With 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?

Question

Accepted Answer

A) 1 only — Statement 1 is correct as the processing timeline was cut from 90 to 45 days. Statement 2 is incorrect because the amendment specifically dispenses with the prior approval requirement for certain low-risk BA/BE studies, converting it to a simple intimation-based system.

NDCT Rules Draft Amendment for BA/BE Studies

Passage of Bharatiya Vayuyan Vidheyak, 2024