Modern Pharma - 1-15 October 2012 by Infomedia18

1-15 Oct ober 2012 I Vol 1 I N o 7 I `100

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In Conversation With 16

Special Focus 19

Interface 20

Automation Trends 21

Sohang Chatterjee Director and Chief Executive, Inbiopro Solutions Pvt Ltd

Regulations in parenterals and injectables Managing the manufacturing conundrum

Murali Sundrani Business Director, BD Pharmaceutical Systems

Pharm‘automated’ Reducing manual intervention for better productivity

India generics giant wins cancer drug patent case

CIPLA has scored a landmark court win in a patent challenge launched by Switzerland’s Roche Holding over the Mumbai firm’s version of a lungcancer drug. Delhi High Court Justice Manmohan Singh ruled that Cipla’s drug, Erlocip, did not violate the Roche patent on its anti-lung cancer medication Tarceva due to its different molecular make-up. “It is a landmark judgment in a patent case. The court has taken all efforts to analyse claims of both parties in terms of legality and scientific evidence,” said Pratibha Singh, a patent lawyer who represented Cipla.

Quintiles ranks 6th in Information Week 500

QUINTILES ranks 6th in this year’s InformationWeek 500, a list of the top technology innovators in the United States. The annual list was revealed on September 11, 2012, at an awards ceremony in Dana Point, CA. The driving factor behind this year’s InformationWeek 500 ranking was Quintiles’ collaboration with Eli Lilly on an IT-enabled project to re-engineer the way clinical trials are planned and designed. The ultimate goal of this collaboration was to develop an integrated approach that eliminates costly inefficiencies and uses ‘big data’ to drive better drug development decisions.

Biological E Ltd launches JEEV

JEEV, a vaccine to tackle Japanese Encephalitis was launched by an Indian pharma, Biological E Ltd. It is the country’s first indigenous vaccine to tackle JE priced at ` 985, the vaccine will be available in the private domestic market. In due course, it will be exported. The drug is based on a vaccine made by Austrian vaccine maker Intercell. The Hyderabad-based vaccine producer is set to produce 10 million doses, which can be up scaled based on the demand. It also produces vaccines for tetanus, diphtheria, Hib, etc.

Government approves eight foreign pharma investments

INDIA has approved eight foreign investments in drugmakers worth $ 333 million in total, signalling the finance ministry may be winning a battle to open up the country’s fastgrowing markets and giving a boost to global drugmakers hungry for growth. However, the government said the foreign companies including US-based Pfizer and Germany’s B-Braun would have to continue producing cheap drugs and maintain spending in ongoing R&D projects run by their Indian partners for five years.

GoM approves the National Pharmaceutical Pricing Policy THE Group of Ministers (GoM) under Sharad Pawar, Chairman, Group of Ministers – National Pharmaceutical Pricing Policy (NPPP) have finally approved the NPPP to control the prices of all 348 essential drugs and adopted the weighted average price mechanism to cap the prices. This comes after the All India Organisation of Chemists and Druggists (AIOCD) had written a letter to Sharad Pawar, to urgently finalise the new drug pricing policy that seeks to determine prices at which pharma companies sell essential medicines in the retail market. This will dispel Shahani the uncertainty presently prevailing in the market and benefit the patient fraternity and the industry at large. In the letter to Pawar, J S Shinde, President, AIOCD, has also reiterated the need for a market-based drug pricing policy to best address patient needs and balance industry growth as envisioned in the draft NPPP 2011. Acknowledging the move by the

government, Ranjit Shahani, President, Organisation of Pharmaceutical Producers of India (OPPI) said, “We acknowledge the rights of the Government to make essential medicines available to the most vulnerable sections of society at affordable prices. The new proposal will have an impact on industry as

Shah

the span of price control will now increase to cover around 30 per cent of the pharmaceutical market. Still, a market-based policy is a balanced formula and will help improve the availability of essential medicines for patients.” Highlighting the special features of the policy, D G Shah, Secretary General, Indian Pharmaceutical Association

(IPA), said, “1. All formulations (654) of 348 bulk drugs specified in the National List of Essential Medicines 2011 (NLEM) are brought under price control. This will constitute about 30 per cent of the total pharmaceutical market. Currently, about 18 per cent of the market is under price control. 2. The prices of these formulations will be fixed by taking Weighted Average Price (WAP) of all brands having at least 1 per cent or more Market Share (MS) by volume. 3. This will impact about 62 per cent of the NLEM market by value. In other words, prices will be reduced for almost two-thirds of the sales value of NLEM medicines. 4. The average price reduction will be about 11 per cent. However, price reduction of some medicines for many large companies, both domestic and foreign, will be as high as up to 75 per cent. A study shows that prices of 60 per cent of NLEM medicines will be reduced by more than 20 per cent. 5. The average revenue loss to the industry is estimated at about 15 per cent to 17 per cent.” The GoM would soon send the recommendations to the Cabinet for a final call to bring all 348 essential drugs listed by the Health Ministry under price control. - Arshia Khan

BD to enhance value of biotech delivery devices with specialised pre-fillable syringes IN its’ series of BD Hypak glass prefillable syringes Becton Dickinson & Company has designed specialised syringes for biotech drugs in order to provide better patient convenience through auto injector compatibility, reduced container interactions due to low tungsten and reduced number of cosmetic defects. Adding new feathers to their cap, BD has come up with BD Hypak for biotech and BD Neopak. BD Hypak is currently used as a standard product for pre-fillable delivery systems. BD Hypak for biotech is already commercialised in world market, including India. Murli Sundrani,

Business Director, BD Medical – Pharmaceutical Systems in India, said, “BD Hypak for biotech and BD Neopak are two advances made keeping in mind the sensitive nature of biotech drugs, patience

convenience, regulatory agencies and pharma customer needs. Few years ago we realised that tungsten can form residue in the normal syringes if filled with biotech drug. The biotech drugs mostly have large protein molecules and have a tendency to interact with impurities like tungsten, which can lead to protein aggregation that can hamper the efficacy of the product.” BD has done extensive research and developed process capabilities to offer these next generation prefillable syringe systems, which can help pharma partners to better position and offer the sensitive biotech formulations. - Shibani Shah

M o d e rn P harma•1- 15 Oc t obe r 2012

CONTENTS In Conversation With

Dr Sohang Chatterjee Director and Chief Executive, Inbiopro Solutions Pvt Ltd

Special Focus Parenterals and injectables Market dynamics of parenterals and injectables Assessing the opportunities and challenges Regulations in parenterals and injectables Managing the manufacturing conundrum

Interface Murali Sundrani Business Director, BD Pharmaceutical Systems

19 20

Reducing manual intervention for better productivity

Event Preview

Pharmac India 2012 Focussing on SMEs

Insight & Outlook Pharm‘automated’

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REGULAR SECTIONS 5 Editorial / Guest Editorial 6 News, Views & Analysis 22 Tenders / Projects 24 Event List 25 Book Review 26 Products 27 Marketplace 30 List of Products & Advertisers

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Mo de rn Ph a rm a •1 -15 Oct o be r 2 012

Editorial

Per capita patent…

Editorial Advisory Board Ajit Singh

Chairman, ACG Worldwide & Head, ISPE

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah

Chairman, IGPA & Secretary General, IPA

Daara Patel

Secretary General, IDMA

fter five years and reportedly 20 meetings, the government’s interministerial committee has recently recommended the use of a new reference pricing mechanism to regulate prices of patented medicines. Proposed to be linked to per capita income of the country, this is said to have the potential to reduce by up to one-third the prices of several patented medicines. According to the suggestions of this committee, the reference price of patented medicines is to be arrived at by benchmarking with the price at which governments in the UK, Canada, France, Australia and New Zealand purchase these medicines. As per the current market statistics, patented medicines in India make a miniscule percentage of the domestic market. However, this figure is projected to grow significantly over the next few years as the pharmaceutical sector expands here. While the above formula is proposed to be applicable for patented medicines that do not have any therapeutic equivalents in the market, the committee in the case of patented medicines having similar alternatives in the market, has made it clear that their prices should be fixed in a manner such that it should not lead to an overall increase in the cost of treatment. Further, it has suggested due consideration of the cost of developing the drugs and other factors, in the event of a patented medicine being introduced in India as part of its global launch. While this novel pricing mechanism

Guest Editorial

sounds good for the patient community at large (especially those who take life-saving medicine for a long duration or need several dosages that run into exorbitantly high expenses from own pocket), it has posed obvious challenges towards the bottom line of the producers of these patented medicines. This is clearly a path-breaking move from the present system, where there is no scope of price negotiation for patented drugs. While from the perspective of multinational pharma companies, such a cross-country per capita income-linked proposal has been said to be incorrect and needs to be more rational keeping in mind different cost structures prevailing in developing & developed countries, the need of the patients calls for better affordability of patented medicines. Although a final decision on either a reference pricing system or fixed pricing is yet to be taken by the government, a simple and straightforward solution to this evolving paradigm still remains elusive. Suffice to say, it warrants a pragmatic and futuristic approach to arrive at a strategic decision that will work best in this complex case.

Manas R Bastia manas@network18publishing.com

Has pharma weaved a magic for creating brands?

rands’ opting for an image makeover is nothing new in today’s competitive business space. Sometimes this makeover includes changing the brand’s logo. Like any image overhaul, a rebrand can enable a company to update its message, signal a change in direction or appeal to new audiences. For every business, the health of its brand is key to success. Competition in the pharmaceutical industry is robust. The shift in priorities toward marketing means that colour is now a critical component of brand development and product identity. This requires that the colours be researched and tested, a little like the drugs themselves. Nothing can be left to chance. And a logo, along with colour, gives the brand its identity, its bare essence, and is often the essential image consumers have in their mind when they think about a company. Quite simply, you have got to be focussed on exactly what you want your brand to stand for. The associations with which you want to be identified. No ambiguity. No potential for double vision or double meaning. No question at all about what condition it is for, who it is for, or why it is best-in-class. Your goal is a brand vision so cohesive, so right-betweenthe-eyes, it becomes indelible and

motivating to whoever is on the other end of the lens. Products change, but logos endure. Along with colour what is more and more becoming essential is the importance of logo in this industry Pharmaceutical brand marks that are also created with the help of free logo software. They are just like the learning institute’s owner which does not want to dip their toes in launching new promotional strategies every day. They believe that its a kind of serious business, which does not need any marketing efforts and when they need an insignia to present themselves, they head towards free pharma logos that can be found easily over the internet because they do not want to spend their hard won cash on this small colourful business representation. So, I think there are two kinds of business owners: 1 Those who have established their names in the business arena and so they are not much concerned about their brand mark identity. 2 Those who have just dipped their toes in the business arena and so they do not want to spend a single penny on their brand mark identity. Both the types have plausible reasons but creating a corporate identity changes the overall look of a business

for good. Every business owner want to expand his business and here, a corporate identity plays a major role. In short, the whole concept of a business is to invest, invest and invest if you want to get a sizable profit. A corporate identity is literally the other name of investment. Hence, if you will invest in it by hiring a professional graphic design service then you will surely be able to get a good return. It is essential to ensure that the brand’s connectivity with the new logo is appropriate and that consumers relate to the new logo. However, experts caution, as brands cast off the old, they could be waving goodbye to loyal customers. The annals of advertising history are littered with rebrands gone wrong. Successful rebrands are about balance, ensuring the value of the brand remains while signalling a change in direction. The style and the type of logo that is the face of the brand is catching attention to a major extend. The company heads along with the basics in place are focussing on to come up with an enticing colour and logo for the medicine. Barkha Dattani

Managing Director, Barkha’s Brand Clinic

Mod er n P har m a•1 - 15 Oc t ob er 2 012

News, Views & Analysis

Bayer’s stay petition on Nexavar rejected INTELLECTUAL Property Appellate Board (IPAB) of Chennai, India, rejected the stay petition of German drug company Bayer AG, which demanded a ban on the compulsory license given to India’s Natco Pharma to market generic version of Nexavar, a cancer drug, in India. The license binds Natco to pay 6 per cent sales royalty to Bayer on generic Nexavar, which is currently being sold at ` 8,800 for a month’s course against

Bayer’s price of ` 280,000. Bayer had filed a petition against the compulsory license order of Indian Patents Office,

and the plea was pending with the IPAB. The final decision will be out in next few weeks; however, Bayer intends to continue the case at higher court. The decision is significant boost to the Indian generic pharmaceutical market that accounts for 90 per cent of the overall pharma trade in the country. The rejection will also enable low-income needy groups to avail chronic disease medicines at costeffective prices.

