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:

Dr. Dhvani Mehta {B.L.S. LL.B. (University of Mumbai); BCL, D.Phil (Oxon)} is a Senior Resident Fellow and Team Lead of the Vidhi Aid initiative, where she works on environmental and health regulation, medical ethics and the right to education. She has worked specifically on research projects on environmental clearances, the National Green Tribunal, organ transplant laws, end of life care, and pharmaceutical and medical device regulation. She has appeared in the Supreme Court of India in petitions filed by Vidhi on advance medical directives and discrimination against persons affected by leprosy. She has authored chapters on the implementation of environmental judgments and healthcare corruption in India. Dhvani read for a doctoral degree at the University of Oxford on a Rhodes Scholarship, where she was Chairperson of Oxford Pro Bono Publico and an editor of the Oxford Human Rights Hub blog. Her doctoral thesis explores the idea of an environmental rule of law in India and was cited by the Supreme Court of India.