Comments on The Draft Drugs And Cosmetics (Amendment) Bill, 2015

Reports by Vidhi Aid ยท December 31, 2014
Author(s): Dhvani Mehta

The draft Drugs and Cosmetics (Amendment) Bill, 2015, which amends the Drugs and Cosmetics Act, 1940 seeks to bring about some positive changes to the law in this area. It introduces the regulation of medical devices, reconstitutes the Drugs Technical Advisory Board and attempts to reform the law on clinical trials.

It is this last aspect that these submissions are concerned with. The main thrust of these submissions is that the Bill does not go far enough in giving the regulatory framework on clinical trials the complete overhaul that it needs.

Download full report Comments on The Draft Drugs And Cosmetics (Amendment) Bill, 2015

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.