A Scoping Review of the Pharmacovigilance System in India Region

Abstract

Background: Pharmacovigilance (PV) encompasses the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs). India, as the world's pharmacy supplying approximately 20% of global generic medicines by volume, holds a uniquely critical position in global drug safety. The Pharmacovigilance Programme of India (PvPI), established in 2010, has expanded substantially; however, significant gaps in reporting culture, infrastructure, and regulatory enforcement persist, with per-capita ADR reporting rates remaining far below international benchmarks. Objective: This scoping review systematically maps the existing literature on the pharmacovigilance system in India, examining its structure, challenges, reporting trends, and future directions across 2004- 2024, providing actionable synthesis for researchers, clinicians, and policymakers. Methods: A comprehensive literature search was conducted across PubMed, Scopus, EMBASE, Google Scholar, and Indian databases (IndMED, MedIND) following PRISMA-ScR guidelines. A total of 87 studies met final inclusion criteria, spanning observational studies, regulatory analyses, intervention evaluations, and qualitative inquiries. Results: Key findings include pervasive underreporting (<10% of clinical ADRs captured), limited healthcare professional awareness, inadequate digitization, regulatory enforcement gaps, and profound geographic disparities. The PvPI has expanded to 265+ ADR Monitoring Centers (AMCs) nationally, with annual reports growing from 450 in 2011 to over 131,000 by 2023. Conclusion: Despite notable institutional progress, India's pharmacovigilance system requires substantial strengthening through education, technology integration, and policy reform. Collaborative efforts among healthcare professionals,regulators, industry, academia, and patients are essential to transform pharmacovigilance into a genuine public health sentinel.