- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
The Control of Drugs and Cosmetics Regulation gazetted in June 1984 marked the beginning of systematic regulatory control on pharmaceutical products, including traditional medicines. The registration exercise for traditional medicines began in January 1992 under the third phase of implementation of this legislation. This exercise, it was hoped, would ensure safety, quality and, to a certain extent, efficacy of traditional medicines .
The implementation of the registration exercise implies that the Ministry of Health has assumed responsibility for ensuring the safety and quality of imported as well as locally manufactured traditional medicines.
The term traditional medicine covers any product employed in the practice of indigenous medicines, where the drug used consists only of one or more naturally occurring substances of plant, animal or mineral origin or part thereof, in extracted or non-extracted form and any homoeopathic medicines. All these products are required to be registered with the Drug Control Authority prior to marketing. Only products which meet the required standard are registered by the Drug Control Authority's secretariat, the National Pharmaceutical Control Bureau (NPCB), Ministry of Health, and allowed to be manufactured, imported, supplied or sold. Up to October 1995, more than 15 000 applications were received by the NPCB, 67% of which were for Chinese traditional medicines, and 13% for Malay traditional medicines. Of the remainder, 49% were for Indian products and 51% were for locally manufactured ones. Initial findings show that most local manufacturers of traditional medicines are small-scale and rarely have modern facilities, and that most of them lack know-how on new technologies. The registration exercise can be considered as the starting point of the government's efforts to upgrade the local pharmaceutical industry of traditional medicines.
Traditional medicines must comply with certain basic criteria of acceptable quality to qualify for registration. Quality specifications set by the Drug Control Authority, while safeguarding the public, also allow gradual upgrading of the traditional medicines industry. Local manufacturers and importers are advised to start with some basic quality control parameters even though this requirement is not mandatory. The list of requirements includes visual inspections, and tests for moisture content, uniformity of weight, etc. With effect from September 1993, the Drug Control Authority has imposed parameters for contamination by heavy metals, and microbial contamination to be tested on all traditional preparations, and disintegration tests for tablets and capsules submitted for registration. Local manufacturers are advised to include stability studies as part of the quality control requirements of traditional medicines.
Registrable traditional medicines should be free from dangerous or hazardous ingredients. Incorporation of chemical drugs or scheduled poisons is forbidden. The content of heavy metals such as lead, mercury and arsenic and also pesticides should be below the acceptable limits. Labels for traditional medicines, which are a very important safety/quality feature, must give information adequate and clear enough for the consumers to use the product properly and safely.
As provided in the "Medicines (Advertisement of Sale) Act 1956", traditional medicines and other over-the-counter products are not allowed to claim that they are effective for contraception, for improving kidney function and cardiac function, or for the treatment or diagnosis of 20 major diseases or conditions such as diabetes, epilepsy and asthma .