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Approval of Covid 19 Related Medicines under Ayush

Covid-19 By Ayush


The Government of India has released “National Clinical Management Protocol based on Ayurveda and Yoga for Covid 19 management” prepared by the National Task force in consensus from various expert committees.

An Inter-disciplinary Ayush R&D Task Force has been formed by the Ministry of Ayush for having representation from Indian Council of Medical Research (ICMR), All India Institute of Medical Sciences (AIIMS),  Council of Scientific and Industrial Research (CSIR),) Department of Biotechnology (DBT), and Ayush Institutions. The Inter-disciplinary Ayush R&D Task Force has designed and formulated clinical research protocols for prophylactic studies and add-on interventions in Covid 19 positive cases for studying four different interventions viz. Yashtimadhu, Ashwagandha, Guduchi + Pippali and a poly herbal formulation (AYUSH-64).

AYUSH-64 and Kabasur Kudineer have been identified for Covid-19 treatment. The research outcomes of the clinical trials has illustrated the efficacy of AYUSH- 64 in treating asymptomatic & mild cases as standalone and for the management of mild and moderate Covid 19 as an adjunct to standard care.  AYUSH-64 showed a significant improvement in clinical recovery as adjunct treatment to Standard Care. Further, Kabasur Kudineer, a siddha preparation, was also used in clinical trials for studying the efficacy in Covid-19 patients by the Central Council for Research in Siddha (CCRS) under the Ministry of Ayush. This proved useful in the treatment of mild to moderate Covid 19 infection.

In order to offer maximum advantage of Ayush systems of medicine, a nationwide campaign has been initiated for distribution of AYUSH-64 and Kabasura Kudineer through  the National Institutes and the Research Councils under the Ministry of Ayush across the country.

The Ministry has issued orders to all the States Ayush Licensing Authorities/Drug Controllers and Expert Committees there under to allow the licensed manufacturers for AYUSH-64 under their jurisdiction to include new indications of AYUSH-64. This is for repurposing as an intervention for the management of asymptomatic, mild to moderate Covid 19 in addition to 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 to AYUSH-64 technology by CCRAS through National Research Development Corporation (NRDC).

The Ministry of Ayush has formed  an Interdisciplinary Technical Review Committee (ITRC) for Covid 19. This is for the purpose of the examination of the applications/claims on patent & proprietary (P&P) ASU&H medicines/ classical ASU&

H medicines with 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 Ministry of Ayush. 

So far, the following applications have been approved in the ITRC with respect to Covid 19 claims:-

  1. Divya Coronil tablet of Patanjali Research Foundation Trust, Haridwar, Uttarakhand- recommended as supporting measure in the management of Covid 19 without claiming cure.
  2. Clevira Tablet of M/s Apex Laboratories Private Ltd., Tamilnadu has been recommended as a supporting measure for Covid 19 mild to moderate condition.
  3. Kabasura Kudineer of Sri Sri Tattva, Sriveda Sattva Pvt. Ltd. Bangalore has been recommended as an intervention for prevention and mild to moderate Covid 19 symptoms.

As per the requests received from State/UT Governments regarding utilization of National Ayush Mission (NAM) funds for 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 of Ayush.

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