Health Ministry publishes draft amendments to New Drugs and Clinical Trials Rules, 2019 to ease test licences and BA/BE studies
Draft amendments to the New Drugs and Clinical Trials Rules, 2019, published in the Gazette on 28 August 2025, propose replacing most test licences with an intimation system and cutting processing time from 90 to 45 days.
Summary
The Union Health Ministry published draft amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 in the Gazette of India on 28 August 2025, seeking public comments. Under the proposal, the test licence system would become a notification or intimation system, so applicants need only inform the Central Licensing Authority except for a small category of high-risk drugs, and the statutory processing time for test licence applications would fall from 90 to 45 days. The licence requirement would also be dropped for certain categories of bioavailability/bioequivalence (BA/BE) studies, which the Ministry says will cut licence applications by about 50% and let CDSCO deploy its staff more efficiently.
Key facts
- Draft published
- 28 Aug 2025, Gazette of India (public comments)
- Rules
- New Drugs and Clinical Trials Rules, 2019
- Test licences
- Licence → intimation system (except high-risk drugs)
- Processing time
- 90 days → 45 days
- BA/BE studies
- Licence dispensed with for certain categories
- Expected impact
- ~50% fewer licence applications
- Regulator
- Central Drugs Standard Control Organization (CDSCO)
Practice MCQs 3 questions
Under the draft amendments to the NDCT Rules, 2019 published on 28 August 2025, the statutory processing time for test licence applications is proposed to be reduced from 90 days to:
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Correct answer: D — 45 days
The draft reduces the overall statutory processing time for test licence applications from 90 days to 45 days.
In the context of drug regulation, 'BA/BE studies', addressed in the draft NDCT amendments of August 2025, stand for:
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Correct answer: B — Bioavailability / Bioequivalence studies
The draft amendments concern applications for Bioavailability/Bioequivalence (BA/BE) studies.
Consider the following statements about the draft amendments to the New Drugs and Clinical Trials Rules, 2019 (August 2025): 1. Test licences for all drugs, including high-risk categories, will be replaced by an intimation system. 2. The Ministry expects the number of licence applications to fall by about 50%. Which of the above is/are correct?
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Correct answer: B — 2 only
Statement 1 is wrong: a small category of high-risk drugs is excluded from the intimation system. Statement 2 is correct.