Tiyani Milta Maluleke1,2†
Biset Asrade Mekonnen3†
Chukwuemeka Michael Ubaka4†Bene D. Anand Paramadhas5†Mukhethwa Munzhedzi1†Aubrey Chichonyi Kalungia6†Ester Hango7†
Santosh Kumar8†
Brian Godman1,9,10*†
Johanna C. Meyer1,11†- 1Department of Public Health Pharmacy and Management, School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria, South Africa
- 2Saselamani Pharmacy, Saselamani, South Africa
- 3Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia
- 4Public Health Supply Chain and Pharmacy Practice Research Unit, Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Nigeria
- 5Quality Assurance Unit, Central Medical Stores, Ministry of Health, Gabarone, Botswana
- 6Department of Pharmacy, School of Health Sciences, University of Zambia, Lusaka, Zambia
- 7Department of Pharmacy Practice and Policy, School of Pharmacy, Faculty of Health Sciences, University of Namibia, Windhoek, Namibia
- 8Department of Periodontology and Implantology, Karnavati School of Dentistry, Karnavati University, Gandhinagar, India
- 9Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom
- 10Antibiotic Policy Group, Institute for Infection and Immunity, City St. George’s, University of London, London, United Kingdom
- 11South African Vaccination and Immunization Centre, Sefako Makgatho Health Sciences University, Pretoria, South Africa
Antimicrobial resistance (AMR) is a global public health threat exacerbated by inappropriate antibiotic use. This is particularly important in Africa. The availability of substandard and falsified antibiotics, particularly among African countries, contributes to this adding to the burden of AMR. Poor monitoring and regulatory controls among African countries increases the public health risks of these antibiotics. This is especially the case in the informal sector. Addressing Africa’s battle against substandard and falsified antibiotics requires an integrated approach building on current WHO, Interpol and Pan-African initiatives. Activities include harmonizing regulatory activities across Africa and increasing the monitoring of available antibiotics as well as fines and sanctions for offenders. In addition, reducing the current high levels of inappropriate antibiotic use makes the market for falsified and substandard antibiotics considerably less attractive.
1 Introduction
Antimicrobial resistance (AMR) increases both morbidity and mortality as well as appreciably increases healthcare costs if not addressed (1–4). As a result, AMR is now considered a critical global public health threat and the next potential pandemic unless multiple activities are undertaken across countries to address this situation (5–7). The principal countries to target to reduce AMR are low- and middle-income countries (LMICs) since the burden of AMR is greatest among these countries, which includes African countries (8–10).
AMR is driven by high levels of inappropriate use of antibiotics (11–13). High levels of AMR among African countries are also enhanced by the considerable availability of substandard and falsified antibiotics (14–18). The economic burden of substandard and falsified medicines is considerable with an estimated US$30.5 billion globally spent on these medicines each year alone (19, 20), which includes antibiotics (20). In addition to the appreciable monies spent on these medicines, Beargie et al. (2019) estimated that in the Northern Region of Nigeria alone, 9,700 deaths each year were due to substandard and falsified medicines with an estimated economic loss of $698 million ($697–$700 million) (21).
In their study, Feeney et al. (2024) documented that antibiotics accounted for 36% of all counterfeit medicines seized globally by Customs (22). Similarly, Ozawa et al. (2018) ascertained that the overall prevalence of substandard medicines among LMICs was 13.6%, highest in Africa at 18.7% (23). Wada et al. (2022) also found that the African region had the highest prevalence of poor-quality medicines, which they estimated to be 18.7% of available medicines (14, 24). Similar rates were reported by Asrade Mekonnen et al. (2024), who estimated that the prevalence of substandard or falsified medicines across Africa was 22.6%, with antibiotics accounting for the majority of these (44.6%) (16). Similar rates were also seen in the studies by Waffo Tchounga et al. (2021), Chiumia et al. (2022), and Maffioli et al. (2024) (25–27). Some of the highest rates of substandard and falsified medicines have been seen in Ghana, where in one study 66.4% of the total number of sampled antibiotics were seen as substandard (28, 29). Studies in Kenya also documented a 37.7% prevalence rate for substandard amoxicillin/co-amoxiclav (30). Falsified amoxicillin has also recently been reported in Cameroon and the Central African Republic (31). However, lower rates of falsified and substandard antimicrobials have been documented in other studies in Ghana and across Africa (32–35).
