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New regulations on compensation for injury and death in drug trials

Amar Jesani

DOI: 10.20529/IJME.2013.026


In 2005, the government amended Schedule Y of the Drugs and Cosmetics Act, 1940, and Rules, 1945, to liberalise the conduct of global drug trials in India. Proponents of this policy had asserted that we needed less, and not more, regulation, in order to expand the business of drug trials. Many from the medical profession, the bioethics community and civil society groups have been critical of this policy.

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