Data Exclusivity Explained: Is India Introducing a Data Exclusivity Regime?

Document Type

Research Article

Abstract

This article examines whether India is transitioning toward a pharmaceutical data exclusivity regime in light of recent regulatory and trade developments. Historically, India has resisted such measures under its existing framework, which allows generic manufacturers to rely on an originator’s clinical data after a four-year period, provided they conduct bioequivalence and bioavailability studies. However, a 2025 notice from the Central Drug Standard Control Organisation (CDSCO) and government rhetoric linking intellectual property (IP) reforms to foreign investment commitments under the Trade and Economic Partnership Agreement (TEPA) suggest a possible policy shift.

The article argues that while no statutory data exclusivity currently exists, the CDSCO’s proposal to mandate repetitive clinical trials for all applicants seeking “new drug” approval could establish a de facto form of exclusivity. Such a shift would raise significant ethical concerns regarding redundant human testing, increase manufacturing costs, and potentially delay the entry of affordable generic medicines. Ultimately, the analysis concludes that India is at a policy crossroads, attempting to navigate a “middle path” that balances pharmaceutical innovation and international investment goals with its long-standing commitment to public health and medicine access.

Publication Date

2026

Journal

NLUD Journal of Legal Studies

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