Modern Pharmaceuticals - June 2011 by Infomedia18

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Editorial

The innova on impetus

he pharmaceutical sector seems to be at an inflection point, especially with regard to R&D. With patents of many drugs set to expire over the next few years, and only limited players having strong enough product pipelines to bridge the imminent revenue gap, the writing is on the wall. Prima facie there is an ardent need to develop more innovative products with substantial benefits for multiple stakeholders in the pharma value chain that include healthcare players, providers and patients, as well as product manufacturers. The critical question is how one can attain a significant level of R&D productivity in the backdrop of sweeping changes impacting the regulatory and socio-political ecosystem across the globe. According to a recent report by PricewaterhouseCoopers, a typical challenge in the R&D space is about deciding which elements of the innovation process to pursue and retain in-house versus accessing the operational changes needed to improve the speed of response for various types of innovative treatments via new types of strategic partnerships. Some other key challenges include the impact of migrating from the current linear phase R&D process towards in-life testing and live-licensing; approaches to collaborating more closely with regulators and healthcare providers

about pricing, efficacy and value for money; the implications for a company’s current business model and human capital issues, to list a few. As far as the Indian Novel Drug Delivery System (NDDS) segment is concerned, although there have been several positive steps taken in the recent years, it still seems to lag behind the advanced markets. Examples could be in areas such as using nanocarriers for gene delivery, protein or peptide-based systems, etc. Digging deeper, one can see the causative factors to be lack of availability of the latest polymers, raw materials, state-of-the-art equipment, or some sort of disconnect between academia and industry research. On the other hand, this offers tremendous opportunities to leverage on the growing NDDS products market. ‘Industry Update’ offers an in-depth perspective on the recent R&D trends in pharma with a focus on NDDS. Also, take a look at ‘Market Trends’ and ‘Roundtable’ for the latest on the impact of the Minimum Alternate Tax and data exclusivity on the Indian Inc, respectively, among others.

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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

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Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Infomedia 18 Ltd and printed at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J.K.Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharmaceuticals is registered with the Registrar of Newspapers of India under No. 14798/2005. Views and opinions expressed in this publication are not necessarily those of Infomedia 18 Limited. Infomedia 18 Limited reserves the right to use the information published herein in any manner whatsoever. While every effort has been made to ensure accuracy of the information published in this edition, neither Infomedia 18 Ltd nor any of its employees accept any responsibility for any errors or omission. Further, Infomedia 18 Ltd does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition. No part of this publication may be reproduced in any form without the written permission of the publisher. All rights reserved.

Editor: Manas R Bastia

June 2011 I Modern Pharmaceuticals

Contents REGUL A R SEC TIONS

FE AT URES 20 28

Editorial .........................................................13 National News...............................................16 World News...................................................22 Tech Updates.................................................26 Events Calendar.............................................76 Technology Transfer ......................................78 Book Shelf .....................................................80 Product Update ............................................82 Product Index ................................................91 Advertisers’ List.............................................92

NEWS ANALYSIS Sanofi Pasteur’s Pentaxim®: A step towards preventing infectious diseases

LEADERS SPEAK 'Data protection is not a tool for extending the patent period for the medicines' ...says Ranga Iyer, Advisor, Pharmaceutical Research and Manufacturers of America (PhRMA)

34 38 42 50 52

ROUNDTABLE Data exclusivity for Indian pharma: Beneficial or detrimental?

FACILITY VISIT

Anthem Biosciences Pvt Ltd: Making waves in the field of bioscience

INDUSTRY UPDATE R&D in pharma: From imitation to innovation

MARKET SCOPE Crohn’s disease market: Increased uptake of biologics

IN DIALOGUE 'MAT should be abolished, or at least the rate should be brought down to 10 per cent’ ...says Satish Reddy, Chairman, Confederation of Indian Industry (CII) National Committee on Drugs and Pharmaceutical and MD & COO, Dr Reddy’s Laboratories Ltd

54 58

MARKET TRENDS Pharma SEZs in India: Is MAT taxing more problems?

SPOTLIGHT

Highlights of Next Edition:

Lonza: Leveraging the SEZ advantage

RETAIL ZONE Training pharmacy staff: Providing assistance and beyond Rajendra Pratap Gupta, International Healthcare Policy & Retail Expert

LEGAL EDGE Compulsory licensing: Access to innovative pharmaceuticals Anuradha Salhotra, Managing Partner, Lall Lahiri & Salhotra

Details on page no.

Industry Update Supply chain management & logistics for pharma Market Trends HR issues/policies in pharma sector

Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

BUSINESS MANTRA Marketing and analytics: Services for leading the competitive advantage

INTERFACE 'We plan on generating awareness and buiding on our presence in India’ ...says Jamie Hintlian, Vice President, Pharmaceutical Business Unit, AspenTech

INDUSTRY INSIGHTS Cancer vaccines market: High ummet needs GlobalData

CURTAIN RAISER 2nd Annual Biosimilars and PharmaLytica India: Aiming for a stronger foothold

Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818. Modern Pharmaceuticals I June 2011

National News Sanoﬁ and DNDi in pact to generate new drugs for neglected tropical diseases Sanofi and Drugs for Neglected Diseases initiative (DNDi) recently declared a three-year research collaboration agreement for the research of new treatments for nine Neglected Tropical Diseases (NTDs) listed by the World Health Organization (WHO) for which new and efficient tools are urgently required to treat patients in endemic countries. The rights to results produced by this partnership will be co-owned by Sanofi and DNDi. Further, the partners will facilitate publication of the results to ensure access to the wider community of researchers focusing on NTDs. The public sector will benefit from the drugs developed through this agreement under the best possible conditions to ease access for patients in all endemic countries, irrespective of their level of economic development. “Sanofi is committed to bringing therapeutic solutions to those most affected and exposed to NTDs,” said Dr Elias Zerhouni, President, Global Research & Development, Sanofi. “In this new research collaboration with DNDi, we have taken a firm step towards greater flexibility in the sharing of knowledge to produce new medicines,” he added. “This agreement is a major milestone in our access to molecules that can help combat neglected diseases,” said Dr Bernard Pécoul, Executive Director, DNDi.

Lincoln launches Tinnex injec on in India Lincoln Pharmaceuticals Ltd (LPL), recently introduced the much awaited Tinnex injection in India; this is a part of its agreement with Phafag AG, Switzerland to produce the caroverine molecule for the treatment of tinnitus – commonly known as ‘ringing in the ear’. LPL is the sole manufacturer and distributor of Tinnex injection in India and the first company in the country to introduce a cure for Tinnitus. LPL has sold 500 ampoules of Tinnex injection all over India in the last one month. Already 70 per cent of the patients on the treatment have experienced relief from tinnitus. Mahendra G Patel, Managing Director, Lincoln Pharmaceutical Ltd, said, “The launch of Tinnex injection makes LPL the first company to provide a treatment for tinnitus in India. Tinnex injection will be a boon to patients who have been silently suffering from this disease.” He further added, “With over 48 million people suffering from tinnitus in India there is a huge potential for Tinnex injection. With our efforts to promote Tinnex all over India through well-trained field staff, we are aiming to create substantial demand in the first year itself. This product will further strengthen our position in the Indian pharma industry and will go a long way in establishing the brand.”

Bharat Biotech announces the price of ‘ROTAVAC’ Bharat Biotech, a multidimensional biotechnology company, recently declared the price of RotaVac®, India’s first indigenously developed rotavirus vaccine. The vaccine Dr Krishna Ella will be sold in global market, governments worldwide including United Nations (UN) procurement agencies at a price of $1.0 per dose. Bharat Biotech hopes its new vaccine will help prevent part of the ~ 500,000 child deaths each year caused due to rotavirus diarrhoea and therefore improve access to better, affordable rotavirus vaccines. RotaVac® expects India licensure during 2014 and World Health Organization (WHO) prequalification in 2015 for supply to UN agencies. The vaccine is currently undergoing phase III clinical development for safety and efficacy in 8000 subjects, one of the largest such clinical trial ever conducted in India. Announcing the price, Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Offering rotavirus vaccines at $1 is a reaffirmation of our commitment to make vaccines affordable globally. It is a great effort by the Bharat Biotech team that made this a possibility. The key to our success of bringing down cost of vaccine is our novel concepts in vaccine development and innovative manufacturing processes with public health in mind.”

Indegene bags seven Hermes Crea ve Awards for 2011 ‘Advertising Campaign’. In the Gold awards Indegene Lifesystems Pvt Ltd recently announced grouping, Indegene won three under the that it has won seven awards at the prestigious categories of ‘Overall Website,’ ‘e-Learning’ and Hermes Creative Awards 2011. Hermes Creative ‘Video-Marketing Services.’ Awards is an international competition for creative Speaking on winning the Hermes awards, professionals involved in the concept, writing and design of traditional materials and programmes, Manish Gupta, Chief Executive Officer, Indegene, and emerging technologies. They are administered said, “This is an important achievement for us. We are honoured to get this recognition as we and judged by the Association of Marketing and Manish Gupta, CEO continue to add value to the commercialisation Communication Professionals (AMCP). This year Indegene won four Platinum awards under the and marketing initiatives of our clients through high-quality categories of ‘Overall Website,’ ‘e-Learning Solutions’ and and cost-effective solutions and services.” 16

Modern Pharmaceuticals I June 2011

National News Mylan to rebrand Matrix Laboratories Mylan Inc has recently announced that it plans to rebrand its Hyderabad-based subsidiary Matrix Laboratories Ltd as Mylan. Mylan had purchased Matrix in 2007. Since then, Mylan has successfully integrated the two organisations, along with the generic business of Merck KGaA, to build a platform with $5.5 billion in 2010 revenues, a workforce of more than 17,000 employees, and commercial sales in more than 150 countries and territories. Since Mylan’s acquisition, Matrix’s workforce has grown from approximately 3,800 employees to more than 8,500 employees. Robert J Coury, Chairman and Chief Operating Officer, Mylan, said, “Today, we are building on our accomplishments by announcing our intention to rebrand Matrix as Mylan. This

rebranding will lay the groundwork for continued expansion in India through our entry into the Indian commercial market with our own prescription pharmaceuticals within the next 12 months. As we grow, we will continue to apply our global standards of excellence to our operations around the world.” Further, Heather Bresch, President, Mylan, commented, “Having led the integration of Matrix and Mylan, I am particularly excited about today’s milestone. Changing Matrix’s name to Mylan represents a natural next step for our business in India, and we believe it will produce many benefits. Key among them will be the ability to speak with a more unified and powerful voice.”

Companies get two weeks to ﬁnalise compensa on for trial deaths

Elder Pharma to launch ﬁve products in the European market

Pharma companies have been given two weeks to finalise the amount they have to pay as compensation to the legal heirs of those who died in their clinical trials in 2010. Dr Surinder Singh, Drug Controller General (India) (DCGI), cracked the whip on nine pharma companies for not paying up ‘compensation for trial related death’ in the case of 20 people. These individuals died last year due to the drugs being tested on them. The nine companies are: Wyeth, Quintiles, Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, PPD and Pfizer. Further, a DCGI official added, “Many of the companies said they had not paid the compensation yet because their ethical committees were yet to finalise the amount. We have therefore told them that an interim arrangement has to be made by June 20, 2011.”

Elder Pharmaceuticals recently said that it plans to launch five products, including its top domestic brands such as calcium-loaded Shelcal, in Europe this fiscal in a bid to increase overseas revenue. The company will be introducing these products in Europe through its subsidiaries in UK and Bulgaria. Alok Saxena, Director, Elder Pharmaceuticals, informed, “In the current financial year, five products will be launched in European countries.” Among the five products to be introduced in Europe is the company’s calcium supplement for women, Shelcal, one of its largest selling pharmaceutical products in India, with annual revenues of around ` 200 crore. Currently, revenues from foreign markets contribute around 10 per cent to the total revenue of the company and the management aims to take it to 20 per cent by the end of the current fiscal, Saxena added. “Our subsidiaries in the UK and Bulgaria have a strong marketing and distribution network in Europe, which will help us to increase our penetration there,” he said. Elder Pharma has set a revenue target of ` 1,000 crore for the current financial year and ` 1,200 crore for FY’13. The company plans to launch around 40 products in the pain management, women’s healthcare, nutraceuticals and dermatology areas in the domestic as well international market during the next two years to achieve this target, Saxena added.

Plethico Pharmaceu cals announces Q1 FY 11 results Plethico Pharmaceuticals Ltd, a leading global healthcare and pharma company, with a strong emphasis on the herbal and nutraceutical segments, recently declared its financial results for Q1 FY 11, ending March 31st, 2011. Consolidated revenues stood at ` 354 crore. Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA) margin stood at 20.1 per cent as against 14.3 per cent for Q4 FY 10; an increase of 580 bps. Further, consolidated net profit before extraordinary items for the quarter stands at ` 54.4 crore as against ` 24.7 crore of Q4 FY 10; a growth of 120 per cent and after extraordinary items for the quarter stands at ` 55.2 crore as against ` 26.5 crore of Q4 FY 10; a growth of 108.8 per cent. Again, basic Earnings Per Share (EPS) for the quarter stood at ` 16.0 Commenting on the results, Shashikant Patel, Chairman and Managing Director, Plethico Pharmaceuticals Ltd, said, “I am happy to announce that we closed the first quarter with consolidated revenue of ` 354 crore. The key highlight of this quarter has been the resilience shown by margins and net profits which bounced back smartly to 20.1 per cent and 16 per cent, respectively. The focus of the company will be continued concentration markets that would give us better margins as we move forward.” June 2011 I Modern Pharmaceuticals

National News Glenmark conﬁrms se lement for hydrocor sone butyrate Glenmark Pharmaceuticals Ltd and Glenmark Generics Inc, USA have entered into a settlement and licence agreement with Triax Pharmaceuticals, LLC, Astellas Pharma Europe BV and Astellas Pharma International BV (Astellas and Triax) to resolve a United States patent infringement suit related to Glenmark’s filing of an Abbreviated New Drug Application (ANDA) for 0.1 per cent hydrocortisone butyrate cream, Glenmark’s generic version of Locoid Lipocream®. Subject to the terms of the settlement and licence agreement, Glenmark will be permitted to market and distribute Glenmark’s 0.1 per cent hydrocortisone butyrate cream under a royalty-bearing licence from Astellas and Triax in the US near the end of 2013. Glenmark believes that it is entitled to 180 days of exclusivity with respect to its hydrocortisone butyrate cream, as the first generic company to file an ANDA for the product. Locoid Lipocream® is available as a 0.1 per cent hydrocortisone butyrate topical corticosteroid cream. According to IMS Health data, for 2010, Locoid Lipocream® achieved sales of approximately $38 million.

Granules India plans to invest `100 crore Granules India, a large scale manufacturing company, is planning to invest `100 crore this financial year in order to increase the capacity of its manufacturing facilities. This is aimed to help the pharma company to meet the increasing demand from multinational companies for finished dosages and Pharmaceutical Formulation Intermediates (PFIs). “We will increase our finished dosage capacity to 18 billion tablets a year from 6 billion. The expansion will be over by end of this financial year. We are also increasing PFI capacity to 15,000 tonnes from 8,000 tonnes a year,’’ said C Krishna Prasad, Managing Director, Granules India. Over 60 per cent of the funding for expansion will come from internal accruals, while the rest from borrowing. The company’s debt equity combination stands at 0:0.42. The Hyderabad-based company also plans to bring down its dependency on Active Pharmaceutical ingredients (APIs) with the expansion.

Redox Labs to train 10,000 people Redox Laboratories, Visakhapatnambased pharmaceutical finishing school in the country that trains science graduates from rural background, aims to train 10,000 people in the next three years. Started in 2009 with the support from the District Rural Development Agency (DRDA), Redox has so far trained 800 people. “We will train 3,000 people this year — assigned to us by the State Government,” said P Durga Prasad, Founder and Managing Director, Redox Laboratories.

There is currently a gap of 60 per cent between the current requirement and supply of skilled manpower in the pharma and drug industry, he said. The industry requires 80,000-90,000 people in India and 30,000 in Andhra Pradesh. The gap will only widen in the next 4-5 years as some of the major drugs would expire while a lot of new generics were being developed here, he said. Redox Laboratories takes BSc graduates (with chemistry major) between the age group of 21 and 26 years from rural

background and gives a 45-day practical training in production systems, methods, licences and environment hazards. “We try to bridge the gap between academics and shop-floor practices and techniques through the training centre,” he said. The DRDA bears all expenses right from training, accommodation to food, according to Prasad. The trained students are hired by major companies and Small and Medium Enterprises (SMEs). The salary ranges from `6,000 (in SMEs) to `12,000 (large industries).

Contract research to grow at a healthy clip, says ICRA

According to a recently released report by ICRA Ltd, the domestic market for outsourced pharma research and manufacturing activities also called Contract Research and Manufacturing Services (CRAMS) is in the pink of health and looks set to capture a sizeable chunk of the global outsourcing pie by 2012. 18

Further, the CRAMS sector in the country is expected to almost double to $7.6 billion (around `34,000 crore at the current rate) in 2012, up from $3.8 billion in 2010. Of this, contract manufacturing was $2.3 billion. The segment will grow at a globally high 41.4 per cent Compounded Annual Growth Rate (CAGR) during the fiscal years 2010-12, while worldwide, the outsourcing market is expected to grow at a far lower 12.6 per cent CAGR, the report says. Custom or contract manufacturing will lead the segment. “The growth will be supported by the huge number of US Food and Drug Administration (FDA)-approved plants,

skilled manpower coupled with inherent cost advantages, which will enable India to capture a significant chunk of the current $67 billion global pharma outsourcing market,” the report reveals. Among some significant CRAMS players, the report mentions Jubilant, Biocon, Strides Arcolab, Dishman Pharma and Divi’s Labs that have gained from some winning global deals. Again, Contract Research Organisations (CROs) grew five-fold in three years, from around 20 in 2005 to around 100 in 2008. The number may reach 150-200 by 2012, the report said. Modern Pharmaceuticals I June 2011

News Analysis

Sanoﬁ Pasteur’s Pentaxim®

A step towards preven ng infec ous diseases The launch of Pentaxim® marks the beginning of a new era in the immunisa on ﬁeld in China. This vaccine aims to immunise against diphtheria, tetanus, pertussis, polio and haemophilus inﬂuenzae type b. in which no one suffers or dies from a vaccine-preventable disease.”

Strategising the marke ng

Chandreyee Bhaumik

anofi Pasteur, the vaccines division of Sanofi, recently launched Pentaxim®, the first 5-in-1 combination vaccine in China in order to immunise against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b.

The debut… The introduction of the first 5-in-1 combination vaccine was celebrated with over 200 Chinese and international experts and hailed as the beginning of a new era in the immunisation field in China. Further, in order to facilitate the adoption of the new combination vaccine for the benefit of consumers, the Chinese Preventive Medicine Association (CPMA) introduced a first-of-itskind technical guideline for doctors at Points of Vaccination. Discussing the cost of the Pentaxim® in China, the spokesperson from the company, said, “Pentaxim is currently supplied to the private, out-of-pocket market and the complete schedule includes four shots. 20

The pricing of Pentaxim in different countries is based on the local situation and subjected to government approval. In many countries, Pentaxim is included in the national immunisation programme.” Pentaxim® (DTaP-IPV-Hib) vaccine was first marketed in 1997. To date, more than 100 million doses of Pentaxim® have been distributed in over 100 countries, and the vaccine has been included in the national immunisation programmes in 23 countries. It is the first acellular pertussis pentavalent vaccine in China against five deadly childhood diseases. It reduces the number of shots from twelve to four, and achieves the same level of protection as immunised with single-antigen vaccines. Presiding over the launch ceremony, Christopher A Viehbacher, Chief Executive Officer, Sanofi, commented, “We are truly excited and proud to bring the first 5-in-1 combination vaccine to China, and are greatly encouraged by the confidence and support of immunisation experts in China. Over a century after Louis Pasteur invented the world’s first rabies vaccine, Sanofi Pasteur remains committed to its vision, which is a world

The launch of Pentaxim® vaccine comes just 18 months after Sanofi Pasteur introduced the first and only Inactivated Poliomyelitis Vaccine (IPV) to China. It also adds to a long list of innovative vaccines that Sanofi Pasteur has brought to the country, including the first rabies vaccine, the first influenza vaccine and the first Hib vaccine. Elaborating on the marketing strategy of this product, the spokesperson explained, “Consumer education is the key to the marketing of Pentaxim because it is the first 5-in-1 paediatric combination vaccine in China. Again, there is also the need for strong professional support for combination vaccines and particularly Pentaxim, the first 5-in-1 vaccine. Pentaxim will be distributed through the Center for Disease Control & Prevention (CDC) system. Experts pointed out that, in addition to less shots for infants and greater comfort for parents, the new 5-in-1 (DTaPIPV-Hib) combination vaccine ensures better compliance with the vaccination schedule. Fewer shots also mean time saved for parents and more efficiency at points of vaccination. Shen Xuzhuang, Professor, Beijing Children’s Hospital, said, “The launch of the first 5-in-1 combination vaccine supports the shared commitment of the Chinese government and the scientific community to enhance preventive healthcare. Vaccination remains the only effective way to prevent infectious diseases, and combination vaccines are clearly the future trend of vaccine development because of greater convenience, comfort and safety.” MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I June 2011

World News Waters welcomes Duke University Proteomics Core Facility into Centers of Innova on Program Waters Corporation has recently welcomed into its Centers of Innovation Program the Proteomics Core Facility at the Duke University School of Medicine (Durham, NC). In a ceremony at Duke University, Waters recognised Associate Research Prof M Arthur Moseley, Director of Proteomics, for his research and support of ongoing research at the Duke University School of Medicine to bring about improvements in human health. Proteomics is a burgeoning science focussed largely on an understanding of protein functions and structures and

the interplay between genes and proteins and protein/protein interactions that play a key role in causing and preventing disease. “We consider the Proteomics Core Facility led by Dr Moseley to be our flagship core facility. Our vision was to create an intellectual resource and equip it so that we could provide our biomedical researchers the best possible analytical results. Under Arthur’s direction its value has increased exponentially,” said Dr Sally Kornbluth, Vice Dean - Research, Duke University.

Thermo Fisher Scien ﬁc acquires German provider of laboratory water puriﬁca on systems Thermo Fisher Scientific Inc., the world leader in serving science, has recently completed the acquisition of TKA Wasseraufbereitungssysteme GmbH, a European provider of laboratory water purification systems. Based in Niederelbert, Germany, TKA has nearly 60 employees and had 2009 full year revenue of approximately 10 million. Thomas Loewald, President Laboratory Equipment, Thermo Fisher Scientific, said, “The addition of TKA’s comprehensive offering of laboratory water purification systems to our portfolio of laboratory equipment and consumables enables us to meet our customers’ growing needs for versatility and productivity in their laboratories. The demand for ultrapure water, in particular, is driven by the ever-increasing sensitivity of analytical instruments used in life science research.” The Niederelbert location will become a centre for R&D and manufacturing of laboratory water purification systems and will be integrated into Thermo Fisher’s Laboratory Products and Services segment.

Claris Lifesciences receives in-principle approval for Propofol in EU Claris Lifesciences Ltd (Claris), one of the largest sterile injectables’ pharmaceutical companies, recently received an in-principle approval for its blockbuster drug Propofol in the European Union (EU). This will allow the company to process the registration across 25 countries in the EU. Propofol, a flagship product of Claris, is an anaesthetic product that is widely replacing other anaesthetic drugs, as recovery from Propofol is more rapid and clear when compared to other anaesthetic drugs. The molecule involves a complex manufacturing technology, and has few competitors worldwide. The market size for Propofol is estimated to be at $750 million worldwide and in EU is estimated to be about $150 million. Claris is one of the few companies to have the competence to manufacture this product on a large scale and has one of the largest manufacturing capacities in India. This registration will benefit Claris as EU is a lucrative market both in terms of revenue and margins. Going ahead, Propofol in EU would be a very big growth driver for Claris. Claris has already received 125 approvals in Europe, while another 105 are in the pipeline. Further, it has received 95 approvals for Propofol across different geographies and another 60 registrations are in the pipeline.