India-made offer for patent SWISS pharma company Novartis held out the hope of producing its antileukaemia medicine Glivec in India, an arrangement that will have the potential to bring down prices, if it were granted a patent on the drug. Gopal Subramanium, Lead Counsel, Novartis told the Supreme Court that grant

of patents allowed ‘free flow’ of medicines into a country, and cited the checks in place in India’s patent laws to allay fears of adverse consequences. Glivec is now priced in India at ` 1.2 lakh for a month’s treatment. “If a patent is allowed, a manufacturing unit may even be set up in India. It would be perfectly

all right for Indian authorities to impose the condition of manufacturing in India,” said Subramanium. Adding to this, he said, “Before India had signed multilateral treaties such as the Trade-related Intellectual Property Rights (TRIPS), similar drugs would come to India 20 years after their launch.”

In Brief CPhI to hold key conference on the commercialisation of biosimilars

CPhI India is launching Commercialisation of Biosimilars 2012, a strategic initiative focussing on the most critical issues pertaining to biosimilars commercialisation in different markets. This event will take place from November 1-2, at The Chancery Pavilion in Bengaluru, India and will provide speedy market entry strategies, effective licensing agreements, profitable pricing models, successful marketing and branding strategies and access to key markets such as the US, UK, China and LATAM.

Collaborative focus on fight against counterfeit

REPRESENTATIVES from healthcare agencies and enforcement organisations throughout the Greater Mekong Sub-region (GMS) convened in Bangkok on August 28-29, 2012, for the inaugural meeting of ‘Building Regional Expertise in Medicines Regulation, Information Sharing, Joint Investigation and Enforcement,’ or BREMERE. The purpose of BREMERE is to create a mechanism for information sharing about counterfeit and substandard medicines that can support joint investigations and promote collective enforcement actions within and among countries.

Kilitch Company buys 6.16 lakh shares of Kilitch Drugs

KILITCH Company Pharma Ltd bought 616,600 shares of Kilitch Drugs (India) at ` 78.95 on the BSE. Mukund Mehta sold 308,300 shares at ` 78.95 and Paresh Prataprai Mehta sold 308,300 shares at ` 78.95 on the BSE.

Pharma exports: India asks Japan to remove non-tariff barriers INDIA has asked Japan to remove all non-tax barriers to help the domestic industry take advantage of the comprehensive free-trade agreement and increase share in the Japanese market. The issue was flagged by Anand Sharma, Commerce and Industry Minister, India, in his meeting with Yukio Edano, Minister of Economy, Trade and Industry, Japan, in Cambodia. The Indian minister has strongly urged the Japanese side to remove all non-tariff barriers so that real benefits envisaged under the Comprehensive Economic Partnership Agreement (CEPA). The CEPA between India and Japan came into effect from August 1, 2011. Both the sides expect that it would boost bilateral trade to $ 25 billion by 2014. The official said though there is Sharma a considerable increase of drugs exports to Japan, but India’s share is still less than 1 per cent of the total Japanese pharmaceutical market. The demand of generic medicines in the Japanese market and the capability of India to meet this demand will prove a win-win situation for both the countries. As per the pact, the Japanese government would accord no less favourable treatment to the applications of Indian companies than it accords to the like applications of its own persons for drug registration. This would greatly help Indian pharma companies. India has also asked Japan to soon start negotiations on nursing and healthcare professional services.

Mo de rn Ph a rm a •1 -15 Oct o be r 2 012

News, Views & Analysis

India, Cambridge tie up for research venture at Bengaluru TO develop new scientific approaches for treatment of diseases such as cancer, India’s Department of Biotechnology and the University of Cambridge are setting up a new initiative for chemical biology and molecular therapeutics at inStem, Bengaluru. Funded by the DBT, the initiative will be conducted in collaboration with the National Centre for Biological Sciences (NCBS). The DBT will provide the rupee equivalent of 11 million pounds for the research, in which researchers will combine methods from genetics, chemistry, cell biology, biochemistry and imaging to understand the alterations in cellular systems that underlie human diseases, and identify ways to correct them using drugs. The initiative is expected to develop powerful new scientific approaches for the treatment of diseases such as cancer, integrating expertise from the basic and

clinical sciences in India. The initiative is expected to create a multidisciplinary environment for training young researchers and physicians in the translation of fundamental research to clinical application. The new initiative is the result of a collaboration that links Professors S Ramaswamy; K Vijay Raghavan; Satyajit Mayor and colleagues at inStem and NCBS in Venkitaraman Bengaluru, with Professor Ashok Venkitaraman at the University of Cambridge. The initiative began in September 2011 when Cambridge University’s Vice-Chancellor Professor Sir Leszek Borysiewicz signed a memorandum of understanding with the inStem

Thermo Fisher inaugurates new biological centre in Lithuania THERMO Fisher Scientific is inaugurating a new molecular biology centre of excellence in Vilnius, Lithuania. The 156,000 sq ft centre will expand R&D and manufacturing capabilities for developing various technologies including PCR-based testing, nucleic acid sample preparation, protein purification and antibodies for enzymelinked immunosorbent assay testing. Marc Casper, President & CEO, Thermo Fisher, said, “The expanded R&D and manufacturing presence in Vilnius strengthens the company’s ability to serve the growing biotechnology community in Eastern Europe, particularly its research customers who

Casper

rely on innovations in molecular biology to accelerate developments in diagnosing and treating disease. We now have a solid foundation from which we can continue to increase our depth of capabilities for high-growth life sciences markets in the region, from PCR-based products to our broader biosciences portfolio.” In addition to developing scientific workforce in Lithuania, the company supports science education through a series of initiatives including internships and scholarships that provide students with practical experience and financial support.

and NCBS. Professor Venkitaraman, Ursula Zoellner Professor, Cancer Research, University of Cambridge and Director, Medical Research Council Cancer Cell Unit, said, “Having originally trained and practiced as a physician in India, I am delighted that the Department of Biotechnology, Government of India, will be supporting this exciting new initiative. The excellence of my colleagues in Bengaluru, and the terrific research environment they have created, inspires confidence that we can work together not only to improve our fundamental understanding of the cellular abnormalities that cause human diseases like cancer but also to translate this information for the benefit of patients.”

Indian doctor makes it to the top list of world’s most influential people in the pharma industry DR Surinder Singh, Directorin-Charge, National Institute of Biologicals, Ministry of Health & Family Welfare, has been featured in the list of the world’s 40 most influential people in the global pharma industry, three times in a row, for his valuable contribution to the Dr Singh pharmaceutical industry. Adjudged by a panel of experts of the UK Pharma magazine ‘World Pharmaceutical Frontiers’, the definitive yet diverse list includes names like Bill & Melinda Gates; President Barrack Obama; Dr Margaret Chan, WHO; and Bill Clinton, founder William J Clinton Foundation, among

others. The list comprises of renowned businesspersons, philanthropists, scientists, regulators and legislators. Dr Singh has been recognised for the valuable contribution he has made towards improving India’s regulatory system in his capacity as the former Drug Controller General of India. The magazine has lauded Dr Singh’s achievements of launching a pharma co-vigilance programme to study the adverse effect of drugs and strengthening the number of drug inspectors to maintain quality parameters in the countries from which India imports drugs.

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News, Views & Analysis

Pfizer and Hisun announce launch of Hisun-Pfizer Pharmaceuticals Co Ltd PFIZER Inc, the world’s largest research-based pharmaceutical company, and Zhejiang Hisun Pharmaceuticals, a leading Chinese pharmaceutical company, announced the launch of HisunPfizer Pharmaceuticals Co, Ltd (hereafter referred to as HisunPfizer), a Joint Venture (JV) formed between the two companies to develop, manufacture and commercialise off-patent pharmaceutical products in China and global markets. The creation of the JV marks an important milestone in strengthening the ability of both companies to reach more patients with highquality and low-cost medicines in the branded generics arena. Off-patent medicines, including branded generics, represent one of the fastest-growing segments in the global pharmaceutical market. Hisun-Pfizer will take advantage of Hisun’s strong product portfolio, broad market outreach and experience with the production

and commercialisation of branded generic medicines. The joint venture will also benefit from Pfizer’s world class R&D, manufacturing quality management, international market promotion and operational capabilities. It will focus on R&D and the production and commercialisation of high-quality branded generic medicines, and the broader commercialisation of existing medicines through a local and global sales and marketing infrastructure. It will be operated in accordance with international quality standards to advance both companies’ mission of bringing high quality and affordable medicines to address the medical needs of patients in China and worldwide. Hisun and Pfizer first signed the Memorandum of Understanding to establish the JV during the Zhejiang Provincial Government Delegation’s visit to the US in June 2011. In February 2012, during the visit of Xi Jinping,

Vice President of China, to the US, the two companies signed the Framework Agreement at the Sino-US Economic & Trade Cooperation Forum held in Los Angeles. Xi and John Bryson, US Secretary of Commerce, in addition to other senior officials from China and the US, attended the signing ceremony. Hisun-Pfizer has an aggregate investment of $ 295 million and a registered capital of $ 250 million. Hisun holds 51 per cent of the share and Pfizer holds 49 per cent. The registration facilities and production plants of the joint venture will be located in Fuyang, Zhejiang province, while the management and R&D centres will be located in Shanghai and Hangzhou, respectively. The JV aims to build a robust sales network that covers most areas and hospitals in China and to enter the international market by leveraging on Pfizer’s global business networks.

Bayer HealthCare starts special lab space-model CoLaborator™ for promising life science companies B AY E R HealthCare officially opened its new life sciences hub for early stage research companies, dubbed the ‘CoLaborator™’, in San Francisco’s Mission Bay. The CoLaborator™approach is to support start-ups in establishing their research labs, with academic researchers spinning out new firms. In addition to lab facilities, access to the global expertise and equipment of Bayer’s research network will be available to CoLaboratorscientists. In return for ready to use lab space and access to its global expertise, Bayer would seek preferred access to partner with the emerging companies. “The CoLaborator seeks to address the need for new approaches to research

partnerships that allow for a collaborative process with shared risks and rewards. We are aiming to create something beyond the traditional incubator that truly fosters collaboration between Bayer scientists and these exciting young companies,” said Prof Andreas Busch, Member, Bayer HealthCare Executive Committee & Head-Global Drug Discovery. The CoLaborator life sciences hub is directly adjacent to Bayer HealthCare’s US Innovation Center located in San Francisco and seeks to work with technology platforms, drug targets or drug candidates that align with Bayer’s research strategy.

