Traditional medicine regulation status and challenges in Malawi and Nigeria

Abstract

Background

The World Health Organization encourages governments to develop legal frameworks for the regulation of traditional medicines to ensure safety, quality, and efficacy. There is inadequate published research on the traditional medicine legislative tools and Good manufacturing practices compliance by manufacturers in many countries in Sub-Saharan Africa. The study assessed the traditional medicine regulatory status and challenges in Malawi and Nigeria.

Methods

A descriptive cross-sectional study was done using a structured questionnaire and a checklist of regulatory requirements to collect data from officers, manufacturing facilities, and herbal medicinal products. Twenty-three officers from the Medicines Regulatory Authorities and Ministries of Health from Malawi and Nigeria were interviewed. Thirty-one small-scale manufacturers, sixty-six herbal medicinal products from Malawi, and twenty-eight herbal medicinal products from Nigeria, that were used by people living with HIV and AIDS, were evaluated.

Results

The Pharmacy and Medicines Regulatory Authority scored 7.7% in Malawi while the National Agency for Food and Drug Administration and Control in Nigeria, scored 77.0% on the 13-item regulatory checklist of regulatory requirements. The Ministry of Health, Malawi scored 28.6% while Nigeria scored 71.4% on the 7-item checklist of regulatory requirements. Both countries have no regulations on traditional medicine practice, and traditional medicine has not been integrated into the healthcare system. Most Malawian manufacturers showed poor compliance, with deficiencies observed in personnel hygiene (58.6%), cleaning production equipment (69.0%), storage rooms (72.4%), and documentation on standard operating procedures for cleaning equipment and premises (93.1%). Labelling non-compliance was observed in Malawi and Nigeria, respectively, for the list of active ingredient names (45.5% vs. 93.0%, p < 0.001), quantities of active ingredients (12.1% vs. 53.6%, p < 0.001), side effects (9.1% vs. 57.1%, p < 0.001), and storage conditions (15.2% vs. 67.9%, p < 0.001).

Conclusion

Malawi lacks a strong regulatory framework for herbal medicines, with poor compliance to current Good Manufacturing Practices standards in manufacturing and labelling, posing serious public health risks. Urgent action is needed to establish comprehensive regulations, including guidelines for registering herbal medicines used by people living with HIV and AIDS. While Nigeria has a more developed regulatory framework, enforcement remains a challenge. Strengthening inspections and ensuring adherence to safety and quality standards for herbal products is critical to safeguarding public health and building consumer confidence in both countries’ traditional medicine industries.

Introduction

Traditional medicine is the total sum of knowledge, skills, and practices based on indigenous ideas, beliefs, and experiences utilized in the promotion of health as well as the prevention, diagnosis, improvement, and treatment of physical and mental diseases [1]. Traditional medicine has been in use since ancient times and reports indicate that globally 88.0% of the population uses traditional and complementary medicine [2]. The World Health Organization (WHO) supports governments in the formulation of national policies, herbal medicine safety and quality, universal health coverage, and integration of traditional medicine into the national healthcare systems. The member states are expected to develop and enforce regulations of traditional medicines and practitioners’ practices to ensure product safety, quality, and efficacy [3].

In 2006, the WHO formed the International Regulatory Cooperation for Herbal Medicines (ICRH) to strengthen the regulation of herbal medicines by fostering international cooperation, ensuring consistent regulatory practices, and enhancing the global safety and efficacy of these products [4]. Good Manufacturing Practice (GMP) is a process of ensuring that products are produced according to quality standards while minimizing the risks that affect the quality, safety, and efficacy of such products [5]. Product labelling is a component of GMP for products moving into the market and includes all written, printed, or graphic matter on the immediate container of the herbal medicinal product [6]. The national traditional medicine regulatory framework influences the quality of herbal medicinal products available to the public [7]. In the United States, Canada, the European Union, and Australia, it is mandatory that herbal medicinal products should comply with GMP, and pre-marketing surveillance reports before marketing authorization is granted [8]. The inspection of premises and products, and laboratory reports are the basis for the product registration or product renewal by the Medicines Regulatory Authorities [9, 10]. The development of traditional medicine governance and legal frameworks is a work in progress in many countries in Sub-Saharan Africa [11].

