(2002; 166 pages)
Regulation of herbal medicines in Ghana
Dr Benjamin Kwame Botwe, Ghana
Traditional medicines are widely used in Ghana. Traditional medical practitioners cater for the health care needs of most of the 60-70% of the population who live in rural areas. The majority of practitioners are herbalists.
Since 1961, attempts have been made to regulate traditional medicines, starting with the formation of the Ghana Psychic and Traditional Healers Association. In 1975, the Centre for Scientific Research in Plant Medicines was established; in 1997, the Food and Drugs Board was established; and in 2000, a Traditional and Alternative Medicines Directorate was established in the Ministry of Health.
Under the Food and Drugs Law, the manufacture, import, export, distribution, use and advertisements of food, drugs, cosmetics, chemical substances and medical devices are controlled. No person may manufacture, prepare, supply, sell, distribute, export or import any herbal medicine or homoeopathic drug, unless it has been registered with the Food and Drugs Board. The Board seeks to ensure that herbal medicines are safe, of good quality and effective. Regulations may prescribe the information to be provided for the registration of herbal medicines and homoeopathic drugs.
Any person who labels or advertises any drug in contravention of any regulations under the Food and Drugs Law, or in a manner that is false or misleading as regards its character, constitution, value, potency, quality, composition or safety commits an offence.
Traditional medicinal products are defined under the Food and Drugs Law. The Traditional and Alternative Medicines Directorate, the practitioners, the research institutions and the universities were invited to develop the guidelines for registration. University institutions are now offering courses in traditional medicines and the Government also facilitates training on quality assurance of traditional medicines.
In respect of safety data for product registration, basic toxicological studies are required. Product samples are submitted for testing for prohibited chemicals, heavy metals and microbial contamination.
In respect of quality data for product registration, the Government has introduced GMP inspection at the level of the manufacturer. Product samples are submitted for testing for adulterants, physical and chemical parameters, and orthodox drugs.
In respect of efficacy data for product registration, only evidence of long use with minimum side-effects is requested. The Government has also introduced a pharmacovigilance system to continuously monitor marketed products for possible adverse effects.
There are several challenges:
• Clinical assessment of the efficacy of the products needs to be improved.
• Comprehensive long-term toxicological testing of the products is needed.
• A National Herbal Pharmacopoeia should be developed.
• Postmarketing testing should be strengthened to eliminate products that are not useful.
• The concept of GMP should be promoted to the pharmaceutical industry.
Herbal medicines play a useful role in many countries. Stakeholders must integrate and coordinate efforts to provide accurate scientific evidence of their safety and efficacy, and to ensure that the products are of good quality.