Keynote Speech By Prof. Adeyeye C. M
Director General NAFDAC
The African Traditional Medicine Day
The Role Of NAFDAC In Traditional Herbal Medicine Development And Approval In Nigeria
29th August, 2019.
INTRODUCTION
Traditional herbal medicines are naturally occurring, plant-derived substances with minimal or no industrial processing that have been used to treat illness within local or regional healing practices. They are described as “finished, labelled medicinal products that contain as active ingredients, aerial or underground parts of plants, or other plant material or combinations thereof, whether in the crude state or as plant preparations. Plant materials include juices, gums, fatty oils, alkaloids, glycosides, essential oils, and any other substance of this nature. Herbal medicines may also contain excipients in addition to the active ingredients” (WHO, 2007)
The use of traditional herbal medicines dates back to the earliest history of mankind and its use is still on the rise. In China, traditional herbal medicine played a prominent role in the strategy to contain and treat Severe Acute Respiratory Syndrome (SARS). Eighty per cent of African populations use some form of traditional herbal medicine, and the worldwide annual market for these products approaches US$ 60 billion.
In Nigeria, traditional herbal medicines have continued to gain popularity. At the moment, a high percentage of our population, particularly in remote, rural and peri-urban areas depend on herbal medicines for their primary healthcare needs. It also provides a source of livelihood for a sizeable number of the population who depend on them as their main source of income. The wide acceptance of traditional herbal medicines in Nigeria may be attributed to the following:
- Some traditional herbal remedies have been found to be efficacious and affordable.
- Long history of use of several herbs both as medicines and food provides basis for acceptance.
- Several communities have cultural/historical association with the traditional herbal medicines which they use.
- Traditional herbal medicine is perceived to offer a holistic approach to life: equilibrium between the mind, body and the environment, and an emphasis on health rather than on disease.
- There is the general (but wrong) notion that traditional herbal medicines are less likely to cause adverse reactions as compared to orthodox medicines.
- Lack of access to standard orthodox medical facilities by a large segment of the population.
- Our immensely rich plant biodiversity makes traditional herbal medicines readily available and accessible.
Despite our vast flora, the widespread use and inherent benefits of traditional herbal medicines, it saddens me that the development of affordable traditional herbal medicines that are effective and safe for use still pose great challenge. Additionally, the regulation and development of traditional herbal medicine in Nigeria has been hampered by an array of factors including the question of their safety. These factors include;
- Poor documentation
- Lack of standardization and validation of methods and practices
- Lack of clinical trial of existing herbal medicines
- Lack of scientific proof of claims
- Inadequate number of standards for raw materials
- Lacing of herbal preparations with orthodox medicines
- Inadequate level of research and low output of researched herbal medicines
- Lack of cooperation/collaboration of practitioners with scientists/researchers
- Low level of understanding of protection of invention and the Intellectual Property Right Laws (IPR)
- Secrecy and lack of incentive for complete disclosure of herbal actives in the products have contributed
- Ineffective implementation of existing policies within the sector
- Inadequate collaboration among the various stakeholders
This snail pace of development of the sector underscores the need to harness, document, research, standardize and regulate traditional herbal medicines in line with international best practices. In order to enhance the development of traditional herbal medicines and facilitate its contribution to the national healthcare delivery system in Nigeria, there is need for strict regulation and control of the products by NAFDAC.
The Act that created NAFDAC mandates the Agency to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs (including traditional herbal and nutraceutical products), cosmetics, medical devices, packaged water, chemicals and detergents (collectively known as regulated products). In accomplishing of the provisions of this Act, NAFDAC regulates traditional herbal medicines via:
- Traditional Herbal Medicines Listing/Registration
The listing/registration process includes document review, cGMP inspections, laboratory evaluation of products and product approval. To ensure the development of quality and safety standards for traditional herbal medicines, NAFDAC has established regulations and appropriate guidelines for the listing and/or registration of traditional herbal medicinal products in Nigeria. The Registration and Regulatory Affairs Directorate of NAFDAC coordinates the registration of traditional herbal medicines in Nigeria. A duly registered traditional herbal medicine is one in which the medicinal/therapeutic claim(s) have been evaluated by through clinical trials approved by NAFDAC. The registration status of the product is renewable every five years. Listed traditional herbal medicine on the other hand are those whose therapeutic/medicinal claims have not been evaluated through clinical trials. The listing status is renewable every two years.
It is also stipulated that all traditional herbal preparations meet specific labelling requirements before listing. An example is the need to carry a disclaimer that “these claims have not been evaluated by NAFDAC”. This should be placed immediately below the indication for the product.
The Agency has built in safety requirements in the herbal medicines registration guidelines. These includes the need for toxicology and safety evaluation report which is mandatory for the approval of any herbal product. The guidelines and regulations relating to the listing/ registration of traditional herbal medicines in Nigeria can be found on the NAFDAC website, https://nafdac.gov.ng/resources/nafdac-regulations/
https://nafdac.gov.ng/resources/guidelines/
- Conduct of Good Manufacturing Practice Inspection of Traditional Herbal Medicines Manufacturing Facilities.