The prevalence of unregistered herbal medicinal products on the market continues to grow in both countries despite the availability of the Medicines Regulatory Authorities [12, 13]. The Pharmacy and Medicines Regulatory Authority (PMRA) in Malawi [14], and the National Agency for Food and Drug Administration and Control (NAFDAC) [15], in Nigeria, are mandated to regulate and control the manufacture, importation, exportation, distribution, and sale of herbal medicinal products [16]. The Ministries of Health in both countries provide policy direction and oversight functions on the regulation of traditional medicines. There is very little published research on the availability of herbal medicine regulatory tools and the extent of compliance by manufacturers in many countries in Sub-Saharan Africa. Therefore, the study aimed to assess the regulatory status and challenges of traditional medicine in Malawi and Nigeria. The study specifically investigated the governance and regulatory frameworks at the Ministries of Health and the Medicines Regulatory Authorities. The study further assessed the manufacturers’ compliance with current Good Manufacturing Practices (cGMP) standards and with labelling requirements for herbal medicinal products used by people living with HIV and AIDS (PLWHA) in Malawi and Nigeria. This study is a component of a large study on pharmacovigilance, regulation, quality control, and use of herbal medicinal products among PLWHA in both countries. The initial study indicated that over 80% of individuals living with HIV/AIDS reported using herbal medicinal products [13]. The utilization of these products as alternative therapies poses a potential risk to the adherence and effectiveness of antiretroviral treatment among PLWHA [17, 18]. These products’ labels were evaluated for compliance. This study highlights the critical need to assess the regulatory framework governing the registration, promotion, marketing, and manufacturing of herbal medicinal products to provide evidence-based recommendations for policymakers and regulatory authorities.

Methods

Study design

This was a descriptive cross-sectional study that involved participants from the Medicines Regulatory Authorities (MRA) and the Ministries of Health (MOH), manufacturers of herbal medicinal products, and collection of herbal medicinal products from Malawi and Nigeria. The officers were from the central office of the MRA and MOH whilst the manufacturers and the herbal medicinal products were from two cities: Blantyre in Malawi and Ibadan in Nigeria.

Study setting

Malawi is in Southern Africa and shares a border with Mozambique, Zambia, and Tanzania. Malawi has a land area of 119,000 square kilometers with a population density of 129 people per square meter [19]. According to the 2018 Census, the country has a population of 17.5 million people with 84.0% living in rural areas [20]. The Ministry of Health (MOH) provides strategic leadership in the delivery of health services [21] including the formulation of the National Traditional and Complementary Medicine Policy, which establishes the strategic direction for traditional medicine in Malawi [22]. The Pharmacy and Medicines Regulatory Authority (PMRA) regulates and controls the manufacture, distribution, and sale of medicines, and traditional medicines [14].

Nigeria is in West Africa, bordering Benin to the west, Cameroon and Chad to the east, and Niger to the north along the Atlantic Ocean’s Gulf of Guinea. Nigeria has a population of over 200 million with a population density of 221 people per square kilometer and has 910,770 square kilometers of land [23]. The Federal government established the National Agency for Food and Drug Control and Administration (NAFDAC) to regulate herbal medicines’ listing, advertising, manufacture, importation, exportation, and marketing in the country [9, 15, 24]. The Federal Ministry of Health (MOH) is the world-class government institution that ensures a healthy Nigeria through effective healthcare facilities [25].

Sampling and sample size

A purposive sample of 23 officers from the MRA and MOH from Malawi and Nigeria were interviewed. The sample comprised 7 PMRA, and 9 NAFDAC officers who were heads of sections of herbal medicine registration, quality control, and pharmacovigilance. Furthermore, the sample included 5 and 2 MOH officers from Malawi and Nigeria, respectively, who were heads of sections responsible for traditional medicine policy formulation, strategy, research and development, manufacturing, and control of herbal medicinal products. The use of purposive sampling to select participants who are heads or directors of units within regulatory authorities and ministries of health is justified by the need to obtain informed perspectives from individuals with direct oversight and decision-making authority in relevant areas. These participants possess specialized expertise in healthcare regulation, including the governance of herbal medicine practices, and are uniquely positioned to offer valuable insights into the policies, challenges, and frameworks that shape their sectors. By targeting key stakeholders involved in policy and regulatory processes, the study ensures that the data collected is both pertinent and authoritative, providing a robust understanding of the issues at hand [26].