No counterfeit medicines were identified in South Africa in the study of Lehmann et al. (2018), with only a limited number seen in community outlets in practice Botswana and Namibia in recent years with their stricter controls regarding the supply and monitoring of medicines in these countries (36–38). In Botswana, there is a specific enforcement unit responsible for establishing and maintaining an effective import system for the Botswana Ministry of Health, with planned inspections increasing in recent years (39). The number of trained law enforcement officers helping with this activity has also increased in recent years in Botswana, which have resulted in greater confiscation of substandard medicines and other products in recent years (39). This included limited supplies of gentamicin and tetracycline especially among informal vendors (39). Increased collaboration between the various government departments in Botswana, alongside coordinated law enforcement activities, has resulted in a 65% increase in the confiscation of goods and medicines in recent years, amounting to 35,097 units of various unauthorized regulated items principally from informal sellers (39, 40). Informal sellers are also being increasingly monitored in Botswana as an appreciable percentage of unregistered medicines are seen in this sector (39, 40). Personnel from the Botswana Police Department are also used to help disrupt the activities of informal sellers; however, the instigation of fines for illegal activities is currently limited (40).
Issues with substandard and falsified medicines in Africa are exacerbated by concerns with community pharmacists’ knowledge and practices on these issues (41, 42), coupled with high rates of dispensing of antibiotics without a prescription across a number of African countries (37, 43, 44).
Overall, substandard and falsified antibiotics can be found in both formal sectors, involving community pharmacies, and informal sectors across Africa (7). The informal sector plays an important role across Africa where higher rates of substandard and falsified antibioitics are seen compared with the situation in community pharmacies (45). This situation is exacerbated among African countries where the monitoring and control of medicine importation and distribution are generally currently limited (7, 39, 46–48). Typically where this occurs, informal sector for medicines outlets can be better stocked with medicines, including antibiotics, than government health facilities (49, 50). However, the informal sector is not evident, or only in limited numbers, in some African countries, including Namibia and South Africa, with their increasingly stricter controls. Definitions of the informal sector are documented in Table 1.
Table 1. Definitions of the informal sector.
To date, principal initiatives to reduce the prevalence of substandard and falsified medicines across Africa have been centered on regulatory activities (45). These include the World Health Organization’s (WHO) “Lome´ Initiative” alongside the development of an African Medicines Agency (7, 18, 55–60), building on the ongoing efforts among the East African community (61). Governments within several African countries have also endorsed the Council of Europe’s Medicrime Convention Treaty to help reduce the extent of substandard and falsified medicines (7, 62). We are also seeing leading agencies such as the Nigerian National Agency for Food and Drug Administration and Control initiating multiple activities to reduce the problem (25).
Potential ways forward to reduce the extent of substandard and falsified antibiotics across Africa are discussed in Section 2, which is based on the considerable knowledge of the co-authors. The potential activities include governments and health authorities instigating multiple activities across Africa. The suggested activities include a continued focus on substandard and falsified medicines, including antibiotics, prioritizing the registration of essential antibiotics and away from all antibiotics, undertaking greater monitoring of drug stores and community pharmacies as well as instigating fines where there are concerns with the quality of dispensed antibiotics. Alongside this, reducing the current high levels of inappropriate prescribing and dispensing of antibiotics currently seen across Africa (7, 37, 63, 64). In addition, greater education of all key stakeholder groups to help identify and report substandard and falsified medicines (65, 66). Focusing and encouraging the appropriate use of only essential antibiotics will also reduce the attractiveness of this market and subsequently improve public health (7).
We are seeing, for instance, LMICs such as China making appreciable progress with improving the quality of their locally produced multiple-sourced medicines, including antibiotics, with appreciable penalties when substandard and falsified medicines are found (67–69). We are also seeing countries such as India and Pakistan instigate a number of measures, including bar coding on packs of antibiotics, in an attempt to reduce the prevalence of counterfeit medicines (70, 71). Similarly, in Botswana, there has been increased monitoring of facilities, including among informal sellers, to disrupt this market (39, 40).
2 Policy options to reduce the extent of substandard and falsified medicines across Africa
A number of policy options have been proposed to reduce the extent of substandard and falsified medicines across Africa. These include activities aimed at both the formal and informal sectors (Table 2), and involve initiatives by governments which includes enhancing current regulations as well as other initiatives to reduce the extent of substandard and falsified medicines.
Table 2. Potential policy options to tackle falsified and substandard medicines.
Ongoing initiatives among all key stakeholder groups to reduce the high levels of inappropriate prescribing and dispensing of antibiotics seen among African countries, thereby reducing the attractiveness of marketing substandard and falsified antibiotics, are discussed elsewhere in this Frontiers Special Issue as well as by Saleem et al. (2025) (7, 63). Consequently, they will not be part of Table 2.
