African Customary and Religious Law Review (ACARELAR) 5 (2024) 33 | P a g e AN ASSESSMENT OF THE REGULATORY FRAMEWORK FOR AFRICAN TRADITIONAL MEDICINAL PRACTICE IN NIGERIA* Abstract Traditional medicine (TM) by World Health Organization (WHO) is the totality of knowledge, skills, and practices based on theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance and preservation of health, whether physical or mental. African traditional medicine is the holistic healthcare system specializing on divination, spiritualism, and herbalism. In Nigeria, most indigenes rely on TM to meet their primary healthcare needs. WHO’s strategy for TM is to promote TM integration and complementary and alternative medicine (CAM) into the healthcare systems of countries. Therefore, the aim of this study was to critically assess the regulatory framework for traditional medicinal practice in Nigeria. The research methodology was doctrinal approach, using expository and analytical research design. The main sources of data collection were literatures from physical library and e-library. This research found, among others, that there is need to have a working national framework for the safe practice of TM in Nigeria. Thus, this research recommended, among others, a distinct national framework for the practice of TM in Nigeria which will also establish a functioning regulatory institution in various states, thereby ensuring proper regulation and enlightenment in this milieu. Keywords: Alternative, Complementary, Traditional Medicine, Regulatory Framework, Nigeria, Assessment 1. Introduction Governments all over the world are increasingly embracing and recognizing Trado-medical practice which been propelled by the fact that many diseases which have proven resistant to orthodox medicine requires attention from alternative therapy. The challenge of adopting trado-medical practice into the mainstream health care sector is that it is not backed with a specific legislation regulating its practice and practitioners. In most developing countries, including Nigeria, the majority of the populace lives in the rural areas, where the use of herbal medicines is common. The use of herbal medicines in the urban areas is on the increase, arising from the global inflationary trend, which hampers the sustainable supply of orthodox medicines and reduces the purchasing power of the populace.1 Basically, traditional medicine occupies a pivotal position in the Nigerian rural health service delivery system which cannot be neglected. This poses a major problem in the necessity to create statutory flavour, institutional basis and an enabling environment for the development of traditional medicine and its eventual integration into the health care delivery system of the country. These weaknesses also include the unverifiable and inexplicable aspects of occultic/witchcraft practices, the practitioners lacking the skill for correct diagnosis of serious disorders, inadequate coordination of practitioners’ activities giving room to dubious and unscrupulous elements. Also, it a problem to effectively regulate and sustain the opportunities which exist for traditional medicine practice which include existence of a virile Herbs and Leaves Traditional Medicines Practitioners’ Association of Nigeria, large number of population of traditional medical practitioners with great spread over all ethnic groups coupled with a large Nigerian population of about 170million consumers.2 There are also threats in the activities and practices of charlatans, the importation of higher quality traditional medicine products and the reality of some herbs are going into extinction of which these problems could be addressed through a working legislation and institution. This is manifested in the Nigeria government’s reluctance to accord medicine its primate position in the healthcare delivery system. As a matter of fact, traditional medicine is practiced in Nigeria today without enabling national legislation that will regulate its practice as obtained in many parts of the world.3 However, many states in the country have established traditional medicine boards/agencies to monitor the activities of its practitioners. Given these quandaries, the crux of the matter for this article is to critically assess the regulatory framework for African traditional medicinal practice in Nigeria. 2. Conceptual Analysis of African Traditional Medicine Traditional Medicine (TM) is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.4 TM includes herbal medicine, bone setting, spiritual therapies, circumcision, maternity care, psychiatric care, massage therapy, *By Pius OSUNYIKANMI, LLB, LLM, PhD, Formerly Adjunct Lecturer, Department of Private and Public Law, Faculty of Law, Adekunle Ajasin University, Akungba Akoko, Nigeria. Email: Phone No: +2348034711143 / +2348148022385 1 ‘Regulation of Herbal Medicines in Nigeria: The Role of the National Agency for Food and Drug Administration and Control (NAFDAC)’ Online Source accessed 10 May, 2024. 