**Executive Summary**
This document from the Ministry of Health and Family Welfare, published on October 16, 2025, proposes amendments to the Drugs Rules, 1945, specifically regarding liquid antiseptics. The draft rules are published for public comment, with a 30-day period for objections and suggestions, after which they will be considered by the Central Government. The rules are scheduled to come into force on the date of their final publication in the Official Gazette.
**Key Points / Main Content**
* **Amendment Overview**:
* The document amends Schedule K of the Drugs Rules, 1945.
* It introduces distinct categories and exemptions for liquid antiseptics based on intended use.
* **Liquid Antiseptics for Household Use**:
* Sale requires a license under Chapter IV of the Drugs and Cosmetics Act, 1940.
* Conditions for Exemption:
* Must be manufactured by licensed manufacturers.
* Must not contain any substance specified in Schedule G, H, H1 or X.
* Must be sold in the original unopened containers.
* Packaging must be labelled "For household use."
* **Liquid Antiseptics for Hospital and Other than Household Use**:
* Sale requires a license in Form 20 or Form 20A under Chapter IV of the Act.
* Conditions for Exemption:
* Must be manufactured by licensed manufacturers.
* Must not contain any substance specified in Schedule G, H, H1 or X.
* Must be sold in the original unopened containers.
* Must be purchased from a licensed wholesaler or manufacturer.
* Packaging must be labelled "For hospital and other than household use."
**Impact Analysis**
**Licensed Manufacturers of Liquid Antiseptics**
* **Impact**: Must adhere to the new labeling requirements and manufacturing conditions based on the intended use of the antiseptic.
* **Action Required**: Ensure products are manufactured according to the new rules, appropriately labeled, and adhere to regulations regarding substance contents.
**Licensed Wholesalers and Retailers of Liquid Antiseptics**
* **Impact**: Will need to ensure that they are selling and stocking antiseptics that meet the revised regulations based on intended use (household, hospital, other).
* **Action Required**: Familiarize themselves with the new labeling requirements and ensure that they are purchasing and selling products that comply with the updated rules.
**Consumers (Household, Hospitals and Other Institutions)**
* **Impact**: Will be able to identify the liquid antiseptics made for the intended use, and can be assured of the relevant quality and safety standards.
* **Action Required**: Check labeling of liquid antiseptics to ensure it meets their intended use.
**Drugs Technical Advisory Board**
* **Impact**: Already consulted, and the proposed draft has been published after consultation.
* **Action Required**: Monitor and provide oversight and quality control, according to Drugs and Cosmetics Act, 1940.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary legislation being amended, governing the regulation of drugs and cosmetics in India.
Drugs Rules, 1945: The set of rules under the Drugs and Cosmetics Act, 1940, which this notification proposes to amend.
Ministry of Health and Family Welfare: The central ministry responsible for administering the Drugs and Cosmetics Act, 1940 and proposing the amendments.
Drugs Technical Advisory Board: The advisory board consulted before the proposed rule amendments.
