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News about "New Drugs and Clinical Trials (NDCT) Rules, 2019"
CDSCO Clarifies Approval Process for Lyophilized Injection Combi-Packs
The drug regulator has specified when combi-packs of lyophilized injections with diluents will require fresh CDSCO approval and when licenses can be issued directly by State Licensing Authorities.
New Drugs And Clinical Trials (NDCT) Rules, 2019 | 30/09/2025 | By Dineshwori
India to Reform New Drugs and Clinical Trials Rules, Halve Processing Time for Test Licences
By amending the New Drugs and Clinical Trials (NDCT) Rules, 2019, the Indian government aims to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies.
New Drugs And Clinical Trials (NDCT) Rules, 2019 | 04/09/2025 | By Dineshwori
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