Talk on "Impact of regulatory structure on quality of medicines in India"
By Dinesh Thakur, Sciformix Corporation
Date and time:
Tuesday, 19 April, 2016 04:30 PM - 06:00 PM
Ground floor conference hall, R&T building, NIPFP, near JNU East gate.
Quality of medicines dispensed in the Indian market has been an area of concern for quite some time now. Prosecution of Ranbaxy Laboratories, once India's largest pharmaceutical company in the US brought issues of data integrity and product quality to light. Since that time, foreign regulators like the US FDA and the EMA have increased their focus on Indian manufacturers to make sure that the medicines made in India and sold in those markets are of high quality. Unfortunately, precious little has changed in India.
One of the key challenges to creating public awareness about this issue is the lack of think-tanks and research organizations which focus on this issue. This talk outlines the efforts undertaken to approach the Supreme Court challenging the constitutionality of the legal framework that forms the basis of drug regulation with an intent to develop a better understanding among policy analysts.
Details on NIPFP site.