A convenient sample of 94 herbal medicinal products comprised 66 and 28 herbal medicinal product samples were collected from Blantyre and Ibadan, respectively. Herbal medicinal products that were commonly used by PLWHA were included in the study [13]. Samples with medical/therapeutic claims of managing HIV/AIDS, alleviating antiretroviral side effects, boosting immunity, and appetite were selected and collected from community pharmacies, medicine stores, supermarkets, and open markets.

The manufacturers’ contact details portrayed on the label of the herbal medicinal products were used to contact and recruit the manufacturers into the study. Out of 31 small-scale manufacturers who were approached in Malawi, 29 (94.0%) agreed to have their facilities assessed using a current Good Manufacturing Practice (cGMP) checklist. None of the 15 manufacturing companies that were approached in Nigeria agreed to participate in the study despite having the NAFDAC inspection permit.

Data collection

Data were collected between July 2020 and January 2021. A structured questionnaire was used to collect data from study participants through interviews or self-administration when direct interviews were not feasible. Participants from regulatory authorities and ministries of health were approached for data collection through both physical and online methods, depending on their availability and accessibility. In cases where participants were geographically accessible, face-to-face interviews were conducted to facilitate direct interaction and engagement. For participants who were located in distant areas or where physical meetings were not feasible, online platforms such as email, virtual and phone call interviews were utilized to collect data. This flexible approach ensured inclusivity and maximized participation, accommodating the schedules and preferences of the targeted respondents while maintaining the quality and depth of data collection [27].

The questionnaire was developed and adapted using the WHO assessment checklist for herbal medicine regulation [2, 11]. The questionnaire included the 13-item checklist for the assessment of MRA and the 7-item checklist for the assessment of MOH. The structured questionnaire had sections designed to collect information on background information, national regulations, governance, legal framework, and instruments, post-marketing surveillance, and herbal medicine pharmacovigilance, challenges in post-marketing surveillance, and general challenges of the herbal medicine industry.

The cGMP checklist was developed to collect information on personnel, facilities, premises, production equipment, raw packaging materials and sources, environmental sanitation, and documentation while the product labelling checklist was designed to collect data on herbal medicinal products’ description, production information, and manufacturers/distributors’ information. The checklists were developed by modifying the WHO, PMRA, and NAFDAC checklists [13, 15, 28, 29]. The first author collected data through inspection of the manufacturers’ facilities, and herbal products using facility checklist and product labelling checklist, respectively.

Reliability and validity

Reliability refers to the consistency and trustworthiness of the data measured and collected through the questionnaires and checklists. The validation of these tools also ensure accuracy, and usefulness of the findings for decision making. The questionnaires and checklists were validated by pretesting them on officers at the same facility in Malawi and in Nigeria but these participants were not included in the study [30]. The reliability and validity of the questionnaires and the checklists was also ensured through expert review assessment for content and construct validity [31, 32].

Data management and analysis

Data collected on the 13-item and the 7-item checklist for the assessment of MRA and MOH, respectively, were analyzed by scoring 1 for a “Yes” response and 0 score for a “No” response. Data were imported into Stata 15 (Stata Corp, Texas, USA) from Microsoft Access for preparation before any formal statistical analysis. The Student t-test was used to determine the significant differences between the variables based on their descriptive characteristics. Data were analyzed with Stata and p < 0.05 was considered statistically significant.

Confidentiality

All questionnaires, checklists were anonymous and appropriately coded. All information collected in the study were coded and not linked to any publication, report or clinical record.

Ethics approval and informed consent

This study was approved in Malawi by the College of Medicine Research and Ethics Committee (COMREC) No. P.02/20/2932) and in Nigeria by the University of Ibadan, University College Hospital (UI/UCH) No. UI/EC/20/0054. All the study participants underwent the informed consent process and written informed consent was obtained before voluntary participation.

