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Pharmaceuticals in India<br />From Wikipedia, the free encyclopedia<br />Jump to: navigation, search <br />This article has multiple issues. Please help improve it or discuss these issues on the talk page.Its references would be clearer with a different or consistent style of citation, footnoting or external linking. Tagged since December 2010. It may need to be wikified to meet Wikipedia's quality standards. Tagged since July 2010. It may require general cleanup to meet Wikipedia's quality standards. Tagged since July 2010. <br />The Indian pharmaceutical industry is the world's second-largest by volume and is likely to lead the manufacturing sector of India.[1] India's bio-tech industry clocked a 17 percent growth with revenues of Rs.137 billion ($3 billion) in the 2009-10 financial year over the previous fiscal. Bio-pharma was the biggest contributor generating 60 percent of the industry's growth at Rs.8,829 crore, followed by bio-services at Rs.2,639 crore and bio-agri at Rs.1,936 crore.[2] The first pharmaceutical company are Bengal Chemicals and Pharmaceutical Works, which still exists today as one of 5 government-owned drug manufacturers, appeared in Calcutta in 1930. For the next 60 years, most of the drugs in India were imported by multinationals either in fully-formulated or bulk form. The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970, enabled the industry to become what it is today. This patent act removed composition patents from food and drugs, and though it kept process patents, these were shortened to a period of five to seven years. The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market, and while they streamed out, Indian companies started to take their places. They carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs. Although some of the larger companies have taken baby steps towards drug innovation, the industry as a whole has been following this business model until the present.<br />Contents[hide]1 The Indian pharmaceutical industry (IPo) today 1.1 Statistics 1.2 Patents 1.3 Product development 1.4 Small and medium enterprises 1.5 Challenges 1.6 R&D 1.7 Labor force 2 Biotechnology 2.1 Relationship between pharmaceuticals and biotechnology 2.2 Biotechnology statistics 2.3 Comparison with the U.S. 2.4 Relationship with IT 2.5 Government support 2.6 Foreign investment 2.7 Challenges 3 Major players 3.1 Ranbaxy Laboratories 3.2 Dr. Reddy's Laboratories 3.3 Nicholas Piramal 3.4 Cipla 3.5 Others 4 See also 5 References 6 Reference <br />[edit] The Indian pharmaceutical industry (IPo) today<br />[edit] Statistics<br />Top 10 Pharmaceuticals in India, as of 2010[update]RankCompanyRevenue 2010 (Rs crore)Revenue 2010 (Rs billion)1Ranbaxy Laboratories4,198.9641.9892Dr. Reddy's Laboratories4,162.2541.6223Cipla3,763.7237.6374Sun Pharmaceutical2,463.5924.6355Lupin Ltd2,215.5222.1556Aurobindo Pharma2,081.1920.8017GlaxoSmithKline1,773.4117.7348Cadila Healthcare1,61316.139Aventis Pharma983.809.83810Ipca Laboratories980.449.8044<br />In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and Russia[25]. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market [1]. Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago[20].<br />Most pharma companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high level management. Mirroring the social structure, firms are very hierarchical. Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise. Although many of these companies are publicly owned, leadership passes from father to son and the founding family holds a majority share.<br />In terms of the global market, India currently holds a modest 1-2% share, but it has been growing at approximately 10% per year[27]. India gained its foothold on the global scene with its innovatively-engineered generic drugs and active pharmaceutical ingredients (API), and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research. There are 74 U.S. FDA-approved manufacturing facilities in India, more than in any other country outside the U.S, and in 2005, almost 20% of all Abbreviated New Drug Applications (ANDA) to the FDA are expected to be filed by Indian companies[21,27]. Growth in other fields notwithstanding, generics are still a large part of the picture. London research company Global Insight estimates that India’s share of the global generics market will have risen from 4% to 33% by 2007[27].<br />[edit] Patents<br />As it expands its core business, the industry is being forced to adapt its business model to recent changes in the operating environment. The first and most significant change was the January 1, 2005 enactment of an amendment to India’s patent law that reinstated product patents for the first time since 1972. The legislation took effect on the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognize not only new patents but also any patents filed after January 1, 1995.[3] Indian companies achieved their status in the domestic market by breaking these product patents, and it is estimated that within the next few years, they will lose $650 million of the local generics market to patent-holders[42].<br />In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals narrowed their focus onto high-end patients who make up only 12% of the market, taking advantage of their newly-bestowed patent protection. Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations[45].<br />[edit] Product development<br />Mahendra Companies are also starting to adapt their product development processes to the new environment. For years, firms have made their ways into the global market by researching generic competitors to patented drugs and following up with litigation to challenge the patent. This approach remains untouched by the new patent regime and looks to increase in the future. However, those that can afford it have set their sights on an even higher goal: new molecule discovery. Although the initial investment is huge, companies are lured by the promise of hefty profit margins and the recognition as a legitimate competitor in the global industry. Local firms have slowly been investing more money into their R&D programs or have formed alliances to tap into these opportunities.<br />[edit] Small and medium enterprises<br />As promising as the future is for a whole, the outlook for small and medium enterprises (SME) is not as bright. The excise structure changed so that companies now have to pay a 16% tax on the maximum retail price (MRP) of their products, as opposed to on the ex-factory price. Consequently, larger companies are cutting back on outsourcing and what business is left is shifting to companies with facilities in the four tax-free states - Himachal Pradesh, Jammu & Kashmir, Uttaranchal and Jharkhand.[12]<br />As SMEs wrestled with the tax structure, they were also scrambling to meet the July 1 deadline for compliance with the revised Schedule M Good Manufacturing Practices (GMP). While this should be beneficial to consumers and the industry at large, SMEs have been finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of many facilities. Others invested the money to bring their facilities to compliance, but these operations were located in non-tax-free states, making it difficult to compete in the wake of the new excise tax.<br />[edit] Challenges<br />All of these changes are ultimately good for the Indian pharmaceutical industry, which suffered in the past from inadequate regulation and large quantities of spurious drugs. They force the industry to reach a level necessary for global competitiveness. However, they have also exposed some of the inadequacies in the industry today. Its main weakness is an underdeveloped new molecule discovery program. Even after the increased investment, market leaders such as Ranbaxy and Dr. Reddy’s Laboratories spent only 5-10% of their revenues on R&D, lagging behind Western pharmaceuticals like Pfizer, whose research budget last year was greater than the combined revenues of the entire Indian pharmaceutical industry[13, 37]. This disparity is too great to be explained by cost differentials, and it comes when advances in genomics have made research equipment more expensive than ever. The drug discovery process is further hindered by a dearth of qualified molecular biologists. Due to the disconnect between curriculum and industry, pharmas in India also lack the academic collaboration that is crucial to drug development in the West[13].<br />[edit] R&D<br />Both the Indian central and state governments have recognized R&D as an important driver in the growth of their pharma businesses and conferred tax deductions for expenses related to research and development. They have granted other concessions as well, such as reduced interest rates for export financing and a cut in the number of drugs under price control. Government support is not the only thing in Indian pharma’s favor, though; companies also have access to a highly-developed IT industry that can partner with them in new molecule discovery.