2 A O Ajala, ‘Traditional Medicine Practices in Nigeria: A SWOT Analysis’ (2019) (10) (2) International Journal of Mechanical Engineering and Technology (IJMET) (IAEME Publication Scopus Indexed) p. 117-26. 3 World Health Organization, ‘Legal Status of Traditional Medicine and Complimentary/lternative Medicine: A Worldwide Review’ accessed 10 May 2024. 4 World Health Organisation, WHO, ‘Traditional Medicine’ (2008) Fact Sheet, p. 134. OSUNYIKANMI: An Assessment of the Regulatory Framework for African Traditional Medicinal Practice in Nigeria 34 | P a g e aromatherapy, music therapy, homeopathy and a lot of others.5 Section 2 of Delta State Traditional Board Edict provides that ‘traditional medicine include prescription, treatment, concoction or and drugs indigenous to the Nigerian Traditional Society intended for curing or preventing disease or any form of ill health.’6 A traditional medicine practitioner mean a provider or purveyor of traditional medicine and includes herbalists, bone setters, traditional birth attendants and midwives, healers, of psychological and allied illness, traditional surgery herbal healers and every other person whose beneficial practices fall within traditional medicine practice.7 African traditional medicine is a form of holistic health care system organized into three levels of specialty, namely divination, spiritualism, and herbalism. The traditional healer provides health care services based on culture, religious background, knowledge, attitudes, and beliefs that are prevalent in his community. Illness is regarded as having both natural and supernatural causes and thus must be treated by both physical and spiritual means, using divination, incantations, animal sacrifice, exorcism, and herbs. Herbal medicine has been an integral part of healthcare in Nigeria for centuries, deeply rooted in the country's rich cultural heritage and traditional healing practices. In a nation where cultural diversity thrives, herbal remedies have served as primary healthcare options for millions, offering an alternative to conventional medicine, particularly in rural and underserved communities. However, as Nigeria advances towards modernization and global integration, the regulation of herbal medicine stands as a pressing challenge, necessitating a delicate balance between preserving traditional practices and upholding modern healthcare standards.8 In African traditional setting, there was always an explanation as to why someone was suffering from a certain disease at a particular time. According to Ayodele9, diseases mostly revolve around witchcraft/sorcery, gods or ancestors, natural, as well as inherited. Illness in the African society is different from the allopathic Western medicine point of view. Illness is believed to be of natural, cultural, or social origin.10 Cultural or social illness is thought to be related to supernatural causes such as angered spirits, witchcraft, or alien/evil spirits, even for conditions now known to be well understood in modern medicine such as hypertension, sickle-cell anemia, cardiomyopathies, and diabetes. African traditional beliefs consider the human being as being made up of physical, spiritual, moral, and social aspects. The functioning of these three aspects in harmony signified good health, while if any aspect should be out of balance, it signified sickness. Thus, the treatment of an ill person involves not only aiding his/her physical being but may also involve the spiritual, moral, and social components of being as well. Many traditional medical practitioners are good psychotherapists, proficient in faith healing (spiritual healing), therapeutic occultism, circumcision of the male and female, tribal marks, treatment of snake bites, treatment of whitlow, removal of tuberculosis lymphadenitis in the neck, cutting the umbilical cord, piercing ear lobes, removal of the uvula, extracting a carious tooth, abdominal surgery, infections, midwifery, and so on. According to Kofi-Tsekpo,11 the term ‘African traditional medicine’ is not synonymous with ‘alternative and complementary medicine.’ African traditional medicine is the African indigenous system of health care and therefore cannot be seen as an alternative. Nigeria boasts of a diverse array of indigenous healing traditions, encompassing herbal remedies, spiritual rituals, and ancestral knowledge passed down through generations.12 These practices are deeply embedded in the fabric of Nigerian culture, reflecting the country's rich biodiversity and cultural diversity. Herbal medicine, in particular, plays a pivotal role in addressing various health conditions, ranging from common ailments to chronic diseases, and has been a cornerstone of healthcare delivery in both rural and urban settings.13 Amidst the cultural significance and widespread use of herbal medicine, concerns regarding safety, efficacy, and standardization have emerged as critical issues.14 While traditional healers possess invaluable knowledge and expertise, the lack of regulatory oversight raises challenges in ensuring quality control, proper dosage, and accurate labeling of herbal 5 T I Borokini and I O Lawal, ‘Traditional Medicine Practices among the Yoruba People of Nigeria: A Historical Perspective’ (2014) Journal of Medicinal Plants Studies 2(6). 6 Delta State Traditional Board Edict, section 2. 7 Ibid, also per Makwe (dictum) Ibodje v. Delta State Traditional Medicine Board, Nigeria (2011) 1 DLR 11. 8 M A Eruaga, E O Itua and J T Bature, ‘Exploring Herbal Medicine Regulation in Nigeria: Balancing Traditional Practices with Modern Standards’ (2024) (18) (03) GSC Advanced Research and Reviews, pp. 83–90. 9 S J Ayodele, ‘The Yoruba Cultural Construction of Health and Illness’ (2002) (11) (3) Nordic Journal of African Studies (University of Ibadan Press) pp. 322-35. 10 P White, ‘The Concept of Disease and Healthcare in African Traditional Religion in Ghana’ (2015) (71) (3) HTS Theological Studies, pp. 5-17. 11 M Kofi-Tsekpo, ‘Institutionalization of African Traditional Medicine in Healthcare Systems in Africa’ (2004) (11) African Journal of Health Sciences. pp. i-ii. 12 G G Akunna, C A Lucyann, and L C Saalu, ‘Rooted in Tradition, Thriving in the Present: The Future and Sustainability of Herbal Medicine in Nigeria’s Healthcare Landscape.’ (2023) Journal of Innovations in Medical Research 2(11), pp.28-40. 13 A Shaito, ‘Herbal Medicine for Cardiovascular Diseases: Efficacy, Mechanisms, and Safety’ (2022) Frontiers in Pharmacology, 11, p. 422. 14 A S Chopra and others, ‘The Current Use and Evolving Landscape of Nutraceuticals’ (2022) Pharmacological Research, 175, p. 106. African Customary and Religious Law Review (ACARELAR) 5 (2024) 35 | P a g e remedies.15 Moreover, as Nigeria strives to achieve universal healthcare coverage and improve healthcare outcomes, integrating traditional medicine into the formal healthcare system becomes imperative, necessitating effective regulation to protect public health and promote patient safety.16 The increasing popularity and demand for TM services in Nigeria has attracted the attention of policy makers, researchers and healthcare professionals. Although social and cultural issues as well as the nature and severity of diseases constitute some reasons for TM use17 it is difficult to completely unravel what accounts for the vast level of patronage of unorthodox health products and measures employed as TM.18 According to Niggemann and Grüber,19 TM use has often been seen as popular because of its seeming harmlessness since most of TM is considered to be natural. Other reasons for its popularity are attributed to its availability, low cost, accessibility, alignment with patient’s cultural and religious values, and perceived efficacy and safety as well as dissatisfaction with and inadequacy and inaccessibility of orthodox medical healthcare services.20 Traditional medicine has impacted significantly on the lives of the people especially in the rural areas where access to orthodox medicine is minimal. Aside lack of access, the prohibitive cost of western medications makes traditional medicine attractive. On the other hand, WHO21 reported that they are detested by orthodox medical practitioners for their lack of standardization of the dosage regimen, unwanted side effects that arise from the varied nature of combined elements, injuries resulting from mechanical procedure of treatment and increased diagnostic and treatment failures that follow poor training of most providers. Notwithstanding all the above, it must be stressed that TM has a major persuasive appeal to many people. 3. Regulatory Framework of African Traditional Medicinal Practice in Nigeria In Nigeria, the regulation of herbal medicine is governed by various regulatory bodies, including the National Agency for Food and Drug Administration and Control (NAFDAC), the Traditional Medicine Development Division (TMDD) of the Ministry of Health, and state-level agencies.22 These regulatory structures aim to oversee the manufacturing, importation, distribution, and sale of herbal products, ensuring compliance with safety, efficacy, and quality standards. Additionally, there are traditional medicine councils at both federal and state levels, which collaborate with traditional healers to promote regulation and standardization within the traditional medicine sector.23 The existing regulatory frameworks in Nigeria have made significant strides in formalizing the herbal medicine sector and enhancing consumer protection.24 They have helped to create awareness about