Workshop on Drug Regulatory Reform – 1st May, 2015
Ali Mehdi
Wednesday, 9th March 2016
KG Marg, New Delhi 110003

During the course of the ongoing research under the Drug Regulatory project, ICRIER organized a workshop on May 1, 2015, to discuss the first drafts of the two papers under the project viz. Administrative Structure and Functions of Drug Regulatory Authorities in India, and Drug Quality and Safety Issues in India. These drafts were prepared following 9 months of extensive desk and field research mapping responses of over 100 stakeholders across India and select international jurisdictions. The aim of the workshop was to solicit feedback on the papers from a select and limited group of experts to help the research teams enhance the academic content of the papers as well as develop preliminary policy recommendations.
The inaugural address of the workshop was delivered by Dr Shailendra Kumar , Director( Drugs), Ministry of Health and Family Welfare( Govt. of India) and was followed by the keynote address by Dr Kathleen Holloway , Regional Advisor – Essential Drugs and Other Medicines, WHO India – South-East Asia Regional Office (SEARO). The workshop was attended by several distinguished experts from across stakeholder categories including, Dr, Aditya Bhattacharjea, Professor and Head of Department of Economics, Delhi School of Economics; Dr Madhur Gupta, Technical Officer (Pharmaceuticals), WHO India Country Office; Dr. Hemant Koshia, Commissioner, FDCA, Gujarat; Mr. D.G. Shah, Secretary General, Indian Pharmaceutical Alliance; Dr.Dinesh Abrol, Chief Scientist, CSIR-NISTADS; Dr. Santanu K. Tripathi, Investigator & Coordinator, ADR Monitoring Centre, Pharmacovigilance Programme of India; Ms. Susan Winckler, Managing Partner, Leavitt Partners; Mr. Richard Kingham, Partner, Covington and Burling LLP; among others.
The findings from each of the papers under study were presented during the workshop and was followed by two discussion rounds focused on one paper each. During the discussion, the workshop participants provided their valuable comments and suggestions to the research teams, which proved to be immensely useful for further refining of the analysis and preparation of the final drafts of the papers.