In a written response in the Rajya Sabha yesterday, Mahendrabhai Munjapara, Minister of State for AYUSH informed that states and Union Territories (UTs) licensing authorities/drug controllers have been notified to allow the licensed manufactures for AYUSH-64 under their jurisdiction to include new indication of AYUSH-64 for repurposing as an intervention for the management of asymptomatic, mild-to-moderate COVID-19 in addition to existing indication(s).
Further, states/UTs licensing authorities have been requested to expedite the process of the licensing/approval of applications for the manufacturing of AYUSH-64, he added.
According to Munjapara, the Ministry of AYUSH has undertaken the following steps to reduce/exterminate the effects of COVID-19:
- The ministry has formed an inter-disciplinary AYUSH Research and Development Task Force chaired by Professor Bhushan Patwardhan having representation from scientists of 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 Research and Development Task Force has formulated and designed clinical research protocols for prophylactic studies and add-on interventions in COVID-19 positive cases via a review and consultative process of experts of high repute from different organisations across the country for studying four different interventions viz. Ashwagandha, Yashtimadhu, Guduchi + Pippali and a polyherbal formulation (AYUSH-64).
- It has also launched inter-disciplinary studies involving AYUSH interventions for COVID-19 based on recommendations of the Task Force. Under various research organisations and national institutes under the Ministry of AYUSH, 126 research studies at 152 centres in the country have been initiated on AYUSH interventions.
- The ministry has constituted an Interdisciplinary Technical Review Committee (ITRC) for COVID-19 for the examination of applications/claims on patent and proprietary ASU&H medicines/classical ASU&H medicines forwarded by the state licensing authorities/ individuals.
He also informed that the Indian Medicines Pharmaceutical Corporation Limited (IMPCL) (Central Public Sector Enterprise) Mohan, District Almora, Uttarakhand, under the administrative control of the Ministry of AYUSH, has applied for “WHO-GMP/COPP certification for 18 Ayurvedic products. The application has been examined in the office of the Drug Controller General (India) and a joint inspection of the unit was carried out in March 2021 comprising the officials from the Central Drugs Standard Control Organisation (CDSCO), Ministry of AYUSH and State Licensing Authority of the Government of Uttarakhand.
“The observation of the joint inspection team has been communicated to IMPCL for early compliance. The WHO-GMP/COPP shall be issued by DCGI in accordance with the relevant provisions and guidelines,” he said.