Results

Demographic information of participants at the medicines regulatory authorities

The key participants from MRA [16] and MOH [7] had a response rate of 100% from both countries (Table 1). PMRA had 5 (71.4%) males while NAFDAC had 5 (55.6%) males and the majority of participants 10 (62.5%) had worked for more than 10 years. Most participants in Malawi MOH, 4 (80.0%) and Nigeria MOH, 1 (50.0%) had worked for more than 10 years.

Traditional medicine governance and legislative tools at medicines regulatory authorities

The analysis of the legislative framework and tools for herbal medicine regulation are summarized in Table 2. PMRA scored 1/13 (7.7%) while NAFDAC scored 10/13 (77.0%) on the 13-item regulatory checklist. Challenges of herbal medicines post-marketing surveillance and adverse drug reaction reporting are summarized in Table 3. Both countries had post-marketing surveillance challenges of herbal medicinal product variation of the content of active ingredients, while lack of awareness and under-reporting were some of the challenges reported in Malawi and Nigeria, respectively.

Table 1 Demographic information of officers at the medicine regulatory authorities (n = 16) and ministries of Health (n = 7)

Traditional medicine governance and legislative tools at the ministries of health

The analysis of MOH’s governance and legislative tools for traditional medicine in Malawi and Nigeria are summarized in Table 4. The Malawi MOH scored 2/7 (28.6%) while the counterpart Nigeria scored 5/7 (71.4%) on the 7-item checklist of regulatory requirements. Both countries have no regulations on traditional medicine practice, and traditional and complementary medicine (TCM) have not been integrated into the health system.

Major challenges in the traditional medicine industry in Malawi included, lack of unity among herbal medicine manufacturers and distributors, and lack of regulations and guidelines for registration, production, and marketing of herbal medicinal products. Challenges in the Ministry of Health in Nigeria included, lack of supervision of manufacturers, and difficulty in harmonizing different traditional medicine bodies into a representative body as summarized in Table 5.

Table 2 Availability of traditional medicine governance and legislative tools at medicine regulatory authorities

Table 3 Medicines regulatory authorities’ challenges in herbal medicine pharmacovigilance (n = 16)

Table 4 Availability of traditional medicine governance and legislative tools at the ministries of health (n = 7)

Table 5 Ministries of health challenges in herbal medicine industry regulation (n = 7)

Manufacturers and product labelling compliance with current good manufacturing practices

Findings on current Good Manufacturing Practice (cGMP) compliance, presented in Table 6, reveal significant non-compliance among Malawian manufacturers, with serious deficiencies in personnel hygiene (58.6%), cleaning of production equipment (69.0%), maintenance of storage rooms (72.4%), and documentation of standard operating procedures (SOPs) for cleaning equipment and premises (93.1%). Table 7 shows that there was labelling non-compliance was observed in Malawi and Nigeria, respectively, for the list of active ingredient names (45.5% vs. 93.0%, p < 0.001), quantities of active ingredients (12.1% vs. 53.6%, p < 0.001), side effects (9.1% vs. 57.1%, p < 0.001), and storage conditions (15.2% vs. 67.9%, p < 0.001).

Table 6 Herbal medicine manufacturer’s compliance with cGMP in Malawi (n = 29)

Table 7 Herbal medicinal products’ compliance with cGMP labelling requirements (n = 94)

Discussion

The study revealed that the Pharmacy and Medicines Regulatory Authority (PMRA) of Malawi had a lower score than the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria on important legislative instruments and the governance framework for the regulation of herbal medicines. NAFDAC is a well-established Agency in the regulation and listing of traditional medicines [9, 10, 15, 24, 33, 34]. Malawi lacked key regulatory frameworks and governance structures essential for the effective regulation of herbal medicinal products. These included the absence of a national pharmacopoeia for traditional medicines, regulations and guidelines for manufacturing, and provisions for the registration and marketing of herbal medicinal products. In contrast, Nigeria had most of the critical legislative documents and governance structures in place. The absence of these foundational legal instruments in Malawi poses significant challenges for PMRA to effectively oversee the safety, quality, and efficacy of herbal medicinal products used by PLWHA [35].

