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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-05022026-269847
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 93]
NEW DELHI, TUESDAY, FEBRUARY 3, 2026/MAGHA 14, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd February, 2026
G.S.R. 98(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. 434, C 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, 2026.
(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, the sub-rule (3) of rule 17 shall be omitted.
3. In the New Drugs and Clinical Trials Rules, 2019, the sub-rule (4) of rule 17 shall be substituted, namely:—
"On receipt of application in Form CT-01 under sub-rule (1), the authority designated under sub-rule (1) shall
scrutinise the documents and information furnished with the application, and if satisfied that the requirements of these
rules have been complied with, grant final registration to Ethics Committee in Form CT-03; or if not satisfied, reject
the application, for reasons to be recorded in writing".
[F.No. X.11014/02/2026-DR]
HARSH MANGLA, 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......(E), dated.......