Regulation Of Herbal Medicines In Ghana

Herbal medicines should be regulated to safeguard consumers, but questions of efficacy will remain unless and until adequate amounts of scientific evidence accumulate from experimental and controlled human trials. The diversity among countries with the long history and holistic approach of herbal medicines makes evaluating and regulating them very challenging. In addition, there are a great number of different herbs used. Legislative criteria to establish traditionally used herbal medicines as part of approved health care therapies faces several difficulties. In a survey conducted across 129 countries, WHO reported the following issues regarding herbal medicines: lack of research data, appropriate mechanisms for control of herbal medicines, education and training, expertise within the national health authorities and control agency, information sharing, safety monitoring, and methods to evaluate their safety and efficacy. The support needed from different countries includes information sharing on regulatory issues, workshops on herbal medicines safety monitoring, general guidelines on research and evaluation of herbal medicines, provision of databases, herbal medicine regulation workshops, and international meetings.

National policies are the basis for defining the role of traditional medicines in national health care programs, ensuring that the necessary regulatory and legal mechanisms are established for promoting and maintaining good practice, assuring the authenticity, safety, and efficacy of traditional medicines and therapies, and providing equitable access to health care resources and their resource information (WHO 2005). Another fundamental requirement is harmonization of the market for herbal medicines for industry, health professionals, and consumers. Herbal medicines are generally regulated as Over-The-Counter (OTC) in Ghana by the Food and Drugs Authority (FDA). In the United States, where under the Dietary Supplement Health and Education Act (DSHEA) of 1994, any herb, botanical and natural concentrate, metabolite and constituent of extract, is classified as a dietary supplement and do not need approval from the Food and Drug Administration (FDA) before they are marketed. This means that the manufacturer of the herbal medicine is responsible for determining that the dietary supplements manufactured or distributed are indeed safe and that any representations or claims made about them are sustained by adequate evidence to show that they are not false or misleading. However, a dietary supplement manufacturer or distributor of a supplement with a “new dietary ingredient,” that is, an ingredient that was not marketed in the United States before October 1994, may be required to go through premarket review for safety data and other information. Also, all domestic and foreign companies that manufacture package labels or hold dietary supplements must follow the FDA’s current good manufacturing practice (GMP) regulations, which outline procedures for ensuring the quality of supplements intended for sale. Also, In Canada, herbal remedies must comply with the Natural Health Products Regulations (Health Canada 2003). According to these regulations, all natural products require a product license before they can be sold in Canada. In order to be granted a license, detailed information on the medicinal ingredients, source, potency, nonmedicinal ingredients, and recommended use needs to be furnished. Once a product has been granted a license, it will bear the license number and follow standard labelling requirements to ensure that consumers can make informed choices. A site license is also needed for those who manufacture, pack, label, and import herbal medicines. In addition, GMPs must be employed to ensure product safety and quality. This requires that appropriate standards and practices regarding the manufacture, storage, handling, and distribution of natural health products be met. The GMPs are designed to be outcome based, ensuring safe and high-quality products, while giving the flexibility to implement quality control systems appropriate to the product line and business. Product license holders are required to monitor all adverse reactions associated with their product and report serious adverse reactions to the Canadian Department of Health.

In Ghana our regulatory system for Herbal medicines is similar to that of Canada. The FDA is mandated through the Public Health Act, 2012(ACT 851) section 118, to regulate herbal medicinal products, homeopathic products, food supplements.etc. The functions of the FDA include; product evaluation and registration, Good manufacturing practice inspections, Import and export control, Pharmacovigilance, promotion and advertisement.etc. The general requirements for registration include; Certificate to do business in Ghana issued by the Registrar Generals Department, an application letter addressed to the CEO of the FDA, completed application forms with the required supporting documentation, samples of product as per FDA’s sample schedule(available at the FDA website),a non-refundable application fee as per FDA’s approved fee schedule(available at the FDA website) and preliminary evaluation and inspection of manufacturing premises. For Imported herbal or food supplements, the exporting company shall notify the FDA of its local agent in Ghana and the Local Agent must register with the FDA as an importer. The supporting documentation must include phytochemistry analysis report, microbiology analysis report and pharmacological/toxicology analysis report. Collaborating institutions such as Noguchi Memorial Institute, Centre for Plant Medicine Research and the schools of pharmacy in KNUST and UG assist with the analysis reports at a fee.

It is estimated that about 25% of the drugs prescribed worldwide are derived from plants, and 121 such active compounds are in use. Between 2005 and 2007, 13 drugs derived from natural products were approved in the United States. More than 100 natural product–based drugs are in clinical studies, and of the total 252 drugs in the World Health Organization’s (WHO) essential medicine list, 11% are exclusively of plant origin.

By MH/Dr Ernest Aggrey, 0543999776/[email protected]

Reference:
Benzie, I.F. and Wachtel-Galor, S. (2011).Herbal medicine: Bimolecular and Clinical Aspects, Herbal Medicine; An Introduction to Its History, Usage, Regulation, Current Trends, and Research Needs. Second Edition; CRC Press. Pg 5-8