CDSCO grants permission for application in Form CT-11, CT-14, CT-15, CT-17

Feb 25, 2020 | by Avantis RegTech Legal Research Team


Industry Specific Compliance

The Central Drugs Standard Control Organization (CDSCO) on February 20, 2020, has decided to grant permission for application in Form CT-11, CT-14, CT-15, CT-17 for manufacturing or import of new drugs for test and analysis under the New Drugs and Clinical Trials Rules, 2019. It had received concerns on aspects of submission and processing of such applications. CDSCO had given clarifications on submission and processing of applications for grant of permission to manufacture trial batches of new drug or investigational new drug for test and analysis or study vide Notice No. 12-01/20-DC dated February 18, 2020.

Thus, to streamline the process, CDSCO has been decided that such applications will be processed by CDSCO within seven working days of receipt of the applications.

[Notice No. PG/298/import/TL/2019-DCGI]


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