Impact of TRIPS on Indian Pharmaceutical Industry

432-441After India became a founder member of WTO and acceded to the TRIPS Agreement, the product patent regime was reintroduced in India after a gap of 35 years. The significance of the new IP regime on pharmaceutical industry in India, the amendment to the Patents Act, 1970, in fulfillment of the obligations to comply with TRIPS, related developments in other fields of IP as well as enforcement of new IP/Patent regime on the pharmaceutical industry are comprehensively discussed herein. The regulatory interfaces of patents in the Indian and international context are also briefly dealt with. The historical evolution of IP with specific reference to patent regime in India is dealt with. Significance of IP such as patents, trademarks, industrial designs, trade secret and data exclusivity are elaborated. The key elements of the TRIPS Agreement which led to the three consecutive amendments to the Patents Act, 1970 are highlighted. The significance of the patent amendments in 1999, 2002 and 2005 and their highlights as well as the need for such amendments in fulfillment of TRIPS obligations have been described herein. Finally, the impact of post-TRIPS scenario in Indian pharmaceutical industry with specific reference to the international operations and the regulatory interfaces has been analysed. The related fields like biodiversity and plant varieties are also touched with