Regulating Informal Health Product Markets: Governance Challenges and Consumer Safety in the Gambia

1.1 Background of the Study

Cosmetic and pharmaceutical products constitute an important component of contemporary healthcare systems. While pharmaceutical products are primarily associated with the diagnosis, treatment, and prevention of disease, cosmetic products contribute to personal hygiene, dermatological health, and overall wellbeing. Over the past decades, global markets for cosmetic and wellness products have expanded rapidly, driven by increasing consumer demand for skincare products, therapeutic cosmetics, herbal formulations, and natural health remedies. This expansion has not been limited to highly industrialized economies. In many developing countries, the growing popularity of cosmetic and wellness products has also stimulated the emergence of small-scale production networks operating outside conventional pharmaceutical manufacturing systems. These networks frequently consist of beauticians, home-based entrepreneurs, herbal practitioners, and traditional healers who prepare cosmetic creams, soaps, oils, and topical treatments using locally available ingredients. In The Gambia, such products are widely available in urban and peri-urban markets. Skin creams, herbal soaps, body oils, facial treatments, and various forms of therapeutic cosmetic preparations are commonly marketed through beauty salons, local markets, roadside stalls, and small retail outlets. In recent years, social media platforms have also become an important channel for the promotion and sale of these products, allowing small-scale producers to reach broader consumer audiences. For many individuals, participation in these informal production networks represents an important source of livelihood. The relatively low barriers to entry associated with cosmetic product formulation allow individuals—particularly women and youth—to engage in entrepreneurial activities without the substantial capital investments typically required for formal pharmaceutical manufacturing. Despite these socio-economic benefits, the rapid expansion of informal cosmetic production also raises important regulatory concerns. Unlike licensed pharmaceutical manufacturers, informal producers typically operate without standardized production facilities, documented quality control systems, or laboratory-based safety assessments. Ingredient sourcing practices may vary considerably, and the concentration of active compounds within products may not be systematically measured or verified. Consequently, consumers may encounter products containing unverified chemical substances, excessive concentrations of active ingredients, or contaminants introduced during the preparation process. In the context of skincare products, such risks may include exposure to substances associated with dermatological irritation, allergic reactions, or longer-term health effects. The growth of informal product formulation therefore presents regulatory authorities with a complex governance challenge. On the one hand, there is a need to protect consumers from potentially harmful products. On the other hand, regulatory approaches must also recognize the economic and cultural contexts within which these products are produced and used.

1.2 Problem Statement

Despite the existence of legislative frameworks governing pharmaceutical products and professional pharmacy practice in The Gambia, informal cosmetic and therapeutic preparations continue to circulate widely within domestic markets without consistent regulatory oversight. Products produced outside formal manufacturing systems are frequently sold through beauty salons, informal retail outlets, community markets, and online platforms, often without evidence of regulatory approval or quality verification.

Several factors contribute to this situation. First, regulatory institutions may face resource constraints that limit their ability to conduct routine inspections, laboratory testing, and post-market surveillance across a diverse and geographically dispersed marketplace. Monitoring small-scale producers operating within informal economic spaces can therefore present significant logistical and administrative challenges.

Second, the classification of certain products within existing regulatory frameworks remains unclear. Many cosmetic products are marketed with claims that extend beyond aesthetic enhancement and suggest therapeutic or medicinal effects. Herbal preparations and religiously inspired remedies may also be promoted for health-related purposes while being distributed in forms similar to cosmetic products. These overlapping categories can create ambiguity regarding which regulatory standards should apply.

Third, public awareness regarding the regulatory status of cosmetic and herbal products may be limited. Consumers may assume that products available within local markets have undergone safety evaluation, even when such products have not been subject to formal regulatory review.

These factors collectively contribute to gaps in consumer protection and raise broader questions regarding the effectiveness of regulatory governance within emerging health product markets. Addressing these challenges requires a clearer understanding of how existing regulatory frameworks operate and where institutional or legislative reforms may be necessary.

1.3 Research Objectives

The overall aim of this study is to examine the regulatory governance structures responsible for overseeing cosmetic and pharmaceutical products in The Gambia and to evaluate their effectiveness in addressing the challenges posed by informal product markets. To achieve this aim, the study pursues several specific objectives.

First, the research seeks to examine the legislative and institutional framework governing cosmetic and pharmaceutical products in The Gambia. This includes analysing key legal instruments such as the Medicines and Related Products Act of 2014 and the Pharmacy Council Act of 2014, as well as reviewing the regulatory responsibilities assigned to institutions operating under the authority of the Ministry of Health.

