In a move aimed at accelerating drug development while maintaining regulatory oversight, India’s drug regulator has notified sweeping changes to the New Drugs and Clinical Trials (NDCT) Rules, 2019, introducing a faster “prior intimation” route for select test licences and sharply reducing approval timelines.
The amendments, notified on January 20, 2026, under G.S.R. 46(E), mark a significant shift in how manufacturers can produce new drugs and investigational products for clinical trials, bioavailability, bioequivalence studies, and analytical testing
Under the revised framework, manufacturers conducting analytical and non-clinical testing excluding high-risk categories such as cytotoxic drugs, sex hormones, beta-lactams, live biologics, and narcotic or psychotropic substances which can now begin manufacturing after submitting an online prior intimation and receiving an acknowledgement from the Central Licensing Authority.
Earlier, all such activities required formal approval, often extending timelines by several months. Regulatory timelines have also been tightened, with approval periods reduced from 90 working days to 45 working days across multiple provisions, signalling CDSCO’s intent to streamline India’s clinical research ecosystem.
Despite procedural relaxations, the notification reinforces safeguards. Drugs manufactured under test licences or prior intimation cannot be sold or commercially supplied, must be produced in limited quantities, and must strictly comply with Good Manufacturing Practices (GMP). The amendments also empower CDSCO to suspend or cancel permissions or acknowledgements, with clear provisions for appeal, if manufacturers fail to comply with the Drugs and Cosmetics Act or NDCT Rules.
The NDCT Rules amendment is expected to reduce development costs, improve research turnaround time, and make India a more attractive destination for clinical and pre-clinical research, while preserving CDSCO’s authority to intervene in case of non-compliance. The rules will come into force 45 days from the date of publication, giving stakeholders time to align internal processes with the revised regulatory framework.
Alongside the NDCT amendments, CDSCO has stepped up regulatory activity on multiple fronts in recent months. The drug regulator has reiterated the importance of stronger pharmacovigilance, urging companies to ensure faster and more consistent reporting of serious adverse events, particularly for newly approved drugs and vaccines. At the same time, CDSCO, in coordination with state drug controllers, has intensified inspections and enforcement actions against substandard and spurious medicines, with a sharper focus on high-use categories such as antibiotics and cough formulations. The regulator is also pushing deeper digitalisation through the Sugam portal, bringing more licence applications, renewals, and test-related submissions fully online to improve transparency, tracking, and turnaround times.
In parallel, CDSCO has tightened oversight of active pharmaceutical ingredients (APIs) and excipients, placing greater scrutiny on the use of unapproved substances during formulation development in line with global regulatory practices.
