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Biotechnology in India: Emerging Opportunities

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Biotechnology in India: Emerging Opportunities Himanshu Parmar Biotechnology in India: is Industry Analyst for Pharmaceutical and Biotechnology group in Emerging opportunities Healthcare Practice EMEA for Frost & Sullivan. He completed Himanshu Parmar his Btech(Hons) and Date received: 2nd August, 2005 Mtech(Hons) in Biotechnology and Biochemical Engineering from IIT Kharagpur, India. Abstract The global biotechnology and pharmaceutical industry is beleaguered with several challenges such as high R&D costs, increasing regulatory restraints and stagnant product pipelines. Thus, major multinational pharmaceutical and biotechnology companies from the West are increasingly looking for low-cost suitable alternatives. Among the emerging markets, India is seen as a low-cost destination with ample opportunities available to be capitalised on without compromising on the quality. To complement the interest from international community, India is also liberalising its economy and offering increasing opportunities to invest, along with other Keywords: India, several reforms undertaken by the government. After information technology (IT), the focus is biotechnology, biopharmaceutical, vaccines, now on biotechnology in India, as is evident with the release of recent draft of the bioinformatics, genomics, Biotechnology Policy 2005. This paper offer insights into India’s biotechnology sector and clinical research, diagnostics opportunities. INTRODUCTION INDIAN BIOTECHNOLOGY Knowledge-based industries are playing MARKET an increasingly important role in the The Indian biotechnology market is Indian economy. This growing economy valued at US$1.00bn in 2005, comprising is the background against which both the new drug discoveries, bioinformatics, government and the domestic industry are clinical research and synthetic chemistry. investing significant efforts in Today there are over 280 biotechnology biotechnology sector. India plans to companies with more than 200 drugs on expand its biotechnology sector fivefold the market, covering 13 therapeutic over next five years as part of an segments. India’s biotechnology sector is ambitious strategy outlined at the BIO currently made up of four major 2005 annual convention in Philadelphia, segments: biopharmaceuticals (vaccines, the world’s largest biotech conference. human therapeutics, diagnostic products India is now among the top four and animal healthcare); industrial biotechnology hubs in the Asia Pacific biotechnology; agricultural region in terms of attractiveness for biotechnology; and biotechnology investment in this sector. Also a recent services (contract research, contract meeting of the Indo-US High manufacturing, clinical trials). Technology Cooperation Group Biopharmaceuticals remains the largest (HTCG) has made it evident that the segment for Indian biotechnology USA and other industrialised countries are industry. Strong clinical research Himanshu Parmar relying on India for high-technology expertise acquired through bio-services c/o Katja Feick, collaborations particularly in remains the mainstay for Frost & Sullivan Healthcare Practice, biotechnology. The meeting was biopharmaceutical segment progress. Also 4 Grosvenor Gardens, London SW1W 0DH, UK primarily focused on issues dealing with India is high on the radar of international data exclusivity in clinical trials in India pharmaceutical community for custom Tel: +44 (0) 20 7915 7856 Fax: +44 (0) 20 7730 3343 and the transfer of biological materials research, clinical research and E-mail: [email protected] from the USA to India. bioinformatics opportunities. & HENRY STEWART PUBLICATIONS 1478-565X. JOURNAL OF COMMERCIAL BIOTECHNOLOGY. VOL 12. NO 1. 61–66. OCTOBER 2005 6 1 Parmar POLICY INITIATIVES TO sanctioned a bio-IT park, which will BUILD BIOTECH house bioinformatics, bioengineering and The union government, in addition to pharmacogenomics companies and various state governments, have been research institutes. Besides building playing a key role in the development of infrastructure, the Government is also biotechnology sector from the very promoting collaboration between private beginning. Several research institutes have companies and publicly funded research been established by the Indian labs. Also patent reform 2005 opens up a Government during the past two to three possibility of increased partnership decades. All these institutes are dedicated between international and Indian to medical, industrial, scientific and/or companies. agricultural biotechnological research and The regulatory framework is already development. The Government also defined for medical biotechnology such as Increase in budget increased budgetary allocation for the r-DNA healthcare products and stem cell allocation for