**Executive Summary**
This document, published in the Gazette of India on October 16, 2025, is a draft notification from the Ministry of Health and Family Welfare proposing amendments to the Drugs Rules, 1945. It invites objections and suggestions from affected parties, to be submitted within 30 days of the Gazette's availability. The amendments relate to Schedule H2 of the Drugs Rules, 1945.
**Key Points / Main Content**
* **Amendments to Drugs Rules, 1945:**
* The notification proposes amending the Drugs Rules, 1945.
* This is done under powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940, after consulting with the Drugs Technical Advisory Board.
* These rules may be called the Drugs (… Amendment) Rules, 2025.
* These rules shall come into force from the date as specified by the Government at the time of final publication in the Official Gazette.
* **Schedule H2 Changes:**
* The words "Table 1" will be inserted under the title [see sub-rules (6) and (7) of rule 96] in Schedule H2.
* "Table 2" will be inserted after Table 1 in Schedule H2.
* **Table 2 Content:**
* **Serial Number 1: All Vaccines**
* **Serial Number 2: All Antimicrobials**
* **Serial Number 3:** All Narcotic and Psychotropic drugs listed under the Narcotic and Psychotropic drugs Act, 1985
* **Serial Number 4: All Anticancer drugs**
**Impact Analysis**
**Stakeholder: Persons likely to be affected by these draft rules**
* **Impact:** The draft rules introduce changes to the Drugs Rules, 1945, specifically related to Schedule H2, potentially affecting manufacturers, distributors, and users of drugs.
* **Action Required:** Review the draft rules and provide any objections or suggestions to the Director (Drugs regulation), Ministry of Health and Family Welfare, Government of India, within 30 days of the Gazette's availability, either by post to Room No. 407, A Wing, Nirman Bhavan, New Delhi - 110011 or by email to drugsdiv-mohfw@gov.in.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary legislation empowering the government to regulate drugs and cosmetics in India; this notification amends rules under this Act.
Drugs Rules, 1945: The set of rules framed under the Drugs and Cosmetics Act, 1940, governing the manufacture, sale, and distribution of drugs in India; this notification proposes amendments to these rules.
Ministry of Health and Family Welfare: The central ministry responsible for the health policy in India; this notification originates from this ministry.
Drugs (...... Amendment) Rules, 2025: Proposed amendments to the Drugs Rules, 1945, specifically adding therapeutic categories to Schedule H2.
Narcotic and Psychotropic Drugs Act, 1985: Indian legislation dealing with narcotics and psychotropic substances; the notification references substances listed under this act.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-18102025-267026
CG-DxLx-xEG-I1D8H1x0x2x0 25-267026
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.ं 673] 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. 673] 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. 757(अ).— औषजध जनयम, 1945 को और संिोजधत करने के जलए कजतपय जनयमों का जनम्नजलजखत
प्रारूप, जिसे केन्द्रीय सरकार ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उपधारा
(1) और धारा 33 की उपधारा (1) द्वारा प्रित्त िजियों का प्रयोग करत े हुए औषजध तकनीकी सलाहकार बोडड के परामिड के
पश्चात बनान े का प्रस्ट्ताव करती है, को इसके द्वारा प्रभाजवत होने की संभावना वाल े सभी व्यजियों की िानकारी के जलए
प्रकाजित दकया िाता ह ै दक इस अजधसूचना वाले रािपत्र की प्रजतयां प्रकाजित उपलब्ध कराने की तारीख से या तीस दिन
की समाजि ने पश्चात उि प्रारुप जनयमों पर जवचार दकया िाएगा ।
उपरोि जवजनर्िडष्ट अवजध के भीतर दकसी भी व्यजि से प्राि आपजत्तयों और सुझावों पर केन्द्र सरकार द्वारा जवचार
दकया िाएगा।
यदि कोई आपजत्तयों एवं सुझावों यदि कोई हों, को जनिेिक (औषजध जवजनयमन), स्ट्वास्ट््य और पररवार कल्याण
मंत्रालय, भारत सरकार, कमरा संख्या 407, ए ववंग, जनमाडण भवन, नई दिल्ली-110011 को भेिा िा सकता ह ै या
drugsdiv-mohfw@gov.in पर ईमले दकया िा सकता ह।ै
6927 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारुप जनयम
1. (i) इन जनयमों का संजिि नाम औषजध (...... संिोधन) जनयम, 2025
(ii) ये जनयम, सरकारी रािपत्र में इनके अंजतम प्रकािन के समय सरकार द्वारा यथा जवजनर्िडष्ट तारीख से लाग ू
होंगे।
2. (i) औषजध जनयम, 1945 में अनुसूची ि2 के अंतगतड िीषडक के नीचे [जनयम 96 के उपजनयम (6) और (7) िेखें]
िब्ि “सारणी 1” अंतःस्ट्थाजपत दकए िाएंगे।
(ii) औषजध जनयम, 1945 म ें अनुसूची ि2 के अंतगडत ताजलका 1 के पश्चात ् एक ताजलका अंतःस्ट्थाजपत की िाएगी,
अथाडत:् -
ताजलका 2
क्रम संख्या औषधि सूत्र धिधिधमित की धिधकत्सीय श्रेणी
1 सभी टीके
2 सभी रोगाणरु ोधी
3 स्िापक ओषधि और मि:प्रभािी पदार्ि अधिधियम, 1985 के अंतर्ित सूिीबद्ध सभी स्िापक ओषधि और
मि:प्रभािी पदार्ि
4 सभी कैंसर रोिी दिाएं
[फा. स.ं एक्स.11014/07/ 2025-डीआर]
निनिल गजराज, संयुक्त सनिव
िोट: मूल नियम दििांक 21 दिसंबर, 1945 की अनिसूििा संख्या एफ 28-10/45-एि(1) द्वारा राजपत्र म ें प्रकानित
दकए गए थ ेऔर अंनतम बार अनिसूििा संख्या सा.का.नि....(अ), दििांक ....... द्वारा संिोनित दकए गए थे।
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.[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
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.