Health Ministry Proposes Notification-Based Approval for Pharma Export BE Studies Instead of Central Licensing Authority Nod

This relaxation will apply only to single-dose BA/BE studies of oral drugs already approved in India or in major markets like the USA, EU, Japan, Australia, Canada, and the UK, while excluding sensitive categories such as cytotoxic medicines, hormones, narcotics, psychotropic substances, narrow therapeutic index drugs, and those with highly variable pharmacokinetics.

This came as a draft of certain rules further to amend the New Drugs and Clinical Trials Rules, 2019, which the Central Government proposes to make in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, and is hereby published for the information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.

The draft, notified on August 27, 2025, specifies that the relaxation applies only to single-dose, two-period, two-sequence, two-treatment BA/BE studies in normal healthy adult human volunteers for oral dosage forms of drugs already approved in India or in major regulated markets such as the USA, EU, Japan, Australia, Canada, and the UK. However, drugs in categories such as cytotoxic medicines, hormones, narcotics, psychotropic substances, drugs with a narrow therapeutic index, or those with highly variable pharmacokinetics will not qualify.

To ensure oversight, the amendment requires that applications be accompanied by approval from an ethics committee registered with the CLA, with the committee maintaining separate records of such studies. The sample size must not exceed 48 volunteers.

In respect to the above, the proposed draft stated,

"1. ( i) These rules may be called the New Drugs and Clinical Trials (…. Amendment) Rules, 2025.

(ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.

2. In the New Drugs and Clinical Trials Rules, 2019, after sub-rule (2) of rule 31, the following proviso shall be inserted, namely: ―

‘‘Provided that in case of single-dose, two-period, two-sequence, two-treatment, bioavailability or bioequivalence studies in normal healthy adult human volunteers (for export purpose only), of oral dosage form of a drug (other than drugs of Cytotoxic, Hormone, Narcotic and Psychotropic substances categories and not a drug of Narrow Therapeutic Index or a drug having highly variable pharmacokinetics) already approved in the Country or any one of the countries namely, USA, EU, Japan, Australia, Canada and UK, the studies may be conducted after submission of an online application as notification and its acknowledgement by the Central Licensing Authority, subject to the following conditions:

1. The application for the notification must be accompanied with approval of the ethics committee registered with Central Licensing Authority under rule 8.

2. The Ethics Committee shall maintain separately the record of review and approval of such bioavailability or bioequivalence studies being conducted under this notification process, which shall be reviewed by the Central Licensing Authority at the time of renewal of the Registration of the Ethics Committee.

3. The samples size should not be more than 48."

In addition, the draft introduces a new provision under Rule 33, specifying that these notification-based BA/BE studies will be routed through Form CT-05, making the process more structured. It also substitutes the existing sub-rule to clarify that while other BA/BE studies for new or investigational drugs must continue to be filed with the required fee and supporting documents, government institutions conducting such studies will be exempted from paying any fee.

Regarding the above, the proposed draft read,

"3. In the New Drugs and Clinical Trials Rules, 2019, after sub-rule (1) of rule 33,the following proviso shall be inserted, namely: ―

"Provided that in case of bioavailability or bioequivalence studies as referred in proviso to sub-rule (2) of rule 31, the bioavailability or bioequivalence studies may be conducted by submitting an online application in Form CT-05 as notification."

4. In the New Drugs and Clinical Trials Rules, 2019, after sub-rule (2) of rule 33 shall be substituted, namely: ―

"(2) An application for grant of permission to conduct a bioavailability or bioequivalence study of any new drug or investigational new drug, or for notification for initiation of bioavailability or bioequivalence studies as referred in proviso to sub-rule (2) of rule 31, as the case may be, shall be accompanied by a fee as specified in the Sixth Schedule and such other information and documents as specified in the Table 2 of the Fourth Schedule:

PROVIDED that no fee shall be payable for conducting a bioavailability or bioequivalence study by an institution or organisation owned or funded wholly and partially by the Central Government or a State Government."

Further, the gazette notification stated that objections and suggestions that may be received from any person within the period specified above will be considered by the Central Government.

"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 545, A Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in." the notification added.

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