Overview of Indian pharmaceutical industry
Executive summary: The Indian pharmaceutical industry valued at $12 billion has portrayed tremendous progress with reference to infrastructure development, technology base creation and a wide range of production. The domestic market in India is estimated to be at US$ 12 billion by 2010. The pharmaceutical industry produces bulk drugs belonging to major therapy groups. India ranks 4th worldwide accounting for 8 per cent of the world's production (In terms of Volume) and 13 in terms of value. The industry has developed Good Manufacturing Practices (GMP) facilities for the production of different dosage forms. The pharma industry exports drugs and pharmaceuticals worth over $ 3.8 billion. It ranks 17th in terms of export value of bulk actives and dosage. Indian exports cover more than 200 countries including the highly regulated markets of USA, Europe, Japan and Australia. Certain bulk drugs &their formulations are subject to price control under DPCO. Presently, under DPCO, 1995 there are 74 bulk drugs and their formulations under price control covering approximately 40% of the total market. Research & Development is the key to the future of pharmaceutical industry. The R & D expenditure by the Indian pharmaceutical industry is around 1.9% of the industry’s turnover. However, now that India is entering into the Patent protection area, many companies are spending relatively more on R & D. Success factors of the Indian pharmaceutical industry can be enumerated as Low cost based, skilled labour force and good manufacturing facilities, Understanding of International regulatory framework & Research & development. The driving force that will change the character and shape of the pharmaceutical industry will be the impending Product Patent regime. At present, under the Indian Patents Act, 1970, there is no Product Patent protection for pharmaceuticals. There is only Process Patent protection.
6