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Abstract

CURRENT SCENARIO OF PHARMACOVIGILANCE IN INDIA AND ITS COMPARISION WITH U. S. A. AND E. U.

T. Sai Kishore*, Vallepu Aswani, S. Sri Lakshmi Nikhitha, Brahmaiah Bonthagarala, Y. Ratna Sindhu, G. Ramakrishna and M. V. Nagabhushanam

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Abstract

Pharmacovigilance (PV) is an integral part of the drug regulation system. PV plays an indispensable role in the identification, assessment, and publicizing of adverse drug reactions (ADRs) through various methods. ADRs account for serious harm to the patients and even lead to morbidity and mortality. The PV databases help in the promotion of safe drug use and protection of public health safety. This article compares the PV system in the USA, Europe, and India, highlighting the challenges and future perspectives to be adapted to widen the horizon of the existing PV structure in India. In India, PV programs are still at the dawning stage when paralleled to the other countries. The National Pharmacovigilance Program and the Pharmacovigilance Program of India are the most recent advancements in this field in the country. The USA and Europe have well-established PV systems in place thanks to technological progress and other resources. India is the largest producer of pharmaceuticals in the world and a major clinical research hub; hence, it requires a more stringent PV setup. With the increase in population and novel drugs in the market each day, there is a need for an effective PV system in India.

Keywords: Pharmacovigilance systems, Legislation, European Union, United States of America, Adverse Drug Reaction; European Medicines Agency (EMA), USFDA, Marketing Authorization Holder (MAH).


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