<br />[edit] Labor force<br />India’s greatest strengths lie in its people. India also boasts of well-educated, English-speaking labor force that is the base of its competitive advantage. Although molecular biologists are in short supply, there are a number of talented chemists who are equally as important in the discovery process. In addition, there has been a reverse brain drain effect in which scientists are returning from abroad to accept positions at lower salaries at Indian companies. Once there, these foreign-trained scientists can transfer the benefits of their knowledge and experience to all of those who work with them[13,25]. India’s wealth of people extends benefits to another part of the drug commercialization process as well. With one of the largest and most genetically diverse populations in any single country, India can recruit for clinical trials more quickly and perform them more cheaply than countries in the West[47]. Indian firms have just recently started to leverage.<br />[edit] Biotechnology<br />[edit] Relationship between pharmaceuticals and biotechnology<br />Unlike in other countries, the difference between biotechnology and pharmaceuticals remains fairly defined in India. Bio-tech there still plays the role of pharma’s little sister, but many outsiders have high expectations for the future. India accounted for 2% of the $41 billion global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region and 11th in the world in number of biotechs.[45] In 2004-5, the Indian biotech industry saw its revenues grow 37% to $1.1 billion.[2,9] The Indian biotech market is dominated by biopharmaceuticals; 75% of 2004-5 revenues came from biopharmaceuticals, which saw 30% growth last year. Of the revenues from biopharmaceuticals, vaccines led the way, comprising 47% of sales[46]. Biologics and large-molecule drugs tend to be more expensive than small-molecule drugs, and India hopes to sweep the market in biogenerics and contract manufacturing as drugs go off patent and Indian companies upgrade their manufacturing capabilities.<br />[edit] Biotechnology statistics<br />Top 20 Biotechnology Companies in India, 2004RankCompanyRevenue 2004 (Rs crore)Revenue 2004 (USD millions)1Biocon646148.62Serum Institute of India565129.93Panacea Biotec21750.04Venky's (India) Limited18843.25Mahyco Monsanto16638.36Novo Nordisk13531.07Rasi Seeds8720.08Aventis Pharma8419.49Bharat Serums8118.610Chiron Behring Vaccines7817.911GlaxoSmithKline7817.912Indian Immunologicals7216.613Shantha Biotechnics7016.114Novozymes6915.915Eli Lilly and Company6815.716Wockhardt6715.417Bharat Immunological & Biological Corp.5312.318Bharat Biological International419.419Advanced Biochemicals409.120Biological E368.3USD 1 = Rs 43.5Source: BioSpectrum Top 20: A threshold crossed<br />Most companies in the biotech sector are extremely small, with only two firms breaking 100 million dollars in revenues. At last count there were 265 firms registered in India, over 75% of which were incorporated in the last five years.[2,47] The newness of the companies explains the industry’s high consolidation in both physical and financial terms. Almost 50% of all biotechs are in or around Bangalore, and the top ten companies capture 47% of the market. The top five companies were homegrown; Indian firms account for 62% of the biopharma sector and 52% of the industry as a whole.[4,46] The Association of Biotechnology-Led Enterprises (ABLE) is aiming to grow the industry to $5 billion in revenues generated by 1 million employees by 2009, and data from the Confederation of Indian Industry (CII) seem to suggest that it is possible.[7,47]<br />[edit] Comparison with the U.S.<br />The Indian biotech sector parallels that of the U.S. in many ways. Both are filled with small start-ups while the majority of the market is controlled by a few powerful companies. Both are dependent upon government grants and venture capitalists for funding because neither will be commercially viable for years. Pharmaceutical companies in both countries have recognized the potential effect that biotechnology could have on their pipelines and have responded by either investing in existing start-ups or venturing into the field themselves.[36] In both India and the U.S., as well as in much of the globe, biotech is seen as a hot field with a lot of growth potential.<br />[edit] Relationship with IT<br />Many analysts have observed that the hype around the biotech sector mirrors that of the IT sector. Biotech colleges have been popping up around the country eager to service the pools of students that want to take advantage of a growing industry.[7] The International Finance Commission, the private investment arm of the World Bank, called India the “centerpiece of IFC’s global biotech strategy.” Of the $110 million invested in 14 biotech projects investment globally, the IFC has given $43 million to 4 projects in India.[29] According to Dr. Manju Sharma, former director of the Department of Biotechnology, the biotech industry could become the “single largest sector for employment of skilled human resource in the years to come.”[5] British Prime Minister Tony Blair was similarly impressed, citing the success of India’s biotech industry as the reason for his own country’s own biotech opportunities.[22] Malaysia is also looking to India as an example for growing its own biotech industry.[41]<br />[edit] Government support<br />The Indian government has been very supportive. It established the Department of Biotechnology in 1986 under the Ministry of Science and Technology.[47] Since then, there have been a number of dispensations offered by both the central government and various states to encourage the growth of the industry. India’s science minister launched a program that provides tax incentives and grants for biotech start-ups and firms seeking to expand and establishes the Biotechnology Parks Society of India to support ten biotech parks by 2010. Previously limited to rodents, animal testing was expanded to include large animals as part of the minister’s initiative.[10] States have started to vie with one another for biotech business, and they are offering such goodies as exemption from VAT and other fees, financial assistance with patents and subsidies on everything ranging from investment to land to utilities[19].<br />[edit] Foreign investment<br />The government has also taken steps to encourage foreign investment in its biotech sector. An initiative passed earlier this year allowed 100% foreign direct investment without compulsory licensing from the government1.[6] In April, a delegation headed by the Kapil Sibal, the minister of science and technology and ocean development, visited five cities in the U.S. to encourage investment in India, with special emphasis on biotech.[32] Just two months later, Sibal returned to the U.S. to unveil India’s biotech growth strategy at the BIO2005 conference in Philadelphia.[9]<br />[edit] Challenges<br />The biotech sector faces some major challenges in its quest for growth. Chief among them is a lack of funding, particularly for firms that are just starting out. The most likely sources of funds are government grants and venture capital, which is a relatively young industry in India. Government grants are difficult to secure, and due to the expensive and uncertain nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet developed a commercially viable product.[26] As previously mentioned, India hopes to solve its funding problem by attracting overseas investors and partners. Before these potential saviors will invest significant sums in the industry, however, there needs to be better scientific and financial accountability. India is slowly working towards these goals, but it will be a while before they are up to the standards of Western investors.<br />India’s biotech firms share another problem with their pharmaceutical cousins: a lack of qualified employees. Biotech has the additional disadvantage of competing against IT for ambitious, science-minded students but not being able to guarantee the same compensation. An aspiring researcher in India needs 7–10 years of education covering a range of specialties in order to qualify to work in biotech. Even if a student does choose to go on the biotech path, the ineffectual curriculum at many universities makes it doubtful as to whether he will be qualified to work in the field once finished. One estimate shows that 10% of upper-echelon biotech recruits have come from foreign countries. While this is not a problem, per se, it drives up cost in a country whose competitive advantage is based on cheap, high-quality labor. Far from ending with scientists, there is also a shortage of people with a knowledge of biotechnology in related fields: doctors, lawyers, programmers, marketing personnel and others.