Pharmacovigilance in Contrast: A Comparative Analysis of ADR Reporting in India and Sub-Saharan Africa

Abstract

Adverse Drug Reactions (ADRs) represent a persistent global health concern, demanding robust pharmacovigilance systems to ensure drug safety and patient protection. This comparative study evaluates ADR reporting frameworks in India, Morocco, Liberia, and Tanzania, highlighting their operational differences, strengths, and key challenges.

India's well-established Pharmacovigilance Programme (PvPI) employs both digital and manual mechanisms, yet suffers from significant underreporting driven by limited awareness and reluctance among healthcare professionals. In contrast, Morocco’s Directorate of Medicines and Pharmacy oversees a largely manual system that remains in its developmental phase, affecting data efficiency. Liberia’s system, coordinated by the Liberia Medicines and Health Products Regulatory Authority (LMHRA), is nascent and constrained by resource scarcity, inadequate training, and minimal public involvement. Tanzania’s system, under the Tanzania Medicines and Medical Devices Authority (TMDA), incorporates digital tools more effectively and demonstrates notable progress; however, underreporting and limited rural healthcare engagement continue to hinder its performance.

A cross-country analysis reveals shared challenges, including low awareness, minimal patient engagement, lack of healthcare worker incentives, and inconsistent adoption of electronic platforms. The study recommends enhancing pharmacovigilance through targeted training, improved digital infrastructure, and integration with international networks such as the WHO Programme for International Drug Monitoring.