China decided to turn to vision they realised they needed a supplier who could assure high standards with respect to the accuracy of product label detection while maintaining high production speeds. Cognex Checker proved to be the best choice.

s one of the leading pharmaceutical companies in the world, AstraZeneca has a business presence in over 100 countries, including 31 manufacturing sites in 20 countries. AstraZeneca China has its headquarters in Shanghai, with branch oﬃces in 15 cities and a manufacturing plant in Wuxi city. The challenge: Achieving accurate label inspection and maintaining high speed production Product quality is a decisive factor in the increasingly competitive pharma industry, in which the content of the label is closely tied to consumer safety and can also inﬂuence consumer perceptions. AstraZeneca needed to improve the accuracy of label detection in order to maintain production quality. The problem arose from the assistant system counting product labels as traditional electric-photo sensors often encounter errors when checking the edge of two neighboring labels. These sensors are not competent enough to meet such high speed production requirements. In

order to reach zero defect level in production, AstraZeneca needed a more accurate vision system to count label numbers, to check whether the edge of the neighboring labels on the production line are correctly aligned and to raise the alarm when an error occurred.

Checker advantage AstraZeneca performed a series of tests on their production line using vision systems from Cognex as well as from several other vision suppliers. While they found that all the systems tested met basic production requirements, the Cognex Checker stood out as the intelligent sensor capable of going further. What gives Checker a primary competitive advantage is an integrated LED illumination and lens. Other vision systems need an extra light source, which can mean higher costs. Therefore, Checker was the obvious choice for AstraZeneca.

automated, running at a fast speed and is capable of self-adjustment according to labeling speed. To ensure the optimum performance of Checker on the production line, free run was chosen as the trigger and pattern sensors to check the edge of neighboring labels and detect the right place to label them. Checker has an integrated LED illumination and lens. As well as having a compact appearance, it is easy to configure and install. The output ports transfer two kinds of signal, 0 output as counting and 1 output as alert. Checker can analyse up to 500 images per second and is characterised by ‘train and go’ capability communicating with a PLC that controls the equipment. The system uses a touch operation panel to display the number of labels. The operation staff can quickly and easily carry out job selection and inspection tasks just by touching the panel. Cognex Checker is suitable for the high speed production system, so it easily meets AstraZeneca’s requirements. It checks whether the edge of neighboring labels is properly aligned during production, ensures the counting of labels and sounds an alarm to alert operational personnel in case of error. As a result production is carried out effectively and a zero defect level is ensured.

Problem solved and costs reduced Thanks to the stability and accuracy of Checker, the quality of detection and counting is maintained and a high level of productivity is guaranteed. Costs are reduced while resolving a diﬃcult problem. AstraZeneca is considering expanding the application to inspect date codes and inspect packaging. As Cognex’s Checker distributor, Wuxi Tubang Electrics Co Ltd has been a successful partner of Cognex in Jiangsu and Zhejiang provinces for several years, providing strong support in promoting Cognex products in the region. (sales.in@cognex.com)

Didier Lacroix

The smooth operator Every production line in the plant is fully

Senior Vice President - Worldwide Sales & Marketing, Cognex Inc

Modern Pharmaceuticals I October 2011

Industry Insights

Hepatitis A preventive vaccines

Driven by increased tourism The Hepatitis A vaccine protects against more than 95 per cent of cases. The report identifies the key trends shaping and driving the global Hepatitis A preventive vaccines market. It also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Hepatitis A preventive vaccines, global, revenue and market forecast ($ million), 2005-2017 800 CAGR (2010-2017): 6.2% 700

ahead and get oneself vaccinated. Nearly 100 per cent of adults will develop protective levels of antibody within one month after a single dose of vaccine. Similar results are obtained with children and adolescents in both developing and developed countries. GlobalData estimated the global Hepatitis A preventive vaccines market to be worth $ 476 million in 2010, and it is forecast to grow at 6.2 per cent annually for the next seven years to reach $ 726 million by 2017. This signiﬁcant growth is primarily attributed to growth in vaccination coverage due to increases in recommendation for Hepatitis A vaccination. The growth is further supported by an increase in tourist traﬃc globally as Hepatitis A vaccines are used as traveler vaccines by tourists. However, supply issues with some vaccines act as a barrier to the market.

600

Revenues ($ million)

500

Competition in market remains strong

CAGR (2005-2010): 5%

400 300 200 100 0 2005

2010

2017

Source: GlobalData, World Health Organization, Centers for Disease Control and Prevention, Hepatitis Foundation International, GlobalData Epidemiology-Based Market Forecasting Model, Primary Research Interviews

epatitis A is an acute disease aﬀecting the liver. It is caused by the Hepatitis A virus (HAV). Hepatitis A vaccines are all highly immunogenic. It is a mild, self-limiting disease, resolving on its own with no treatment within 4-8 weeks. Most of these infections are asymptomatic and usually patients do not show any complicated symptoms. Hepatitis A is a disease of poor personal hygiene, bad sanitation, poverty, overcrowding – that is why the occurrence is more prominent in under developed or third world countries. Unlike Hepatitis B, Type A hepatitis disappears completely after acute infection, and does not contribute to chronic

liver disease or to cirrhosis. It is important to note that after the patient recovers, he/she has lifetime immunity. It has almost become mandatory for kids to take this vaccine. But the question that arises is did we need a vaccine for a rare disease that resolves by itself in a few weeks? Some studies have shown that 6 out of 1,000 people infected with Hepatitis A die, though these ﬁgures vary from country to country. To prevent the loss of people for cases where a treatment option is available, vaccines are a good alternative. Observing the modes of transmission of the disease (contact with stool, blood or ﬂuids of the infected person), it seems to be a wise move to go

GlobalData analysed that GlaxoSmithKline and Merck shall remain the leaders in the hepatitis preventive vaccines market. The current products display high safe and efficacy profile thereby leaving low unmetneed. The supply issues with Merck’s brand is taken care of with adequate supply of GSK vaccines. Hence, the current products are sufficient to meet the current market demands leaving little scope for new entrants in the near future. The only opportunity for a new entrant lies in developing an oral formulation of Hepatitis A vaccine, which should improve patient compliance.

Current preventive vaccines meet demand The current competition in Hepatitis A preventive vaccines market is strong and available treatment options are quite successful in meeting market demand. The products currently in market have displayed high efficacy in terms of almost 100 per cent people being seropositive after vaccination. The products also display a high safely profile with less than 1 per cent of the vaccinated people showing serious sideeffects. The usage of preventive vaccines has successfully and consistently decreased the incidence of Hepatitis A infection. Courtesy: GlobalData

Modern Pharmaceuticals I October 2011

Events Calendar

National AHMEDABAD: Gujarat, Oct 14-17, 2011, Gujarat University Exhibition Hall PUNE: Maharastra, Nov 18-21, 2011, Auto Cluster Exhibition Centre CHENNAI : Tamil Nadu, Dec 8-11, 2011, Chennai Trade Centre INDORE: Madhya Pradesh, Jan 6-9, 2012, Poddar Plaza, Nr Gandhi Hall AURANGABAD: Maharashtra, Feb 17-20, 2012, Garware Stadium India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Infomedia 18 Ltd,

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in

National Symposium on Current Trends in Pharmaceutical Sciences The symposium is aimed to cover promising approaches in the drug discovery research and strategies to address the challenges of 21st century. There will be a galaxy of experts lined up for scientific sessions, both f rom academia and industries; November 12, 2011; BITS-Pilani, Hyderabad campus For details contact: Department of Pharmacy, BITS-Pilani, Hyderabad campus Tel: +91-9705351182 Email: bitshydctps2011@gmail.com Website: www.bits-hyderabad.ac.in