the importance of quality control, good manufacturing practices, and product labeling. However, weaknesses persist, including inadequate enforcement of regulations, limited resources for monitoring and inspection, and challenges in coordinating efforts between regulatory agencies.25 Moreover, there is a lack of harmonization between national and state-level regulations, leading to inconsistencies in implementation and oversight. Several gaps exist in the regulatory frameworks governing herbal medicine in Nigeria, with significant implications for public health and safety.26 These include the absence of standardized training and certification requirements for herbal practitioners, which can lead to variations in practice and quality of care. Additionally, there is a lack of comprehensive data on the safety and efficacy of herbal remedies, making it difficult to assess 15 E Y Enioutina and others, ‘How can We Improve the Safe Use of Herbal Medicine and other Natural Products?’ Expert Review of Clinical Pharmacology, 13(9), pp. 935-44. 16 C Jansen, ‘Medicine in Motion: Opportunities, Challenges and Data Analytics-based Solutions for Traditional Medicine Integration into Western Medical Practice’ (2021) Journal of Ethnopharmacology, 267, p. 113-47. 17 J L Onyiapat, I L Okoronkwo and N P Ogbonnaya, ‘Complementary and Alternative Medicine Use among Adults in Enugu, Nigeria’ (2011) BMC Complement Altern Med Obafemi Awolowo University, Vol. 30 No. 1. 18 World Health Organisation (WHO), ‘Traditional Medicine’ (2003) Fact Sheet. No. 134. 19 B Niggemann and C Grüber, ‘Side-effects of Complementary and Alternative Medicine’ (2003) (58) Allergy Journal, pp. 707-16. 20 T Adefolaju, ‘Traditional and Orthodox Medical Systems in Nigeria: The Imperative of a Synthesis.’ (2014) American Journal of Health Research. Vol. 2, No. 4, pp. 118-124. doi: 10.11648/j.ajhr.20140204.13. 21 World Health Organisation (WHO), ‘Traditional Medicine’ (2003) Fact Sheet. No. 134. 22 A F Ojonugwa, D Gwom and S Gwom, ‘The Role and Challenges of the National Agency for Food and Drug Administration and Regulation of Alternative Medicine in Nigeria’ (2021) World Health, pp 21-45. 23 O M Kasilo and C Wambebe, ‘Traditional and Complementary Medicine in Global Health Care’ In Handbook of Global Health (Cham Springer International Publishing 2021) pp. 1-47. 24 T C Odubo, ‘Socioeconomic Values of Herbal Medicine’ In Herbal Medicine Phytochemistry: Applications and Trends (Cham Springer International Publishing, 2023) p. 31. 25 A O Noah, P Adhikari, B O Ogundele and H Yazdifar, ‘Corporate Environmental Accountability in Nigeria: An Example of Regulatory Failure and Regulatory Capture’ (2021) Journal of Accounting in Emerging Economies, 11(1), pp. 70-93. 26 Y A Adebisi and others, ‘Revisiting the Issue of Access to Medicines in Africa: Challenges and Recommendations’ (2002) Public Health Challenges, 1(2), p. 9. OSUNYIKANMI: An Assessment of the Regulatory Framework for African Traditional Medicinal Practice in Nigeria 36 | P a g e their risks and benefits accurately.27 Furthermore, the proliferation of unregistered and unregulated herbal products in the market poses serious health risks to consumers, including contamination, adulteration, and drug interactions. Addressing these gaps requires concerted efforts to strengthen regulatory capacity, enhance collaboration between stakeholders, and promote evidence-based practices in the herbal medicine sector.28 In some countries, especially China29 and India30 the policy direction is to train, retrain Trado-Medical practitioners and control their practice by special national legislation. Some African countries like Ghana are presently emulating these other countries to update traditional medicine and practice.31 Before attempting to gauge the impact of the regulatory mechanisms of trado medical practice in Nigeria, it is pertinent to highlight the said mechanisms which is a combination of legislation, institutions and agencies at all levels.32 4. Option of Complementary and Alternative Medicine (CAM) and Effort to Regulate in Nigeria Complementary and Alternative Medical Council of Nigeria33 promotes the growth and regulate the practice of alternative medicine in Nigeria. When traditional medicine is adopted outside its traditional culture, it is often referred to as ‘complementary and alternative medicine (CAM).’ Under the enabling law, the CAM Council is primarily concerned with the alternative and complementary medicine to the exclusion of traditional medicine,34 but an analysis of this agency as part of the regulatory framework becomes germane due to the fact that traditional medicine and complimentary/alternative medicine are used interchangeably in some countries. Complementary and Alternative Medicine (CAM) practice in Nigeria is very comprehensive covering many areas with various forms and therapies such as herbal medicine, massage, homeopathy, mud bath, music therapy, wax bath, reflexology, dance therapy, hydrotherapy, mind and spirit therapies, dieting, spinal manipulation, psychotherapy, bone setting, delivery by traditional birth attendants, circumcision by traditional surgeons, traditional medicinal ingredient dealers.35 This is another threat which is the issue of secrecy of the CAM practitioners. Some of their procedures cannot be learnt by outsiders. The expertise was regarded as secret and was passed down within family members as inheritance. As a result of the poor literacy level of some of the TM practitioners and their secrecy, a lot of useful information has perished with aged originators due to lack of organized record keeping and documentation. Most traditional medicine practitioners in Nigeria regard the medicine they use as their personal property and conduct their practices under strict confidentiality.36 The Complementary and Alternative Medicine bill sets up the council and charges the council with the following responsibilities: prepare and formulate criteria and standards for the registration and maintenance of an e-register of complementary and Alternative Medical Practitioners in Nigeria;37 determine what standards of knowledge and skill are to be attained by persons seeking to become members of the relevant professions and raising those standards from time to time as circumstances may require;38 secure in accordance with the provision of this Act the establishments and maintenance of an e-register of persons registered under this Act as members of the relevant profession and to publish from time to time the list of those members;39 conduct assessment examinations in the relevant disciplines, register and /or issue practicing license to qualified candidates as appropriate, and for such purpose as the council shall prescribe fees in respect thereof;40 create and regularly upgrade minimum standard required for the establishment of clinics, hospitals of complementary and alternative medicine;41 register, de- register, expel, suspend, seal and apply any form of disciplinary measure that is deemed fit by the council for any erring practitioner, clinic, hospital, or private medical institution of complementary and alternative medicine;42 27 E Faulkner, ‘Being Precise about Precision Medicine: What should Value Frameworks Incorporate to Address Precision Medicine?’ (2020) A Report of the Personalized Precision Medicine Special Interest Group Value in Health, 23(5), pp. 529- 39. 28 Y Veziari, S Kumar and M Leach, ‘Addressing Barriers to the Conduct and Application of Research in Complementary and Alternative Medicine: A Scoping Review’ (2021) BMC Complementary Medicine and Therapies, 21(1), pp. 1-12. 29 WHO, ‘Traditional Herbal Medicine and Human Health: Regulatory Situation of Herbal Medicines: A Worldwide Review’ Online Source accessed 10 May 2024. 30 The Central Council of Indian Medicine Act of 1970. 31 T. M. P Act, S.8 - 17 (2000) which establishes a Council to regulate the practice of traditional medicine, register practitioners and issue them with practicing licenses in Ghana. The Act also regulates the preparation and sale of herbal medicines. 32 E A Okojie, ‘Impacts of Regulatory Mechanisms on Trado-Medical Practice in Nigeria’ (2015) Journal of Law, Policy and Globalization, p. 5, ISSN 2224-3240. 33 Complementary and Alternative Medical Council of Nigeria Bill. 34 Ibid, s. 14 of the Bill. 35 T Adefolaju, ‘The Dynamics and Changing Structure of Traditional Healing System in Nigeria’ (2011) Int J Health Res.; 4(2):99-106. 36 Ibid. 37 Complementary and Alternative Medical Council of Nigeria Bill, s. 4 (1) (a). 38 Ibid, s 4 (1) (b). 39 Ibid, s. 4 (1) (c). 40 Ibid, s. 4 (1) (d). 41 Ibid, s. 4 (1) (e). 42 Ibid, s. 4 (1) (f). African Customary and Religious Law Review (ACARELAR) 5 (2024) 37 | P a g e validate through scientific research the various claims on complimentary an alternative medicine products by the manufacturers and practitioners;43 promotion of scientific research and clinical trials in complementary and alternative medicine;44 collate, publish, disseminate and exchange information on complementary and alternative medicine research;45 establish a data base management system/library on all forms of alternative complimentary medicine resources;46 determine the standards required for academic and non- academic staff, offices, classrooms, structures, equipment and learning environment in respect of institution(s) established in Nigeria for the purpose of awarding certificates of diplomas and degrees in any discipline(s) of complementary and alternatives medicine;47 evaluate foreign diplomas and degrees in any discipline(s) of complementary and alternatives medicine for purposes of registering the practitioner in Nigeria;48 ensure