Second, the study aims to identify regulatory gaps affecting informal cosmetic and therapeutic product markets. Particular attention is given to the ways in which existing legislation addresses—or fails to address—the activities of small-scale cosmetic producers, herbal product manufacturers, and informal health practitioners.

Third, the research analyses the role of traditional and religious therapeutic preparations within informal health markets. In The Gambia, herbal remedies and prophetic treatments rooted in Islamic medical traditions continue to form an important component of community health practices. Understanding how these practices intersect with formal regulatory frameworks is therefore essential for developing culturally informed regulatory policies.

Fourth, the study compares regulatory governance in The Gambia with regulatory systems implemented in selected jurisdictions, including Ghana, Nigeria, Senegal, and the European Union. Comparative analysis allows for the identification of institutional practices and regulatory mechanisms that may inform policy development within the Gambian context.

Finally, the study seeks to propose policy recommendations aimed at strengthening regulatory oversight while recognizing the economic and cultural realities associated with informal cosmetic and therapeutic product production.

2. Regulatory and Institutional Framework in The Gambia

2.1 National Medicines Regulatory Legislation

The regulation of medicines and related health products in The Gambia is primarily governed by the Medicines and Related Products Act of 2014, which established the Medicines Control Agency (MCA) as the national regulatory authority responsible for overseeing medicines and related products within the country. The enactment of this legislation represented a significant milestone in the development of the national pharmaceutical regulatory system, as it introduced a more comprehensive legal framework for regulating the safety, quality, and distribution of health products. The Medicines and Related Products Act grants the Agency broad regulatory authority over the lifecycle of medicines and related products. This includes powers to regulate the manufacture, importation, exportation, distribution, advertisement, and use of medicines in order to ensure that products available within the Gambian market meet established standards of safety, quality, and efficacy (Medicines and Related Products Act, 2014). Through these provisions, the Act seeks to protect public health by preventing the circulation of substandard, falsified, or potentially harmful products. Importantly, the scope of the legislation extends beyond conventional pharmaceutical products. The regulatory mandate of the Medicines Control Agency also includes cosmetic products, herbal medicines, medical devices, and certain categories of household chemical substances that may have implications for public health. This broad regulatory scope reflects the recognition that health risks may arise not only from conventional medicines but also from a variety of consumer products that contain biologically active ingredients or chemical compounds. Another important institutional feature introduced by the Act is the establishment of a National Medicines Control Laboratory. The laboratory is intended to provide scientific and technical support for regulatory decision-making by conducting laboratory-based testing of medicines and related products entering the Gambian market. Quality control testing carried out by such laboratories plays a critical role in detecting counterfeit medicines, verifying the composition of pharmaceutical products, and ensuring compliance with regulatory standards. Despite the existence of this legislative framework, the practical implementation of regulatory oversight can be affected by several structural challenges, including limited technical resources, constraints in laboratory infrastructure, and the difficulty of monitoring products circulating within informal market spaces. These challenges are particularly relevant in relation to cosmetic and herbal products that are manufactured on a small scale and distributed through decentralized commercial networks.

2.1 Professional Regulation of Pharmacy Practice

Professional pharmacy practice in The Gambia is regulated under the Pharmacy Council Act of 2014, which established the Pharmacy Council of The Gambia as the statutory body responsible for regulating the professional practice of pharmacy within the country. The creation of the Council introduced a formal mechanism for ensuring that pharmaceutical services are delivered by appropriately trained and licensed professionals. Under the provisions of the Act, the Pharmacy Council is responsible for a range of regulatory functions that include the registration and licensing of pharmacists, the accreditation of pharmacy premises, and the maintenance of professional standards within the pharmaceutical sector. The Council also plays a role in overseeing professional conduct and may take disciplinary action where practitioners fail to comply with established professional and ethical standards. Through these regulatory responsibilities, the Council contributes to ensuring that medicines are dispensed in accordance with recognized professional guidelines. Proper dispensing practices are essential for safeguarding patient safety, particularly in relation to prescription medicines that require professional supervision. The Pharmacy Council operates in coordination with the Medicines Control Agency, and the functions of the two institutions are complementary. While the Medicines Control Agency focuses primarily on the regulation of products, including their safety and quality, the Pharmacy Council focuses on the regulation of professionals and pharmacy premises responsible for the handling and dispensing of those products. The establishment of these two institutions in 2014 represented a significant reform of the pharmaceutical regulatory system in The Gambia. Prior to these reforms, regulatory oversight of medicines and pharmaceutical practice was more fragmented. The creation of dedicated regulatory bodies therefore marked an important step toward strengthening national capacity for medicines governance and public health protection.

