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

 

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.

Download the complete submissions on the draft New Drugs and Clinical Trials Rules, 2018