Regulatory Scenario of Herbal Medicines

Guru Prasad Mohanta, P. K. Manna and S. Parimalakrishnan

Abstract: In spite of spectacular advances in modern medicine including genetic engineering, biotechnology, organ transplant, designer drugs etc., a large population in the developing countries rely on herbal and other complementary medicines for primary health care. Herbal medicines formed the basis of health care through out the world since the earliest days of mankind. They have considerable importance in international trade. Despite the use of herbal medicines over many centuries, only a relatively small number of plant species have been studied for possible medicinal applications. Safety and efficacy data are available only for smaller number of plants, their extracts and active ingredients and preparations containing them.
World Health Organization (WHO) define’ herbal medicines as a plant derived material or preparations with therapeutic or other human health benefits, which contains either raw or processed ingredients from one or more plants. They include herbs, herbal preparations and finished herbal products that contain as active ingredients parts of plants, or other plant materials, or combinations. Herbal medicine is a major component in all indigenous peoples’ traditional medicine and is a common element in Ayurvedic, Homeopathic, Naturopathic, Traditional Oriental and Native American Indian Medicine. The sophistication of herbal remedies used around the world varies with technological advancement of the countries that produce and use them. These remedies range from medicinal teas and crude tablets used in traditional medicine to concentrated, standardized extracts produced in modern pharmaceutical facilities and used in modern medical systems under a physician’s supervision.
Like modern medicines herbal medicines needs to be studied scientifically to establish safety and effectiveness. Herbal medicines have two special characteristics, which distinguish them from chemical drugs: use of crude herbs and prolonged use. A single herb may contain a great many natural constituents and combination of herbs even more. Experience has shown that there are real benefits in the long-term use of while medicinal plants and their extracts, since the constituents in them work in conjunction with each other.


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