NDCT Rules Draft Amendment for BA/BE Studies
In News
What Happened
Why It Matters
Background
History & Context
What Changed
- ▶
BA/BE Studies for Export: BEFORE: Pharmaceutical companies required full prior approval and a formal licence to conduct BA/BE studies. NOW: The licence requirement is dispensed with for certain low-risk oral generics already approved in select global markets (like the US, EU, and Japan), allowing commencement upon simple online prior intimation.
- ▶
Test Licence System: BEFORE: Applicants had to wait for a formal test licence to manufacture investigational drugs for analytical and preclinical testing. NOW: Converted to an online notification system for most drugs, bypassing the need for prior approval except for high-risk categories like sex hormones and narcotics.
- ▶
Statutory Processing Timelines: BEFORE: The maximum timeline for granting permissions under rules 53 and 60 was 90 working days. NOW: The statutory processing time for high-risk drug test licence applications has been halved to 45 working days.
Prelims Angle
NCERT Connection
Practice Questions
Q1
With Reference ToWith reference to the 2025 draft amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, consider the following statements: 1. The statutory processing time for high-risk test licence applications has been reduced from 90 days to 45 days. 2. Bioavailability and Bioequivalence (BA/BE) studies for all categories of drugs now require full prior approval before commencement. Which of the statements given above is/are correct?