Keywords
falsified medicines
Democratic Republic of the Congo
regulatory system
quality assurance
market surveillance
How to Cite
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
References
Abraham, J. (2010a). International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. In C. Tietje & A. Brouder (Eds.), Handbook of transnational economic governance regimes (pp. 1041–1053). Brill | Nijhoff. https://doi.org/10.1163/ej.9789004163300.i-1081.897
Abraham, J. (2010b). International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. In C. Tietje & A. Brouder (Eds.), Handbook of transnational economic governance regimes (pp. 1041–1053). Brill | Nijhoff. https://doi.org/10.1163/ej.9789004163300.i-1081.897
Ahmed, J., Modica de Mohac, L., Mackey, T. K., & Raimi-Abraham, B. T. (2022). A critical review on the availability of substandard and falsified medicines online: Incidence, challenges, and perspectives. The Journal of Medicine Access, 6, 23992026221074548. https://doi.org/10.1177/23992026221074548
Arman, B. Y., Clarke, R., Bharucha, T., Fernandez, L. G., Walsby-Tickle, J., Deats, M., Mosca, S., Lin, Q., Banerjee, S., Chunekar, S. R., Patil, K. D., Gairola, S., Dunachie, S., Merchant, H. A., Stokes, R., Kuwana, R., Maes, A., Charrier, J.-P., Probert, F., & Gangadharan, B. (2025). Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry. NPJ Vaccines, 10, 19. https://doi.org/10.1038/s41541-024-01051-3
Arrêté ministériel n° 1250/CAB/MIN/SP/008/CPH/OBF/2015 du 28 septembre 2015 portant réglementation du commerce des produits pharmaceutiques en République démocratique du Congo. (2015). https://www.leganet.cd
Asrade Mekonnen, B., Getie Yizengaw, M., & Chanie Worku, M. (2024). Prevalence of substandard, falsified, unlicensed, and unregistered medicines and associated factors in Africa: A systematic review. Journal of Pharmaceutical Policy and Practice, 17(1). https://doi.org/10.1080/20523211.2024.2375267
Beargie, S. M., Higgins, C. R., Evans, D. R., Laing, S. K., Erim, D., & Ozawa, S. (2019). The economic impact of substandard and falsified antimalarial medications in Nigeria. PLoS ONE, 14(8), e0217910. https://doi.org/10.1371/journal.pone.0217910
Bhandari, B., & Rayamajhi, G. (2022). Counterfeit healthcare products: Nepal at a vulnerable position. JNMA: Journal of the Nepal Medical Association, 60(256), 1070–1072. https://doi.org/10.31729/jnma.7684
Cavany, S., Nanyonga, S., Hauk, C., Lim, C., Tarning, J., Sartorius, B., Dolecek, C., Caillet, C., Newton, P. N., & Cooper, B. S. (2023). The uncertain role of substandard and falsified medicines in antimicrobial resistance. Nature Communications, 14, 6153. https://doi.org/10.1038/s41467-023-41542-w
Chiumia, F. K., Nyirongo, H. M., Kampira, E., Muula, A. S., & Khuluza, F. (2022). Burden of and factors associated with poor-quality medicines in Malawi. PLoS ONE, 17(12), e0279637. https://doi.org/10.1371/journal.pone.0279637
Ciapponi, A., Donato, M., Gülmezoglu, A. M., Alconada, T., & Bardach, A. (2021). Mobile apps for detecting falsified and substandard drugs: A systematic review. PLoS ONE, 16(2), e0246061. https://doi.org/10.1371/journal.pone.0246061
Congolese Pharmaceutical Regulatory Authority. (2024, March 29). Assessment tools for national regulatory authorities: GBT Rev VI, ver. 1 (F) Democratic Republic of the Congo (Visit date: 19.09.2022 - 23.09.2022) [Self-assessment report]. World Health Organization.
Delforge, C. (2017). La vente en ligne de médicaments: Quelles exigences pour les e-pharmacies belges et quelles protections pour les consommateurs? Droit de la Consommation.