3 Actionable recommendations
The actionable recommendations (Table 3) are based on their impact where known in published studies across LMICs, including African countries, combined with the considerable experience of the co-authors. As mentioned, initiatives to reduce inappropriate prescribing and dispensing of antibiotics, thereby reducing the attractiveness of the substandard and falsified antibiotics market, are discussed elsewhere in this Frontiers Special Issue as well as in Saleem et al. (2025) (7, 63). Similar to the data in Table 2, this will include activities surrounding regulations as well as other initiatives to reduce the extent of substandard and falsified medicines across Africa.
Table 3. Actional recommendations and their impact.
We are aware of a number of limitations with our policy brief. This primarily includes the fact that we have not undertaken a systematic review. However, we have undertaken a narrative review including examples of potential policy options to tackle falsified and substandard medicines followed by potential actionable recommendations. The guidance is based on the considerable experience of the co-authors working across Africa and other LMICs. We have successfully used this approach before (7, 37, 63, 104).
4 Conclusions
Addressing Africa’s battle against substandard and falsified antibiotics to reduce AMR requires integrated, scalable, and context-specific policies to address gaps in regulation, enforcement, education, affordability, and supply chain monitoring. This builds on ongoing initiatives among the WHO, Interpol and Pan-African agencies as well as exemplars in other LMICs. Reducing high levels of inappropriate use of antibiotics across Africa, alongside encouraging INN prescribing with appropriate safeguards, will also help reduce the attractiveness of the counterfeit antibiotic market. These combined activities will help address high levels of AMR across Africa.
Author contributions
TM: Investigation, Data curation, Methodology, Writing – review & editing, Conceptualization, Validation, Formal analysis, Writing – original draft. BM: Writing – review & editing, Formal analysis, Investigation, Data curation, Methodology, Writing – original draft, Conceptualization. CU: Data curation, Methodology, Formal analysis, Validation, Writing – review & editing. BP: Writing – review & editing, Validation, Formal analysis, Methodology. MM: Investigation, Writing – review & editing, Validation, Methodology, Formal analysis. AK: Writing – review & editing, Investigation, Formal analysis, Validation, Data curation. EH: Writing – review & editing, Formal analysis, Data curation, Validation, Investigation, Visualization. SK: Formal analysis, Data curation, Validation, Investigation, Writing – review & editing. BG: Investigation, Data Curation, Methodology, Conceptualization, Formal analysis, Validation, Writing – original draft, Writing – review & editing, Supervision. JM: Writing – review & editing, Visualization, Conceptualization, Methodology, Supervision, Investigation, Validation.
Funding
The author(s) declare that no financial support was received for the research, and/or publication of this article.
Conflict of interest
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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Keywords: antibiotics, antimicrobial resistance, substandard antibiotics, falsified antibiotics, informal sector, policy initiatives, health authorities, sub-Saharan Africa
Citation: Maluleke TM, Mekonnen BA, Ubaka CM, Paramadhas BDA, Munzhedzi M, Kalungia AC, Hango E, Kumar S, Godman B and Meyer JC (2025) Potential activities to reduce the extent of substandard and falsified antibiotics across Africa and associated antimicrobial resistance. Front. Trop. Dis. 6:1634029. doi: 10.3389/fitd.2025.1634029
Received: 23 May 2025; Accepted: 25 August 2025;
Published: 24 September 2025.
Edited by:
Sylvia Opanga, University of Nairobi, KenyaReviewed by:
Shoaib Ahmad, Punjab Medical College, PakistanGayathri Govindaraju, Rutgers, The State University of New Jersey, United States
Copyright © 2025 Maluleke, Mekonnen, Ubaka, Paramadhas, Munzhedzi, Kalungia, Hango, Kumar, Godman and Meyer. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Brian Godman, YnJpYW4uZ29kbWFuQHNtdS5hYy56YQ==
†ORCID: Tiyani Milta Maluleke, orcid.org/0000-0001-6437-7198
Biset Asrade Mekonnen, orcid.org/0000-0001-8799-7146
Chukwuemeka Michael Ubaka, orcid.org/0000-0001-7193-2305
Aubrey C. Kalungia, orcid.org/0000-0003-2554-1236
Santosh Kumar, orcid.org/0000-0002-5117-7872
Brian Godman, orcid.org/0000-0001-6539-6972
Johanna C. Meyer, orcid.org/0000-0003-0462-5713
Ester Hango, orcid.org/0000-0002-7112-4049
Bene D. Anand Paramadhas, orcid.org/0000-0002-8204-1417
Mukhethwa Munzhedzi, orcid.org/0000-0003-1082-0881