Schedule K: A schedule within the Drugs Rules, 1945, being amended regarding exemptions for liquid antiseptics.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-18102025-267024
CG-DxLx-xEG-I1D8H1x0x2x0 25-267024
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 675] नई दिल्ली, बृहस्ट्प जतवार, अक्त बू र 16, 2025/ आजव न 24, 1947 ल्ली, िक्रु वार, मई 9, 2025/विै ाख 19, 1947 946
No. 675] NEW DELHI, THURSDAY, OCTOBER 16, 2025/ ASVINA 24, 1947 3, 1946
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 16 अक् तूबर, 2025
सा.का.जन. 759(अ).— केन्द्र सरकार, औषधि एव ं प्रसािन सामग्री अधिधनयम, 1940 (1940 का 23) की िारा
12 और िारा 33 द्वारा प्रदत्त शधियों का प्रयोग करते हुए, औषधि तकनीकी सलाहकार बोर्ड के परामश ड के पश्चात,
कधतपय धनयमों के धनम्नधलधित प्रारूपण का प्रस्ताव करती ह ै धिसे एतद्द्वारा उन सभी व्यधियों की िानकारी के धलए
प्रकाधशत ककया िाता ह ै धिनके इससे प्रभाधवत होने की संभावना ह ै और एतद्द्वारा सूधित ककया िाता ह ै कक उि प्रारूप
धनयमों पर के प्रकाशन की धतधि स,े धिस धतधि को भारत के रािपत्र की इन प्रारूप धनयमों वाली प्रधतया ं िनता को
उपलब्ि कराई िाती ह,ैं तीस कदनों की अवधि की समाधि पर या उसके पश्चात धविार ककया िाएगा ।
उपरोि धनर्दडष्ट अवधि के भीतर ककसी भी व्यधि स े प्राि आपधत्तयों और सुझावों पर केंर सरकार द्वारा धविार
ककया िाएगा।
यकद कोई आपधत्तयााँ और सुझाव हों, तो उन्द्ह ें धनदेशक (औषधि धवधनयमन), स्वास््य और पररवार कल्याण
मंत्रालय, भारत सरकार, कमरा संख्या 407, ए ववंग, धनमाडण भवन, नई कदल्ली - 110011 को भेिा िा सकता ह ै या
drugsdiv-mohfw@gov.in पर ई-मले ककया िा सकता ह।ै
6929 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
मसौदा धनयम
1. इन धनयमों को औषधि (...संशोिन) धनयम, 2025 कहा िाए ।
(2) य ेधनयम सरकारी रािपत्र म ें अंधतम प्रकाशन की तारीि स ेलागू होंग े ।
2. औषधि धनयम, 1945 की अनुसूिी 'ट' म,ें क्रम संख्या 39 म,ें धनम्नधलधित को प्रधतस्िाधपत ककया िाएगा:-
“
औषधियों की श्रेणी छूट की सीमा और शत ें
39. घरेलू उपयोग के अधिधनयम के अध्याय IV के प्राविानों और उसके तहत बनाए गए धनयमों के अनुसार, धिन्द्ह ें
धलए धलकिर् धनम्नधलधित शतों के अध्यिीन धबक्री लाइसेंस के अंतगडत शाधमल ककया िाना आवश्यक ह,ै
एंटीसेधटटक्स नामत: ─
(क) औषधियााँ, लाइसेंस प्राि धनमाडताओं द्वारा धवधनर्मडत की िाती ह;ैं
(ि) अनुसूिी छ, ि, ि1 या एक्स म ें धनर्दडष्ट कोई पदािड औषधियों में नहीं ह;ै
(ग) औषधियााँ, लाइसेंसिारी धनमाडता के मलू बंद कंटेनरों म ें बिे ी िाती ह;ैं
(घ) पैककंग की प्रत्येक सतह पर " घरेल ूउपयोग के धलए " शब्द अंककत होंग े ।
39क. अस्पताल और अधिधनयम के अध्याय IV के प्राविानों और उसके तहत बनाए गए धनयमों के अनुसार, धिन्द्ह ें
घरेलू उपयोग के धनम्नधलधित शतों के अद्यिीन फॉमड 20 या फॉमड 20ए म ें धबक्री लाइसेंस के साि शाधमल ककया
अलावा धलकिर् िाना आवश्यक ह,ै नामत: ─
एंटीसेधटटक्स (क) औषधियां लाइसेंस प्राि धनमाडताओं द्वारा धवधनर्मडत की िाती ह;ैं
(ि) औषधियों म ेंअनुसूिी छ, ि, ि1 या एक्स म ेंधनर्दडष्ट कोई पदाि ड शाधमल नहीं ह;ै
(ग) औषधियां लाइसेंस प्राि धनमाडता के मूल बंद कंटेनरों म ेंबेिी िाती ह;ैं
(घ) औषधियां लाइसेंस प्राि िोक धवक्रेता या लाइसेंस प्राि धनमाडता स े िरीदी िाती ह।ैं
(ड़) पैककंग के प्रत्येक सतह पर "अस्पताल और घरेल ू उपयोग के अन्द्यिा " शब्द अंककत होंग े
।
”
[फा. स.ं एक्स.11014/07/ 2025-र्ीआर]
धनधिल गिराि, संयुि सधिव
रटटपणी : मलू धनयम कदनांक 21 कदसंबर, 1945 की अधिसूिना संख्या एफ. 28-10/45-एि(1) के तहत सरकारी रािपत्र
म ें प्रकाधशत ककए गए ि े और अधं तम बार अधिसूिना संख्या सा.का.धन.____ कदनांक ______ के अंतगडत संशोधित
ककए गए िे।
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[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
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.