The Union Ministry of AYUSH has sought details of licencing applications for Ayurvedic, Siddha, and Unani drugs as well as the results of clinical trials and research studies in these systems of medicine from States and Union Territories in the wake of their claims on COVID-19 treatment.
In a recent order, the Ministry pointed out that guidelines had been issued in April on the conduct of research studies or clinical trials of Ayurveda, Siddha, Homoeopathy and Unani medicines for COVID-19 treatment. According to Rule 158-B of the Drugs and Cosmetics Rules, 1945, proof of effectiveness for new indication or use is required for granting licence or approval to manufacture and sell Ayurvedic, Siddha and Unani medicines.
It had, however, come to the notice of the Union government that “approvals are being given for the medicinal products selected or registered for clinical trials or research studies” and “spurious claims and misleading advertisements are placed in the media” about the treatment of COVID-19 patients.
Against this backdrop, the Union government directed the licencing authorities in States and Union Territories to forward the details of licencing applications of such formulations and results of clinical trials and research studies for verification by the AYUSH Ministry. It is in exercise of the powers under Section 33 P of the Drugs and Cosmetics Act, 1940, the order said.
The respective licencing authorities should grant approval or licence to manufacture for sale of such formulations only after getting clearance from the Ministry, it added.
