Health Ministry eases drug trial norms; cuts licence requirement, Pg14

Key Highlights:

• The Union Health Ministry amended the New Drugs and Clinical Trials (NDCT) Rules, 2019 to ease regulations.
• Requirement for test licenses for non-commercial drug manufacture is replaced with prior intimation, except for high-risk drugs.
• Processing time for applicable test licenses reduced from 90 to 45 days.
• Prior permission is no longer needed for low-risk Bioavailability/Bioequivalence (BA/BE) studies; online intimation suffices.

Detailed Insights:

• The existing regulatory framework required pharmaceutical companies to obtain a test license from the CDSCO for manufacturing small drug quantities for research.
• The amendment is expected to reduce the drug development life cycle by a minimum of 90 days, boosting pharmaceutical research.
• The CDSCO processes approximately 30,000 to 35,000 test license applications annually, and this reform will reduce regulatory burden.
• High-risk drugs, including cytotoxic drugs, narcotic drugs, and psychotropic substances, are excluded from the prior intimation mechanism.
• Bioavailability/Bioequivalence (BA/BE) studies can now be initiated with a simple online intimation to CDSCO, expediting clinical research.

Key Concepts Involved:

• CDSCO (Central Drugs Standard Control Organisation): National regulatory body for pharmaceuticals and medical devices in India.
• Bioavailability: Rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action.
• Bioequivalence: Comparison of bioavailability between different formulations of the same drug.