**Executive Summary**
This document is a notification from the Ministry of Health and Family Welfare regarding proposed amendments to the Drugs Rules, 1945. The notification invites objections and suggestions from the public on the draft rules. Objections must be submitted within thirty days from the date the Gazette is available to the public, to the address provided.
**Key Points / Main Content**
* **Proposed Amendments to Drugs Rules, 1945:**
* The new rules will be called the Drugs (...... Amendment) Rules, 2025.
* The rules will be effective from the date of their final publication in the Official Gazette.
* In Schedule V of the Drugs Rules, 1945, the unit for Folic Acid will be changed. "mg." will be substituted with "mcg".
* **Call for Objections and Suggestions:**
* The Central Government will consider any objections or suggestions received within the specified period.
* Objections and suggestions can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India.
* The address for submission is: U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001.
* Alternatively, objections can be emailed to drugsdiv-mohfw@gov.in.
* Objections/Suggestions must be made within 30 days from the date the copies of the Gazette of India containing these draft rules are made available to the public.
**Impact Analysis**
**Public**
* **Impact:** The proposed amendments to the Drugs Rules, 1945, and change in the unit for Folic Acid may affect how drugs containing folic acid are prescribed and administered.
* **Action Required:** Review the draft rules and submit objections or suggestions to the Ministry of Health and Family Welfare within thirty days from the date the Gazette is available to the public.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary legislation being amended by the draft rules.
Drugs Rules, 1945: The set of rules being amended by the notification.
Ministry of Health and Family Welfare: The ministry responsible for issuing the notification and overseeing the rules.
Drugs Technical Advisory Board: Body consulted before making amendments to the Drugs Rules, 1945.
New Delhi: Location of the Ministry and place of notification
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-27012026-269588
CG-DxLx-xEG-I2D7H0x1x2x0 26-269588
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.ं 53] नई दिल्ली, बहृ स्ट्प जतवार, िनवरी 22, 2026/माघ 2, 1947 ष 25, 1947 26/पौष 17, 1947
No. 53] NEW DELHI, THURSDAY, JANUARY 22, 2026/MAGHA 2, 1947 /PAUSHA 17, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 21 िनवरी, 2026
सा.का.जन. 53(अ).— औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा
(1) और धारा 33 की उप-धारा (1) द्वारा प्रित्त िजियों का प्रयोग करते हुए, केंद्र सरकार, औषजध तकनीकी सलाहकार बोड ड
स े परामि ड के पश्चात,् औषजध जनयम, 1945 म ें और संिोधन करने के जलए कुछ जनयमों का जनम्नजलजखत प्रारूप बनाने का
प्रस्ट्ताव करती ह,ै जिसे उन सभी व्यजियों की िानकारी के जलए एतद्द्वारा प्रकाजित दकया िाता ह,ै जिनके इससे प्रभाजवत
होने की संभावना ह,ै
और एतद्द्वारा यह सूजचत दकया िाता ह ैदक उक्त प्रारूप जनयमों पर भारत के रािपत्र की प्रजतयां, जिनम ेंय ेप्रारूप
जनयम अंतर्वडष्ट ह,ैं िनता को उपलब्ध कराए िाने की तारीख स े तीस दिन की अवजध समाप्त होने पर या उसके पश्चात
जवचार दकया िाएगा।
उपर्यक्ु त जवजनर्िडष्ट अवजध के भीतर दकसी भी व्यजि स े प्राप्त आपजत्तयों और सुझावों पर केंद्र सरकार द्वारा जवचार
दकया िाएगा।
आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय, भारत सरकार,
यू-6, वकड हॉल सी ववंग, प्रथम तल, कतडव्य भवन-1, नई दिल्ली, 110001 को संबोजधत दकया िा सकता ह ैअथवा ई-मले के
माध्यम स े drugsdiv-mohfw@gov.in पर भेिा िा सकता ह।ै
491 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (i) इन जनयमों को औषजध (...... संिोधन) जनयम, 2025 कहा िा सकता ह।ै
(ii) य ेिासकीय रािपत्र म ें उनके अंजतम प्रकािन की तारीख को प्रवृत्त होंगे।
2. औषजध जनयम, 1945 म,ें अनुसूची V की ताजलका के अधीन, फोजलक एजसड के सामन ेउजल्लजखत इकाई अथाडत्
"जम.ग्रा." के स्ट्थान पर "माइक्रो.ग्रा." प्रजतस्ट्थाजपत दकया िाएगा।
[फा.स.ं एक्स.11014/14/2025-डीआर]
हष ड मगं ला, संयिु सजचव
रिप्पणी: मूल जनयम िासकीय रािपत्र म ें अजधसूचना संख्या एफ. 28-10/45-एच(1) तारीख 21 दिसंबर, 1945 के तहत
प्रकाजित दकए गए थ ेऔर अंजतम बार अजधसूचना संख्या सा.का.जन.…..(अ), तारीख.…… के तहत संिोजधत दकए
गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, 21st January, 2026
G.S.R. 53(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 Under Secretary (Drugs), Ministry of
Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1,
New Delhi, 110001 or emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.
(ii) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs Rules, 1945, under the Table of Schedule V, unit mentioned against the Folic acid
i.e. “mg.” shall be substituted with “mcg”.
[F. No. X.11014/14/2025-DR]
HARSH MANGLA, 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.