he full integration of complementary and alternative medicine in the national healthcare delivery system;49 promote integration between practitioner’s complementary and alternative and other health related workers;50 and to carry out any other activity that would assist in achieving the objectives of the council.51 Despite the elaborate functions and scope of the council as enumerated in the bill, the bill has not been passed into law therefore rendering the proposed regulation of alternative medicine via the bill impossible. We humbly contend that this provision therefore compromises the independence of the council. Our argument on this point is further justified by section 3(3)(a)–(c) of the Bill which empowers the president to remove a member of the council at any time for either the inability of that member to discharge the functions of the office (whether rising from infirmity of mind or any other cause) or for misconduct or if the president is satisfied it is not in the interest of the council that the member should continue in office.52 5. Challenges to Regulatory Framework The problems of traditional medicine may seem unlimited and invariable challenging effort to viable regulations. This is because, apart from the legal and institutional framework, there is also lack of financial support for production and dissemination of key species for cultivation, limited human resources knowledgeable on process technology and development of industries, the low prices paid for traditional medicinal plants by herbal medicine traders and urban herbalists, lack of appropriate technology for post-harvest and pre-processing purposes adapted productivity and insufficient documentation for verification of the traditional health practitioner’s claims on quality, safety and efficacy. There is also lack of preservation of medicinal extracts for extended shelf life. Erinosho buttresses that traditional medical practice, in spite of its popularity has been challenged on many grounds.53 One of such is that its popularity is based on the anecdotal experiences of patients. Osborne notes that the practitioners inflate the claims attached to advertisement and its products as well as not having scientific data about its effectiveness, thus making it difficult to ascertain legitimate and effective therapy and therapist.54 Some of the other arguments against traditional medicine according to Erinoso include the fact that: Traditional medical practitioners lack the skills required for correct diagnosis of serious disorders, that they are always unwilling to accept the limitations of their knowledge, skills and medicines particularly in complicated organic disorders, also that traditional medicine lacks standard dosage and have not been subjected to scientific verifications. That even though the educated are convinced, the healers have supernatural knowledge and that this knowledge is medically useful, they have found them to be unscrupulous and dubious, and that the healers lack the equipment required to conduct physical examinations.55 In a similar vein, the National Agency for Food and Drug Administration and Control (NAFDAC)56 expressed the challenges being faced in regulating traditional medicines to include, lack of documentation, inadequate coordination of the practitioners’ activities, poor communication between the practitioners and their patients, secrecy of actual contents and/or difficulty in determining actual ingredients. Furthermore, most of the claims of the traditional practitioners are said to be unsubstantiated and their post- market monitoring has been difficult. Patients are also said to have reported adverse reactions. 43 Ibid, s. 4 (1) (g). 44 Ibid, s. 4 (1) (h). 45 Ibid, s. 4 (1) (i). 46 Ibid, s. 4 (1) (j). 47 Ibid, s. 4 (1) (k). 48 Ibid, s. 4 (1) (l). 49 Ibid, s. 4 (1) (m). 50 Ibid, s. 4 (1) (n). 51 Ibid, s. 4 (1) (o). 52 E A Okojie, ‘Impacts of Regulatory Mechanisms on Trado-Medical Practice in Nigeria’ (2015) Journal of Law, Policy and Globalization, p. 5, ISSN 2224-3240. 53 O A Erinoso, Health Sociology (Ibadan, Sam Bookman Educational Communication Services 2021) p. 88. 54 O Osborne, Healthcare Dystem in Post-colonial Africa (Microsoft Student Publishers 2007) p. 29. 55 Erinoso (n61) p.89. 