Burrill & Co to invest $30 million in Taiwan’s biotech industry Minister Christina Liu of the Cabinetlevel Council for Economic Planning and Development (CEPD) recently convinced life sciences merchant bank Burrill & Co to invest $30 million in Taiwan’s biotech industry during her visit to the US as leader of a Taiwanese delegation. Burrill & Co focusses exclusively on companies involved in biotechnology, pharmaceuticals, diagnostics, devices, human healthcare and related medical technologies, nutraceuticals and wellness, agricultural biotechnology, and industrial biotechnology with over $950 million under management. Liu led the trade mission composed of around 100 executives from five industries, including computer software, surveillance technology related to construction structures and land development, to solicit American investments in Taiwan. The biotech group of the delegation also visited Impax Laboratories, Inc, which has introduced over 40 generic drugs and is known for its achievement in Parkinson`s disease medication. In Taiwan, it has invested around $110 million in its branch. Computer software group visited Oracle, whose corporate data bank equipment and cloud computing solutions can help Taiwan’s ICT industry generate higher value. Acellent is among the companies visited by the delegation’s security-surveillance interest group visited. The National Science Council (NSC) of Taiwan’s Executive Yuan will set up an office to deal with Acellent’s investment plan in Taiwan.

Modern Pharmaceuticals I June 2011

World News Pﬁzer teams with top CROs Pfizer has recently announced its strategic partnership agreements with Clinical Research Organisations (CROs) – Paraxel and Icon. In this collaboration Parexel will provide Pfizer with a range of clinical development services in a five-year agreement. Josef von Rickenbach, Chief Executive Officer (CEO), Parexel, said, “Pfizer has engaged Parexel in a strategic partnership model and we have been selected as one of only two strategic partners that will handle their clinical development needs over the next five years.” He further added, “Parexel will leverage its proven clinical processes and expertise combined with its market-leading eClinical technology platform. This will help Pfizer gain greater visibility into trials and improve data access for faster, better decision making.” John Hubbard, Senior Vice President - Worldwide Development, Pfizer, said, “This new strategic partnership model is part of a comprehensive programme to sharpen our research focus, and creates a more flexible cost base through outsourcing of certain research and development services. We are creating partnerships for activities that can be performed most effectively and efficiently outside of the company.” Added Peter Gray, CEO, Icon, “This announcement is another significant indicator of Icon’s ability to partner with major companies in helping them transform their drug development model, and validates the investments that we are making to capitalise on the changing market environment.”

Prima BioMed to market and distribute CVac in Dubai Fresh from raising $38 million recently for the development of the drug, Prima BioMed has won approval for the vaccine - CVac from Dubai Healthcare City (DHCC), Dubai’s largest medical centre. First sales at DHCC are expected before the end of next year. CVac is administered after surgery and chemotherapy to treat ovarian cancer sufferers. Prima BioMed values the Middle East cancer therapy market at $517 million. It has signed a Memorandum of Understanding (MoU) laying out the terms for CVac to be available in DHCC through Prima’s partnership with the City Hospital, a multidisciplinary hospital in DHCC. The company is also seeking approval in the US, Europe and Australia.

Valeant Pharmaceu cals agrees to acquire Sanitas Group Valeant Pharmaceuticals International, Inc, has recently announced that it has agreed to acquire AB Sanitas for approximately 314 million in cash. The major shareholders of Sanitas have agreed to sell Valeant 87.2 per cent of the outstanding shares of Sanitas, with at least 82.6 per cent of the outstanding shares required to be delivered at closing. After the acquisition of this controlling block of shares, Valeant would commence a mandatory tender offer to acquire the remaining minority interest. The total purchase price is expected to be approximately 314 million in cash, in addition to the assumption of approximately 50 million in debt. The exact purchase price shall be calculated and announced at closing. J Michael Pearson, Chairman and Chief Executive Officer, Valeant, said, “The acquisition of Sanitas should provide Valeant with an exciting opportunity to expand our European branded generics product portfolio with dermatology and hospital injectable compounds that have a strong track record of growth and profitability. With 80 per cent of the Sanitas portfolio consisting of non-reimbursed products with limited exposure to government pricing pressures, Valeant will be in a key position to continue our expansion into Central and Eastern Europe.”

INC Research to acquire Kendle Interna onal INC Research, LLC and Kendle International Inc have jointly announced a definitive merger agreement under which INC Research will acquire Kendle in an all-cash transaction with a total equity value of approximately $232 million. Kendle is a leading global clinical research organisation with extensive expertise in phase I-IV clinical development and more than 3,000 associates in 31 countries worldwide. Under the terms of the agreement, INC Research will acquire all of the outstanding shares of Kendle for $15.25 per share in cash, representing a 60.5 per cent premium over Kendle’s closing share price on May 4, 2011. This represents a premium of 51.3 per cent over the 30-trading day average of Kendle’s closing price. The Board of Directors of Kendle unanimously approved the 24

transaction, which is expected to close in the third quarter subject to approval by Kendle’s shareholders as well as satisfaction of customary closing conditions and regulatory approvals. Said Dr Stephen Cutler, President and Chief Executive Officer, Kendle, said, “Joining forces with INC Research is the right decision for our customers and shareholders. Combining our highly complementary assets will provide the scale and scope for the combined company to deliver outstanding global teams, therapeutic expertise and operational excellence for clinical trials of all sizes. Because both companies are known for conducting high-quality clinical work and share a common culture based on excellent service delivery, we will be able to maintain a customercentric focus on each individual project.” Modern Pharmaceuticals I June 2011

World News BioCri ca licenses US rights to Xigris® Eli Lilly and Company has signed agreements with private investors - Care Capital and NovaQuest Capital - to establish BioCritica Inc, a newly formed and privately held biotechnology company. BioCritica, based in Central Indiana, will initially focus on the continued US development and commercialisation of Xigris® (drotrecogin alfa - activated), Lilly’s medicine for severe sepsis. BioCritica intends to ultimately build a broad portfolio of innovative, hospital-based critical care medicines. “We are pleased to announce the formation of a new life sciences company in Central Indiana, BioCritica. The collaboration between Lilly and BioCritica will benefit companies, as well as the patients we serve and the Indianapolis community in which we operate,” said Dr John C Lechleiter, President, Chairman and Chief Executive Officer - Lilly. As part of a licensing agreement, BioCritica will acquire the US development and commercialisation rights to Xigris®. It will also receive the rights to potentially acquire several critical care compounds currently in pre-clinical development at Lilly. The collaboration also includes a supply agreement, a services agreement and an option for BioCritica to potentially acquire the development and commercialisation rights to Xigris® outside the US at a later date. In return, Lilly will receive royalties on future US sales of Xigris® and will also receive an equity stake in BioCritica. Specific financial terms of the transaction are not being disclosed.

FDA approves INCIVEK™ for Hepa s C Vertex Pharmaceuticals Inc has announced the US Food and Drug Administration (FDA) approval for INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease with cirrhosis. INCIVEK™ is approved for people, who are new to treatment, and for those who were treated previously but did not achieve a viral cure. “Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade, the best we could offer patients were a year of difficult treatment that resulted in a viral cure for fewer than half of them. However, with INCIVEK™, 79 per cent of people new to treatment achieved a viral cure,” said Dr Ira Jacobson, Chief - Gastroenterology and Hepatology Divisions, Weill Cornell Medical College and Principal Investigator for a phase III study of INCIVEK™.

RadPharm and Medifacts Interna onal merge to form an independent core lab RadPharm, Inc, a leading Imaging Core Laboratory, and Medifacts International, Inc, a leading Cardiovascular Core Laboratory, have merged their business operations. The combined company will be named CoreLab Partners and will have its corporate headquarters in Princeton, New Jersey. The combination of RadPharm and Medifacts brings together two best-in-class companies and creates

one of the largest independent core labs serving the market today. The CoreLabs global footprint comprises more than 400 employees and includes offices with operational capabilities in North America, Europe and Asia. The company has leveraged this worldwide infrastructure to support over 100 sponsors, including a wide range of pharmaceutical, biotech, medical device and contract research organisations,

and more than 450 clinical trials in 60 countries. Dr Michael Woehler, President and Chief Executive Officer, CoreLab Partners, said, “As they seek to gain cost advantages over their competitors, drug development companies and CRO continue to shift their paradigm by streamlining their outsourcing functions and partnering with a smaller universe of key vendor relationships.”

Aragen Bioscience awarded three preclinical development NIAID subcontracts Aragen Bioscience, Inc, has recently announced it is a subcontractor on a National Institute of Allergy and Infectious Diseases (NIAID) contract for the preclinical development of monoclonal antibodies for the prevention and treatment of infectious diseases. Aragen Bioscience was awarded three subcontracts to generate and characterise stable cell lines expressing antibodies June 2011 I Modern Pharmaceuticals

against polio virus, pandemic influenza virus and Candida albicans, and to develop cell culture and purification processes to produce the antibodies for preclinical studies. “We are pleased to be working with Aragen Bioscience on these important projects. Working together, we will advance promising therapeutics to the clinic,” said Dr Jon Mirsalis, DABT, Managing Director, SRI International’s

Biosciences Division and principal investigator for the contract from NIAID, part of the National Institutes of Health (NIH). “These novel antibodies represent the next generation in infectious disease treatment. We look forward to supporting this important work in developing these new therapies,” added Rick Srigley, President and Chief Executive Officer, Aragen Bioscience. 25

Tech Updates

High-performance con nuous cartoning machine

New tools for studying epigene c processes to aid drug developers

C o n t i n u o u s cartoning machines are the best selling model in the IMA cartoner range. Flexa is a high performing, Flexa - continuous reliable, efficient and cartoning machine modular cartoner. It offers product handling combined with fast changeovers, ensured by advanced computercontrolled technology. IMA design with cantilever structure ensures total accessibility and best ergonomics. CentraFlexa offers compact layout for the best use of space. Positive carton opening and belt carton and product transport ensure maximum care of the components. Its working process is adaptable to the specific product due to advanced electronic technology applied to carton opening and product insertion. With Flexa, a fast and easy tool-free changeover (central adjustments) is possible. There is a touch screen interface with online machine status control and changeover data storage. It provides best ergonomics for access, changeover, cleaning, trouble shooting achieved thanks to cantilever stainless steel structure and guards design, which also help to reduce the physical strain of component loading. Comes with wide range of product infeed systems and optional systems (various coding systems, leaflet/booklet, barcode readers, rejection groups) and an automatic rejection of incomplete products/cartons or faulty barcode reading.

Development of tools to study epigenetic processes is a major project undertaken by PerkinElmer, Inc. Now, PerkinElmer’s epigenetic and post-translational screening tools cover nine different histone markers as well as the p53 tumour suppressor, with more than 15 validated enzyme assays to aid researchers developing novel drug compounds directed against several epigenetic enzymes, such as histone methyltransferases, demethylases, acetyltransferases and deacetylases. Dr Martina Bielefeld-Sévigny, Vice President and General Manager, Drug Discovery and Research Reagent Solutions Group, PerkinElmer, explained, “The development of novel therapies aimed at epigenetic drug targets has intensified over the last several years. PerkinElmer is excited to be in the forefront of this research by introducing a wide range of screening reagents that focus on assay selectivity, sensitivity and speed, factors which researchers indicate are critical requirements.”

US patent for Serina’s polyoxazoline polymer delivery tech Serina Therapeutics, Inc, a pharmaceutical research and development company, was recently awarded a patent from the United States Patent and Trademark Office (USPTO) covering its polymer technology. The patent entitled ‘Polyoxazoline and compositions comprising the same’ covers the synthesis and composition of polyoxazolines for the delivery of different drug molecules. Serina Therapeutics has developed a new way of Synthesising Polyoxazoline (POZ) polymers for drug delivery applications, which is free of the drawbacks that

have hampered previous production methods. POZ polymers, chains of 2-substituted-2oxazoline residues, have potential, low-viscosity alternatives to Polyethylene Glycol (PEG) molecules used to improve the performance of a wide range of drugs. The patent represents years of groundbreaking research in the development of safe POZ polymers for drug delivery. It is the first of many patents that Serina has applied for.

Steuler KCH GmbH uses Malvern Kinexus rheometer in formula on development Development teams at Steuler KCH Materials GmbH (Siershahn, Germany) are using the Kinexus rotational rheometer from Malvern Instruments to help analyse the rheological characteristics of products such as spray coatings. Steuler KCH GmbH is a world leader in the provision of industrial corrosion protection, in the form of mechanically and thermally resistant materials and linings for steel and concrete structures. According to Dr Daniel Kessler, Head - Research and Development, Rubber Linings, “Kinexus helps us to study the rheological properties of our systems analytically and develop future 26

The Kinexus rotational rheometer from Malvern Instruments

formulations. It allows us to continually improve product quality, leading to a direct saving in time and costs.” Dr Kessler explained, “We use the Kinexus system to simulate the complete processing cycle of our products. This ranges from storage stability, such as settling of fillers, through to the actual injection process, which involves high shear rates and shear thinning of the material. It also enables us to analyse the products’ behaviour on the wall, where we can observe flow, rupture strength at constant shear stresses, yield point and build up of homogenous layers.” Modern Pharmaceuticals I June 2011

Tech Updates

New IFC to accelerate workﬂow Fluidigm Corporation has introduced its new 192.24 Dynamic Array Integrated Fluidic Circuit (IFC) array chip. This microarray was designed to genotype 192 samples against 24 Single Nucleotide Polymorphism (SNP) assays in a single run, providing 4,608 data points in just one hour. The Fluidigm 192.24 Dynamic Array IFC provides the ideal solution for high sample throughput SNP genotyping. It is designed to genotype 192 samples against 24 SNP assays in a single run and incorporates innovative design

features to greatly increase The 192.24 Dynamic sample throughput, provide Array IFC’s new flowoutstanding data quality and through design allows an accelerated workflow. for ultra-fast loading and Further, Fluidigm thermal cycling, resulting in a greatly accelerated Dynamic Array IFCs have a workflow. Genotyping proven history of providing results can be obtained outstanding data quality and 192.24 Dynamic Array IFC in about one hour and the 192.24 Dynamic Array IFC continues that tradition. Call rates five times more IFCs can be run of 99 per cent or higher and accuracy of in a single day. Up to sixteen 99.75 per cent or higher can be routinely 192.24 chips can be run in one achieved. Additionally, existing SNP day enabling users to process over 3,000 samples. genotyping assays can be used.

New Malvern video highlights versa lity of Parsum In-line Par cle Probe

Injected nanoﬁbre spheres carrying cells to grow ssue

A novel 3-minute video highlighting the versatility of the Parsum IPP 70 In-line Particle Probe (IPP) is now available on the Malvern Instruments website. Designed to continuously measure the size, size distribution and velocity of granular particles, directly in the process, the IPP is a valuable Parsum In-line Particle Probe tool for process development and automated production. It has applications in many sectors including the food, chemical and pharmaceutical industries. Further, the Parsum probe uses patented spatial filter velocimetry to measure particles in the size range 50-6000 µm travelling at velocities of between 0.01-50 m/s. Easily fitted in line, or into a process vessel, it can be applied in both gaseous and liquid media and is especially well suited to granulation applications, both high shear and fluidised bed.

Scientists have made star-shaped, biodegradable polymers that can self-assemble into hollow, nanofibre spheres. These spheres biodegrade when injected with cells into wounds but the cells live on to form new tissue. “Developing this nanofibre sphere as a cell carrier that simulates the natural growing environment of the cell is a very significant advance in tissue repair,” said Peter Ma, Professor - University of Michigan School of Dentistry. He further added, “Repairing tissue is very difficult and success is extremely limited due to shortage of donor tissue. The quality of the tissue repair by the ACI technique is not good because the cells are injected loosely and are not supported by a carrier that simulates the natural environment for the cells.” The procedure gives hope to people with certain types of cartilage injuries for which there are no good treatments now. The nanofibrous hollow spheres are combined with cells and then injected into the wound. When the nanofibre spheres, which are slightly bigger than the cells they carry, degrade at the wound site, the cells they are carrying have already gotten a good start growing because the nanofibre spheres provide an environment in which the cells naturally thrive. This approach has been more successful than the traditional cell matrix currently used in tissue growth, he says. Until now, there has been no way to make such a matrix injectable so it is not been used to deliver cells to complex-shaped wounds.

Single-use bioreactor by Sartorius Stedim The Sartorius Stedim Biotech’s UniVessel® SU is a singleuse bioreactor with two-litre working volume. It is a single-use bioreactor vessel with built-in pH and dissolved oxygen sensors suitable for work with mammalian, insect and plant cell cultures is now available to researchers in biopharmaceuticals and other life sciences. Key features of the UniVessel® SU are the single-use sensors for optical measurement of pH and Dissolved Oxygen (DO). UniVessel® SU The determination of pH and DO with the SENSOLUX system is based on fluorescence detection. Each UniVessel® SU contains two sensor patches for pH and DO, respectively. The actual measurement is performed optically and noninvasively from outside the vessel. The sensor patches contain fluorescent dyes, which can be excited with light of a given wavelength. Each UniVessel® SU unit is irradiated prior to delivery and is ready-to-use out of the box. It is designed to the same safety standards that are required for classical multi-use bioreactors. The complete culture vessel is disposed after use, eliminating cleaning time, autoclaving and reinstallation bother as well as the risk of cross-contamination. June 2011 I Modern Pharmaceuticals

Leaders Speak

‘Data protec on is not a tool for extending the patent period for the medicines’ …says Ranga Iyer, Advisor, Pharmaceu cal Research and Manufacturers of America (PhRMA). With an MBA in Finance, Iyer started as an Assistant Accountant and through various roles rose to become Wyeth’s Finance Director and Chief Financial Oﬃcer in 1990, and later the Managing Director in 2000. Alongwith PhRMA, he is also an advisor to EuropeanFedera on of Pharmaceu cal Industries and Associa on (EFPIA) and Japan Pharmaceu cal Manufacturers Associa on (JPMA) and various Indian and mul na onal pharma companies. He shares the need for data protec on in the Indian pharma industry.

Photo by: Joshua Navalkar

Modern Pharmaceuticals I June 2011

Leaders Speak Arshia Khan World Pharmaceu cal Fron ers, Britainâ&#x20AC;&#x2122;s foremost pharma magazine ranked you 33rd in its annual list for 2009 of the 40 most inďŹ&#x201A;uen al people globally in the industry. What is next for you? The biggest satisfaction lies in the efforts put in through OPPI for curbing spurious goods. One of the assignments I am currently working on is to bring newer technologies into India to help combat the menace of spurious drugs. The next big achievement will be when access to healthcare increases in India.

Why did you move out from Wyeth? Leadership changes are common during mergers. In my case, it gave me an opportunity to branch out on my own. I started my own consultancy, in the areas of Business Development, Business Strategy, M&As and Intellectual Property Rights (IPR) in the pharma industry.

You have had a long s nt with the Indian pharma industry. How has been the transi on? The Indian pharma sector is growing at a fast pace. The industry now has a market size of 100,000 crore. It however has not reached its full potential due to low access to healthcare and weak IPR laws. When I joined the industry it was very small, burdened with more problems than solutions. There was price control, little to no R&D and no new drugs were being launched in the market. But now it has come a long way and the Indian pharma companies have done enormous work in ensuring that they are a force to reckon with. India is fast becoming a hub for global investments into the pharma sector.

What are the three great challenges that the industry faces? There is low access to modern medicines; only one-third of the population has June 2011 I Modern Pharmaceuticals

access to modern medicines. Next, the budget spending on healthcare by the Government is just over one per cent of the Gross Domestic Product (GDP), which is less than Srilanka, China and other neighbouring countries. An increase in spending is paramount, in order to achieve universal access to healthcare. Lastly, India is known worldwide as a manufacturing hub for pharma products. India however has the potential of becoming a leader in innovation. This will happen only if the government encourages innovation in India, through more comprehensive IPR laws.

Why are we lagging behind when it comes to innova on? It is not capital alone that hinders our growth; it is also lack of good patent laws and government support in terms of infrastructural facilities.

Industrial Policy and Promo on/ Foreign Investment Promo on Board (DIPP/FIPB), from the present automa c route. What are your views? None of the recent acquisitions were hostile takeovers; these were companies that were willing sellers. The cap on FDI in pharma would be a retrograde step as pharma MNCs only constitute 25 per cent of the Indian pharma industry, this number will not increase to even 50 per cent by 2020 despite the present trend. This means that more than 50 per cent of the pharma industry will still be indigenously owned. The fears of increased prices due to foreign acquisitions are also unfounded as almost 20 per cent of the drugs are under cost based price control and the prices for the rest cannot be increased by more than 10 per cent in a year.

What trend will rule the Indian pharma industry? It is not capital alone that hinders our growth; it is also lack of good patent laws and government support in terms of infrastructural facili es.

The government should incentivise innovation through research grants and stronger IPR laws.

So why is the government not taking a step forward?

The major growth opportunities lie in Contract Research and Manufacturing Services (CRAMS), Clinical Data Management (CDM) and bioinformatics. The bulk of the market in India however is going to remain branded generics. An analysis of the Indian market indicates that even though the normal product life cycle is a bell-shaped curve, in the Indian market the curve is flat as the demand for products never dies down because of the huge number of companies manufacturing a particular drug. Moreover, the older drugs are still providing therapeutic relief to patients.

The government also faces challenges. We have come a long way since India signed the TRIPS agreement in 2005 but there is still a long way to go. These decisions take time in any democracy.

What kinds of alterna ve plans should be considered to ramp up FDI other than the M&A route, given the fact that M&As cons tute almost three-fourths of the FDI?

The Ministry of Commerce has proposed to put a cap on Foreign Direct Investment (FDI) at 49 per cent, making it mandatory to get clearance from the Department of

Let us look at it this way. China gets more FDI than India, why is that? China has better infrastructure and data protection laws, in addition to a better IP environment. A better IP environment will divert investments 29

Leaders Speak from China to India. India was slated to become a global hub for clinical trials, this however has not happened. Companies are apprehensive to operate in an uncertain environment, where the intellectual property generated by them is not secure – this specifically refers to lack of data protection laws in the country. Data protection will not only help attract FDI into the country, but also ensure that generic drug manufacturers perform the adequate clinical trials and thus ensure the safety of medicines. The government is already considering legislation to extend data protection for agricultural products.

Then why is the argument to reinvent the wheel again? No, data protection is not a tool for extending the patent period for medicines. It is in place to provide safe and efficacious drugs to patients. The allegations that data protection would lead to a decrease in the access to medicines is also untrue as data protection is only required for newer not the existing drugs which comprise of 98 per cent of the pharma market.

How can one ensure the availability of good quality, safe, eﬃcacious and aﬀordable medicines? The government should strictly enforce Schedule M, which will ensure quality of medicines. It has to then be upgrade to World Health Organization – Good Manufacturing Practices (WHO-GMP). These changes need to be ensured and companies not complying need to be pulled up.

An interna onal aid agency indicates that rich countries use the prolifera on of poor quality and substandard medicines in poor countries as an excuse to ghten IP rules, drive up the proﬁts of big pharma, while making it diﬃcult for the poor to get access to essen al medicines. What is your take on this? This is totally untrue, most essential medicines needed by lower socioeconomic class of people are not under patent protection. Less than 1 per cent of all drugs are patented in India, most of the others are under stringent price control/monitoring by the NPPA, these allegations therefore are simply untrue. However, any patent be it for domestic companies or MNCs should be respected.