[7,15,17]<br />While little has been done about the latter half of the employee crunch, the government has addressed the problem of educated but unqualified candidates in its Draft National Biotech Development Strategy. This plan included a proposal to create a National Task Force that would work with the biotech industry to revise the curriculum for undergraduate and graduate study in life sciences and biotechnology. The government’s strategy also stated intentions to increase the number of PhD Fellowships awarded by the Department of Biotechnology to 200 per year. These human resources will be further leveraged with a “Bio-Edu-Grid” that will knit together the resources of the academic and scientific industrial communities, much as they are in the U.S.[5]<br />[edit] Major players<br />[edit] Ranbaxy Laboratories<br />Ranbaxy is the leader in the Indian pharmaceutical market, taking in $1.174 billion in revenues for a net profit of $160 million in 2004. It was the first Indian pharmaceutical to have a proprietary drug (extended-release ciprofloxacin, marketed by Bayer) approved by the U.S. FDA, and the U.S. market accounts for 36% of its sales. 78% of Ranbaxy’s sales are from overseas markets; its offices in 44 countries manage manufacturing in 7 countries and distribution in over 100.<br />IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in the world and that it is the 15th fastest growing company. By 2012, Ranbaxy hopes to be one of the top 5 generics producers in the world, and it consolidated its position with the purchase of French firm RGP Aventis in 2003. Ranbaxy also has higher aspirations, however, “to build a proprietary prescription business in the advanced markets.” To this end, it keeps a dedicated research facility in Gurgaon staffed with over 1100 scientists. They currently have two molecules in Phase II trials and 3-5 in pre-clinical testing. It spent $75 million in R&D in 2004, a 43% increase over its 2003 expenditure.<br />Arun Puri is the chairman and CEO Brian Tempest is the only non-Indian on the senior management team.38,39<br />[edit] Dr. Reddy's Laboratories<br />Founded in 1984 with $160,000, Dr. Reddy’s was the first Asia-Pacific pharmaceutical outside of Japan and the sixth Indian company to be listed on the New York Stock Exchange. It earned $446 million in fiscal year 2005, deriving 66% of this income from the foreign market. In order to strengthen its global position, Dr. Reddy acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare. Anji Reddy is the chairman of Dr.Reddy's.<br />Although 58% of Dr. Reddy’s revenues come from generic drugs, the company was committed to WTO-compliance long before the 2005 bill took effect, and most of these products were already off patent. Dr. Reddy has long been a research-oriented firm, preceding many of its peers in setting up a New Drug Development Research (NDDR) in 1993 and out-licensing its first compound just four years later. Dr. Reddy’s has since outlicensed two more molecules and currently has three others in clinical trials.<br />Although Dr. Reddy’s is publicly-traded, the Reddy family (including founder/chairman K. Anji Reddy, son-in-law/CEO GV Prasad and son/COO Satish Reddy) holds a hefty 26% share in the company.11,44<br />[edit] Nicholas Piramal<br />The comapny led by Asish Mishra grossing $350 million per year, Nicholas Piramal started its existence with the 1988 acquisition of Nicholas Laboratories and grew through a series of mergers, acquisitions and alliances. The company has formed a name for itself in the field of custom manufacturing. It cites its 1700-person global sales force as another core strength; with its acquisition of Rhodia’s inhalation anaesthetics business, Nicholas Piramal gained a sales and marketing network spanning 90 countries34.<br />Nicholas Piramal is well-poised for the challenge of surviving in the aftermath of product patent protection. The company has respected intellectual property rights since its inception and refused to quot;
support generic companies seeking first-to-file or early-to-market strategies.quot;
 Instead, it decided to make its own intellectual property and opened a research facility last November in Mumbai with hopes of launching its first drug in 2010 at a cost of $100,000.24,33<br />[edit] Cipla<br />Cipla is one of the lodest drug manufacturers in India. It is led by Dr. Yusuf K. Hamied, Chairman and Managing Director. Cipla burst into the international consciousness in 2000 with Triomune, an AIDS treatment costing between $300 and $800 per year that infringed upon patents held by several companies who were selling the cocktail for $12,000 per year. Long before this news, Cipla had been building a strong global presence, and it now distributes its 800-odd products in over 140 countries. Privately-held Cipla holds a prominent spot in its home country as well; it is the leader in domestic sales, having just unseated GlaxoSmithKline for the first time in 28 years. Revenue in 2004 totaled $552 million (using Rs 43.472 = $1) about 75% of which was derived in India. Cipla did not report having a research program.8,18<br />|Dr. Kiran Mazumdar-Shaw]] is the Chairman and Managing Director of BiocoIrish chemicals company seeking to break into the Indian market, Biocon is now the leading biotech in India, bringing in Rs 646.36 crore (almost $150 million) in revenue for fiscal year 2004. It initially made its money by producing enzymes, but Biocon recently decided to become a research-oriented company with the goal of bringing a proprietary new drug to market.<br />The company went public in March 2004, and quot;
its shares were oversubscribed by 33 times on opening day.quot;
 Eight months later it launched Insugen, a bio-insulin that is its first branded product. Biocon also has two wholly-owned subsidiaries, Syngene and Clinigene, that perform custom research and clinical trials.3,14,31<br />===Serum Institute of India===[4] The Serum Institute of India can make the enviable claim that 2 out of every 3 children in the world are immunized with one of their vaccines. It is the world’s largest producer of measles and DTP vaccines, and its portfolio includes other vaccines, antisera, plasma products and anticancer compounds. The Serum Institute earned Rs 565 crore ($130 million) in revenue in fiscal year 2005, selling mainly to UN agencies and to the Indian government. The Serum Institute is part of the Poonawalla Group, whose holdings include a horse stud farm and manufacturers of industrial equipment and components. Dr. Cyrus Poonawalla is the Chairman of the company.1,4,40<br />[edit] Others<br />Other important domestic companies Lupin Ltd :Dr. Desh Bandhu Gupta, Chairman<br />Sun Pharmaceuticals :Dilip S. Sanghvi, Chairman and Managing Director<br />Torrent Pharmaceuticals :Sudir Mehta, Chairman<br />Wockhardt :Habil F. Khorakiwala, Chairman<br />Cadila Healthcare :Pankaj R. Patel, Chairman and Managing Director<br />Hetero Drugs :Dr. B. Partha Saradhi Reddy, Chairman and Managing Director Nectar Lifesciences[5] :Mr. Sanjiv Goyal, Chairman<br />Macleods Pharma[6] :Dr. Rajendra Agarwal, Managing Director<br />Intas Biopharmaceuticals :Dr. Urmish Chudgar, Managing Director<br />Bharat Serums[7] :Mr. Bharat V. Daftary, Chairman and Managing Director<br />Orchid Pharmaceuticals :Mr. R. Narayanan, Chairman<br />Panacea Biotec[8] :Mr. Soshil Kumar Jain, Chairman<br />AMN Pharmaceuticals[9] :Amndip, Chairman and Managing Director<br />Ajanta Pharma[10] :Yogesh Agrawal, Managing Director<br />Green Apple Lifesciences Limited[11] :Mitesh Mehta, Chairman<br />Reliance Life Sciences Pvt Ltd[12] : Mr. K.V. V. Subramaniam, President and CEO<br />[edit] See also<br />Medicine in China <br />Pharmaceutical industry in China <br />Pharmacology <br />Biotechnology <br />Pharmaceutical marketing <br />Pharmaceutical industry <br />National pharmaceuticals policy <br />Opium and Alkaloid Works <br />[edit] References<br />1 Serum Institute of India. 15 June 2005. Biospectrum. 1 August 2005 <http://www.biospectrumindia.com/content/BSTOP20/10506153.asp>.<br />2 quot;
50% of country's biotech firms based in Karnataka.quot;
 The Economic Times 23 April 2005.<br />3 Biopharmaceutical and Biotechnology Company. Biocon. 26 July 2005 <http://www.biocon.com/>.<br />4 “BioSpectrum 20: A Threshold Crossed.” BioSpectrum 3:6 (June 2005): 24-32.<br />5 “Biotech development strategy to boost domestic, foreign investments: CII.” The Hindustan Times 20 May 2005.<br />6 “Biotech sector to be single largest job churner: expert.” Global Newswire – Asia Africa Intelligence Wire 21 February 2005.<br />7 quot;
BT has jobs but where are the takers?quot;
 Asia Africa Intelligence Wire 7 January 2005.<br />8 Cipla. Cipla. 28 July 2005 < http://www.cipla.com/>.<br />9 Cookson, Clive. quot;
India to expand biotech sector.quot;
