(2002; 166 pages)
How regulation of herbal medicines was established in Thailand
Ms Yupin Lawanprasert, Thailand
Herbal medicines play an important role in the everyday life of the Thai people. The use of herbal medicines has increased remarkably in line with the global trend of people returning to natural therapies. The Government and authorities concerned have taken part in the promotion and regulation of local herbal medicines in order to ensure that their quality, efficacy and safety meet international requirements and that they are used rationally. Manufacturers are also encouraged by the Government to improve their production standards to meet the requirements of Good Manufacturing Practices (GMP) and to conform to the higher specifications needed for the global market.
Under the Drug Act, herbal medicines are classified into four categories:
• herbal household remedies;
• traditional herbal medicines;
• modern herbal medicines;
• new drugs.
The Drug Act requires that any person who wishes to produce, sell or import drugs into Thailand must obtain a licence from the Food and Drug Administration (FDA) of Thailand. Herbal medicinal products must be registered before they can be produced or imported for marketing. An applicant must hold a manufacturing or importing licence granted by the FDA. The procedures for registration of herbal medicinal products are in two stages:
• application for permission to manufacture or import drug samples;
• application for drug registration.
Every application is evaluated by an expert subcommittee; if it is found that the product is proven to be safe and effective, it is registered.
Thailand has participated in the development of the ASEAN Guidelines on GMP for Herbal Medicines. GMP for herbal medicine is currently being implemented. It is recommended that herbal medicinal products should be manufactured in a GMP environment to ensure acceptable quality.
The main problem affecting the quality of traditional drugs is microbial contamination, since the use of synthetic preservatives is not permitted. Herbal medicinal products must therefore comply with the accepted limits for microbial stability specified in the Thai Pharmacopoeia.
Under the Drug Act, all materials used in the advertising and promotion of medicines, including herbal medicines, are subject to approval by the FDA of Thailand.
Thai traditional medicine is a valuable heritage of the Thai people. The Royal Thai Government has tried to revitalize its significance as an effective alternative treatment.