Do you believe that Sec 3(d) is an integral part of the Act to check evergreening or whether it could help Indian companies innovate in the short term? According to a McKinsey report, “Even by 2020, less than 10 per cent of drugs will be patented,” this is still a miniscule portion of the total market. These drugs therefore will not affect pricing and differential pricing will be employed for patented drugs to make them affordable to masses. Januvia is an example. Pharma MNCs also have access programmes for those who cannot afford these medicines. Over one billion dollars worth of the cancer drug – Glivec has been given away for free for patients who cannot

afford the medicine. Institutions like Global Alliance for Vaccines and Immunisation (GAVI) can also fill gaps in access to healthcare. In addition to the partnerships there is a need to enhance the available healthcare infrastructure. The immunisation coverage needs to be increased, as of today it is less than 60 per cent – lower than most neighbouring countries. This would not be the case if price was the reason for access as vaccines under the National Immunisation Programme are provided free by the government.

What are the opportuni es that you foresee in the Indian market? With the immense technical capability of the Indian pharmaceutical companies, an indigenously developed New Chemical Entity is not long away and there are several such entities currently in development. These make for a tremendous opportunity for Indian pharmaceutical companies both in the Indian as well as the global market. There is a huge opportunity for the industry in India as a large percentage of the population does not have access to basic healthcare. Compared to the international market, India is perceived to have huge potential. The Indian pharmaceutical sector offers cost effective and good quality products. Once Indian companies master drug development, there is no doubt that they will be the leaders in the global pharma industry. MPh (arshia.khan@infomedia18.in)

Photo by: Joshua Navalkar

Modern Pharmaceuticals I June 2011

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An invite that rewards as well...

Dear Reader, ‘Modern Pharmaceuticals’ 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 3000 words, while that of a product write-up should not exceed 200 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. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will receive a complimentary copy of that particular issue and an honorarium cheque. Published by Infomedia 18 Limited, ‘Modern Pharmaceuticals’ is the leading monthly magazine exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

Roundtable

Data exclusivity for Indian pharma

Beneﬁcial or detrimental? Overlooking the ceaseless pressure from the European Union (EU) to provide data exclusivity for pharmaceu cals, the Indian Government in April 2011 decided not to consider the same for the Indian pharma sector. India denied an extension keeping in mind that the thriving domes c generic industry would be worst hit by this change. But are there any beneﬁts of data exclusivity being overlooked? Titash Roy Choudhury

ndia-EU Free Trade Agreement (FTA) allows data protection for pharma companies in India, but developed nations such as EU are insisting on extending this already existing Act by including even data exclusivity. MNCs and developed nations want developing nations like India to introduce data exclusivity, which will provide protection to the test data of any new drug that is generated by the innovator companies. To prove the safety and efficacy of any new drug, the company has to submit clinical test data to a regulatory agency and data exclusivity refers to the protection of that data to restrict generic manufacturers from using it. The generic drug companies in India have been resisting this change since it would hamper the entry of generic drugs in the market and this will affect the cost of the drug too. The Indian Government finally solved the debate by firmly saying no to such a request stating that such an inclusion will adversely affect the Indian generic drug market. Anand Sharma, Minister of Commerce and Industry, commented that data exclusivity would gravely impact the generic drug market in India, especially in the short run. But impacts it will have in the long run is something we need to calculate now.

The immediate effect of data exclusivity would be adverse as there are many emergency drugs to be cleared under the fast track procedure, which would be obstructed. Many of these drugs are life-saving drugs required for emergency or long term treatment of hypertension, diabetes, cancer, leukaemia, HIV, anti-viral, leprosy etc and delaying the availability of such vital drugs will surely harm the patients by denying them the generic equivalent drugs at affordable prices. It would also hinder the development of our generic industry. The government is aware of the dangers and is right in resisting such demands for providing data exclusivity as it is clearly a Trade-Related Aspects Of Intellectual Property Rights (TRIPS)-plus measure and would take away the licensing authority’s discretion and also deny consumers from availing the benefits of affordable quality generic alternatives during the exclusivity period. Under the existing provisions of Drugs and Cosmetics Act, it is possible and lawful for the generic manufacturers to obtain without delay, the required approvals and licences 34

to manufacture new drugs previously approved in India or other countries. This helps the subsequent applicants to reduce the costs and delay of conducting the same tests and trials to obtain market approval of the same drug. The consumers are benefitted by faster availability of competitive generic products at fair prices, and in reducing the cost of the drug by avoiding duplication of tests and trials to arrive at the same conclusion. This avoids delay and additional costs of trial and enables introducing generic production faster. The subsequent applicant is only required to establish bioequivalence of his ‘new drug’ product by appropriate tests. The rationale is that clinical studies conducted by a pioneer sponsor to demonstrate the safety and effectiveness of the pioneer drug need not be repeated for the products that are shown to be ‘the same as’ the pioneer product. Daara Patel Secretary-General, Indian Drug Manufacturers’ Association (IDMA) Modern Pharmaceuticals I June 2011

Roundtable

Countries with innovative pharmaceutical companies have sought data exclusivity provisions in FTA with their trading partners. As per the government, although data exclusivity would not raise the price of drugs, it would prevent prices from falling due to generic competition and make it more costly for the poor to gain access to life-saving drugs. Indian drug firms that make generic versions of innovator companies do not conduct clinical trials to generate data needed to prove its safety under current laws. Since producing test data is so expensive, it is fair if other companies are disallowed from relying on that data without having to pay additional costs. If the government would allow data exclusivity it would effectively offer a monopoly to the developer of a new drug, even without a patent and restrict cheaper versions of the drug for several years. If the proposal would be accepted, a drug regulator would not be

allowed to use the clinical test data submitted by an innovator company, to give marketing approval to companies, which are developing cheaper generic versions. Thus, forcing them to repeat time-consuming and expensive studies to receive regulatory approvals, delaying the launch of medicines. India should provide an effective period of exclusivity that is independent of patent protection. Data exclusivity is attractive as it is automatic just like a copyright. There are no fees incurred for application or maintenance of the right, and there is more limited scope than exists in patent law for legal challenges, which are expensive to mount and to defend.

Introducing a period of data exclusivity for the innovative drug companies would be beneficial for the Indian pharma industry and the economy as a whole. This would lead to an increase in foreign investment in R&D and may also help facilitate a shift from a primary generic to an innovative pharma sector in India. A shift to an innovative model will help India achieve universal healthcare access by producing drugs and services designed specifically for an emerging economy like India. Not providing data exclusivity is an overprotectionist move and would be detrimental in the long run. India has one of the largest patient pools for non-communicable and communicable diseases in the world and yet clinical trials are now being outsourced to China and other countries, which provide data exclusivity provision. This does not bode well for the robust growth rate of the Indian pharma sector, which has

been consistently growing in the double digits for the better part of the decade. The fear of such laws being an impediment to access to healthcare are also unfounded as less than 1 per cent of the total drugs sold in the Indian market are patented. The above facts may merit a relook into Indiaâ&#x20AC;&#x2122;s policy going into new decade. Companies making generic versions would hence be forced to repeat time-consuming and expensive studies to receive regulatory approvals, delaying the launch of medicines. India should provide an effective period of exclusivity that is independent of patent protection.

The pharma industry invests $1,318 million and 10-15 years on an average for introducing a new drug in the market; 60 per cent is spent on data collection. With such huge investment, the innovative pharma industry has every right to expect a return on investment. Lack of returns in the absence of robust Intellectual Property Right (IPR) protection will discourage further R&D and foreign investments. Data Exclusivity or Regulatory Data Protection (RDP) should not to be confused with patents. Both offer distinct and separate intellectual property protection. RDP accepts exclusivity and patentability of data submitted to regulatory authorities as part of product registration meant exclusively for this purpose, thereby protecting and providing incentives to substantial financial investment in drug discovery and development.

With life-threatening ailments, it may be argued that to facilitate timely market access and prevent expensive, repetitive animal and human clinical trials, competitors should be permitted access to the original proprietary data filed with regulatory authorities. Although this seems fair, it should be permitted only after the expiry of a reasonable protection period. Without this period of protection, data would never be generated and new medicines would never reach the public. The government needs to provide specific protection that create an environment where trained scientific personnel enjoy space and freedom to design new products.

June 2011 I Modern Pharmaceuticals

Partha Mukherjee Vice President - Sales, Anglo-French Drugs & Industries Ltd

Ranga Iyer Advisor, Pharmaceutical Research and Manufacturers of America (PhRMA) and Former President, Organisation of Pharmaceutical Producers of India (OPPI)

Ranjit Shahani President, OPPI 35

Roundtable

Data exclusivity for the pharma sector for now may prove convenient but in the long run it would adversely affect the generic drug market of India. In the coming 5 to 10 years, the pharma market will be flooded with patents and each patent lasts for at least 20 years and this will badly hit the generic drug companies of India. The Indian Government did not adopt data exclusivity for the main reason that it would delay the entry of generic drug making companies. But more than data exclusivity it will be the patent protection that would hinder the generic drug making companies from entering the drug market. As a developing country, we should have negotiated and pushed for data exclusivity over patent protection, since in data exclusivity the product data will be excluded from the market for a limited period of time after which it would be available for all. Now, since we have said no to data

exclusivity all the innovator companies will be relying on patent protection, which will be very harmful for the generic pharma company. There can be one drawback with respect to cost, initially during the data exclusivity period the price of the drugs can be high but this can also be tackled if the government agrees to provide subsidies to these companies, which will also encourage companies to introduce more drugs. We should try to create a scenario where there is a mutual co-existence of both the generic drug companies and the innovator companies. And data exclusivity can help in creating such a situation.

The extension of data protection by including data exclusivity will hamper the accessibility of the Indian companies to information, which they used to rely on for the generics product development. The generic drug companies highly depend on the test data of any new drug for producing a generic version of it and introduction of data exclusivity will affect the availability of that information. However, the Indian pharma industry is mature and is well prepared for data exclusivity. This new inclusion will either drive the Indian pharmaceutical market to innovation and encourage new product development, or become pure marketing engines for the international biotech and pharma companies or they will sell their companies to the highest bidder. For a developing country like India it can work both ways. It may generate the sprouting of new innovative

companies and perhaps help in building a stronger Indian Healthcare sector or it could go the other way and affect the cost of the drugs making it expensive and out of the reach of the poor people. And therefore support for our poor population and for the new upcoming companies should be the highest priority of the government. As of now the decision of the Indian Government of not supporting data exclusivity will not hamper the Indian pharma sector but in the long run like after 2015 government will need to support the Indian innovation biotech sector, which will also demand data security.

Innovator companies seek assurance that the analytical and clinical data of the New Chemical Entity (NCE) on its safety and efficacy, submitted to the regulatory authorities for the marketing approval would remain as a trade secret or â&#x20AC;&#x2DC;exclusiveâ&#x20AC;&#x2122; for a limited period. But the patients, civil society groups and Indian Government are concerned, that this data exclusivity will hamper access to affordable, life-saving quality generic medicines for the needy. As everyone is aware that before the General Agreement on Tariffs and Trade (GATT) and TRIPS agreement and in the pre-product patent era, generic drugs could be introduced into the market on the basis of bioequivalence tests without having to replicate time consuming and expensive clinical trials in India and there is no data protection. We need to harmonise our regulations into global arena, ie, we do not

have to move into TRIPS plus arrangement as requested by some of the developed countries but at the same time respect the data exclusivity for a limited period of time. This is contingent upon a valid patent and this should be applicable to all dosage forms of an NCE so that there will not be any ever greening of the patent. Also, restrict this data exclusivity in this country provided the innovator launches the product in India within 1 year of its marketing approval. Also, under compulsory licensing arrangement, the submission for marketing approval or export approval should be granted exempting from provisions of data exclusivity.

Dr Shirish Kulkarni Vice President - Advanced Drug Delivery Systems, Lupin Ltd

Dr Villoo Morawala-Patell Founder, Avesthagen Ltd

Venkat Jasti Chairman & Chief Executive Officer, Suven Life Sciences Ltd Modern Pharmaceuticals I June 2011

Facility Visit

Anthem Biosciences Pvt Ltd

Making waves in the ﬁeld of bioscience With advancement in technology and research in the ﬁeld of bioscience, Anthem Biosciences Pvt Ltd makes its mark and showcases the unique way of being a support and service company. From providing chemistry, discovery and analy cal services it has been successful in achieving its aim since incep on.

Jasleen Kaur Batra

oday, when India tries to catch up with the world in technology for almost every sector, Anthem Biosciences Pvt Ltd emerges as a company that offers a helping hand for supporting research efforts in the discovery of new compounds by pharmaceutical, biotechnology, speciality chemicals, agriculture chemicals and material science companies. The Bengaluru -based Discovery Research Alliance Partner (DRAP) has been in service since only a few years, but has achieved considerable success in this short span of time. Anthem was established

in 2006 with the aim of leveraging India’s significant scientific talent pool to assist research programmes of global companies.

Growth trajectory With a wealth of experience behind them, the three founders of Anthem Bioscience, Founder and Chief Executive Officer, Ajay Bharadwaj, and co-founders Dr Ganesh Sambasivam and KC Ravindra, established Anthem to achieve professional growth and to push the research services model to new challenging heights. All three of them have achieved considerable success in their previous assignments and are considered reliable, creditable

professionals in their field. Bharadwaj had been a part of Biocon for 21 years, almost since the inception of the company and was the President of Biocon at the time he ventured out. “Biocon had grown to be a very large company and hence there was no scope of vertical growth. The only movement had to be lateral, hence Anthem,” says Bharadwaj. On a similar note, avers Dr Sambasivam, Chief Scientific Officer, “One of the reasons behind this establishment was that we had reached a saturation point and there was no scope of growth or improvement, and I wanted to achieve difficult targets and provide high quality science.” Since establishment, Anthem has been vigorously involved in conducting contract-based research for pharma companies and has helped them in various ways. They provide varied services right from Medicinal Chemistry, Custom synthesis, Good Manufacturing Practices (GMP) synthesis, to generation of hits and transforming hits into leads. Stressing on the reason to start such a company, Dr Sambasivam says, “India is known more for chemistry than biology, so we thought it was a good idea to enter biotechnology.” Today, they are not just into bioscience but have also expanded their wings to products in the enzymes, nutraceutical and drug industry. Anthem has two main branches; Anthem Bioscience (R&D), Anthem Cellutions (Enzymes).

Projects in the ki y To small virtual biotech companies Anthem Bioscience brings a sigh of relief Modern Pharmaceuticals I June 2011

Facility Visit as they provide services for research on contract basis. They undertake projects mostly for drug developing companies, research or synthesis of new molecules of material science, polymer science and dietary products. They are also involved with projects, which deal with oncology, metabolism, anti-infectives and molecular science and have recently stepped into exploring the central nervous system by undertaking projects in this therapeutic category. Additionally, their expertise lies in the field of enzymes and nutritional supplements. Their contribution to the project is in the initial stages, which is the first stage of the research, wherein the drugs are created in the lab. Here the research is virtual as well as physical in nature and they not only derive the required compound but also check its durability and precision by conducting experiment on the animals to note whether they are receiving the required outcome. Anthem also undertakes extra efforts of being transparent with its clients to achieve a state of complete belief. “Communication is extremely important, hence we affectively communicate with our clients proactively,” says Dr Sambasivam. To achieve this, they follow a system wherein a weekly report is sent to the company providing frequent updates on the research along with the various stages and procedures that are being followed to acquire the desired result. The scientists as well as managers are sent reports on a regular basis and their feedback is valued. The regular quality audits make them carefree as far as the standardisation of the machines as well as laboratories is concerned. In spite of strict internal controls, they grant all clients access to their unit to conduct an audit of the R&D facility at every stage of the research.

Business model Anthem caters to an extremely niche audience, hence their business model is well structured and organised. “There is an unmet need to do more, hence June 2011 I Modern Pharmaceuticals

It is not possible to reach diﬀerent places at once as we do not have the management bandwidth as of now, but we are coming up with another manufacturing unit in Hosur, Tamil Nadu, which should be up and ready in a few years me. Ajay Bharadwaj Founder and Chief Execu ve Oﬃcer

we are trying to establish effective technology that will be able to help this industry, and that is our ultimate goal,” informs Dr Sambasivam. To ensure a sturdy growth Anthem is not only well equipped in terms of machinery and other facilities but has more than 300 scientists working with them, most of which have masters in their area of specialisation. Anthem has tried to spread its wings and has attracted not just the Indian fraternity, but even the sector abroad. Most of its clients are from US, Europe and Japan. About 50 per cent of the clients are from US, 40 per cent from Europe and Japan and 10 per cent from India. They have also hired plenty of experienced scientists from US, UK and other countries. This business structure has helped them complete more than 500 projects in a shot span of four years. The understanding between the departments makes the work fast and accurate. The success as well as accuracy rate of the research that Anthem undertakes every year is 99 per cent according to Tom Thomas, Assistant Director, Chemistry Services.

Automa on Anthem was certain about the type

of machinery they wanted for their setup and thus no compromise was made as far as investment or importing machinery was concerned. Their rigidity towards achieving top notch equipment has been one of their strengths today. The machinery they possess is not seen in abundance in R&D centres across India. They have various systems installed namely, Nuclear Magnetic Resonance (NMR), Liquid Chromatography Mass Spectrometer (LCMS), High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Liquid Chromatography Mass/Mass Spectrometer (LCMSM). These machines are acquired from companies like Agilent, GE, PerkinElmer, Hitachi, Shimadzu, all of which are manufactured overseas. It is not just the list of machinery that is impressive but also the layout. They have a multi-storey R&D centre where all the research work is carried out. One would be able to spot at least two labs for each department like that of molecular biology, R&D, LCMS lab, which helps in keeping the purity of the mass under check, NMR, GMP lab, ADME lab, logistics lab, production room, etc. These facilities were incorporated to have a high-tech research centre

One of the reasons behind this establishment was that we had reached a satura on point and there was no scope of growth or improvement, and I wanted to achieve difficult targets and provide high quality science. Dr Ganesh Sambasivam Co-Founder and Chief Scien fic Officer

Facility Visit was established two years back in Bengaluru and has now joined hands with Anthem Biosciences. The work Anthem has produced over the years has not just caught the attention of the companies they have dealt with but also of the state government; hence it was rewarded by the Karnataka State Government as the Emerging Company of the Year, 2011 under the Bio-services category.

Today’s genera on is very health conscious, and so we have plans of stepping into the nutraceu cals industry. Malay Barua Vice President, Anthem Cellu ons

that would make work easier for them and the findings more accurate for their clients. Anthem also provides a comfortable atmosphere for its employees. It has a creche facility for working women-cummothers where the children are taken care of throughout the day.

For a new company the biggest fear is earning profits. This surprisingly was never a problem for them. “We have never made a loss. Last year the company had revenues of ` 65 crore and this year we have grown to ` 80 crore. We are doing fairly well,” says Bharadwaj. Most of the profits earned are re-invested in improving R&D, the infrastructural development.

Investment pa ern Establishing such a huge company was not at all an easy task for Anthem. The total investment including land, infrastructure and machinery was ` 100 crore. ` 25-30 crore was spent on land and infrastructure, and ` 60-65 crore on machinery and the remaining on other requirements. The founders believe that they were blessed as they managed to get the support from one of the leading banks in India, State Bank of India (SBI) to finance them.

Aﬃlia ons and awards Reputation plays a vital role in attracting companies. Anthem is accredited by the Pollution Control Board of India, Department of Scientific and Industrial Research (DSIR). Soon it will be applying to the United States Food and Drug Administration (US FDA) and is in the process of getting a drug license for its new venture with Vestas Life sciences Pvt Ltd, a company that deals with formulation of drugs for cardio and diabetic segment. This company

Business model at Anthem R&D domains Organic Synthesis

Discovery Research Platform Technology ADME ADMET

Molecular Biology

Cell Biology

Quality Assurance QA Medicine Chemistry

Quality Chemistry QC

Manufacturing Pilot Lab

Micro biology

Process Chemistry

Kilo Lab

Expanding wings As per the founders, they can never and would not wish to reach a saturation point and hence they are exploring more and more options within their industry with passing time. Anthem was started as a bioscience company with a section on Cellutions, which dealt with the study of enzymes etc. Today, Anthem Cellutions has made such rapid growth that it is capable of functioning as a second wing of Anthem. Cellutions has done well for itself and will soon bag a few more projects. The founders are now looking at explorign the emerging markets. “Today’s generation is very health conscious, and so we have plans of stepping into the nutraceuticals industry,” says Malay Barua, Vice President, Anthem Cellutions. For nutraceuticals, the company plans on taking projects on: IP led formulations Dietary supplements Digestive enzymes Industrial sectors-detergents, leather, paper etc Food industry; baking, Beverages industry-fruit juices, alcohol, wine etc Extract anti-oxidants to fight cancer and other diseases Anthem is also expanding its infrastructure by coming up with a new five-storey building to increase its capacity to undertake more research projects. This building will be dedicated to R&D, an animal house as well as the chemical research department. “It is important to learn and grow, and we will grow but only in concentric circles because we want to stick to what we Modern Pharmaceuticals I June 2011

Facility Visit know best,” says Bharadwaj. Anthem has joined hands with a company in a completely new venture, that of medicines. It has also joined hands with Vestas, and would now be dealing with the sale of ready drugs in India. On asking about their geographical expansion plans, Bharadwaj informs, “It is not possible to reach different places at once as we do not have the management bandwidth as of now, but we are coming up with another manufacturing unit in Hosur, Tamil Nadu, which should be up and ready in a few years time.”

R&D lab

Lab technician conducting tests in Quality Assurance lab

Technician working in molecular biology lab Quality control lab - HPLC

Excellence on a pla er Anthem Biosciences along with its various departments is like a breath of fresh air for the healthcare fraternity. Its services are not just new but also convenient for research centres, hospitals, drug manufacturers etc. The services Anthem provides is the new face of services sector out of India and more so Karnataka. Its R&D facility is a major cost saver for drug and new molecule development

June 2011 I Modern Pharmaceuticals

Scientists working in NMR lab

companies as a lot of investment and time is required to carry out research. Anthem’s excellence in this industry is coming handy not only for domestic but also for companies worldwide. The growth trajectory of this company is worth following. MPh (jasleen.batra@infomedia18.in)

Discovery Biology lab (molecular cell lab) Photos by: Shrikant SY

Industry Update

R&D in pharma

From imita on to innova on

Since the late 1990s, Indian pharma companies have started inves ng in developing new drugs and Drug Delivery Systems (DDS), thus moving away from imita on. Most pharmaceu cal companies today have accepted Novel Drug Delivery System (NDDS) as a major aspect of their R&D programme. We review the success Indian pharma companies have achieved in exploring this innova ve pathway and the future.

Parita Dholakia

ould anyone have imagined in the 1960s that there will be a cure for motion sickness, and that medication will not have any side-effects? Or would not involve ingesting any bitter pills or thick syrups? And all one would need to do would be to put an almost invisible small patch behind his/her ear! Innovation in DDS has helped mankind in not only overcoming the disadvantages of ingestion, but also providing a bang-on-target delivery. Major pharma companies in the industry are spending in NDDS as a major aspect of their development programme. Experts believe that focussing on innovative drug

delivery platforms will propel the growth of the NDDS industry. Fewer New Chemical Entities (NCEs) are coming to market, and with NDDS-based products there is lower risk, because most often one is working with a known molecule and working on improving its delivery, so the probability of succeeding is much higher in this case. Considerable success has been achieved by the generic-dominant Indian pharma industry, and more is on the track. There is a gap between the global and Indian NDDS industry, and it presents a lucrative opportunity to develop and capitalise upon the growing NDDS products market. Indian pharma companies may have Modern Pharmaceuticals I June 2011

Industry Update started off NDDS with an aim to extend the life of products as they were about to go off patent then, but recent years has witnessed hectic activities in most of the major companies.

