Substandard and Falsified Medicines in West and Central Africa: A Systematic Review of Prevalence, Detection Methods, and Regulatory Gaps

Abstract

Introduction: Substandard, falsified, unlicensed, and unregistered medicines pose a significant threat to public health, particularly in West and Central Africa, where weak regulatory frameworks and informal pharmaceutical markets facilitate their widespread distribution. This systematic review assesses the prevalence, dosage forms, analytical techniques, and regulatory challenges associated with poor-quality medicines in the West and Central African sub-region. Methods: A systematic review was conducted in accordance with the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). A Medline, Embase, and PubMed search identified 467 articles published between January 2015 and December 2024. After abstract and title screening and full-text assessment, 17 studies met the inclusion criteria. Studies were evaluated based on methodological quality, sampling techniques, and analytical approaches. Results: The median prevalence of substandard and falsified medicines across the 17 studies is 26.9%, ranging from 0.5 % to 74.2%. The prevalence of substandard and falsified (SF) medicines was significantly higher in informal markets (up to 74.2%) compared to regulated pharmaceutical outlets (as low as 0.5 %). Tablet and capsule formulations were the most frequently analyzed dosage forms, particularly antimalarials, antibiotics, and maternal health medicines, with high failure rates in Active Pharmaceutical Ingredient (API) content and dissolution tests. Despite their lower sensitivity, high-performance liquid chromatography (HPLC) emerged as the most reliable analytical technique. In contrast, thin-layer chromatography (TLC) and Minilab screening were widely used in resource-limited settings. Significant challenges persist due to weak regulatory enforcement, inadequate supply chain monitoring, and insufficient post-market surveillance, resulting in substantial disparities in regulatory capacity across various West and Central African countries. Conclusions: This review underscores the urgent need for harmonized pharmacovigilance systems, stricter regulatory enforcement, and enhanced access to advanced screening technologies to combat the circulation of substandard and falsified (SF) medicines in West and Central Africa. Strengthening collaborations between governments, regulatory agencies, and global health organizations will ensure the integrity of medicine quality, patient safety, and the pharmaceutical supply chain in the subregion.