Health Ministry Reduces Clinical Trial Approval Time from 90 to 45 Days

These amendments, notified as the New Drugs and Clinical Trials (Amendment) Rules, 2026, have been issued under the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB). The rules will come into force 45 days from the date of publication in the Official Gazette.

A key reform introduced through the amendment is the modification of Rule 52, which earlier required formal permission for manufacturing new drugs or investigational new drugs for clinical trials, bioavailability (BA), bioequivalence (BE) studies, or for examination, testing and analysis.

Under the revised framework, while such activities still require application in Form CT-10, a proviso now allows manufacture based on “prior intimation”—acknowledged online by the Central Licensing Authority—for drugs meant for analytical and non-clinical testing, except for specified high-risk categories such as sex hormones, cytotoxic drugs, beta-lactams, biologics with live microorganisms, and narcotic or psychotropic substances.

The gazette proposed,

"for the clauses (i) to (iii), the following clauses shall be substituted, namely: ―

“(i) the holder of the permission or acknowledgment of prior intimation under the proviso of subrule (1) of rule 52, as the case may be, shall make use of new drugs manufactured only for the purposes of conducting clinical trial or bioavailability and bioequivalence study or for examination, test and analysis and no part of it shall be sold in the market or supplied to any other person or agency or institution or organisation;

(ii) the holder of the permission or acknowledgment of prior intimation under the proviso of subrule (1) of rule 52, as the case may be, shall manufacture new drugs only for the purposes of conducting clinical trial or bioavailability and bioequivalence study or for examination, test and analysis in small quantities in accordance with the provisions of these rules and at places specified and in accordance with the principles of Good Manufacturing Practices;

(iii) the holder of the permission or acknowledgment of prior intimation under the proviso of subrule (1) of rule 52, as the case may be, shall keep a record of new drugs manufactured and persons to whom the drugs have been supplied for specified purposes; ”

The amendment also introduces similar prior intimation provisions for manufacturers of pharmaceutical formulations and active pharmaceutical ingredients (APIs) under Rule 59, through online applications in Forms CT-12 and CT-13, enabling manufacture upon acknowledgment of such intimation. This marks a shift from a purely permission-based regime to a hybrid system combining permission and acknowledgment mechanisms.

The gazette stated,

In the said rules, in rule 59, ―

i. in the marginal heading, for the word “permission”, the words “permission or prior intimation” shall be substituted;

ii. after the sub-rule (1), the following proviso shall be inserted, namely: ―

"Provided that where a manufacturer of a pharmaceutical formulation intends to procure 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 lactum, biologics with live microorganism and narcotics and psychotropic drugs) an online application to manufacture such drug shall be made, as prior intimation, to the Central Licencing Authority by the manufacturer of pharmaceutical formulation in Form CT-12 and manufacturer of the active pharmaceutical ingredient in Form CT-13 and the applicant may manufacture such drugs based on the acknowledgment of such intimation."

In another major change aimed at expediting regulatory decisions, the timelines under multiple rules—including Rules 53 and 60—have been reduced from “ninety working days” to “forty-five working days.” This effectively halves the processing time for certain regulatory actions, signalling a push towards faster approvals in the research and development pipeline.

In the said rules, in rule 53, ―

a. in the sub-rule (1), for the words “ninety working days” wherever they occur, the words “forty-five working days” shall be substituted;

b. in the sub-rule (2), for the words “ninety working days”, the words “forty-five working days” shall be substituted;

c. in the sub-rule (3), in clause (ii), for the words “ninety working days”, the words “forty-five working days” shall be substituted.

In the said rules, in rule 60, for the words “ninety working days” wherever they occur, the words “forty-five working days” shall be substituted.

The conditions attached to such permissions or prior intimations have also been elaborated. Drugs manufactured under these provisions are to be used only for clinical trials, BA/BE studies, or examination, testing and analysis, and must not be sold in the market. Manufacturing must follow the principles of Good Manufacturing Practices (GMP), be carried out in specified facilities, and be limited to small quantities. Detailed records of manufacture, supply, use, and disposal are also mandated.

Further, the amended rules provide for suspension or cancellation of either permission or acknowledgment of prior intimation if the manufacturer fails to comply with the Act or the rules, after due opportunity for hearing. Appeal provisions to the Central Government have also been specified.

Another notable insertion relates to labelling requirements under Rule 66. Where a new or investigational drug is manufactured on behalf of another person, the label must indicate the name and address of the manufacturer and the person to whom it is supplied, along with the scientific name or identifying reference of the drug and the purpose for which it has been manufactured.

In the said rules, in rule 66, for the sub-rule (2), the following sub-rule shall be substituted, namely: ―

“(2) Where a new drug or an investigational new drug is manufactured by the holder of permission or acknowledgement of prior intimation, on behalf of another person, he shall indicate on the label of the container of such drug, the name and address of the manufacturer and the person to whom it is being supplied along with the scientific name of such drug, if known, or the reference which shall enable such drug to be identified and the purpose for which it is manufactured.”.

Overall, the amendment reflects an attempt to balance regulatory control with procedural efficiency, easing compliance for low-risk, research-stage manufacturing through prior intimation, while retaining strict conditions, traceability, and enforcement powers for authorities. By reducing approval timelines and digitizing intimation processes, the government appears to be encouraging clinical research and drug development, without diluting safeguards embedded in the NDCT framework