Research and Articles

• The Ministry of Health and Family Welfare has amended the New Drugs and Clinical Trials Rules, 2019 to introduce a permission-free pathway for certain BA/BE studies conducted exclusively for export purposes.

• The amendment replaces the requirement of prior regulatory approval with a prior intimation and acknowledgement mechanism, subject to specified conditions.

I. BACKGROUND

The New Drugs and Clinical Trials Rules, 2019 (“NDCTR”) have been amended by the Ministry of Health and Family Welfare (“MoHFW”) in exercise of its powers under Sections 12 and 33 of the Drugs and Cosmetics Act (“Act”), 1940, vide notification G.S.R. 50(E) dated January 21, 2026, the New Drugs and Clinical Trials (Second Amendment) Rules, 2026 (“Amendment Rules”). It shall come into force upon expiry of ninety (90) days from the date of its publication in the Official Gazette.

By way of background, Rule 31 of the NDCTR governs the conduct of bioavailability and bioequivalence (“BA/BE”) studies for new drugs or investigational new drugs in India. Under the pre-amendment framework, BA/BE studies could be undertaken only pursuant to prior permission granted by the Central Licensing Authority (“CLA”). The entity proposing to conduct such studies was required to submit an application in Form CT-05, which, upon approval by the CLA, resulted in the grant of permission in Form CT-07 for the conduct of the BA/BE studies.¹

II. KEY CHANGES

Pursuant to the Amendment Rules, a limited exception from the requirement of prior regulatory permission has been introduced for certain BA/BE studies conducted for oral dosage form of drugs exclusively for export purposes. Under the amended framework, such studies may be initiated on the basis of a prior intimation submitted to the CLA in Form CT-05, coupled with an acknowledgement issued by the CLA, without the need for obtaining a formal permission in Form CT-07.²

The availability of the exemption is subject to compliance with specified conditions provided below:

• Applicable only to single-dose, two-period, two-sequence, two-treatment BA/BE studies conducted in normal healthy adult human volunteers, in respect of oral dosage forms of drugs for export purposes;

• Prior intimation must be submitted to the CLA in Form CT-05, along with approval for the study from an Ethics Committee registered with the CLA;

• Ethics Committee is required to maintain a separate record of its review and approval of BA/BE studies conducted pursuant to the acknowledgement of such prior intimation, which record may be reviewed by the CLA at the time of renewal of the Ethics Committee’s registration;

• Study drug must already be approved in India or in at least one of the following jurisdictions - the United States of America, the European Union, Japan, Australia, Canada, or the United Kingdom;

• The sample size for such BA/BE studies must not be less than eighteen (18) subjects.

This exemption is expressly unavailable for BA/BE studies involving cytotoxic drugs, hormones, narcotic or psychotropic substances, drugs with a narrow therapeutic index, or drugs exhibiting highly variable pharmacokinetics.

III. IMPLICATIONS FOR INDUSTRY

The Amendment Rules enable eligible sponsors to initiate BA/BE studies upon submission of an online application as prior intimation and receipt of an acknowledgement from the CLA, without awaiting formal regulatory approval for such low-risk BA/BE studies.

Given that the CLA processes approximately 4,000 to 4,500 BA/BE study applications annually, the revised mechanism is expected to substantially reduce procedural delays and administrative burden for both industry stakeholders and the regulator.³ By facilitating quicker initiation of BA/BE studies, testing, and examination of drugs for research purposes, the amendment is likely to minimise delays across the drug development and approval mechanism.

The Amendment Rules are likely to ease the clinical research phase for the industry especially the generic pharmaceutical industry.  

IV. CONCLUSION

The introduction of a prior intimation–based mechanism for select export-oriented BA/BE studies reflects a conscious regulatory shift towards procedural efficiency under the NDCTR. By carving out a narrowly defined exemption from prior permission, the amendment seeks to balance ease of doing research with continued regulatory oversight.

By reducing regulatory friction while retaining appropriate safeguards, the amendment is expected to support R&D-led growth of the Indian pharmaceutical industry and further align India’s clinical research framework with global best practices.

Naveli Sharma, Tanya Kukade and Dr. Milind Antani
You can direct your queries or comments to the authors.

¹Rule 31 of the New Drugs and Clinical Trials Rules, 2019

²Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4Mjk=

³https://www.pib.gov.in/PressReleasePage.aspx?PRID=2219422&reg=3&lang=1