Indo-US Joint Symposium on Nanomedicine: Prospects and Challenges This event aims to bring prominent scientists and business experts discussing the latest research, development and commercialisation of nanomedicine. Further, the exchange of knowledge will foster the collaboration between the Indian and the US investigators and thereby benefit the students and young investigators. Thus, this event will be a suitable platform for exchange of relevant information and thereby leverage on the knowledge gained. This will help in the advancement of the industry;

October 2011 I Modern Pharmaceuticals

November 14-15, 2011, Institute of Chemical Technology, Mumbai For details contact: Institute of Chemical Technology Tel + 91 22 3361 2201 Fax + 91 22 3361 1020 Email ictindoussymposium@gmail.com Website- www.ictmumbai@edu.in

2nd Annual SCM Pharma India 2011 This event aims to transform the supply chain into a robust, integrated and costeffective network in order to achieve maximum visibility and protect the quality of the pharma products. This two-day conference and two practical workshops have a dedicated focus on building the skills and knowledge required for meeting the challenges of modern pharma supply chain management; November 15-17, 2011; The Westin Mumbai Garden City, Mumbai For details contact: UBM India Pvt Ltd Tel: +91 (022) 4046 1466 Fax: +91 (022) 4046 1477 Email: conferences-india@ubm.com Website: www.scmpharma-india.com

CPhI India 2011 The event will feature key decision makers in the pharma industry from 92 countries, including India,

China, US, UK, France, Italy, etc. The CPhI conference will include updates on latest innovations, technologies, trends and developments in the pharmaceutical industry in India; November 30 December 2, 2011; Bombay Exhibition Centre, Mumbai For details contact: UBM India Pvt Ltd Tel: + 91 22 6612 2600 Fax: + 91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

9th Annual BioPharma India Convention 2011 This event aims to manage the manufacturing networks and implement effective bioprocess strategies. It also mitigates risks in upstream and downstream manufacturing operations. Again, the event maximises the potential of disposable technologies to increase overall productivity; December 6-7, 2011; Grand Hyatt, Mumbai For details contact: Terrapinn Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email: enquiry.sg@terrapinn.com Website: www.terrapinn.com

Pharmapack Bombay The event aims to provide an innovative platform to showcase the latest information, technology and products to a focussed and target audience. The event promises to cater to the exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals, etc; February 23-25, 2012, Bombay Exhibition Centre, Mumbai For details contact: Intel Trade Fairs & Expositions Pvt Ltd Tel: + 91 22 2862 8126 Fax: + 91 22 2281 9008 Email: intelexpo@vsnl.net Website: www.intelexpo.com

Events Calendar

International Ukrainian Pharmaceutical Forum This three day event will bring together all professionals from the pharmaceutical industry, and will provide an opportunity for the business community, practitioners and analysts to start the necessary dialogue with representatives of state authorities. The event will be filled with analysis, interactive formats, topical discussions and strategic ideas exchange between more than 60 speakers and 150 participants; October 17-19, 2011, InterContinental Hotel, Kyiv, Ukraine For details contact: Adam Smith Conferences Tel: +44 20 7017 5095 Fax: +44 20 7017 7447 Email: iBondareva@adamsmithconferences.com

Pharmacovigilance Asia 2011 Pharmacovigilance Asia 2011 is an unique learning platform that will bring together regulators as well as practitioners from the industry in order to discuss the ongoing pressing issues faced in drug safety, risk management, timeline constraints and varied regulatory standards. A featured panel of experts from the US and Europe will also be invited to provide key learning opportunities. The event will discuss best practices for both post-market and clinical stage pharmacovigilance and exploring ways of developing and reinforcing a harmonised pharmacovigilance framework; October 18-19, 2011; Amara Hotel, Singapore For details contact: Tel: +65 6722 9388 Email: enquiry@iqpc.com.sg Website: www.pharmacovigilanceasia.com

World Pharma Innovation Congress 2011 This is Europeâ&#x20AC;&#x2122;s leading conference

delivering innovative, fully integrated and collaborative approaches to next generation drug discovery and development. This event aims to bring together various collaborative approaches that are being adopted to create an industry that is fertile for innovation. It will also identify how to initiate and successfully coordinate research alliances and also learn best practices to restructure internally to facilitate innovation in the future. Again, it will also discuss how to decrease pipeline attrition and therefore optimise R&D operating efficiency. There will be a session on how to strengthen and rationalise the existing safety monitoring system. Further, measures for better prevention, and detection and assessment of adverse reactions of medicines to improve patient safety and public health will be analysed; October 18-20, 2011; Venue Jumeirah Carlton Tower, London, UK For details contact: Organiser Terrapinn Ltd Tel: +44 (0)20 7092 1000 Fax: +44 (0)20 7242 1508 Email: enquiry.uk@terrapinn.com Website: www.terrapinn.com

ICSE Europe The ICSE Europe aims at targeting the top leaders of the pharmaceutical industry. The event will organise an exhibition along with concurrent conferences. The exhibitors profile includes biotrails, pharmacology, pre-clinical, biotechnology, pharma equipment and machinery, production equipment, clinical research, patient safety monitoring, etc. Therefore, this event will be bringing together all the key decision makers from the industry on one platform; October 25-27, 2011, Messe Frankfurt, Frankfurt, Germany

For details contact: UBM Live Tel: + 31 20 409 9544 Fax: + 31 20 363 2616 Email: icse@ubm.com Website: www.icseexpo.com

16th China International Pharmaceutical Industry Exhibition The 16th edition of this exhibition will see participants from different pharmaceutical fields, from Pharmaceutical Machinery, Biopharmaceuticals, Pharmaceutical Water Treatment Equipment Pharmacy Facility & Display Equipment, Pharmacy Logistic and etc; October 25-28, 2011, Shanghai New International Expo Center China, China For details contact: China Center for Pharmaceutical International Exchange Tel: + 8621- 61698300 Fax: + 8621- 61698301 Email: chinapharm@ccpie.org Website: www.chinapharmex.com

Cell-Based Assays The event will consist of a two-day conference and a post-conference workshop, focussing on a range of topics relating to the challenges faced by those involved in using and developing cell-based assays. Thus, this event will try to resolve several concerns faced by the industry and endeavour to offer solutions to the challenges; November 21-22, 2011; Marriott Hotel Reagents Park, London, UK For details contact: SMi Conferences Tel: +44 0 870 9090 711 Fax: +44 0 870 9090 712 Email: client_services@smi-online.co.uk Website: www.smi-online.co.uk

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals

Modern Pharmaceuticals I October 2011

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Pharmac India 2011

A platform aiding future goal setting The success of Pharmac India 2011 remained unhampered despite sudden venue changes. The event serving as a perfect platform for the entire pharma industry offered practical and reliable solutions to several intriguing problems of the sector. Chandreyee Bhaumik

harmac India is one of the prominent pharma exhibitions catering to the healthcare and pharma industry. The event was held on September 17-19, 2011 at Mahatma Mandir, Gandhinagar. Initially, the venue was Gujarat University Exhibition Hall in Ahmedabad. But the event had to be shifted elsewhere due to some last minute changes.

