International Journal of Research in Social Sciences
Year : 2016, Volume : 6, Issue : 11
First page : ( 28) Last page : ( 45)
Online ISSN : 2249-2496.

'Data Exclusivity’ and IPR Policy: Indian Context

Prof Sople Vinod

Prof Vinod Sople, Director, ITM-SIA Business School, Mumbna

Online published on 24 April, 2018.

Abstract

Data Exclusivity is about the test data that indicates safety and efficacy of a drug, which is required by regulatory authority for marketing approval. The data exclusivity matter is controversial and each side has their own valid points. However, we cannot ignore the major issue of the accessibility and affordability of the life saving drugs to millions of people in developing countries. The benefits of the new drugs are known to public only after trial data is generated which indicates drug's safety, quality and efficacy to the satisfaction of regulatory authorities. The process of generating test data is time consuming and costly. For example clinical trial process to test the efficacy, quality and safety of a new anti-cancer drug may take 6–7 years or in some cases exceed 10–12 years. Hence, protection of test data is key to company decisions on the locations of clinical trials. Patent protection and data exclusivity are two separate issues and to be viewed with separate perspectives of promoting innovation and accessibility to affordable generic drugs by common people.

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Keywords

Clinical Trials, Generic Drug, Evergreening, Efficacy, .

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