WHO-GMP/COPP Certification for Ayurvedic Products
The Indian Medicines Pharmaceutical Corporation Ltd. (IMPCL) (Central Public Sector Enterprise) Mohan, Dist. Almora, Uttarakhand under the administrative control of Ministry of AYUSH, Government of India has applied for “WHO-GMP/COPP certification for 18 Ayurvedic products. The application has been examined in the office of Drug Controller General (India) and joint inspection of the unit was carried out in the month of March, 2021 comprising of the officials from Central Drugs Standard Control Organization (CDSCO), Ministry of AYUSH and State Licensing Authority of 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 Drug Controller General (India) in accordance with the relevant provisions and guidelines.
Research on Ayush Medicines to Curb Covid-19 Outbreak
During the second wave of this pandemic, AYUSH-64 and Kabasura Kudineer were repurposed for COVID 19 after the robust scientific studies found them useful in asymptomatic, mild and moderate COVID-19 infection as standalone and/or as an adjunct to Standard care as per the studies conducted by Ministry of Ayush in collaboration with Ministry of Health and family Welfare, Ministry of Science and Technology (CSIR & DBT), Department of Science and Technology and reputed scientific organisations and hospitals. However, Govt. of India has released “National Clinical Management Protocol based on Ayurveda and Yoga for management of COVID-19”.
States/ UTs licensing authorities / Drug Controllers has been informed 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 application for the manufacturing of AYUSH-64.
The Ministry has undertaken following steps to reduce/ exterminate the effects of COVID-19:-
i. Ministry of Ayush has formed an Inter-disciplinary AYUSH Research & Development Task Force chaired by Prof. Bhushan Patwardhan having representation from scientists of Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT), Council of Scientific & Industrial Research (CSIR), All India Institute of Medical Sciences (AIIMS) and Ayush Institutions. The Interdisciplinary 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 through thorough review and consultative process of experts of high repute from different organizations across the country for studying four different interventions viz. Ashwagandha, Yashtimadhu, Guduchi + Pippali and a poly herbal formulation (AYUSH-64).
ii. Ministry of Ayush has also launched interdisciplinary studies involving AYUSH interventions for COVID-19 based on recommendations of the Task force. Under various Research Organizations and National Institutes under Ministry of Ayush, 126 research studies at 152 centres in the country have been initiated on AYUSH interventions.
iii. Ministry of Ayush has constituted an Interdisciplinary Technical Review Committee (ITRC) for COVID-19 for the examination of applications/ claims on patent & proprietary ASU&H medicines/ Classical ASU&H medicines forwarded by State Licensing Authorities/ Individuals.