Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 34newly drafted Good Post-Marketing Surveillance Practice (GPMSP) has been used on a pilot scale for Westerndrugs dispensed in Japan. When new Kampo drugs are approved and appear on the market, this guidelinewill also apply to them [136].MalaysiaThe Control of Drugs and Cosmetics Regulation gazetted in June 1984 marked the beginning of systematicregulatory control on pharmaceutical products, including traditional medicines. The registration exercise fortraditional medicines began in January 1992 under the third phase of implementation of this legislation. Thisexercise, it was hoped, would ensure safety, quality and, to a certain extent, efficacy of traditional medicines[127].The implementation of the registration exercise implies that the Ministry of Health has assumed responsibilityfor 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 thedrug used consists only of one or more naturally occurring substances of plant, animal or mineral origin orpart thereof, in extracted or non-extracted form and any homoeopathic medicines. All these products arerequired to be registered with the Drug Control Authority prior to marketing. Only products which meet therequired standard are registered by the Drug Control Authority's secretariat, the National PharmaceuticalControl Bureau (NPCB), Ministry of Health, and allowed to be manufactured, imported, supplied or sold. Up toOctober 1995, more than 15 000 applications were received by the NPCB, 67% of which were for Chinesetraditional medicines, and 13% for Malay traditional medicines. Of the remainder, 49% were for Indianproducts and 51% were for locally manufactured ones. Initial findings show that most local manufacturers oftraditional medicines are small-scale and rarely have modern facilities, and that most of them lack know-howon new technologies. The registration exercise can be considered as the starting point of the government'sefforts 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 gradualupgrading of the traditional medicines industry. Local manufacturers and importers are advised to start withsome basic quality control parameters even though this requirement is not mandatory. The list ofrequirements includes visual inspections, and tests for moisture content, uniformity of weight, etc. With effectfrom 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 andcapsules submitted for registration. Local manufacturers are advised to include stability studies as part of thequality control requirements of traditional medicines.Registrable traditional medicines should be free from dangerous or hazardous ingredients. Incorporation ofchemical drugs or scheduled poisons is forbidden. The content of heavy metals such as lead, mercury andarsenic and also pesticides should be below the acceptable limits. Labels for traditional medicines, which area very important safety/quality feature, must give information adequate and clear enough for the consumers touse the product properly and safely.As provided in the "Medicines (Advertisement of Sale) Act 1956", traditional medicines and other over-thecounterproducts are not allowed to claim that they are effective for contraception, for improving kidney functionand cardiac function, or for the treatment or diagnosis of 20 major diseases or conditions such as diabetes,epilepsy and asthma [127].MongoliaMongolian traditional medicine has 2 400 years experience and has a close relationship with Chinese, Indianand Tibetan traditional medicine. The current Mongolian Government considers traditional medicine as animportant part of medical service to the population, develops it in association with Western medicine, and isinvestigating the scientific foundation of traditional medicine to identify its optimal applications.In 1989, a Traditional Medicine Department was established at the Mongolian National Medical University withtraining courses in traditional Mongolian medicine. There are seven units producing traditional medicine drugs[138].New Zealand