The Substandard and falsified medicines in the Democratic Republic of the Congo: Situational analysis and future perspectives

Abstract

Introduction The circulation of counterfeit medicines in the Democratic Republic of the Congo (DRC) and elsewhere is driven by several factors, including regulatory weaknesses, inadequate inspections, and porous borders. This issue is frequently highlighted in case reports and scientific publications, demonstrating the link between regulatory capacity—particularly the maturity level of the National Regulatory Authority (NRA)—and the prevalence of substandard and falsified medicines. Purpose To assess the extent of counterfeit medicines in the DRC and propose future perspectives. Methods Publications related to counterfeit medicines were collected from databases such as ScienceDirect, PubMed, Google, Google Scholar, ACOREP, the World Health Organization (WHO), websites of major organizations, case reports, and alerts. Searches were conducted using the keywords “falsified,” “substandard,” “counterfeit,” and “alert” (in both English and French). References were managed using Zotero software and analyzed through a structured literature review flowchart. Inclusion criteria comprised articles published between 2010 and 2025, including case reports, alerts, and study summaries focusing on the prevention, detection, and response to counterfeit medicines for human use in the DRC or other low- and middle-income countries. Results Of the 238 articles and documents identified, 62 met the inclusion criteria. The average prevalence of counterfeit medicines in Africa was estimated at 18.7% (range: 12.9%–24.5%), with 34.6% classified as unregistered. In the DRC, the consolidated average prevalence rates were 22.4% for counterfeit medicines, 22.2% for substandard medicines, and 35% for unregistered medicines. Conclusion The Congolese Pharmaceutical Regulatory Authority (ACOREP) has not yet achieved WHO maturity level 3 (ML3) in accordance with good regulatory practices. The Congolese government is therefore encouraged to strengthen its commitment to establishing a robust and deterrent national regulatory system (NRA) to combat the circulation of counterfeit medicines, particularly given the high proportion (approximately 35%) of unregistered products