USP recognises volunteer experts for contributions to standards setting and public health AT its annual Science & Standards Symposium held this week in Boston, the US Pharmacopeial Convention (USP) recognised the exceptional contributions of two of its volunteer bodies to improving the health of people worldwide through public standards as part of its awards and recognition programme for USP expert volunteers. The 2012 USP awards were presented to its food ingredients expert committee and joint expert panel. “These two groups embody the volunteer spirit that has guided USP since its founding nearly 200 years ago,” said Dr Roger L Williams, CEO, USP. “Their dedication and commitment, exemplary leadership and creativity in developing standards that address the complex challenges facing the global pharma and food industries benefits manufacturers, regulators, and above all, patients and consumers. I congratulate these two volunteer bodies on their Dr Williams rigorous work, and thank them for their contributions to USP and public health.” The Food Ingredients Expert Committee, chaired by Dr Andrew Ebert, received the 2012 USP Award for an Innovative Response to Public Health Challenges. It was selected for its outstanding work and leadership in transitioning the Food Chemicals Codex (FCC) from the Institute of Medicine to USP (USP acquired the compendium of food ingredients in 2006) as well as specifically addressing the public health challenge of food adulteration.

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News, Views & Analysis

ABLE, DUKE and OSHL conduct workshop on meeting the challenges of developing new anticancer therapies THE Association of Biotechnology Led Enterprises (ABLE), the DUKE University and the Open Source Health Laboratories (OSHL) organised a workshop on Meeting the Challenges of Developing New Anticancer Therapies in New Delhi on September 17 that attracted interest and participation from public agencies and private companies. The workshop was led by internationally renowned cancer researcher, Dr H Kim Lyerly of Duke University who discussed methods of developing new anticancer therapies in India and the US for worldwide distribution. Strategic planning, clinical trial initiatives, translational research and regulatory elements of the drug development process were

discussed. Further, attendees were provided with a broad overview of the annual USFDA workshop whose goal is to expedite the development and validation for new anticancer and cancer prevention agents. Cancers are the leading cause of deaths in almost all countries. Cancer drugs constitute a significant portion of the $ 1 trillion global pharma market. The oncology community and the pharma industry have been shifting the focus of clinical research towards performing trials in emerging markets like India due to the positives such as faster recruitment timelines, patient populations, who could benefit from trials with cutting-edge therapeutics and also lower overall costs. Dr Lyerly commented, “Indian pharma

and biotech companies and public institutions have

Dr Lyerly

researchers and facilities that are capable of researching and developing new anti-cancer drugs. The traditional Indian medicine systems too have several remedies but in order for them to be validated for global use they too need to go through the same procedure as any other chemical or biotech

drug. The workshop will surely help in improving the drug

Dr Chandru

development processes of anticancer drugs in India.” Dr Vijay Chandru, CEO, Strand Life Sciences and EC member (ABLE) observed, “We are grateful to Dr Lyerly for having come all the way to offer his expert advice on these topics. Drug development is one of the

most expensive aspects of getting drugs to the market. The prowess of researchers and regulators in India in this highly regulated space depends on timely knowledge of global standards and benchmarks and how to approach them. The biopharma sector in India is active in oncology therapeutics with global market aspirations and welcomes such interactions with thought leaders in development.” Charles Maynard, ED, OSHL, commented, “This workshop is one example of the types of international collaborations that OHSL seeks to initiate, nurture and develop. The speed with which global collaborative medical research is being launched continues to be enigmatic and therefore it is necessary for organisations such as OHSL to exist.”

Novo Nordisk ranks 4th among the world’s top 20 science employers NOVO Nordisk was ranked as number four on the Science 2012 Top Employer list up from ninth place last year. The company’s ‘social responsibility’, ‘respect for employees’ and ability to inspire ‘loyalty among its employees’ were cited as key drivers of this impressive global ranking. Mads Krogsgaard Thomsen, Chief Science Officer & Executive VP, Novo Nordisk, said, “We are proud to have jumped to the top five in this widely recognised ranking of the world’s best Thomsen science employers. Our excellent researchers around the world are the main source of this company’s strong innovation. The fact that they feel respected and take pride in working for a company that operates in a sustainable way is great to see. In the battle to recruit the best researchers, there is nothing more powerful than peer-to-peer communication.” R&D professionals at Novo Nordisk comprise world-class experts in the engineering, expression, formulation and delivery of therapeutic proteins, as well as in the development of compounds into safe, effective and convenient treatment options for people living with chronic conditions such as diabetes, haemophilia and rheumatoid arthritis. More than 4,000 employees work in Novo Nordisk R&D in Denmark, US, China and India.

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News, Views & Analysis

Wockhardt gets US FDA approval for anti-ulcer drug DRUG firm Wockhardt recently said it has received approval from the USFDA to market lansoprazole in the American market in strengths of 15 mg and 30 mg. “Lansoprazole delayed release formulation is a challenging product and it once again demonstrates Wockhardt R&D’s capability in the

NDDS technology space,” said Habil Khorakiwala, Founder Chairman and Group CEO. Lansoprazole is the generic name for the brand Prevacid, marketed in the US by Takeda. According to IMS Health Sales data, the total market for the product in the US is about $ 700 million. Wockhardt already markets

an over-the-counter version of 15 mg lansoprazole DR capsules in the US. Wockhardt will be manufacturing the lansoprazole Active Pharmaceutical Ingredient (API) in its facility at Ankleshwar, India and the delayed-release capsules of Lansoprazole at its facility in Aurangabad.

Votubia® recommended by CHMP for EU approval to treat patients with non-cancerous kidney tumours THE Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Votubia® (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with Tuberous Sclerosis Complex (TSC) who are at risk of complications (based on factors such as tumour

size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. Votubia would be the first medication available in the European Union (EU) for these patients. Hervé Hoppenot, President, Novartis Oncology, said, “Today’s positive CHMP opinion for Votubia is important for

Biogen Idec observes ‘Care Deeply’ week in India EMPLOYEES of one of the world’s oldest bio pharma companies, Biogen Idec, observed ‘Care deeply’ week in India as part of its CSR initiative. Some of the initiatives run during the ‘Care Deeply’ week were a donation drive for Assam Rahat in partnership with ‘Goonj’, where employees donated clothes, accessories and utility items for Savkur bringing relief for Assam floods victims and Akshaya Patra supporting the mid-day meal for children by promoting primary education. Further, Biogen Idec employees are working to clean roads near Khushboo Welfare Society. The ‘Day of Service’ was designed to increase the role of employee volunteerism with focus on patients, science education and local communities. Biogen Idec also offered logistic support and interacted with the disabled children suffering from various neurological disorders and disabilities. Sameer Savkur, MD, Biogen Idec, said, “This offers an opportunity to give back to the communities in which we live and work.” Speaking on behalf of the NGO, Aparjita Verma, Deputy Director, Communications and Resource Mobilisation, Khushboo Welfare Society, said, “We appreciate the effort of the corporate world to spare time and extend support by physically being on the ground and engaging with a worthwhile cause.”

patients in the EU with TSC, as renal angiomyolipoma is among the most difficult-totreat manifestations of this debilitating disease. There remain many unmet medical needs in TSC, and Novartis is committed to understanding and improving the lives of people affected by this rare disease through clinical research, education and collaboration with the global TSC community.”

In Brief Ten pharmaceutical companies for TransCelerate

TEN leading biopharmaceutical companies have formed a non-profit organisation to accelerate the development of new medicines. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi launched TransCelerate BioPharma Inc (‘TransCelerate’), the largest ever initiative of its kind, to identify and solve common drug development challenges with the end goals of improving the quality of clinical studies and bringing new medicines to patients faster.

Mylan introduces generic antivert tablets in the US market

THE US FDA has granted final approval for Mylan Pharmaceuticals Inc for its ANDA for meclizine hydrochloride tablets USP, 12.5 mg, 25 mg and 50 mg. This product is the generic version of Pfizer’s Antivert, which is indicated for the management of nausea and vomiting, and dizziness associated with motion sickness.

Astex Pharmaceuticals discontinues amuvatinib clinical development programme

ASTEX Pharmaceuticals, Inc recently announced that clinical development of amuvatinib (MP-470), a multi-targeted tyrosine kinase inhibitor that inhibits the mutant forms of c-Kit and PDGFR alpha and disrupts DNA repair likely through suppression of homologous recombination protein Rad51, has been discontinued.

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News, Views & Analysis

Granules India awarded India’s CCI clears Mistui’s acquisition most admired company in exports of additional 26.71 per cent GRANULES India Ltd, a fast growing pharma manufacturing company, recently announced it has been recognised as India’s most admired company in exports & India’s most admired company in bulk drugs at the 5th Annual Pharmaceutical Business Leadership Awards organised by Pharmaleaders in association with BSE, Pharmexcil and IBEF. “We are proud to receive these awards since they recognise our long-term efforts to add value for our customers. Manufacturing efficiency is our top priority and is why we are able to offer an optimal blend of quality and value. We have earned the trust of brand owners and leading generics companies, which is why more than 90 per cent of our business is from exports with 66 per cent coming from North America and Europe. Due to the strong

Prasad

Harsha

Waters and Nonlinear Dynamics to co-develop next generation research solutions WATERS Corporation and Nonlinear Dynamics Ltd have recently entered into an agreement to co-develop a new analytical solution that derives information from complex data sets generated by large-scale proteomics and metabolomics experiments. Used in small molecule research, protein characterisation, metabolite identification and bio-pharmaceutical applications, the Synapt HDMS system is still the only mass spectrometer to employ high efficiency ion-mobility based measurements and separations to enable the analysis of sample ions differentiated by size, shape and charge as well as mass. The added dimension of shapeselective separation increases the analytical specificity and sample definition so that scientists can extract more information from their samples, including the detection of components previously unseen by conventional mass spectrometers. “The complexity of biological samples is so great that the sensitivity and specificity of analytical techniques required for biological discovery presents scientists with significant challenges when it comes to managing experimental data,” said James Langridge, PhD, Director of Pharmaceutical & Life Sciences Discovery, Waters Division. “We believe that through our partnership with Nonlinear Dynamics we can address this situation and advance the pace of discovery.” “I am delighted to see this exciting partnership bring together the latest MS technology with world-renowned data analysis software,” said Will Dracup, Executive Chairman, Nonlinear Dynamics.

performance of our finished dosage division, we expect our export business to continue to increase” said Harsha, Executive Director, Granules India Ltd after receiving the awards from K Sankaranarayanan, Hon’ble Governor, Government of Maharashtra. “In order to provide further value to customers, we actively invest in process development R&D, offer value-add products such as rapid-release caplets and provide access to regulated markets through ANDAs and dossiers. We have demonstrated the value proposition India offers by becoming among the premier global companies for our products. In order to drive further value, we have been actively adding capacity across all our manufacturing facilities,” added C Krishna Prasad, MD, Granules India Ltd.

stake in Arch Pharmalabs

MITSUI, based in Japan, received clearance from Competition Commission of India (CCI) for its proposed acquisition of 26.71 per cent additional stake in Arch Pharmalabs, an Indian manufacturer of biopharmaceuticals. Mitsui submitted an application one month ago to own additional stake in Arch. Subsequent to the deal, Mitsui’s total share in Arch Pharma will increase to 31.96 per cent. CCI also acknowledged that the new tie up will not impact the competitive landscape in the sector. Despite strong opposition on allowing M&A in pharma industry by several groups, the recent decision by CCI seems to be a gateway for more acquisition activities in the

Indian pharmaceutical sector in future. The existing bilateral trade agreement between the two parties include: Mitsui supplies two raw materials to Arch; while Arch also provides some products to Mitsui, for use in pharmaceutical production. The deal also favoured by the factor that Mitsui’s owns no indirect or direct stake in any other pharmaceutical business in the country. The transaction is expected to open a new era of M&A activities in the Indian pharmaceutical industry, as the Prime Minister of India is not keen on curbing FDI in pharma sector. The ministry of commerce and industry has sought to limit the FDI in domestic pharma sector to 49 per cent only.

