The regulatory framework for Ayurvedic medicines is by and large modeled on the lines for allopathic medicines. Drugs & Cosmetics Act, 1940 and Rules thereunder have exclusive provisions for regulation and quality control of Ayurvedic medicines. Regulatory Officers are appointed in the Central and State Governments to oversee the enforcement of legal provisions for Ayurvedic medicines. Manufacturing of Ayurvedic medicines need license from the concerned State Government as well as compliance to Good Manufacturing Practices (GMP) and the standards prescribed in the Ayurvedic Pharmacopoeia. Proof of safety and effectiveness is required for licensing of various categories of Ayurvedic medicines. Central Government has the powers to frame and amend the regulatory provisions and issue direction to the State Governments for their enforcement. In this regard, the Central Government is advised by the Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) and Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC), which are statutory bodies under the provisions of Drugs & Cosmetics Act, 1940, in the regulatory matters and enforcement issues respectively pertaining to Ayurvedic medicines. Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Ayurvedic Pharmacopoeia Committee are in place to develop the quality standards and Standard Operating Procedures for Ayurvedic medicines, which are mandatory for the manufacturers to comply with. Central and State Governments have established Drug Testing Laboratories for Ayurvedic medicines and their raw materials and 55 laboratories so far are approved or licensed in the country in accordance with the Drugs & Cosmetics Rules, 1945 for quality testing of Ayurvedic drugs. Quality certification schemes for Ayurvedic medicines are also administered as per WHO Guidelines and International Standards by Central Drug Standards Control Organization (CDSCO) and Quality Council of India (QCI) respectively. Like allopathic medicines Ayurvedic medicines are also covered under the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder. Central Government has initiated pharmacovigilance system for safety monitoring of Ayurvedic medicines etc and grant in aid is provided through National AYUSH Mission to strengthen quality control activities in the states.

Drugs & Cosmetics Act, 1940 and Rules thereunder as on date do not have explicit provisions for the clinical trials of Ayurvedic medicines. Rule 158-B of the Drugs & Cosmetics Rules, 1945 does provide the requirement of pilot study to generate proof of safety & effectiveness of certain categories of Ayurvedic medicines. Ministry of AYUSH has published Good Clinical Practice Guidelines for conduct of clinical trials on Ayurvedic, Siddha and Unani medicines on voluntary basis.

This information was given by the Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik in written reply to a question in Rajya Sabha today.

 

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