Regulatory issues

All countries where medicinal plants and traditional medicines are used are aware of the need for regulating the use of medicinal substances. Indeed, most developing countries have a heritage in the use of plant-based medicine that is far older than the modem of medicine. China probably has the strictest criteria for regulating the sale of traditional plant-based medicines. Chinese authorities are well aware of the problems and constraints facing them in the production, processing, and marketing of herbal medicines. The Government of India, while constantly upgrading its controls, does not exercise any regulatory control over the use of "home-made" remedies that are used by a large segment of the vast Indian population.

The European Scientific Cooperative for Phytotherapy (ESCOP) is currently drafting fifty monographs of product characteristics to be used as a basis for licensing phytotherapeutics in all member states of the European Union (EU). Since January 1995, a decentralized marketing authorization procedure has existed in addition to the national licensing of individual member states. Following enactment in 1994 by the United States Government of the Dietary Supplement and Health Education Act (DSHEA) greater effort has been made to develop guidelines for quality control, good management practice, and to provide a sound scientific basis for ensuring proper identity and purity of finished products. Such activities by the industrialized countries put greater pressure on the developing countries to regulate trade in medicinal plant raw materials.