The lack of regulatory framework for the registration of herbal medicinal products in Malawi may be the reason for the high prevalence of use of herbal medicinal products among PLWHA [12]. PMRA had already committed, to regulating traditional medicines under the PMRA Act No. 9 of 2019, during the period of the study. However, the regulations and guidelines to support the commitment are yet to be developed [14]. Malawi is among 51.0% of the countries in the WHO African region that have no registration system for traditional medicines [2]. The study also revealed that evaluation and approval of traditional medicine claims was not being done in both countries. This is the most significant gap as most herbal medicinal products carried therapeutics claims to cure HIV thereby increasing prevalence of use among PLWHA [13]. The public needs to be guided on utilization of traditional medicines and unfortunately, both countries did not have guidelines for rational use of herbal medicinal products for the public. The status is the same in most developing countries [36]. Zhang in 2018, reported that it is difficult to promote rational use of traditional medicines [37]. It is also difficult to safeguard public health safety in traditional medicines where tools for enforcement of laws are not available. Despite having most of the necessary legislative tools and regulatory framework in Nigeria, the study revealed that limited financial and human resources contributed to inadequate enforcement of traditional medicine regulation and listing [24].

Malawi lacked more of the most important tools of herbal medicine pharmacovigilance than Nigeria. Malawi has made progress in pharmacovigilance, establishing a fully functional pharmacovigilance center equipped with ADR (adverse drug reaction) forms to monitor and document ADRs related to conventional medicines [38]. However, the country lacks legislative frameworks and tools specific to herbal medicines, such as a national herbal medicine register, a comprehensive national pharmacovigilance policy, guidelines for pharmacovigilance activities, and specific protocols for herbal medicine pharmacovigilance [2]. The policy, legislation, and governance system are critical for setting up the functional pharmacovigilance system including herbal medicine pharmacovigilance [39]. The study reported challenges in both countries related to post-marketing surveillance and these are consistent with Sub-Saharan Africa reports by Dodoo and Ampadu [40]. The concept of herbal medicine pharmacovigilance is relatively new in Africa, despite the fact that over 80% of the population relies on traditional medicines, highlighting the need to monitor adverse reactions associated with their use [1]. In both Malawi and Nigeria, adverse reaction reporting forms are utilized to collect information on herbal medicines alongside conventional medicines [38, 41].

Findings show that Malawi’s Ministry of Health did not have adequate important legislative instruments for the regulation of herbal medicines as compared with Nigeria’s Ministry of Health. Malawi did not have the national program, the national institute and the national office for traditional medicines as compared with Nigeria. These governance structures are crucial for championing the oversight of traditional medicine agenda. Nigeria had most of the important legislation instruments despite inadequate enforcement mechanisms. These herbal medicine legislative framework aspects are important milestones for the development of traditional medicine industry according to the World Health Organization [2]. However, both countries have national policies and expert committees on traditional medicines. Both countries were not regulating traditional medicine practice and further to this, traditional and complementary medicine was not yet integrated into the healthcare system [11]. When traditional medicine practitioners are not regulated, it is difficult to ensure the quality, safety, and effectiveness of health services and the products that are provided [42]. The herbal medicine regulatory status may also be affected by the level of economic development, resource availability, political commitment, research capacity, infrastructure, and prevailing healthcare system [43]. For example, limited resources and inadequate research capacity in Malawi might be responsible for the lack of legislative framework and political commitment. Nigeria’s availability of the most important legislative structures and instruments may be due to healthcare system demand, economic development, and political commitment of the government [44].

Both countries indicated they were working towards developing policies for the regulation of traditional medicine practitioners’ practice. In Malawi, the Pharmacy and Medicines Regulatory Authority has yet to start regulating herbal medicinal products based on a risk-based approach. In this approach, it is argued that the herbal medicinal products placed on the market, are those that carry a higher risk if something goes wrong with the product. Products on the market are more accessible to the majority of the public and pose a greater health risk than those prescribed by traditional medicine practitioners in the course of their practice [20, 33]. In Nigeria, a similar risk-based approach is used for regulating and listing herbal medicinal products on the public market by the National Agency for Food and Drug Administration and Control [10]. The study revealed that the herbal medicine manufacturers and distributors in both countries were not organized despite efforts to bring them together under an association. The lack of regular supervision of manufacturing, inadequate vetting of advertisements carrying unsubstantiated claims [45], and difficulty in harmonizing different traditional medicine associations of manufacturers and distributors were also common in other countries [46].