Catering to… The three-day fair brought pharmaceutical manufacturers, pharmaceutical packaging material and machinery makers, active pharmaceutical ingredients (APIs-bulk drugs), biopharmaceutical companies and largest suppliers & distributors of pharmaceutical products under one roof in order to facilitate exchange of ideas for better growth of the industry. The event was organised by Indian Drug Manufacturers’ Association – Gujarat State Board (IDMA – GSB) in association with Orbitz Exhibitors Pvt Ltd. Commenting on the event, Kamlesh Patel, Chairman, Pharmac Committee, IDMA – GSB, said, “Pharmac India oﬀers an opportunity to all the players in pharma industries to tap the market potential to the best extent possible and also to enhance brand image of their products. The event also helps in analysing the market potential for various products existing in the global markets and also the competition scenario.” Further, Rupen Vikamsey, Managing Director, Orbitz Exhibitions Pvt Ltd, said,

“We feel extremely proud that that IDMA has entrusted Orbitz Exhibitions Pvt Ltd for organising Pharmac India 2011. The exhibition is an opportunity for the SME’s to display their expertise and skills beyond geographical boundaries.” Continuing on this strain, he said, “As the event managers and organisers, we are conﬁdent that the next edition of Pharmac India will be even more successful and beneﬁcial for the exhibitors as well as visitors.”

Taking a step forward The ﬁrst edition of Pharmac India, held in November 2009, had achieved a phenomenal success on debut itself with over 200 participants; it emerged as one of the mega event for the Indian pharma industry. It drew attention of close to 10,000 trade visitors including some overseas visitors. This year the event had more participants than last year. The speakers at the conference discussed that today regulators are extremely quality conscious and thus drugs that are manufactured have their own brand equity. Citing the reason behind choosing Gujarat as the venue for the event, the speakers said that it is true that progress should be made by the entire country but Gujarat has carved out a niche in this space. The event also discussed serious concerns about how branding of drugs make them extremely expensive and thus access to healthcare becomes a challenge. Further, it was announced that soon similar to the 108 emergency facilities in healthcare sector, there will be 104 facilities that will aim to advise solutions pertaining to pharma sector. Judging by

the speciﬁc needs of the patients, they can be transferred accordingly. It can be accessed in three languages: Hindi, Gujarati and English.

Overall success The exhibition at the event was an immense success with the presence of various trade visitors. There were visitors from several segments of the industry like pharmaceutical company marketing/ purchase, pharma distributors, generic & over-the-counter (OTC) manufacturer & wholesalers and many others. Commenting on the success of the event, Daara B Patel, Secretary - General, IDMA, commented, “Several professionals from diﬀerent segments of the industry have come under one roof. Thankfully, the sudden change in the venue did not hamper the reach of the event.” (chandreyee.bhaumik@infomedia18.in)

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Workshop on ‘Future Supply Chain Strategies – the way ahead’

Of communion and concrete ideas The industry on the move took a break… only to cover the distance and difference of perspectives between logistics service providers and end users regarding the future needs and challenges in logistics functions across industries. While a lot of discrepancies cropped up between these two worlds during the Frost & Sullivan second annual strategy workshop in Goa, the well steered discussions and practical workshop managed to get the industry and its players back on track with one vision, one mission and one anthem. Archana Tiwari-Nayudu

uilding trust and collaboration between logistics service providers (LSPs) and end users is the critical need of the hour. This was the guiding thought at Frost & Sullivan’s second annual strategy workshop for the logistics sector titled, ‘Future Supply Chain Strategies – The Way Ahead’, held at the Zuri White Sands Resort, Goa, from September 14-16, 2011. Group 1: MEGATRENDS Globalisation Challenge: Increased wages and salaries Solutions: Use automation to increase ‘total productivity’ and decrease ‘total cost’ Post GST Challenge: How to take advantage? Solutions: Outsource 3PL Gain the expertise and redeﬁne your warehouses based on the ‘Hub & Spoke’ model Issue of ‘governance’ Cost and value add, state and federalbased Service Tax structure. Dedicated Freight Corridors (DFC) Challenge: How to take advantage? Solutions: LSPs need to consider investing in modern infrastructure facilities near ports, if possible, on a toll basis. Multimodal Challenge: There is a lack of seamless integration of air, sea, rail and road Solutions: LSPs need to consider investment in other modes of transport, if required on a toll basis. Green Logistics Challenge: How to protect our environment? Solutions: Work on ‘carbon credits’ using ‘collaborative’ methods, perform last mile delivery using ‘electric vehicles’.

Progressing from last year’s workshop, this year’s workshop explored the critical areas of focus for the logistics sector along with the essential next steps which would help key industries such as automotive (auto components), healthcare, retail & electronics, IT and telecom achieve ideal future supply chains. The workshop emphasised on the need for a combined eﬀort from the LSPs and end users.

Providing more

Group 2: AUTOMOTIVE Macroeconomic factors Challenge: Inability to match the ﬂuctuations in demand Solution: Develop a robust forecasting model covering national and state level savings data, seasonal trends and per capita income. Outsourcing Challenge – Having complete logistics solutions from LSPs Solution: Achieve cost + relationship + synergy through collaboration with LSPs Services needed from 4PL coordination, in-plant logistics, own ﬂeet and external logistics. Critical success factors – Roadmap for achieving 15 per cent CAGR by 2020 Information visibility across the chain and a collaborative approach from all stakeholders to provide information in real-time through IT integration. Infrastructure development to address delays in deliveries Investment by the LSPs (for e.g. vehicles in good condition). Talent retention Collaboration with B-schools for generation of suitable talent Better pay structures.

Group 3: IT / ELECTRONICS Challenges Solution: Fragile nature of product (high damage percentage) Post sale and reverse logistics infrastructure and resources not being in place Information system for supply chain in ﬁeld (non-urban sectors) is poor Large service providers either have no or have poor infrastructure in nonurban areas Franchisee reliability and delivery predictability in terms of timing and safety is very poor. Opportunities and Solutions: Incentivise non-damage and timely services LSPs should study and understand the post-sale and reverse logistics needs of industry LSPs should provide standardised solutions, especially for remote sector logistics Web-enabled information sharing infrastructure development for common use by multiple LSPs and end users for reducing the burden on the franchisee On the whole, the IT electronics industry and LSPs should collaborate for designing and implementing industry-speciﬁc solutions.

The workshop, which commenced with a presentation from Frost & Sullivan on ‘Frost & Sullivan’s Perspectives on Future Supply Chain Strategies’, provided strategic insights from Frost & Sullivan’s research studies and set the context. The session explored the mega trends impacting the logistics industry, key logistics challenges requiring collective eﬀorts by LSPs and end users, and the critical aspects in building a roadmap for eﬃcient and sustainable

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Eminent dignitaries on the dais

Breakthrough session in progress

supply chains for the future. This was followed by an interactive panel discussion comprising renowned executives from LSPs and end users to enlighten the logistics fraternity on the need and the way forward in collaborative logistics. Subsequent sessions had leading LSPs present their perspectives on the logistics scenario for key end user industries. Furthermore, two intense activity workshops spread over two days were conducted. These workshops comprised of multidisciplinary expert groups with each involving a speciﬁc end user industry, logistics decision makers, LSPs and thought leaders. Group 4: RETAIL Challenges Lack of cold chain facilities Non-existent infrastructure of the wholesale markets that lead to large amount of wastage Fragmented production that lead to fragmented chains Traders dominate the chain and so there is no transparency in pricing at the primary producer’s end. Solutions: Cold chain storage to be set-up on PPP model Tax holiday for cold chain/ processing industry Invest in infrastructure development Setting up distribution centres (packing, grading, sorting and cold storages) Developing linkages with primary producers Investment in the procurement areas.