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News, Views & Analysis

Sanofi and TB alliance announce collaboration SANOFI and the Global Alliance for TB Drug Development (TB Alliance) announced a new research collaboration agreement to accelerate the discovery and development of novel compounds against Tuberculosis (TB), a deadly infectious disease that resulted in almost 1.5 million deaths worldwide in 2010. Under the agreement, Sanofi and TB Zerhouni Alliance will collaborate to further optimise and develop several novel compounds in Sanofi’s library that have demonstrated activity against Mycobacterium tuberculosis, the bacterium that causes TB. This includes in-depth

research of lead compounds based upon identified chemical derivatives of natural products, which have promising potential to treat all forms of TB, and the chemical optimisation of other series of compounds that have been identified as hits through high-throughput screening. “Sanofi’s longstanding commitment to delivering treatments for people living with TB - including the discovery of rifampicin, the gold-standard drug for TB treatment, as well as the manufacture of TB treatments - continues with this collaboration,” said Elias Zerhouni, MD, President, Global R&D, Sanofi.

Roche to open research centre in NYC ROCHE plans to open a new research centre in Manhattan. The new centre will take on some of the former responsibilities of its Nutley, N J campus. The new centre would be at the Alexandria Center for Life Science at East 29th Street in Manhattan. The company had announced in that it would close the Nutley site in an economic move that would eliminate some 1,000 jobs. Roche will keep 50 management-level positions in northern New Jersey. About 200 workers from Nutley will work at the new site.

Rajendra V Gogri elevated to the post of CMD of Aarti Industries Ltd RAJENDRA V Gogri has been elevated to the post of CMD of Aarti Industries Ltd, a leading manufacturer and exporter of chemicals and pharmaceuticals. Gogri was holding the office of Vice Chairman and MD and has been appointed as CMD in line with succession plan earlier approved by the company. He holds a Masters Degree in Chemical Engineering Gogri from the US and is a rank holder in Bachelor of Chemical Engineering from UDCT. He has been with the company since its inception and was later on appointed as MD in 1993 and Vice Chairman & MD in 2003. He has worked shoulder to shoulder with Chandrakant V Gogri in order to help the company achieve its present height and stature. He is a key reason for development of export of the company and has been handling the portfolios of marketing, purchase and other commercial matters.

Mettler Toledo publishes white paper: ‘Don’t Be Thrown off Balance – Safer Operations in Biofermentation’ METTLER Toledo Process Analytics recently announced the publication of a white paper entitled ‘Don’t Be Thrown off Balance – Safer Operations in Biofermentation,’ that discusses how recent developments in process analytics can reduce the risk of operator error during fermentation runs. Active Pharmaceutical Ingredients (APIs) produced via biofermentation are extremely sensitive to the manufacturing

process. Whether continuous or fed-batch mode, biofermentation requires careful control of analytical parameters in order to minimise batch inconsistency and prevent batch loss. The goal is to keep parameters such as pH and dissolved oxygen at a constant level or following a predefined course. However, as a run progresses, cell metabolism and accumulation of metabolic side products may alter the fermentation medium in an

unpredictable way, necessitating corrective action. Bioreactors on which several analytical parameters are being monitored can be complex for technicians to operate and therefore carry risks of human error. Mettler Toledo’s white paper shows how recent developments in process analytics have simplified analytical measurements on bioreactors and reduced the possibility of mistakes being made.

Aurobindo receives final approval for escitalopram oxalate tablets AUROBINDO Pharma Ltd recently announced that the company has received final approval from the US FDA to manufacture and market escitalopram oxalate tablets 5 mg, 10 mg and 20 mg (ANDA 090432), which was earlier tentatively approved. The product is ready for launch. Escitalopram oxalate tablets 5

mg, 10 mg and 20 mg are the generic equivalent of Forest Laboratories Inc’s Lexapro® tablets 5 mg, 10 mg and 20 mg is an anti-depressant and falls under the Central Nervous System (CNS) segment. It is indicated for treatment of depression associated with mood disorders and has a market size of approximately

$ 2.8 billion for the twelve months ending March 2012 according to IMS. The product has been approved out of Unit III formulations facility in Hyderabad, India. Aurobindo now has a total of 158 ANDA approvals (133 final approvals including 1 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA.

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In Conversation With

There is money, but not many people understand the field and realise that biotech requires long-term investment …says Sohang Chatterjee, Director and Chief Executive, Inbiopro Solutions Pvt Ltd. In a tête-à-tête, Chatterjee sheds light on the various opportunities for biosimilars in India and discusses the road map of Inbiopro Solutions Pvt Ltd.

Jasleen Kaur Batra jasleen.batra@network18publishing.com

What piqued your interest in biosimilars and made you start Inbiopro? One of my favourite visionaries, the American computer scientist, Alan Kay famously said, ‘The best way to predict the future is to invent it’. This has had a profound effect on my thought process and I wanted to contribute to the future of the biotechnology industry. Biotechnology is still an emerging field with scope for high impact entrepreneurship. There is an obvious market opportunity for biosimilars in India and

The more the challenging it is to develop a product, higher the entry barrier, the better is the product. there were a number of big pharma companies who wanted to get into biologics and biosimilars. This is what got my attention to this field. My position and role in my first company after coming back to India, gave me good exposure to the potential and possibilities of collaborative product development. I and my founder partners saw a clear market opportunity wherein we could work with larger pharma companies and also in a few cases develop their pipeline or indirectly contribute to their R&D for product development. The second major driver was the lack of inclusive and open work culture in Indian organisations. It is most often individually run or family driven with limited scope for leadership and entrepreneur development from such a set up. Along with technology and market aspect, we were also keen on setting up a different and open work culture, one that is not only dynamic but also leverages the combined strengths of the entire team and not just one or two

individuals. Thus, looking at the market opportunity and the broad field that we had to explore, I along with my two partners - Kavitha Iyer Rodrigues and Aditya Julka embarked on setting up Inbiopro. How has been the journey ever since? The journey has been exciting and rewarding. It is impossible to experience such a steep learning curve from any routine job. For a start-up we kept sight on a all rounded organisational development from day one. To inculcate a certain work culture, we tied up with organisational development consultants. To ensure inclusive progress, we developed the vision and mission of the company with the entire core team. We ensured exposure of every individual in the organisation to the management through various planned weekly and monthly activities. After a couple of years of successful product co-development, we wanted to expand our capabilities and sought growth funding. That is when Strides came in with equity based funding. This has definitely helped the organisation and has given us the bandwidth to grow faster. What challenges came your way and how did you overcome them? Globally, biosimilars is a reasonably new industry. Sadly, India has been behind in pretty much everything except IT. So, finding investors who understand the field was probably the biggest challenge. Getting the first investor was not much of a challenge as we got investors within two months after starting the company. But stepping up and expanding is where we faced a problem. There is money, but not many people really understand the field and realise that biotech requires long-term investment. But with Strides coming in, this challenge was also taken care of. What is your business model? We are purely a product development company. We are not into large scale manufacturing and marketing is really not our core competency. Our strategy

was to develop products and then find marketing partners. Because of difficulty in finding knowledgeable PE funds in biotechnology in India, we were to some extent forced to align ourselves with marketing partners earlier. If we had capital we would have licensed out in a much later stage of the product development lifecycle. But what we did was, once we got proof of concept for our products and we could prove with certainty that we do have what we claim, we took that and went to the marketing partners and took the funding through licensing. Going ahead we do not necessarily want to change the strategy but want to move on to the next stage - which is once we have biosimilars ready to go into the market, we want to enter true innovation that is moving from biosimilars to improved biosimilars, which is also known as biobetters, and then also look at new products. What are your goals for Inbiopro for the coming years? Our first major goal is to get products to the market.

It has been 5 years since we entered the industry and it takes approximately 7-8 years to get in the market. But we want to get in the market before that. We want to take up challenging projects. The more the challenging it is to develop a product, higher the entry barrier, the better is the product. So, we would like to work on products that others would think twice or thrice before getting into. Also, our second goal is to move towards innovation. We want to come up with products that would be the first in the global market. These are the goals we have set as an organisation and I hope we achieve them soon. What can people expect from Inbiopro in the coming 5 years? Innovation! We are definitely going to come up with new products of global standards. It would cater to the Indian market but would be at par with the global standards. What has been your catalyst to success? Belief in what you do is the

most important thing. One needs to ask oneself if you are doing this only for money or are you seriously passionate towards this. There will always be difficulties in the management, market, etc but if you are convinced that

Our second goal is to move towards innovation. We want to come up with products that would be the first in the global market. what you are doing is right than nothing can stop you from achieving success. Also, having a strong core team really helps an organisation. Thankfully for me, my core team has stayed with me. Over the last 5 years we have been able to hold together our core team, so critical for a technology and IP-driven organisation. To build a different organisation and to cater to the needs of the market, this is what you need and I am glad we have a capable team committed to common goals.

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Special Focus

Market dynamics of parenterals and injectables Jasleen Kaur Batra jasleen.batra@network18publishing.com

lobally, injectable medications form the second most preferred class of drugs, with oral route of administration leading the global pharma market. Injectable drug delivery devices have evolved from traditional needles and syringes to recently developed needle-free injectors. The market has evidenced a trend shifting from administration of injections in clinician settings to home care settings, which has resulted in increasing the focus of industry players toward the development of user friendly and patient-compliant devices. The market for injectable devices has evolved over the period from conventional injectables to recently developed needle-free injectors. The conventional injectables form a higher share of this market in terms of volume. However, in terms of value proposition, this segment has lower significance as compared to other device technologies. Looking at the rising trend towards selfadministration therapies, injectable drug delivery devices such as pen injectors, auto injectors and needle-free injectors show a significant growth potential in the near future. This market is expected to double itself at a CAGR of 14.5 per cent during 2010-2015 and reach $ 1,276 million in 2015 from $ 570 million in 2009.