Why the novelty? Delivery systems used since a long time always had certain flaws, which were overlooked in the absence of alternatives. But today, scientists are exploring beyond the obvious. The advantages offered by NDDS are multiple, most important of which is the targeted delivery of the drug to the requisite site of action. This results in prevention of systemic presence of the drug, regulates the concentration of the same in the blood stream thus preventing the fluctuation of the drug concentration in the bloodstream. It helps reducing dosing frequency, which leads to reduced interactions with the caregiver. Several adverse events occur due to incorrect medication dose or frequency, and the same can be reduced with the reduced frequency of dosing. Fewer visits from doctors or nurses save administration costs and time, and reduce inconvenience for patients and caregivers. In the words of Rajani Patel, Joint Managing Director, Lincoln Pharmaceuticals Ltd, “NDDS is more beneficial to the patients. Pharma companies may think of these systems from a good turnover point of view, but there is no denying that the development in NDDS has benefitted doctors and patients alike. For pharma companies, it acts as a USP for selling drugs.” Dr Igor Skidan, Preclinical Pharmacologist, involved with NDDSbased research, describes the biggest advantages of NDDS as, “The important technological advantages of NDDS (in most cases) are high stability, high carrier capacity, feasibility of incorporation of both hydrophilic and hydrophobic substances, and feasibility of variable routes of administration, including oral application, transdermal delivery, inhalation, etc .” In the same vein, Alok Saxena, Director, Elder Pharmaceuticals, mentions, “NDDS has advantages such as better therapy by increasing the efficiency June 2011 I Modern Pharmaceuticals

When we are releasing a product in the market with similar drug as our compe tor, the delivery system will make all the diﬀerence. It will control the taste, bioavailability, side eﬀects and onset of ac on of the drug. Rajani Patel Joint Managing Director, Lincoln Pharmaceu cals Ltd

and duration of the drug activity, increased patient compliance through decreased dosing frequency and easy routes of administration and improved targeting for a specific site to reduce unwanted side effects.” What may have been impossible during the yesteryears, is not only achievable today, but is possible with the maximum novelty. Researchers armed with a never before array of sophisticated technologies and the wealth of knowledge accumulated over years are developing potential drug delivery candidates at breakneck speed. Believes Saxena, “NDDS as a market has become very competitive and is fetching high rewards for many pharmaceuticals companies. This field is a representation of the R&D side of the pharma industry and has increased the awareness about patents, challenges in new drug delivery as well as its potential for the coming years.”

Indian scenario: Poten al tapped? In developed countries, pharma companies have started shifting their focus from the R&D on drug molecules discovery to developing novel delivery systems. In India, pharma companies have embraced investing and research

on NDDS since not more than a decade. Informs Dr Ninad Deshpandey, PresidentPharma Research and Development, Lupin Ltd, “NDDS came to India only in the 90s and we are a decade behind advanced markets.” Also, the drug delivery technologies are in the nascent stage, and much efforts are required to keep updated with the acceptance and using the latest technologies in their research programme. But success has been achieved. Avers Dr Anil Gandhi, General ManagerIP & Formulation Research, Rubicon Research Pvt Ltd, “There have been several success stories in this regards for Indian companies starting with Ranbaxy and Bayer for Cipro OD; Alembic and UCB for Keppra; Rubicon and Avantor Performance Materials on ODT platform.” India also has an advantage. Believes Dr Gandhi, “Indian Pharmacy graduates can be considered as excellent formulators and like strength in chemistry, India also has great strength in pharmaceutics. Though development of generic formulation is considered as imitation, it demands special skills of processing, excipient knowledge, understanding of equipment, pharmacokinetics etc. And with this the skills for NDDS comes naturally.”

The success of NDDS in the US is largely due to ini a ves taken by academic ins tu ons and Contract Research Organisa ons (CROs), which were mostly funded by grants from Na onal Ins tutes of Health (NIH). Dr Igor Skidan Preclinical Pharmacologist

Industry Update

Many pharma companies are involved in the development of new DDS, and there is an increased number of products in the market. Alok Saxena Director, Elder Pharmaceu cals

It is an encouraging sign that many academic institutions and research centres in India are actively engaged in drug delivery research. There are more than 40 university departments, colleges and research institutions engaged in NDDS-related research. The major areas of research are

product development, standardisation and basic research at cellular and molecular level. What is required is good collaboration between academia research and pharma companies. It may be that the latest delivery systems and research that is happening in the laboratory of academic institutes are

NDDS at a glance Elder Pharmaceuticals - Sustained release formulation A water soluble vitamin, which gets excreted from the body rapidly makes it cumbersome to give large doses of this product. They developed a matrix wherein the water soluble vitamin was embedded & the release profile was adjusted in such a manner so as to ensure that the blood levels are maintained adequately over a long period of time. Thus, the formulation contains higher dose of the active ingredient but is not released entirely into the bloodstream but happens on a sustained manner. Lincoln Pharmaceuticals Ltd - Nasal spray pump for vomiting Novel alternative to the oral and injection conventional forms for the prevention of vomiting with this formulation of ondansetron hydrochloride. Positive effects can be reached within five minutes. Nasal administration can therefore be used as an alternative to oral administration if instant relief is desired or if the oral drug is extensively degraded in the gut or liver. Lincoln won a patent for this novel nasal DDS. Lupin Ltd - Bio-adhesive drug delivery technology (Out-licensed to Salix) This technology has been used with Rifaximin, resulting in an extended release product. It combines controlled-release as well as slowed gastrointestinal transit, and provides an extended release formulation of Rifaximin that comprises an important component of Salix’s lifecycle management strategy. Rubicon Research Pvt Ltd RubiSRT, RubiERT and RubiReten (gastroretentive technology) technologies provide controlled release formulations thus reducing frequency of administration and improving patient compliance. Dispersible tablets (based on RubiDT technology) or orally disintegrating tablets (based on Rubicon’s RubiODT technology) helps administering a dosage form to elderly patient with dysphagia. RubiODT technology also helps to develop products for ‘people on move’ where the formulation can be taken without water, anywhere any time. RubiEn technology aims at reducing the adverse effects of the drug by improving bioavailability leading to reduction in dosage of active ingredient.

the ones one needs to adapt today, and not tomorrow. The cost of R&D and product development in India when compared with that of US, Europe or Japan, appears minuscule. Also, the regulatory requirements are fewer for a generic drug than a new drug molecule. Consequently, Indian companies can use new DDS to gain a long-term competitive advantage and lower barriers for an entry into the international market. In addition, there is also considerable scope for the development of NDDS for the Indian market, both for human and veterinary use. India needs an improved interaction among the industry, the academia, the medical profession and the government as well as improved interface among the pharma industry and excipient/ machine manufacturers to be one of the leading countries in NDDS. We have the capabilities to turn drug delivery research challenge into an excellent business opportunity for the pharma industry. Although certain positive steps have been taken, the status level of NDDS in India needs to take some huge strides to match the advanced markets. Informs Dr Deshpandey, “In certain areas like using nanocarriers for gene delivery, protein or peptide-based systems, we are lacking behind advanced markets.” The major reason can be the lack of availability of new polymers, raw materials, specialised equipment, or the above mentioned gap between academia and industry research. Also, one needs to focus on keeping themselves up-to-dated with the latest patent literature and regulatory guidelines for the approval of NDDS in India.

Associated technology The ultimate goal of a drug delivery device, whether traditional or novel, should be to attain and maintain drug concentrations within the therapeutic window or close to the average concentration. The overall action of a drug molecule is dependent on its inherent therapeutic activity and the Modern Pharmaceuticals I June 2011

Industry Update efficiency with which it is delivered to the site of action. An increasing appreciation of the latter has led to the evolution and development of NDDS, aimed at performance enhancement of potential drug molecules. The emergence of biotechnology and nanotechnology into DDS has kicked off innovative means of administering medicine, and their success, popularity and increasing demand is also because of factors like cost effectiveness, convenience and better compliance from the patient’s point of view. Informs Dr Deshpandey, “There is a certain degree of proprietariness to these products and Indian company with great technologies are rare to see. Many colleges do contract development work but nobody has a platform or patent on these technologies. Basic technology is used to develop a product or patent it but there is no patented or platform based development.” In Dr Skidan’s viewpoint, nanoparticles like micelles and liposomes provide some superior benefits. “Through encapsulation of small molecules in nanoparticles such as a liposome or polymeric micelles, the volume of distribution is significantly reduced and the concentration of drug in the tumour or other target organs is increased. And on the other hand, if small molecules have a fast clearance from blood (bad characteristics) we can use the long circulating DDS.” He believes, “The success of NDDS in the US is largely due to initiatives taken by academic institutions and Contract Research Organisations (CROs), which were mostly funded by grants from National Institutes of Health (NIH). After success in the first few years, pharma companies started funding such projects.”

Indian pharma is essen ally where it wants to be and has achieved success in this space. In terms of capability, funds, quality, we do not have a long way to go. Dr Ninad Deshpandey

Director, President- Pharma Research and Development, Lupin Ltd For getting that edge, when a competitor is introducing a new drug with superior benefits that threatens to erode the market share of one’s drug, a drug delivery technology can be an effective defensive marketing strategy. A relevant new benefit, such as reduced side-effects, one can boost their drug’s market value and revive their marketplace position. Similarly, these systems can jump-start products in a mature life cycle stage. Says Patel, “When we are releasing a product in the market with similar drug as our competitor, the delivery system will make all the difference. It will control the taste, bioavailability, side effects and onset of action of the drug.”

Money ma ers NDDS development is considered to be one of the most attractive options because the development it ensures better efficacy and safety, convenience, compliance and a lower cost, and is one of the areas where investments at acceptable levels will yield acceptable returns. Typically, development of a NDDS would take 2-4 years and investments in the range of $1030 million. Application of modern technology for oral, parenteral, nasal, pulmonary and intraocular

Projec ons The global market for Advanced Drug Delivery Systems (ADDS) amounted to $134.3 billion in 2008, and was projected to increase to $139 billion in 2009. The estimate for 2014 is $196.4 billion, for a Compounded Annual Growth Rate (CAGR) of 7.2 per cent in the 5-year period. The largest segment of the market is targeted drug delivery, which reached $50.9 billion in 2009 and is expected to increase to $80.2 billion in 2014, for a CAGR of 9.5 per cent. Sustained-release products have the second-largest market share, with estimated sales of $36.1 billion in 2009 and $45.8 billion in 2014, for a CAGR of 4.9 per cent. Source: Dr Igor Skidan

formulations of drugs, which are already in use in conventional dosage forms and finding of newer and better routes of administration of proven drugs, are important areas of cost-effective research. Explains Patel, “Infrastructure is already there. We have scientists working in the R&D department, the same people are working for the development of NDDS. What may be different is the high cost involvement in the form of tests required and clinical trials.” But does this outweigh the investment? Avers Patel, “Most of the times, once the product has spent sufficient time in the domestic market, we send it to the international market. Once there, the turnover shoots up. We cover all the involved development costs in no time.” Dr Deshpandey maintains that the investment is not too high and based on the figures he provided, it is about how well one maintains balance between investing in developing NDDS and other R&D at this stage. “At Lupin, we have lots of investment in the R&D programme. About 8.5 per cent of our global revenue is invested in R&D. NDDS research is embedded in Lupin’s Pharmaceutical Development Programme. Hence, it is difficult to monetise. However, about 33 per cent of this investment goes for developing ADDS.” Similarly, the figures at Lincoln indicate a high investment in NDDS. Informs Patel, “Out of the sanctioned budget for R&D this year, we typically plan to invest 50 per cent of it on NDDS.” For developing NDDS, if one is the first or within the first 3 to 4 to receive approval they can command 50-80 per cent price of the innovator product Modern Pharmaceuticals I June 2011

Industry Update What is in store?

Though generic formula on development is considered as imita on, it demands skills of processing, excipient knowledge, understanding of equipment, pharmacokine cs. And with this the skills for NDDS comes naturally. Dr Anilkumar Gandhi General Manager- IP & Formula on Research, Rubicon Research Pvt Ltd

and reap millions. If one fails to defend the legal challenge to their product, they pay $10-15 million expenses and penalties and lose all R&D efforts and money. It can be expensive at times due to the fact that there is a considerable patent and technical challenge involved in achieving equivalence to brand leader while designing a new NDDS. Its a teamwork of number of qualified professionals for a period of 6 to 7 years. Development of generic NDDS involves conducting several bioequivalence tests before a company can scale up and go for expensive US/EU biotrials. Failure of a biostudy can lead to a loss of ` 1-2 crore. A generic company, which is successful in filing first applications gets six months market exclusivity and nobody is allowed to introduce second generic version of NDDS till this exclusivity is over. Since there are enormous commercial advantages of first-to-file or even get second, third or fourth approval, many generic companies in the US are trying hard to be the winner in this race. Some India companies have demonstrated capabilities to develop generic versions of NDDS.

Challenges Stability testing for NDDS is difficult due to the fact that pharmacopoeial or published method do not work exactly for these products and needs development of new methods and validate these methods. It is cumbersome to identify a patentable concept/idea from the voluminous existing patents. Another challenge is ensuring stability, 48

bioavailability or bioequivalence. Stabilisation of NDDS productprocesses and generating validation data that gives evidence of consistency in quality is a long and tedious process. New analytical methods are required to be developed and validated to ascertain product quality and stability. In order to circumvent patients, many times R&D has to use different materials, which pose special challenges in analysis and stability studies of the product. Hence, NDDS development scales up required considerable time and resources.

Points to ponder It is interesting to notice the buzz that the term ‘novel’ has created in the industry. Dr Skidan presents a thought-provoking issue when he states that the definition of ‘novel’ is been used incorrectly. He says, “At times, it is not appropriate to state certain systems as ‘novel’ considering they have been in market since a long time and there is nothing much unique in it. For example, sustained or controlled drug release. This system has been used repeatedly for years and should not be labelled ‘novel’ anymore.” As Dr Deshpandey mentions, “Modified, sustained or controlled release are all basically about reducing dosage from twice or thrice a day to once. These systems all have similar attributes - reduces dosage frequency, modifies release characteristics, with the same end result. We prefer to use ADDS.” Patel provides yet another interesting terminology when he mentions NDDS as ‘progressed technology.’

The development of new drugs would act as a challenge for developing new delivery systems. Believes Saxena, “Many pharma companies are involved in the development of new DDS, and there is an increased number of products in the market. Upcoming drugs definitely will be more challenging in terms of the development of delivery systems, and pharma companies will have to be ready for a difficult task ahead.” Major companies have released NDDS formulations consistently in the market. For Lincoln, near about half a dozen more formulations are in trials currently, and Lupin has some four formulations post the development stage. Rubicon mentions that more than 50 per cent of the products pipeline is based on NDDS. With a steady flow of new NDDS-based drugs, and the good turnover, green pastures are nearer than they seem. So how far are we from achieving international standards? Dr Deshpandey sounds optimistic when he says, “Indian pharma is essentially where it wants to be and has achieved success in this space. In terms of capability, funds, quality, we do not have a long way to go. We have been marketing products to US companies. Where we do need to spend time is doing the actual R&D; more investment is required from companies in R&D and actual product development for the next 3-5 years. In the next 5 years, India’s competency will greatly increase and easily match the US and European markets.” Thus, while watching some new sci-fi medical movie if one sees a novel delivery system, s/he should not be amused to find it in actual practice. Think about a drug that gets released only when one feels the pain. Or an ointment that is used to treat heartburn or acidity? Or better, a transdermal patch to heal the injured muscle or broken ligament? Let your imagination run wild! NDDS is here to provide a solution. MPh (parita.dholakia@infomedia18.in)

Modern Pharmaceuticals I June 2011

Market Scope

Crohn’s disease market

Increased uptake of biologics Crohn’s Disease (CD) is an inflammatory disease affec ng any part of the gastrointes nal tract. Worldwide incidence is 1-3 per 100,00 individuals. The market is abuzz with Sanofi licensing a poten al treatment for CD from Glenmark Pharmaceu cals. A review. Arshia Khan

ccording to GlobalData, the global CD therapeutics market was valued at $2.8 billion in 2009. It is expected to grow to $4.7 billion with a Compounded Annual Growth Rate (CAGR) of 6.6 per cent by 2017. This growth is primarily attributed to the increased competition among the existing products and also the strong pipeline with more emerging therapies. The report further states that, the growth will be supported by the increased uptake of biologics. The growth is attributed to the launch of the biologics, which include Humira (adalimumab), Cimzia (certolizumab pegol) and Tysabri (natalizumab). Recently, Glenmark Pharmaceuticals SA (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd India (GPL), signed an agreement with Sanofi to grant Sanofi a licence for the development and commercialisation of GBR 500, a novel monoclonal antibody for the treatment of CD and other inflammatory conditions. The transaction is expected to close in a month’s time subject to customary closing conditions, including the

expiration or early termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act. Under the terms of the agreement, Glenmark will receive an upfront payment of $50 million, of which $25 million will be paid upon closing of the transaction and $25 million, which is contingent upon Sanofi’s positive assessment of certain data to be provided by Glenmark.

Compe tve landscape GlobalData further analyses that the current competition in the CD therapeutics market is becoming more intense due to the increased entry of biologics. Compared to other autoimmune disease markets, this market has witnessed the increased entry of biologics. Though only a small segment of people can use biologics, their launch has increased competition in the CD therapeutics market. Johnson & Johnson’s Remicade (infliximab) is the market leader and is followed by AstraZeneca/Prometheus’s Entocort EC (budesonide), Biogen Idec’s Tysabri (natalizumab) and Abbott’s Humira (adalimumab), respectively. There is increased competition between Remicade, Humira and the

We are pleased to have this second licensing collabora on with Sanofi, one of the largest pharmaceu cal companies in the world and the first one from Glenmark in the field of novel biologics. Glen Saldanha Chief Execu ve Officer & Managing Director, Glenmark Pharmceu cals

recently approved product Cimzia to be the market leader. Humira and Cimzia are presenting tough competition to Remicade, which has been in the market the longest. Tysabri has a different mechanism of action from these biologics, but its low safety record compared to other biologics is a concern. The global CD therapeutics market has seen intense competition, which is expected to further intensify in the coming years. However, Glenmark’s GBR 500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody and has established proof of concept in animal models across a range of anti-inflammatory conditions. Glenmark has completed phase I dosing of GBR 500 in the US and the drug has been well tolerated with a good pharmacokinetic profile. Plans are in place to initiate clinical proofof-concept studies in CD. Sanofi has licenced the rights to all therapeutic indications. “There continues to be a strong medical need for safer and more efficacious products for the treatment of inflammatory diseases,” remarks Elias Zerhouni, Managing Director, President, Global Research & Development, Sanofi. “GBR500 brings an innovative approach to Sanofi’s Immuno-Inflammation portfolio, which we believe may address a significant gap in treating inflammatory diseases, which would be of huge benefit to patients.”

Emerging therapies Also, according to GlobalData, there are over 49 molecules in various stages of the pipeline. Traficet-EN, Myoconda, Modern Pharmaceuticals I June 2011

Market Scope MLN0002, Prochymal and Stelara are some of the late stage pipeline molecules. These pipeline molecules differ in their target of action from the existing therapies, and are likely to offer better safety. They are also likely to benefit patients who have become resistant to Anti-Tumor Necrosis Factor (TNF)-alpha therapies. The pipeline has seen an increase in the development of emerging therapies such as biologics as they have the ability to change the natural course of the disease. Emerging therapies have gained a positive perception among physicians in the maintenance of remission. There is likely to be a marginal increase in the prescription of biologics for long term maintenance as they have the capacity to avoid the need for steroids. The emerging therapies are likely to crowd the market and there seems to be the possibility of a price war.

CD in India: Incidence and prevalence data Although CD is a rarity in India with a low incidence rate in the past, the total number of people suffering from this disease is high compared to developed countries because of the large population of India, which is only second to China. As Glen Saldanha, Chief Executive Officer & Managing Director, Glenmark Pharmceuticals, says, “We do not have market data for India.” However, the rarity of the disease in the past can be attributed to the limited diagnostic services available then and misdiagnosis of the disease. In India, CD is commonly misdiagnosed as enteric tuberculosis/Gastro Intestinal Tuberculosis (GITB) and sometimes even as amoebic colitis. According to the Inflammatory Bowel Disease - Asia Pacific Working Party (IBD-APWP), the incidence of CD in Asia ranges from 0.5 to 1.0 per 100,000 person years. The number of CD patients in India has risen to 21,061 patients in 2001 from 5,000 in 1987. With the increasing incidence of inflammatory disease in Asia, over the last few years the incidence of June 2011 I Modern Pharmaceuticals

The focus for the Switzerland biologics R&D centre has been to discover and develop exci ng novel monoclonal an bodies for the poten al treatment of inﬂammatory and oncology condi ons. Dr Michael Buschle President - Biologics, Glenmark Pharmaceu cals

CD has also increased in India. This is mainly attributed to the changing environmental conditions like childhood infections, dietary patterns, smoking and other psychosocial factors. The increase in the incidence of CD is also credited to the identification of the existence of CD and availability of proper diagnostic methods.

Market dynamics CD is a chronic condition and persists throughout the life. The mortality rate of CD is very less (approximately 1 per cent). Low mortality rates coupled with increased incidence population would in turn increase the diseased population and this diseased population would drive the activity of this market. The prescription rate is considered to be one of the drivers of this market as there is an increase in the prescription of biologics. Generally with autoimmune disease therapeutics, there is a trend for the increased uptake of biologics. These biologics give more options to the physicians and patients who do not respond to conventional treatments. In addition, physicians prefer to prescribe biologics early to patients who they identify as more probable to develop an advanced form of the disease. Physicians believe that the early identification of such patients and the prescription of biologics to them could prevent them from reaching more severe stages. The prescription of these high-priced biologics serves as an important driver of the CD therapeutics market.

Key deals One of the key deals in the CD market has been the licensing agreement

between Glenmark Pharmaceuticals and Sanofi-Aventis for the development and commercialisation of GBR 500, a monoclonal antibody used for the treatment of CD and other chronic autoimmune disorders. In North America, Europe, Japan, Argentina, China and Uruguay, Sanofi will have exclusive marketing rights, and will comarket the product in Australia, Brazil, New Zealand and Russia. For India and other countries in the rest of the world, Glenmark will retain the exclusive marketing rights. In addition, Glenmark could receive potential success-based development, regulatory and commercial milestone payments. The total of these payments could reach $613 million. In addition, Glenmark is eligible to receive tiered double-digit royalties on sales of products commercialised under the licence. According to Saldanha, “This collaboration on a novel first-inclass monoclonal antibody validates Glenmark’s world-class innovative R&D capabilities in the drug discovery arena. We are pleased to have this second licensing collaboration with Sanofi, one of the largest pharmaceutical companies in the world and the first one from Glenmark in the field of novel biologics. Dr Michael Buschle, President Biologics, Glenmark, remarks, “The focus for the Switzerland biologics R&D centre has been to discover and develop exciting novel monoclonal antibodies for the potential treatment of inflammatory and oncology conditions. This deal is a testimony to the strong biologics platform that Glenmark has established in a relatively short frame of time.” MPh (arshia.khan@infomedia18.in)

In Dialogue

‘MAT should be abolished, or at least the rate should be brought down to 10 per cent’ …opines Sa sh Reddy, Chairman, Confedera on of Indian Industry (CII) Na onal Commi ee on Drugs and Pharmaceu cal & Managing Director and Chief Opera ng Oﬃcer, Dr Reddy’s Laboratories Ltd. He analyses the probable impact of increase in Minimum Alternate Tax (MAT) and provides CII’s take on it. Chandreyee Bhaumik Share CII’s views on the proposed MAT of 18.5 per cent on the book profits of Special Economic Zones (SEZ) developers and units. As far as this issue is concerned, the following points should be considered: MAT should be abolished, or at least

We fear that the imposition of MAT on SEZ would adversely impact our business, since most of the export units of drug firms are located in various SEZs. Further, significant investments made by most of the major pharma firms in these zones will now be affected adversely as the planned returns on these investments will not materialise now as planned.

contract manufacturing business, and for developing capability in existing clusters, the government is considering provision of concessional finance for large scale advanced testing centres, stability testing centres, effluent treatment infrastructure, bioequivalence centers, etc. This will enable the individual entrepreneurs to build relevant manufacturing capacities.

