Read or download the official PDF of this gazette notification issued by the Ministry of Health and Family Welfare on 19th August 2026. Classified under Extra Ordinary.
Executive Summary
The Ministry of Health and Family Welfare issued a draft notification on August 19, 2026, proposing amendments to the Drugs Rules, 1945, to include four specific substances in Schedule H1. Stakeholders are invited to submit objections or suggestions within 30 days of the draft's publication. The final rules are set to come into force 180 days after their official publication in the Gazette.
Key Points / Main Content
Regulatory Amendments
The notification introduces the "Drugs (…… Amendment) Rules, 2026," exercising powers under the Drugs and Cosmetics Act, 1940.
The proposal was drafted following consultation with the Drugs Technical Advisory Board.
Additions to Schedule H1
The draft rules propose inserting four new entries into Schedule H1 of the Drugs Rules, 1945, following serial number 52:
53. Flupentixol
54. Zopiclone
55. Gabapentin
56. Carisoprodol
Submission of Feedback
Any person likely to be affected by these changes may submit objections or suggestions to the Central Government.
Feedback should be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or sent via email to drugsdiv-mohfw@gov.in.
Timeline for Enforcement
The government will consider feedback received within 30 days from the date the Gazette copies are made available to the public.
The rules will officially take effect 180 days after the final rules are published in the Official Gazette.
Impact Analysis
Pharmaceutical Manufacturers and DistributorsImpact
These entities will be required to comply with the stringent labeling and distribution requirements associated with Schedule H1 drugs for Flupentixol, Zopiclone, Gabapentin, and Carisoprodol.
Action Required
Manufacturers must update packaging and documentation to reflect Schedule H1 status and submit any objections to the draft within the 30-day window.
Pharmacists and Healthcare ProvidersImpact
The sale and prescription of the four specified drugs will be subject to the recording and dispensing restrictions mandated by Schedule H1.
Action Required
Pharmacists must prepare to maintain specific registers for these substances and ensure they are only dispensed against valid prescriptions once the rules are finalized and enforced.
General Public/PatientsImpact
Consumers may find stricter controls over the accessibility of these medications due to their classification under Schedule H1.
Action Required
Individuals or consumer groups may submit suggestions or objections regarding the inclusion of these drugs in the schedule within the specified 30-day period.
Key Entities Referenced
Ministry of Health and Family Welfare: The central ministry responsible for issuing this notification and overseeing drug safety and regulation in India.
Drugs Technical Advisory Board: The statutory body consulted by the Central Government before proposing amendments to the Drugs Rules.
Drugs and Cosmetics Act, 1940: The primary legislation that grants the Central Government authority under Sections 12 and 33 to regulate the manufacture and sale of drugs.
Drugs Rules, 1945: The regulatory framework being amended to include new substances under controlled schedules for stricter monitoring.
Schedule H1: A specific schedule in the Drugs Rules containing substances that require a prescription for retail sale; the amendment adds Flupentixol, Zopiclone, Gabapentin, and Carisoprodol to this list.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-21082026-275641
xxxGIDHxxx
CG-DLxx-ExG-I2D1E0x8x2x0 26-275641
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 679] नई दिल्ली, बुधवार, अगस्ट्त 19, 2026/श्रावण 28, 1948
No. 679] NEW DELHI, WEDNESDAY, AUGUST 19, 2026/SHRAVAN 28, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 19 अगस्ट् त, 2026
lk.का.fu. 745(अ).— औषजध एव ं प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की
उपधारा (1) तथा धारा 33 की उपधारा (1) द्वारा प्रित्त िजियों का प्रयोग करते हुए, तथा औषजध तकनीकी सलाहकार
बोडड स े परामि ड करने के पश्चात,् जिन कजतपय जनयमों द्वारा औषजध जनयम, 1945का और संिोधन दकया िाना प्रस्ट्ताजवत
ह,ै उनका जनम्नजलजखत प्रारूप, इससे प्रभाजवत होने की संभावना रखन े वाल े सभी व्यजियों की िानकारी के जलए एतद्द्वारा
प्रकाजित दकया िाता ह;ै तथा यह सूचना िी िाती ह ै दक इन प्रारूप जनयमों पर उस तारीख स,े जिस दिन इन प्रारूप
जनयमों स े यिु भारत के रािपत्र की प्रजतया ं िनसाधारण को उपलब्ध कराई िाएगं ी, तीस दिन की अवजध की समाजि के
पश्चात ्अथवा उसके बाि जवचार दकया िाएगा।
उि अवजध के भीतर दकसी भी व्यजि स े प्राि होन े वाली आपजत्तयों एव ं सुझावों पर केन्द्रीय सरकार द्वारा जवचार
दकया िाएगा।
आपजत्तयां एव ं सुझाव, यदि कोई हों, अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत
सरकार, य-ू 6, वकड हॉल-सी ववगं , प्रथम तल, कतडव्य भवन-1, नई दिल्ली – 110001 को संबोजधत दकए िा सकत े ह ैं अथवा
drugsdiv-mohfw@gov.in पर ई-मले द्वारा भेि े िा सकत ेह।ैं
प्रारूप जनयम
1. (i) इन जनयमों का संजिि नाम औषजध (...... संिोधन) जनयम, 2026 होगा।
6412 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(ii) ये जनयम, अंजतम जनयमों के रािपत्र म ें प्रकािन की जतजथ स े एक सौ अस्ट्सी दिन के पश्चात् प्रवृत्त होंगे।
2. औषजध जनयम, 1945 की अनुसूची H1 म,ें क्रम संख्या 52 तथा उससे संबंजधत प्रजवजियों के पश्चात ् जनम्नजलजखत क्रम
संख्याए ं और प्रजवजियां अंतःस्ट्थाजपत की िाएंगी, अथाडत्:-
“53. फ्लूपेंरिक्सोल”
“54. िोजपक्लोन”
“55. गैबापेंरिन”
“56. कैररसोप्रोडोल”
[फा. स.ं एक्स.11014/11/2026-डीआर]
हष ड मंगला, संयुि सजचव
रिप्पण :मूलजनयम, अजधसूचना संख्या फा. स.ं 28-10/45-एच(1), दिनांक21 दिसम्बर, 1945द्वारा भारत के रािपत्र म ें
प्रकाजित दकए गए थ े तथा उनका अंजतम संिोधन अजधसूचना संख्या सा.का.जन. ….. (अ), दिनांक ……द्वारा दकया गया।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 19th August, 2026
G.S.R. 745(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, 2026.
(ii) They shall come into force after one eighty days of publication of the final rules in the Official
Gazette.
2. In the Drugs Rules, 1945, in Schedule H1 after serial number 52 and entries relating thereto, the following
serial numbers and entries shall be inserted, namely:-
“53. Flupentixol”
“54. Zopiclone”
“55. Gabapentin”
“56. Carisoprodol”
[F. No. X.11014/11/2026-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.