Amendments to New Drugs and Clinical Trials Rules, 2019

• 30 Jan 2026

Source: PIB 

The Union Ministry of Health and Family Welfare has notified significant amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aiming to simplify regulatory processes and accelerate pharmaceutical research under the Ease of Doing Business framework. 

• Waiver of Test Licence: The requirement to obtain a test licence from Central Drugs Standard Control Organization (CDSCO) for non-commercial manufacture of small quantities of drugs for research, examination, or analysis has been replaced with a prior-intimation mechanism. 
  • The waiver does not apply to high-risk categories such as cytotoxic drugs, narcotic drugs, and psychotropic substances, which still require a licence. 
• Reduced Timelines: The reform is expected to save 90 days in the drug development cycle.  
  • For categories still requiring a licence, the statutory processing time has been halved from 90 days to 45 days. The reforms will optimise utilisation of existing CDSCO manpower and improve regulatory efficiency. 
• Ease for Clinical Studies: Prior permission for low-risk Bioavailability/Bioequivalence (BA/BE) studies has been removed, now studies can now commence via simple online intimation to CDSCO. 
• Digital Integration:  To ensure smooth implementation, dedicated online modules will be launched on the National Single Window System (NSWS) and the SUGAM portal (CDSCO e-governance platform), enabling transparent, paperless, and hassle-free submission of intimations. 
• Jan Vishwas Siddhant: These trust-based reforms align with the government's Jan Vishwas principles, aiming to make India a global hub for pharmaceutical R&D. 

Read more:  Drugs and Clinical Trials Rules, 2019