Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-18102025-267024
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 675]
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. 759(E).— The following draft of certain rules, which the Central Government proposes to make, in exercise of the powers conferred by sections 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with 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. (1) These rules may be called the Drugs (... Amendment) Rules, 2025.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs Rules, 1945, in Schedule K, the Serial No. 39, following shall be substituted:
“
+------------------------------------+------------------------------------------------------------------+
| Class of Drugs | Extent and Conditions of Exemptions |
+------------------------------------+------------------------------------------------------------------+
| 39. Liquid | The provisions of Chapter IV of the Act and rules made thereunder, which |
| Antiseptics for | require them to be covered with a sale license subject to the following |
| household use | conditions, namely:— |
| | (a) The drugs are manufactured by licensed manufacturers; |
| | (b) the drugs do not contain any substance specified in Schedule G, H, H1 or |
| | X; |
| | (c) the drugs are sold in the original unopened containers of the licensed |
| | manufacturer; |
| | (d) the label at each level of packaging shall bear the words “For household |
| | use". |
+------------------------------------+------------------------------------------------------------------+
| 39A. Liquid | The provisions of Chapter IV of the Act and rules made thereunder, which |
| Antiseptics for | require them to be covered with a sale license in Form 20 or Form 20A, subject |
| Hospital and | to the following conditions, namely:— |
| other than | (a) the drugs are manufactured by licensed manufacturers; |
| household use | (b) the drugs do not contain any substance specified in Schedule G, |
| | H, H1 or X; |
| | (c) the drugs are sold in the original unopened containers of the |
| | licensed manufacturer; |
| | (d) the drugs are purchased from a licensed wholesaler or a licensed |
| | manufacturer. |
| | (e) the label at each level of packaging shall bear the words “For |
| | hospital and other than household use”. |
+------------------------------------+------------------------------------------------------------------+
”
[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. _____, 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 KUMAR SRIVASTAVA SRIVASTAVA Date: 2025.10.18 14:0 +0530