Breakthrough chances The Indian pharmaceutical market has a lot of potential in the field of injectables and parenterals. “The market has been growing over the years. A number of new diseases and infections have been affecting people, which have given rise to

Considerable exports are being done from India to various countries as the cost of injectables that India has to offer is far cheaper than what other countries offer. Dr Ajaykumar Sharma Associate Director, Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East

Assessing the opportunities and challenges Parenterals are an important part of the pharma industry. With the growing innovation in the space of drug delivery, we discuss the market dynamics of parenterals and injectables along with the opportunities and challenges that it faces today.

the development of parenterals and injectables. Also, globally India has a huge potential in terms of contributing to this market,” says Dr Ajaykumar Sharma, Associate Director, Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East. Further explaining the opportunities for injectables globally, he adds, “Considerable exports are being done from India to various countries as the cost of injectables that India has to offer is far cheaper than what other countries offer. Thus, there is an Indian presence in the global scenario, which is a positive sign.” Another are of opportunity for the injectables market is the population, which is increasingly spending money in healthcare. Explaining this phenomenon, Alok Ghosh, President - Technical Operations, Lupin Ltd, says, “The population in India has been growing rapidly. This has further given rise to a large middle-class population, which has started spending money in healthcare. This development has definitely given rise to the growth of the injectables industry in India. Besides this, some of the trends in western world like pre-filled syringes will have more acceptance in India, which will further create more opportunities.”

Pertinent challenges Though the opportunities in this sector are in abundance, there area a few factors that are restraining the growth of injectabeles and parenterals in India. One of the biggest challenge is that of regulations. “There are many challenges that the pharma injectables sector has to face today. A few of the challenges present are the high infection rates due to the wrong administration of drugs. Transportation is another key challenge because we do not have the infrastructure at least in India. Also, the cold chain systems are expensive and thus not easy to maintain,” informs Dr Sharma. Other challenge is that of maintaining the cold chain system. The worldwide sale of vaccines is predicted to increase to $ 35 billion by 2014. The huge growth of temperaturesensitive vaccines is driving the development of novel technologies for transportation and logistics such as thermo stable vaccines, solar battery free refrigerators, zero energy cold chain electric vehicles and longer-term passive storage containers and more. Also, driven by regulations, more pharmaceutical products require temperature control handling from refrigerated to ambient to cold, broadening the cold chain market. Break in this crucial cold chain system

for most products may result in value erosion financial loss, but break in cold chain of pharma products, especially vaccines, life-saving drugs, etc could be fatal for patients. Thus, it is extremely crucial for every pharma injectable manufacturing company to have a robust cold chain system. A few more cold chain challenges that are unique to the Indian market are: In the hot climate of India it is definitely a challenge

Indian companies need to upgrade the systems and procedures at par with international regulatory requirements. Alok Ghosh President - Technical Operations, Lupin Ltd

maintaining product temperature throughout the distribution network, with external temperatures easily over 30°C India’s cold chain market is still in its developing stages, and thus there is a lack of temperaturesensitive services from the point of origin to the point of consumption “By the inherent nature of the product, which is required to be introduced at the critical stage of patient care, it is important that the product is manufactured with utmost care following all the safety and GMP procedures, since any mistake could be life threatening for patients. So, right from design of the product to the building of facilities, to the procedures followed to make the products are to be rigorously monitored,” says Ghosh. Another challenge faced today is that of infrastructure. A number of companies lack the basic technology and infrastructure required to produce high quality injectables and parenterals. As these are temperature sensitive, it is important that their chain of delivery is of high quality. Further explaining the importance of having good infrastructure Ghosh explains, “Indian companies need to upgrade the systems and procedures at par with international regulatory requirements. Once the quality of products is established, the products manufactured in India will have much more confidence with medical fraternity.”

The future trends The market for parenterals and injectables will grow as life stylerelated diseases such as diabetes, blood pressure, cancer and many more are affecting huge populations in India. Also, with better detection procedures now, like early detection of cancer and other fatal diseases would lead to the growth of injectables. “Antibiotics for serious infection, heart-related diseases where immediate attention is required, anti-cancer drugs, diabetes, for example insulin injections, would also increase with time, which will help the growth of this sector,” says Ghosh. Explaing the coming 5-10 years of injectables and parenteals, Dr Sharma says, “The growth definitely will continue; it will be natural growth as it is dependent on various other factors such as resources, which is the biggest crunch. The growth is expected to be steady as the number of consumers will keep increasing. Also, I do not see parenterals and injectables being replaced as a major drug delivery system, at least in the coming 10 years.”

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Special Focus

Regulations in parenterals and injectables Shibani Shah shibani.shah@network18publishing.com

arenterals were first manufactured on an industrial scale in early 1900s. Manufacturing of parenterals is associated with cGMP practices and sterility of the product needs to be maintained throughout the process. There are several categories of parenteral preparations and they can distinguished as injections, infusions, concentrates for injections or infusions, powders for infusion and injections and gels for injections. The main driver of the parenteral market is injectables, which include both branded and generic ones. The market includes manufacturing of small-volume and largevolume parenterals. Cytotoxics are expected to be the growth driver for the small-volume dosages parenterals because of the increase in demand of oncological drugs. Sterile parenterals are developed for vaccines, cancer therapies, antibodies, gene therapies, specialised antibiotic treatments and proteins.

Managing the manufacturing conundrum Parenteral manufacturing is regulated by guidelines for the purpose of maintaining sterility. There are differences in the EU and US norms for parenteral manufacturing. We take a look at the different standards and guidelines in parenteral manufacturing.

Visible trouble

Norms in parenteral manufacturing Sterilisation is the most important aspect in parenteral manufacturing. The filling and sealing of containers with parenterals under high quality sterile conditions is extremely important in order to minimise the microbial contamination. The final product is also subjected to a sterialisation process like heat or irradiation to ensure the sterility of the product. For products that are heat sensitive, manufacturing is done under aseptic conditions. In aseptic manufacturing the excipients and all other materials used are sterilised and the working steps are performed in clean environment, therefore high standards are established concerning the manufacturing area, personnel handling it, equipment and container closure systems used. The air system, water for injection, sterile gases and other materials used are also thoroughly checked before use. Sterile filtration using membrane filter of 0.2 µm or less is one the methods adopted to achieve sterility. Since prevention of contamination is a mandate for parenteral manufacturing, all the materials used are checked at every step. Manual and mechanical manipulation of the sterilised drug, its components, containers or closures prior to or during aseptic assembly poses a risk of contamination and thus requires continuous monitoring. V Srini Srinivasan, Head - USP International

recognise that manufacturers and suppliers may be operating under different regulatory frameworks and may have differing cGMPs. In order to help ensure the quality of parenterals and injectable drugs, manufacturers need to apply the necessary measures to control for microbial contamination which, in turn, minimise potential risk to the patients as well as the products.” The European Pharmacopoeia insists on sterilisation of the final container in manufacturing sterile products and aseptic manufacturing is seen as a last resort. But according to the USP guidelines the final sterilisaiton of the product is done if the product is stable and aseptic manufacturing is emphasised along with in a more detailed manner.

Sites and USP Global Verification Programs, US Pharmacopeial Convention, says, “Parenteral products must be sterile. To make good quality parental drugs, their manufacturers need to operate in environments that ensure sterility. Facilities should employ cGMPs, and manufacturers must ensure that their processes and packaging practices are sterile enough to minimise the risk of microbial contamination of the product.” As per the EU standards injections, infusions and other parenteral forms for application on eyes and on mucous membranes must be sterile but there is no general requirement for sterility for aqueous-based oral inhalation solutions, suspensions and sprays. There were side effects in patients observed after using

aqueous-based oral inhalation solutions, suspensions and inhalation spray that were intended for delivery to the lungs for local or systemic effects.

Challenges practices

Unwanted and unintentional visible particles can tell you many things about a manufacturer’s process. V Srini Srinivasan Head - USP International Sites and USP Global Verification Programs, US Pharmacopeial Convention

cGMP

Maintaining a controlled environment and avoiding microbial contamination is a major challenge. While there are different set of standards for parenteral manufacturing in the US and EU, even different companies manufacturing these parenterals follow different standards. At these places, manufacturing units have classified areas within the facility depending upon the requirement of each step. Srinivasan adds, “With the global sourcing of drug products and their components, it is important to

Containers for parenteral preparations are made from materials that are transparent and permit visual inspection of the contents. The transparencies of the containers are maintained in order to visually inspect the contents of the container from time to time. To validate the quality of filled containers optical inspection is also seen as one of the parameters. The containers filled with the parenteral dosages are also temperature mapped during storage to document and evaluate the conditions. Generally glass containers are used for these sterile products and often sterilisation in done by both dry heat and depyrogenised at the same time at a temperature above 210°C. Srinivasan elaborates, “Unwanted and unintentional visible particles can tell you many things about a manufacturer’s process. Any extraneous particle should be controlled in a drug product, given that it is not desired or intended in that final product. Thus, visible particles must always be controlled so that the quality of the product is not compromised. Generally, manufacturers also should control the levels of subvisible particles, such as microbial contaminants, in order minimise risk to the product and the patient.” Even with differences in norms in the parenteral manufacturing as per the EUP and USP, sterility remains basic for parenteral manufacturing. The guidelines are thoroughly followed while manufacturing parenterals since contaimation can easily occur in such products and render it unfit for human use.

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Special Focus: Interface

There is an increasing segment of the Indian market that is demanding for better drug delivery solutions Shibani Shah shibani.shah@network18publishing.com

How are auto injectables designed? What parameters should one bear in mind while designing them? Auto injectables, particularly pre-fillable syringes, are designed for self-administration of the drug. Auto injectors are designed in a way such that once one spreads the top of the auto injector over the surface, the drug will automatically be released at a predetermined rate such that even if one wishes to stop the delivery of the drug it is not possible. After the drug delivery is complete one hears a prominent click sound that determines the completion of the drug delivery. At one click it will automatically deliver the drug, and one needs to manually press it continuously like conventional syringes that need continuous pressing and the rate is determined manually. The speed is predetermined depending on the viscosity of the drug. What are the benefits of pre-filled syringes over conventional syringes? While safety is the main advantage of the pre-filled syringes, they also provide convenience in terms of time required for administration. The time required for drug delivery in case of pre-filled syringes is much less as compared to conventional syringes. Drug administration through

a conventional syringe involves at least ten to twelve steps but with pre-filled syringes the number of steps gets reduced to just three to four steps; this allows saving almost 60-70 seconds per syringe, which when looked at in a larger manner will save almost 1-1.5 hours everyday of the doctors. Another benefit is the reduction in the chances of making an error. In addition to these, the drug overfill in a vial is 20 per cent while in a pre-filled syringe it is almost 2-4 per cent, hence one can save the costly drug and get a better output out of the same packaging. The valuable drug can be made available to a larger number of patients and in a time of mass break out or epidemic the same drug is available for a larger pool of patients. In case of a pre-filled syringe the same container is being used for storage and drug delivery device as opposed to the conventional disposable syringe for which one has to manage the logistics of both vial and syringe separately. There are instances when vials are available but syringes are not. There are chances of contamination since while filling the syringe, the vial is punctured multiple times and this leaves a potential passage for micro-organisms, thus causing contamination. What are the commercialisation prospects that you see in India? In India we have commercialised

â&#x20AC;Śsays Murali Sundrani, Business Director, BD Pharmaceutical Systems, as he talks about the benefits of pre-filled syringes and the Indian market. With the increase in lifestyle disease there is an increase in demand for home-based drug delivery solutions, and India has a huge potential for such market.

the self-injection pen. The difference between the pen and syringe is that the pen is cartridge based and allows delivery of drug of micro millilitre volume dosages. Auto injectables are used for large volume doses. Pens are easier to use for patients but auto injectors we have not had an opportunity to commecialise in India. There is an increasing segment of the Indian market that is demanding for better drug delivery solutions. And with increase in the healthcare spend because of the income available and insurance schemes, people are demanding and getting better delivery devices. Even for vaccinations parents are demanding products that are safer for the kids and are willing to pay that small extra amount for safety reasons. What are the different kinds of innovations in the drug delivery systems segment of the pharma industry? There are several systems being designed such that the drug delivery process becomes less painful and allows easy penetration of the drug. Nasal drug delivery devices are also being developed, which are altogether a new route of administration. There are also intradermal delivery systems developed that allow the dosage to be reduced to one fifth, which can cause five times patients to be treated with the same volume of dose.