56 The Nation, August 28, 2008, P. 44. OSUNYIKANMI: An Assessment of the Regulatory Framework for African Traditional Medicinal Practice in Nigeria 38 | P a g e Long before the advent of Western medicine, Africans had developed their own effective way of dealing with diseases, whether they had spiritual or physical causes, with little or no side effect.57 As posited by Ozioma and Okaka,58 African traditional medicine, of which herbal medicine is the most prevalent form, continues to be a relevant form of primary health care despite the existence of conventional Western medicine. Improved plant identification, methods of preparation, and scientific investigations have increased the credibility and acceptability of herbal drugs. On the other hand, increased awareness and understanding have equally decreased the mysticism and ‘gimmicks’ associated with the curative properties of herbs. As such, a host of herbal medicines have become generally regarded as safe and effective. This, however, has also created room for quackery, massive production, and sales of all sorts of substandard herbal medicines, as the business has been found to be lucrative.59 Akinleye, corroborated this when he identifies some of the drawbacks of traditional medicine as incorrect diagnosis, imprecise dosage, low hygiene standards, the secrecy of some healing methods and the absence of written records about the patients.60 Traditional medicine practice in Nigeria, however, faces greater challenges in the hands of government officials who look at it with disdain and disrespect. This is a carry-over from the colonialists who ‘needed’ to uproot this traditional medical practice for their own medical system to thrive and therefore portrayed the former as nothing more than witchcraft and fetish. Their successor, the Nigerian elite, despite the cultural background, was not better as the western propaganda had been infused to smear the historical and the indigenous health care system.61 This is manifested in the Nigeria government’s reluctance to accord medicine its primate position in the healthcare delivery system. As a matter of fact, traditional medicine is practiced in Nigeria today without enabling national legislation that will regulate its practice as obtained in many parts of the world.62 However, many states in the country have established traditional medicine boards/agencies to monitor the activities of its practitioners. Given these quandaries, the crux of the challenges is underpinned with ethical issues, Sustainability, the secrecy of practitioners and poor documentation of its procedures, Tribalism and religion, Possibility of drug interaction when used with Orthodox medicine. 6. Prospects of Regulatory Framework for the Practice of African Traditional Medicine Effective regulation of African traditional medicinal practice in Nigeria would be viable with collaboration and dialogue between traditional healers and modern healthcare practitioners. By fostering mutual respect, understanding, and partnership, regulatory agencies can harness the expertise of traditional healers while integrating evidence-based practices into the formal healthcare system. This collaboration can involve joint training programs, interdisciplinary workshops, and advisory committees to develop guidelines and protocols for safe and effective herbal medicine use.63 To enhance regulation, there is a need to promote research and evidence- based practices in traditional medicine. This involves supporting scientific studies on the safety, efficacy, and pharmacological properties of medicinal plants, as well as clinical trials to evaluate their effectiveness in treating specific health conditions. By generating robust evidence, regulatory agencies can make informed decisions about product registration, quality standards, and dosage recommendations, thereby improving the credibility and acceptance of herbal medicine within the healthcare community. Empowering traditional medicinal practitioners and consumers through capacity building and education is essential for effective regulation.64 Training programs can provide practitioners with knowledge and skills in quality control, good manufacturing practices, and regulatory compliance, enabling them to produce safe and standardized herbal products. Similarly, consumer education initiatives would raise awareness about the risks and benefits of traditional medicine, helping individuals make informed choices and seek appropriate healthcare advice.65 Policy reforms are essential to address the evolving landscape of traditional medicine regulation in Nigeria. This includes updating and harmonizing existing regulations to ensure consistency and effectiveness across national and state levels.66 Additionally, policymakers should prioritize the integration of traditional medicine into the formal healthcare system, recognizing its role in expanding access to healthcare services, particularly in 57 I Trinter, ‘African Traditional Healers: Cultural and Religious Beliefs Intertwined in a Holistic Way’ (2007) (74) (8) South African Pharmaceutical Journal pp. 56-60. 58 E J Ozioma and A N C Okaka, ‘Herbal Medicines in African Traditional Medicine’ In P F Builders (Ed.), Herbal Medicine (Intech Open Limited 2019). 59 Ibid. 60 O B Akinleye ‘Plants and their Products: Natural Wealth for Better Economic and Primary Health Care Delivery in Nigeria’ Prof. E. K. Obiakor Lecture Series (The Federal Polytechnic, Ado-Ekiti. 