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

Reports by Vidhi Aid ยท March 26, 2018
Author(s): Dhvani Mehta and Nivedita Saksena

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


About Dhvani Mehta:

Dhvani is a Senior Resident Fellow in Vidhi Aid. She has supervised research projects on the functioning of the National Green Tribunal, on grievance redressal mechanisms at public health establishments, and on the withdrawal of medical treatment from terminally-ill patients. She has assisted the Indian Council of Medical Research with regulatory reform on clinical trials and has provided legal research and drafting assistance to the Ranjit Roy Chaudhury Expert Committee constituted to suggest reforms to the Medical Council of India. Dhvani has a D.Phil in Law from Magdalen College, University of Oxford. Her doctorate explores the idea of an environmental rule of law in the Indian context and analyses the role of the legislature, executive and judiciary in strengthening or weakening it. Dhvani also has an M.Phil and BCL from Oxford and a B.L.S; LL.B from Government Law College, University of Mumbai.


About Nivedita Saksena: