Vol. 10 (2014)

The Data Exclusivity Debate In India: Time For A Rethink?

Prashant Reddy T.

Data exclusivity or regulatory marketing exclusivity is a concept that has been subject to much debate in the Indian context – with specific reference to the Indian pharmaceutical and agro-chemical industries. This debate has been carried on in the backdrop of obligations under the TRIPS as well as the Indo-EU Free Trade Agreement. In this paper, the author discusses the concept of data exclusivity in the light of the existing regulatory regime for pharmaceuticals and agro-chemicals in India. He also examines various Committee reports to glean the Indian stance on data exclusivity for agro-chemicals as well as pharmaceuticals and the contradictions therein. The paper proposes data exclusivity as an incentive for drug companies to conduct clinical trials, particularly local clinical trials in India rather than free-riding on foreign trials. Although such local clinical trials are in the interest of public health, they remain almost prohibitively expensive. Therefore, it is necessary that the conduct of such trials is incentivised. As the high threshold for patentability in India deters patents from being employed as such incentive, this paper nominates data exclusivity as a possible solution

Author

B.A. LLB, (Hons.)National Law School of India University (’08). Masters of Law (Law, Science & Technology) Stanford Law School (’13).