Mo de rn Ph a rm a •1 -15 Oct o be r 2 012

Automation Trends

Pharm‘automated’

Jasleen Kaur Batra jasleen.batra@network18publishing.com

rining in automation in any field helps bring together all the elements in a time-efficient manner, which also helps reduce the level of human involvement that in turn reduces the chances of human errors. Automation has ushered in every segment of various industries due to the growing need to remove repetitive and strenuous work, standardise the quality of output, enhance operator safety and increase productivity to match the rapidly increasing demand for pharma products.

Automation becoming a must Today, automation has become a necessity rather than a luxury due to various reasons. One, for being present in the competitive world and creating a brand name, second; there are a lot of regulations, which are required and all those required regulations force the companies to provide the best quality products so that the end users (the consumers) receive the best quality products. To attain this quality product, automation is of critical importance.

Automation is crucial for the growth of a sector. Today, finding labour is becoming difficult, which in a way is a positive sign as high labour leads to increased human errors in an organisation. Madan Mishra, MD, Prama Instruments Pvt Ltd

“Automation is extremely crucial for the growth of a company or a sector at large. Today, finding labour is becoming difficult, which in a way is a positive sign as high labour leads to increased human errors in an organisation. Thus, to ensure that the manufactured product is of high quality, manual intervention needs to be minimised, which is why automation is important,” informs Madan Mishra, Managing Director, Prama Instruments Pvt Ltd, Mumbai. Today, automation is important to reduce the major source of contamination, which is human intervention. Also, creating batch-to-batch accuracy can be attained from automation.

Impact of automation in pharma Semi-automatic machines require manual intervention at different stages of the process, which gives rise to a number of issues in the quality of the product. Even semi-automatic line machines require at least three operators, resulting in a higher manpower cost. In addition, semiautomatic machines put operators at risk due to the high level of product dust

Reducing manual intervention for better productivity Costs related to R&D, production, packaging, and distribution, and more can be reduced by global pharmaceutical manufacturers through greater efficiencies. We review how advent of automation has reduced manual intervention in the pharma space and given rise to better outcomes. in the atmosphere. With semi-automatic filling systems, there is relatively high amount of powder wastage. To pay for higher manpower, as well as absorb the complications of unskilled operators, human error, and wastage of powder during filling, eventually raises the total cost to company. Thus, having a fully automated manufacturing process is always an advantage for a pharma company. There are clear benefits of output when semi-automatic and fully automatic filling machines are compared. For instance, a semiautomatic machine can meet a target of

1,35,000 capsules per shift, but it depends on the size of the capsules. Fully automated capsule filling machines can fill up to 30,000 capsules per hour, making the per shift output 2,10,000 capsules. This makes an impressive 99.5 per cent yield as compared to the 98 per cent of a semi-automatic. “The benefits of automation can be seen in the smallest of things. For example, initially the doctors used to sterilise the needle themselves, then came disposable syringes-where one syringe is used for one patient. Now, the trend has come out for disposable pre-filled syringesthis has helped reduce the risk of the

patient acquiring any infection and has made the life of a doctor/nurse much simpler,” explains Mishra. Manufacturing facilities’ automation systems for the biotechnology and pharmaceutical industries provide HVAC control, badging, security alarm monitoring, video surveillance, access control and environmental monitoring for regulated facilities, Which is crucial as every company needs to clear the regulatory issues time and again. “Also, looking at injectables, microbiology is the key area and is so the area of drug delivery. This sector has seen a lot of new innovation in recent times, which is lead by rapid microbiological methods known as RMM. This process helps in tracking microbes, which takes weeks together. This has saved a lot of time,” says Mishra This shows that automation is of critical importance in the pharmaceutical industry. With the development of technology, a number of changes have been seen in the pharma space, which has helped the industry tremendously. There are a number of products in the pipeline already, which will further strengthen the pharma sector and help it grow.

Mod er n P har m a•1 - 15 Oc t ob er 2 012

Projects

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. 6-Amino Penecillin Acid (6aps) Project Project type: New facility Project news: Vardhman Life Sciences Pvt Ltd is planning to set up a new pharmaceuticals project at Cuddalore in Tamil Nadu. The project involves manufacturing of 6-Amino Penicillin Acid (6apa). Project location: Cuddalore, Tamil Nadu Project cost: NA Implementation stage: Planning Contact details: Vardhman Life Sciences Pvt Ltd A-7, Sipcot Industrial Complex, Cuddalore,

Tamil Nadu, 607005 Tel : 0172-2622985 Fax : 0172-4676918 Website: www.vardhmanlifesciences. com Atorvastatin 10 mg tabs Project type: New facility Project news: Epsilon Pharmaceuticals Pvt Ltd is planning to set up a new pharmaceuticals project at Mahaboobnagar in Andhra Pradesh. The project involves manufacture of Atorvastatin 10 mg tabs. Project location: Mahaboobnagar, Andhra Pradesh Project cost: NA Implementation stage: Planning

Contact details: Vance And Health Pharmaceuticals Pvt.Ltd 201, Koushik Sai Rama Residency, Hyderabad - 500038, Andhra Pradesh Tel : 91-40-23736533 / 2736558 Fax : 91-40-23817051 Bendamustine Hcl injection Project type: New facility Project news: Natco Pharma Ltd is planning to set up a new pharmaceuticals project at Mahaboobnagar in Andhra Pradesh. The project involves manufacturing of Bendamustine Hcl Injection 100 mg/25 mg. Project location: Mahaboobnagar, Andhra Pradesh Project cost: NA Implementation stage: Planning Contact details: Natco Pharma Ltd Natco House, Road No 2, Banjara Hills, Hyderabad – 500033 Tel : 040 23547532 Website: www.natcopharma.co.in

Cefpodoxime proxetil Project type: New facility Project news: Aurobindo Pharma Ltd is planning to set up a new pharmaceuticals project at Srikakulam in Andhra Pradesh. The project involves manufacture of Cefpodoxime Proxetil. Project location: Srikakulam, Andhra Pradesh Project cost: NA Implementation stage: Planning Contact details: Aurobindo Pharma Ltd Plot No.2, Maithri Vihar Ameerpet, Hyderabad – 500038, Andhra Pradesh Tel : +91 (40) 6672 5000 Fax : +91 (40) 2374 1080 / Email : info@aurobindo.com Website:www.aurobindo.com/ Clozapine project Project type: New facility Project news: Natco Pharma Ltd is planning to set up a new pharmaceuticals project at Mahaboobnagar in Andhra Pradesh. The project involves

manufacturing of Clozapine. Project location: Mahaboobnagar, Andhra Pradesh Project cost: NA Implementation stage: Planning Contact details: Natco Pharma Ltd, Natco House, Road No.2, Banjara Hills, Hyderabad – 500033 Tel : 040 23547532 Cyclophosphamide for Injection project Project type: New facility Project news: Epsilon Pharmaceuticals Pvt Ltd is planning to set up a new pharmaceuticals project. The project involves manufacturing of Cyclophosphamide for injection 1g. Project location: Mahaboobnagar, Andhra Pradesh Project cost: NA Implementation stage: Planning Contact details: Epsilon Pharmaceuticals 8-2-322,Road No. 3,Banjara Hills, Hyderabad-500034 Tel : +91 40 44609020 Fax : +91 40 44609007

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India • Tel: 022 28666134 • Fax: 022 28013817 • Email: parmeet.d@tendersinfo.com

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Mo de rn Ph a rm a •1 -15 Oct o be r 2 012

Event Report

Pharmac India 2012

Focussing on SMEs Shibani Shah shibani.shah@infomedia18.in

ujarat, the state that contributes 42 per cent to the total pharma turnover of India recently played host to Pharmac India 2012. The international exhibition on pharma machinery, equipment and material was held at the Gujarat University Exhibition Center, at Ahmedabad from September 8-10, 2012. The exhibition aimed at bringing the various Small and Medium Enterprises (SMEs) from the severl aspects of pharma manufacturing under one roof. It had exhibitors from various domains of pharma manufacturing such as equipment, raw material and machinery. It included companies dealing with pharma formulations, API for bulk drugs, pharma machinery, pharma packaging material, bio pharmaceuticals, and other allied services. The event this year saw great participation not only from in and around Gujarat but from around the world. The event was inaugurated by M Sahu, Principal Secretary Industries and Mines Department, Government of Gujarat and H G Koshia, Commissioner, Food & Drug Control Administration, Gujarat.

Main attractions

The third edition focussed on accommodating the different sourcing requirements of the pharma industry under one roof. This year Pharmac received a huge response from the industry and attracted over 150 top exhibitors and 7,000 plus visitors. The USP of Pharmac 2012 was its SME-centric profile. It offered a platform for exhibitors to make their presence felt and rub shoulders with the pharma giants from around the world and showcase their products. In spite of being focussed largely on the Indian SMEs, Pharmac 2012 also witnessed participation from overseas exhibitors and visitors from China, Germany and Portugal to name a few.

From the organisers desk

Pharmac India 2012 was promoted and organised by Orbitz Exhibitions Pvt Ltd in association with Indian Drug Manufacturers’ Association – Gujarat State Board (IDMA – GSB). Expressing his views on the event, Rupen Vikamsey, MD, Orbitz Exhibitions Pvt Ltd, said, “Over the years, Orbitz has been striving hard to popularise Pharmac India as an SMEcentric trade event, and we have always focussed on giving this segment a platform to showcase their products, which is not possible in other pharma exhibitions in India. The momentum gathered by Pharmac India since inception has ensured a consistent growth rate of around 35 per cent and we look forward to promoting the SME sector in future staging of Pharmac India.” The organisers further added that

Pharmac 2012 in its third edition was bigger and better. With a huge turnout of visitors it provided a great platform for SMEs to showcase their products. After the success this year, the next edition will be held in Hyderabad. the exhibitors were satisfied with the turnout and found the response to be highly encouraging and good value for their money.

Next edition

The 3rd edition of Pharmac underway

With the success of its third edition the organisers have already set sails for the next edition. Almost 95 per cent of the exhibitors have showed a positive response on their participation in the next edition. Pharmac India 2013 is proposed to be hosted at Hyderabad, which is coming up as the next pharma hub.

