PHARMACOVIGILANCE: AN INEVITABLE PATH TOWARDS DRUG SAFETY IN INDIA

Abstract

Thalidomide disaster is one of the overturn jolt in the field of allopathic medicine that attracted the attention of practitioner all over the world towards adverse effects of drugs, then only the actual concept of monitoring of adverse drug reactions came into limelight. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Pharmacovigilance not only allopathic drugs; but also include herbals, traditional medicines, blood products (Haemovigilance), biological (biovigilance), medical devices (materiovigilance) & vaccines. United Kingdom firstly introduced the yellow card for adverse drug reaction reporting. In India pharmacovigilance came into existence in 2010. Indian pharmacopoeia commission (IPC) is the national coordinating centre for pharmacovigilance program of India, responsible for collection, assessment of reported ADRs from the various adverse drug reaction monitoring centers & pharmaceutical companies, also consulting central drug standard control organization (CDSCO) in generation of signal. IPC is also collaborating with World health organization (WHO) drug safety program. Main source of data collection of ADRs is spontaneous reporting method & mainly from healthcare professionals. For drugs, IPC-suspected ADRs reporting form for healthcare Professionals is used for reporting ADRs by doctors. IPC- has currently availed the ADRs reporting form for patient in english & local languages. National institute of biologicals - has availed the form for Haemovigilance. Pharmacovigilance target towards signal detection, creating warning, restricting drug use, sometimes withdrawal of drug from market & finally decreasing mortality & risk of ADRs in patients.