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

Application for manufacturing, sale and distribution of drug or new drug shall be apply simultaneously with application of renewal

24-Aug-2022 | G.S.R. 654(E)

The Department of Health and Family Welfare has issued Drug (Seventh Amendment) Rules, 2022. By the virtue of notification, ensure to apply simultaneously, for the application for grant of approval to manufacture the new drug under Rule 122B of the Drugs Rules, 1945 or for the application for permission to manufacture new drug for sale or distribution under Rule 80 of New Drugs and Clinical Trials Rules, 2019 and the application for grant or renewal of licence to manufacture for sale or for distribution of drugs under Rule 75(3) of the Drugs Rules, 1945. Further, ensure that for the manufacture of drugs formulation falling under the purview of new drug under rule 80 of the New Drugs and Clinical Trials Rules, 2019 or rule 122B, the licence to manufacture for sale or distribution of the drugs shall be granted after approval of the drug as new drug.

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