What will be the next step for the Indian pharma?

The industry and the government would have to work together for the Indian pharma industry to tap the opportunity from government sourcing of pharma products.

the rate should be brought down to 10 per cent The industries, which are otherwise eligible for tax exemptions should also be exempted from MAT Long-term capital gains exempt from tax should be excluded from MAT computation

How will the players tackle this change in the tax structure? 52

How can the government help? In the export strategy, a paper released last month by the Ministry of Commerce and Industry (MoCI), the government is considering various types of packages for the pharma industry as a whole. These include government support for R&D by initiating a pharma innovation fund, and development of pharma corridors or cities. Again, to attract more

The India Japan Comprehensive Economic Partnership Agreement (CEPA) has already granted national treatment status to Indian pharma. Further, India’s agreements with Korea also incorporate tariff reductions for pharma-related tariff lines. Again, it can be said that pharma being one of the priority industries, the government will make tariff and non-tariff barrier reduction in pharma as a critical element of all bilateral agreements. Additionally, the other area of concern is government procurement of pharma, since in many countries the government is the largest buyer of medicinal products. Therefore, the industry and the government would have to work together for the Indian pharma industry to tap the opportunity from government sourcing of pharma products.

Shed some light on what CII is doing for this. CII had protested against the imposition of MAT but the Finance Ministry did not accept our recommendation. MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I June 2011

Market Trends

Pharma SEZs in India

Is MAT taxing more problems? While Special Economic Zones (SEZs) are gaining prominence in every ver cal, pharma space is not far behind. With the announcement of the Minimum Alternate Tax (MAT) of 18.5 per cent the scenario might change. It is not going to be smooth sailing for the SEZ players, be it the pharma companies or the SEZ developers. Weighing the beneﬁts

Chandreyee Bhaumik

t was in 2006 that the Indian Government decided to set up SEZs for Indian pharma and biotechnology industries so that several pharma companies could leverage on the benefits. However, in the Union Budget 2011, the government proposed to levy a MAT of 18.5 per cent, effective April 2012, on the book profits of the SEZ developers and units, and the players now do not find this congenial enough. Pharma companies now fear that this imposition of MAT on SEZ would adversely impact their profits as most export units of drug firms are located in various SEZs. Discussing the nitty gritty of a SEZ, Bodh Raj Sikri, Co-Chairman, 54

Federation of Pharma Enterpreneurs (FOPE), elaborates, “SEZ is totally dedicated for Export-Oriented Units (EOUs), whereas Tax Free Zone is meant for domestic industry. For example, in case of Himachal Pradesh, Uttarakhand, Jammu and Kashmir, Sikkim etc, Government of India has introduced a tax free zone where there is no income tax, no sales tax and no excise duty. In addition, there are also other benefits such as capital subsidy.” In this context, he adds that the basic purpose of government to introduce a tax free zone is to create employment for youth of that particular area where industries do not exist. He explains, whereas in the case of SEZ one has to have a unit meant for export of the end products.

In this scenario, the fundamental question that torments is whether SEZs will now be actually reaping the benefits that they had once expected? An SEZ offers many advantages for the unit holder compared to the unit that was set up on own. Government provides incentives and facilitates Foreign Direct Investment (FDI), duty-free import/domestic procurement of goods, exemption of 100 per cent income tax, central excise, service tax, single window clearance of goods etc. Elaborating in this strain, Kayvanna Shah, Chief Executive Officer, JB SEZ Pvt Ltd, avers, “First of all, land for a unit holder is readily available with core infra facilities in place like water, electricity, telecom. Moreover, other basic facilities like logistics, security, hospitality and so on are offered by the developer in a SEZ.” Further, discussing the advantages of a SEZ, Shah continues, “Above all this, the government has ensured a slew of incentives to the unit holders. Some of them include 100 per cent FDI in the manufacturing sector permitted through the automatic route and income tax exemption on export income till 15 years.” Again, there will be an exemption from custom duties and central excise duties on import of capital goods, raw materials and exemption from duties on import and procurement of goods for the development, operation and maintenance of the SEZ. Shah adds, “Other benefits include single window clearance for central and state-level approvals, in-house customs clearance for import and export cargo, relaxation Modern Pharmaceuticals I June 2011

Market Trends in External Commercial Borrowings (ECB) till $500 million and exemption from Central Sales Tax and Service Tax.” However, the basic concern that emerges is whether the advantages are fading out after the declaration of the taxes?

Concern areas The declaration of the imposition of MAT tax came as a shock to many. Explaining this Shah reiterates, “To be candid, we were indeed taken aback by the Finance Ministry’s announcement of imposing MAT on the SEZ developers and unit holders.” Seconding the above thought, Sikri opines, “Definitely, there was an advantage earlier in the case of SEZ but now industry is not getting attracted because 18.5 per cent MAT is being levied, and basic attraction to set up a unit is gradually disappearing. It has been observed that new SEZs are not at all attracting the investors. Therefore, if government wants to attract the investors and exporters to invest in SEZ, there should be a firm policy and there should not be any withdrawal of any incentive once the plot is allotted to an allottee. Further, this along with

Deﬁnitely, there was an advantage earlier in the case of SEZ but now industry is not ge ng a racted because 18.5 per cent MAT is being levied, and basic a rac on to set up a unit is gradually disappearing. Bodh Raj Sikri Co-Chairman, Federa on of Pharma Enterpreneurs (FOPE)

We were indeed taken aback by the Finance Ministry’s announcement of imposing MAT on the SEZ developers and unit holders. We expect the ministry to have a second look on the announcement and hope that a reversal in this decision is on the cards. Kayvanna Shah Chief Execu ve Oﬃcer, JB SEZ Pvt Ltd

the introduction of the Dividend Distribution Tax (DDT) has turned out to be dampener for the future of SEZs.” Continuing in this tone, Shah adds that one should not forget the fact that the SEZs in India have contributed immensely in generating the net foreign exchange of the country along with creating employment (both direct and

indirect) opportunities. He opines, “We expect the ministry to have a second look on the announcement and indeed hope that a reversal in this decision is on the cards.” The declaration of MAT has evoked an aura of apprehension among pharma companies and SEZ developers. Dr Lal Krishna, Chief Executive Officer,

Tale of a few zones North zone M/S Next Wave (India) is situated in Paonta Sahib, Himachal Pradesh. The company is primarily into contract manufacturing for leading companies of India. This facility started its journey 5 years ago and over this period there has been substantial amount of investment in order to upgrade the plant as the developers propose to go for WHO certification so that they can plan to enter into the export market in the near future. After completion of 5 years, the income tax benefit is going to be over and it is required to have viability of the unit in days to come. This is a state-of-the-art unit for non betalactam range of products covering various segments of tablets, capsules, ointment and syrup. They faced infrastructural problem initially. However, it has been more or less improved by the state governments. But increase in the manpower cost in hilly area, shortage of skilled manpower, frequent increase in the tariff of electricity, stringent environment rules, which they are facing at present are a few challenges. However, they propose to resolve it by meeting with the Chief Minister and ministers of respective states. West zone HBS Pharma SEZ envisaged setting up an SEZ few years

June 2011 I Modern Pharmaceuticals

back and it was in the process of scouting for land in Gujarat. This state is proactive in its business approach and the state government has put many projects on fast track basis. Once the land was identified that was in close proximity to various chemical and pharma companies, it was a natural choice to set-up a pharma SEZ. The developers have committed about `160 crore from their side on the project and expect unit-holders to invest approximately ` 1000 crore over the course of next 2-3 years generating employment for about 20,000 people. In this context, they have also been successful in tying up with various renowned partners and project consultants for this SEZ. With IL&FS as the financial partner to other project consultants like CPG, Singapore (master-layout), Voyants (infra consultant), HEC Infra Projects (electrical layout consultant) etc, the SEZ is positive for its journey. South zone In Ramky Pharma City India Ltd, out of the total area of 2400 acres, 611 acres is allotted for SEZ. Further, along with the tax benefits there is also the integrated environmental management facilities provided. Only the core manufacturing work is done by the pharma companies, the remaining activities are taken care of by the developers.

Market Trends

With the imposi on of MAT, a pharma company stopped a deal that was worth $ 400 million. People should voice their diﬃcul es to the government. However, though we have represented our problems, there was no response from the government. Dr Lal Krishna Chief Execu ve Oﬃcer, Ramky Pharma City India Ltd

Now that the sunset clause is not extended to EOUs, we have suggested to the Commerce Ministry that MAT at the rate of 18.75 per cent may be imposed on the EOUs similar to SEZs. This will also provide a relief for EOUs to migrate to SEZs. Daara B Patel Secretary-General, Indian Drug Manufacturers’ Associa on (IDMA)

Ramky Pharma City India Ltd shares, “With the imposition of MAT, a pharma company stopped a deal that was worth $ 400 million. People should voice their difficulties to the government. However, though we have represented our problems, there was no response from the government. Thus, growth and the start up will definitely be delayed for several pharma companies.” However, there are also few suggestions in this area. Daara B Patel, Secretary-General, Indian Drug Manufacturers’ Association (IDMA), explains, “Now that the sunset clause is not extended to EOUs, we have suggested to the Commerce Ministry that MAT at the rate of 18.75 per cent may be imposed on the EOUs similar to SEZs. This will also provide a relief for EOUs to migrate to SEZs.”

Winning during tough mes After this announcement of MAT, the pharma industry is disheartened and demotivated. Sikri explains, “Changing the policy by government due to political reasons puts us on the back seat. There has to be continuity in the incentive and any adverse change in the policy will certainly affect the promoter of industry.” Thus, he says, “To encourage export, infrastructure has to 56

be improved, MAT should be withdrawn and other incentives such as insurance coverage of the plant and building of the investor, insurance of workers, and subsidy on R&D, subsidy on generator set, freight subsidy etc should be introduced if government is really serious to boost the export. Similarly, uninterrupted power supply is another major factor that the government has to keep in mind. Many pharma segments like fermentation-based products are not viable in India because it needs affordable power availability.” Discussing the ways to bring a solution, Shah says, “Concentrated efforts on the part of ministry as well as SEZ developers to educate and inform such prospective clients or unit holders, especially Small and Medium Enterprises (SMEs), on the benefits of setting up units in a SEZ should take place. Moreover, financial assistance granted to such enterprises would facilitate investments in this space.” Further, he adds, “Our vision is to develop a SEZ offering world-class facilities thereby creating an industry benchmark of sorts. Our next agenda is to set up a well suited and full fledge residential township, which would complement the unit holders and their employees. Along with the residential

apartments, this township will have all the necessary facilities and social amenities like healthcare, schools, hotels, recreational parks etc, which shall be self-sufficient and will cater to the requirements of all residing there.”

Hoping for be er… There are constant efforts to ensure a better and a brighter future for the SEZs. IDMA is supporting the Government’s move to allow clearance of approvals for units in SEZs, special incentives and also offer loans to players uniformly all over India to set up units in SEZ at concessional rate of interest. This will definitely boost the pharma exports immensely. Explaining the future of the pharma SEZ in India, Patel reiterates, “The future is bright and it is the way forward for promoting and boosting pharma exports in the highly competitive global pharma market. Therefore, government must encourage setting up of dedicated pharma SEZs such as the ones coming up in Maharashtra at Nanded and JB SEZ in Gujarat all over the country. The benefits and concessions provided by government to players in SEZs will also enable India to be more competitive vis-à-vis China.” He adds that SEZs also provide job opportunities and signs off saying, “Companies can invest heavily in R&D, as well as effluent treatment plants, which are capital intensive, as equipment, raw materials etc can be imported duty free. Government can also encourage more players to establish units in pharma SEZs by providing more concessions and benefits to further boost India’s pharma turnover to achieve the level of ` 250,000 crore ($50 billion) by 2020 from the present ` 100,000 crore ($26 billion).” With the debut of SEZ culture in the pharma domain, this arena has surely witnessed various changes. But, it is now a well pronounced apprehension that the introduction of the MAT at 18.5 per cent will introduce a new chapter in the pharma dynamics. MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I June 2011

Spotlight

Lonza

Leveraging the SEZ advantage The unveiling of the plaque at BioAsia 2011 marked the launch of Lonza R&D facility that will be built in the biopharma Special Economic Zone (SEZ) – Genome Valley, Hyderabad. Here is an insight into what brought this leading supplier in the life science industry to the Indian soil. Dr Asma Mohd Yousuf

n the recent past, India has witnessed tremendous growth in almost every industrial segment. Today, there is hardly an MNC which does not have its premises in India. Infact, an established organisation not having an office in India is a surprise element in itself. One of the evidences of humungous growth and development in India are the rising SEZ. And Genome Valley, the knowledge park developed exclusively for the biotech industry in Hyderabad, is one of its kinds among the SEZs in India. Today, it houses leading biopharma companies. This year, with the launch of projects, such as Lonza Knowledge Centre, it has seen yet another major investment coming its way. Lonza is a global leader in the production and support of Active Pharmaceutical Ingredients (APIs) both chemically and biotechnologically. From 1897 to the present day, combining Swiss tradition with global experience, the company has had an enterprising character, adapting its offerings and services to the needs of customers and to changing technologies. Discussing, why India was the chosen destination

for setting up the Lonza R&D sector, Dr Harry Rathore, Managing Director/ Head - India Operation, Lonza India Pvt Ltd, says, “India has an excellent science education systems and it produces highly skilled scientists. Availability of scientific talent was a driver for us to choose India. Excellent infrastructure in Hyderabad, coupled with government friendly norms of Andhra Pradesh attracted us to choose Hyderabad.”

Hyderabad as a des na on Indeed, Hyderabad is the fastest growing city in biotechnology R&D innovation and contract manufacturing. And what could be a better destination than the ideal Bio SEZ location – the Genome Valley. Discussing Lonza’s plan of setting up R&D facility at Genome Valley, Dr Rathore informs, “Lonza Knowledge Centre will be a state-of-art energy efficient R&D facility of 50,000 sq ft in phase I, which will be expanded to 80,000 sq ft over time, depending on the need of the business. We will be conducting R&D in cell biology, molecular biology and regenerative medicine. In future, we will consider development of services offering cell line construction and down stream processes for biopharmaceuticals. We will also be conducting research in

Lonza Knowledge Centre will be in the-state-of-art energy eﬃcient R&D facility of 50,000 sq in phase one, which will be expanded to 80,000 sq over me. We will be conduc ng R&D in cell biology, molecular biology and regenera ve medicine. Dr Harry Rathore Managing Director/Head - India Opera on, Lonza India Pvt Ltd

the areas of personal care formulation, hygiene & preservatives and bio catalysis for API/advanced intermediates.” Further, he adds, “First phase of the facility is expected to be ready on or before August 01, 2012 at Genome Valley. In addition to building R&D facility, Lonza is moving its headquarters to Krishnamma House situated at Road No - 7, Banjara Hills, Hyderabad by end of September 2011. We will also keep a sales and marketing office in Mumbai. The facility will provide employment opportunities to around 100-150 technically qualified professionals, coupled with 50-60 people in headquarter and sales office.” This setup will be a part of Lonza’s global R&D expansion and will be Lonza’s first R&D setup in Asia Pacific in the field of bioscience. Dr Rathore mentions, “Lonza’s major involvement is in the development and manufacturing of advance intermediates/API and bulk biopharmaceuticals for the innovators. Besides, our major areas of interests are disorders cardiovascular diseases, diabetes, oncology and monoclonal antibodies.” However, every new establishment faces challenges in some form or the other. The inclusion of single clearance for setting up an SEZ in the SEZ Rules has its own pros and cons. Dr Rathore shares his opinion, “The creation of SEZ and tax incentive by Central and State Government was an attractive feature to establish export-oriented R&D and manufacturing facility. We were enthused by a single window clearance policy of SEZ that would enable us to build and operate the facilities in a record time of 18 months. Modern Pharmaceuticals I June 2011

Spotlight However, in practice, we found the single window clearance just does not work, and it only exists on paper. We have to move door-to-door of different licensing authorities to get permits, which cause delay. Also, the licensing process was found to be bureaucratic.”

Challenges Discussing other difficulties faced during the setup, Dr Rathore mentions, “Genome Valley is about 30 kms away from the Hyderabad city and due to the lack of adequate housing and recreational facilities near Genome Valley, it is becoming a challenge to hire and retain the highly skilled R&D scientists. However, to ease the burden of our employees, we will be arranging transportation facility from multiple locations.” There is no doubt that an organisation has to overcome several obstacles before, during and even after the establishment process. Only a through research and planning in advance can help in overcoming these issues. However, any company can pose a big challenge to the environment if it has not taken adequate measure right at the time of inception. However, the $12 million Lonza R&D facility will be an eco-friendly structure. Elaborates Dr Rathore, “With the interaction of our architects Venkat Raman & Associates, we are designing and installing a plus energy standard in our building design. The annual energy generation through active solar devices (photovoltaic and solar thermal) will exceed the overall energy consumption of the building that includes internal heating, water heating, lighting, ventilation, electrical appliances, etc.”

What’s next? Revealing the future focus of the company, Dr Rathore says, “We are focussed on three major areas: First, opportunities in water, especially providing biocides and nutraceuticals for clean and fortified drinking water. Second, hygiene and preservation, and third, emerging field of cell therapy/ regenerative medicines as well as diagnostic tools such as mycotools for micro plasma detection in the manufacturing of biopharmaceuticals, which is an emerging opportunity in India.” He optimistically states, “Lonza has just started its journey in India; we had a very good start and I see a bright future for Lonza in India.” MNCs like Lonza making large investments in India itself broadens the horizon of the Indian biopharma world. Knowledge Parks like Genome Valley have, of course, become the preferred destination for global biopharmaceutical companies. If all the companies here work with the mission of finding solutions to improve human health through the application of cutting-edge research in integrated disciplines of life sciences, at the same time keeping environment safety in mind, then this Indian valley will indeed be the most treasured and memorable valley in the history of drug development. MPh (asma.yousuf@infomedia18.in)

June 2011 I Modern Pharmaceuticals

Retail Zone

Training pharmacy staﬀ

Providing assistance and beyond Whenever one visits a pharmacy, sight of a qualiﬁed person/pharmacist who understands his/her prescrip on and provides some valuable sugges ons, is indeed welcome! Trained staﬀ in a pharmacy can act as a boon for the pa ent popula on with limited health literacy skills.

harmacy is not about medicine sales but servicing prescriptions, because the sale has already been affected by the doctor writing the prescription. Pharmaceutical prices are regulated by the government and a customer has choice to go to any pharmacy to buy the products, and so, the retailer cannot do much on having low price as a USP. So it calls for creating some key differentiators for pulling the customer in the pharmacy. ‘Service’ can be a key differentiator, and it is all about delivery and perceptions!

Rajendra Pratap Gupta International Healthcare Policy & Retail Expert

Every pharmacy has staff, which may include owners, pharmacists & sales persons, and staff training is the key to deliver consistent and outstanding service. Some of the key things to keep in mind for training, to deliver outstanding pharmacy services, is to understand the basic fact that: A doctor is next to God, nurse is next to the doctor, and only a pharmacist is closest to the patient! This makes the relationship between the customer and pharmacy staff (including the pharmacist) very crucial. This calls for a detailed training of the entire staff within the pharmacy and continuous training programmes (CMEs) for the pharmacy staff every 6 months When it comes to training, a few questions will creep into the mind about: When to start? How often to train? and Whom to train?

Induction training: Ideally, the pharmacy owners must have an induction programme when an employee joins the organisation; be it a standalone pharmacy or a pharmacy chain. This includes training the staff on Store layout and product placement (product planogram), within the pharmacy Store policies Key customers Other than the induction programme, the pharmacy staff needs to be trained on the store operations and that includes training the staff about: Product knowledge: There are almost 15,000 Stock-Keeping Units (SKUs) in a good pharmacy. Since about two products get launched every day, so it is important, that the pharmacists and the other store staff keep updating their knowledge. This is a continuous process, and the pharmacists and sales staff must spend at least 30 minutes every day, randomly going through the product literature normally accompanying the product packs. Also, the scheduled drugs information needs to be at the fingertips regularly, to avoid legal and regulatory hassles involved in dispensing them. This product knowledge must be linked to the product placement in the pharmacy so that it does not take more than 3-5 minutes to service a prescription. Inventory management training: Store staff (store manager) must be trained to use the lean hours (afternoon hours) in analysing the Modern Pharmaceuticals I June 2011

Retail Zone non-moving stock and inventory management. This can help every pharmacy, to move to, stocking right mix than stocking more inventory. Rush hour training: How to deal with the customers in the rush hour? Pharmacies selling over ` 30,000.00 per day witness unusual rush during the evening hours. It is imperative that during these hours the consumers are addressed before they are served so that they do not disappear. Whenever the consumers are standing in multiple rows surrounding the counter, the pharmacy staff at the counter must notice and greet every new customer entering the pharmacy. This gives an impression to the customer that he has been noticed and feels that he is important to the pharmacy. So, the customer will not walk away as he knows that he has been noticed. This is the most important thing to do when you run a busy pharmacy counter. The moment you see a new customer entering the pharmacy, do say, ‘Sir/Madam, Good day, I will be with you in just a few minutes.’ Greet: Do greet and talk to children accompanying the customers. This has a good impact on increasing the bonding with the consumers with children. If you wish to go further, it might be worth giving out a candy to the child, and this way, you will see that many times the children bring their parents to the pharmacy, because they like the staff for the ‘token gifts’ they get and they love to meet the pharmacy staff. And believe me, 80 per cent of the times customer with a child will spend more than a customer walking alone. Respect: Customers feel flattered when you know their names, so the pharmacy staff must respectfully use their names whenever possible. Never say ‘No’: If a customer asks for a product that you do not have, and if that is an Over-The-Counter (OTC)/Non-pharma product, do recommend another product with added benefits, and you will see that June 2011 I Modern Pharmaceuticals

50 per cent of the time the customer will end up going by your advice and even spend more. Expand the basket of the consumer: It would be worth spending 2 minutes with a chronic patient, eg: If a consumer is diabetic or suffering from hypertension. As most of these chronic customers are not aware of the options that exists for them for health supplements, and high fibre foods etc., it is better to show your concern for these chronic patients and educate them on the benefits of additional healthcare supplements etc, which might help them in managing their disease. With this, the pharmacy staff is able to show that they care for such consumers and understand the problems associating in managing the disease. Also, that chronic patients are looking for products that can reduce the sideeffects and help them better manage the disease or avoid co-morbidities. Database maintainance: Training the staff to maintain the database of chronic patients and reviewing their buying habits. Almost all progressive pharmacies (stand-alone or chains) have a software that captures customers & sales data. Pharmacists and sales people must be trained to analyse the data regularly, and ensure that the top most customers are given regular calls with regards to their well being and also help them with prescription refills and home delivery , if applicable. Training for billing desk: Training the staff for billing instruction is very important. Staff at the billing desk must be trained to ask your customers if they have a loyalty membership card (provided your pharmacy has a loyalty card). This will help educate customers about the loyalty benefit and also market your loyalty programme. Providing more: Before the staff jumps to start billing, it is important to ask the customer if s/he needs anything more? The staff could prompt for some products, which

might be relevant to the customer or a new product that has been launched and could be helpful. Signing the bill and handing over to the customer: The rules require that all prescriptions have the patients name, doctor’s name and signature of the pharmacist besides the name, expiry, batch number quantity and price of the medicines. Staff must be trained how to make a bill so that they do not get into the legal hassles due to errors in issuing the bills. Dealing with arrogant customers: Four out of hundred will be arrogant customers, and it is better to politely listen to them and let them vent their anger. No point debating with them. It goes without saying that the customer is not always right, but he has the money and he can take it elsewhere. It is proven through studies that 68 per cent customers do not give a repeat visit to a store due to employees attitude and 14 per cent due to dissatisfaction. There are following categories of outlets in the market for every segment: Available outlets: All outlets in the area are in this category Considered outlets: Customer may consider a few outlets of the available outlets due to proximity to his/her residence Acceptable outlets: Out of considered outlets, a few are considered as acceptable outlets due to various other preferences besides the location Preferred outlets: This is the outlet the customer prefers to visit. All retailers should aim to be the preferred outlet for the consumers To get into the category of preferred outlets, one has to give best of service. It goes without saying that you can only drive the car from inside and no one else can drive it for you. So the staff within the pharmacy is extremely important for making the pharmacy a success and needs to be trained well and regularly. MPh (office@rajendragupta.in)

Legal Edge

Compulsory licensing

Access to innova ve pharmaceu cals With compulsory licensing, local drug makers will be able to make low-cost versions of patented drugs by innovator companies. If the innovator company fails to reach an agreement, which primarily involves a royalty fee for each generic drug sold, to be paid to it, the generic manufacturer can approach the patent oﬃce for a compulsory licence. A legal perspec ve... alone. Pharma giants of the developed nations use non-TRIPS mechanisms to force adherence to TRIPS plus regime. Such compliance by the pharma sector developing countries and least developed countries would pose further difficulties.