 The Financial Times (21 June 2005): 8.<br />10 Datta, P.T. Jyothi. “More global buys by pharma cos likely.” The Hindu Business Line (Internet Edition), 22 July 2005.<br />11 Dr. Reddy Laboratories Ltd. Dr. Reddy’s Laboratories Ltd. 27 July 2005 <http://www.drreddys.com/>.<br />12 D’Silva, Jeetha. “Pharma SMEs gasp for breath as big companies move to better climes.” The Economic Times 28 May 2005.<br />13 Dyer, Jeff and Khozem Merchant. “An experiment in globalization: how India hopes to reshape the world drugs industry.” Financial Times 18 August 2004: 15.<br />14 Egan, Mary Ellen. quot;
Big Shot in Bangalore. (Kiran Mazumdar-Shaw ).quot;
 Forbes 174:8 (18 October 2004): 88.<br />15 Ghatak, Lopamudra. “Fat pay, yuppie lifestyle - join biotech, not IT.quot;
 Asia Africa Intelligence Wire 15 March 2005.<br />16 “Government to allow 100% FDI in Biotech (Biotech will be exempted from the requirement of compulsory licensing) ” India Business Insight - Global Newswire – Asia Africa Intelligence Wire 31 May 2005.<br />17 Hector, Darlington Jose. quot;
NRIs, expats fuel biotech boom in India.quot;
 The Economic Times 20 April 2005.<br />18 Hoovers Company Records – In-Depth Records: Cipla. 26 July 2005. Lexis-Nexis Academic Universe. 28 July 2005.<br />19 quot;
Incentives for bio-tech units.quot;
 Asia Africa Intelligence Wire 2 July 2005.<br />20 “India industry: Desperate for quality healthcare services.” Economist Intelligence Unit: Country ViewsWire. 24 June 2005.<br />21 Indiainfoonline.com. Indian Pharmaceutical Sector: Big Pharma Opportunity. By Atul Rastogi and Abhimanyu Verma. 28 August 2003.<br />22 “India’s biotech strides prompts UK to hike funds in sector.” Nationwide International News (The Press Trust of India) 7 March 2005.<br />23 “Intellectual property: protection and enforcement.” WTO: Understanding the WTO. World Trade Organization. 1 August 2005 <http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm><br />24 Jarvis, Lisa. quot;
NPIL sets ambitious growth targets.quot;
 Chemical Market Reporter 267:16 (18 April 2005): 32-33.<br />25 Joshi, Hemant N. “Analysis of the Indian pharmaceutical industry: with emphasis on opportunities in 2005.” Pharmaceutical Technology 27:1 (2003): 74-84.<br />26 Kathuria, Vinish & Vandita Tewari. quot;
Venture capitalists and biotech sector: Discovering the potential.quot;
 Asia Africa Intelligence Wire 29 December 2004.<br />27 Kripalani, Manjeet. quot;
Pharma Karma; Tougher patent protection laws are spurring rapid growth in new drug research across India.quot;
 Business Week 39:29 (18 April 2005): 20.<br />28 Krishnan, Unni. “India enters a new era.” Manufacturing Chemist 76:2 (2005): 27-29.<br />29 Ludwina, Joseph. “IFC Committed to Support Indian Biotech Sector.” International Finance Corporation: Press Releases South Asia. 20 June 2005.<br />30 Malhotra, Prabodh & Lofgren, Hans. “India's pharmaceutical industry: hype or high tech take-off?” Australian Health Review 28:2 (2004): 182-193.<br />31 Mazumdar, Sudip. “First Lady; In Asia: India’s top biotech CEO begs to differ with those who say Singapore leads the field.” Newsweek International 11 October 2004: 39.<br />32 Na, K. Oanh. quot;
India's sales pitch to Silicon Valley.quot;
 San Jose Mercury News 12 April 2005.<br />33 Nicholas Piramal India Limited. Nicholas Piramal India Limited. 26 July 2005. <http://www.nicholaspiramal.com>.<br />34 “NPIL buys Rhodia business for 7m [pounds sterling].” ACN: Asian Chemical News 11:475 (17 January 2005): 6.<br />35 Pharmaceutical and Drug Manufacturers Homepage. Pharmaceutical and Drug Manufacturers. 30 July 2005 <http://www.pharmaceutical-drug-manufacturers.com/>.<br />36 Prasad, Girish Chandra. quot;
Outlook improves for India's biotechnology sector.quot;
 The Economic Times 31 December 2004.<br />37 “R and D spend of top 5 Indian pharmaceutical companies touches Rs1,000 crore.” Asia Africa Intelligence Wire 17 February 2005.<br />38 Ranbaxy – Indian Pharma Research & Pharmaceutical Company India. Ranbaxy Laboratories Ltd. 26 July 2005 <http://www.ranbaxy.com/>.<br />39 Ranbaxy Laboratories Ltd. Annual Report. Gurgaon, India: Ranbaxy Laboratories Ltd. (2004).<br />40 Serum Institute of India. Serum Institute of India. 29 July 2005 < http://www.seruminstitute.com>.<br />41 Singh, Karamjit. “Net value: Tapping biotech know-how.” The Edge Malaysia 16 May 2005.<br />42 Singh, Seema. “India kicks the habit; local drugmakers have built a thriving industry on pilfering patents. The party ends in January.” Newsweek International (22 November. 2004): 56.<br />43 Sridharan, R. et al. “Indian pharma’s mid-life crisis.” Business Today 27 February. 2005: 50.<br />44 Tanzer, Andrew. “Pill factory to the world.” Forbes (internet) 10 December 2001. 29 July 2005.<br />45 Unnikrishnan, C H. “Patents carve up drug market.” Business Standard 29 July 2005.<br />46 “Vaccines push BioPharma sales.” BioSpectrum 3:6 (June 2005): 70-71.<br />47 Wilkie, Dana. “India wants to be your biotech source.” The Scientist 25 October 2004: 51-53.<br />48 Zinnov, quot;
Pharmaceutical Outsourcing in Indiaquot;
 <http://www.zinnov.com/presentation/Pharmaceutical_Outsourcing_Overview.pdf>.<br />[edit] Reference<br />^ quot;
Pharma to topple IT as big paymasterquot;
. The Economic Times. http://economictimes.indiatimes.com/News/News-By-Industry/Jobs/Pharma-engineering-to-topple-IT-as-big-paymaster/articleshow/6022202.cms?curpg=1. Retrieved 8 Jun 2010.  <br />^ quot;
Indian biotech industry grew 17 percent in 2009-10: Surveyquot;
. Economic Times. 21 June 2010. http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/biotech/Indian-biotech-industry-grew-17-percent-in-2009-10-Survey/articleshow/6075713.cms. Retrieved 21 Jun 2010.  <br />^ quot;
Understanding the WTO - Intellectual property: protection and enforcementquot;
. WTO. http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm. Retrieved 2010-07-27.  <br />^ quot;
Serum Institute of India | Manufacturer of Vaccines & immuno-biologicals - GMP Vaccine Manufacturerquot;
. Seruminstitute.com. http://www.seruminstitute.com. Retrieved 2010-07-27.  <br />^ quot;
Nectar Lifesciences Ltd.: Nurturing. Enriching. Caringquot;
. Neclife.com. http://www.neclife.com. Retrieved 2010-07-27.  <br />^ http://macleodspharma.com <br />^ quot;
Bharat Serums and Vaccines - plasma, pharma and biotechnology productsquot;
. Bharatserums.com. http://www.bharatserums.com/. Retrieved 2010-07-27.  <br />^ quot;
India : Pharmaceuticals Business, pharmaceutical company india, pharma outsourcing india, pharmaceuticals brand, pharmaceuticals intellectual property, pharmaceutical formulations, vaccines, natural productsquot;
. Panacea Biotec. http://www.panacea-biotec.com/. Retrieved 2010-07-27.  <br />^ amnpharmaceuticals.com. quot;
Pharmaceutical Companies in Indiaquot;
. Amnpharmaceuticals.com. http://www.amnpharmaceuticals.com. Retrieved 2010-07-27.  <br />^ quot;
Welcome To Ajanta Pharmaquot;
. Ajantapharma.com. http://ajantapharma.com. Retrieved 2010-07-27.  <br />^ quot;
Welcome to Green Apple Lifesciences Limitedquot;
. Greenapple.co.in. http://www.greenapple.co.in. Retrieved 2010-07-27.  <br />^ quot;
Reliance Life Sciences :: Reliance Industries :: Reliance Groupquot;
. Rellife.com. http://www.rellife.com. Retrieved 2010-07-27.  <br />Retrieved from quot;
http://en.wikipedia.org/wiki/Pharmaceuticals_in_Indiaquot;
<br />Categories: Biotechnology | Clinical research | Healthcare in India | Pharmaceuticals policy | Pharmacology | Pharmacy | Pharmaceutical companies of India | Pharmaceutical industry of India<br />Hidden categories: Wikipedia references cleanup from December 2010 | Articles that need to be wikified from July 2010 | All articles that need to be wikified | Articles needing cleanup from July 2010 | All pages needing cleanup | Articles containing potentially dated statements from 2010 | All articles containing potentially dated statements<br />Personal tools<br />Log in / create account <br />Namespaces<br />Article <br />Discussion <br />Variants<br />Views<br />Read <br />Edit <br />View history <br />Actions<br />Search<br />Top of Form<br />Bottom of Form<br />Navigation<br />Main page <br />Contents <br />Featured content <br />Current events <br />Random article <br />Donate to Wikipedia <br />Interaction<br />Help <br />About Wikipedia <br />Community portal <br />Recent changes <br />Contact Wikipedia <br />Toolbox<br />What links here <br />Related changes <br />Upload file <br />Special pages <br />Permanent link <br />Cite this page <br />Print/export<br />Create a book <br />Download as PDF <br />Printable version<br />Languages<br />Català <br />Deutsch <br />Français <br />This page was last modified on 21 March 2011 at 11:26.<br />Text is available under the Creative Commons Attribution-ShareAlike License; additional terms may apply. See Terms of Use for details.Wikipedia® is a registered trademark of the Wikimedia Foundation, Inc., a non-profit organization.<br />Contact us <br />Privacy policy <br />About Wikipedia <br />Disclaimers <br />