Eshce. (2007). Serialization [Photograph]. Wikimedia Commons. https://commons.wikimedia.org/wiki/File:Serialization.jpg
Fryze, I., & Naughton, B. D. (2025). Substandard and falsified medicine recalls in the legitimate supply chain: A systematic review. BMJ Open, 15(10), e103672. https://doi.org/10.1136/bmjopen-2025-103672
Guterres, A. (2023). The sustainable development goals report. United Nations.
Hauk, C., Hagen, N., & Heide, L. (2021). Identification of substandard and falsified medicines. The American Journal of Tropical Medicine and Hygiene, 104(5), 1936–1945. https://doi.org/10.4269/ajtmh.20-1612
Journal officiel de la République démocratique du Congo. (2015). Arrêté ministériel relatif à la création de la commission d’homologation des produits pharmaceutiques.
Khurelbat, D., Dorj, G., Sunderland, B., Sanjjav, T., Bayarsaikhan, E., Damdinjav, D., Jigjidsuren, A., Lkhagvasuren, O., & Erdenetsetseg, B. (2020). A cross-sectional analysis of falsified medicines. BMC Public Health, 20, 743. https://doi.org/10.1186/s12889-020-08897-x
Kiwfo, K., Woi, P. M., Seanjum, C., & Grudpan, K. (2021). Paper-based analytical devices for drug detection. Talanta, 236, 122848. https://doi.org/10.1016/j.talanta.2021.122848
Kniazkov, S., Dube-Mwedzi, S., & Nikiema, J.-B. (2020). Prevention, detection, and response to substandard and falsified products. Journal of Pharmaceutical Policy and Practice, 13, 71. https://doi.org/10.1186/s40545-020-00257-9
Lächele, M., Gabel, J., Sunny-Abarikwu, N., Ohazulike, R. E., Ngene, J., Chioke, J. F., & Heide, L. (n.d.). Screening for substandard medicines in Nigeria. Journal of Pharmaceutical Policy and Practice.
Leem. (2017). Contrefaçon de médicaments: Une atteinte à la santé publique. Les Entreprises du Médicament.
Leem. (2020). Le médicament et sa mise au point. Les Entreprises du Médicament.
Manzambi, M., Kuwekita, J., Bongo-Pasi Nswe, C., Mbinze, J. K., Liégeois, S., Kalenda Tshilombo, N., Kwete Minga, M., Ciza Hamuli, P., Hubert, P., & Marini Djang’ieng’a, R. (2019). Quality of antimalarials in Kinshasa. International Health, 12(4), 253–263. https://doi.org/10.1093/inthealth/ihz070
Ministère de la Santé Publique de la RDC. (2016). Plan national de développement sanitaire 2016–2020.
Ministère de la Santé de la RDC. (2020). Plan stratégique national pour la couverture santé universelle 2021–2030.
Monneret, C. (2017). Médicaments contrefaits ou falsifiés. L’Actualité Chimique.
Mosca, S., Lin, Q., Stokes, R., Bharucha, T., Gangadharan, B., Clarke, R., Fernandez, L. G., Deats, M., Walsby-Tickle, J., Arman, B. Y., Chunekar, S. R., Patil, K. D., Gairola, S., Van Assche, K., Dunachie, S., Merchant, H. A., Kuwana, R., Maes, A., McCullagh, J., & Matousek, P. (2023). Detection of falsified vaccines using Raman spectroscopy. Vaccine, 41(47), 6960–6968. https://doi.org/10.1016/j.vaccine.2023.10.012
Muya, C. B., Ntambwe, N. M., Bisuta, L. B., Miyila, M. B., Sita, N. G., Mafuta, K. D., Masansa, V., & Mbinze, K. J. (2025). Post-marketing surveillance of doxycycline in the DRC. Orapuh Journal, 6(10). https://doi.org/10.4314/orapj.v6i10.92
Nana, R. (2025). Plan stratégique ACOREP 2025–2029.
Nduu, F. N., & Ngoy, R. S. (2023). Les médicaments contrefaits et sous-standards. Revue de l’Infirmier Congolais, 7(1), 30–35.
Ngwato, J. W., Mankulu, K. J., Mayangi, M. M., Ntambwe, M., Mufusama Koy-Sita, J. P., Liesse, I. J. M., & Ciza, H. P. (2025). Quality of azithromycin in Kisangani. Orapuh Journal, 6(10). https://doi.org/10.4314/orapj.v6i10.93
OpenAFRICA. (2015). SARA survey data.
