Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 37to be seen by TCM practitioners. At present, the government imposes minimal control on Chinese medicinalmaterials (CMM), and registration of herbal products is not required. The situation, however, will change whena system of listing Chinese proprietary medicinal products will be implemented. This control would include theissue of a product licence, an import licence, a wholesalers' licence and a manufacturers' licence includingWHO GMP guidelines for herbal products. Legislation is being developed.In July 1994, the Minister of Health appointed a Committee, headed by the Senior Minister of State for Healthand Education, to review the practice of traditional Chinese medicine (TCM) and recommend measures tosafeguard patients' interest and safety, and to enhance the standard of training of TCM practitioners. TheCommittee released its report in September 1995.The enforcement activities currently carried out are targeted more towards safeguarding the public from toxicsubstances and the prevention of adulteration and exaggerated claims. As most raw herbs have low toxicityand herbs containing toxic substances are already controlled under the Poisons Act, the control of raw CMM (interms of import, export, sale and distribution) can be maintained at the present level. For the control of Chineseproprietary medicines (CPM), the Committee recommends:- Strengthening the control of CPM quality and safety standards. Control measures should beintroduced gradually. For a start, a simplified system of product registration, generally referred to as"listing", should be implemented. This will involve the issuing of product licences for individualproducts and licensing local CPM manufacturers and importers/wholesalers.- Establishing a CPM Advisory Committee under the Medicines Act to advise the Ministry of Health onthe evaluation of CPM products and the granting of licences to manufacturers andimporters/wholesalers. The members of the CPM Advisory Committee will be appointed by theMinister of Health and will include CMM experts.- Setting up a CPM Listing Unit in the Ministry of Health. This unit will be responsible for processingapplications for product listing and licensing of local CPM manufacturers, importers and wholesalers[127,143].Viet NamViet Nam possesses an old system of traditional medicine. Medicinal plants have made a tremendouscontribution to the national health, and the Vietnamese people, especially in the countryside and themountains, have used locally available medicinal plants for medical treatment and certain vegetables andspices as food to protect their health. The government has adopted a policy of integrating modern andtraditional systems of medicine and pharmacy. To implement this policy of integration, scientific research onmedicinal plants plays an important role [144].Market Importance of Herbal MedicinesThe percentage of herbal medicines prescribed in medical treatment is still increasing. Several places havealready succeeded in using 100% plant-based drugs which reduces the burden of the State's subsidy onmedicines. Thousands of communes have achieved a certain percentage of herbal drugs to be used intreatment, as set by the Ministry of Health. The successful combination of modern and traditional medicine hasgiven impetus to the gradual modernization of herbal medicine to facilitate handling and promote exports.Medicines are produced from plant extracts and purified products, and they are exported as finished or semi-