ADVERSE DRUG REACTIONS AND THE LIABILITY OF PHARMACEUTICAL COMPANIES IN NIGERIA

Adverse Drug Reactions (ADRs) pose a significant public health challenge in Nigeria, contributing to increased morbidity, mortality, and weakened trust in the pharmaceutical and health care systems. Despite the crucial role of pharmaco-vigilance in identifying, assessing, and preventing drug-related harm, ADR reporting in Nigeria remains profoundly inadequate due to low awareness, insufficient training of health professionals, weak regulatory enforcement, systemic corruption, and poor reporting infrastructure. Pharmaceutical companies are legally obligated to ensure drug safety; however, gaps in Nigeria’s legal and regulatory frameworks hinder effective accountability when ADRs occur. Although the National Agency for Food and Drug Administration and Control (NAFDAC) and the Federal Competition and Consumer Protection Act (FCCPA) provide statutory safeguards for drug regulation and consumer protection, enforcement challenges persist, enabling substandard, adulterated, or counterfeit drugs to penetrate the market. This research examines the liability of pharmaceutical companies under Nigerian law in relation to ADRs, focusing on the statutory, institutional, and legal mechanisms designed to protect consumers. It explores negligence, product liability, and strict liability principles, highlighting obstacles that prevent victims from seeking legal redress. The study further evaluates the pharmaco-vigilance system in Nigeria, assessing barriers such as inadequate funding, lack of skilled manpower, limited public awareness, and poor inter-agency collaboration. Through doctrinal analysis of legislation, case law, and scholarly sources, the research identifies critical deficiencies in drug safety oversight and calls for reforms to strengthen pharmaco- vigilance, enhance legal accountability, and improve patient protection. The findings underscore the need for a more effective regulatory framework to ensure drug safety, foster transparency, and uphold the rights of consumers within Nigeria’s pharmaceutical sector.