(a) the details of the indigenous medicines pendingapproval from the Government during the last threeyears and the current year;
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(b) whether the application of several medicines forapproval have been kept pending for long periods andvery few medicines are approved; and
(c) if so, the details thereof including list of AYUSH medicines approved, rejected and pending approvalduring the last three years?
THE MINISTER OF AYUSH
(SHRI SARBANANDA SONOWAL)
(a) to (c): The data of approved, pending and rejected applications of indigenious medicines is not maintained in the Ministry of Ayush since the power to grant license to manufacture Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs is vested with State Licensing Authority (SLA) as per the provisions of Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
However, for considering the applications relating to claims of COVID-19, the Ministry of Ayush has constituted an Interdisciplinary Technical Review Committee (ITRC) on 28th October, 2020 for 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 State Licensing Authorities/Individuals referred by Ministry of Ayush.
The Committee has so far considered 46 such applications, out of which 3 applications were approved for supportive measure in COVID-19, 5 applications are pending for discussion in ITRC, compliance of deficiencies is awaited from 5 applications and rest 33 applicants were turned down in ITRC owing to deficiencies in the applications and non-submission of compliance.
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