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Pharmaceuticals in india

  • 1. Pharmaceuticals in India<br />From Wikipedia, the free encyclopedia<br />Jump to: navigation, search <br />This article has multiple issues. Please help improve it or discuss these issues on the talk page.Its references would be clearer with a different or consistent style of citation, footnoting or external linking. Tagged since December 2010. It may need to be wikified to meet Wikipedia's quality standards. Tagged since July 2010. It may require general cleanup to meet Wikipedia's quality standards. Tagged since July 2010. <br />The Indian pharmaceutical industry is the world's second-largest by volume and is likely to lead the manufacturing sector of India.[1] India's bio-tech industry clocked a 17 percent growth with revenues of Rs.137 billion ($3 billion) in the 2009-10 financial year over the previous fiscal. Bio-pharma was the biggest contributor generating 60 percent of the industry's growth at Rs.8,829 crore, followed by bio-services at Rs.2,639 crore and bio-agri at Rs.1,936 crore.[2] The first pharmaceutical company are Bengal Chemicals and Pharmaceutical Works, which still exists today as one of 5 government-owned drug manufacturers, appeared in Calcutta in 1930. For the next 60 years, most of the drugs in India were imported by multinationals either in fully-formulated or bulk form. The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970, enabled the industry to become what it is today. This patent act removed composition patents from food and drugs, and though it kept process patents, these were shortened to a period of five to seven years. The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market, and while they streamed out, Indian companies started to take their places. They carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs. Although some of the larger companies have taken baby steps towards drug innovation, the industry as a whole has been following this business model until the present.<br />Contents[hide]1 The Indian pharmaceutical industry (IPo) today 1.1 Statistics 1.2 Patents 1.3 Product development 1.4 Small and medium enterprises 1.5 Challenges 1.6 R&D 1.7 Labor force 2 Biotechnology 2.1 Relationship between pharmaceuticals and biotechnology 2.2 Biotechnology statistics 2.3 Comparison with the U.S. 2.4 Relationship with IT 2.5 Government support 2.6 Foreign investment 2.7 Challenges 3 Major players 3.1 Ranbaxy Laboratories 3.2 Dr. Reddy's Laboratories 3.3 Nicholas Piramal 3.4 Cipla 3.5 Others 4 See also 5 References 6 Reference <br />[edit] The Indian pharmaceutical industry (IPo) today<br />[edit] Statistics<br />Top 10 Pharmaceuticals in India, as of 2010[update]RankCompanyRevenue 2010 (Rs crore)Revenue 2010 (Rs billion)1Ranbaxy Laboratories4,198.9641.9892Dr. Reddy's Laboratories4,162.2541.6223Cipla3,763.7237.6374Sun Pharmaceutical2,463.5924.6355Lupin Ltd2,215.5222.1556Aurobindo Pharma2,081.1920.8017GlaxoSmithKline1,773.4117.7348Cadila Healthcare1,61316.139Aventis Pharma983.809.83810Ipca Laboratories980.449.8044<br />In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and Russia[25]. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market [1]. Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago[20].<br />Most pharma companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high level management. Mirroring the social structure, firms are very hierarchical. Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise. Although many of these companies are publicly owned, leadership passes from father to son and the founding family holds a majority share.<br />In terms of the global market, India currently holds a modest 1-2% share, but it has been growing at approximately 10% per year[27]. India gained its foothold on the global scene with its innovatively-engineered generic drugs and active pharmaceutical ingredients (API), and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research. There are 74 U.S. FDA-approved manufacturing facilities in India, more than in any other country outside the U.S, and in 2005, almost 20% of all Abbreviated New Drug Applications (ANDA) to the FDA are expected to be filed by Indian companies[21,27]. Growth in other fields notwithstanding, generics are still a large part of the picture. London research company Global Insight estimates that India’s share of the global generics market will have risen from 4% to 33% by 2007[27].<br />[edit] Patents<br />As it expands its core business, the industry is being forced to adapt its business model to recent changes in the operating environment. The first and most significant change was the January 1, 2005 enactment of an amendment to India’s patent law that reinstated product patents for the first time since 1972. The legislation took effect on the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognize not only new patents but also any patents filed after January 1, 1995.[3] Indian companies achieved their status in the domestic market by breaking these product patents, and it is estimated that within the next few years, they will lose $650 million of the local generics market to patent-holders[42].<br />In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals narrowed their focus onto high-end patients who make up only 12% of the market, taking advantage of their newly-bestowed patent protection. Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations[45].<br />[edit] Product development<br />Mahendra Companies are also starting to adapt their product development processes to the new environment. For years, firms have made their ways into the global market by researching generic competitors to patented drugs and following up with litigation to challenge the patent. This approach remains untouched by the new patent regime and looks to increase in the future. However, those that can afford it have set their sights on an even higher goal: new molecule discovery. Although the initial investment is huge, companies are lured by the promise of hefty profit margins and the recognition as a legitimate competitor in the global industry. Local firms have slowly been investing more money into their R&D programs or have formed alliances to tap into these opportunities.<br />[edit] Small and medium enterprises<br />As promising as the future is for a whole, the outlook for small and medium enterprises (SME) is not as bright. The excise structure changed so that companies now have to pay a 16% tax on the maximum retail price (MRP) of their products, as opposed to on the ex-factory price. Consequently, larger companies are cutting back on outsourcing and what business is left is shifting to companies with facilities in the four tax-free states - Himachal Pradesh, Jammu & Kashmir, Uttaranchal and Jharkhand.[12]<br />As SMEs wrestled with the tax structure, they were also scrambling to meet the July 1 deadline for compliance with the revised Schedule M Good Manufacturing Practices (GMP). While this should be beneficial to consumers and the industry at large, SMEs have been finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of many facilities. Others invested the money to bring their facilities to compliance, but these operations were located in non-tax-free states, making it difficult to compete in the wake of the new excise tax.<br />[edit] Challenges<br />All of these changes are ultimately good for the Indian pharmaceutical industry, which suffered in the past from inadequate regulation and large quantities of spurious drugs. They force the industry to reach a level necessary for global competitiveness. However, they have also exposed some of the inadequacies in the industry today. Its main weakness is an underdeveloped new molecule discovery program. Even after the increased investment, market leaders such as Ranbaxy and Dr. Reddy’s Laboratories spent only 5-10% of their revenues on R&D, lagging behind Western pharmaceuticals like Pfizer, whose research budget last year was greater than the combined revenues of the entire Indian pharmaceutical industry[13, 37]. This disparity is too great to be explained by cost differentials, and it comes when advances in genomics have made research equipment more expensive than ever. The drug discovery process is further hindered by a dearth of qualified molecular biologists. Due to the disconnect between curriculum and industry, pharmas in India also lack the academic collaboration that is crucial to drug development in the West[13].<br />[edit] R&D<br />Both the Indian central and state governments have recognized R&D as an important driver in the growth of their pharma businesses and conferred tax deductions for expenses related to research and development. They have granted other concessions as well, such as reduced interest rates for export financing and a cut in the number of drugs under price control. Government support is not the only thing in Indian pharma’s favor, though; companies also have access to a highly-developed IT industry that can partner with them in new molecule discovery.