Pharmacovigilance Programme of India

Abstract

Pharmacovigilance is defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, principally long term and short term adverse effects of medicines. It is an important and integral part of clinical research. India is the world’s second most populated country with over one billion potential drug consumers. Although, India is participating in the UMC program, its contribution to the UMC database is very little. This problem is essentially due to the absence of a robust ADR monitoring system and also the lack of awareness of reporting concept among Indian HCP. The specific aims of Pharmacovigilance are to advance patient care and safety in relation to the use of medicines and all medical and paramedical interventions, contribute to the assessment of benefit, harm, effectiveness, and risk of medicines, promising their safe, rational, and more effective  use, promote indulgent, education, and clinical training in Pharmacovigilance and its effective communication to the public. Pharmacovigilance methods must also be capable to designate which patients are at risk of developing an ADR. A suitably working Pharmacovigilance system is important if medicines are to be used cautiously. It will be advantage for healthcare professionals, regulatory authorities, pharmaceutical companies and the consumers. It aids pharmaceutical companies to monitor their medicines for risk.

Keywords: Adverse drug reaction, India, Pharmacovigilance, Uppsala monitoring centre