Present era of drug safety in India: An overview

Abstract

Introduction: 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 with and keeping regular vigil on the drugs being used. Methods: 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 requires 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. Results: Thus, several regional, zonal and peripheral centers are developed for ADR reporting. Clinicians, Nurses, laypersons, pharmacists, and other healthcare professionals can fill ADR reporting forms online or offline at the nearest centers 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 centers through Vigi-flow software, which detects and assesses the signal strength reported at CDSCO and World Health Organisation (WHO) for the required regulatory action. Conclusions: The final decision of CDSCO-WHO is passed by a suitable media source for the advancement of society's health.