The Government of India has released the “National Clinical Management Protocol based on Ayurveda and Yoga for management of COVID-19” prepared by the National Task force in consensus from various expert committees, informed Sarbananda Sonowal, Minister of State for AYUSH, in Rajya Sabha yesterday.
The Ministry of AYUSH has formed an Inter-disciplinary AYUSH R&D Task Force having representation from the Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT), Council of Scientific and Industrial Research (CSIR), All India Institute of Medical Sciences (AIIMS) and AYUSH Institutions. The Inter-disciplinary AYUSH R&D Task Force has formulated and designed clinical research protocols for prophylactic studies and add-on interventions in COVID-19 positive cases for studying four different interventions viz. Ashwagandha, Yashtimadhu, Guduchi + Pippali and a poly herbal formulation (AYUSH-64), he added.
AYUSH-64 and Kabasur Kudineer have been identified for COVID-19 treatment. The research outcomes of the clinical trials have demonstrated efficacy of AYUSH- 64 in the treatment of asymptomatic and mild cases as standalone and for the management of mild and moderate COVID-19 as an adjunct to standard care, the minister said.
He also mentioned that it was observed that AYUSH-64 as an adjunct treatment to standard care resulted in significant improvement in clinical recovery. AYUSH 64 is also recommended in the “National Clinical Management Protocol based on Ayurveda and Yoga for management of COVID-19” prepared by the National Task Force in consensus from various expert committees. Further, Kabasur Kudineer, a Siddha preparation was also subjected to clinical trials for studying the efficacy in COVID-19 patients by the Central Council for Research in Siddha (CCRS) under the Ministry of AYUSH, and is also found useful in the treatment of mild-to-moderate COVID-19 infection.
“In order to provide the maximum benefit of AYUSH systems of medicine, a nationwide campaign has been undertaken for the distribution of AYUSH-64 and Kabasura Kudineer through the research councils and the national institutes under the Ministry of AYUSH across the country,” Sonowal said.
He further added that the ministry has issued orders to all the State AYUSH Licensing Authorities/Drug Controllers and Expert Committees to allow the licensed manufacturers for AYUSH-64 under their jurisdiction to include the new indication of AYUSH-64 for repurposing as an intervention for the management of asymptomatic, mild-to-moderate COVID-19 in addition to the existing indication(s) and to expedite the process of the licensing/approval of such applications for the manufacturing of AYUSH-64 medicine, provided the prescribed standards and relevant provisions of the Drugs & Cosmetics Rules, 1945, are fulfilled. So far, 37 manufacturing units of 11 states have been transferred AYUSH-64 technology by CCRAS through the National Research Development Corporation (NRDC).
The minister notified that the Ministry of AYUSH has also constituted an Interdisciplinary Technical Review Committee (ITRC) for COVID-19 for the examination of the applications/claims on patent & proprietary (P&P) ASU&H medicines/classical ASU& H medicines with a new indication or re-purposing of licensed P&P, ASU&H medicines for COVID-19, forwarded by the State Licensing Authorities/Individuals referred by the Drug Policy Section of the Ministry of AYUSH. So far, the following applications have been approved in the ITRC with respect to COVID-19 claims:
- Divya Coronil tablet of Patanjali Research Foundation Trust, Haridwar, Uttarakhand- recommended as a supporting measure in the management of COVID-19 without claiming cure
- Clevira Tablet of M/s Apex Laboratories, Tamilnadu, has been recommended as a supporting measure for mild-to-moderate condition of COVID-19
- Kabasura Kudineer of Sri Sri Tattva, Sriveda Sattva, Bengaluru, has been recommended as an intervention for prevention of mild-to-moderate symptoms of COVID-19.
As per the requests received from state/UT governments regarding utilisation of the National AYUSH Mission (NAM) funds for the purchase of medicines, including AYUSH-64 medicine in the context of COVID-19 pandemic, an amount of Rs 2271.551 lakh has been approved by the ministry till date.