A REVIEW ON PHARMACOVIGILANCE; PAST, PRESENT AND FUTURE PROSPECTIVE IN INDIA

Dr. Pooja Agrawal, *Dr. Virendra Kushwaha and Dr. Mangeshkumar Tripathi

ABSTRACT

The main responsibility of any drug regulatory authority is to ensure the quality, efficacy, and safety of all marketed products. The first two criteria can be established through data obtained from in vitro testing to ensure compliance with acceptable standards and data obtained from animal studies, preclinical and clinical trials involving humans. It is a well-established fact that pre-marketing clinical trials do not have the statistical power to detect rare adverse drug reactions (ADRs) nor do they have significant follow-up to identify delayed ADRs or effects from long-term exposure. In view of this, Pharmacovigilance plays a prominent role in establishing the safety profile of marketed drugs. Originally a modest appendix of drug regulation; it has become a major activity now.

Keywords: Pharmacovigilance, adverse drug reaction, post-marketing surveillance, regulatory authorities.