Proposed Amendments to New Drugs and Clinical Trials (NDCT) Rules, 2019

The Union health ministry is considering amendments to the NDCT Rules, 2019 to expedite drug development and approval processes.

Key Amendments and Objectives

• Reduction in statutory processing time for test licence applications from 90 to 45 days.
• Simplification of procedures for obtaining test licences and submitting applications for bioavailability/bioequivalence (BA/BE) studies.
• Conversion of the current test licence system into a notification/intimation system to allow certain trials to proceed without a license.

Impact on the Indian Pharmaceutical Industry

The proposed changes aim to:

• Enhance the ease of doing business in India and align with global best practices.
• Increase India's attractiveness as a global hub for pharmaceutical research and development.
• Encourage domestic clinical research by reducing regulatory bottlenecks.

Specific Provisions for Oral Formulations

• Relaxation applies only to oral formulations already approved in countries with stringent regulatory systems like the EU, UK, Japan, Australia, US, and Canada.
• A high-risk category of drugs will still require approval.

Expected Outcomes

• Potential 50% reduction in licence applications, optimizing the Central Drugs Standard Control Organisation's (CDSCO) resource deployment.
• Quicker initiation of BA/BE studies and testing processes, reducing drug development delays.

Past Efforts and Context

The CDSCO has previously allowed the entry of novel drugs into India without local clinical trials if approved by a stringent foreign regulator, indicating ongoing efforts to streamline the drug approval process.