Health Ministry to Revise 2019 Rules on New Drugs and Clinical Trials

Swift Summary:

• The Union Health Ministry plans to amend the New Drugs and Clinical Trials Rules, 2019, to promote ease of doing business in the pharmaceutical and clinical research sectors.
• Proposed amendments were published in The Gazette of India on August 28, inviting public comments.
• Key changes include:

– Simplified submission processes for test licences and bioavailability/bioequivalence studies.
– Conversion of the current system for test licences into a notification and intimation system (except for high-risk category drugs).- Reduction in processing time for test license applications from 90 days to 45 days.

• Certain bioavailability/bioequivalence studies will now require only intimation or notification submission rather of prior licensing approval.
• Expected outcomes include reduced application submissions by approximately 50%, quicker initiation of drug-related studies, and streamlined drug progress processes.
• Efficiency gains are anticipated through optimized human resource deployment within the Central Drugs Standard Control Organisation.

Indian Opinion analysis:

The proposed amendments represent a significant step toward simplifying regulatory frameworks in India’s pharmaceutical sector. By reducing procedural timelines, introducing automated systems via notifications rather than exhaustive approvals, and streamlining drug testing protocols for non-high-risk categories, these changes aim to attract investments while enabling faster scientific advancements. These reforms might also enhance India’s competitiveness globally as it improves operational efficiency without compromising oversight integrity. However, clear implementation strategies will be critical to ensuring that quality standards remain uncompromised during this transition.Read More: Source Article