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Pharmacovigilance Program of India

history, evolution and current status

Thatte, Urmila M.; Chaudhari, Nayan L.; Gogtay, Nithya J.

doi: 10.1097/FAD.0000000000000036
Invited Review Article

Summary Unlike developed nations most of whom put into place systems of pharmacovigilance in the early 1960s following the thalidomide disaster, India's Pharmacovigilance Program formally began only in the mid-1980s. After several unsuccessful attempts, a robust program was put in place by the Central Drugs Standard Control Organization in 2010 called the Pharmacovigilance Program of India. Today, this is a stable system with the Indian regulator at the helm, a formal legislation in place to support the program and a National Coordinating Center located at the Indian Pharmacopoeia Commission. In the 8 years since its resurrection, the activities have expanded by leaps and bounds. There are 250 adverse reactions monitoring centers throughout the country and India contributes 1.7% of Individual Case Safety Reports to the Uppsala Monitoring Center's database. The WHO, recognizing India's concerted efforts in the area of pharmacovigilance, established its first WHO Collaborating Centre for Pharmacovigilance in Public Health Programs and Regulatory Services at the National Coordinating Center. The proposed expansion of the program in the coming years will further strengthen the cause of medicines safety in the country in line with the WHO's Third Global Patient Safety Challenge of Medication without Harm.

Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Mumbai, India

Correspondence to Urmila M. Thatte, Seth GS Medical College & KEM Hospital, Mumbai, India. E-mail:

Editor: Kim Peder Dalhoff, MD, DMSc, FEAPCCT, Professor of Clinical Pharmacology, Department of Clinical Pharmacology, Bispebjerg and Frederiksberg University Hospital, Frederiksberg, 2400 Copenhagen, Denmark. Associate Editor: Jon Trærup Andersen, MD, PhD. Editorial Board: Australia: Dr M Kennedy, Professor G M Shenfield; England: Dr J K Aronson, Dr A Hitchings; India: Professor N Gogtay; Ireland: Dr J Feely; Netherlands: Professor C J van Boxtel, B H Ch Stricker; Sweden: Dr S Hagg; Wales: Professor P A Routledge.

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