- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
As the use of herbal medicine started to decline at the beginning of this century, the government, aware of the potential of medicinal plants and traditional medicine to treat common diseases and symptoms in primary health care, has adopted a national policy on their utilization, including research and development.
There is no government control on the production and distribution of medicinal plants in Thailand provided that the plants are sold as such. However, in so far as medicinal plants are mixed or put into dosage forms, the distributors are required by law to obtain permission from the Food and Drug Administration .
In accordance with the Drug Act B.E. 2510 and its amendment, "traditional drug" means a drug intended for use in the practice of the traditional medicine, and which appears in a pharmacopoeia of traditional drugs notified by the Minister, or a drug notified by the Minister as a traditional drug, or a drug of which the formula has been registered as that of a traditional drug. In contrast, "household medicine" means a modern or traditional drug notified by the Minister as a household medicine, and "herbal drug" means a drug of plant, animal or mineral origin which has not yet been compounded, dispensed or denatured. No one is allowed to produce or sell a traditional drug or to import one without a licence from the licensing authority. This does not apply to the preparation of a traditional remedy by a traditional medical practitioner in accordance with the pharmacopoeia for his own patients or for resale, nor to the sale of a herbal remedy which is not a dangerous drug or the sale of a household medicine.
There are three categories of licences relating to traditional drugs: to produce; to sell; and to import or order. Persons licensed to produce traditional drugs must have premises, staff and equipment to ensure their correct manufacture and control; they have to provide labels corresponding to the registered formula indicating that it is a "traditional drug"; and they have to use labels and accompanying literature corresponding to the registered formula. Any person licensed to produce or import drugs including traditional drugs is required first to apply for the registration of the formula. This, however, does not apply to crude drugs. Within the application for registration of a drug the following particulars shall be given: name of the drug, names and quantities of the ingredients, content, label, leaflet, etc. The Minister is empowered to give notice in the Government Gazette listing pharmacopoeias, substances classified as drugs, dangerous drugs, common household drugs, traditional drugs, etc. .
The Thai Pharmacopoeia
Arrangements have been made to control the quality of crude drugs, but not of compound medicines prepared from them because of the complexity of the assay procedures. There are different government agencies involved in quality control and specifications of crude drugs. For example, the Department of Medical Sciences has been appointed to head the Thai Pharmacopoeia Committee with the aim to establish quality control of drugs sold in the Thai market. Monographs on crude drugs are prepared, some with reference to international pharmacopoeias such as the British Pharmacopoeia, and the United States Pharmacopoeia .