Bengaluru, December 4, 2015: Government has set up Central Research Councils for promoting scientific validation of Ayurvedic, Unani and Homoeopathic medicines. Ministry of AYUSH has taken steps to facilitate clinical trials in AYUSH, like publication of Good Clinical Practice (GCP) guidelines, issuing directive for registration of AYUSH clinical trials in Clinical Trials Registry of India and setting up of an Expert Committee to make recommendations for grant of approval to new clinical trial proposals. Also, Rule 158-B has been inserted in the Drugs and Cosmetics Rules, 1945 for seeking the proof of effectiveness and safety of certain categories of Ayurvedic, Siddha and Unani medicines as a licensing requirement.
Drugs and Cosmetics Rules, 1945 provide for requirement of evidence of safety and proof of effectiveness from authoritative books or scientific literature or generated through clinical trials for grant of license to manufacture for sale certain kinds of Ayurvedic, Siddha and Unani medicines. Similarly, prior to licensing of new homoeopathic medicines there is a regulatory requirement of documentary and other evidence of therapeutic efficacy including the minimum proving carried out with them. The term ‘Clinical Trial’ as such is not prescribed in the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder pertaining to Ayurvedic, Siddha, Unani and Homoeopathic medicines.
This information was given by the Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik in reply to an unstared question in Rajya Sabha today.
Corporate Comm India(CCI Newswire)