Department of Biotechnology (DBT) by research. Reforms are under continual biotechnology by the over 40.0 per cent in 2002–2003. consideration to further streamline the Indian Government Union and state governments took regulatory system and to overhaul the several steps last year, focusing on scientific research system. The Indian infrastructure development to support the Government has recently promulgated a sector’s growth. In October 2004, India’s draft ‘National Biotechnology Commerce and Industry Minister Development Strategy’ outlining plans to announced plans to set up special set up a National Biotechnology economic zones (SEZs) for Regulatory Authority with dedicated biotechnology, including biotechnology sections for recombinant drugs, industrial Government is parks and free trade warehouse zones. products, agricultural products, transgenic planning 10 more There were proposals to set up at least 10 animals, aquaculture and transgenic food biotechnology SEZs in biotech parks, all promoted by individual and feed. The draft also outlines that a the future state governments. Gujarat state national task force will be constituted for government is planning to establish a re-designing curricula for biotechnology US$12.4m biotech park and a US$11.5m and life sciences programmes aligning it to venture capital fund. Rajasthan state Western standards. Meanwhile a list of government has also charted out plans for priorities has been drafted, including key three biotech parks and a biotech policy research intensive areas – molecular and to offer concessions on land and lower cellular biology, neuroscience, molecular stamp duty. In the continued efforts, the genetics, transplantation biology, government of West Bengal has also genomics, proteomics, system biology, delineated plans including the RNA interference and stem cell research. establishment of a US$22.7m biotech The biotechnology policy also focuses park and a research centre. The on incentives and services such as government has announced these zones as incubator services, financial assistance and 100 per cent foreign direct investment infrastructure. The Government’s main (FDI) zones along with permission for real aim of such initiatives is to provide a estate developments in those areas. Several favourable business environment for start- other states, such as Andhra Pradesh, ups and to promote innovation in the Karnataka, Maharashtra, Kerala, domestic industry. Tamilnadu and Himachal Pradesh, are also taking initiatives to establish biotech IMPORTANCE OF INDIA IN parks and designing policies to improve CLINICAL RESEARCH the situation of industry at the state level. India is rapidly gaining global recognition Recognising opportunities in information as ideal destination for biotechnological technology (IT) application for life manufacturing and R&D. Also India is sciences, the Indian Government has already realising significant back office 62 & HENRY STEWART PUBLICATIONS 1478-565X. JOURNAL OF COMMERCIAL BIOTECHNOLOGY. VOL 12. NO 1. 61–66. OCTOBER 2005 Biotechnology in India service outsourcing. This category research organisations (CROs) have includes services in human resources, already set up operation in India. Clinical research information technology and finance and Multinational firms such as Pfizer, Aventis facilities established by multinational firms such accounting. Developments in and Eli Lilly have also established clinical as Pfizer, Aventis and biotechnology sector are further research facilities in India. Recently Eli Lilly in India accelerated by significant government Merck has also announced its return to efforts with several policies already in India. Also to utilise the well-known IT effect to reduce various regulatory expertise available in India, Pfizer, Clinical data approval timelines, to encourage FDI and GlaxoSmithKline, Quintiles and many management centres to establish 20 world-class clinical research other foreign companies have also by Pfizer, GlaxoSmithKline, centres. established clinical data management Quintiles and many The quality of data and good clinical centres in India. others practice (GCP) compliance are very important considerations in all the BIOPHARMACEUTICALS government initiatives to encourage The estimations indicate that three- clinical research in India. Recent quarters of the total Indian biotechnology Recent amendments amendments to Schedule Y (Part of Drugs market is contributed by the to Schedule Y (Part of and Cosmetics Rules of India 1945) have biopharmaceutical segment. Drugs and Cosmetics illustrated a very progressive attitude on Recombinant products and vaccines are Rules of India 1945) have illustrated a very the Government’s part. Schedule Y 2005 the two important development areas for progressive attitude has significantly clarified clinical research domestic companies. India
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