An Integrated Review of Pharmacovigilance, Materiovigilance, and Hemovigilance Programs in India: Evolution, Implementation, and Impact on Patient Safety

The drug development process is complex, with a central focus on ensuring quality, safety, and efficacy. Despite rigorous clinical trials, adverse drug reactions (ADRs) often become apparent only after widespread clinical use, making post-marketing surveillance and pharmacovigilance essential components of patient safety. The prevalence of ADRs is amplified by factors such as polypharmacy and age-related physiological changes, contributing significantly to hospitalizations and healthcare expenditures. Although ADR reporting practices in India have recently been revised, reporting rates remain lower than those observed in high-income countries. This review provides a comprehensive overview of the evolution, structure, and current practices of pharmacovigilance in India, with particular emphasis on the roles of the Pharmacovigilance Programme of India (PvPI), as well as emerging initiatives such as materiovigilance and hemovigilance. The paper highlights the importance of robust ADR monitoring systems, regulatory frameworks, and public awareness in enhancing patient safety and improving therapeutic outcomes.