The observed lapses in cGMP compliance among herbal medicine manufacturers in Malawi pose serious risks to the safety and quality of herbal medicinal products. Poor hygiene practices, the absence of personal protective equipment, and the lack of regular medical examinations among personnel raise concerns about product contamination during production. Additionally, noncompliance with cGMP requirements for premises increases the risk of product admixing and contamination, further compromising quality [15, 29]. The complete failure to adhere to cGMP documentation standards undermines traceability and accountability in manufacturing processes, hindering efforts to ensure product consistency and safety [47]. These companies were predominantly Micro, Small and Medium Enterprises operated by individuals with limited financial resources to meet the minimum cGMP standards for herbal medicine production [48]. Proper documentation is critical for ensuring quality assurance throughout the production process, and non-compliance in this area significantly compromises product quality. Regulatory guidelines mandate that all herbal medicinal products entering the market adhere to minimum cGMP standards to enhance overall product quality [49]. However, the inspected facilities fell short of meeting the WHO’s minimum cGMP standards for herbal medicine manufacturing [29]. Adequate human and financial resources are critical to the establishment of an efficient regulatory environment for the local manufacturing of herbal medicinal products [50]. PMRA should prioritize capacity building by providing targeted training programs for manufacturers on cGMP requirements, focusing on personnel hygiene, equipment use, and documentation practices. Regular inspections and enforcement of cGMP compliance are also critical to address these gaps and reduce risks to public health. Developing detailed guidelines for cGMP compliance specific to herbal medicine manufacturing in Malawi is essential for improving regulatory oversight and ensuring the production of safe and high-quality products [47, 51, 52].

The level of compliance with minimum cGMP standards by herbal medicine manufacturing companies in Nigeria remains unknown, as the manufacturers declined to participate in the study. Although no specific reasons were provided for their refusal, several plausible explanations can be considered based on existing industry dynamics and regulatory observations. One possible reason for the refusal is the general reluctance of herbal medicine manufacturers to be monitored [53]. NAFDAC has previously reported that manufacturers in this sector often resist regulatory oversight, possibly due to limited compliance with established standards or a preference to operate without external scrutiny. Reputation concerns may have also played a significant role. Manufacturers might have worried that participation in the study could expose non-compliance issues, potentially damaging their public image and eroding consumer trust in their products. The risk of reputational harm could have been a strong deterrent, particularly in a competitive market where consumer confidence is critical [54, 55].

Another likely factor is the fear of regulatory consequences. If the study uncovered non-compliance, the findings could be reported to authorities, triggering inspections, penalties, or other legal actions [15, 56]. This potential for increased regulatory attention might have discouraged participation. Additionally, manufacturers may have been skeptical about the intentions behind the study or the neutrality of the researchers. They might have feared that the findings could be used to favor certain competitors, harm their business interests, or even compromise proprietary information, such as patents or trade secrets [57].

Herbal medicine manufacturers in Malawi did not decline to participate in the study for several possible reasons. Firstly, establishing trust between the researchers and the manufacturers likely fostered a positive perception of the study. The transparency provided through the informed consent process, which clearly outlined the study’s objectives, procedures, and potential benefits, may have further increased their confidence in participating. Additionally, manufacturers may have recognized the potential future benefits of the study, such as improved regulation, increased visibility, and formal support for their industry. Participation may also have been seen as an opportunity to gain recognition, validate their products, and contribute to evidence-based research on herbal medicines. Furthermore, manufacturers might have viewed the study as a platform to engage with policymakers and regulatory authorities to address gaps in the regulatory framework and support the formalization of herbal medicine practices [58]. Lastly, the absence of perceived risks associated with the study and a generally positive cultural attitude towards health-related research likely further encouraged participation [59].

