In a significant stride towards strengthening India’s pharmaceutical research ecosystem, the Union Health Ministry notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, on Wednesday.
These reforms are specifically designed to strip away bureaucratic layers, reduce approval timelines by at least 90 days, and promote a “trust-based” regulatory environment for drug development and clinical research.
The cornerstone of these amendments is the transition from a traditional licensing system to a streamlined prior-intimation mechanism for the non-commercial manufacture of drugs. Previously, pharmaceutical companies were required to obtain a formal test licence from the Central Drugs Standard Control Organisation (CDSCO) for manufacturing small quantities of drugs intended for examination, research, or analysis.
Under the new rules, researchers can now proceed with pharmaceutical development immediately after submitting an online intimation via the SUGAM portal or the National Single Window System (NSWS). This shift is expected to drastically reduce the procedural load on the CDSCO, which currently processes between 30,000 and 35,000 test licence applications annually. However, a “high-risk” safety net remains; formal licences are still mandatory for specific categories, including cytotoxic drugs, narcotics, and psychotropic substances.
To further expedite the drug development life cycle, the ministry has slashed the statutory processing timelines for categories that still require test licences. These timelines have been halved, dropping from 90 days to 45 days.
Furthermore, the requirement for prior permission has been dispensed with for certain low-risk Bioavailability and Bioequivalence (BA/BE) studies. These studies, which are vital for the generic pharmaceutical industry to prove that their versions of drugs work the same way as the originals, can now be initiated through a simple online notification. This is expected to benefit roughly 4,500 BA/BE applications each year, ensuring that life-saving generic medicines reach the market far more quickly.
The Health Ministry has emphasised that these reforms align with the government’s Jan Vishwas Siddhant and broader Ease of Doing Business framework. By automating low-risk approvals, the CDSCO can now optimise its manpower to focus on more complex, high-risk regulatory oversight. Ultimately, these measures aim to harmonise Indian regulations with global best practices, cementing the nation’s position as a preferred global destination for cutting-edge pharmaceutical R&D.