Challenges and solu ons

ompulsory licences are ‘involuntary agreements’ between a patent holder and a third party imposed or granted by the government. Compulsory licences empower the government/state for allowing itself or a third party to have access to, produce, use or sell the patented product or process without the consent of the patentee.

Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra

Genesis The genesis of compulsory licensing may be mapped back to Articles 7, 8, 30 and 31 of Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, however, the concept has been reinforced more emphatically in the 2001 Doha Ministerial Conference, popularly known as Doha Declaration. Compulsory licensing is one of the flexibilities on patent protection included in TRIPS Agreement. Patents versus patients is an ongoing battle. In the knowledge-based pharma industry, most of the innovations are cradled by pharma giants, and they leave no stone unturned for providing strong Intellectual Property (IP) protection to their innovations and are no more satisfied with TRIPS provisions

Post-product patent regime, India is facing a daunting task and challenge of devising a solution, which appeals to patent holders as well as the end users of the pharma products. The problem is peculiar in the pharma industry, since the stakes on both sides are high. On one side are the high costs of R&D, years of research and huge efforts put by patentee and on the other side lie the lives of millions of poor patients. Compulsory licensing provisions are envisaged as striking a delicate balance between the needs of innovators and public health. Compulsory licence provides most effective safeguard against the lack of use of a patented invention or potential misuse of the patent holder’s monopoly rights in order to protect public interest. Compulsory licence is one of the tools with the government to check that the patents do not translate into neoimperialism. Compulsory licensing is an intervention mechanism enabling the government to strike a balance between the rights of the patentee and its obligation to provide products at reasonable price, in particular to medicines. Article 4 of the TRIPS agreement affirms that TRIPS does not prevent member countries from taking measures Modern Pharmaceuticals I June 2011

Legal Edge to protect public health and Article 6(b) and 6(c) recognises flexibilities of the TRIPS agreement to grant compulsory licences under circumstances of emergency. In the amended Indian Patent Act 2005, these flexibilities have been incorporated in Sections 84, 91, 92 and 92 A.

Patents Act provisions According to Section 84 of the Indian Patents Act, any interested individual after expiry of three years from grant of patent may put forward an application to the Controller for grant of compulsory licence based on the grounds and conditions set forth therein in the Act. As per Indian patent laws, compulsory licence is granted when the reasonable requirements of the public with respect to the patented invention have not been satisfied; or the patented invention is not available to the public at a reasonable price or the invention is not worked commercially to fullest extent in territory of India. As per Section 91(a), on application, compulsory licence is issued for a related patent, subject to certain conditions, if working of a patent is hindered in absence of a license to work the related patent. Section 92 deals with grant of compulsory licence in circumstances of national emergency or extreme urgency or in case of public non-commercial use. Section 92A is manifestation of Doha Declaration allowing the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity. Though provisions of grant of compulsory licence appear to be balanced, in practical terms many issues still remain unresolved, particularly in context of pharma industry, since availability and affordability of life saving/improving medicines cannot be ensured by implementing such laws alone that too in a nation like India, where still 65 per cent of the population lacks access to essential drugs.

is currently in a flux. On one hand, it is trying to cope with post-product patent regime, while on the other hand it trying to fend off the ever-growing competition from multinational pharmaceuticals. Though India ranks third in terms of volume of production of pharmaceuticals, with exports growth at exponential rate of 29 per cent in 2008-09, yet domestic consumption is seen to fall down, indicating a need to increase the availability and accessibility of medicines to large poor masses of India. The Indian pharma industry is witnessing a paradigm of changes since its inception of product patent regime and one of the critical issues of concern is taking over of pharma companies of Indian origin by overseas pharma giants.

Compulsory licensing is an interven on mechanism enabling the government to strike a balance between the rights of the patentee and its obliga on to provide products at reasonable price.

Further, there have been tieups between MNCs and domestic companies including GSKâ&#x20AC;&#x2122;s link with Dr Reddyâ&#x20AC;&#x2122;s; Pfizer with three companies - Aurobindo, Strides Arcolab and Claris Life Sciences; Abbott with Cadila Health Care and Astra Zeneca with Torrent. The data mentioned above has sent alarming signals indicating consolidation in the Indian pharmaceutical industry in the hands of multinational giants, outcompeting the Indian companies and it is feared that the larger companies shall use patents as weapons or shields to secure higher profits and the hardest hit shall be the poorer section of Indian society.

Indian pharma industry

Compulsory licensing scenario

The Indian pharmaceutical industry

In the wake of these developments,

June 2011 I Modern Pharmaceuticals

India is evaluating the compulsory licensing provisions. Reviewing the global scenario, it is seen that compulsory licences have been issued in many countries including many Asian countries, availing the provisions of compulsory licence in their respective laws, well within the ambit of TRIPS agreement. In 2003, Malaysia became the first country to issue a compulsory licence to import generic version of HIV anti-retrovirals from India, thus aiding in reducing the cost of treatment. Indonesia also issued compulsory licence to local manufacturer for production of an anti-retroviral. In 2006, Thailand also issued a compulsory licence for production of HIV drug Efavirenx locally. Compulsory licensing permitted by the South African government helped them to licence Indian companies Cipla and Hetero Drugs to produce cheaper versions of drugs, particularly HIV drugs. Although 39 drug pharmaceutical corporations from developed nations filed lawsuit against the South African government, however, the tireless international campaign for availability of affordable medicines to poor and needy patients forced the pharmaceutical giants drop to the lawsuit unconditionally. Brazil and Ecuador have also issued compulsory licences for AIDS-curing drugs. All these countries have demonstrated that TRIPS flexibilities can be used effectively for catering to the needs for public health and simultaneously pressurise the developed countries for formulating the conducive strategy in developing and least developed countries.

Indian generics In India, no compulsory licences have been issued so far. However, momentum has been already set in this direction. In 2007, Natco Pharma, a Hyderabad-based generics manufacturer filed a request for issuance of compulsory licences with the Indian Patent Office. The applications pertained to cancer drugs, Sutent of Pfizer and Rocheâ&#x20AC;&#x2122;s Tarceva Erlotinib. 63

Legal Edge Indian companies acquired by MNCs Indian company Year Taken over by taken over Aug 2006 Matrix Lab Mylan Inc April 2008 Dabur Pharma Fresenius Kabi Ranbaxy June 2008 Daiichi Sankyo Laboratories July 2008 Shantha Biotech Sanofi Aventis December 2009 Orchid Chemicals Piramal Health May 2010 Care

Hospira

US SG

Price in $ (million) 736 219

4600

783

400

Country

Abbott Laboratories US

3720

Source: Press Reports

Compulsory licensing application filed by Natco argued that in view of a public health problem in Nepal, it ought to be granted a compulsory licence to export generic copies of Pfizer’s patented anti-cancer drug, Sutent (and Roche’s patented drug, Tarceva) to Nepal. However, Natco Pharma withdrew these applications subsequently. Natco Pharma has now filed another application and wishes to manufacture and sell its generic version of Maraviroc, anti-retroviral drug in India at ` 15,000 for a month’s supply, compared with the ` 65,000 price tag for Pfizer’s branded version. Pfizer has secured the patent for Maraviroc in January 2007. Natco has also sought a voluntary licence from Pfizer, but if turned down, it will press for compulsory licence. Natco has already informed Pfizer that the price it is charging for the brand name version of Maraviroc is too expensive for the Indian consumer. Natco proposes to reduce Pfizer’s price by 77 per cent to better serve India’s 2.3 million HIV patients. Indian patent law allows a third party to seek compulsory licence three years after a patent is awarded - the three years period was over in January 2010. Pfizer has time until May to respond to Natco’s voluntary license request. Natco Pharma has also written to German drugs-to-agrochemicals giant Bayer to provide it with a ‘voluntary licence’ to manufacture and market its anti-cancer drug brand Nexavar (sorafenib). Natco Pharma could get permission to make and sell a low-cost copy of Maraviroc/ Nexavar in India under a 64

‘compulsory licence’ for the remaining term of the patent if it can be established that the patented product is not available to the public in the country at an affordable price. Natco Pharma is the first generic drug maker that sought to apply for a compulsory licence and many generics are following the trend.

Ongoing debate In response to concerns about overseas takeovers, rising drug prices, need for innovation for second and third generation drugs and petitions filed by domestic players for issuance of compulsory licences, compulsory licensing is currently undergoing a serious debate in India. Department of Industrial Policy and Promotion (DIPP), Ministry of Industry & Commerce had released a discussion paper on the compulsory licensing policy, inviting responses from the general public and 30 responses were received. The organisations representing Indian drug manufactures informed DIPP about consensus on the use of compulsory licensing provisions in accordance with Indian Patents Act, whereas organisations representing foreign firms expressed concern that such provisions will discourage the companies to invest and partner in pharmaceutical sector thereby shall affect the Foreign Direct Investment (FDI) and dampen the Gross Domestic Product (GDP) of India. Further, it has also been argued that patented products contribute only 1 per cent to Indian pharmaceutical industry and are not primary barrier to access to

essential medicines in India. Thus, such organisations are of the opinion that promotion of compulsory licensing is not viable and sustainable solution to healthcare sector in India. The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing and many terms have been left undefined like ‘public non commercial use’, national emergency, extreme emergency, adequate remuneration. The ambiguity of these provisions has been interpreted and flexibly applied by most of the countries as per respective national requirements.

Balanced approach India is following a very cautious and balanced approach for deciding the patent matters. Indian Patent Office is neither succumbing to international pressure from lobbying of MNC pharmaceutical giants nor is randomly adopting any biased approach favoring domestic pharmaceutical players. In Natco vs Pfizer, Patent Office gave Pfizer as well as Roche an opportunity to be heard in the matter before deciding the matter, which is not mandatory as per the patent legislation. While this move of Patent Office was questioned by Indian firms, the Patent Office was of the opinion that hearing the patentee would not only serve as an aid in deciding upon the application but would also prevent any abuse of the provisions of Section 92-A. India is following a robust practice of granting compulsory licence, ensuring that compulsory licence can only be granted if a voluntary licence cannot be obtained within six months from the start of negotiations with the patent owner. Perhaps availability of compulsory licensing is sufficient to encourage patent owners to grant voluntary licences. In spite of having adequate legislative provisions, India has little experience with compulsory licensing. Indian Patent Office is well aware that indiscriminate grant of compulsory licences is likely to adversely affect the future, as it would create a less Modern Pharmaceuticals I June 2011

Legal Edge stable investment climate, thus may dampen the foreign investment in pharmaceutical sector. However, MNCs will come forward only when an incentive is provided in terms of reasonable profitable returns. Furthermore, it is questionable whether a compulsory licence would really be useful in the case of some high-technology products, involving undisclosed information held as trade secret, that patents do not cover.

Working of inven on After the advent of product patent regime in India, working of patents and compulsory licensing are being given due importance. One of the steps taken in this regard is publication by Controller General of patents of a list of pharmaceutical patents granted to foreign firms and Indian firms. This publication will enable the third parties to monitor the desired patents and would enable them to file applications for compulsory licence. Filing of working statement by all the patentees for the previous calendar year, before the end of each financial year is being stressed by Patent Office, so that non working of patents can be monitored on regular basis. However, the working of patent has not been defined clearly in the Indian patents Act with regard importation from abroad. Patents Act and Rules appear to consider importation also as working of patent. Since it is not possible for foreign firms to set up pharmaceutical manufacturing plants in all jurisdictions, Indian patent law ensures availability of drugs in India, no matter whether it is being manufactured domestically or imported. Indian government needs to come up with amendments clearly defining various terms used in the provisions in the Patents Act relating to working of Patents.

Moving ahead... Compulsory licensing system in India has not been put to effective use in pharma sector so far. If used with due caution, it can be a potent tool in the hands of the government to ensure that public requirement of drugs and pharmaceuticals is sufficiently met at reasonable prices. In addition, Indian government needs to streamline its policies related to pharmaceutical sector, including revamping national pharmaceutical policy and national pharmaceuticals pricing system and expanding the ambit of competition law, Drugs and Cosmetics Act etc. The Department related Parliament Standing Committee on Health and Family welfare, in its report presented on August 04, 2010, expressed concerns regarding availability of drugs in India. A robust policy development related to the pharma industry is on the radar of the policy makers in India. It should include judicious use of compulsory licensing provisions aimed at striking a good balance between affordability of life saving drugs and adequacy of incentives to innovator entities. MPh (salhotra@lls.in)

June 2011 I Modern Pharmaceuticals

Business Mantra

Marke ng and analy cs

Services for leading the compe ve advantage Pharma companies worldwide are facing persistent pressure on bo om lines and see the need to work with service providers who have the ability to partner with them in the transforma on they are going through. A suite of scien fic services with an aim to achieve maximum benefits throughout the product life cycle are offered by various experts today, and Indegene Lifesystems Pvt Ltd is one such solu on provider. Parita Dholakia

trong convictions precede great actions. While it is essential for the life sciences industry to discover, develop and design novel drugs and delivery systems, in this cut-throat competitive world it is also essential to maintain and balance the cost of these activities. Software solutions provided by Information Technology (IT) helps these organisations to optimise their entire stage of drug development and help them maintain a competitive advantage. Backing from a solution and services provider ensures that the great action the company in concern is contemplating is a planned and well guarded move. Indegene is one such scientific partner that helps a company through the entire product cycle to enhance commercialisation and marketing success. Explaining the services provided by Indegene, Manish Gupta, Chief Executive Officer, says, “Indegene is a scientific partner to global pharmaceutical and life sciences companies. We deliver a spectrum of medical, marketing and analytics

services and a range of proprietary platforms for marketing and analytics. Through the depth of our scientific expertise, scale of our operations, offshore delivery model and global footprint, we deliver value to global pharma companies across multiple dimensions.” Thus, when a life sciences company needs to develop and market its product with the maximum returns, it can rely on scientific expertise provided by such experts.

Helping hand While small organisations are in need to acquire the correct software tools as their business grows, large organisations are looking to better define and control their discovery, design and development processes. There is a growing regulatory and business requirement to integrate early stage processes with the wider business in order to avoid being cliché and ensure patient safety, but at the same time value the innovative thinking that leads to the development of real ‘blockbuster’ products. In all cases, their is an increasing business need to provide better

Through the depth of our scientific expertise, scale of our operations, offshore delivery model and global footprint, we deliver value to global pharmaceutical companies across multiple dimensions. Manish Gupta Chief Execu ve Oﬃcer, Indegene Lifesystems Pvt Ltd

budgeting, cost control and project management and to collaborate with other stakeholders within the organisation as well as external collaboration partners. Avers Gupta, “During the development stage (phase II and III), we work with pharma companies in areas like clinical development programme benchmarking, forecasting, publication planning and medical writing, developing 3D Mechanism of Action (MOAs) animations, running live and virtual advisory board meetings, etc.” This highlights the fact that almost all stages of drug development can be refined and polished so as to achieve maximum benefits. And this does not stop at the development stage. These scientific insights are also offered post development. As Gupta informs, “At closer to launch or launch and maturity stages we work with companies on sales training, medical education, patient compliance programmes, teledetailing and digital programmes, sales force effectiveness and data analytics. The nature of services provided and the design of programs change depending on the stage in the lifecycle and the therapy area.” A company may utilise the available solutions or may customise a tool as per their requirements. The solutions currently offered by Indegene include: Phynyx: A multichannel solution for e-marketing and doctor engagement Optimax: A versatile patient support and compliance platform Modern Pharmaceuticals I June 2011

Business Mantra Medengage: A proprietary virtual platform for management of advisory boards and KOL engagement Trialpedia: A sophisticated clinical trial analytics and benchmarking platform

Need of the hour Scientific insights in this sector helps people support their strategic decision making. Commercialisation, medical education and marketing services – these cover almost the entire spectrum of services required by a pharma company. Add to it, the reliability and the amazing figures on paper. The advantage of working with such solution providers lie in the commitment they reflect to treat someone’s business their own, and tackle it their own way. Says Gupta, “We work closely with global pharmaceutical companies enabling them to implement new commercial models in areas like patient value services and alternate sales channels. Here we bring together our proprietary platforms, interactive and engaging content development capabilities, and specialised contact centre infrastructure to enable our clients implement new commercial models.”

Global scenario While there are multiple service providers in the US as well as Europe, there are hardly any credible service providers in emerging markets. In developed markets one of the most important concerns is cost reduction. At such junctures, one needs solutions that can cover the entire gamut and provide a distinct advantage. Cross functional teams across multiple geographies need to work together to produce extremely high-quality programmes in the most cost-effective way. The other important priority for all markets is new commercial models. And Gupta says Indegene provides all this. “We not only have in-depth expertise and knowhow but also proprietary products that can be leveraged by June 2011 I Modern Pharmaceuticals

How Indegene helps a pharma client? Phynyx is a multichannel sales and marketing platform with a physician-centric approach to deliver personalised clinically relevant medical education and brand communication programs. Physicians can log on to the web-based interface to access interactive medical content available in multiple formats or use on-demand live video/tele-chat services, as per their convenience and preference. Phynyx offers proprietary collaboration methodologies for peer-to-peer and peer-to-Key Opinion Leaders (KOL) engagements. Data collected from across these channels is seamlessly aggregated into a central database for analysis and predictive modeling to improve future interactions. Indegene conceptualised, designed and deployed the Virtual Oncology Center in the US for a top 5 pharmaceutical company bringing together over 2000 oncologists, 4000 physicians and 7000 nurses and care staff within the first 12 months. The scope covered deploying the technology platform, creating and repurposing content (case studies, slide decks, MOAs, patient-and-physician videos, editorial and publication of content, etc), engaging KOLs, conducting and repurposing webcasts and the like. This was achieved at 40 per cent lower costs as compared with traditional models. This platform enabled the company to build significant equity with oncologists and gain share of voice. pharma companies. These proprietary platforms have been built by making investments over a two-year period and encapsulate significant understanding of medicine, and physician and patient behaviours.” Such platforms would indeed act as a significant advantage and provide value to any company.

Trends for outsourcing With the focus on cost reduction, variable cost structures and leaner organisations outsourcing will continue to increase. Pharma companies worldwide are facing persistent pressure on bottom lines and see the need to work with service providers who have the ability to partner with them in the transformation they are going through. This will lead to more best-in-breed outsourcing and much more due diligence and research on the part of pharma companies while choosing their service providers. Avers Gupta, “Consolidation of spend to drive economies of scale and cost benefits is also something we see happening more.” Such providers are set to see a bright future. He continues, “Service providers with significant capabilities and processes to scale will see a bright future. This will require

service providers to make investments in building capabilities and systems, processes, as well as infrastructure to scale.”

Healthy growth The growing business of pharma companies needs a fresh and new outlook. These solution providers assist them by developing new business models, plans and strategies to accelerate their business and growth. With similar plans for the future, Indegene believes much more can be achieved. Says Gupta, “We continue to focus on the life sciences industry and are excited about the value we can create for the industry through driving productivity in the areas of commercialisation and marketing, partnering for new commercial models especially around patient value services and alternate sales channels and helping companies expand in emerging markets.” Thus, by leveraging their expertise of the pharma market, alongwith their valuable technology and multimedia capabilities, get prepared to evolve transformational solutions that serve to address some of the most critical challenges the industry may face. MPh (parita.dholakia@infomedia18.in)

Interface

‘We plan on genera ng awareness and buiding on our presence in India’ …says Jamie Hintlian, Vice President, Pharmaceu cal Business Unit, AspenTech. He discusses the o no ced trends in the pharma industry along with AspenTech’s posi on in this space. Chandreyee Bhaumik How has been the transi on of the industry? Over two decades, it has been relatively placid until the past two to four years when change has become significant. During this period, the industry economics have shifted dramatically. For example, 22 drugs out of the top 25 prescribed drugs are generic equivalents, and the remaining three drugs will also go off patent in the next two to three years. This opens up dynamic opportunities for the Indian

this area over time. Companies are not investing as much in this area to find the next blockbuster drug as they did previously. In fact, the pipeline of drugs has continued to shrink. However, there is a noticeable rise in the number of relationships with the Contract Research Organisations (CROs). Third parties are replacing or supplementing traditional R&D organisations in conducting clinical trial management along with process development. Another key observation is that there is an increase in biologics investments, as this area spells high

A key challenge facing researchers is the declining investment and eﬀort in this area over me. Companies are not inves ng as much in this area to ﬁnd the next blockbuster drug as they did previously.

the global economy in its doldrums, we saw significant M&As including key industry players such as Pfizer, Merck and Roche, just to name a few. These help increase value for shareholders and concentrate on specific therapeutics. This has also helped traditional big pharma accelerate their efforts to move into biologics and the synergy between two companies will presumably reap greater benefits.

What is AspenTech’s value proposi on for this space? With three decades of optimisation experience, AspenTech is considered a veteran in the software technology space, and has been serving clients such as GlaxoSmithKline, Eli Lily and AstraZeneca. Our focus in pharma includes a dedicated global sales team helping create the industry’s best practice across the entire value chain. This can be broken down into three key operational areas, namely R&D, performance management solutions in the manufacturing space and supply chain management. Working across multiple industries – chemicals, energy and engineering – allows us to bring best practices to the pharma industry that does not exist there.

How is AspenTech posi oned in the growing Indian pharma market? pharma industry. Globally, another shift is how traditional pharma companies are collaborating with contractors and other third parties for Active Pharmaceutical Ingredients (APIs) manufacturers.

What are the challenges faced in pharma research in India and overseas? A key challenge facing researchers is the declining investment and effort in 70

potential and massive opportunities with a direct impact on healthcare, especially in the oncology segment.

Do you think M&As will eventually evolve to be more a survival vs strategic op on? For some companies, M&As are often survival strategies, as this enables companies to capture new opportunities and access new markets. In the past few years, despite

Our strategy revolves around bringing the same value to Indian pharma companies as we have too many of the world’s top manufacturers. We plan on generating awareness and building on our presence in India.Thus, we plan to continue our initial traction in India and other emerging markets. This is indeed the inflection point for pharma companies, as change has never been happening so quickly and in the right direction too. MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I June 2011

Industry Insights

Cancer vaccines market

High unmet needs With the rising incidence of cancer, the need to ďŹ nd alterna ve treatment is on the fast track. However, the current global cancer vaccines market displays few promising op ons. On a bright note, the pipeline is not dry and eďŹ&#x20AC;ec ve approved vaccines will emerge soon. GlobalData reviews the current scenario. Cervical cancer vaccines market, global, revenue and market forecasts ($ billion), 2001- 2017 2.5 CAGR (2009-2017): 5%

Revenues ($ bn)

2.0

1.5 CAGR (2001-2009): 82% 1.0

0.5

0 2001

2009

2017

Source: GlobalData, GlobalData sales-based market forecasting model, primary research interviews, KOL interviews

t present, the global cancer vaccines market is occupied by cervical and prostate cancer vaccines. The vaccines available for cervical cancer are all prophylactic; the brands are Gardasil and Cervarix. The only therapeutic vaccine available in the market is Provenge from Dendreon Corporation. GlobalData has estimated that the global cervical cancer vaccine market in 2009 was worth $1.41 billion and is expected to grow at a Compounded Annual Growth Rate (CAGR) of 5 per cent to reach $2.10 billion in 2017. The cost of three complete dose courses of cervical cancer vaccines ranges from approximately $380 to $390.

