Abstract

CONCEPT OF PHARMACOVIGILANCE

Shubhada S. Pawar, Sanjay K. Bais and Payal Vilas Bhosale*

Abstract

The World Health Organization (WHO) (WHO, 2002) and Pal, Duncombe, Falzon, and Olsson (2013) define pharmacovigilance (PV) as the science and activity concerned with the detection, evaluation, understanding and prevention of adverse events. effects or any other drug-related problems. Pharmacovigilance plays an important role in the health care system through the monitoring and interaction of drugs and their effects in the body. The definition of pharmacovigilance, the objectives used in pharmacovigilance, and the types and components of pharmacovigilance were all summarised in this article. Constitution and goals of India's Pharmacovigilance Program (PvPI). An explanation of each National Adverse Drug Monitoring Center's (AMC) role Due to the fact that the pharmaceuticals are used in a manner that is not authorised by regulatory bodies, the biggest issue with this practise is the lack of methods for monitoring adverse drug reactions. Protection of the public's health is therefore not assured. Pharmacovigilance supports the safe and appropriate use of medicines. Spontaneous reporting of adverse drug reactions (ADRs) is an important component of pharmacovigilance. However, there is a significant under-reporting of ADRs. Adverse drug reactions have become a major problem in developing countries. Understanding pharmacovigilance could serve as the foundation for actions meant to increase reporting rates and lower ADRs. In India, a legitimate system for tracking adverse medication reactions was launched in 1986 with the help of 12 regional centres. India joined the World Health Organization's (WHO) Programme for International Drug Watching in 1997. This programme is run by the Upsala Monitoring Center in Sweden. Six regional centres were initially established in Mumbai, New Delhi, Kolkata, Lucknow, and for domestic ADR viewing, go to Chandigarh and Pondicherry. The Indian Pharmacopoeia Commission, which serves as the country's national coordination centre for the pharmacovigilance programme, may prioritise promoting safe drug usage. 179 monitoring facilities for adverse drug reactions currently submit adverse occurrences to India's national coordination centre.

Keywords: Pharmacovigilance, Adverse drug reactions (ADR), PvPI, new drugs and clinical trials, Pharmacology, DCGI, and the Indian programme.