**Executive Summary**
The Ministry of Health and Family Welfare has notified the Drugs (Second Amendment) Rules, 2026, which amend the Drugs Rules, 1945, to include "Pregabalin" in Schedule H1. This notification follows a public consultation period initiated in January 2026 and consultation with the Drugs Technical Advisory Board. The new rules are set to come into force 180 days after their publication in the Official Gazette.
**Key Points / Main Content**
**Legal Authority and Procedural Background**
* **Regulatory Basis:** The rules are made exercising powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
* **Consultation:** The amendment was finalized after consulting the Drugs Technical Advisory Board and considering objections and suggestions received following the draft notification published on January 21, 2026.
**Specific Amendments to Drugs Rules, 1945**
* **Title:** These amendments are officially titled the Drugs (Second Amendment) Rules, 2026.
* **Schedule H1 Update:** In the Drugs Rules, 1945, Schedule H1 is updated to include a new entry.
* **Inclusion of Pregabalin:** "Pregabalin" is inserted as serial number 51 in Schedule H1, following the existing entry for serial number 50.
**Timeline for Implementation**
* **Publication Date:** The notification is dated May 13, 2026, and was published in the Gazette on May 20, 2026.
* **Effective Date:** The rules become effective 180 days from the date of their publication in the Official Gazette.
**Impact Analysis**
**Pharmaceutical Manufacturers and Sellers**
**Impact**
Pregabalin is now officially classified as a Schedule H1 drug, subjecting its manufacture, sale, and distribution to the specific regulatory requirements governing this schedule.
**Action Required**
Entities must update their labeling, packaging, and sales documentation processes to comply with Schedule H1 requirements for Pregabalin within the 180-day transition period.
**Healthcare Providers and Pharmacists**
**Impact**
The classification of Pregabalin under Schedule H1 changes the legal requirements for prescribing and dispensing this medication.
**Action Required**
Pharmacists and medical practitioners must ensure that Pregabalin is dispensed and recorded in accordance with the regulations established for Schedule H1 substances once the rules take effect.
**Regulatory Authorities**
**Impact**
Central and State drug controllers are responsible for overseeing the implementation of this addition to the controlled drug schedules.
**Action Required**
Authorities must monitor the industry for compliance with the new Schedule H1 entry for Pregabalin starting 180 days after the publication of the notice.
Key Entities Referenced
Drugs (Second Amendment) Rules, 2026: The specific amending rules introduced to update the regulatory status of certain substances.
Pregabalin: The pharmaceutical substance being added to Schedule H1, subjecting it to stricter prescription and record-keeping requirements.
Drugs Rules, 1945: The principal regulatory framework for the manufacture, sale, and distribution of drugs in India being amended.
Drugs and Cosmetics Act, 1940: The parent legislation that empowers the Central Government to make and amend drug-related rules.
Drugs Technical Advisory Board: The statutory body consulted by the Central Government to advise on the technical aspects of these rule amendments.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-21052026-272775
CG-DxLx-xEG-I2D1H0x5x2x0 26-272775
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 342] नई दिल्ली, बुधवार, मई 20, 2026/विै ाख 30, 1948
No. 342] NEW DELHI, WEDNESDAY, MAY 20, 2026/VAISAKHA 30, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 13 मई, 2026
सा.का.जन. 377(अ).— औषजध जनयम, 1945 का और संिोधन करने के जलए कजतपय जनयमों का प्रारूप, औषजध
और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) और धारा 33 की उप-धारा (1) के
अधीन यथा अपेजित, भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) की
अजधसूचना संख्या सा.का.जन. 54 (अ), तारीख 21 िनवरी, 2026 द्वारा भारत के रािपत्र, असाधारण, भाग II, खडं 3,
उप-खंड (i), तारीख 27 िनवरी, 2026 म ेंप्रकाजित दकया गया था, जिसम ेंउक्त अजधसूचना वाली रािपत्र की प्रजतयां िनता
को उपलब्ध कराए िाने की तारीख स ेतीस दिनों की अवजध की समाजि स ेपहले, इससे प्रभाजवत होने वाले संभाजवत व्यजक्तयों
स े आिेप और सुझाव आमंजत्रत दकए गए थ;े
और, उक्त रािपत्र की प्रजतयां 27 िनवरी, 2026 को िनता को उपलब्ध कराई गई थीं;
और, उक्त प्रारूप जनयमों पर िनता स े प्राि आिेपों और सुझावों पर केंद्र सरकार द्वारा जवचार दकया गया ह;ै
3599 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
अतः, अब, केंद्रीय सरकार उक्त अजधजनयम की धारा 12 और 33 द्वारा प्रित्त िजक्तयों का प्रयोग करत े हुए, औषजध
तकनीकी सलाहकार बोडड स े परामि ड के पश्चात,् औषजध जनयम, 1945 का और संिोधन करने के जलए जनम्नजलजखत जनयम
बनाती ह,ै अथाडत:् —
1. (1) इन जनयमों का संजिि नाम औषजध (िसू रा संिोधन) जनयम, 2026 ह।ै
(2) य ेजनयम रािपत्र म ेंइनके प्रकािन की तारीख स े एक सौ अस्ट्सी दिनों के पश्चात ् प्रवृत्त होंगे।
2. औषजध जनयम, 1945 म,ें अनुसूची ि1 म ेंक्रम संख्या 50 और उसस ेसंबंजधत प्रजवजियों के पश्चात,् जनम्नजलजखत क्रम संख्या
और प्रजवजि अंतःस्ट्थाजपत की िाएगी, अथाडत:् ―
“51. प्रेगाबाजलन”।
[फा. सं. एक्स.11014/14/2025-डीआर]
हष ड मंगला, संयुक् त सजचव
रिप्पणी: औषजध जनयम, 1945 रािपत्र म ेंअजधसूचना स.ं एफ. 28-10/45एच(1), तारीख 21 दिसंबर, 1945 द्वारा प्रकाजित
दकए गए थ े और अंजतम बार अजधसूचना संख्या सा.का.जन 135(अ), तारीख 16 फरवरी, 2026 द्वारा संिोजधत
दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 13th May, 2026
G.S.R. 377(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 were published as
required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act,
1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Wel
fare (Department of Health and Family Welfare) number G.S.R. 54 (E), dated the 21st January, 2026 published in the
Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the 27th January, 2026 inviting objections and
suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on
which the copies of the Official Gazette containing the said notification were made available to the public;
And whereas, copies of the said Official Gazette were made available to the public on the 27th January, 2026;
And whereas, objections and suggestions received from the public on the said draft rules have been considered
by the Central Government;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central
Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further
to amend the Drugs Rules, 1945, namely: —
1. (1) These rules may be called the Drugs (Second Amendment) Rules, 2026.
(2) They shall come into force after one eighty days from the date of publication of these 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 Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45H(1), dated the
21st the December, 1945 and last amended vide notification number G.S.R 135(E), dated the 16 February, 2026.
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and Published by the Controller of Publications, Delhi-110054.