The global prostate cancer vaccine market was estimated to be $70 million in 2010. It is expected reach $2.3 billion by 2017, growing at a CAGR of 66 per cent. The present pipeline for cancer vaccines seems to be very promising, with numerous molecules present in the phase II and III stages. From a market perspective, there are going to be multiple launches of vaccines between 2011 and 2013-2015, which is expected to significantly increase the market size and drive growth.

Weak compe on in the global vaccines market At present, the global cancer vaccines market is occupied by cervical and

prostate cancer vaccines. The launch of these vaccines has renewed interest in the development of vaccines for cancer. Though the therapeutic vaccines were in the pipeline for a long period of time, none of them were able to overcome the regulatory barrier except Provenge. It gained Food and Drug Administration (FDA) approval on April 29, 2010 and is indicated in the treatment of metastatic castrationresistant (hormone refractory) prostate cancer. Manufacturers have faced trouble proving the efficacy and safety of these vaccines along with demanding manufacturing guidelines. The market is waiting for a paradigm shift in the treatment of cancer through the introduction of new therapeutic vaccines that have a more targeted approach.

Unmet needs The current cancer vaccine market offers limited options for both prophylactic and therapeutic vaccines, which presents huge unmet needs. These unmet needs are high when it comes to treating the existing condition. With the rising incidence of cancer, there is a huge patient population waiting for a new approach in the management of cancer. There is a need for more therapeutic vaccines to treat the condition. To achieve success and exploit the maximum market potential, the new entrant must be a successful therapeutic option. Therapeutic Modern Pharmaceuticals I June 2011

Industry Insights

Opportunity and unmet need in the global cancer vaccines market, October 2010 Efficacy High

Currently available cervical cancer vaccine provide protection against four types (types 6, 11, 16, 18) of Human papillomavirus (HPV) Unmet needs: Perceived unmet needs are moderate. There is requirement for a broad spectrum multivalent cervical cancer vaccine, which provides the protection against other types of HPV

Low

Safety

High

Low

Cerverix

Gardasil

Next step: Unmet needs can be fulfilled only by introducing multiv alent broad spectrum cervical cancer vaccine

Unmet needs indicate the adverse events and efficacy associated with marketed vaccines Size of the bubble represents approximate cost effectiveness of the product Source: GlobalData

cancer vaccines have huge market potential as they have the capability to address this unmet needs. They have a targeted approach and also have fewer side effects compared to other chemotherapy options. They will provide or increase the options available for cancer treatment.

Current landscape GlobalDataâ&#x20AC;&#x2122;s analysis indicates that the available options in the market are very successful in the area of prevention but the market has few options for treating the condition. The only approved cancer vaccine for treatment is Provenge, which is indicated for prostate cancer. Prophylactic vaccines are efficacious in offering protection against cervical cancer. However, for the patient population who are already suffering from the disease, there are a limited number of effective drug treatment options available. There are moderate unmet needs, especially for people who develop metastatic disease. Besides, there is immense market potential for any new entrant that can cater to these unmet needs. There is a huge market potential for any new therapeutic vaccines for cancers than that of the prostate. These vaccines, if successful, will be the first of their kind to enter the market and will surpass the sales of the prophylactic vaccines. Thus, though prophylactic vaccines are successful in prevention and have the capability to reduce the population needing treatment, there is still a commercial opportunity in the area of drug treatment for people who develop the disease. These prophylactic vaccines will continue to be the primary form of market activity until an effective drug treatment option arrives. MPh Source: GlobalData

June 2011 I Modern Pharmaceuticals

Curtain Raiser

2nd Annual Biosimilars and PharmaLy ca India

Aiming for a stronger foothold With the two upcoming events, intelligence-gathering, high-powered networking and interac ve panel discussions are on the horizon. The events will oﬀer answers to the most businesscri cal ques ons and therefore implementable solu ons to key technical challenges. A preview… 2nd Annual PharmaLy ca India According to the latest estimates, outsourced analytical services are set to grow at a Compounded Annual Growth Rate (CAGR) of 19 per cent by 2016. This event will be taking place during July 26-28, 2011 at The Westin Mumbai Garden City, Mumbai. The event hopes to bring together the leading Indian and international experts to examine the key challenges and opportunities for the Indian analytical laboratory industry.

Do not miss! A glimpse of PharmaLytica India 2010

Chandreyee Bhaumik 2nd Annual Biosimilars India With the Indian biosimilars market expected to grow to $580 million by 2012, and new uses for biosimilars in new therapeutic areas being developed daily, now is the time to take action and strategically position one’s company in order to capitalise on the gamut of available opportunities. This event will be taking place during July 14-15, 2011 at Holiday Inn, Mumbai. The conference hopes to bring a revised and refreshed agenda that offers information on regulatory, R&D and commercial challenges facing the Indian biosimilars industry today.

Focussing on… The Department of Biotechnology (DBT) and US Pharmacopoeia (USP) will define the current regulatory position of biosimilars in India 74

A panel of experts including Lupin Pharmaceuticals, Syngene International and Reliance Life Sciences will explore the ‘dos and don’ts’ of a biosimilar strategy to ensure commercial success The latest innovations in biosimilars with Merck Millipore and Merck Darmstadt Intas Biopharmaceuticals will help in developing robust approaches to the effective characterisation of biosimilars Further, there will be additional speakers from MabPharm, Bharat Serums and Vaccines, Wockhardt, USV, Biological E and Parexel Consulting. “Biosimilars India 2011 has been refreshed on the basis of last year’s successful conference, and will be an essential event that tackles regulatory, technical and strategic concerns within the Indian biopharmaceutical industry,” says Oby George, Programme Manager, CPhI Conferences.

The key regulators will be clarifying the latest developments in US and European Union (EU) Pharmacopeia The latest innovations in instrumentation with Dr Reddy’s Laboratories, Waters India, PerkinElmer India, Sun Pharmaceuticals and NIPER Discussions on 21st Century Health Management on the latest techniques to fully automate laboratories Talks on strategies of Shasun Chemicals, BioOutsource, Novartis Pharma AG and Biogenomics Further, the special attraction of this year will be the pre-conference seminar ‘Analytical Method Development in Biotechnology’, the only one of its kind. “Building on the success of last year’s inaugural conference, PharmaLytica India 2011 has been refreshed and revised to address the most critical issues facing analytical laboratories in India,” highlights Niyoti Trivedi Vyas, Programme Manager, CPhI Conferences. MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I June 2011

Events Calendar

National RUDRAPUR: Uttarakhand, Sept 23-26, 2011, Gandhi Park AHMEDABAD: Gujarat, Nov 14-17, 2011, Gujarat University Exhibition Hall PUNE: Maharastra, Nov 18-21, 2011, Auto Cluster Exhibition Centre CHENNAI : Tamil Nadu, Dec 8-11, 2011, Chennai Trade Centre

provide an excellent opportunity to showcase innovative products and solutions in the industry; October 1214, 2011; Bombay Exhibition Centre, Mumbai

INDORE: Madhya Pradesh, Jan 6-9, 2012, Poddar Plaza, Nr Gandhi Hall AURANGABAD: Maharashtra, Feb 17-20, 2012, Garware Stadium India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Infomedia 18 Ltd,

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

For details contact: Sonia Prashar Indo-German Chamber of Commerce Tel: +91 11 26878721 or 26111730 Email: soniaprashar@indo-german.com Website: www.analyticaindia.com

CPhI India 2011

2nd Annual Biosimilars India This event aims to gather implementable solutions and practical guidance to tackle various challenges such as lack of access to capital, demanding R&D challenges, expensive manufacturing processes, commercialisation of biosimilar products, meeting unclear local and international regulatory requirements and cumbersome multiple clearances, etc; July 14-15, 2011, Hotel Holiday Inn, Mumbai For details contact: UBM India Tel: + 91 22 4046 1466 Email: conferences-india@ubm.com Website: www.biosimilars-india.com

2nd Annual PharmaLytica India TThis event aims to bring together leading Indian and international experts to examine the key challenges and opportunities for the Indian analytical laboratory industry. It hopes to uncover new avenues to drive innovation and automation, and to formulate effective strategies to meet international standards, etc; July 2628, 2011, The Westin Mumbai Garden City, Mumbai For details contact: UBM India

Tel: + 91 22 4046 1466 Email: conferences-india@ubm.com Website: www.pharmalytica-india.com

2nd Pharmac India The three-day event will cater to the pharma and healthcare industry in the country. It aims to attract reputed professionals from the fields of pharmaceutical formulation, herbal products, veterinary drugs, medical & disposal products and pharmaceutical machinery & equipment. The event will have exhibitors such as contract manufacturers, liaison agents, sourcing companies, generic and OTC manufacturers & wholesalers, government suppliers, etc; September 17-19, 2011; Gujarat University Exhibition Hall, Ahmedabad, Gujarat

The event will feature key decision makers in the pharma industry from 92 countries, including India, China, US, UK, France, Italy, etc. The CPhI conference will include updates on latest innovations, technologies, trends and developments in the pharmaceutical industry in India; November 30 - December 2, 2011; Bombay Exhibition Centre, Mumbai For details contact: UBM India Pvt Ltd Tel: + 91 22 6612 2600 Fax: + 91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

Pharmapack Bombay

Analytica Anacon 2011

The event aims to provide an innovative platform to showcase the latest information, technology and products to a focussed and target audience. The event promises to cater to the exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals, etc; February 2325, 2012, Bombay Exhibition Centre, Mumbai

Analytica Anacon 2011 is the 6th international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, which aims to bring together the international exhibitors and market leaders. This event will

For details contact: Intel Trade Fairs & Expositions Pvt Ltd Tel: + 91 22 2862 8126 Fax: + 91 22 2281 9008 Email: intelexpo@vsnl.net Website: www.intelexpo.com

For details contact: Orbitz Exhibitions Pvt Ltd Tel: + 91 22 2410 2801 Fax: + 91 22 2410 2805 Email: info@pharmacindia.com Website: www.pharmacindia.com

Modern Pharmaceuticals I June 2011

Events Calendar

International CPhI China 2011 CPhl China is a platform where pharmaceutical manufacturers, biopharm aceutical, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, new product launches and showcase innovations; June 21-23, 2011; Shanghai New International Expo Centre (SNIEC), Shanghai, China For details contact: CPhl China 2011 UBM International Media Tel: +31 0 204 099 593 Email: haohao.chen@ubm.com Website: www.cphi-china.com

For details contact: SMi Group Ltd Tel: +44 0 20 7827 6000 Fax: +44 0 20 7827 6001 Email: smiproduction@smi-online.co.uk Website: www.smi-online.co.uk

Pharmaceutical Portfolio & Product Life-Cycle Management This event aims to be a well established platform for the managers and directors who are faced with the task of managing the pipeline. Further, the event hopes to showcase various approaches by the largest pharma companies so that they can add value to their organisations; June 29-30, 2011; Holiday Inn Bloomsbury, London, UK

Bio 2011 The event aims to offer an unparalled opportunity for biotechnology and pharma companies, academic research institutions and investors around the world. It will also provide delegates with business opportunities and knowledge transfer; June 27-30, 2011; Walter E Washington Convention Center, USA For details contact: Biotechnology Industry Organization Tel: + 1 202 962 6655 Email: reg2011@bio.org Website: www.convention.bio.org

Pharmaceutical Nanotechnology The event aims to discuss the nano enabled nucleic acid therapeutic delivery. Further, in this event there are discussions on regulatory challenges for nanomedicines and industry partnering opportunities, issues and solutions; June 29-30, 2011; Copthorne Tara Hotel, London, UK

For details contact: SMi Group Ltd Tel: +44 0 20 7827 6000 Fax: +44 0 20 7827 6001 Email: smiproduction@smi-online.co.uk Website: www.smi-online.co.uk

BioProcess International China BioProcess International China will be the 3rd annual event organised in China. The main topics of discussion will be on cell culture, cell line engineering, purification and recovery, process characterisation, process analytics, formulation and disposables technologies. The event will be attended by the biopharma companies, scientists, and executives from all over the world; August 22-24, 2011, Grand Hyatt Shanghai, China For details contact: IBC Life Sciences Tel: + 65 6508 2401

Fax: + 65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifesciences.com

CPhI South America This event aims to be a platform where several pharmaceutical manufacturers, biopharmaceutical, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, new product launches and showcase innovations. The event will be attended by the experts from the entire industry; August 24-26, 2011; Transamerica Expo Center, Sau Paulo, Brazil For details contact: CPhl South America 2011 UBM International Media Tel: +31 0 204 099 561 Fax: +31 203 0632 616 Email: rob.sahi@ubm.com Website: www.cphi-sa.com

ICSE Europe The ICSE Europe aims at targeting the top leaders of the pharmaceutical industry. The event will organise an exhibition alongwith concurrent conferences. The exhibitors profile includes biotrails, pharmacology, pre-clinical, biotechnology, pharma equipment and machinery, production equipment, clinical research, patient safety monitoring, etc; October 25-27, 2011, Messe Frankfurt, Frankfurt, Germany For details contact: UBM Live Tel: + 31 20 409 9544 Fax: + 31 20 363 2616 Email: icse@ubm.com Website: www.icseexpo.com

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

June 2011 I Modern Pharmaceuticals

Technology Transfer

Technology Offered As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration. Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side effects are reported to be the advantages of this product. Moreover, this product has already been launched in American market. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy

Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine Forms of transfer Joint venture, technical services, technology licensing Intravenous fluids An Indian company offers the technology for the production of intravenous fluids (IV). The company has a large volume IV plant and can offer complete support for setting up a new IV plant. Investment required for the fully automatic plant is around ` 15 crore. The company can offer consultancy services/ technical support to set up an IV plant on loan and license basis initially. Later, the collaborating party can set up its own factory when it is ready for investments.

Areas of application Pharmaceutical industry Forms of transfer Joint venture, services

technical

Smart Syringe A company offers technology to manufacture single use safety syringe with spring actuated needle stick injury prevention and auto disable mechanism. The design is adaptable to all sizes of syringes commonly used for injection purpose. Areas of application Healthcare industry Forms of transfer Technology licensing, funding, others Herbal nutraceutical formulation for preventive cardiology – obesity A company offers a nutraceutical formulation comprising probiotics that essentially includes Lactobacillus acidophilus and Lactobacillus sporogenes, and medicinal plants, which essentially includes Commiphora weightii & Terminalia belerica. The present formulation functions in a synergistic manner resulting in enhanced curative properties. Areas of application Pharmaceutical industry, healthcare industry Forms of transfer Consultancy, technical services, technology licensing, research partnerships

Share Your Technology Propositions The mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour by publishing the best technology ideas. Technology developers/sellers are invited to furnish the techno-commercial details (with environmental benefits, if any) for publication in the Technology Transfer column of Modern Pharmaceuticals. R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification. Contact: Modern Pharmaceuticals Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 Fax: 022-3003 4499 Email: spedit@infomedia18.in

Modern Pharmaceuticals I June 2011

Technology Transfer

Technology Requested I V Fluid manufacturing as SME An Indian company needs new and best technology to start manufacture of I V Fluid. Areas of application Medical technology, I V fluid, manufacturing Forms of transfer Technical services, others Disposable Syringes An Indian company is interested in cost effective production line for disposable syringes for both ribbon and blister options. Areas of application Medical industry Forms of transfer Others Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the research and development of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater; which includes cleaning canals, removing sediments from waterways, biogas, microbiology detector and treated system quality. Areas of application Biotechnology, engineering, new technology Forms of transfer Consultancy Calcium gluconate An Indian company requires the technology to manufacture calcium gluconate.

Areas of application Pharmaceutical industry Forms of transfer Technical services, project reports, others Cell lines Thailand-based, ANH Scientific Marketing Co Ltd has been working in the field of life sciences in the country for more than 20 years. In order to complete the companyâ&#x20AC;&#x2122;s product lines and service customers/ researchers/scientists from the beginning to the end of the process, it would like a company to provide commercial cell lines of human and animals. Areas of application Cell culturing - molecular biology Forms of transfer Material supply Extract of medicinal and aromatic plants An Indian company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others Glove automation equipment An Indian company requires technology to produce glove by automation process.

Areas of application Manufacturing especially rubber latex industry Forms of transfer Consultancy

industries, industry and

Kite grading engineering technology A Fiji-based company offers the technology of kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. It seeks assistance from a potential partner to provide equipment and technical support staff. Areas of application Medical research Forms of transfer Joint venture, partnership Blood Grouping Device An Indian company needs technology for manufacturing blood grouping biomedical device. Areas of application Biomedical Forms of transfer Joint Venture, technology licensing Manufacturing technologies for Montelucast, Rosuvastatin, Ursodeoxy cholic acid, D-biotin An Indian company needs Active Pharmaceutical Ingredient (API) or bulk drug manufacturing technologies for Montelucast, Rosuvastatin, Ursodeoxy cholic acid and D-biotin. Areas of application Pharmaceutical industry Forms of transfer Others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016 Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org

For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance. June 2011 I Modern Pharmaceuticals

Book Shelf

Herbal Supplements: Eﬃcacy, Toxicity, Interac ons with Western Drugs Editors : Amitava Dasgupta, Catherine A Hammett-Stabler Price : ` 5400 Despite the wide use and the immense popularity of the complementary and the alternative medicine practices, these products do not undergo the same pre-market testing for safety and efficacy that is required for pharmaceuticals. This book offers a comprehensive introduction to both safe and unsafe herbal supplements. Divided into several chapters the book serves as a guide to the interpretation of test results in otherwise healthy subjects due to use of herbal remedies. It concentrates on discussing herbals and pharmaceuticals, sources of contamination in herbal supplements and analytical techniques used in the investigation of herbal remedies. One of the chapters discusses contamination of herbal supplements from metals, pharmaceuticals and plant poisoning. Also, there are chapters on analytical techniques, including immunoassays, used in the investigation of herbal remedies. Further, there is one chapter that deals with the commonly used homeopathic remedies, their regulations, homeopathic remedies and placebo effects. The effective use of the charts makes the illustrations easy and meaningful. This book is helpful for toxicologists, clinical chemists, analysts and pharmacologists as it offers details on the efficacy, toxicity along with drug interactions of herbal supplements and medicines.

Organic Synthesis via Examina on of Selected Natural Products Editor : David J Hart Price : ` 5300 A wide variety of strategies for the synthesis of organic compounds exists. The book primarily deals within the context of natural products synthesis, but some unnatural products synthesis is also included. Further, multiple approaches to each group of synthesis targets are presented, and the approaches are compared with one another. Divided into several chapters the book discusses general problems in organic synthesis. For example, the problem of acyclic diastereoselectivity, the problem of controlling absolute stereochemistry are introduced in the beginning of the book and explained in detail throughout. There are also some chapters that offer a historical overview of organic and natural products chemistry, and spans synthetic methodology that dates from the 1940s to the present time. Written in a style that the readers find interesting, the book provides a plethora of information on organic synthesis. There is also an interesting chapter on the difunctional relationships of alkaloids and its importance. The book is helpful for pharma professionals, researchers and students.

Available at: 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

Modern Pharmaceuticals I June 2011

Product Update Capsule ﬁlling machine Bosch Indias’ Packaging Technology division offers GKF 2500 capsule filling machine with new technology for micro dosing powdered pharmaceuticals. Micro dosing is a precise filling technique for very small doses, which avoids agglomeration and is suitable for dosing quantities of around 2 milligrams and up. This is particularly suitable for processing highly effective inhalation products within filling ranges of 2-30 milligrams. The GKF 2500 allows for flexible, high performance processing of an extremely wide range of products with varying requirements. The GKF 2500 is available with a newly developed dosing roller which allows the reliable and safe dosing of such very small powder volumes. The flexible modular filling station can also process difficult and sensitive products, as it utilises gentle filling techniques and even allows adjustments to be made during the filling process. The capsule filling machine fulfills the conditions for pharmaceutical production and manufacturers benefit from gentle filling techniques and a high output level. The modular filling station offers easy assembly and disassembly, as well as upgrading capabilities for future requirements. Only a limited number of size parts are required, which significantly speeds up and simplifies adjustments for product change over. Bosch India Ltd - Bengaluru - Karnataka Tel: 080- 4176 8218, Fax: 080-4176 8106, Mob: 098805 96101 Email: narendra.s@in.bosch.com

Microbiological benchtop incubator Thermo Fisher Scientific Inc offers Heratherm microbiological incubators, available in three different models: general protocol, advanced protocol and advanced protocol security. Each unit is available in 60, 100- and 180-litre sizes and combines superior sample protection, ease of use, efficiency and an inner glass door that maintains temperature uniformity. The user-friendly units feature a small footprint, making them stackable without the use of tools, an easy-to-clean rounded interior, and an intuitive display. In addition, a compact 18-litre model incorporates peltier technology to provide temperature conditions around or below ambient for space-restricted labs. With a stainless steel interior, general protocol incubators use gravity convection to provide superior temperature uniformity, ranging from 5°C above ambient to 75°C. A unique airflow design, advanced microprocessor control and an automatic over temperature alarm ensure that an optimal temperature environment is maintained. Operating from 5°C 82 82

above ambient to 105°C, the advanced protocol incubators are equipped with unique, dual convection. This new technology allows flexible fan speed setting from 0 to 100 per cent for application versatility. Advanced protocol security incubators incorporate an over and under temperature alarm, as well as a lockable, alarmed door. The independently certified 140°C decontamination cycle provides additional peace of mind. An optional stainless steel exterior provides the clinical look and feel desired by pharmaceutical and clinical laboratories. Thermo Fisher Scien ﬁc India Pvt Ltd - Mumbai Maharashtra Tel: 022-6716 2200, Fax: 022-6716 2244, Email: Reply.lpg.india@thermofisher.com

Steam boiler Aero Thermo Systems offers fully automatic package steam boiler (IBR) having 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 preheater arrangement which gives high thermal efficiency 86+2 per cent on NCV. It is easy and economical in operation. Its application lies in industries such as dyes, chemicals, textiles, fertiliser, petrochemicals, rubber, wood, pharmaceutical, metal finishing, oils, dairy and construction. Aero Therm Systems Pvt Ltd - Ahmedabad - Gujarat Tel: 079-2589 0158, Fax: 079-2583 4987, Mob: 09825008720 Email: contact@aerothermsystem.com

Ready-to-use component West Pharmaceuticals offers Westar® ready-to-use (RU) components for faster application. Ready-to-use components are sterilised and delivered in integritytested packaging systems, which may include rapid-transfer port bags, to ease introduction of components into the filling line. With ready-to-use components, it is easy to minimise variability in sterile operations and may even eliminate component preparation from the production entirely. West Pharmaceu cals Ltd - Hyderabad - Andhra Pradesh Tel: 040-4026 9378 Email: sales.india@westpharma.com Modern Pharmaceuticals I June 2011

Product Update Water ring vacuum pump and compressor Vacunair Engineering offers water ring vacuum pump and compressor, which has non-pulsating vacuum and pressure. This energy saving pump is designed by operating at low periphery speed and offers specific power of 60 to 65 cubic m/hr, vacuum up to 700 mm hg and pressure up to 3.5 kg/sq cm. The vacuum pump with air ejector is available having capacity from 50 to 2000 cubic m/hr and vacuum up to 25 mm hg abs. Standard pumps are available with stuffing box type glad seal arrangement and can also offer with mechanical seal. Water ring vacuum pump and compressor is applicable in industries like chemical, pharmaceuticals, fertilisers, paper, sugar, coal mines, power, steel, refinery, dairy, plastic, food processing, textiles etc. There is no lubrication required and can handle air, gas, air with water comfortably. It is easy to maintain the pump as axial clearance is minimum in size. The vacuum pump is available in CIFG-260, metal, phosphor bronze, aluminum bronze, SS304, SS-316, and other alloy steel material. Vacunair Engineering Co Pvt Ltd - Ahmedabad - Gujarat Tel: 079-2291 0771-2-3, Fax: 079-2291 0770 Mob: 098240 36375 Email: info@vacunair.com

June 2011 I Modern Pharmaceuticals

Product Update Digital photometer

Bar code reader

MeasureTest Corporation offers 2H digital photometer. It is available in a portable self-contained unit. The 2H digital photometer has been designed with the user in mind for simplicity of operation and virtually maintenance-free use. Its basic purpose is to detect and measure mass concentration of aerosol. Three-stage airflow sensor and optics indicator lights improve data reliability. The microprocessor-controlled 2H enables the operator to quickly set operating functions and parameters. It is easily programmed and operates with just seven push buttons. The digital display has a set-up menu and diagnostic codes for operator convenience. The range of concentration measurable is from 100 to 0.0001 µg/l. The digital photometer has two preset reference values (DOP & PAO) for aerosol agents as well as a user setting, which allows storage of a sampled concentration to be retained as a reference value.

