Author(s): Nitin Verma

Abstract: The present review deals with practice and regulation of herbal medicines in Europe, United States (US) and India. Herbal medicines are widely used for treatment of human ailments in various systems of medicines like Ayurvedic, Homeopathic, Sidha, Unani and other regional systems of medicines. Herbal drug products classification vary from country to country, some categories include functional foods, dietary supplements and traditional medicines. Critical problem in the evaluation of herbal drug products is that these are complex mixtures of constituents and the constituents responsible for the therapeutics effects are unknown which also complicates the stability of these products. A detailed literature survey for regulations of herbal drug products in Europe, US and India was performed to identify recently introduced changes in regulations or newly introduced regulations compliance with the regulatory bodies. Committee for Herbal Medicinal Products (HMPC), Committee of European Medicines Agency (EMA) is developing guidelines for quality, nonclinical studies, clinical efficacy and safety. Traditional herbal medicines registration scheme (THMRS) has been recently introduced by Medicines and Healthcare Products Regulatory Agency (MHRA, UK). US FDA has issued draft guidance for Industry on “Complementary and Alternative Medicine Products and Their Regulation”. Drugs and Cosmetics Rules have been amended recently to control the quality, safety and efficacy of herbal drug products in India. It has been found that regulations for herbal drug products in Europe and United States are more stringent than in India which has been reflected by some reports of safety issues of Indian herbal drug.