Vol , Issue Date of Publication: May 09, 2018
DOI: https://doi.org/10.20529/IJME.2019.020

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

Amar Jesani
Sandhya Srinivasan
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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©Indian Journal of Medical Ethics 2019: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0),
which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.

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