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

Issuance of New Drugs and Clinical Trials (Third Amendment) Rules, 2022

14-Oct-2022 | G.S.R. 778(E)

The Ministry of Health and Family Welfare has issued the New Drugs and Clinical Trials (Third Amendment) Rules, 2022 to further amend the New Drugs and Clinical Trial Rules, 2019. By virtue of this amendment, the following Rules has been made amended: - i. As the application for grant of registration submitted to the Central Licencing Authority in Form CT-01 along with the information and documents as specified in Table 1 of the Third Schedule. As per amendment, In case no communication is received from the Central Licensing Authority within 45 working days from the date of the receipt of the application, the registration of Ethics Committee shall be deemed to have been granted by the Central Licensing Authority. ii. As the permission to manufacture new drug or investigational new drug to conduct clinical trial, bioavailability or bioequivalence study or for examination, test and analysis, by making an make an application in Form CT-10 accompanied with documents and information as specified in the Fourth Schedule. As per amendment, If no communication is received from the Central Licensing Authority within 90 working days, the permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study or test and analysis shall be deemed to have been granted by the Central Licensing Authority For further details, please refer to the attached document.

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