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GROWTH OF PHARMACEUTICAL INDUSTRY IN INDIA

Other Topics - By: - Mr. M. GOVINDARAJAN - Dated:- 11-6-2016 - Introduction The pharmaceutical industry is developing, producing, and marketing drugs or pharmaceuticals. The Pharmaceutical companies are generally dealing in generic or brand medications and medical devices. The phrama products are subject to a variety of laws and regulations in all countries. Because of the multivarious compliance to be complied with as required by law and procedure the pharmaceutical industry has become a large .....

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inue to change and evolve over time. The following are the facts for the growth of Pharmaceuticals industry: Growth in healthcare financing products; Demand in the generics market; Rise in outsourcing activities; and Demand for emerging segments. Pharmaceutical Industry in India The Indian Pharmaceutical Industry has witnessed a robust growth over the past few years. In the year 1990 the turnover is approximately US $ 1 billion. In 2015 the turnover is approximately US$ 30 billion. In 2015 the e .....

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kets.. It has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of products. It has established its presence and determination to flourish in the changing environment. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing technologies. Formulations in various dosage forms are being produced in GMP compliant facilities. Strong scientific and technical manpower and pioneering work .....

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The export initiatives were taken during this period. 1990 - 2010 constituted the third stage. During this period the liberalization led Indian components to launch operations in foreign countries. The Patents Act was amended in the year 2005 which led to adoption to product patents in India. During this period India became a major generic drug manufacturing country. India s position in global India acquired 14th rank in Global Pharma industry during 2005 (6 US billion $). India is projected as .....

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(3rd position) globally during 2005 - 2015 in terms of technology, quality and the vast range of medicines that are manufactured. It ranges from, simple headache pills to sophisticated antibiotics and complex cardiac compounds. 20,000 units are registered in this industry. Being a highly organized sector, the Indian Pharmaceutical market is expected to expand at a CAGR of 23.9% to reach US $55 by 2020. Growth of Exports The export of pharma products by India is commendable one. The following tab .....

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s and their share in percentage are listed in the below table: Table - 3 : Value of Exports to top 10 countries of the world and its share Rank Country Value (US $) Share 1 United States $3.8 billion 32.9% 2 South Africa $461.1 million 3.9% 3 Russia $447.9 million 3.8% 4 United Kingdom $444.9 million 3.8% 5 Nigeria $385.4 million 3.3% 6 Kenya $233.9 million 2% 7 Tanzania $225.2 million 1.9% 8 Brazil $212.7 million 1.8% 9 Australia $182.1 million 1.6% 10 Germany $178.8 million 1.5% Source: www.en .....

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Pharmaceuticals Limited 28,587 Divis Laboratories 24,847 Torrent Pharmaceuticals 22,320 www.en.wikipedia.org Market segment by value Products and their market share in the pharmaceutical Industry in India is furnished in the following table: Table - 5 : Pharma products and their market share in India Product Market Share Anti-infectives 16% Cardiovascular 13% Gastro Intestinal 11% Vitamins, Minerals 8% Respiratory 9% Pain/analgesic 7% Anti-diabetic 7% Others 29% Source: A brief report on pharmac .....

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ollowing table: Table - 6 : Consolidated FDI policy for Pharma Industry Sector/Activity % of Equity/FDI Cap Entry route 6.2.19.1 - Greenfield 100% Automatic route 6.2.19.2. - Brownfield 100% Government Other conditions for FDI in respect of this industry indicated in the above said circular are as follows: Non compete clause would notbe allowed exceptin special circumstanceswith the approval of the ForeignInvestment Promotion Board; The prospective investor and the prospective investee are requi .....

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e Recipient Entity It is certified that the following is the complete list of all inter-se agreements, including the shareholders agreement, entered into between foreign investor(s) and investee Brownfield pharmaceutical entity 1. ……………… 2. ………………. 3. ………………. (copies of all agreements to be enclosed) It is also certified that none of the inter-se agreements, including the .....

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ent to the submission and consideration of the application. The Department of Industrial Policy and Promotion data suggests that the drugs and pharmaceuticals sector has attracted an impressive level of FDI worth US$ 1,882.76 million during April 2000 to March 2011. Industrial licenses are not required in India for most of the drugs and pharmaceutical products. Manufacturers are free to produce any drug duly approved by the Drug Control Authority. Table 7 : FDI INFLOW IN PHARMACEUTICAL INDUSTRY .....

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y in India is also having certain factors on strength and weakness. Strength In India the cost of manufacturing pharma products are less and effective comparing to other countries. India has a strong manufacturing base. Due to the technology development the high skilled work force is available in India. The marketing and distribution system is also on the higher side in India by communication development. The diverse ecosystem also strengthens the sector. Weakness Even though the FDI limit is li .....

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his industry is expected greatly because there is increased export potential. It is also expected that the export of generic drugs to the developed markets will be on the increase. There is immense scope to position India as a centre for international clinical trials. It is also expected that India will be a key player in global pharmaceutical R&D. Threats The product patent regime is one of the major threats to domestic Industry. To face this threat the industry is to take up R&D initia .....

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ugs 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 thus a legitimate competitor in the global industry. Local firms have slowly been investing more money into their R&D programs or ha .....

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an authorities have become more sensitized to the need and importance of IPR protection for the long-term good of industry. The (Indian) Patents Act was enacted in 1970. This act contains provisions relating to pharmaceutical patents. This patent regime has led to the investment from many pharmaceutical multinationals in India. Now they are looking at India not only for its traditional strengths in contract manufacturing but also as a highly attractive location for research and development (R&am .....

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nce 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 launched a program to provide tax incentives and grants for biotech start-ups and helping the firms which are seeking to expand. India establishes the Biotechnology Parks Society of India to support ten biotech parks. Previously limited to rodents, animal testing was expanded to include large animals as part of the initiative. State Governme .....

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vision of prices of pharmaceutical products (bulk drugs and formulations), enforcement of provisions of the Drugs (Prices Control) Order and monitoring the prices of controlled and decontrolled drugs in the country. The Addendum 2015 of the Indian Pharmacopoeia (IP) 2014, published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, is expected to play a significant role in enhancing the quality of medicines that would in turn promote public hea .....

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nture fund for research in the public and private domain; The Government is also embarking on a major multi-billion dollar initiative with 50 per cent public funding through a public-private partnership (PPP) model to harness India s innovation capability. This vision will put India into one of the top five pharmaceutical innovation hubs by 2020.This vision also targets to achieve a global niche with one out of every five to ten drugs discovered worldwide by 2020 originating from India. The Gove .....

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is specially targeted at drugs and pharmaceutical research. The Central Drug Standard Control Organization (CDSCO is made as the primary pharma regulatory body in India. The Drug Controller General of India (DCGI) presides over the CDSCO at both the central and state levels. The Government also plans to set up a Pharmacopeial Commission to support Ayurveda,Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) through guidelines laid down in the review of the Eleventh Plan; The Department .....

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ns worth ₹ 1,000 crore (US$ 150 million) in the pharmaceutical sector of Gujarat. Telangana has proposed to set up India's largest integrated pharmaceutical city spread over 11,000 acres near Hyderabad, complete with effluent treatment plants and a township for employees, in a bid to attract investment of ₹ 30,000 crore (US$ 4.5 billion) in phases. Hyderabad, which is known as the bulk drug capital of India, accounts for nearly a fifth of India's exports of drugs, which stood .....

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and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programmes, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies. Future perspective The pharmaceutical industry will have a future in India as well as globally. The future perspective of this industry is based on the high burden of disease, good increase in the higher disposable incomes of the individuals, improvements in healthcare infrastructure and im .....

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