These teams worked together to ideate, evaluate and define the most important challenges, solutions and initiatives for ideal future supply chains of the given industries. Anand Rangachary, MD, Frost & Sullivan, South Asia, Middle East and North Africa, who moderated the workshop sessions, said, “The most important and underlying factor that was established from the deliberations in the workshop sessions was that both LSPs and end users need to develop mutual trust and collaborate in their efforts to address identified challenges & thus, enhance the performance of both the partners.”

Top logistics executives from leading end user companies such as Tata Motors, Toyota Kirloskar, Mahindra Navistar, Fenner India, Federal-Mogul, Pricol, Apollo Tyres, Acer India, Blue Star Electronics, AlcatelLucent, Xerox, Samsung, Novartis, Abbott Laboratories, Dr Reddy’s Laboratories, Alkem Laboratories, Himalaya Healthcare, B Braun, Hypercity Retail, Mahindra Retail, Café Coﬀee Day, ITC, Globus, etc. participated in the workshop. Leading participant organisations among LSPs included Safexpress, Allcargo, CHEP, TCI, Uniworld Logistics, etc.

Group 5: PHARMACEUTICALS Challenges: Strict regulations of different state/national level organisations which control the appointment/removal of a distributor. All the damaged/expiry/near expiry goods present in the market have to be taken back by the company. Reverse logistics is a challenge. Distribution hubs are run by local clearing & forwarding agents (C&FAs) and not professional LSP/3PLs. Difficult to maintain the temperature of the product across the supply chain High pricing pressures leave low margins for spending on logistics Raw material import is an issue because of poor infrastructure of customs, congestion at port, lack of visibility throughout the chain. Solutions and take aways: For Pharma Industry: Well defined SOPs - Detailed process maps and activity charts Need to coordinate with channel partners and LSPs to develop a suitable reverse logistics SOP Development of specialised skill sets in logistics among channel partners (C&FA, etc.) through Internal and External SC Academy. For Logistics Service Providers: Modernisation of infrastructure to meet temperature-controlled logistics across supply chain Training for drivers on the aspect of dealing with Pharma products LSPs can collaborate among themselves to make scale and pass on cost benefits to end users Provide visibility of the consignment across chain through IT upgradation.

October 2011 I Modern Pharmaceuticals

(archana.nayudu@infomedia18.in)

Group 6: SKILLS SCARCITY Challenges Solution: Lack of domain knowledge & lack of training on job Ineﬀective HR policies Solutions and take aways: Collaborate with academic institutes for expanding talent pool relevant to supply chain domain Develop internal training units and systematic training programmes to create fresh graduates from institutes to meet an organisation’s skill requirements.

Report

2nd Annual BIO India International Partnering Conference

Exploring opportunities in Indian biotech The BIO India International Conference held at the Hyderabad International Convention Centre, Hyderabad, during September 21-22, showcased high level keynote addresses and panel sessions, company presentations and exhibiting and networking opportunities in the Indian biotech sector. A report.

Speakers at the event

Chandreyee Bhaumik

he two-day event organised by Biotechnology Industry Organization (BIO) brought several industrial players together on one platform. The US Indian Industry Dialogue met for its second annual meeting and agreed to jointly develop a white paper that outlined areas of concern as well as recommend measures in order to ease the diﬃculties faced by the industry to promote innovation. Keynote speakers included Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals; Aaron Schacht, Executive Director and COO, Global External R&D, Eli Lilly & Company; Vivek Mohan, Managing Director, Abbott India Ltd; and Cartikeya Reddy, Senior Vice-President and Head, Biologics, Dr Reddy’s Laboratories Ltd.

Successful edition Speaking about the event, Alan Eisenberg, Executive Vice President, Emerging

Companies & Business Development, BIO, said, “The second annual BIO India International Partnering Conference acts a platform for providing networking, outstanding programming and business partnering opportunities; attendees and presenters alike were able to capitalise on the two-day event designed to grow the Indian biotech community.” He added that these leaders have been directly engaged in establishing R&D programmes and collaborations that will help to deﬁne India’s world class industry. Interesting panel discussions were also a part of the event. Plenary and panel sessions highlighted the latest issues and trends related to business in India. BIO India panel sessions included: CrossCultural Deal Making-Diving into Pﬁzer-Biocon; Beyond Outsourcing – Uncovering Innovation in India, moderated by Glen Giovannetti, Global Biotechnology Leader, Ernst & Young and Strategic Roadmap for India: A Discourse Among Global Pharma Executives, moderated by Sri Mosur, CEO, Jubilant Biosys.

Further, BIO’s one-on-one partnering tool arranged private meetings between investors, large biotech and pharmaceutical companies and emerging Indian biotech companies.The 2011 participating companies provided highquality contract research, manufacturing and clinical trials support and oﬀered the potential for partnerships on discovery and development deals.

Conference Additionally, this year’s conference featured company presentations by biotech and pharmaceutical companies. Nearly 20 companies were able to capitalise on this unique opportunity that placed their organisations in the forefront of a diverse global audience. In its second year, BIO India International Partnering conference provided an exclusive, two-day forum, which gathered biotechnology and pharmaceutical companies from North America, Europe and Asia in order to meet and explore business opportunities within India’s emerging biotech sector. (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I October 2011

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Product Update Junction boxes Katlax Enterprises has announced the launch of its 4, 6 & 8 I/ O junction boxes (wireless, MODBUS, wired connection & connector version). The 8 I/O junction box units transfer status of 8 input devices as well as activate 8 output devices through X’bee wireless communication. They have transmission ranging from 50 to 60 meters for indoor application and 1.2 km for outdoor application. The working band of frequency is 2.4 GHz. These accept 24 V DC as a supply voltage. The junction boxes have a very wide application in the ﬁeld of machine-to-machine communication. They can work in mesh topology or point-to-point topology. Key features include: collect status of each sensor, actuator (input/output) connected to 8 I/O junction box and transmits it to the master (controller) through wireless communication. These modern devices are useful for pharmaceutical industry, CNC machinery, textile machinery, food processing industry (all automation applications) and many more. Katlax Enterprises Pvt Ltd Dist Gandhinagar - Gujarat Tel: 02764-286784, Fax: 02764–286793, Mob: 09724506614 Email: info@katlax.com, Website: www.katlax.com

Pharmaceutical wallets Ecobliss India oﬀers pharmaceutical wallets. The company uses a pressure sensitive fold-over-card combined with a transparent blister to create a wide range of packaging designs, such as easy-opening, re-closable, dispenser, etc. In all Ecobliss packaging, the two materials plastic and board are always 100 per cent separated after the blister package has been opened. Various products available making use of this concept are: carded blister packs, wallet packs with various options, dose packs, clinical wallets, promotional packs, combination packs, standy packs for vials, etc. The concept is an ingenious cold seal walleting and packaging process. It is designed to address the problems of packaging clinical and pharmaceutical wallets in an eﬃcient and controlled process. It combines simplicity of use, guaranteed sealing and the ability to keep a record of the sealing parameters. The innovative cold seal pharma packaging system provides increased brand awareness, improved patient compliance, interactive & engages patient, child-resistant & senior-friendly packs, etc. Ecobliss India Pvt Ltd Hyderabad - Andhra Pradesh Tel: 040-2371 0829, Fax: 040-2371 0429, Mob: 09951061408 Email: ecoblissindia@ecobliss.com, Website: www.ecobliss.in

