The New Drugs and Clinical Trials Rules, 2019 regulate the manufacture of new drugs and investigational new drugs for clinical trials, bioavailability or bioequivalence studies, and for examination, test and analysis. Prior to this amendment, such manufacture generally required prior permission from the Central Licensing Authority within prescribed timelines. The draft amendment was published on August 27, 2025, and objections and suggestions received from the public were considered by the Central Government before finalisation.

1. Rule 52 – Introduction of “prior intimation” mechanism
   In rule 52, the marginal heading substitutes the word “permission” with “permission or prior intimation”. Sub-rule (1) is substituted to provide that no person shall manufacture a new drug or investigational new drug for clinical trial, bioavailability or bioequivalence study, or for examination, test and analysis without obtaining permission in Form CT-10.
   Provided that, for manufacture of new drugs or investigational new drugs for analytical and non-clinical testing (excluding sex hormones, cytotoxic drugs, beta lactams, biologics with live microorganisms, and narcotic and psychotropic drugs), an online application in Form CT-10 shall be submitted as prior intimation, and manufacture may commence on the basis of acknowledgement of such intimation. Sub-rule (2) is omitted, and references in sub-rule (3) are aligned accordingly.
2. Rule 53 – Reduction in approval timelines
   In rule 53, the time limit of “ninety working days” is substituted with “forty-five working days” in sub-rules (1), (2), and clause (ii) of sub-rule (3).
3. Rules 54 to 57 – Alignment with prior intimation framework
   Rules 54, 55, 56, and 57 are amended to replace references to “permission” with “permission or acknowledgement of prior intimation”, and to extend conditions, validity, obligations, and record-keeping requirements equally to holders of prior intimation acknowledgements under rule 52.
4. Rule 58 – Suspension or cancellation
   Rule 58 is substituted to empower the Central Licensing Authority to suspend or cancel either a manufacturing permission or an acknowledgement of prior intimation for non-compliance, after providing an opportunity of being heard. An appeal to the Central Government is permitted within sixty days of receipt of the order.
5. Rule 59 – Prior intimation for formulation and API manufacturers
   Rule 59 inserts a proviso allowing manufacturers of pharmaceutical formulations and active pharmaceutical ingredients to submit prior intimation in Forms CT-12 and CT-13 respectively, for analytical and non-clinical testing of new drugs or investigational new drugs (with specified exclusions), and to manufacture based on acknowledgement of such intimation.
6. Rules 60 and 61 – Timeline reduction and terminology changes
   In rule 60, the approval timeline is reduced from ninety to forty-five working days. Rule 61 substitutes references to “permission” with “permission or acknowledgement of prior intimation” and aligns validity provisions accordingly.
7. Rules 62 and 63 – Suspension, cancellation, and conditions for unapproved APIs
   Rules 62 and 63 are substituted to provide for suspension or cancellation of permission or prior intimation for manufacture of unapproved active pharmaceutical ingredients, and to prescribe detailed conditions governing their use, manufacture, record maintenance, and destruction of unused or substandard material.
8. Rules 64 and 66 – Consequential amendments
   Rules 64 and 66 are amended to extend inspection, compliance, and labelling requirements to cases involving prior intimation acknowledgements.
9. Eighth Schedule – Amendment of Forms
   Forms CT-10, CT-12, and CT-13 in the Eighth Schedule are amended to include references to “prior intimation” in addition to “permission”.