Judicial Navigation of Drug Name Regulation in India

Tiwari, Kuhu ; Bhattacharya, Niharika Sahoo

Abstract

Almost two decades back the Supreme Court of India while deciding the trademark disputes related to pharmaceutical products raised serious concerns towards the medicines sold under unregulated similar proprietary names. Thereby the judiciary issued directions to the drug regulatory authority for drug name regulation. However, since then in the absence of a definite regulatory structure, the judiciary has continued navigating the scope of India’s drug name regulation. In this context, the article reflects upon the judicial attempts for integrating drug-name regulations in the current regulatory structure, while critically analyzing the judiciary-backed recent amendments in the Drugs and Cosmetics Rule, 1945.

Keyword(s)

Drug Name Regulation; Pharmaceutical regulation; Trademarks; Drugs and Cosmetics Act; Drug Regulatory Authority; Central Drug Standard Control Organization

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