2.2 Role of the Ministry of Health

The Ministry of Health plays a central role in shaping the broader policy environment within which pharmaceutical regulation operates in The Gambia. As the principal governmental authority responsible for national health policy, the Ministry provides strategic oversight and policy direction for the regulation of medicines, medical products, and other health-related commodities. Through the development of national health policies, pharmaceutical sector strategies, and regulatory guidelines, the Ministry supports the implementation of legislative frameworks governing medicines and related products. The Ministry also facilitates coordination between regulatory institutions such as the Medicines Control Agency and the Pharmacy Council, ensuring that regulatory activities align with national public health priorities. In addition to policy coordination, the Ministry of Health contributes to regulatory capacity development through initiatives aimed at strengthening technical expertise, improving regulatory infrastructure, and promoting collaboration with international partners. Such partnerships may include cooperation with organizations such as the World Health Organization and regional regulatory networks that support the strengthening of national medicines regulatory systems. However, the rapidly evolving nature of health product markets—particularly those involving informal production and distribution—continues to present challenges for regulatory authorities. Addressing these challenges requires not only effective legislation but also sustained institutional support, adequate technical resources, and ongoing public engagement.

3. Informal Cosmetic and Pharmaceutical Markets in The Gambia

3.1 Nature of Informal Production

Informal cosmetic production in The Gambia encompasses a diverse range of products that are prepared outside formal pharmaceutical manufacturing environments. These products are typically produced on a small scale and often rely on locally available ingredients or commercially purchased raw materials. The range of products commonly encountered within informal markets includes:

• skin creams and body lotions
• herbal soaps and body washes
• skin-lightening preparations
• hair treatment oils and conditioners
• herbal therapeutic formulations intended for topical use or otherwise

The individuals involved in producing these products vary widely in terms of their backgrounds and expertise. Some producers are trained beauticians who have acquired practical knowledge through beauty therapy training or professional experience in cosmetic services. Others are traditional healers who prepare herbal remedies based on indigenous medical knowledge or family traditions. In addition, a growing number of small-scale entrepreneurs have entered the cosmetic production sector in response to increasing consumer demand for locally produced skincare products. Many of these entrepreneurs operate home-based production enterprises that allow them to participate in small-scale commercial activities with relatively low start-up costs. Although these activities may generate important livelihood opportunities, the absence of standardized production procedures can raise concerns regarding product consistency and safety. Informal producers may not have access to laboratory testing facilities, standardized formulation guidelines, or regulatory training related to cosmetic manufacturing practices. As a result, variations in ingredient quality, product composition, and storage conditions may occur.

3.2 Distribution Channels

The distribution of informal cosmetic and therapeutic products in The Gambia occurs through a variety of decentralized channels. Unlike formally registered pharmaceutical products, which are typically distributed through licensed pharmacies or regulated wholesale supply chains, informal products circulate through more flexible and community-based commercial networks.

Common distribution channels include:

• beauty salons and cosmetic service establishments
• street markets and roadside vendors
• small informal retail outlets
• social media platforms and online marketing networks

Beauty salons often serve as both production and distribution sites for cosmetic products. In many cases, beauticians formulate skincare products that are used within their own services and subsequently sold directly to clients. Street markets and community retail spaces also play an important role in the circulation of locally produced cosmetics and herbal remedies. In recent years, digital platforms such as social media have expanded the reach of informal product markets. Producers are increasingly able to advertise and sell cosmetic products online, thereby accessing wider customer bases without relying solely on physical retail spaces. The decentralized and informal nature of these distribution systems makes systematic regulatory monitoring particularly challenging. Regulatory authorities may find it difficult to identify all producers operating within the market or to conduct routine inspections of production environments. This complexity highlights the need for regulatory strategies that combine formal oversight with public awareness initiatives and engagement with small-scale producers.

