Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-18102025-267026
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
NEW DELHI, THURSDAY, OCTOBER 16, 2025/ ASVINA 24, 1947
No. 673]
6927 GI/2025
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 16th October, 2025
G.S.R. 757(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 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 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. (i) In the Drugs Rules, 1945, under Schedule H2, below the title [see sub-rules (6) and (7) of rule 96] the
words "Table 1" shall be inserted.
(ii) In Drugs Rules, 1945, under Schedule H2, after the Table 1, a Table shall be inserted namely: -
Table 2
+--------------+--------------------------------------------------------------------------+
| Serial Number| Therapeutic Category of drug formulations |
+--------------+--------------------------------------------------------------------------+
| 1 | All Vaccines |
| 2 | All Antimicrobials |
| 3 | All Narcotic and Psychotropic drugs listed under the Narcotic and |
| | Psychotropic drugs Act, 1985 |
| 4 | All Anticancer drugs |
+--------------+--------------------------------------------------------------------------+
[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.
SARVESH KUMAR Digitally signed by SARVESH
SRIVASTAVA KUMAR
Date: 2025.10.18 14:02:30+0530