7th August 2008). 61 T Adefolaju, ‘The Dynamics and Changing Structure of Traditional Healing System in Nigeria’ (2011) (4) (2) International Journal of Health Research, pp. 99-106. 62 World Health Organization, ‘Legal Status of Traditional Medicine and Complimentary/lternative Medicine: A Worldwide Review’ accessed 10 May 2024. 63 G E A Okojie, ‘Impacts of Regulatory Mechanisms on Trado-Medical Practice in Nigeria’ (2015) Journal of Law, Policy and Globalization, p. 15, ISSN 2224-3240. 64 Ibid. 65 Ibid. 66 Ibid. African Customary and Religious Law Review (ACARELAR) 5 (2024) 39 | P a g e underserved communities. Furthermore, increased investment in research, infrastructure, and capacity building to support evidence-based regulation and innovation in the traditional medicine sector is a watch-out. To enhance regulatory mechanisms, stakeholders must address remaining challenges such as inadequate enforcement, lack of standardized training, and limited public awareness.67 This requires strengthening regulatory capacity through increased funding, manpower, and technology for monitoring, inspection, and enforcement activities. Additionally, efforts should focus on improving collaboration between regulatory agencies, traditional healers, healthcare practitioners, and consumers to foster a shared understanding of regulatory requirements and promote compliance with best practices. The future of traditional medicine regulation in Nigeria holds promise for continued progress and innovation. With growing recognition of the importance of traditional medicine in healthcare delivery, there is an opportunity to build upon existing regulatory frameworks to create a more inclusive and sustainable system.68 This includes leveraging advancements in science and technology to enhance product quality, safety, and efficacy, while preserving and respecting traditional knowledge systems. By embracing a holistic approach that balances tradition and modernity, Nigeria can chart a path towards a regulatory environment that promotes the health and well-being of its citizens.69 Succinctly put, the future of African traditional medicine is bright if viewed in the context of service provision, increase of health care coverage, economic potential, and poverty reduction, thus regulating accordingly. Formal recognition and integration of traditional medicine into conventional medicine, through viable legislation and institutional frameworks, will hold much promise for the future. 7. Conclusion and Recommendations From the foregoing, the regulation of traditional medicine in Nigeria presents a complex and multifaceted challenge that requires a nuanced and collaborative approach. From the historical evolution of traditional medicine to the current regulatory landscape, this article has highlighted the importance of balancing traditional practices with modern standards to ensure the safety, efficacy, and accessibility of traditional medicine remedies. The importance of balancing tradition and modernity in trado-medicine regulation cannot be overstated. While traditional healing practices hold cultural significance and provide valuable healthcare options, they must also adhere to contemporary standards of safety, quality, and accountability. By embracing a harmonized approach that respects cultural heritage while promoting evidence-based practices, regulators can foster a healthcare system that integrates the best of both traditional and modern medicine. In view of the analysis, it is concluded that traditional medicine occupies a pivotal position in the Nigerian rural health service delivery system which cannot be neglected but rather need be improved. While it is the truth and general belief that health care delivery system in Nigeria is very poor, traditional medicine because of its obvious availability, accessibility, affordability and effectiveness is relied upon for care and cure by more than 80 per cent of the population, it therefore deserves to be fully developed, regulated and sustained by all stakeholders. Thus, government should stop giving a lip-service commitment to traditional medicine but rather creating an enabling environment for its development and eventual integration into the rural health care delivery system of the country and for the benefit of the people. The establishment of Colleges of Natural Medicine in some selected Universities and the full registration of traditional medicine clinics to ensure that best practices are ensured are inevitable for a virile development of traditional medicine practices. The Government should ensure that researches into traditional medicine and its practices are more funded and advanced. 67 Ibid. 68 E J Ozioma and A N C Okaka, ‘Herbal Medicines in African Traditional Medicine’ In P F Builders (Ed.), Herbal Medicine (Intech Open Limited 2019). 69 Ibid.