<br />[edit] Labor force<br />India’s greatest strengths lie in its people. India also boasts of well-educated, English-speaking labor force that is the base of its competitive advantage. Although molecular biologists are in short supply, there are a number of talented chemists who are equally as important in the discovery process. In addition, there has been a reverse brain drain effect in which scientists are returning from abroad to accept positions at lower salaries at Indian companies. Once there, these foreign-trained scientists can transfer the benefits of their knowledge and experience to all of those who work with them[13,25]. India’s wealth of people extends benefits to another part of the drug commercialization process as well. With one of the largest and most genetically diverse populations in any single country, India can recruit for clinical trials more quickly and perform them more cheaply than countries in the West[47]. Indian firms have just recently started to leverage.<br />[edit] Biotechnology<br />[edit] Relationship between pharmaceuticals and biotechnology<br />Unlike in other countries, the difference between biotechnology and pharmaceuticals remains fairly defined in India. Bio-tech there still plays the role of pharma’s little sister, but many outsiders have high expectations for the future. India accounted for 2% of the $41 billion global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region and 11th in the world in number of biotechs.[45] In 2004-5, the Indian biotech industry saw its revenues grow 37% to $1.1 billion.[2,9] The Indian biotech market is dominated by biopharmaceuticals; 75% of 2004-5 revenues came from biopharmaceuticals, which saw 30% growth last year. Of the revenues from biopharmaceuticals, vaccines led the way, comprising 47% of sales[46]. Biologics and large-molecule drugs tend to be more expensive than small-molecule drugs, and India hopes to sweep the market in biogenerics and contract manufacturing as drugs go off patent and Indian companies upgrade their manufacturing capabilities.<br />[edit] Biotechnology statistics<br />Top 20 Biotechnology Companies in India, 2004RankCompanyRevenue 2004 (Rs crore)Revenue 2004 (USD millions)1Biocon646148.62Serum Institute of India565129.93Panacea Biotec21750.04Venky's (India) Limited18843.25Mahyco Monsanto16638.36Novo Nordisk13531.07Rasi Seeds8720.08Aventis Pharma8419.49Bharat Serums8118.610Chiron Behring Vaccines7817.911GlaxoSmithKline7817.912Indian Immunologicals7216.613Shantha Biotechnics7016.114Novozymes6915.915Eli Lilly and Company6815.716Wockhardt6715.417Bharat Immunological & Biological Corp.5312.318Bharat Biological International419.419Advanced Biochemicals409.120Biological E368.3USD 1 = Rs 43.5Source: BioSpectrum Top 20: A threshold crossed<br />Most companies in the biotech sector are extremely small, with only two firms breaking 100 million dollars in revenues. At last count there were 265 firms registered in India, over 75% of which were incorporated in the last five years.[2,47] The newness of the companies explains the industry’s high consolidation in both physical and financial terms. Almost 50% of all biotechs are in or around Bangalore, and the top ten companies capture 47% of the market. The top five companies were homegrown; Indian firms account for 62% of the biopharma sector and 52% of the industry as a whole.[4,46] The Association of Biotechnology-Led Enterprises (ABLE) is aiming to grow the industry to $5 billion in revenues generated by 1 million employees by 2009, and data from the Confederation of Indian Industry (CII) seem to suggest that it is possible.[7,47]<br />[edit] Comparison with the U.S.<br />The Indian biotech sector parallels that of the U.S. in many ways. Both are filled with small start-ups while the majority of the market is controlled by a few powerful companies. Both are dependent upon government grants and venture capitalists for funding because neither will be commercially viable for years. Pharmaceutical companies in both countries have recognized the potential effect that biotechnology could have on their pipelines and have responded by either investing in existing start-ups or venturing into the field themselves.[36] In both India and the U.S., as well as in much of the globe, biotech is seen as a hot field with a lot of growth potential.<br />[edit] Relationship with IT<br />Many analysts have observed that the hype around the biotech sector mirrors that of the IT sector. Biotech colleges have been popping up around the country eager to service the pools of students that want to take advantage of a growing industry.[7] The International Finance Commission, the private investment arm of the World Bank, called India the “centerpiece of IFC’s global biotech strategy.” Of the $110 million invested in 14 biotech projects investment globally, the IFC has given $43 million to 4 projects in India.[29] According to Dr. Manju Sharma, former director of the Department of Biotechnology, the biotech industry could become the “single largest sector for employment of skilled human resource in the years to come.”[5] British Prime Minister Tony Blair was similarly impressed, citing the success of India’s biotech industry as the reason for his own country’s own biotech opportunities.[22] Malaysia is also looking to India as an example for growing its own biotech industry.[41]<br />[edit] Government support<br />The Indian government has been very supportive. It established the Department of Biotechnology in 1986 under the Ministry of Science and Technology.[47] Since then, there have been a number of dispensations offered by both the central government and various states to encourage the growth of the industry. India’s science minister launched a program that provides tax incentives and grants for biotech start-ups and firms seeking to expand and establishes the Biotechnology Parks Society of India to support ten biotech parks by 2010. Previously limited to rodents, animal testing was expanded to include large animals as part of the minister’s initiative.[10] States have started to vie with one another for biotech business, and they are offering such goodies as exemption from VAT and other fees, financial assistance with patents and subsidies on everything ranging from investment to land to utilities[19].<br />[edit] Foreign investment<br />The government has also taken steps to encourage foreign investment in its biotech sector. An initiative passed earlier this year allowed 100% foreign direct investment without compulsory licensing from the government1.[6] In April, a delegation headed by the Kapil Sibal, the minister of science and technology and ocean development, visited five cities in the U.S. to encourage investment in India, with special emphasis on biotech.[32] Just two months later, Sibal returned to the U.S. to unveil India’s biotech growth strategy at the BIO2005 conference in Philadelphia.[9]<br />[edit] Challenges<br />The biotech sector faces some major challenges in its quest for growth. Chief among them is a lack of funding, particularly for firms that are just starting out. The most likely sources of funds are government grants and venture capital, which is a relatively young industry in India. Government grants are difficult to secure, and due to the expensive and uncertain nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet developed a commercially viable product.[26] As previously mentioned, India hopes to solve its funding problem by attracting overseas investors and partners. Before these potential saviors will invest significant sums in the industry, however, there needs to be better scientific and financial accountability. India is slowly working towards these goals, but it will be a while before they are up to the standards of Western investors.<br />India’s biotech firms share another problem with their pharmaceutical cousins: a lack of qualified employees. Biotech has the additional disadvantage of competing against IT for ambitious, science-minded students but not being able to guarantee the same compensation. An aspiring researcher in India needs 7–10 years of education covering a range of specialties in order to qualify to work in biotech. Even if a student does choose to go on the biotech path, the ineffectual curriculum at many universities makes it doubtful as to whether he will be qualified to work in the field once finished. One estimate shows that 10% of upper-echelon biotech recruits have come from foreign countries. While this is not a problem, per se, it drives up cost in a country whose competitive advantage is based on cheap, high-quality labor. Far from ending with scientists, there is also a shortage of people with a knowledge of biotechnology in related fields: doctors, lawyers, programmers, marketing personnel and others.