Pharmacovigilance in India – A Success Story

Although pharmacovigilance was recognized as an important activity by India as early as in 1986, the initial attempts of the country to set up a pharmacovigilance system did not succeed due to several reasons. The meticulously strategized Pharmacovigilance Programme of India (PvPI) was launched in July 2010 with a more realistic outlook than its predecessors and gradually began to show promise. Within the past 9 years, PvPI has grown to such an extent that the Indian Pharmacopoeia Commission (IPC, which is the National Coordinating Centre for PvPI) is in the process of becoming the first WHO Collaborating Centre for Safety of Medicines and Vaccines in the South-East Asia Region. The programme’s structure of a central processing unit at IPC’s headquarters in Ghaziabad (Uttar Pradesh) to which all peripheral ADR Monitoring Centres (AMCs) throughout the country would report simplified the whole ADR reporting life cycle. This strategic move supported by the intra-governmental cooperation, broad-based stakeholder engagement initiatives of professional bodies, and the diligent work of the entire PvPI team led to the success of the programme. The fact that India recorded exponential growth in the global pharmacovigilance industry function during the past 12 years deserves special mention as it lent some degree of peer pressure from the pharmacovigilance experts in the industry. This, in addition to the pharmacovigilance obligations for the industry that were introduced by the competent authorities in India, has further facilitated the overall development India has achieved in pharmacovigilance within quite a happening decade.

About the speaker
Dr J Vijay Venkatraman

Dr J Vijay Venkatraman is a Diabetologist, Drug Safety Physician and Entrepreneur, with almost 2 decades of experience. He holds a MBA degree in Services Management. He is the first Indian to have been conferred the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK.

Dr Vijay founded Oviya MedSafe, a global Pharmacovigilance consulting & Drug Safety services providing company incorporated in Coimbatore, India and London, UK, which has been fulfilling the compliance needs of the pharmaceutical industry since 2012.

Dr Vijay holds the honorary position ‘Regional Editor, India’ of Global Forum, the official magazine of the Drug Information Association (DIA). He has been the Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR) since the inception of the council in 2015. He is the Chairman of the Pharmacovigilance Standing Committee of the Indian Medical Association – Tamil Nadu State Branch, for the year 2018.

Dr Vijay is an invited speaker and chairperson in national and international conferences. He has numerous publications to his credit. He is a member of several professional associations and is actively involved in promoting pharmacovigilance awareness among all stakeholders of the discipline.

Dr Vijay is a recipient of many awards including the ‘Leadership Excellence Award’ and the ‘State Appreciation Award for Co-ordinating Academic Activities’ by the Indian Medical Association.

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