A Review on the Evolution and Implementation Challenges of Pharmacovigilance in India

Review Article

Abstract

The escalation of pharmaceutical use and the emergence of India as a global leader in drug manufacturing and clinical research necessitate a robust pharmacovigilance (PV) system. This review discusses the trajectory of drug safety monitoring in India, from its nascent, fragmented beginnings to the establishment of the formal Pharmacovigilance Programme of India (PVPI). It analyzes the current operational structure coordinated by the Indian Pharmacopoeia Commission (IPC), which aims to collate and evaluate Adverse Drug Reaction (ADR) data from across the nation. Despite significant structural progress, the system's efficacy is impeded by critical challenges. Foremost among these is a pervasive culture of under-reporting by healthcare professionals, compounded by gaps in medical and pharmacy education where PV is often not integrated as a core clinical responsibility. Infrastructural deficits, particularly in rural healthcare settings, and a lack of standardized implementation across states further fragment the national data landscape. Patient reporting, a valuable data source in many Western nations, remains minimal. This analysis indicates the urgent need for a multi-pronged strategy focused on regulatory enforcement, educational reform, and the integration of clinical pharmacists into safety-monitoring protocols. Strengthening this system is a public health imperative to protect the population and ensure the benefits of therapeutic agents outweigh their risks