[7,15,17]<br />While little has been done about the latter half of the employee crunch, the government has addressed the problem of educated but unqualified candidates in its Draft National Biotech Development Strategy. This plan included a proposal to create a National Task Force that would work with the biotech industry to revise the curriculum for undergraduate and graduate study in life sciences and biotechnology. The government’s strategy also stated intentions to increase the number of PhD Fellowships awarded by the Department of Biotechnology to 200 per year. These human resources will be further leveraged with a “Bio-Edu-Grid” that will knit together the resources of the academic and scientific industrial communities, much as they are in the U.S.[5]<br />[edit] Major players<br />[edit] Ranbaxy Laboratories<br />Ranbaxy is the leader in the Indian pharmaceutical market, taking in $1.174 billion in revenues for a net profit of $160 million in 2004. It was the first Indian pharmaceutical to have a proprietary drug (extended-release ciprofloxacin, marketed by Bayer) approved by the U.S. FDA, and the U.S. market accounts for 36% of its sales. 78% of Ranbaxy’s sales are from overseas markets; its offices in 44 countries manage manufacturing in 7 countries and distribution in over 100.<br />IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in the world and that it is the 15th fastest growing company. By 2012, Ranbaxy hopes to be one of the top 5 generics producers in the world, and it consolidated its position with the purchase of French firm RGP Aventis in 2003. Ranbaxy also has higher aspirations, however, “to build a proprietary prescription business in the advanced markets.” To this end, it keeps a dedicated research facility in Gurgaon staffed with over 1100 scientists. They currently have two molecules in Phase II trials and 3-5 in pre-clinical testing. It spent $75 million in R&D in 2004, a 43% increase over its 2003 expenditure.<br />Arun Puri is the chairman and CEO Brian Tempest is the only non-Indian on the senior management team.38,39<br />[edit] Dr. Reddy's Laboratories<br />Founded in 1984 with $160,000, Dr. Reddy’s was the first Asia-Pacific pharmaceutical outside of Japan and the sixth Indian company to be listed on the New York Stock Exchange. It earned $446 million in fiscal year 2005, deriving 66% of this income from the foreign market. In order to strengthen its global position, Dr. Reddy acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare. Anji Reddy is the chairman of Dr.Reddy's.<br />Although 58% of Dr. Reddy’s revenues come from generic drugs, the company was committed to WTO-compliance long before the 2005 bill took effect, and most of these products were already off patent. Dr. Reddy has long been a research-oriented firm, preceding many of its peers in setting up a New Drug Development Research (NDDR) in 1993 and out-licensing its first compound just four years later. Dr. Reddy’s has since outlicensed two more molecules and currently has three others in clinical trials.<br />Although Dr. Reddy’s is publicly-traded, the Reddy family (including founder/chairman K. Anji Reddy, son-in-law/CEO GV Prasad and son/COO Satish Reddy) holds a hefty 26% share in the company.11,44<br />[edit] Nicholas Piramal<br />The comapny led by Asish Mishra grossing $350 million per year, Nicholas Piramal started its existence with the 1988 acquisition of Nicholas Laboratories and grew through a series of mergers, acquisitions and alliances. The company has formed a name for itself in the field of custom manufacturing. It cites its 1700-person global sales force as another core strength; with its acquisition of Rhodia’s inhalation anaesthetics business, Nicholas Piramal gained a sales and marketing network spanning 90 countries34.<br />Nicholas Piramal is well-poised for the challenge of surviving in the aftermath of product patent protection. The company has respected intellectual property rights since its inception and refused to quot; support generic companies seeking first-to-file or early-to-market strategies.quot; Instead, it decided to make its own intellectual property and opened a research facility last November in Mumbai with hopes of launching its first drug in 2010 at a cost of $100,000.24,33<br />[edit] Cipla<br />Cipla is one of the lodest drug manufacturers in India. It is led by Dr. Yusuf K. Hamied, Chairman and Managing Director. Cipla burst into the international consciousness in 2000 with Triomune, an AIDS treatment costing between $300 and $800 per year that infringed upon patents held by several companies who were selling the cocktail for $12,000 per year. Long before this news, Cipla had been building a strong global presence, and it now distributes its 800-odd products in over 140 countries. Privately-held Cipla holds a prominent spot in its home country as well; it is the leader in domestic sales, having just unseated GlaxoSmithKline for the first time in 28 years. Revenue in 2004 totaled $552 million (using Rs 43.472 = $1) about 75% of which was derived in India. Cipla did not report having a research program.8,18<br />|Dr. Kiran Mazumdar-Shaw]] is the Chairman and Managing Director of BiocoIrish chemicals company seeking to break into the Indian market, Biocon is now the leading biotech in India, bringing in Rs 646.36 crore (almost $150 million) in revenue for fiscal year 2004. It initially made its money by producing enzymes, but Biocon recently decided to become a research-oriented company with the goal of bringing a proprietary new drug to market.<br />The company went public in March 2004, and quot; its shares were oversubscribed by 33 times on opening day.quot; Eight months later it launched Insugen, a bio-insulin that is its first branded product. Biocon also has two wholly-owned subsidiaries, Syngene and Clinigene, that perform custom research and clinical trials.3,14,31<br />===Serum Institute of India===[4] The Serum Institute of India can make the enviable claim that 2 out of every 3 children in the world are immunized with one of their vaccines. It is the world’s largest producer of measles and DTP vaccines, and its portfolio includes other vaccines, antisera, plasma products and anticancer compounds. The Serum Institute earned Rs 565 crore ($130 million) in revenue in fiscal year 2005, selling mainly to UN agencies and to the Indian government. The Serum Institute is part of the Poonawalla Group, whose holdings include a horse stud farm and manufacturers of industrial equipment and components. Dr. Cyrus Poonawalla is the Chairman of the company.1,4,40<br />[edit] Others<br />Other important domestic companies Lupin Ltd :Dr. Desh Bandhu Gupta, Chairman<br />Sun Pharmaceuticals :Dilip S. Sanghvi, Chairman and Managing Director<br />Torrent Pharmaceuticals :Sudir Mehta, Chairman<br />Wockhardt :Habil F. Khorakiwala, Chairman<br />Cadila Healthcare :Pankaj R. Patel, Chairman and Managing Director<br />Hetero Drugs :Dr. B. Partha Saradhi Reddy, Chairman and Managing Director Nectar Lifesciences[5] :Mr. Sanjiv Goyal, Chairman<br />Macleods Pharma[6] :Dr. Rajendra Agarwal, Managing Director<br />Intas Biopharmaceuticals :Dr. Urmish Chudgar, Managing Director<br />Bharat Serums[7] :Mr. Bharat V. Daftary, Chairman and Managing Director<br />Orchid Pharmaceuticals :Mr. R. Narayanan, Chairman<br />Panacea Biotec[8] :Mr. Soshil Kumar Jain, Chairman<br />AMN Pharmaceuticals[9] :Amndip, Chairman and Managing Director<br />Ajanta Pharma[10] :Yogesh Agrawal, Managing Director<br />Green Apple Lifesciences Limited[11] :Mitesh Mehta, Chairman<br />Reliance Life Sciences Pvt Ltd[12] : Mr. K.V. V. Subramaniam, President and CEO<br />[edit] See also<br />Medicine in China <br />Pharmaceutical industry in China <br />Pharmacology <br />Biotechnology <br />Pharmaceutical marketing <br />Pharmaceutical industry <br />National pharmaceuticals policy <br />Opium and Alkaloid Works <br />[edit] References<br />1 Serum Institute of India. 15 June 2005. Biospectrum. 1 August 2005 <http://www.biospectrumindia.com/content/BSTOP20/10506153.asp>.<br />2 quot; 50% of country's biotech firms based in Karnataka.quot; The Economic Times 23 April 2005.<br />3 Biopharmaceutical and Biotechnology Company. Biocon. 26 July 2005 <http://www.biocon.com/>.<br />4 “BioSpectrum 20: A Threshold Crossed.” BioSpectrum 3:6 (June 2005): 24-32.<br />5 “Biotech development strategy to boost domestic, foreign investments: CII.” The Hindustan Times 20 May 2005.<br />6 “Biotech sector to be single largest job churner: expert.” Global Newswire – Asia Africa Intelligence Wire 21 February 2005.<br />7 quot; BT has jobs but where are the takers?quot; Asia Africa Intelligence Wire 7 January 2005.<br />8 Cipla. Cipla. 28 July 2005 < http://www.cipla.com/>.