Regulatory Status of Herbal Drugs in India

Abstract

 India is the leading supplier of medicinal plants and herbs. Plants and herbs are commonly utilized as medications, and many choose them since they have less adverse effects. Herbal drugs have been used in various medical systems around the world, including Ayurveda, Siddha, Homeopathy, Unani, and Chinese medicine, and are classified as complementary medicines, nutraceuticals, prescription drugs, over the counter (OTC) drugs, supplements, and conventional herbal drugs. If sold commercially, herbal drugs must adhere to country-specific safety, quality, and potency requirements. Currently, herbal medication legislation varies per nation. As a result, herbal medicine manufacturers are unable to provide a standardized product for the worldwide market. Therefore, international regulatory agencies and institutions such as the World Health Organization (WHO) work together to develop a unified and standardized regulation for herbal drugs. The regulatory status of herbal drugs in India and strategies to improve it are highlighted in this article. Herbal products are regulated under the Drug and Cosmetic Act (DCA) 1940 and Rules 1945, and the governing agency is the Department of AYUSH. A manufacturing permit is needed to produce or trade herbal drugs.