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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-18102025-267029
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 674]
NEW DELHI, THURSDAY, OCTOBER 16, 2025/ASVINA 24, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 16th October, 2025
G.S.R. 758(E). - The following draft of certain rules further to amend the Drugs Rules, 1945, which the
Central Government proposes to make, in exercise of the powers conferred by 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 Director (Drugs regulation), Ministry of Health
and Family Welfare, Government of India, Room No. 407, A Wing, Nirman Bhavan, New Delhi - 110011 or emailed
at drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Drugs (...... 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 Drugs Rules, 1945, under the sub-rule (3) of rule 75, after the words “Recombinant DNA (r-DNA)
derived drugs," the words "Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,
etc." shall be inserted.
3. In the Drugs Rules, 1945, under the sub-rule (1A) of rule 75A, the words "Recombinant DNA (r-DNA)
derived drugs" shall be substituted with the words “Recombinant DNA (r-DNA) derived drugs', 'Cell or
Stem Cell derived products', 'Gene therapeutic products or Xenografts', etc.".
4. In the Drugs Rules, 1945, under the rule 76 and 76A, wherever the words "Recombinant DNA (r-DNA)
derived drugs" occurred shall be substituted with the words “Recombinant DNA (r-DNA) derived drugs,
Cell or Stem Cell derived products, Gene therapeutic products or Xenografts, etc.”.
5. In the Drugs Rules, 1945, under the title of Form 27D, Form 27DA, Form 28D and Form 28DA, the words
“RECOMBINANT DNA (R-DNA) DERIVED DRUGS" shall be substituted with the words
“RECOMBINANT DNA (R-DNA) DERIVED DRUGS/CELL OR STEM CELL DERIVED
PRODUCTS/ GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS, ETC.".
6. In the Drugs Rules, 1945, under the para 1 of Form 27D, Form 27DA, Form 28D and Form 28DA, the words
"Recombinant DNA (r-DNA) derived drugs" shall be substituted with the words "Recombinant DNA
(r-DNA) derived drugs/ Cell or Stem Cell derived products/ Gene therapeutic products or
Xenografts, etc.".
[F. No. X.11014/07/2025-DR]
NIKHIL GAJRAJ, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st the
December, 1945 and last amended vide notification number G.S.R......(E), 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.