Regulatory Framework and Challenges

The Indian pharmaceutical sector a key sciencebased industry has come a long way, from nominal and costly presence before 1970 to a prominent provider of pharmaceutical products, meeting more than 90 percent of the country’s pharmaceutical needs. Thanks to the thoughtful patent policy adopted by the government in 1970, among other things. Indian pharmaceutical industry is one of the high performing knowledge based segments of the manufacturing sector. The pharmaceutical industry is a part of the larger chemicals industry. The ‘organised’ sector of India’s pharmaceutical industry consists of about 300 companies, which account for 70 percent of products on the market, with the top 10 firms representing 30 percent.1 However, the total sector is estimated at nearly 20,000 businesses, some of which are extremely small. There are about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including five Central Public Sector Units).2 Pharmaceutical companies in India manufacture bulk drugs in several therapeutic categories and the industry has amenities to manufacture various types of dosages namely capsule, tablets, injectables, orals, and liquids. Of the 400 bulk drugs in the Indian market, it is estimated that 300 are domestically produced. Moreover, India is emerging as the most favoured destinations for collaborative Research & Development (R&D) bioinformatics, contract research and manufacturing and clinical research as a result of growing compliance with internationally harmonised standards such as Good Laboratory Practices (GLP), current GMP (cGMP) and Good Clinical Practices (GCP). India today has the distinction of producing high quality generic medicines that are sold around the world. Further, India is poised to be one of the fastest growing pharmaceutical markets in the world. Consequently, there are several trade associations in the industry representing different groups of producers, the Organisation of Pharmaceutical Producers of India (OPPI) representing big Indian pharma with high R&D base, Indian Pharmaceutical Association (IPA) a professional association of pharmacists in India. Indian Pharmaceutical Alliance (IPA); Confederation of Indian Pharma Industry (CIPA) – the apex body of small scale manufacturers of drugs and pharma in India; Bulk Drug Manufacturers Association (BDMA); and Indian Drug Manufacturing Association (IDMA). After signing the WTO accord, India became obliged by the World Trade Organisation’s Agreement on Trade Related Aspects of Intellectual Property Rights (WTO-TRIPs) and hence incorporated provisions to provide product patents since January 01, 2005 after making amendments in its Patents Act of 1970. 1/2013