This review paper highlights the current advances in knowledge about the safety, efficacy, quality control and regulatory aspects of Phytopharmaceuticals. The growing use of Phytopharmaceuticals (drug and other products derived from plants) by the public is forcing moves to evaluate the health claims of these agents and to develop standards of quality and manufacture. At present there is almost no policy worth its name to regulate the procurement and sale of medicinal plants in developing countries. Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.It is clear that the herbal industry needs to follow strict guidelines and that regulations are needed. This paper presents the element of methods of different aspects on efficacy, safety, quality control and standardization of herbal drugs and formulation. It is followed by international guidelines of WHO for manufacture quality control and evaluation of botanicals. Herbal drugs regulations in India is discussed in detail, followed by an overview of regulatory status of herbal medicine in USA, China, Australia, Brazil, Canada and Germany.
SOURCE: PHARMATUTOR.ORG
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