Banner Engineering India offers iVu Bar Code Reader (BCR), which reads 11 industry-standard bar codes to facilitate advanced traceability in packaging, material handling, automotive, pharmaceuticals and many industrial applications. The BCR with an integrated or remote touchscreen and intuitive interface allows users to configure, monitor, modify and inspect without a PC or external controller. It has following features: first-time users can also learn to use it without training; compact; rugged IP67rated housing available with or without an integrated ring light; and RS-232 serial communication port is provided for exportingbar code data. The sensor is available with a remote touchscreen for setup and inspection monitoring. The BCR is available with three different trigger modes to determine how the sensor captures and processes images.

MeasureTest Corpora on - Mumbai - Maharashtra Tel: 022-2202 7982, Mob: 098690 12701 Email: sheesh@mtnl.net.in

Banner Engineering India Pvt Ltd - Pune - Maharashtra Tel: 020-6640 5624, Fax: 020-6640 5623 Mob: 9322339208 Email: salesindia@bannerengineering.com

Mo on horizontal cartoner Capsule ﬁlling machine Anchor Mark offers automatic capsule filling machine (encapsulation equipment). Its features include compact, sturdy, covered with stainless steel panels, hood covered with acrylic guard, etc. The fill weight adjustment takes place within seconds. It is provided with tamping mechanism’ for powder filling, which enables capsules to be filled with a weight variation with ± 2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. The faulty capsule and filled capsule ejection stations come with individual air controls. It is simple to operate and easy to maintain and has special purpose gauges for quick and easy changeover. The company also offers powder processing, granulation and coating equipment, whose design and finish confirms to cGMP standards. It comes with special air-purged shaft seals which keep powder away from mechanical drives and prevent product contamination.

ACG Pampac offers ‘K120i’, an intermittent motion horizontal cartoner for automatic transfer of blisters or bottles into cartons. This eco-friendly solution is ideal for single as well as multiple blisters. Built to meet upcoming norms of secure cartons, ‘K-120i’ can handle tuck-ins, glue in cartons, leaflet folding and insertion, and offers multiple choices of on-line inspection. Capable of handling blister, tubes, bottles and customised applications, this cartoner delivers impressive performance and versatility. This cartoner has the advantage of a balcony design that helps easy cleaning of the machine without removing its parts. Its output is up to 120 cartons per minute with leaflet folding and carton insertion. It is integrated with a camera-based inspection system to detect and check barcodes, pharma codes and 2D matrix codes. K120i offers: GMP balcony design; easy and quick change over; reliable product feeding; compliance to EC regulations & GE standards; flexibility to handle various packaging containers such as blisters, bottles, tubes, vials etc; and ability to handle tamper-evident cartons.

Anchor Mark Pvt Ltd - Mumbai - Maharashtra Tel: 022-2868 2001, Fax: 022-2868 2250 Email: sales@anchormark.com

ACG Worldwide - Mumbai - Maharashtra Tel: 022-2287 2557-59, Fax: 022-2287 2560 Email: rajendra.khimsaria@acg-world.com

86 86

Modern Pharmaceuticals I June 2011

Product Update Humidity and temperature indicator Katlax Enterprises Controller and Instrumentation Group (CIG) offer humidity (RH) and temperature indicator (ceiling hanging). This latest industrial automation instruments can be positioned right where they are required, indicator feature dual LCD displays, RH and temperature readings one by one at the same time. Humidity and Temperature (Ceiling Hanging) indicator’s features consists of: supply voltage230VAC ± 10 per cent @ 50 Hz; display type- seven segment Red 4.0”; display- three digits scrolling (every 5 sec); and display range consists of -50°C to + 150°C temperature & 0 to 100 per cent humidity. Its application are in automotive, HVAC, consumer goods, weather stations, humidifiers, dehumidifiers, food & agro, textile, test & measurement, space electronic assembly, ICU, air handling unit, multiplex, data logging and automation. Katlax Enterprises Pvt Ltd - Gandhinagar - Gujarat Tel: 02764-286784, Fax: 02764–286793, Mob: 09724506614 Email: info@katlax.com

Medical refrigerator Sigmatech Scientific Products offers ‘Sigmazk’ medical refrigerator with glass door manufactured by Zhongke Meiling Cryogenics Ltd, China. The medical refrigerator is a specialised equipment for cold storage of pharmaceutical and biological products. It is suitable for hospitals, drugstores, pharmaceutical factories, sanitation & antiepidemic stations and clinics. This medical refrigerator is provided with microprocessorbased temperature control system, combined with two sensors monitoring the chamber temperature and one sensor monitoring the ambient temperature. A stable and accurate chamber temperature can be maintained at ambient temperature ranging from 0°C to 32°C. Forced air circulation system provided with this refrigerator ensures temperature uniformity. Sigmatech Scien ﬁc Products - Hyderabad - Andhra Pradesh Tel: 040 - 6453 4491, Mob: 098496 32904, Fax: 040-4003 1896 Email: s_tech07@yahoo.com June 2011 I Modern Pharmaceuticals

Product Update Transmi ers Ace Instruments offers digital differential pressure transmitters. These are high-accuracy differential pressure transmitters with integrated display & 4-20 mA output. The transmitter has a 4-digit red LED display 0.5” high with 0.1 decimal resolution. Industry standard 2-wire 4-20 mA output is available as standard output. The option of 0-5 V or 0-10 VDC output is also available. These are available in ranges from -10.0 to +10.0 mm; WC 0.0 to 10.0, 20.0, 25.0, 50.0, 100.0, 500.0, 1000, 2500, 5000 and 10,000 mm WC. These instruments are also available in Pascal unit of measurement. Other standard metric units that can be accommodated include cm WC, in WC, in Hg, mm Hg, etc. These instruments are available in all three versions of differential pressure, gauge pressure & vacuum. For gauge pressure & vacuum, option of ¼” BSP male threading is available for direct mounting on to system. These transmitters are used in pharmaceutical clean rooms, air handling units, HEPA filters, filters, pharma machinery, etc.

laser and video channels. It provides complete sample information on particle size distribution and numerous particle shape parameters with the help of very high analytical resolution (analysing each sampled particle individually) and real-time sample visualisation. The analyser has a wide measurement range of 0.1-5,000 microns. It comes bundled with the software for comprehensive data analysis and report generation. The instruments can be fitted with a variety of modular measurement cells, which can be manually interchanged to allow for particle analysis in liquids, emulsions, creams, dry powders, fibres, heated liquids, aerosols and more, with minimal (or no) sample intervention and original state analysis. Analytical data can be displayed in a wide variety of tables and graphs. TTL Technologies Pvt Ltd - Bengaluru - Karnataka Tel: 080-2525 1859, Fax: 080-2529 1285 Email: analyticaldirect@ttlindia.com

Diﬀeren al pressure transducer Ace Instruments - Hyderabad - Andhra Pradesh Tel: 040-2307 8848, 3290 1226, Fax: 040-2307 8848, Mob: 093940 30848 Email: sales@aceinstrumentshyd.com

High eﬃciency freezers Eppendorf India offers High efficiency freezers from New Brunswick Scientific (NBS). This minimises operating costs and laboratory space requirements, while providing superior protection for critical samples. Its 570 and 410 ltr upright models, and 660 ltr chest model are the first in the new HEF line, consuming up to 65 per cent less energy than competitive units. These systems significantly lower carbon impact on the environment when compared to competitive units and also meet the conformance with government, industry and environmental directives. This has been made possible by combining superior-performing vacuum insulation panels with additional insulation techniques and using environmentfriendly, more efficient hydrocarbon refrigerants instead of traditional HFCs in 50 Hz models. Eppendorf India Ltd - Chennai - Tamil Nadu Tel: 044-4211 1314, Fax: 044-4218 7405, Mob: 093801 76423 Email: info@eppendorf.co.in

Katlax Enterprises offers Differential Pressure Transducer (DPT). The transducer measures pressure differences between two points and give proportional analogue output (0-10 V or 4-20 mA). It has unsurpassed performance due to Complementary Metal-OxideSemiconductor (CMOS) technology, offset and hysteresis free. It has excellent accuracy and reproducibility; even below 10 Pa, it is fully calibrated and temperature compensated with out being sensitive to mounting orientation. Its sensor continuously monitors differential pressure between two ports. Integrated circuit converts differential pressure to electrical signal (0-10 V or 4-20 mA). An optional microcontroller-based circuit is also available for future upgradation to connect with Supervisory Control & Data Acqusition (SCADA) on Modbus protocol and conditioning/control circuit can be supplied in enclosure (IP-66). This device can communicate on different communication protocols, ie, Modbus, RS232, RS485, etc. Katlax differential pressure transducers are available with various measuring ranges that starts from -0.5 mbar to 100 mbar. This is applicable in Variable Air Volume (VAV) systems; Heating, Ventilating and Air Conditioning (HVAC); filter pressure drop; fan/ventilator control; duct air flow measurements; room/cabin pressure control; burner control; CPAP equipment; sleep apnoea monitors; air handling units; textile air engineering and pharmaceutical industry.

Analyser TTL Technologies offers ‘DIPA 2000’ particle size and shape analyser from Donner Technologies. It combines two complementary measurement techniques by integrating 88 88

Katlax Enterprises Pvt Ltd - Gandhinagar - Gujarat Tel: 02764-286 784 - 85, Fax: 02764-286 793 Email: info@katlax.com Modern Pharmaceuticals I June 2011

Product Update Fermentor/bioreactor Shree Biocare India offers fermentor/bioreactor. The company offers lab scale, pilot scale fermentors. These are optimum quality fermentors and are developed & designed for microbiology, pharmaceuticals, DNA, proteins, cell culture, biofertilisers, vaccines, biopesticides, biofuels or customer application & requirement. Biocare fermentor offers glass vessel, glass vessel with SS jacket, complete SS vessel autoclaveble or in situ (in place) sterilisation, 3-1000 ltr with controlled parameters such as agitation, aeration, pH, temperature, antifoam, DO or other special parameters. Biocare fermentors are PLC-based, with touchscreen module or LCD module attached with PC and software data as per GMP/GLP. Biocare also offers IQ/PQ/OQ documentations.

circuit so that the heaters can be operated only after the blowers are switched on to avoid burning of the heaters. The coating pan is manufactured from SS-304 ‘AISI’ 2B prime material quality with adequate mouth opening and depth. The coating machine is also provided with the control panel, which comes with indicating lamps, coating pan main on-off switch, blower on-off switch, thermostat, heater switch, etc. The entire panel can be mounted on the stand. The machine is designed as per GMP standards, with all arrangements inside the enclosure, except electric control panel and SS pan.

Shree Biocare India - Ahmedabad - Gujarat Tel: 079-4008 4116, Fax: 079-4008 4116, Mob: 098989 99146 Email: shreebiocare@gmail.com

Allegro Pharmachem Equipment - Thane - Maharashtra Tel: 022-4014 6872-73, Fax: 022-4014 6874 Email: allegro@allegroindia.com

Con nuous inkjet printer

Digital USB microscope

Bakshi Mark offers continuous inkjet printer. The Linx 7300 printer provides fast, noncontact printing of static & dynamic codes, messages on almost any moving surface in the production line. It provides a flexible coding solution, which is designed to be easy to use in any environment. It has a simple to use qwerty keyboard and multicolour display screen, which allows easy code creation and editing, a robust design for trouble-free operation and a powerful feature. Linx 7300 has a USB message & printer backup & restore and has mistake proof refill with ‘surefill’ code. Its rebundled features include standard 3 lines of print, longer service intervals (dynamic adjustment up to 6,000 hours or 12 months), mistake proof message selection (rebranding DIP to QuickSwitch) and standard data matrix. It also has an easy to clean enclosure.

Cole-Parmer India offers digital USB microscope. The digital USB microscope is based on the active pixel technology which produces crisp, sharp images and accurate colour reproduction. Six LEDs illuminate the object - turn the LEDs on or off and adjust the brightness using the control wheel on the body. For versions with the 10x to 200x magnification range, magnification automatically adjusts based on the distance from the object. Units include a basic stand with adjustable height; optional boom stand can be ordered for greater flexibility.The handheld digital microscopes find their applications in science and engineering, digital microscopy, laboratories, pathology or other biomedical labwork.

Bakshi Mark Pvt Ltd - New Delhi

Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222; Fax: 022-6716 2211 Email: response@coleparmer.in

Tel: 011-2526 2395, Fax: 011-4299 0011, Mob: 097112 00744 Email: info@markode.in

Coa ng pan Allegro Pharmachem Equipment offers coating pans, which are totally enclosed with SS cladding and are available with standard gear box, motor and hot air blowing arrangement. These coating pans are provided with interlocked electrical 90 90

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

Modern Pharmaceuticals

Modern Pharmaceuticals I June 2011

Product Index Sl No Product

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62

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Accelerated ageing test.....................................................67 Access control system......................................................... 85 Acoustic enclosure.............................................................. 32 Acquity UPLC system........................................................ 45 Air filter .........................................................................47, 49 Air shower controller......................................................... 85 Analyser ............................................................................... 88 Analytical instrumentation ............................................... 45 Autoclaves.............................................................................. 9 Automation software ......................................................... 19 Axial flow fan...................................................................... 85 Banking services...............................................................59 Barcode reader.................................................................... 86 Bearing................................................................................. 71 Biodiesel............................................................................... 67 Biological safety cabinet ..............................................47, 49 Blower & fan....................................................................... 85 Cable carrier .....................................................................71 Cable connector.................................................................. 71 Capsule filling machine ...........................................9, 82, 86 Cartoner................................................................................. 9 Cartridge................................................................................ 9 Centrifugal air blower........................................................ 85 Chain.................................................................................... 71 Clean room door..........................................................47, 49 Coating pan......................................................................... 90 Columns & chemistries ..................................................... 45 Compositional & trace metal analysis............................. 67 Compressor......................................................................... 85 Conference ....................................................................10, 81 Conical screw dryer.............................................................. 7 Connector............................................................................ 71 Continuous inkjet printer ................................................. 90 Conveying blower............................................................... 85 Counters & power supplies.................. Front Inside Cover Crusher ................................................................................ 11 Diesel - fuel .......................................................................67 Differential pressure transducer ....................................... 88 Digital photometer............................................................. 86 Digital USB microscope .................................................... 90 Dispensing booth .........................................................47, 49 Door interlock system ....................................................... 85 Dry van pump .................................................................... 32 Dust collector system......................................................... 85 Empower ...........................................................................45 Encoder................................................... Front Inside Cover Exhibition - Engineering Expo - 2012 ............................ 12 Exhibition - India Chem Gujarat - 2011 .......................... 8 Exhibition - Pharmac India - 2011.................................. 75 Exhibition - Telemedicon - 2011...................................... 89 Failure analysis .................................................................67 Fan........................................................................................ 85 Fan filter unit................................................................47, 49 Fermentor/ bioreactor ....................................................... 90 Filler compositional analysis............................................. 67 Filter ..................................................................................... 11 Filtration equipment.......................................................... 11 Filtration system................................................................. 11 Financial services................................................................ 59 Fire alarm ............................................................................ 85 Food analysing & testing machine................................... 11 Fuel....................................................................................... 67

June 2011 I Modern Pharmaceuticals

Sl No Product

63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124

Pg No Sl No Product

Fuel burner.......................................................................... 85 Gases ..................................................................................67 Gear oil ................................................................................ 67 Gear pump.......................................................................... 37 GMP heat exchanger............................................................ 7 GMP reactor ......................................................................... 7 Heart valve frame.............................................................23 HEPA filter terminal housing .....................................47, 49 High efficiency freezer ....................................................... 88 HPLC ................................................................................... 45 Humidity & temperature indicator ................................. 87 Hydrogenator/autoclave ...................................................... 7 Industrial chilling equipment ........................................41 Industrial control & sensing device .... Front Inside Cover Injectable manufacturing line.....................................47, 49 Invertor/variable frequency drives ...... Front Inside Cover Knife mill...........................................................................11 Laminar air flow workstation...................................47, 49 Level controller ...................................... Front Inside Cover Liquid food processing system ......................................... 11 Liquid ring vacuum pump ............................................... 85 Liquid sterile filling machine.............................................. 9 Lubes - engine oil............................................................... 67 Machine safety solution ..................................................53 Material identification system .......................................... 67 Measuring & monitoring relay ........... Front Inside Cover Medical refrigerator............................................................ 87 Metallography system ........................................................ 67 Microbiological benchtop incubator ............................... 82 Motion control ...................................... Front Inside Cover Motion horizontal cartoner .............................................. 86 Muller................................................................................... 11 Multi-function mill............................................................ 11 Multistage centrifugal air blower...................................... 85 Nano DSC autosampler system .....................................57 Oil / gas firing equipment...............................................85 Online B2B marketplace .............................................15, 91 Packaging solution...........................................................21 Pallet..................................................................................... 87 Passbox...........................................................................47, 49 Passbox inter lock system.................................................. 85 Petrol & fuel oil .................................................................. 67 Pharma manufacturing solution...........Back Inside Cover Pharma packaging solution ...................Back Inside Cover Pharmaceutical packaging product.................................. 21 Photoelectric sensor.............................. Front Inside Cover Pneumatic component ...................................................... 11 Pneumatic conveying system............................................ 85 Polymer characterisation................................................... 67 Portable loader.................................................................... 85 Pre-engineered & pre-fabricated modular panel .....47, 49 Prefilled syringe component............................................. 21 Process heat exchanger ........................................................ 7 Process reactor ...................................................................... 7 Programmable logic controller............ Front Inside Cover Programmable terminal ....................... Front Inside Cover Proximity sensor.................................... Front Inside Cover Pump..................................................32, 37, 85, Back Cover Pumping filtering unit vacuum pump............................ 85 Pure steam generator ........................................................... 9 Quick change terminal hose.....................................47, 49 R&D solution........................................Back Inside Cover

125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172

Pg No

Rapid endotoxin detection system................................... 87 Ready-to-use component .................................................. 82 Return air riser .............................................................47, 49 Revolutionary user interface ............................................. 57 RFID........................................................ Front Inside Cover Roots blower ....................................................................... 32 Rotary gear pump .............................................................. 37 Rotary vacuum dryer........................................................... 7 Rotocone dryer ..................................................................... 7 Safe change housing...................................................47, 49 Safety light curtain ................................ Front Inside Cover Sampling booth ............................................................47, 49 Screening machine ............................................................. 11 Self adhesive tape ............................................................... 73 Separator.............................................................................. 11 SEZ developer...............Cover On Cover, Front Gate Fold Side channel blower ........................................................... 85 Silicone carbide heat exchanger.......................................... 7 SME finance........................................................................ 59 Spherical paddle chopper dryer ......................................... 7 Steam boiler ........................................................................ 82 Sterilising/ depyrogenating tunnel .............................47, 49 Switching relay....................................... Front Inside Cover Syringe & ampoule .............................................................. 9 Transducer.........................................................................57 Temperature controller......................... Front Inside Cover Testing system..................................................................... 67 Three parameter display.................................................... 85 Timer ...................................................... Front Inside Cover Transmission fluid.............................................................. 67 Transmitter.......................................................................... 88 Trim handling system ........................................................ 85 Turnkey project...............................................................7, 85 Twin - screw co-rotating extruder ................................... 23 Twin - screw element......................................................... 23 Twin - screw extruder........................................................ 23 UPLC..................................................................................45 Vacuum booster pump....................................................32 Vacuum system................................................................... 32 Vane damper....................................................................... 85 Ventilator ............................................................................. 73 Vision sensor.......................................... Front Inside Cover Walk-away automation ...................................................57 Wastewater treatment equipment .................................... 11 Water for injection generation stills................................... 9 Water ring vacuum pump................................................. 85 Water ring vacuum pump and compressor.................... 85 Zero liquid discharge system..........................................31

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

Advertisers’ List Advertiser’s Name & Contact Details

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Advertiser’s Name & Contact Details

Pg No

ACG Worldwide BIC T: +91-22-26780127 E: shabir.badami@acg-worldwide.com W: www.acg-worldwide.com

Grundfos Pumps India Pvt Ltd T: +91-44-45966922 E: salesindia@grundfos.com W: www.grundfos.in

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

Ani Engineers T: +91-2752-241479 E: anivarya@sancharnet.in W: www.anivaryapumps.com

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

Bosch Limited T: +91-80-41768218 E: narendra.S@in.bosch.com W: www.boschindia.com/pa

IC Ice Make Refrigeration Pvt Ltd T: +91-2764-291022 E: icemake1@gmail.com W: www,icemakeindia.com

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

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

Standard Chartered Bank T: +91-22-39401616 E: sme.custoercare@sc.com W: www.standardchartered.co.in Steer Engineering Pvt Ltd T: +91-80-23723309 E: info@steerworld.com W: www.steerworld.com

TA Instruments-Thermal Analysis T: +91-80-23194177 E: india@tainstruments.com W: www.tainstruments.com

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

CPHI Conferences T: +91-22-40461466 E: conferences-india@ubm.com

15, 91

IndiaMart Intermesh Ltd T: +1800-200-4444 E: pr@indiamart.com W: www.indiamart.com

COC, FGF

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

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

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

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

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

Orbitz Exhibitions Pvt Ltd T: +91-22-24102801 E: sanjeev@orbitzexhibitions.com W: www.orbitzexhibitons.com

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

47, 49

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

Dipesh Engineering Works T: +91-22-26743719 E: sales@dipeshengg.net W: www.dipeshengg.com

Frost & Sullivan T: +91-22-66072019 W: www.frost.com

FIC

Advertiser’s Name & Contact Details

Pg No

Telemedicon’11 89 T: +91-22-28475949 E: chairman@telemedicinecongress.com 85

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

Rockwell Automation T: +91-120-4671694 E: dghosh@ra.rockwell.com W: www.rockwellautomation.com

Waters (India) Private Limited T: +91-80-28371900 E: waters_india@waters.com W: www.waters.com West Pharmaceutical Services T: +91-40-40021790

Shiva Analyticals (India) Limited T: +91-80-27971322 E: gupta@shivatec-india.com W: www.shivatec-india.com

Siemens Ltd W: www.siemens.com/pharma

Sintex Industries Ltd T: +91-2764-253500 E: sg-chakraborty@sintex.co.in W: www.sintex-plastics.com

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Modern Pharmaceuticals I June 2011

Modern Pharmaceuticals

June 2011