India Halved Test Licence Timelines Under the 2026 NDCT Rules Amendments

The New Drugs and Clinical Trials Rules, 2019 govern the approval of new drugs and the conduct of clinical trials, bioavailability and bioequivalence (BA/BE) studies in India. In September 2025 government reporting indicated that the Health Ministry intended to amend the Rules to ease compliance. The first set of amendments was notified as G.S.R. 46(E) dated 20 January 2026, and government news coverage of the notification was published on 28 January 2026.

The main change concerns Rule 52, which governs the manufacture of new drugs or investigational new drugs for clinical trials, BA/BE studies, or examination, test and analysis. For non-commercial manufacture of this kind, the requirement to obtain a test licence has been replaced in most cases by an online intimation to CDSCO through the SUGAM portal. Commentaries describe this as a prior intimation route under which the applicant submits the intimation and awaits acknowledgment before proceeding.

Test licences remain mandatory for higher-risk categories. Sources list these as cytotoxic drugs, narcotic drugs, psychotropic substances, sex hormones, beta-lactams and biologics containing live microorganisms. For applications that still require a test licence, the amendment substitutes forty-five working days for the previous ninety working days as the review period.

Taken together, the changes move a routine administrative step, licensing the manufacture of small quantities of investigational product, from an approval model to a notification model for most products, while keeping prior regulatory review for product classes considered to carry higher risk. One legal commentary describes the 2026 amendments as reflecting a shift towards a more risk-based regulatory framework for clinical research in India. The practical effect is greatest for early-phase and BA/BE programmes, where the time needed to obtain a test licence could previously delay the start of manufacture for a study.

A separate instrument, the New Drugs and Clinical Trials (Second Amendment) Rules, 2026, was notified as G.S.R. 50(E). One law firm newsletter dates it 21 January 2026, while other sources give 22 January 2026. It introduces a prior intimation pathway, distinct from the existing permission route, for certain BA/BE studies. Commentaries indicate that the eligible category is narrow and is defined by study design, including single-dose, two-period, two-sequence designs; the full eligibility conditions should be read in the gazette notification, which was not reviewed in full for this brief.

Government reporting stated that the reforms are expected to save a minimum of 90 days across the drug development life cycle. Commentators have cautioned that the amendments should not be read as shortening the overall approval timeline for clinical trial applications, since the permission timeline for clinical trials under the 2019 Rules does not appear to have been changed by these notifications.

Sources consulted for this brief report that the first amendment came into force 45 days after its publication in the Official Gazette, with one summary giving 7 March 2026 as the effective date and others referring to early or mid-March 2026. The exact date should be confirmed against the gazette text.

A further draft notification, G.S.R. 45(E) dated 20 January 2026, proposed exemptions from animal toxicity studies under certain conditions. Its final status could not be confirmed at the time of checking, so it is not treated here as being in force.

Because the first and second amendments were notified within days of each other and are often reported together, secondary summaries do not always distinguish between them. Readers should note that the prior intimation route for investigational product manufacture derives from the first amendment, while the prior intimation route for eligible BA/BE studies derives from the second. Where a summary gives a different date, numbering or unit of time, the text published in the Gazette of India should be treated as authoritative.

Sponsors and contract research organisations should review their standard operating procedures for investigational product manufacture and import planning, replacing test licence steps with the SUGAM prior intimation where the product is not in an excluded category. Planning timelines for products that still require a test licence can be updated to reflect the 45 working day review period, while allowing for queries from the regulator.

BA/BE study sponsors should check whether a planned study design falls within the eligibility conditions of the Second Amendment before relying on the intimation route. Regulatory teams should keep copies of the gazette notifications on file, as several secondary summaries differ on dates and terminology, and should seek specialist advice where the classification of a product or study is unclear. This brief does not constitute legal advice.