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Pharmacovigilance Process in India: An overview

Prashant N Amale, Deshpande SA, Nakhate YD and Arsod NA

Clinical trial study of drug generally detects common Adverse Drug Reaction (ADR) but, the reaction which occurs after long duration in a specific person or population remains undetected. Pharmacovigilance (PV) is a scientific activity which keeps constant watch on the drug throughout its life cycle. In India, Indian Pharmacopoeia Commission (IPC) and National Coordination Committee (NCC) through the Central Drug Standard Control Organization (CDSCO) cordially regulate the PV activity. To build a potential PV system in India, Pharmacovilance Program of India (PvPI) have been proposed and implemented by the Indian government in 2010. The accurate detection and reporting of ADR is a heart of this system. Hence various regional, zonal and peripheral centres have been proposed for the smooth and effective reporting of ADR. Anyone can report ADR by filling the suspect ADR reporting form available online or offline to the nearest centre in suitable language. Considering Indian geographical distribution, huge population and mobile network connectivity, a toll free number and the mobile app is also provided for timely and effective reporting of ADR. The reported ADRs are collected and processed at the centres in Vigi-flow software. These centres detect signal which are reported to CDSCO and World Health Organisation (WHO) for the further regulatory action. CDSCO-WHO communicates their decision through a suitable media for the betterment of public health.