Rajeev Raghuvanshi
Drug Controller General of India Government of India
<p>Dr Rajeev Singh Raghuvanshi has completed his Bachelors and Masters from IIT-BHU (Formerly IT-BHU), Varanasi and PhD from National Institute of Immunology, New Delhi. His PhD work is in the area of Extended Release Formulation of Vaccines, a project conceptualized to help reduce the number of injections required to be given for complete immunization. He has also done ISB-Kellogg Global Advanced Management Program. After working for 7 yrs at National Institute of Immunology, New Delhi, Dr Rajeev moved to join the leading Indian multinational, Ranbaxy Laboratories Ltd., where he worked for development, registration and launch of NDDS, Generics and Branded Generics for various global markets. After having spent 12 years with Ranbaxy, he moved to another Indian Multinational, Dr Reddy’s Laboratories Ltd, Hyderabad. In his 11 years of stay with Dr Reddy’s Labs, first eight years was in development of 505b(2) NDA products for US market. In this role, he successfully led the CMC team to get 6 products approved in 1st review cycle by USFDA. During this tenure, he had the opportunity of multiple face to face interactions with USFDA, MHRA and agencies from South Korea, Sweden, Romania etc. Last three years at Dr Reddy’s has been in a different role of establishing an R & D Team for markets like India, China, Russia and other Emerging Markets in the space of Pharmaceutical Product Innovation / Differentiation, registration and launches. He is widely travelled throughout the world and has worked with team members and partners in countries like USA, UK, China, Russia, South Africa, Romania, Sweden, Canada, France, Australia and Japan. Dr Raghuvanshi’s expertise lies in dosage form design and development, mainly in the domain of pharmaceutical innovation. He has been involved in development of different kind of products like Oral Solids, Oral liquids, Topicals, Injections, Nasal Sprays, Auto-injectors, Sublingual, Mouth Dissolve, Extended Release and Delayed Release for global markets. More than 200 products developed by him and his teams are currently being sold in India, US Europe and Emerging Markets. Dr Raghuvanshi has 14 granted US patents along with more than 250 published PCTs and Indian Patents. He has more than 25 publications in peer reviewed journals and has co-authored 6 chapters in books. He has been visiting faculty at NIPER – Hyderabad and IIT-BHU and has taught students of NIPER-Mohali. He is a regular speaker at different International and National conferences on Pharmaceutical Innovation. For his contribution, Dr Reddy’s Labs has twice awarded him with “Dr Reddy’s Excellence Award”. Leadership development has been his passion and many of his team members mentored by him are holding leadership roles in Indian and global pharmaceutical companies. After a very successful career with corporate pharma, he decided to do something completely different which is socially more impactful. Of many possibilities, he chose to work with Govt. of India and joined Govt’s Ministry of Health and Family Welfare, as Secretary-cum-Scientific Director of Indian Pharmacopoeia Commission on 16 Feb’21. In a short stint of 2 yrs, he changed the face of IPC and bought multiple long lasting changes impacting quality standards for medicines being sold in India. Cultural shift to more open and receptive organization scaling up the Impurity Standards inventory, harmonization of quality specification with ICH and other global standards, increasing user base for IP and IPRS, PDG membership for IP, international recognitions and scaling up of Pharmacovigilane and Materiovigilance program of India are some of them. Govt of India has now been given him the responsibility of Drugs Controller General of India. He joined the new position of 23rd Feb 2023 and working towards changing the way Indian pharmaceutical regulation is looked in this country and beyond.</p>