Opuni, K. F.-M., Nettey, H., Larbi, M. A., Amartey, S. N. A., Nti, G., Dzidonu, A., Owusu-Danso, P., Owusu, N. A., & Nyarko, A. K. (2019). Combined screening methods for falsified medicines. Malaria Journal, 18, 403. https://doi.org/10.1186/s12936-019-3045-y
Ozawa, S., Higgins, C. R., Nwokike, J. I., & Phanouvong, S. (2022). Modeling the impact of falsified medicines. The American Journal of Tropical Medicine and Hygiene, 107(1), 14–20.
Persson, A., Troein, M., Lundin, S., Midlöv, P., & Lenander, C. (2024). Pharmacists’ perspectives on falsified medicines. Exploratory Research in Clinical and Social Pharmacy, 13, 100421. https://doi.org/10.1016/j.rcsop.2024.100421
Pinel, P. J., Caudron, J.-M., Macé, C., Pouget, C., Ravinetto, R., Renchon, J., Rigal, J., Schiavetti, B., & Vandenbergh, D. (2016). Les médicaments de contrefaçon et sous-standards. Éditions du Seuil.
PharmaliZr. (n.d.). [Dispositif de sérialisation] [Photograph]. https://www.pharmalizr.com/img/dispositif-serialisation.jpeg
Pozsgai, K., Szűcs, G., Kőnig-Péter, A., Balázs, O., Vajda, P., Botz, L., & Vida, R. G. (2022). Pharmacovigilance analysis of falsified medicines. Frontiers in Pharmacology, 13, 964399. https://doi.org/10.3389/fphar.2022.964399
Sanada, T., Yoshida, N., Kimura, K., & Tsuboi, H. (2020). Raman spectroscopy detection of falsified medicines. Pharmacy, 9(1), 3. https://doi.org/10.3390/pharmacy9010003
SlideServe. (n.d.). A CTD triangle [Image]. https://slideserve.com
Suárez-González, J., Cáceres-Pérez, A. R., Oliva, A., Santoveña-Estévez, A., & Fariña, J. B. (2022). Detection of substandard drugs using UPLC. Molecules, 27(20), 7141. https://doi.org/10.3390/molecules27207141
Tshilumba, P. M., Amuri, S. B., Kaghowa, E. R., Mbikayi, D. M., Impele, A. B., Duez, P., & Kalonji, J. B. (2015). Counterfeit anti-infectives in Lubumbashi. Pan African Medical Journal, 22. https://doi.org/10.11604/pamj.2015.22.318.7302
Tshilumba, P. M., Ilangala, A. B., Mbinze Kindenge, J., Kasongo, I. M., Kikunda, G., Rongorongo, E., Impele, A. B., Marini Djang’ieng’a, R., & Ndoumba, J.-B. K. (2023). Detection of falsified antibiotics in the DRC. The American Journal of Tropical Medicine and Hygiene, 109(2), 480–488. https://doi.org/10.4269/ajtmh.23-0045
United Nations Conference on Trade and Development (UNCTAD). (2019). Illicit trade and the SDGs.
Valentin, M. (2022). WHO good regulatory practices.
Waffo Tchounga, C. A., Sacré, P.-Y., Ciza Hamuli, P., Ngono Mballa, R., De Bleye, C., Ziemons, E., Hubert, P., & Marini Djang’ieng’a, R. (2023). Poor-quality antibiotics in Cameroon. The American Journal of Tropical Medicine and Hygiene, 108(2), 403–411. https://doi.org/10.4269/ajtmh.22-0221
World Health Organization. (2010). WHO technical report series 957: Good manufacturing practices.
World Health Organization (2017a). WHO Global Surveillance and Monitoring System for substandard and falsified medical products. Geneva: World Health Organization.
World Health Organization (2017b). Seventieth World Health Assembly A70/23: Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products. Agenda item 13.6. 20 March 2017. Geneva, Switzerland: WHO.
World Health Organization. (2018). WHO global benchmarking tool.
World Health Organization. (2022). World malaria report 2022.
World Health Organization. (2023). Medical product alert No. 1/2023.
World Health Organization. (2025). Medical product alert No. 2/2025.
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