October 2011 I Modern Pharmaceuticals

Product Update Aluminum blister foils Krish Pharmapack offers different kinds of aluminum blister foils that are widely used in various industries. Aluminum blister foils are suitable for high-speed packing applications. These foils are one side coated with heat lacquer and the other side unprinted or printed to facilitate pharmaceutical blister packaging. The range of aluminum blister foils are resistant to moisture, vapour and gases. These are available in compact sizes and are economical as compared to strip packs. The foils help in the easy removal of the tablets as hard foils break easily when pressed hard. Also offered is a range of foils as per specific requirements of customers. Krish Pharmapack Dist Thane - Maharashtra Tel: 0250-3249666, Mob: 09594000600 Email: krishpharmapack@gmail.com Website: www.krishpharmapack.com

Pharmaceutical medicines Schwitz Biotech is engaged in offering a wide assortment of pharmaceutical medicines that are known for their effective results. Made in proper hygienic conditions, these medicines are categorised into topical, oro-dental, gynaec & haemostats, intravenous fluids, anti-allergic, cold & cough medicines, antibiotics & quinolones & cephalosporins, antacids, anti-ulcerants & laxatives and appetite stimulants enzymes. These are formulated under the supervision of experts for ensuring optimum quality and durability of medicines. Schwitz Biotech Ahmedabad - Gujarat Tel: 079-2749 3057, Fax: 079-2749 7416, Mob: 09825374233 Email: schwitz_rkb@rediffmail.com Website: www.schwitzbiotech.com

Motion horizontal cartoners ACG Pampac offers an intermittent motion horizontal cartoners (model K-120i) for automatic transfer of blisters or bottles into cartons. This eco-friendly solution is ideal for single as well as multiple blisters. Built to meet the upcoming norms of secure cartons, the cartoners can handle tuck-ins, glue-in cartons, leaflet folding & insertion, and offers multiple choices of online inspection. Capable of handling blister, tubes, bottles and customised applications, these cartoners deliver impressive performance and versatility. The cartoners have the advantage of a balcony design that helps easy cleaning of the machine without removing its parts. The output is up to 120 cartons per minute with leaflet folding and carton insertion. Motion horizontal cartoners offer

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GMP balcony design; easy & quick change over; reliable product feeding; compliance to EC regulations & GE standards; ﬂexibility to handle various packaging containers such as blisters, bottles, tubes, vials etc; and ability to handle tamper-evident cartons. ACG Worldwide Mumbai - Maharashtra Tel: 022-3008 9444, Fax: 022-2287 2560 Email: info@acg-world.com, Website: www.acg-pampac.com

Gas detector tubes UniPhos gas detector tubes offered my United Phosphorous are easy, quick and accurate method for direct, onsite measurement of gases, vapours and aerosols. These tubes are simple to use, requiring minimum maintenance and no calibration. The gas detector tubes are available for NH₃, H₂S, SO₂, CL₂, PH₃, HCI, HCN, CO, CO₂, O₂, C₆H₆ and many other gases and vapours. These are also available with spot check of toxic gas concentration at work place at specified intervals. The gas detector tubes are calibrated for a fixed volume of air sample, which is drawn using a sample draw pump. The scale on the glass tube reacts to the stain length of PPM of contaminant concentration. This method of measurement is simple, accurate and highly specific. In addition to the short term detector tubes, there are a number of other UniPhos chemical detectors, such as dosimeter tubes, dissolved substance detector tubes, charcoal tubes for chemical vapours, detector strips, air flow indicator tubes, available. United Phosphorous Ltd Dist Valsad - Gujarat Tel: 0260-2730156, Fax: 0260-2730130 Email: gasdetection@uniphos.com Website: www.chemo-electronic.com

Temperature data loggers Ambetronics oﬀers temperature loggers that are suitable for pharmaceutical industries. These data loggers have measuring range of -35ºC to 80ºC, accuracy ±0.5ºC and resolution of 0.1ºC with sensor Pt1000. The measuring rate can be selected from 1 minute to 8 hours. The data loggers can store 4,000 values data in memory. Measuring mode has automatic with loop, start/stop or start with set measuring rate. Battery life is 3 to 5 years. The data logger housing is made up of stainless steel, PEEK. They have IP68 protection class/housing for pharmaceutical industries. Ambetronics Mumbai - Maharashtra Tel: 022-2837 1086, Fax: 022-2822 6570 Email: info@ambetronics.com Website: www.ambetronics.com Modern Pharmaceuticals I October 2011

Product Update Digital flow meters MTS Engineers offers digital flow meters and digital conductivity meters manufactured by Vatturkar Industrial. Operators can easily install and recalibrate the meters online. The flow meters are proven in harsh industrial environment and are service free units based on the state-ofthe-art advance microprocessor technology. Both field-mounted as well as panelmounted meters are available. The digital flow meters come in different forms, ie, standard panel-mounted and field-mountable type (specially designed IP-65 enclosure to suit open atmosphere industrial conditions). They are based on paddle wheel insertion type sensor. This technology is adopted by many manufacturers worldwide. The flow sensors work on Faraday’s law of electromagnetic induction. Rotating paddle wheel generates a signal in proportional to the velocity of the moving fluid, which is read in terms of the flow rate. As the cross-section area is known and remains fixed, the average velocity is an induction of the flow rate. The digital flow meters find applications in water treatment industry, pharmaceutical industry, beverage/distillery industry, bottling industry, oil/refining industry, ready mix concrete plants, automatic liquid dispensers, chemical industry, etc. MTS Engineers Pvt Ltd Ahmedabad - Gujarat Tel: 079-2640 0063, Fax: 079-4004 7430, Mob: 09879407970 Email: sanjay.prajapati@mtsengrs.com, Website: www.mtsengrs.coj

Pharmaceutical label seals Safcon Security Seal offers materials that provide excellent adhesion, resist chipping and scraping. These seals are also perfect for pharmaceutical labelling and security label seals type-D. The seals are provided with covert security mark and a warning message to be applied on individual carton reaches retail outlets. Once applied, the seals cannot be removed in one piece and must be broken to access. The seals are designed to break into small pieces during any attempt to remove it from the applied surface and prevent subsequent re-application. Evidence of tamper is obvious. The pharmaceutical label seals are provided with invisible hidden mark for authentication. They can be used for a multitude of identification purpose and as tamper evident seals in pharmaceutical, bulk drugs, chemicals, agrochemicals, etc. Also offered are ultimate packaging solutions, exceptional product security for benefit of both the manufacturer and the consumer. Safcon Security Seal Kolkata - West Bengal Tel: 033-2226 0513, Fax: 033-2226 5939 Email: safcon@vsnl.com, Website: www.safconsecurityseal.com, Certification: An ISO 9001:2000 certified company

October 2011 I Modern Pharmaceuticals

Product Update Autoclavable stirred tanks Navin Process Systems manufactures and offers autoclavable stirred tanks and pressure vessels, a novel concept of in biotech and pharma manufacturing. A final formulationcum-blending tank is usually employed during filling of sterile liquid formulations. The tanks are sterilised in an empty condition inside an autoclave large enough to hold the tank. These can be autoclaved in vertical and horizontal orientation, without causing damage to the agitators. After autoclaving, the motor is fitted and the product is aseptically transferred into the tank under stirring. Salient features include: available in a variety of sizes, vessels can be autoclaved in horizontal position; maximum operating temperatures up to 130°C & pressure up to 2.5 bar(g); all nozzles provided with sanitary TC ends; manufactured from good quality stainless steel, grade SS-316/316L, as per requirements; top-mounted magnetic agitators provided that are ideally suited for aseptic processes; low maintenance downtime & cost; easy to operate & clean; microprocessor-based variable speed drive for motor can be provided (if required); and trolley-mounting can be provided (if required). Navin Process Systems Pune - Maharashtra Tel: 020-2546 0214, Fax: 020-2546 0214, Mob: 09273107155 Email: info@napro.co.in, Website: www.napro.co.in