4. Traditional, Herbal, and Prophetic Therapeutic Preparations

4.1 Prophetic Medicine and Religious Health Practices

Traditional and religious health practices continue to play a significant role in many African healthcare systems, including that of The Gambia. Alongside conventional biomedical treatments, individuals often seek therapeutic solutions derived from herbal medicine, traditional healing practices, and religious health traditions. In predominantly Muslim societies such as The Gambia, certain therapeutic practices are influenced by the traditions associated with prophetic medicine, commonly referred to as Tibb al-Nabawi. These traditions are rooted in historical Islamic medical literature and are based on remedies and health practices attributed to the teachings of the Prophet Muhammad (saw). Prophetic medicine frequently involves the use of natural substances that are referenced within Islamic traditions, including honey, black seed (Nigella sativa), olive oil, dates, and various herbal preparations. These substances are widely regarded within Islamic medical tradition as possessing beneficial health properties and are often used in the preparation of remedies intended to support general wellbeing. In some cases, these remedies are combined with spiritual practices such as Qur’anic recitation, supplications (duʿāʾ), or spiritual counselling. Such practices are commonly performed by religious scholars or traditional healers who provide spiritual and therapeutic guidance within their communities. For many individuals, the use of prophetic or herbal remedies reflects deeply rooted cultural and religious beliefs regarding health, healing, and spiritual wellbeing. As a result, these practices remain widely accepted and continue to coexist with biomedical healthcare services.

4.2 Regulatory Implications

The intersection between traditional therapeutic practices and formal regulatory systems presents a complex governance challenge. When prophetic or herbal remedies are prepared for personal or household use, they typically fall outside the scope of formal regulatory oversight. Individuals preparing remedies for their own consumption or for use within family settings are generally not subject to regulatory controls governing pharmaceutical manufacturing. However, the situation becomes more complex when such remedies are commercially packaged, advertised, or sold to the public as treatments for specific medical conditions. Once products enter the marketplace and are marketed with therapeutic claims, they may fall within the regulatory scope of medicines legislation. The Medicines and Related Products Act of 2014 recognizes herbal medicines and related products as part of the regulatory mandate of the Medicines Control Agency. In principle, this means that herbal preparations marketed for therapeutic purposes may require regulatory evaluation to ensure that they meet basic safety and quality standards. In practice, however, the regulation of herbal and traditional remedies can be difficult to implement. Informal production, limited documentation of product ingredients, and the cultural sensitivity associated with regulating traditional health practices may complicate enforcement efforts. Developing effective regulatory strategies therefore requires a balanced approach that protects public health while respecting the cultural significance of traditional and religious health practices. Collaborative engagement between regulatory authorities, traditional practitioners, and community leaders may provide a constructive pathway for improving safety oversight without undermining culturally embedded systems of knowledge and healing.

METHODOLOGY

5.1 Research Design

This study adopts a qualitative desk-based policy analysis approach to examine the regulatory governance structures that oversee cosmetic and pharmaceutical products in The Gambia. Desk-based research involves the systematic review and interpretation of existing documentary sources, including legislation, institutional reports, regulatory guidelines, and academic literature. Rather than relying on primary data collection through surveys or interviews, this method focuses on analysing policy frameworks and institutional arrangements as they are articulated in official documents and scholarly studies. The use of desk-based policy analysis is particularly appropriate for research concerned with regulatory governance systems. Regulatory frameworks are primarily embedded within legal instruments, institutional mandates, and policy documents. Consequently, examining these sources allows researchers to assess how regulatory authority is structured, how responsibilities are distributed among institutions, and how policy objectives are translated into operational practices. In the context of pharmaceutical and cosmetic regulation, desk-based analysis also enables the comparison of national regulatory frameworks with international standards and best practices. By reviewing legislation and policy documents alongside comparative regulatory literature, it becomes possible to identify areas in which regulatory systems align with or diverge from internationally recognized governance models. The approach adopted in this study therefore facilitates a comprehensive examination of the legal foundations, institutional arrangements, and operational capacities that shape regulatory oversight of medicines and related products in The Gambia. In addition, the desk-based method allows for a comparative assessment of regulatory systems in other jurisdictions, thereby situating the Gambian framework within a broader global regulatory landscape.

5.2 Data Sources

The analysis draws upon three primary categories of documentary sources: legal and regulatory documents, institutional reports, and academic literature. Each category provides a distinct perspective on the structure and functioning of the regulatory system.

5.3 Legal and Regulatory Documents

The first category of sources consists of national legislation and regulatory frameworks that define the legal authority of regulatory institutions. Key documents reviewed in this study include:

• Medicines and Related Products Act (2014)
• Pharmacy Council Act (2014)
• National medicines policy documents
• Regulatory guidelines issued by the Medicines Control Agency

These documents provide the legal basis for the regulation of medicines, cosmetics, herbal products, and pharmaceutical practice in The Gambia. They establish the mandates of regulatory institutions, outline the procedures for product registration and licensing, and define enforcement mechanisms designed to protect public health. Reviewing these legal instruments allows the study to assess the scope, clarity, and coherence of the regulatory framework governing health products within the country.

