 The Central Drugs Standard Control Organisation (CDSCO) has informed the stakeholders in the pharma industry and regulatory authorities that the industry can submit application for analytical and non-clinical testing in various forms under the New Drugs and Clinical Trials Rules (NDCTR), 2019, for prior intimation, in line with the amendment notified recently.
The Union health ministry had on January 20, 2026, notified various amendments to the 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.
Based on the amendment, the stakeholders can proceed to manufacture new drug or investigational new drugs for analytical and non-clinical testing excluding certain categories by simply filing the application and attaining an acknowledgment from the Central Licensing Authority (CLA) as a prior intimation.
"Accordingly, it is hereby informed that all the stakeholders shall submit application for analytical and non-clinical testing in Forms CT-10, CT-12 and CT-13 as the case may be at National Single Window System (NSWS) portal for the 'prior intimation' purpose....," said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), in a circular to the stakeholders.
As per the notification, the prior intimation system shall not apply to new drug and investigational new drug under the categories of sex hormones, cytotoxic, beta lactam, biologics with live microorganism and narcotics and psychotropic substances.
The DCGI said that once the application in the requisite form is submitted at the NSWS portal, the acknowledgment of application submission received from the portal or email may be treated as prior intimation and the concerned applicant can accordingly use the intimation for further use as required under the rule.
"For all other purposes or categories not covered under the amended rules, the system of prior approval shall remain applicable," said the DCGI.
As reported earlier, the Ministry of Health, amended 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 was also 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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