Question : Ayush Medicine

a) whether the approval of several indigenous medicines from the ministry of Ayush have been pending since last three-four years;

b) if so, the details thereof and their current status;

c) whether the applications for approval of medicines from the AYUSH Ministry have been deliberately kept pending for long periods alongwith only few approvals; and

d) if so, the detailed list of Ayush medicines registered for approval, finally approved, rejected and pending during the last five years including the state of Uttar Pradesh?

THE MINISTER OF AYUSH
(SHRI SARBANANDA SONOWAL)

(a) & (b) No Sir, As prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda, Siddha, and Unani drugs, is vested with the State drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha and Unani medicines in accordance with the proof of safety and effectiveness.
As per allocation of Government Business Rules 1961 and Drugs and Cosmetics Act, 1940 and Rules 1945, approval of any product is not granted by the Ministry of Ayush in Central Government. It is granted by the concerned State/UT Government.

(c) & (d) As per the information received from State/ UT Governments, list of Ayush medicines registered for approval/finally approved/rejected and pending during the last five years is at Annexure I.
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