The Data Exclusivity Debate in India: Time for a Rethink?

Posted: 11 Mar 2013

Date Written: March 9, 2013


For the last few years, India has been witness to several debates on the suitability of a data exclusivity regime for the country, initially in the context of TRIPs and later in the context of the proposed Indo-E.U FTA. The Indian stand on ‘data exclusivity’, be it the reports of Government of India or Parliamentary Standing Committees, has been marked by several contradictions. For example, why is it that the Indian government is denying a data exclusivity regime for pharmaceuticals on the grounds that it would be ‘TRIPs plus’ but pushing ahead with a data exclusivity regime for agro-chemicals? This paper seeks to unwrap some of these contradictions and make a case for introducing a data exclusivity regime even for the pharmaceutical industry in India, provided that it is accompanied with a requirement for mandatory local clinical trials on a varied group of Indians. The latter portion of the paper discusses the possibility of using data exclusivity as an incentive for those areas of pharmaceutical innovation which are not served by patent law.

Keywords: data exclusivity, Satwant Reddy Committee, regulatory data protection, pharmaceutical innovation, local clinical trials

Suggested Citation

Reddy, Prashant, The Data Exclusivity Debate in India: Time for a Rethink? (March 9, 2013). Available at SSRN: or

Prashant Reddy (Contact Author)

Independent ( email )

No Address Available

Register to save articles to
your library


Paper statistics

Abstract Views
PlumX Metrics