Capsule filling machines Karishma Pharma Machines offers manually-operated capsule filling machines for smaller batches and R&D purpose. These capsule filling machines are simple to operate, having negligible rejections and weight variation. They can be supplied with interchangeable parts for all standard sizes. The capsule filling machines have recommended interchangeability for optimum output of 0/00-0/1/2—3/4/5. Output ranges from 55,000 to 60,000 capsules per 8-hour shift. Karishma Pharma Machines Mumbai - Maharashtra Tel: 022-2380 5979, Fax: 022-2381 1849, Mob: 09821069064 Email: zabinmenon@vsnl.com, Website: www.karishmapharma.com

Conductivity meters Vatturkar Industrial manufactures and oﬀers VATS mhoCounter CT-10 & CT-11 conductivity meters. The mhoCounter CT-10 is a conductivity indicator & mhoCounter CT-11 is the meter with relay output option, which is programmable. Microprocessorbased electronics allow wide operating range and long term signal stability. Optional relays provide control for adjustment or alarms.

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Also the meters come with saddle mounting option or standard fittings to adopt to any process flow solution. Salient features include: easy installation options (clamp-on saddle/adaptor); display in microS/CM, ppm (TDS); relay options; customised 4-digit LCD; weather-proof enclosure; tactile keys on front panel; easy programming with front panel keys; branded meter at the most economic price; and clearly marked terminal labels. Technical specifications are: function: conductivity/ TDS indication & relay output; accuracy: ±2 per cent of FSD; meter dimensions: 111 mm x 106 mm x 68 mm; display: 4-digit customised LCD; mounting; online type vertical or horizontal; installation: solventable T or clamp-on saddle; protection: weatherproof enclosure; and programming: through front panel keys. Vatturkar Industrial Pune - Maharashtra Tel: 020-2538 0568, Email: response@vatsmeter.com Website: www.vatsmeter.com

Electric blankets Aristocrat electric blankets offered by Medico Pharmaceuticals are waterproof, shockproof, autocut, soft underlay to provide constant slow motherly warmth. It is a relief for the patients of asthma, gout-arthritis, backaches, bodyaches & pains, patients of diabetes, low blood pressure, and the aged alike. These blankets supplement the much needed body energy and as such are really useful for senior citizens, some of whom pop out during sleep in extreme winters for need of energy. Features include: close contact, wide spread, uniform, low heat therapy; help one in maintaining body heat & hence conserve much needed body energy required for running the vital functions of the body; come with a one-year guarantee and lifetime repair warranty against any manufacturing defect & years of comfortable usage; fitted with thermal cutouts that cutoff the power supply once electric health aid attains level set for the desired safety level; and consume 60 W of power. The electric blankets can be used in hotels to reduce high electricity bills; and can also be used in hospitals to provide comfort to patients. Medico Pharmaceuticals Processors Amritsar - Punjab Tel: 0183-2258586, Fax: 0183-2257577, Mob: 09356000059 Email: info@medico.co.in, Website: www.medico.co.in

Modern Pharmaceuticals I October 2011

Product Update Tablet compression machines

In-line filling & stoppering machines

Shiv Pharma Engineers oﬀers tablet compression machines (tablet press) that are used to make tablets according to a predetermined design. Punches and dies are set into the tablet presses to actually shape the tablets. The tablet compression machines make tablets for a variety of industries; but their largest application is pharmaceuticals and vitamins. These are provided with turret made of special grade SG iron casting and interlock switches to all guard for safety of operator. Features include: paintfree compression zone, variable speed step pulley, dust extraction nozzles, anti-vibration mounting, etc. The models of tablet compression machines available include lab press, single-rotary tablet compression machine, double-rotary tablet compression machine, and heavy-duty tablet compression machine.

Industria Macchine Automatiche offers Sterifill F200 inline filling and stoppering machines for aseptic environments that can reach an output of up to 320 pieces per min. These machines are standard in design to accept LAF, RABS or isolator. There are no change parts in a defined vial range due to the puck transport system. A narrow basement allows the operation from one machine side only and the wall installation as well. The machines are manufactured in AISI-304 or AISI-316 L and are fully compliant with cGMP standards. Also offered are high shear mixers that are designed to perform wet granulation processes, combining active products by adding a binder solution. The granulation process is carried out very quickly due to the high energy transmitted to the product by the turbulence caused by the combined action of impeller and chopper blades. The impellers are specially designed to reduce product sticking to the blades, and can be easily removed for cleaning. The machines’ lid is pre-arranged for automatic product loading, binder or solvent addition, installation of washing nozzles, internal light and inspection window.

Shiv Pharma Engineers Ahmedabad - Gujarat Tel: 079-2909 2380, Fax: 079-2909 2380, Mob: 09824169934 Email: sales@shivpharma.com

Filling & capping machines Marchesini Group offers Steril 400 filling and capping machines for sterile applications in the pharmaceutical industry. These machines can be installed under an isolator. They consist of three modules and are suitable for different layout requirements. The machines are completely accessible from the front and are protected by laminar flow recycling. Special care is taken to prevent obstacles to the linearity of the sterile air flow so that negative eddies would not form. Due to the bottle conveyor system, which uses a SS-316L belt, there is no bottle friction and no particles are formed. Each pump consists of only two parts, for perfect sterilisation in an autoclave. Each filling valve piston is driven by a brushless motor, for independent and precise adjustment of the dosing volume. The machines are setup for installation of a statistical check weigher, with a robotised bottle pick-&-place device and feedback for automatic adjustment of the volume dosed. These machines have a capacity of 400 bottles/min, filling volumes of up to 30 ml and bottle diameter of up to 36 mm.

IMA - Industria Macchine Automatiche SpA - Bologna - Italy Tel: +39-51-783111, Fax: +39-51-784422 Email: corporate.communications@ima.it

Marchesini Group - Bologna - Italy Tel: +51-651-8711, Fax: +51- 651-64 57 Email: sales@marchesini.com

October 2011 I Modern Pharmaceuticals

Product Update Cap welding systems

Capsule filler & encapsulation machines

Weiler Engineering manufactures and oﬀers both fully automated and manual load cap welding systems to mate with the ASEPTECH blow/ﬁll/seal machines to produce a multi-entry insert format for LVPs. These units can be supplied as an integrated package along with a new machine, or provided as stand-alone unit for an existing machine. The cap welding systems are designed with an accumulation station and an independent control system that can be linked to the BFS machine. Production output is paired with the BFS machine output for maximum productivity. A variety of injection moulded after-market caps can be used with these systems.

Capplus Technologies offers CPT CF50 capsule filling and encapsulation machines that are equipped with PLC control system with 10” colour touchscreen control panel mounted on swing out arm. These machines are available with AC variable speed frequency control, four swing-up acrylic doors, two capsule magazines with 9 feeding trucks, two capsule raceways, side pushers and down pushers. They are provided with SS-316 powder hopper, powder chamber, dosing disk, twelve upper and lower capsule segments (6 holes each), capsule separating station and segment cleaning station (pneumatic operation). The capsule filling and encapsulation machines are manufactured with FDA approved contact parts. They are fitted with inching step drive button.

