International Journal of Development in Social Sciences and Humanities

Indian Patent regime has undergone major changes with TRIPs Agreement of WTO. New product patent regime replaced the age-old process patent regime in India. This required certain policy changes as part of the legal framework. Indian Patents Act (1970) was amended three times in 1999, 2002 and 2005. There were debates on complying TRIPs agreement, both in favour of and against the provisions. While the major pharmaceuticals companies have argued that this compliance would stimulate transfer of technology, expand Research and Development and encourage foreign direct investment (FDI) in this sector, certain civil society groups argued against the compliance as it would bring ill effects such as inaccessibility of medicines, impact on prices and survival problems to small and marginal pharma units of domestic industry1. It was believed by the government that the entry of Multinational Companies would push FDI and provide employment opportunities to Indian Youth. In addition, the active engagement of multinationals in Research and Development would create a viable clinical trials (Field Trials) sector that augments inventions and improvements. There are also optimistic views that Research and Development sponsored by big giants would facilitate technology transfer. In view of the above perceptions, certain issues like, impact of TRIPs agreement on policy framework, prices, generic medicines, availability and accessibility of medicines, Research and Development, growth of clinical trials sector, emergence of big giants in the pharma industry and influences on small and medium scale pharma units are to be studied.