Vaccine pharmacovigilance in India: systematic approaches and lessons from mass immunization programs

Vaccination remains a cornerstone of public health, yet monitoring vaccine safety is essential to
sustain confidence and guide policy. India’s large birth cohort, complex health system, and recurrent mass immunization campaigns necessitate a robust vaccine pharmacovigilance framework. This review systematically evaluates India’s vaccine safety surveillance landscape, including institutional mechanisms, surveillance models, causality assessment, and operational lessons from major immunization initiatives, to propose strategic priorities for 2025–2030.