The Recent Trends and Development of Pharmacovigilance in India

Abstract

Introduction: Pharmacovigilance (PV) is essential for monitoring, detecting, and preventing adverse drug reactions (ADRs) to ensure drug safety. In India, PV has progressed from a fragmented system in the late 1980s to the structured Pharmacovigilance Programme of India (PvPI) under the Indian Pharmacopoeia Commission (IPC). This review evaluates the evolution, current status, and challenges of PV in India, focusing on ADR reporting, regulatory frameworks, and technological integration. Methods: We reviewed published literature, regulatory documents, and PvPI reports to assess ADR reporting trends, stakeholder roles, and emerging technologies in Indian PV. Key areas analyzed included healthcare professional participation, public involvement, and implementation of artificial intelligence (AI), natural language processing (NLP), and Bayesian signal detection methods. The impact of pharmacogenomics and multimodal ADR detection was also examined. Results: India currently contributes approximately 3% of global ADR reports to VigiBase, showing improved reporting over time. Despite growth, under-reporting persists due to limited awareness, inadequate training, and weak integration of PV into healthcare curricula. Pharmacists play a pivotal role in strengthening ADR reporting, though public participation remains low. AI, NLP, and Bayesian methods have improved signal detection efficiency. The COVID-19 pandemic highlighted the need for robust PV systems to monitor repurposed and investigational drugs. Regional disparities and limited digital infrastructure continue to hinder progress. Conclusion: India has made significant strides in pharmacovigilance, yet challenges in awareness, education, and digital integration remain. Strengthening regulatory policies, expanding PV education, and adopting advanced technologies are critical to enhance drug safety monitoring and promote rational medicine use across the country.