<br />9 Cookson, Clive. quot; India to expand biotech sector.quot; The Financial Times (21 June 2005): 8.<br />10 Datta, P.T. Jyothi. “More global buys by pharma cos likely.” The Hindu Business Line (Internet Edition), 22 July 2005.<br />11 Dr. Reddy Laboratories Ltd. Dr. Reddy’s Laboratories Ltd. 27 July 2005 <http://www.drreddys.com/>.<br />12 D’Silva, Jeetha. “Pharma SMEs gasp for breath as big companies move to better climes.” The Economic Times 28 May 2005.<br />13 Dyer, Jeff and Khozem Merchant. “An experiment in globalization: how India hopes to reshape the world drugs industry.” Financial Times 18 August 2004: 15.<br />14 Egan, Mary Ellen. quot; Big Shot in Bangalore. (Kiran Mazumdar-Shaw ).quot; Forbes 174:8 (18 October 2004): 88.<br />15 Ghatak, Lopamudra. “Fat pay, yuppie lifestyle - join biotech, not IT.quot; Asia Africa Intelligence Wire 15 March 2005.<br />16 “Government to allow 100% FDI in Biotech (Biotech will be exempted from the requirement of compulsory licensing) ” India Business Insight - Global Newswire – Asia Africa Intelligence Wire 31 May 2005.<br />17 Hector, Darlington Jose. quot; NRIs, expats fuel biotech boom in India.quot; The Economic Times 20 April 2005.<br />18 Hoovers Company Records – In-Depth Records: Cipla. 26 July 2005. Lexis-Nexis Academic Universe. 28 July 2005.<br />19 quot; Incentives for bio-tech units.quot; Asia Africa Intelligence Wire 2 July 2005.<br />20 “India industry: Desperate for quality healthcare services.” Economist Intelligence Unit: Country ViewsWire. 24 June 2005.<br />21 Indiainfoonline.com. Indian Pharmaceutical Sector: Big Pharma Opportunity. By Atul Rastogi and Abhimanyu Verma. 28 August 2003.<br />22 “India’s biotech strides prompts UK to hike funds in sector.” Nationwide International News (The Press Trust of India) 7 March 2005.<br />23 “Intellectual property: protection and enforcement.” WTO: Understanding the WTO. World Trade Organization. 1 August 2005 <http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm><br />24 Jarvis, Lisa. quot; NPIL sets ambitious growth targets.quot; Chemical Market Reporter 267:16 (18 April 2005): 32-33.<br />25 Joshi, Hemant N. “Analysis of the Indian pharmaceutical industry: with emphasis on opportunities in 2005.” Pharmaceutical Technology 27:1 (2003): 74-84.<br />26 Kathuria, Vinish & Vandita Tewari. quot; Venture capitalists and biotech sector: Discovering the potential.quot; Asia Africa Intelligence Wire 29 December 2004.<br />27 Kripalani, Manjeet. quot; Pharma Karma; Tougher patent protection laws are spurring rapid growth in new drug research across India.quot; Business Week 39:29 (18 April 2005): 20.<br />28 Krishnan, Unni. “India enters a new era.” Manufacturing Chemist 76:2 (2005): 27-29.<br />29 Ludwina, Joseph. “IFC Committed to Support Indian Biotech Sector.” International Finance Corporation: Press Releases South Asia. 20 June 2005.<br />30 Malhotra, Prabodh & Lofgren, Hans. “India's pharmaceutical industry: hype or high tech take-off?” Australian Health Review 28:2 (2004): 182-193.<br />31 Mazumdar, Sudip. “First Lady; In Asia: India’s top biotech CEO begs to differ with those who say Singapore leads the field.” Newsweek International 11 October 2004: 39.<br />32 Na, K. Oanh. quot; India's sales pitch to Silicon Valley.quot; San Jose Mercury News 12 April 2005.<br />33 Nicholas Piramal India Limited. Nicholas Piramal India Limited. 26 July 2005. <http://www.nicholaspiramal.com>.<br />34 “NPIL buys Rhodia business for 7m [pounds sterling].” ACN: Asian Chemical News 11:475 (17 January 2005): 6.<br />35 Pharmaceutical and Drug Manufacturers Homepage. Pharmaceutical and Drug Manufacturers. 30 July 2005 <http://www.pharmaceutical-drug-manufacturers.com/>.<br />36 Prasad, Girish Chandra. quot; Outlook improves for India's biotechnology sector.quot; The Economic Times 31 December 2004.<br />37 “R and D spend of top 5 Indian pharmaceutical companies touches Rs1,000 crore.” Asia Africa Intelligence Wire 17 February 2005.<br />38 Ranbaxy – Indian Pharma Research & Pharmaceutical Company India. Ranbaxy Laboratories Ltd. 26 July 2005 <http://www.ranbaxy.com/>.<br />39 Ranbaxy Laboratories Ltd. Annual Report. Gurgaon, India: Ranbaxy Laboratories Ltd. (2004).<br />40 Serum Institute of India. Serum Institute of India. 29 July 2005 < http://www.seruminstitute.com>.<br />41 Singh, Karamjit. “Net value: Tapping biotech know-how.” The Edge Malaysia 16 May 2005.<br />42 Singh, Seema. “India kicks the habit; local drugmakers have built a thriving industry on pilfering patents. The party ends in January.” Newsweek International (22 November. 2004): 56.<br />43 Sridharan, R. et al. “Indian pharma’s mid-life crisis.” Business Today 27 February. 2005: 50.<br />44 Tanzer, Andrew. “Pill factory to the world.” Forbes (internet) 10 December 2001. 29 July 2005.<br />45 Unnikrishnan, C H. “Patents carve up drug market.” Business Standard 29 July 2005.<br />46 “Vaccines push BioPharma sales.” BioSpectrum 3:6 (June 2005): 70-71.<br />47 Wilkie, Dana. “India wants to be your biotech source.” The Scientist 25 October 2004: 51-53.<br />48 Zinnov, quot; Pharmaceutical Outsourcing in Indiaquot; <http://www.zinnov.com/presentation/Pharmaceutical_Outsourcing_Overview.pdf>.<br />[edit] Reference<br />^ quot; Pharma to topple IT as big paymasterquot; . The Economic Times. http://economictimes.indiatimes.com/News/News-By-Industry/Jobs/Pharma-engineering-to-topple-IT-as-big-paymaster/articleshow/6022202.cms?curpg=1. Retrieved 8 Jun 2010.  <br />^ quot; Indian biotech industry grew 17 percent in 2009-10: Surveyquot; . Economic Times. 21 June 2010. http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/biotech/Indian-biotech-industry-grew-17-percent-in-2009-10-Survey/articleshow/6075713.cms. Retrieved 21 Jun 2010.  <br />^ quot; Understanding the WTO - Intellectual property: protection and enforcementquot; . WTO. http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm. Retrieved 2010-07-27.  <br />^ quot; Serum Institute of India | Manufacturer of Vaccines & immuno-biologicals - GMP Vaccine Manufacturerquot; . Seruminstitute.com. http://www.seruminstitute.com. Retrieved 2010-07-27.  <br />^ quot; Nectar Lifesciences Ltd.: Nurturing. Enriching. Caringquot; . Neclife.com. http://www.neclife.com. Retrieved 2010-07-27.  <br />^ http://macleodspharma.com <br />^ quot; Bharat Serums and Vaccines - plasma, pharma and biotechnology productsquot; . Bharatserums.com. http://www.bharatserums.com/. Retrieved 2010-07-27.  <br />^ quot; India : Pharmaceuticals Business, pharmaceutical company india, pharma outsourcing india, pharmaceuticals brand, pharmaceuticals intellectual property, pharmaceutical formulations, vaccines, natural productsquot; . Panacea Biotec. http://www.panacea-biotec.com/. Retrieved 2010-07-27.  <br />^ amnpharmaceuticals.com. quot; Pharmaceutical Companies in Indiaquot; . Amnpharmaceuticals.com. http://www.amnpharmaceuticals.com. Retrieved 2010-07-27.  <br />^ quot; Welcome To Ajanta Pharmaquot; . Ajantapharma.com. http://ajantapharma.com. Retrieved 2010-07-27.  <br />^ quot; Welcome to Green Apple Lifesciences Limitedquot; . Greenapple.co.in. http://www.greenapple.co.in. Retrieved 2010-07-27.  <br />^ quot; Reliance Life Sciences :: Reliance Industries :: Reliance Groupquot; . Rellife.com. http://www.rellife.com. Retrieved 2010-07-27.  <br />Retrieved from quot; http://en.wikipedia.org/wiki/Pharmaceuticals_in_Indiaquot; <br />Categories: Biotechnology | Clinical research | Healthcare in India | Pharmaceuticals policy | Pharmacology | Pharmacy | Pharmaceutical companies of India | Pharmaceutical industry of India<br />Hidden categories: Wikipedia references cleanup from December 2010 | Articles that need to be wikified from July 2010 | All articles that need to be wikified | Articles needing cleanup from July 2010 | All pages needing cleanup | Articles containing potentially dated statements from 2010 | All articles containing potentially dated statements<br />Personal tools<br />Log in / create account <br />Namespaces<br />Article <br />Discussion <br />Variants<br />Views<br />Read <br />Edit <br />View history <br />Actions<br />Search<br />Top of Form<br />Bottom of Form<br />Navigation<br />Main page <br />Contents <br />Featured content <br />Current events <br />Random article <br />Donate to Wikipedia <br />Interaction<br />Help <br />About Wikipedia <br />Community portal <br />Recent changes <br />Contact Wikipedia <br />Toolbox<br />What links here <br />Related changes <br />Upload file <br />Special pages <br />Permanent link <br />Cite this page <br />Print/export<br />Create a book <br />Download as PDF <br />Printable version<br />Languages<br />Català <br />Deutsch <br />Français <br />This page was last modified on 21 March 2011 at 11:26.<br />Text is available under the Creative Commons Attribution-ShareAlike License; additional terms may apply. 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