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New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights
Amar Jesani1, Sandhya Srinivasan2
1Independent Consultant Researcher and Teacher in Bioethics and Public Health, 31, Swatantrya Sainik Nagar, Andheri West, Mumbai 400 058 INDIA.
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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