Mod er n P har m a•1 - 15 Oc t ob er 2 012

Event List

N AT I O N A L E V E N T S Indian Lab Automation conference and exhibition ILA 2012 will feature three technical conference tracks; ‘Drug Discovery and Development’, ‘Advances in Bioanalysis’ and ‘Advances in Genomics and Informatics.’ The event will also provide excellent networking opportunities. Each track will provide attendees with the opportunity to listen to presentations on cutting edge research in specific application areas, with an underlying theme of automating the technique, equipment or associated informatics; October 30-31, 2012, Renaissance Hotel & Convention Centre, Mumbai For details contact: Select Biosciences Ltd Tel: +44 1787 315110 Fax: +44 1787 315111 Email: enquiries@selectbiosciences.com Website: www.selectbiosciences.com

Automation 2012 This is a prolific trade show that strives to present a wide range of scientific, laboratory, biotechnology equipment. The visitors will be highly benefitted from the event as there will be a conference too at the event. The event will also provide excellent networking opportunities. The event will be focussing on clinical research and will be attended by industry leaders; November 2-4, 2012, Hyderabad International Trade Exposition Centre, Hyderabad

For details contact: S D (India) Corporation Tel: + 91 11 4703 4600 Fax : +91 11 4705 6500 Email: info@indialabexpo.com Website: www.indialabexpo.com

P-MEC India P-MEC India, the most well attended and talked about Pharmaceutical Machinery, Equipment and Technology event. In this event the leading Indian and international pharmaceutical machinery exhibitors showcase their latest technologies and announce product launches. P-MEC focuses on key challenges in pharmaceutical services to develop more efficient production routes and systems of increasingly complex healthcare products. Technology demonstrations and onsite seminars will complement your visit to the show floor; November 21 - 23, 2012, Bombay Exhibition Centre For details contact: Chaitali Davangeri UBM India Pvt Ltd Tel: +91-22-6612 2642 Email: chaitali.patil@ubm.com Website: http://www.pmec-india.com/

Pharma Biotech Expo & Conferences Pharma Biotech Expo & Conferneces is an exciting new networking platform & international exhibition for pharmaceutical machinery & equipment, biotechnology & applications industry. The event will be a preferred destination for the pharma

AHMEDABAD

PUNE

CHENNAI

Gujarat, Oct 5-8, 2012

Maharashtra, Nov 2-5, 2012

Tamil Nadu, Nov 22-25, 2012

INDORE

AURANGABAD

RUDRAPUR

Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

LUDHIANA

Punjab, Dec 21-24, 2012

HYDERABAD

Andhra Pradesh, May 31- June 3, 2013

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details

Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@network18publishing.com

and biotech and it will attract more than 10,000 visitors & exhibitors with 100 stalls; November 21-23, 2012, Hotel Le Mariet, Baddi

Tel: +91 80 41131912 Fax: +91-80-41131914 Email: jagdish@mmactiv.in Website: www.mmactive.in

For details contact: Paramount Exhibitors Tel: + 91 172 2274801 Fax: + 91 172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

Pharma Technology Show – Delhi

Bangalore Nano Bangalore Nano event has truly emerged as the premier event for research fraternity and industry to come together and explore emerging opportunities in this sector. The event comprising of exhibition & conference will encompass two full days of presentations and discussions and interactive networking activities; a meeting place for the global scientists, industry, academia & government with a focus on ‘Frontiers of Nanotechnology: Impact on India’; December 5-7, 2012, Hotel Lalit Ashok, Bengaluru For details contact: MM Active Bengaluru

The event aims at bringing together world renowned companies as well as newly launched companies on one platform. It is an invitation to all those who want to seize this opportunity and to further galvanizing their position to take share of this lucrative market. The expected visitors will be the CEOs & top executives from pharma manufacturing industry, executives from production, quality control, R&D & purchase departments, professionals from R&D institutions, pharmacists from trade & profession, biotechnology specialists, top officials from regulatory agencies; December 7-10, 2012, India Expo Centre and Mart, Greater Noida For details contact: Print Packaging.com Pvt Ltd Tel: +91 22 27812619 Fax: +91-11 41722130 Email: info@indiapackagingshow.com Website: www.print-packaging.com

I N T E R N AT I O N A L E V E N T S 10th Functional Genomics Screening Strategies This event will cover the latest use of chemical genomics tools, potential use of micro RNA (miRNA), and long coding RNAs for identifying and validating drug targets, exploring unknown cellular pathways and for performing translational studies such as biomarker discovery, drug modifier screens, etc. In other words, this event aims to be a massive success; October 2, Boston, USA For details contact: Cambridge Healthtech Institute Tel: + 781 972 5400 Fax: + 781 972 5425 Email: chi@healthtech.com Website: www.discoveryontarget/RNAiScreens-Functional-Genomics.com

CSBio 2012 CSBio 2012 will also cover the engineering sciences related to the pharmaceutical industry, in both material and manufacturing sciences. This conference would like to gather like minded researchers and industrial counterparts who are involved in designing, developing and improving industrial processes and equipment for large-scale chemical and pharma manufacturing; planning and testing methods of manufacturing; developing methods for the treatment of bi-products; devising production processes that are safe, efficient, profitable

and environmentally sound; October 3-5, 2012, Bangkok, Thailand For details contact: School of Information Technology Tel: +66 2470 9834 Fax: +66 2872 7145 Email: csbio2012@sit.kmutt.ac.th Website: www.csbio.org

BIO-IT World Europe 2012 With the slogan ‘Enabling Technology. Leveraging Data. Transforming Medicine’ the 4 th annual BIO-IT World Europe 2012 attracts life sciences, pharmaceutical and IT professionals to share the research advances, information trends and new enabling technology driving today’s biomedical and drug development. This event aims to cater to all the professionals from the industry and hopes to be a sure success in this regard; October 9-11, 2012, InterContinental, Vienna, Austria For details contact: Cambridge Healthtech Institute Tel: + 781 972 5400 Fax: + 781 972 5425 Email: chi@healthtech.com Website: www.bio-itworldexpoeurope.com

CPhI Worldwide The event hosts over1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three

co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and providevisitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain 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

Maximizing Pharmaceutical Patent Life Cycles American Conference Institute’s (ACI’s) Maximizing Pharmaceutical Patent Life Cycles conference is the pharma industry’s leading and integral source for information and analysis on patent life cycle management for both small and now large molecule pharma products. It is the forum where lawyers, executives and policy makers for brand name and generic manufacturers gather each year to prepare for the life cycle challenges they currently face as well as those which they anticipate; October 10-11, 2012, New York Marriott Downtown, New York, US For details contact The American Conference Institute Tel: 1-212- 352-3220 Fax: 1-212-352-3231 Email: clehelp@americanconference.com

Website: www.americanconference.com

2012 Nanotechnology Conference The event aims to bring together a panel of highly-accomplished nanotechnologists and well recognised authorities in various aspects of nanomedicine. This unique international conference offers an opportunity for pharma scientists, clinical researchers, physicians, therapists and industrial leaders to discuss the important international breakthrough developments in drug discovery, drug development, drug delivery, drug therapy and commerce to share their thoughts and exchange ideas and knowledge. It will also serve as a platform for networking. The fourday conference will focus on the basic studies through translational efforts and clinical trials and address topics of novel issues concentrating more on recent advances, difficulties, and breakthroughs. This is how the event aims to reach out to the experts and decision makers of industry; October 31- November 3, 2012, Riviera Maya, Mexico For details contact: Zing Conferences Tel: +44 1223 750020 Fax: +44 1223 280270 Email: info@zingconferences.com Website: www.zingconferences.com

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 Pharma.

Mo de rn Ph a rm a •1 -15 Oct o be r 2 012

Book Review Handbook of Analytical Validation

Editors: Michael E Swartz & Ira S Krull

A concise guide to method validation processes in the pharmaceutical and biotechnology industry, this book takes a practical view on the day-to-day decisions faced by the chemist or the scientist. The book is special from a regulatory standpoint as it explains each process from a regulator’s requirement perspective. The book uses the technique of liquid chromatography and its many applications to describe every step in the analytical process. The book starts by explaining the regulatory landscape and its requirements in the present era and then goes on to give a checklist for every step in the analytical process. Discussion right from choice of instruments to choice of processes to precision, accuracy of methods gives a complete insight into validation of the entire process. A good ready reckoner for daily reading and a good concise guide to HPLC-related analytical methods. This book is particularly written for practitioners in both the drug and biotechnology industries. It carefully compiles most of the current regulatory requirements on the validation of new or modified analytical methods. In other words it summarises the latest regulatory requirements for all aspects of method validation, even those coming from the USP. Thus, the book covers development, optimisation, validation, and transfer of many different types of methods used in the regulatory environment. In other words, it simplifies the overall process of method development, optimisation and validation, etc. Editors: Patricia M Danzon, Sean Nicholson Price:

` 4,995/-

Publisher: Wiley Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

` 8,200/-

Price:

Publisher: CRC Press Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

The Oxford Handbook of The Economics of the Biopharmaceutical Industry The biopharmaceutical industry has received a share of spending in the large few decades. This spending has driven for innovation-based products, better healthcare products for consumers, good returns for stake holders and increased funding towards R&D. The book is a complete guide to the economic aspect of this industry. The editors have put together brilliantly monographs from esteemed personalities in this industry to give a complete view of this industry economics. The first part of the book deals with ‘innovation in pharmaceutical industry’ and the cost & returns on R&D. It also deals with funding for research, raising capital, regulatory landscape, patents and exclusivity and the economics linked to them. The second part on ‘market for pharmaceuticals’ deals with pricing policy in the US and other countries and reimbursement through insurance. It also explores special markets like developing nations and needs for vaccines and anti-infectives. There is a dedicated chapter on advertising and promotion to physicians that is a contentious issue in every market. The book concludes with guidance on M&A in this sector of the industry, which has been a recent trend changing the industry landscape across the globe. Every chapter relies heavily on published scientific data and papers and the authors have compiled them comprehensively. A great book for the economic researchers, pharmaceutical stakeholders and investors. Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

invite that

rewards as well... An

Dear Reader, ‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

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2012 I Vol 1 I No 6 I `100

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Dr Rajesh Jain Joint MD, Panacea Biotec Ltd

Cipla wins patent case against Roche

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Cosmeceutical trials in India Scanning the growth opportu nities

Strategy 18

‘Catching’ young doctors Hit hard, hit early!

