Comments on the draft New Drugs and Clinical Trials Rules, 2018

Submissions to the Ministry of Health and Family Welfare

Summary: Vidhi recommends changes to better protect the rights and safety of clinical trial volunteers, facilitate harmonisation with international standards where needed, ensure integrity of the drug regulatory process and improve enforcement.

Vidhi responded to a call for public comments on the Draft New Drugs and Clinical Trials Rules, 2018. We have recommended changes to these Rules to better protect the rights and safety of clinical trial volunteers, ensure harmonisation with international standards where needed, ensure the integrity of the drug regulatory process and improve enforcement.

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