As a part of ICRIER’s Health Policy Initiative, an inaugural roundtable discussion was conducted on importance of strong drug regulatory systems in India on November 3, 2015 in New Delhi. It was attended by distinguished experts from the academia,industry representatives, patient groups and policymakers. The discussions deliberated on the following two themes- 1) Clinical trials and new drug approvals and 2) Harmonization of certification standards. The panelists emphasized on the ways and means through which drug regulatory agencies can achieve safety, quality and efficacy in their regulatory framework. Also, much emphasis was led on the need for strong compliance and harmonization of global good practices which can be made India centric. Further, India’s scope to support clinical trials was discussed and the need to prioritize safety in conducting clinical trials was underlined.
The inaugural address at event was delivered by Dr S Eswara Reddy, Joint Drugs Controller (India), CDSCO, Government of India. Also, a special address was delivered by Mr Kenneth C Frazier, Chairman and CEO, Merck. The distinguished panelists included Dr Hemant Koshia, Commissioner, Food and Drugs Control Administration, Gujarat; Dr Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon; Dr Ratna Devi, CEO, Dakshama Health & Indian Alliance of Patient Groups; Dr Samir Brahmachari, Chief Mentor, Open Source Drug Discovery, & Scientist and Founder Director, CSIR-IGIB; Dr Y K Gupta, Professor &Head, Department of Pharmacology, AIIMS.