The findings on compliance with cGMP-based labelling, showed that very few products from Malawi and Nigeria were labelled with scientific binomial names. Product scientific binomial naming is important in herbal medicine pharmacovigilance especially when analysing some herbal-related adverse reactions that may be deduced from the genus or species [60, 61]. WHO reported naming challenges in identifying signals from herbal medicinal plants whose names were not properly identified by Latin names through labelling [49]. There was also a lack of information on the list of active ingredients and quantities on the labels. Herbal medicine manufacturers may fail to disclose all active ingredients on product labels due to limited regulatory oversight and weak enforcement mechanisms often contributing to non-compliance with labelling standards [62,63,64]. Some manufacturers may lack the technical expertise or resources to identify and quantify all active components accurately. Additionally, the desire to protect proprietary formulations or trade secrets may discourage full transparency regarding ingredients [57]. Manufacturer’s failure to list active ingredients and their quantities may attract penalties from regulators [46]. Most herbal medicinal products were labelled with English or local names without mentioning other herbal products added to the powders. The list of active ingredients and their quantities are important when assessing herbal medicine-related adverse effects [65].

Most herbal medicinal products’ labels carried therapeutic and health claims from Malawi and Nigeria. The study revealed that neither Malawi nor Nigeria has specific regulations addressing the advertising claims of herbal medicinal products, although Nigeria has broader regulations governing advertising practices [9, 22]. Herbal medicine manufacturers and sellers advertise their products with unevaluated claims through television, radio, and other mass media often include medical claims for herbal medicinal products, yet neither country currently evaluates the validity of these claims. The lack of regulation for herbal medicine claims and unregulated advertising in both countries can have significant consequences for public health and consumer safety. Unsubstantiated claims in advertisements may mislead consumers into believing in the efficacy or safety of products without scientific evidence, potentially delaying or replacing the use of evidence-based treatments for serious conditions [62, 66,67,68,69]. This can result in adverse health outcomes, including the progression of untreated diseases or harm caused by undisclosed or poorly understood product ingredients [70]. Globally, regulatory bodies e.g. Singapore, do not allow manufacturers to attach medical claims on herbal medicinal products e.g. treatment of serious diseases [46]. To protect the public in Nigeria, NAFDAC advises manufacturers to add the disclaimer “claims have not been evaluated by NAFDAC” to listed herbal medicinal products [71], while in Malawi, PMRA and MOH have a list of diseases that no traditional medicine or herbal medicinal product can claim to treat or heal through an advert or labelling [14]. Unfortunately, most herbal medicinal products from Malawi did not have lot/batch manufacturing numbers and company physical addresses which are critical in product recall when a problem is identified on the market or when tracing the manufacturer [72]. The WHO, PMRA, and NAFDAC guidelines have described the importance of adequate information on labels of herbal medicinal products [15, 28, 29]. In the case of Malawi, the lack of a legal framework for herbal medicine registration and local production reflects the unacceptable conditions in which herbal medicinal products are being manufactured and lapses in labelling requirements. While for Nigeria, despite not having cGMP results from production facilities, herbal medicinal products labelling, may be a proxy for a well-functioning registration and inspection system for herbal medicines. However, several herbal medicine sellers were freely selling and producing unregistered products thereby exposing the public to consumption of products whose quality and efficacy are not established. This observation calls for NAFDAC and MOH-Nigeria to intensify supervisory inspections of traditional medicine to safeguard public health.

The quality of herbal medicines in any country is the product of a well-functioning and efficiently reinforced national legal framework established by the government [44]. Malawi has yet to establish the governance structure and regulatory framework to fully support the traditional medicine industry, besides the development of the national traditional medicines policy, and the establishment of the Pharmacy and Medicines Regulatory Authority mandated to regulate allied substances including herbal medicines. Furthermore, the lack of legislative tools for herbal medicines is reflected in the poor compliance with manufacturing and labelling cGMP minimum requirements. This may have resulted in the unregulated production and marketing of herbal medicinal products whose quality and safety are not established putting public health at risk [50]. There is an urgent need for Malawi MOH and PMRA to put in place the legislative tools and fast track the development of the regulations and guidelines for control and registration of herbal medicines used by PLWHA in the country.

