Ministry of Ayush Published Good Clinical Practice Guidelines for Clinical Trials on Siddha, Ayurvedic and Unani Medicines: Ayush Minister

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The regulatory framework for Ayurvedic medicines have been modeled following the lines of allopathic medicines. Drugs and Cosmetics Act, 1940 and Rules have special provision for regulating quality of Ayurvedic medicines. Ayurvedic manufacturing requires license from the concerned State Government and compliance to (GMP) Good Manufacturing Practices as well as the standards mentioned in the Ayurvedic Pharmacopoeia. 

Effectiveness and proof of safety are recommended for licensing of different categories of Ayurvedic medicines. The Central Government reserves the rights to create and modify the regulatory provisions and direct the State Governments for their enforcement. In this regard, the Central Government gets advice by the Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC) and Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) that are the statutory bodies under the provisions of Drugs & Cosmetics Act, 1940, in the enforcement issues and regulatory matters respectively pertaining to Ayurvedic medicines. 

Ayurvedic Pharmacopoeia Committee and Pharmacopoeia Commission of Indian Medicine & Homoeopathy frame  the quality standards and Standard Operating Procedures for Ayurvedic medicines that are compulsory for the manufacturers to comply with the set standards. Central and State Governments have set up Drug Testing Laboratories for Ayurvedic raw materials and medicines. So far, 55 laboratories have been licensed or approved in the country as per the Drugs & Cosmetics Rules, 1945 for quality testing of Ayurvedic drugs. 

Quality certification schemes for Ayurvedic medicines are regulated in accordance with the WHO Guidelines and International Standards by Central Drug Standards Control Organization (CDSCO) and Quality Council of India (QCI). Ayurvedic medicines also come under the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules like Allopathic medicines. The Central Government has started with the pharmacovigilance system for safety management of Ayurvedic medicines etc and grant in aid is provided via National AYUSH Mission to solidify quality control activities in the states.

Drugs and Cosmetics Act, 1940 and Rules do not contain clear provisions for the clinical trials of Ayurvedic medicines. The Ministry of AYUSH has published Good Clinical Practice Guidelines for conduct of clinical trials on Ayurvedic, Siddha and Unani medicines on a voluntary basis.

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