Weiler Engineering Inc - Illinois - USA Tel: +1-847-6974900, Fax: +1-847-6974915 Email: creed@weilengineering.com Website: www.weilerengineering.com

Aseptic machines Romellag offers Bottelpack 4010M aseptic machines for making unit dose eye drops and, a highvoltage leak detector HVLD 926 for the non-destructive leak testing of large-volume containers. A complete range of packaging solutions and services for filling liquids, gels and pastes is offered. These are tailored to the individual needs of the customers in terms of container design, production capacity, unit volumes, product development and include a first-class worldwide customer/spare part service along with the facility to carry out stability tests and also contract filling. The centrepiece is the sterile pyrogen-free container manufacture, aseptic filling of sterile products and the hermetic sealing in one operation. Hourly outputs can reach 30,000 ampoules for container sizes from 0.1 ml to over 2000 ml. An integrated US class 100 (ISO 3) clean room in the filling area is also offered with the machine, as is automatic CIP/SIP cleaning. The bottelpack machines are simple to operate and particularly suited to 24/7 operation as a result of the automatic machine process. Rommelag Ag - Buchs - Switzerland Tel: +41-62-8345555, Fax: +41-62-8345500 Email: claus.munk@rommelag.ch, Website: www.rommelag.com

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Capplus Technologies - Arizona - USA Tel: +1-623-5822800, Fax: +1-623-5824099 Email: info@capplustech.com

Freezers Sanyo MDF-C2156VAN freezers from Sanyo E&E Europe provide stable and highly uniform ultralow temperatures for the longterm preservation of viable cells, tissues and biological materials. Offering significant advantages compared with liquid nitrogen systems, these large capacity 150ºC freezers combine exceptional performance and durability with reduced energy consumption and quiet operation. They incorporate patented third-generation VIP PLUS insulation panels, reducing the wall thickness from 175 mm to 135 mm. This achieves up to 25 per cent more storage capacity compared with a conventionally insulated freezer without increasing the footprint. The resulting capacity of 231 litres will accommodate up to 14,000 2 ml cryo-tubes. In addition to the Sanyo-developed insulation, a double lid gasket helps maintain internal temperature stability by preventing cold-air loss. Compared to liquid nitrogen systems, the freezers offer advantages of lower running costs, greater ease-of-use and accessibility to stored samples, and no risk of contamination from liquid nitrogen. The freezers also provide uniform storage temperatures without the risks from sudden liquid nitrogen eruptions or splashing when samples are removed. Sanyo E&E Europe BV - Etten-Leur - Netherlands Tel: +31-76-5433833, Fax: +31-76-5413732 Email: sales.nl.seee@sanyo.com, Website: www.eu.sanyo.com

The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of

Modern Pharmaceuticals Modern Pharmaceuticals I October 2011

Product Index Sl No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74

Product

Pg No

AC motors ..............................................................33 Access control systems ...................................................21 Acoustic enclosures...........................................................8 Agitators..........................................................................39 Air filters ...................................................................43, 45 Air shower controllers ....................................................21 Air treatment systems ....................................................73 Aluminum blister foils ...................................................86 Analytical instrumentation.............................................49 AS interface systems ......................................................61 Aseptic machines ............................................................90 Autoclavable stirred tanks ..............................................88 Automation & storage systems......................................61 Axial flow fans ................................................................85 Bag filters ................................................................51 Batch dispersers ..............................................................39 Bearings...........................................................................10 Biological safety cabinets .........................................43, 45 Blowers & fans ...............................................................85 Blow-fill seal machines...................................................67 Booklet & leaflet labels ............................................ COC Brake motors ..................................................................33 Cable carriers ..........................................................10 Cable connectors ............................................................10 Cables for bus systems ...................................................61 Cables handling & processing systems .........................61 Cables scanps ..................................................................61 Calorimeters....................................................................39 Cap welding systems ......................................................90 Capacitive and magnetic sensors ...................................61 Capsule filler & encapsulation machines ......................90 Capsule filling machines ................................................88 Carbon filters ..................................................................51 Cartridge filters...............................................................51 Centrifugal air blowers ...................................................85 Chains .............................................................................10 Chemical processing equipment ....................................31 Chlorine gas cylinders & tonners ..................................89 Cleanroom doors ......................................................43, 45 Columns & chemistries .................................................49 Compressors ...................................................................85 Conductivity meters .......................................................88 Connectors accessories ...................................................61 Connectors ......................................................................10 Conveyers belts ...............................................................87 Conveying blowers .........................................................85 Cooling towers................................................................73 Counters & power supplies ........................................FIC Crimp contact & tools ...................................................61 Crushers ..........................................................................17 Custom-made cables ......................................................61 Data cables..............................................................61 DC motors......................................................................33 Digital flow meters .........................................................87 Digital temperature controllers ......................................71 Dispensing booths ....................................................43, 45 Dispersers........................................................................39 Door interlock systems...................................................21 Drives ........................................................................19, 71 Dry vane pumps ...............................................................8 Dual channels with modbus ..........................................71 Duo labels ................................................................. COC Dust collector systems....................................................85 Dynamic controllers .......................................................71 Electric blankets......................................................88 Electricals - HT & LT ..................................................21 Electronic chlorine dosing systems & chloroscopes .....89 Empower.........................................................................49 Encoders ......................................................................FIC EngineeringExpo exhibitions.............................12, 47, 77 Exhibitions ....................................................12, 47, 77, 79 Fan filter units....................................................43, 45 Filling & capping machines...........................................89 Filling machines..............................................................53

Sl No 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148

Product

Pg No Sl No

Filter housing & assemblies ...........................................51 Filters...............................................................................17 Filtration equipment.......................................................17 Filtration systems ............................................................17 Fire alarms ......................................................................21 Flag labels ................................................................. COC Flameproof motors .........................................................33 Flange mounting motors ...............................................33 Food analysing & testing machines ..............................17 Freezers ...........................................................................90 Fuel burners ....................................................................85 Gas chlorinators ......................................................89 Gas detector tubes ..........................................................86 Geared boxes ..................................................................57 Hanger labels .....................................................COC Heating baths .................................................................39 Heating range .................................................................51 HEPA filter terminal housings................................43, 45 High efficiency mills ......................................................53 High pressure homogenisers ..........................................39 Hot plates .......................................................................39 HPLC .............................................................................49 Identification systems..............................................61 India Chem-2012 exhibition .........................................79 Inductive switches...........................................................61 Industrial connectors ......................................................61 Industrial control & sensing devices ..........................FIC Industrial coolers ............................................................73 Informatics ......................................................................49 Injectable manufacturing lines .................................43, 45 Inline dispersers ..............................................................39 In-line filling & stoppering machines ...........................89 Instrumentation made cables .........................................61 Inverter/variable frequency drives ...............................FIC Junction boxes .........................................................85 Kneading machines .................................................39 Knife mills ......................................................................17 Lab equipment ........................................................51 Laboratory mills .............................................................53 Laboratory reactors.........................................................39 Laboratory software .......................................................39 Laminar air flow workstations .................................43, 45 Level controllers .............................................................fic Liquid food processing...................................................17 Liquid-ring vacuum pumps ...........................................85 Magnetic stirrers .....................................................39 Measuring & monitoring relays .................................FIC Mills ................................................................................39 Motion controls ...........................................................FIC Motion horizontal cartoners ..........................................86 Motors ...........................................................................33 Mullers ............................................................................17 Multi-function mills .......................................................17 Multi-position stirrers ....................................................55 Multi-stage centrifugal air blowers ................................85 Nano mills ..............................................................53 Oil/gas firing equipment .........................................85 Online b2b marketplace ...........................................35, 92 Optical range ..................................................................51 Overhead stirrers ............................................................39 Packaging machines ................................................27 Pass box interlock systems .............................................21 Pass boxes..................................................................43, 45 PBEGL geared motors ..................................................33 Pharmaceutical label seals ..............................................87 Pharmaceutical medicines ..............................................86 Pharmaceutical wallets ...................................................85 Photoelectric sensors .............................................FIC, 61 PID controllers ...............................................................71 Pilot plants ......................................................................39 Platinum cured silicon tubings ......................................51 PLCs ...............................................................................71 Pleated filters ..................................................................51 Pneumatic components ..................................................17

