Union Government has set up Central Research Councils for promoting scientific validation of Ayurvedic, Unani and Homoeopathic medicines. Before the licensing process, the manufacturers of these medicines will also be required to submit the proof of effectiveness and safety.
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.
Two new institutes namely, All India Institute of Ayurveda with 200 bedded referral hospital, New Delhi and North Eastern Institute of Ayurveda & Homoeopathy, Shillong, Meghalaya with attached 100 bedded teaching hospital of Ayurveda and 50 bedded teaching hospital of Homoeopathy are in advance stage of construction.
Under the Ministry’s Centrally Sponsored Scheme of National AYUSH Mission, there is a provision for providing Grant-in aid to State and UT Governments for setting up of 50 bedded integrated AYUSH Hospital where patients suffering from various ailments can avail affordable treatment.
Government of India has set up Research Councils for Ayurveda, Siddha, Unani and Homoeopathy with a network of 80 field units spread across the country to undertake research and development and other scientific activities in the area of herbal medicines. A central sector scheme of Extra-Mural Research has also been implemented to promote and support scientific exploration of AYUSH interventions and remedies in various medical and other R&D institutions.
Multi-dimensional Research and Development activities have been taken up by the scientific institutions of the country to tap the potential of the herbal remedies including Ayurveda, Unani and Siddha systems. Considerable progress has been made in this regard in the form of development of new formulations, scientific publications and award of patents. So far, 26 patents have been granted to Ayurvedic, Siddha and Unani Research Councils and 56 patents have been granted to the Council for Scientific & Industrial Research (CSIR) for herbal formulations and compositions. Many herbal remedies have also been developed by CSIR to address issues relating to tuberculosis, gastrointestinal side effects, prostate megaly, improving memory, diabetes, improving immune system, acute phase inflammatory response etc.
Research Councils are engaged in validation studies and safety and efficacy evaluation of the remedies described in the authoritative books. In these studies, integrated protocols involving both traditional and modern scientific parameters are used to evaluate the efficacy of medicinal formulations of Ayurveda, Siddha and Unani systems.
This information was given by the Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik in reply to a question in Rajya Sabha on Wednesday.