**Executive Summary**
This document from the Ministry of Health and Family Welfare, dated January 21, 2026, proposes amendments to the Drugs Rules, 1945, following consultation with the Drugs Technical Advisory Board. The draft rules are published for public information, and the government will consider objections or suggestions received within 30 days of the gazette's publication. The proposed changes include the insertion of “Pregabalin” in Schedule H1 of the Drugs Rules, 1945.
**Key Points / Main Content**
* **Proposed Amendments to Drugs Rules, 1945**
* The document contains draft rules to further amend the Drugs Rules, 1945.
* The Central Government proposes these amendments after consulting with the Drugs Technical Advisory Board.
* **Drugs (Amendment) Rules, 2025**
* The rules may be called the Drugs (...... Amendment) Rules, 2025.
* The rules shall come into force three months after the publication of the final rules in the Official Gazette.
* **Schedule H1 Amendment**
* In Schedule H1 of the Drugs Rules, 1945, after serial number 50 and entries relating thereto, the serial number and entry “51. Pregabalin” shall be inserted.
* **Public Consultation**
* The draft rules are published for public information.
* The government will consider objections or suggestions received within 30 days of the gazette's publication.
* Objections and suggestions can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, or emailed to drugsdiv-mohfw@gov.in.
**Impact Analysis**
**Stakeholders: Drug Manufacturers and Suppliers**
* **Impact:** Must comply with the updated Drugs Rules, 1945, including the regulation of Pregabalin.
* **Action Required:** Understand the implications of the inclusion of “Pregabalin” in Schedule H1. Ensure compliance with the new rules after they come into force.
**Stakeholders: Healthcare Professionals and Patients**
* **Impact:** May experience changes in the availability and prescribing guidelines for Pregabalin.
* **Action Required:** Stay informed about the updated Drugs Rules, 1945 and consult updated guidelines for prescribing and using Pregabalin.
**Stakeholders: General Public**
* **Impact:** Indirectly affected through changes in the regulation and availability of drugs.
* **Action Required:** Opportunity to submit objections or suggestions regarding the draft rules within 30 days of publication.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The central act empowering the government to regulate drug and cosmetic standards.
Drugs Rules, 1945: The rules under the Drugs and Cosmetics Act, 1940, which are being amended.
Ministry of Health and Family Welfare: The central ministry responsible for administering the rules related to drugs and cosmetics.
Drugs Technical Advisory Board: Advisory board consulted by the Central Government before making amendments to the Drugs Rules.
Schedule H1: A schedule within the Drugs Rules, 1945, being amended to include 'Pregabalin'.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-27012026-269587
CG-DxLx-xEG-I2D7H0x1x2x0 26-269587
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.ं 54] नई दिल्ली, बहृ स्ट्प जतवार, िनवरी 22, 2026/माघ 2, 1947 ष 25, 1947 26/पौष 17, 1947
No. 54] 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. 54(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 बोडड से परामिड के पश्चात्, औषजध जनयम, 1945 का और संिोधन करने के जलए कुछ जनयमों का जनम्नजलजखत
प्रारूप बनान ेका प्रस्ट्ताव करती ह,ै जिसे इसस ेप्रभाजवत होने वाले सभी व्यजियों की िानकारी के जलए इसके द्वारा प्रकाजित
दकया िाता ह,ै और इसके द्वारा यह सूचना िी िाती ह ैदक उि प्रारूप जनयमों पर उस तारीख से, जिसको इन प्रारूप जनयमों
को अंतर्वडष्ट करने वाले भारत के रािपत्र की प्रजतयां िनता को उपलब्ध करा िी िाती हैं, तीस दिन की अवजध समाप्त होन े
पर या उसके पश्चात ्जवचार दकया िाएगा।
ऊपर जवजनर्िडष्ट अवजध के भीतर दकसी भी व्यजि स े प्राप्त होने वाल े आक्षेपों और सुझावों पर केंद्र सरकार द्वारा
जवचार दकया िाएगा।
आक्षेप और सुझाव, यदि कोई हों, अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, 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।ै
492 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (क) इन जनयमों को औषजध (...... संिोधन) जनयम, 2025 कहा िा सकता ह।ै
(ख) ये रािपत्र म ेंअंजतम जनयमों के प्रकािन के 3 महीने के पश्चात ्प्रवृत्त होंगे।
2. औषजध जनयम, 1945 म,ें अनुसूची एच1 म ेंक्रम संख्या 50 और उससे संबंजधत प्रजवजष्टयों के पश्चात्,
जनम्नजलजखत क्रम संख्या और प्रजवजष्ट अंतःस्ट्थाजपत की िाएगी, अथाडत:्
― “51. प्रगे ाबाजलन”
[फा.स.ं एक्स.11014/14/2025-डीआर]
हष ड मगं ला, संयिु सजचव
रिप्पणी: मूल जनयम रािपत्र में अजधसूचना संख्या एफ. 28-10/45-एच(1) तारीख 21 दिसंबर, 1945 द्वारा प्रकाजित दकए
गए थे और अंजतम बार अजधसचू ना संख्या सा.का.जन.…..(अ), तारीख.…… द्वारा 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. 54(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 after the 3 months of publication of the final rules in the Official
Gazette.
2. In the Drugs Rules, 1945, in Schedule H1 after serial number 50 and entries relating thereto, the
following serial number and entry shall be inserted, namely: ―
“51. Pregabalin”
[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.