Amendments to New Drugs and Clinical Trials (NDCT) Rules, 2019
The Union Ministry of Health and Family Welfare has made significant amendments to the NDCT Rules, 2019, to alleviate regulatory constraints and facilitate ease of doing business in the pharmaceutical sector.
Key Changes in Regulatory Framework
- Test Licence Requirement:
- The requirement for a test licence for manufacturing small quantities of drugs for examination, research, or analysis has been replaced with a prior-intimation mechanism to the CDSCO, except for high-risk drugs.
- Categories that still require a test licence now have a reduced statutory processing timeline from 90 days to 45 days.
- Impact on Pharmaceutical Development:
- This change is projected to save at least 90 days in the drug development life cycle.
- CDSCO processes about 30,000 to 35,000 test licence applications annually, so the reform will significantly lower the regulatory burden.
Reforms for Bioavailability/Bioequivalence (BA/BE) Studies
- Low-Risk Studies:
- The need for prior permission for certain low-risk BA/BE studies is now eliminated, requiring only a simple online intimation to CDSCO.
- Expected Outcomes:
- The mechanism is set to reduce delays significantly, with CDSCO handling about 4,000 to 4,500 BA/BE study applications annually.
Implementation and Benefits
- Online Modules:
- New online modules on the National Single Window System (NSWS) and the SUGAM portal will facilitate transparent and hassle-free submission of intimations.
- Overall Benefits:
- Reduction in timelines for BA/BE studies and drug testing, minimizing delays in drug development and approval.
- Improved efficiency and effectiveness of CDSCO's regulatory oversight by optimizing manpower utilization.
Strategic Objectives
- Promote research-led growth in the Indian pharmaceutical industry.
- Align domestic regulations with global best practices.
- Strengthen India's position as a preferred global destination for pharmaceutical research and development.
