The Ministry of Ayurveda, Yoga & Naturopathy, Unami, Siddha and Homeopathy (AYUSH) has issued an order to achieve quality control of Ayurvedic, Siddha, Unami and Homeopathy (ASU&H) medicines. This order was issued on 28th July, 2020.
It may be recalled that the Ministry of AYUSH had on an earlier occasion set forth guidelines to enable the conduct of research studies/ clinical trials on ASU&H interventions on COVID19. Furthermore, the Drugs and Cosmetics Rules, 1945 prescribe that ‘proof of effectiveness for a new indication or use’ is one of the requirements for obtaining a licence/ approval to manufacture for sale of ASU&H medicines.
The Ministry has noted that approvals have been granted for medical products that are selected/ registered for clinical trials/ research. Spurious claims and misleading advertisements have also been made about their treatment of COVID19 patients.
In the light of this, the Ministry has directed that all State/ Union Territory Licensing Authorities must forward licence applications for such formulations to the Ministry of AYUSH of the Central Government. The applications must be accompanied by details and results of clinical trials/ research study. The Central government will then verify the information. The State/ Union Territory Licensing Authorities will grant approval/ licences for manufacture for sale of such formulations only after obtaining clearance from the Central Government.