5.4 Institutional Reports

The second category of sources consists of policy documents and institutional reports produced by governmental and international organizations involved in pharmaceutical regulation. These include:

• Ministry of Health policy documents and strategic frameworks
• Medicines Control Agency strategic plans
• World Health Organization regulatory guidance documents
• European and other West African Medicines Agency documents

Such reports provide insight into the operational priorities, institutional capacity, and strategic objectives of regulatory authorities. They also reveal how legislative mandates are translated into practical regulatory activities such as product evaluation, inspection, and market surveillance. International guidance documents produced by the World Health Organization are particularly valuable because they provide normative benchmarks for evaluating the effectiveness of national medicines regulatory systems.

5.5 Academic Literature

The third category of sources consists of scholarly research examining pharmaceutical regulation, public health policy, and traditional medicine governance. This literature includes:

• studies on regulatory science and medicines governance
• public health policy analyses
• research examining the regulation of herbal and traditional medicines

Academic literature helps contextualize national regulatory systems within broader theoretical and empirical debates about health governance. It also provides insights into regulatory challenges commonly encountered in low- and middle-income countries, including resource limitations, fragmented regulatory structures, and the growing role of informal health product markets.

5.6 Analytical Framework

To evaluate the effectiveness of the regulatory system, the study employs a comparative governance framework that examines regulatory institutions across three key analytical dimensions: regulatory clarity, institutional capacity, and consumer protection. These dimensions capture core elements of effective medicines regulation as recognized in international regulatory policy literature.

Regulatory clarity refers to the degree to which legislation clearly distinguishes between different categories of health products, including medicines, cosmetics, and traditional remedies. Ambiguities in product classification can create regulatory gaps that allow certain products to evade appropriate oversight.

Institutional capacity concerns the ability of regulatory authorities to implement legislation effectively. This includes the availability of trained personnel, laboratory testing facilities, inspection systems, and administrative resources required to regulate complex product markets.

Consumer protection focuses on mechanisms designed to monitor products after they enter the market. These mechanisms include post-market surveillance systems, adverse event reporting procedures, and enforcement measures aimed at removing unsafe products from circulation.

By examining regulatory governance through these three dimensions, the study is able to identify both the strengths and the limitations of the Gambian regulatory system.

6. Comparative Regulatory Approaches

Regulatory responses to informal cosmetic and therapeutic product markets vary considerably across jurisdictions, particularly in low- and middle-income countries where informal economies play an important role in health product distribution. Examining regulatory approaches adopted in other countries provides useful insights for strengthening regulatory governance in The Gambia. In Ghana, the Food and Drugs Authority (FDA) regulates herbal medicines, cosmetics, and traditional medicinal products through a formal product registration system. Herbal medicines intended for commercial distribution must undergo safety and quality evaluation before approval. The Ghanaian regulatory system also includes licensing of herbal medicine manufacturing facilities and market surveillance mechanisms designed to detect unsafe or unregistered products (Food and Drugs Authority Ghana, 2020).

Nigeria operates a more extensive regulatory framework through the National Agency for Food and Drug Administration and Control (NAFDAC). The agency regulates pharmaceuticals, cosmetics, herbal products, and traditional medicines through mandatory registration procedures and post-marketing surveillance. NAFDAC has also implemented public awareness campaigns to educate consumers about the risks associated with unregulated cosmetic products and counterfeit medicines (NAFDAC, 2019).

Outside Africa, regulatory systems in Europe and North America apply more stringent regulatory controls. Within the European Union, cosmetic products are regulated under the EU Cosmetic Regulation (Regulation EC No. 1223/2009), which requires safety assessments, ingredient restrictions, product notification through centralized databases, and responsible person accountability for market compliance (European Commission, 2019). Herbal medicinal products are similarly regulated under specific directives that require evidence of safety and traditional use.

In the United States, the Food and Drug Administration (FDA) regulates cosmetics and therapeutic products under the Federal Food, Drug, and Cosmetic Act. Although cosmetics generally do not require pre-market approval, manufacturers are legally responsible for ensuring product safety, proper labeling, and compliance with ingredient restrictions (U.S. Food and Drug Administration, 2022). Here is a comparative overview of selected regulatory frameworks is presented in Table 1 below.

Table 1 Comparative Regulatory Approaches to Cosmetic and Herbal Product Oversight