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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Guidelines for manufacture and stock of new drug to meet the requirements of emergency arising due to COVID-19

09-Feb-2022 | S.O. 553(E)

The Ministry of Health and Family Welfare notifies the guidelines for the purposes of making available suitable drugs to meet the requirements of emergency arising due to COVID-19.

In which, if any person intends to manufacture and stock a new drug for COVID-19, which is under clinical trial for marketing authorisation for sale or distribution, shall follow the guidelines, namely: -
1) Obtain permission under the New Drugs and Clinical Trials Rules, 2019, in FORM CT-06 to conduct clinical trial of such drug and on successful completion of the clinical trial and after obtaining permission in Form CT-23 to manufacture pharmaceutical formulation of such drug from the Central Licensing Authority.

2) Further, shall make an application for grant of license to manufacture and stock the drug for sale or distribution under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 along with the permission obtained for conducting clinical trial in Form CT-06 under the New Drugs and Clinical Trials Rules, 2019, to concerned Licensing Authority.
If the Central License Approving Authority or the State Licensing Authority is satisfied with the requirements under the provisions of the said Act and the Drugs Rules, 1945 and the New Drugs and Clinical Trials Rules, 2019, grant License to manufacture and stock the new drug.

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