Health Ministry plans to ease licence rules for new drugs, trials , Pg12

Key Highlights:

• The Union Health Ministry plans to amend the New Drugs and Clinical Trials Rules, 2019 to promote ease of doing business.
• Amendments aim to simplify requirements for obtaining test licences and submitting applications for bioavailability/bioequivalence studies.
• The current system for test licenses is proposed to be converted to a notification and intimation system.
• Statutory processing time for test licence applications will be reduced from 90 days to 45 days.

Detailed Insights:

• The proposed amendment dispenses with the existing licence requirement for certain bioavailability/bioequivalence studies.
• Applicants will be able to initiate studies upon submitting an intimation to the Central Licensing Authority.
• These reforms are expected to reduce the number of applications for test licenses by approximately 50%.
• The amendments were published in the Gazette on August 28, seeking public comments.

Key Concepts Involved:

• Bioavailability: The rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action.
• Bioequivalence: The absence of a significant difference in the rate and extent to which the active ingredient becomes available at the site of drug action when administered at the same molar dose.
• Central Licensing Authority: The authority responsible for granting licenses and regulating drugs and clinical trials at the central level.