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The Union health ministry has notified various amendments to the New Drugs and Clinical Trials Rules (NDCTR), 2019, to ease the process of approval for manufacturing of new drug or investigational new drug for analytical and non-clinical testing, and to reduce the timeline for approval of manufacturing of new drug or investigational new drugs for tests.
The amendment allows manufacturing of new drug or investigational new drug for analytical and non-clinical testing excluding certain categories to be carried out after submitting prior intimation in Form CT - 10 and getting an acknowledgement from the Central Licensing Authority (CLA).
The final amendment mandates under the sub-rule (1) of Rule 52 that no person shall manufacture a new drug or an investigational new drug to conduct clinical trial or bioavailability or bioequivalence study or for examination, test and analysis without obtaining permission, by making an application in Form CT-10 to the Central Licencing Authority to manufacture such new drug or investigational new drug, from the Central Licencing Authority.
However, in case of manufacture of new drug or investigational new drug for analytical and non-clinical testing (excluding the new drug and investigational new drug of category of sex hormones, cytotoxic, beta lactam, biologics with live microorganism and narcotics and psychotropic drugs), "an online application in Form CT-10 to the Central Licencing Authority shall be submitted as prior intimation and the applicant may manufacture such drugs based on the acknowledgment of such intimation," said the amended sub-rule.
So far, manufacturing of new drugs or investigational new drugs for analytical and non-clinical testing also were mandated to have an absolute permission from the drug regulator. The Ministry, which issued a draft notification in August, 2025, said that it has considered the objections and suggestions received from the public on the draft rules. The amendment shall come into force after 45 days from January 20, 2026, which is the date of publication of the notification in the Gazette of India.
The marginal heading of the Rule has also been amended to include the provision of prior intimation along with the provision for permission for manufacturing.
Form CT-10, according to the Rules, is an application for grant of permission to manufacture new drug or investigational new drug for clinical trial or BA/BE study or for examination, test and analysis. The CLA grants permission based on the Form CT-10 through Form CT-11.
The timeline for the drug regulator to take decision on the application in Form CT-11 has been reduced from the current 90 working days to 45 working days. The period for the drug regulator to take its call after the submission of rectifications on any deficiency, if the permission is not granted in the initial stage, has also been reduced from 90 working days to 45 working days.
Similar to the manufacturing permissions granted under Form CT-11, the validity of acknowledgement of prior intimation issued under the amended Rule 52 for analytical and non-clinical testing will also be three years. In exceptional cases, similar to the permissions, the validity of acknowledgement will also be extended for a period of one year.
The first three clauses of the Rule 55, which deals with the conditions of permission, which has been amended as "conditions of permission or prior intimation", has also been substituted to include the provisions for the acknowledgement of prior intimation. The Rules 56, 57 and 58 have also been amended in tune with this.
The Rule 59, regarding permission of manufacture of unapproved active pharmaceutical ingredient (API) for development of pharmaceutical formulation for test or analysis or clinical trial of BA/BE study, has also been amended to include the acknowledgement of prior intimation. Timeline for approval process for the same has also been reduced from 90 working days to 45 working days, through the amendment.
Rules related to grant of permission to manufacture such APIs, validity period, and provisions related to suspension or cancellation of permission, among others, have also been amended in tune with the basic amendment.
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