Amendments to New Drugs and Clinical Trials Rules, 2019

Syllabus: GS2/ Governance/ Health

Context

• The Union Ministry of Health and Family Welfare has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, to reduce regulatory burden and promote ease of doing business.

Rational behind the reforms

• India is one of the world’s largest suppliers of generic medicines and vaccines, accounting for nearly 20% of global generic drug exports by volume, according to the World Health Organization (WHO). 
• Issue: The industry stakeholders have long flagged lengthy regulatory timelines as a barrier to faster innovation and global competitiveness. 
• Significance: By cutting approval timelines, reducing licensing requirements, and enabling online intimation mechanisms, the amendments are expected to significantly strengthen India’s pharmaceutical R&D ecosystem while maintaining robust regulatory oversight.

What are the Amendments?

• Test Licence Replaced with Prior Intimation: The requirement of obtaining a test licence from CDSCO for non-commercial manufacture of small quantities of drugs for research, examination, or analysis has been replaced with a prior online intimation mechanism.
  • Exceptions: High-risk categories such as cytotoxic drugs, narcotic drugs, and psychotropic substances continue to require licences.
• Reduced Timelines: The overall statutory processing time for test license applications will be reduced from 90  to 45 days. 
• Waiver of Prior Approval for Low-Risk BA/BE Studies: Prior permission has been waived for specified low-risk Bioavailability/Bioequivalence (BA/BE) studies.
  • Such studies can now commence after simple online intimation to CDSCO.
• Digital Enablement of Compliance: Dedicated online modules will be operationalised on:
  • National Single Window System (NSWS)
  • SUGAM portal

Significance of the Amendments

• Ease of Doing Business: Simplification aligns Indian regulations with global best practices, reducing delays in drug development and approvals.
• Global Competitiveness: With India currently holding only an 8% share in global clinical trials, the reform will make India more attractive for pharmaceutical R&D.
• Resource Optimization: By reducing redundant licensing processes, CDSCO will better deploy its human resources toward high-priority regulatory tasks.
• Industry Confidence: Builds investor and industry confidence by ensuring a faster, transparent, and predictable regulatory environment.

What are the Challenges?

• Ethical Safeguards: Oversight is essential to ensure informed consent, transparency, and protection of trial participants.
• Regulatory Oversight: A lighter compliance burden must not dilute the stringency of safety checks for vulnerable populations.
• Public Trust: Any perception of compromise on safety standards could erode confidence in India’s pharmaceutical regulatory system.

Way Ahead

• Balanced Regulation: While simplifying rules will boost clinical research and industry confidence, India must ensure that speed does not compromise safety and ethics.
• Capacity Building of Regulators: Continuous training and upskilling of CDSCO officials are essential to manage a more facilitative, technology-driven regulatory framework effectively.
• Stakeholder Feedback Loops: Regular consultation with industry, researchers, patient groups, and regulators can help fine-tune the framework and sustain trust-based governance.

Source: TH