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New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights

Amar Jesani, Sandhya Srinivasan

DOI: 10.20529/IJME.2019.020


Abstract

The enactment of the New Drugs and Clinical Trials Rules, 2019 (hereafter New Rules), on March 19 by the Ministry of Health and Family Welfare (MoHFW), Government of India (1), is the use of power delegated to the political executive by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940. Has this power been used wisely? Whose interests do these rules represent?

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