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News about "New Drugs and Clinical Trials (NDCT) Rules, 2019"
Union Health Ministry Revises NDCT Rules
The Union Health Ministry has notified amendments to the NDCT Rules, 2019 to ease compliance and speed up drug development, introducing a prior-intimation mechanism in place of licensing, waiving permissions for select low-risk BA/BE studies, and cutting test licence processing timelines to 45 days.
New Drugs And Clinical Trials (NDCT) Rules, 2019 | 28/01/2026 | By News Bureau
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 | 317
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 | 151
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