Law and statutory body
New Drugs and Clinical Trials (NDCT) Rules, 2019
GS2 Health regulationGS3 Ease of doing businessPrelims and Mains
- Why in news
- On 28 January 2026 the Union Health Ministry notified amendments to the NDCT Rules, 2019. They replace test licences with online prior intimation for most non-commercial drug manufacture and waive prior permission for specified low-risk BA/BE studies.
- What it is
- The New Drugs and Clinical Trials Rules, 2019 are subordinate rules under the Drugs and Cosmetics Act, 1940. They regulate approval of new drugs, clinical trials, bioavailability/bioequivalence studies, ethics committees and compensation for trial injury or death. CDSCO, headed by the Drugs Controller General of India, is the central regulator.
- Test licence replaced
- For non-commercial manufacture of small quantities of drugs for examination, research or analysis, a test licence is replaced by online prior intimation to CDSCO.
- Exceptions
- High-risk drugs such as cytotoxic drugs, narcotic drugs and psychotropic substances stay outside the intimation route.
- Timeline cut
- Where test licences still apply, the statutory processing time falls from 90 days to 45 days.
- BA/BE studies
- Prior permission is dropped for certain low-risk BA/BE studies; a simple online intimation to CDSCO is enough.
- Portals
- Online modules will be on the National Single Window System and the SUGAM portal.
- Legal basis
- The NDCT Rules, 2019 are made under the Drugs and Cosmetics Act, 1940.
Don’t confuse with NDCT Rules, 2019 vs Drugs and Cosmetics Act, 1940: The Act is the parent law; the NDCT Rules are subordinate rules made under it and can be amended by notification.
Don’t confuse with Test licence vs BA/BE permission: Test licence covers small-scale manufacture for research or analysis; BA/BE permission covers studies comparing drug absorption, mainly for generics.
Laws, judgments and statutory bodies: 30 Prelims questions since 2013 (what the law says, who chairs, legal basis). In Mains, 44 news-triggered questions, most in GS2, asking for provisions and challenges.
Why it matters
- Cuts approval delays and compliance costs, helping Ease of Doing Business and pharma R&D.
- Frees CDSCO staff to focus on higher-risk oversight.
Problems
- Trust-based self-intimation may weaken pre-approval checks and raise safety risks.
- CDSCO has limited capacity for post-facto monitoring and inspection.
Way forward
- Strengthen risk-based audits and post-intimation surveillance through the digital portals.
- Build CDSCO capacity and keep high-risk categories under licensing.
Put in your answer
Jan Vishwas principle: The reform is linked to the trust-based Jan Vishwas Siddhant for decriminalising and simplifying compliance.
- 2024Mains GS4 · Q12Ethics of expediting trials for a new drug during a viral outbreak
- 2026Mains GS4 · Q2Ethics of using unproven research before clinical trials on an endangered tribe
- 2015Mains GS4 · Q11Ethical dilemma of developing a veterinary drug for human use in tribal areas
UPSC’s own questions that come close to this issue, from our Prelims and Mains banks.
Prelims practice · Statements
Ours, not from a UPSC paper
Consider the following statements:
- 1.The amendments to the NDCT Rules, 2019 replace the test licence for non-commercial manufacture of small quantities of drugs with an online prior-intimation mechanism, except for a limited category of high-risk drugs.
- 2.Under the amendments, cytotoxic drugs, narcotic drugs and psychotropic substances are covered by the new prior-intimation route.
- 3.Where test licences continue to apply, the statutory processing timeline has been reduced from 90 days to 45 days.
Which of the statements given above is/are correct?
True or false?
1 of 7
Statements the way Prelims prints them. Say first, then see the fact.
1.The amendments replace the test licence for non-commercial manufacture of small quantities of drugs with a prior-intimation mechanism for most drugs.
True. Test licence replaced by online intimation to CDSCO, except for a limited high-risk category.
2.Cytotoxic drugs, narcotic drugs and psychotropic substances are covered by the new prior-intimation route.
False. They are excluded; they remain high-risk categories outside the intimation route.
3.Where test licences continue to apply, the statutory processing period has been cut from 90 days to 45 days.
True. 90 days reduced to 45 days.
4.The amendments require prior permission for all BA/BE studies to be obtained through the SUGAM portal.
False. Prior permission is waived for specified low-risk BA/BE studies; online intimation suffices.
5.The online modules for intimations will be made available on the National Single Window System and the SUGAM portal.
True. NSWS and SUGAM portal host the modules.
6.The NDCT Rules, 2019 are framed under the Drugs and Cosmetics Act, 1940.
True. They are subordinate legislation under the Drugs and Cosmetics Act, 1940.
7.The test licence reform is expected to save a minimum of 90 days in the drug development life cycle.
True. A minimum saving of 90 days is expected.
Written by us from the release, not by UPSC; checked by a second model.
Worth revising until Prelims 2027: most news questions come within two years of the event.