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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-28082025-265776
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 543]
NEW DELHI, THURSDAY, AUGUST 28, 2025/BHADRA 6, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 27th August, 2025
G.S.R. 587(E). — The following 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 is hereby published for 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.
Objections and suggestions which 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.
DRAFT RULES
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."
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 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
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."
[F. No. X.11014/06/2025-DR]
NIKHIL GAJRAJ, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. F.No.X.11014/10/2017- DRS -
Part (1), dated 19th March 2019 and last amended vide notification number G.S.R ...., dated ....
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.
SARVESH KUMAR Digitally signed by SARVESH
SRIVASTAVA
Date: 2005.08.28 21:55:50
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