New Delhi
Under the provisions of Drugs & Cosmetics Rules, 1945, Good Manufacturing Practices and Quality standards given in the respective pharmacopoeias are mandatory for the manufacturing of licensed Ayurvedic, Siddha, Unani and Homoeopathic medicines. In addition, two voluntary certification schemes for Ayurvedic, Siddha and Unani medicines are implemented by Quality Council of India and Central Drugs Standard Control Organization (CDSCO) for grant of AYUSH Standard & AYUSH Premium marks and certification of quality as per WHO guidelines respectively.
Ayurvedic, Siddha, Unani and Homoeopathic drugs are regulated in accordance with the exclusive provisions for them in the Drugs & Cosmetics Act, 1940 and Rules there under. These drugs have to adhere to such standards and quality control parameters as given in the authoritative books, pharmacopoeias and formularies of Ayurvedic, Siddha, Unani and Homoeopathic systems, which are different from that prescribed for allopathic medicines. Till date, monographs of quality standards of 600 single drugs & 152 compound formulations of Ayurveda, 298 single drugs & 100 compound formulations of Unani system, 139 single drugs of Siddha and 1016 Homoeopathic drugs have been published in the respective pharma-copoeias. States have reported incidents of substandard medicine samples and action taken against them. 11889 samples of AYUSH medicines were tested in 24 states during the last three years from 2013-14 to 2015-16, out of which 254 samples failed in quality testing. State Licensing Authorities initiated appropriate action against the samples not complying with the standards and issued show cause notices or suspended/cancelled licenses, recalled the relevant batch of finished goods from the market and initiated prosecution.
Exclusive regulatory provisions for standards and quality of Ayurvedic, Siddha, Unani and Homoeopathic medicines exist in the Drugs & Cosmetics Act, 1940 and Rules there under. Drugs and Cosmetics Rules, 1945 are amended in consultation with the respective Drugs Technical Advisory Board for imposing effective quality control. As of now there is no proposal in the Ministry of AYUSH to introduce new legislation for grading and standardization of AYUSH products.