Interface

Panacea in

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Ramprasad Reddy to hea Aurobindo’s d US arm

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James C Greenw ood President & CEO, Biotechnology Industry

Cathay Pacifi c star Pharma LIFT ts biweekly services

Organization THE Delhi High Court that Indian recently held pharma major not infring Cipla has ed of Swiss drug upon the patent right company La-Roche F Hoffman on a cancer drug. According to Justice INDIA has Singh, erlotin Manmohan about sites for pharm 74 US FDA-approve Roche’s patent ib hydroc hlorid d a manuf e, ed drug, acturing, which is the highes under the promoted t brand Tarcev pharma indust outside the US. With a is like Cipla’s access the shipme ry growin cancer drug also valid than 10 per nt temper under the promoted finger tips. cent per year, g at more trade name Kapur elabora ature at their secured the and having The decisio Erlocip. assure the alert ted, “We also n third largest position of being filed by Rochecame on a petitio the measure when system tricker preven in n tive volume, Cathay the world in terms accusing manufacturin a risk level. temperature reading of Pacific Airway g and marke Cipla of is at developed We cancer drug s have ting the a reputation peace of mind are giving custom under the er a pharma carrier as a qualifie Erlocip, which trade name We have over using CX Pharma LIFT. d LIFT.’ Ashish with its brand ‘Pharm generic version it claimed was the Pharma LIFT 60 stations qualified a Kapur, Region of its patente Manager for al Cargo erlotinib – South Asia, qualifies CX, operation. Once shipper d drug hydrochloride and Africa, it means they Middle East under the , promo CX to all Cathay Pacific can entrust ted brand Tarcev Pharma LIFT said, “We Airways, a. are all under one routes as it most qualifie recognised as one of is service standar Plethico mand the and d pharma traffic d as design monitor by by many CX headqu for debt restruates Elara Capita carriers pharmaceutic The service arter.” l cturing and interna s are render al PLET HICO ed to packag of all sizes tional freight companies using time who also have Pharm aceuti forwarders has manda and temper es packaging cals ted Elara Kapur ature rangin programme. a solid healthcare traffic restructuring Capital for units of contain g from small to many Pharma LIFT its $ 75 a brand is definitely ers and airlines outstanding well million Kapur said, culture. convertible pallet. pharmaceutic established within in October. bonds due the shipme Our staff takes care 747 freight “We have one charter al In Pharma LIFT industries.” er of every nt; the salient company had October 16, 2007, the pharmaceutic carrying about 80T features include automatic requirements. is designed as per of als on one issue of Foreignraised $ 75 million communicat the on-line This year freighter.” Further elabora by ion Curren Cathay the system temperature services render cy Convertible Bond (FCCB ting on Pacific has tracking, priorit , extended its handling, s), which already ed, Kapur “Cathay service 24/7 maturity in are due for y with a added, Pacific produc critical contro support and multip October this biweekly freights to Hyderabad made t is tailor as per le the expans year. l er. Talking comprehensiv points. Overall, we about ion plans, besides our shipper’s requirement, offer believe Notices to Kapur said, wide global information e quality assurance pharma compa in the potent “We we special with are network for non-paymen transparency.” ial of India ise nies in the proces Curren and and cooling in active pharma, t of Service Governmen s of conduc heat with tly, Cathay Pacific extensive pharma, passive Tax: t ting an is working research on GSK, Pfizer, and room THE Govern pharm temperature destinations Sanofi Pasteur a service the differe thrust is s offered by pharma. Our nt recently served ment of India has to embra them include . The continuously in India. temper ce pharm roll out Pharm We also manufacturer show cause notices a lift shipme ature track for active on-line other CX to s of pharm and KA networ a LIFT to solution nt, which who have allows compa of service k as deman failed to pay a products requires.” nies to d worth crore Service Tax of rupees. Accord information ing to the - Shibani Shah provided by Ministry, necessa the Financ e PANACEA the government ry action to safegua Biotec Ltd, rd revenue has has inked as per the other global been taken a provision ten-ye market ar High agreement places. produc of Finance and Service with Act Tax t. Financial Pharm aceut Osmotica generic barrie r entry of Srikant Kumar Rule. According details s are difficu the agreem to Jena, Ministe major US-ba ical, ent a develo for Chemi r of State p with conven lt to disclosed. Both were not sed global cals suppli er tional will companies focus is require and Fertilisers, more techno logies of form a ‘Joint d to be given and are pharm aceuti specia lity specifi collection Steering towards Committee’ cally used cals of intellig DRUG to regulat develo p to monito for a the ence, audits and firm Aurob high barrie r ed anti-evasion intensive Pharm a indo entry generic r in patient delivery of drugs and entire development recent ly prevent evasion checks to and brande said s. comm erciali its Board of tax. pharm aceuti d has approv that sation process. The cals. The appointment ed new strateg new Sun Pharm of P V Rampr the drug portfolio would ic alliance Reddy as asad based on is Executive innovative a in Forbes most a 50:50 profit, on the Depo be based Chairman list of Aurob finance and Injections indo Pharm RANKED and risk sharing among five a USA, Inc. Accord formu lation for a drug companies, other Indian ing to the based on s portfolio Sun Pharm made by filing nanoparticle 18 produc of it to the list a has made With s. ts across a the new of 100 most Aurobindo wide array range firms in innovative products, of therape the world Pharma to both compa of utic catego ries. prepar Forbes, US nies are expecti Subseq uent business magazi ed by BSE, the ng to tap to the deal, Pharmaceutic ne. Sun the opportunity Panacea will al Board of of $ 25 billion be respon pharma compa Industries, special sible for R&D, market in ity Directors the US alone; produ ct order to be ny, is ranked 38. with first identif ication In of considered product launch and manuf the Dr Jain at least 7 in the list, projected to acturing years company hit the market the new of a given firm of financial data Reddy by 2015. compo unds, for has is needed. The allianc while Osmo to Forbes, In additio According e is forecast to tica will firms with approv n, strengt Panac handle ed the market value greater than ea compe hen will also the USFD propo sal obtain titive positio the appoin tment $ 10 billion of approval, A resear which make ns of of Reddy marketing ch emolu fixed Panacea and some investm and those Execu tive and apart as distrib ution Osmotica ments the were conside ent in R&D in from 50 per generic drug of these red. Aurob indo Chairm an of generics in cent of segment the develo throughout the US and pment expens Inc. Furthe Pharm a USA, the US and for each es other r, it also key market that the new added added s. said propo subjected sal is - Nikunj Sharma to further approval of the shareh olders the compa of ny.

Senior Editor Modern Pharma

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Products

Thermo Scientific Molecular Bio Products Molecular Bio Products are made from plastics injection moulding and their core competency and focus is to provide value added solutions to the liquid handling needs of the life science researcher in academia, biotech and pharmaceutical companies around the globe. Bio products like pipette tips, gel loading tips, reach tips, solvent safe tips, wide bore tips and racks are produced by applying statistical process control, statistical quality control, and other cutting edge technology. The products also features patented technology of ARTAerosol resistant tips which are the only barrier tips available in the world which function on unique self sealing barrier preventing pipette contamination and carry over contamination caused by aerosols and liquids. Thermo Fisher Scientific India Pvt Ltd Powai, Mumbai Tel: +91 22 6716 2200, +91 22 6716 2259 Fax: +91 22 6716 2244 Toll Free No: 1800 22 8374 Website: www.thermofisher.com , www.thermo.com

Laboratory chillers Polystat® Laboratory Chillers has quick rampup and cool-down with all operational and preventive maintenance accessed through the front panel. Designed to provide temperature control with the flexibility needed for demanding applications, they fit comfortably on a laboratory bench top. These chillers feature a temperature range of -10 to 80°C. The chillers allows the user to choose between five temperature set points. The air-cooled refrigeration system eliminates need for external water source and the small internal reservoir limits evaporation. With built-in energy-saving mode, this series provides an environmentally friendly option for any laboratory. This mode activates a responsive control that will allow the chillers to operate with minimal energy consumption Cole-Parmer India Mumbai - Maharashtra Tel: 022-6716 2222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Adapplicator system developed by Braun, the spray alternative to needle injection, are few examples. Neejtech India Ahmedabad - Gujarat Tel: 079-26561312 Mob: 09825040231 Email: info@neejtech.com Website: www.neejtech.com

Steam boiler The fully automatic package steam boiler (IBR) has capacity ranging from 100 kg/hr to 2000 kg/hr with operating pressure of 10 kg/cm² g. Smoke tube & water tube version is also available. Coil is made from seamless tube of asthma 106 GR-B pipes. The unit is equipped with high efficiency oil/gas burner with air pre-heater arrangement which gives high thermal efficiency. Aero Therm Systems Pvt Ltd Ahmedabad - Gujarat Tel: 079-25890158 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com

Pharma inspection machine The paper folding, shrink pack and pharma inspection machines are tested for CE marking, and thus fulfill one of the major statutory requirements of European Union. A range of customised solutions as per pharma industry requirements is also offered. Pharma inspection solutions include: pharmacode readers, leaflets and cartons. These have been specially designed for online checking of pharma codes printed on tubes, cartons, leaflets, labels, etc. Pratham Technologies Pvt Ltd Pune - Maharashtra Tel: 020-24352624 Mob: 09822047399 Email: enquiry@prathamtech.com Website: www.prathamtech.com

Filtration and separation products

Cleanroom moulds

Adapplicator, Alu cap, Snap cap, PE bottle pack cap, PE twin port cap are only some of many cleanroom moulds from Braunform. Highly sensitive packaging and measuring components, caps for use in dental and insulin fields, dialysis components, hygiene products and the

Advantec’s wide range of filtration solutions are used for laboratory, research and process applications. These products are used in a wide variety of scientific capacities and applications, such as microbiological analysis, air/gas

filtration, and environmental monitoring. Advantec’s range of filtration products fits comfortably within Cole-Parmer’s own product range. It offers customers an additional and valuable range of unique quality products that will enhance their processes and research. Cole-Parmer India Mumbai - Maharashtra Tel: 022-67162222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Capsule filling machine T h e s e automatic capsule filling machines also known as encapsulat ion equipment are compact, sturdy, covered with stainless steel panels, and hood covered with acrylic guard. The fill weight adjustment takes place within seconds. These machines are provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation with ±2 per cent. Anchor Mark Pvt Ltd Mumbai – Maharashtra Tel: 022-28682001 Email: sales@anchormark.com Website: www.anchormark.com

Swiss eco-friendly disinfectant The product Virosil Pharma is based on H y d r o g e n Peroxide (H2O2) with Silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, and revolutionary. Virosil Pharma is presently being used as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment. The added benefits of Virosil Pharma is that it does not give any foul odor, irritation to the eyes, requires no de-fumigation and is very easy to handle. A room of 1000 cubic feet can be ready and completely sterile within a maximum period of 60 minutes using a 20% of solution of Virosil Pharma. With a recommended ULV fogger which gives a very fine mist that even penetrates between cracks of surfaces ensuring a safe and sterile environment. Sanosil Biotech Pvt Ltd Mumbai Tel No: 022 22872295, +919820016292 Email: info@sanosilbiotech.com Website: www.sanosilbiotech.com

Sieves

These are silicon moulded sifter sieves, fluid bed dryer (FBD) sieves and FBE dryer sieves. The silicon moulded sifter sieves are available in various sizes from 12” to 48” diameter. These are available in rivetted and special non-rivetted design. The mesh sizes vary from 4 mesh to 500 mesh with ASTM & BSS Standards. Atlanto Enterprises Mumbai – Maharashtra Tel: 022-23096098, Mob: 09819942853 Email: atlantoent@yahoo.co.in Website: www.atlanto.net

Metal analyser The 7700 series ICP-MS metal analyser is productive, simpleto-use, high sensitivity, low background, better interference removal, increased flexibility, easier to maintain and service. This workhorse 7700x is used for most applications, and in highthroughput commercial labs. It is designed specifically for semiconductor applications. The new 7700e offers a simplified and easy-to-use system for routine analysis. Featuring a new, configurable MassHunter software platform and a host of hardware developments, including a new frequencymatching RF generator and 3rd generation Octopole Reaction System (ORS3), all three 7700 series mainframes provide unrivalled levels of performance and ease-of-use. Agilent Technologies India Pvt Ltd New Delhi Tel: 011-51496664 Email: agilent@agilent.com Website: www.agilent.co.in

Walk-in humidity chamber The unit has doublewalled insulated PUF modular panels, which can be easily assembled at site. Interior is made of stainless steel and exterior is either made of mild steel finished with powder coating or stainless steel. The unit has full-length inner glass door and outside metal door with magnetic gasket and lock. It is provided with perforated stainless steel trays and has forced air circulation for uniform temperature. The intelligent controlling system has PLC base and PC communication. It has long lasting stainless steel tubular heaters with SS fins. Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in 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

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