Abstract

A system of pharmacovigilance is a field of pharmacological sciences that deals with the Adverse Events Reaction reporting produced by medical devices and or drugs. One of the possible public health problems is an adverse event, which needs ongoing recording, assessment, and surveillance. Drug regulations have improved and got stronger since the 1937 sulphanilamide tragedy and the1960 thalidomide disaster. As such response, a Pharmacovigilance System was developed, which is capable of receiving, diagnosing, evaluating, monitoring, and mitigating harmful effects of medical products.
The Central Drug Standard Control Organization-CDSCO regulates India's pharmacovigilance system, whereas the United States Food and Drug Administration-USFDA regulates the US pharmacovigilance system. In India, the pharmacovigilance programme monitors adverse drug responses. India has a Pharmacovigilance Program in place to track adverse drug reactions. The United States likewise has strict laws in place to strengthen Food & Drug Administration (FDA) pharmacovigilance requirements. (WHO) -World Health Organization established an International Monitoring System in collaboration with (UMC) Uppsala Monitoring Centre.

Key words: Adverse drug reactions, Uppsala monitoring centre (UMC), Pharmacovigilance programme of India, Med watch, National Coordination Centre