CDSCO issues clarification regarding applicability of the New Drugs and Clinical Trial Rules, 2019

Feb 21, 2020 | by Avantis RegTech Legal Research Team


Industry Specific Compliance

The Central Drug Standard Control Organization (CDSCO) on February 18, 2020, gives clarification regarding applicability of the New Drugs and Clinical Trial Rules, 2019. CDSCO had received concerns regarding applicability of the rules for drugs not considered as new drugs as well as submission and processing of applications for grant of permission to manufacture of new drug or investigational new drug for test and analysis.

Thus, it has been clarified that the New Drugs & Clinical Trials Rules, 2019 is only applicable for new Drugs and Investigational New drugs for human use. And in case the drug is truly not a new drug with respect of composition, dosage form, indication, use, patient population etc., no permission from CLA may be required for conduct BA/BE study of such drug, but needs to conducted with due approval of respective ethics committee. It has also clarified that where the application for obtaining permission to manufacture new drug or investigational new drug (Biological drugs and drugs other than Biologicals) for test and analysis.


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