Present era of drug safety in India: An overview

Authors: Patel R.*, Sachan A. K., Chaohan S., Tiwari A., Giri T., Nitish, Ansari A. S., Yadav R. K., Siddiqui E. M., Pandey S. K., Yadav B. S., Chaudhary N.


Common Adverse Drug Reactions (ADR), evaluated by drug clinical trial studies, whereas an individual or specific population might suffer reactions after prolonged dormancy. Pharmacovigilance (PV) is a scientific investigation dealing and keeping regular vigil on the drugs being used. The Indian Pharmacopoeia Commission (IPC) and other regulatory authorities like a National Coordination Committee (NCC) via the Central Drug Standard Control Organization (CDSCO) manage PV activity in synchronicity. Indian Pharmacovigilance (PV) system require carving, therefore the Pharmacovigilance Program of India (PvPI) was enforced by the government in the year 2010, relying on exact ADR detection, evaluation and reporting. Thus, several regional, zonal and peripheral centres are developed for ADR reporting. Clinicians, Nurses, layperson, pharmacist and other healthcare professionals can fill ADR reporting form online or offline at the nearest centres in suitable languages. Additionally, a toll-free number and mobile app could be used for reporting ADR. Every reported ADR gets collected and processed at the centres through Vigi-flow software, which detects and assess the signal strength reported at CDSCO and World Health Organisation (WHO) for the required regulatory action. The final decision of CDSCO-WHO is passed by a suitable media source for the advancement of society’s health.

Keywords: World Health Organization, CDSCO, Pharmacovigilance, Adverse drug reaction.

Article ID: 20212101