GMP is a system that ensures that products are consistently produced and controlled according to quality and safety standards appropriate for their intended use and as required by the product specification. NAFDAC carries out inspections on manufacturing facilities to ensure compliance with current Good Manufacturing Practice (cGMP) guidelines.
GMP covers all aspects of the manufacturing process and involves the assessment of the following: site / location of factory, building / facilities, packaging and raw material source, quality standards, production and process control, packaging and labelling, sanitation, batch formulation, staff welfare and recall procedure and staff training. NAFDAC has simplified the production process for local manufacturers by encouraging them to form cooperatives and build factories for the production of their products where individual cannot afford to own his facility. The guidelines for the production inspection of traditional herbal medicines facilities in Nigeria can be found on the NAFDAC website.
- Laboratory Analysis of Traditional Herbal Medicines
All traditional herbal medicinal products for listing/registration are forwarded to our laboratory for evaluation. NAFDAC laboratories are fully equipped and have attained ISO 17025 accreditation for various test scopes in the standardization and quality evaluation of traditional herbal medicines.
These test scopes conducted for traditional herbal medicines include:
- Physical Test Parameters (moisture content, ash value, extractive value, viscosity, density, bitterness value, solubility, swelling index, foaming index, specific gravity)
- Acute toxicity test
- Microbiological assay like microbial limit test.
- Physico-chemical analysis like Heavy metal testing
- Screening for components of orthodox medicines
These parameters provide safety evidence of the traditional herbal product and suffices for listing of the product. For the purpose of full registration, reports from NAFDAC approved and well-coordinated clinical trials, conducted at an approved center is also required.
Traditional herbal medicinal products with adequate documentation, satisfactory cGMP report and satisfactory lab analysis report are scheduled for approval.
- Control of Advertisement of Traditional Herbal Medicines
It should be noted that NAFDAC registration of a regulated product is not an authorization for advertisement of the product. There are regulatory provisions for control of advertisement of traditional herbal medicines which is aimed at promoting and protecting public health. Advert control unit at the agency also requires that all advertorials shall be vetted to ensure the message is accurate, complete and clear and designed to promote credibility and trust by the general public and statement illustration shall not be misleading directly or indirectly. NAFDAC regulations on advertisement of traditional herbal medicines prohibits the advertisement of unregistered traditional herbal medicine. The regulation also prohibits advertisement of listed traditional herbal remedies in print or electronic media as a cure for specific diseases. Enforcement however poses a challenge due to advertisement practices of some media houses and the traditional herbal medicine practitioners. This situation is being systematically addressed through collaboration with relevant authorities and groups.
The traditional herbal medicines and related products advertisement regulations 2019 can be found on the NAFDAC website.
- Post Marketing and Safety Monitoring of Traditional Herbal Medicines
Post marketing and safety monitoring can be achieved through Post Marketing Surveillance (PMS). PMS is the identification and collection of information regarding medicinal products after their approval by NAFDAC. PMS activities enable NAFDAC to monitor the quality, safety and efficacy of medicinal products on the shelf. It should be noted that adverse reactions to traditional herbal medicines do occur and they should be promptly reported by the use of the ADR reporting forms of the National Pharmacovigilance Center (NPC) to NAFDAC. A new Herbal Vigilance Unit will be part of the Agency’s Pharmacovigilance Division that will soon be expanded.
We are strengthening our structures and activities to undertake the safety monitoring of traditional herbal medicines and encourage the reporting of adverse events associated with their use. Mandatory submission of PMS reports on the use of listed traditional herbal medicinal products to NAFDAC is a requirement for full registration.
It is fulfilling to note that over the years, NAFDAC through her regulatory activities have consistently championed the move for the development of traditional herbal medicines in Nigeria. NAFDAC has held various workshops / symposiums to educate the Traditional Herbal Medicine Practitioners on the basic requirements for the production and registration of their products to improve their medicinal values and market potentials. NAFDAC has also continued to promote the need for research in the traditional herbal medicines sector including encouraging healthy and sincere collaboration between the practitioners and academia to provide the enabling environment to make the transition from research to viable products of benefit to mankind.
Furthermore, the Agency in March 2019 spearheaded the establishment of the Nigerian Herbal Medicinal Products Committee (NHMPC), as a platform for collaboration among the various stakeholders, to promote standardization and research in traditional herbal medicine for the discovery and translation of such into viable commercial products that must be approved by NAFDAC for use by Nigerians.
In order to further ensure safety and quality, NAFDAC also inaugurated a scientific committee to deliberate and report on additional analytical tests that could be conducted in addition to others highlighted under Laboratory Analysis above. The Agency is in the process of renewing a memorandum of understanding with National Institute for Pharmaceutical Research and Development (NIPRD) for research collaboration on herbal medicines. These activities and collaborations will greatly facilitate translation of the low hanging fruit of our biodiversity into palatable public health commodities.
Evidently, NAFDAC is totally committed to ensuring that only safe traditional herbal medicinal products of good quality are available to the general public. The Agency is properly positioned to stand up to the challenges ahead in the regulation and control of these products which are of tremendous importance to public health in Nigeria.
Thank you.
Prof Mojisola Christianah Adeyeye
Director General