The study has shown that MOH and NAFDAC in Nigeria have a relatively comprehensive regulatory framework for traditional medicines, including governance structures and legislative provisions at both federal and state levels, despite the lack of traditional medicine practice regulation and its integration [9, 10, 15, 33, 41, 56, 73, 74]. However, a notable proportion of herbal products in the market remain unregistered with NAFDAC and fail to meet labelling requirements [56]. This discrepancy suggests challenges in enforcement, likely stemming from insufficient inspections by regulatory authorities. The Nigerian Ministry of Health needs to consider the regulation of traditional medicine practices and integration of the same into the healthcare system. We recommend that NAFDAC should reinforce the supervisory inspections on the manufacturing and sale of herbal medicines to ensure the safety and quality of these products.

The lack of a regulatory framework for traditional medicine in Malawi, coupled with poor compliance with cGMP standards in manufacturing and labeling, exposes the public to significant health risks. Many herbal products lack critical information on labels, such as batch numbers and company addresses, which are essential for product recalls and tracing manufacturers in case of issues. Furthermore, the absence of regulation for therapeutic claims on herbal products and unregulated advertising compounds the risk, misleading consumers about the efficacy and safety of these products. There is an urgent need for the MOH and PMRA to establish comprehensive regulatory structures, including the development of guidelines for the registration, manufacturing, and marketing of herbal medicines. This should also include clear regulations on therapeutic claims to protect consumer health and ensure the safety, quality, and efficacy of herbal products used by PLWHA. Although Nigeria has a more established regulatory framework for herbal medicines, challenges remain in enforcing compliance, particularly in terms of unregistered products and poor labeling practices. While NAFDAC has implemented measures such as disclaimers for unverified claims, a significant portion of herbal products on the market fail to meet registration and labeling standards. These discrepancies indicate a need for stronger enforcement, including more frequent inspections and better supervision of manufacturing and sales. Additionally, the Nigerian Ministry of Health should consider the regulation and integration of traditional medicine practices into the formal healthcare system. It is recommended that NAFDAC intensify inspections and ensure that all herbal products on the market comply with established safety and quality standards to safeguard public health and improve consumer confidence [51].

Strengths and limitations

Strengths

This study has several notable strengths. It provides a comparative analysis of traditional medicine regulatory frameworks and compliance levels in Malawi and Nigeria, shedding light on two distinct regulatory environments in Sub-Saharan Africa. By incorporating a multi-stakeholder approach, the study gathered data from regulatory officers, manufacturers, and herbal medicinal products, offering a comprehensive view of the regulatory landscape. The use of standardized tools, such as structured questionnaires and checklists, ensured consistency and reliability in data collection. Furthermore, the study addresses critical gaps in published research, focusing on an underexplored area of traditional medicine regulation and manufacturing practices, and provides actionable findings for policymakers and regulators, especially in Sub-Saharan Africa.

Limitations

The inability to access manufacturing premises in Nigeria limited the study’s ability to collect critical data necessary for a comprehensive understanding of the traditional medicine supply chain. The lack of participation by Nigerian herbal medicine manufacturers represented a missed opportunity to evaluate their compliance with GMP, particularly in areas such as personnel, equipment, premises, and documentation. Consequently, compliance with labeling requirements was used as a proxy indicator to infer the extent of adherence to cGMP standards by manufacturers in Nigeria.

Conclusions

The lack of a regulatory framework for traditional medicine in Malawi, coupled with poor compliance with cGMP standards in manufacturing and labeling, exposes the public to significant health risks. There is an urgent need for the Ministry of Health and the Pharmacy and Medicines Regulatory Authority to establish comprehensive regulatory structures, including the development of guidelines for the registration, manufacturing, and marketing of herbal medicines used by people living with HIV and AIDS. Although Nigeria has a more established regulatory framework for herbal medicines, challenges remain in enforcing compliance, particularly in terms of unregistered products and poor labeling practices. While National Agency for Food and Drug Administration and Control has implemented measures such as disclaimers for unverified claims, a significant portion of herbal products on the market fail to meet registration and labeling standards. It is recommended that National Agency for Food and Drug Administration and Control, intensify inspections and ensure that all herbal products on the market comply with established safety and quality standards to safeguard public health and improve consumer confidence.