149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206

Product

Pg No

Pneumatic conveying systems ........................................85 Portable loaders...............................................................85 Pre-engineered/pre-fabricated modular panels .......43, 45 Profile controllers............................................................71 Programmable logic controllers ..................................FIC Programmable terminals .............................................FIC Protective-conduit systems .............................................61 Proximity sensors .........................................................FIC Pumping filtering units .................................................85 Pumps .........................................................................8, 85 Quick-change terminal hoses .............................43, 45 Rapid endotoxin detection systems ..........................87 Return air risers ........................................................43, 45 RFID systems ..............................................................FIC Roots blowers ...................................................................8 Rotary encoders ..............................................................61 Rotary evaporators..........................................................39 Safe change housings .........................................43, 45 Safety light curtains.....................................................FIC Sampling booths.......................................................43, 45 Screening machines ........................................................17 Self adhesive tapes ..........................................................85 Sensors ............................................................................61 Separators........................................................................17 SEZ developers...........................................................FGF Shakers ............................................................................39 Side channel blowers ......................................................85 Slipring crane duty motors ............................................33 Solid-liquid mixers .........................................................39 Spirac cables....................................................................61 Spun filters ......................................................................51 Stainless steel filters ........................................................51 Steam products ............................................................BIC Sterilizing/depyrogenating tunnels ..........................43, 45 Stirring hot plates ...........................................................55 Switching relays ...........................................................FIC Tablet compression machines ..................................89 Tefzel HHS isotactic PP materials .................................7 Temperature controllers.........................................71, FIC Temperature data loggers ...............................................86 Thermoplastic valves & piping systems .........................7 Thermostats & vacuum dryers/mixers ...........................39 Three parameter displays ................................................21 Timers ..........................................................................FIC Trim handling systems ...................................................85 Ultrasonic sensors ...................................................61 Universal controllers .......................................................71 UPLC systems................................................................49 Vacuum booster pumps .............................................8 Vacuum pumps ...............................................................85 Vacuum range .................................................................51 Vacuum systems................................................................8 Vane dampers .................................................................85 Ventilators .......................................................................85 Vision sensors ..............................................................FIC Wastewater treatment equipment ............................17 Water-ring vacuum pumps ............................................85 Zero liquid discharge effluent treatment ................ BC

Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818.

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Advertisers’ List Advertiser’s Name & Contact Details

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Advertiser’s Name & Contact Details

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Aqua Services T: +91-265-2331748 E: aquaas@satyam.net.in W: www.aquaservicesindia.com

Guan Yeu Machinery Factory Co Ltd T: +886-4-896-5198 E: guanyeu@ms39.hinet.net W: www.guan-yu.net

Shah Brothers T: +91-22-43560400 E: coupling@shahbros.com W: www.shahbros.com

Bobst Group E: bobst@bobstgroup.com W: www.bobstgroup.com

C P K Engineers Pvt Ltd T: +91-40-23735424 E: cpkengi@yahoo.com W: www.cpkengineers.com

Igus India Pvt Ltd T: +91-80-39127800 E: info@igus.in W: www.igus.in

Spirax Marshall Pvt Ltd T: +91-20-27145595 E: response@forbesmarshall.com W: www.forbesmarshall.com

Charles River T: +91-80-25588175 E: india.customercare@crl.com W: www.criver.com

IKA India Private Limited T: +91-80-26253900 E: process@ika.in W: www.ika.in

Sreelakshmi Traders T: +91-44-24343343 E: sreelakshmitraders@gmail.com W: www.sreelakshmitraders.com

Cole-Parmer India T: +91-22-67162222 E: response@coleparmer.in W: coleparmer.in/3125

IndiaMART InterMESH Ltd 35; 92 T: +1800-200-4444 / 91-120-3911000 E: pr@indiamart.com W: www.indiamart.com

SSP Pvt Limited T: +91-129-4183700 E: info@sspindia.com W: www.sspindia.com

FGF

The Indian Electric Co T: +91-20-24474303 E: icemktg@indianelectric.com W: www.indianelectric.com

Danfoss Indus Pvt Ltd T: +91-44-66501555 E: danfoss.india@danfoss.com W: www.danfoss.com

JB Sez Pvt Ltd T: +91-22-66210000 E: aparadkar@jbsez.com W: W: www.jbsez.com

Ultraplast Chainbelts Pvt Ltd T: +91-129-4113187 E: info@ultraplast.in W: www.ultraplastindia.com

Eltech Services Pvt Ltd T: +91-40-27759895 E: sales@eltechservices.com W: www.eltechservices.com

Mifa Systems T: +91-79-26870825 E: sales@mifasystems.com W: www.mifasystems.com

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UNP Polyvalves India Pvt Ltd T: +91-265-2649248 E: mktg@polyvalve.com W: www.polyvalve.com

Engineering Expo T: +91-9819552270 E: engexpo@infomedia18.in W: www.engg-expo.com

Milltech Engineering T: +91-22-41610099 E: sales@milltechengg.com W: www.milltechengg.com

Everest Blower Systems T: +91-11-45457777 E: info@everestblowers.com W: www.everestblowers.com

Fabtech Technologies Intl Pvt Ltd T: +91-22-61592900 E: mails@fabtecheng.com W: www.fabtecheng.ae

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FICCI T: +91-11-23765081 E: mehul@ficci.com W: www.indiachemgujarat.com

Gem Equipments Ltd T: +91-422-3267800 E: sales@gemindia.com W: www.gemindia.com

Omron Automation Pvt Ltd T: +91-80-40726400 E: in_enquiry@ap.omron.com W: www.omron-ap.com

FIC

Pepperl+Fuchs(India) Pvt Ltd T: +91-80-28378030 E: info@in.pepperl-fuchs.com W: www.pepperl-fuchs.com

Premium Transmission Ltd T: +91-20-66314100 W: www.premiumtransmission.com

Reynders Label Printing India Pvt Ltd COC T: +91-149-3305400 E: india@reynders.com W: www.reynders.com Salesworth Synergies Pvt Ltd (Rommel) T: +91-80-25274495 E: mail@salesworth.com W: www.rommelag.com

BIC

Vacunair Engineering Co Pvt Ltd T: +91-79-22910771 E: info@vacunair.com W: www.vacunair.com

Waters (India) Private Limited T: +91-80-28371900 E: waters_india@waters.com W: www.waters.com

Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818.

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Modern Pharmaceuticals I October 2011

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October 2011