Ministry of Health and Family Welfare Department of Health and Family Welfare Not Applicable

Proposal for inclusion of Pregabalin and its drug formulations in Schedule H1 of the Drugs Rules 1945 in light of misuse and intoxication

Published: 27 January 2026 Download PDF

Gazette ID: CG-DL-E-27012026-269587

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Core Purpose

The Central Government publishes draft rules to further amend the Drugs Rules, 1945, by inserting 'Pregabalin' into Schedule H1.

Detailed Summary

This notification, G.S.R. 54(E), issued by the Ministry of Health and Family Welfare (Department of Health and Family Welfare) on January 21, 2026, publishes a draft of rules titled "The Drugs (...... Amendment) Rules, 2025." These rules are proposed by the Central Government under 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. The primary amendment involves inserting "51. Pregabalin" into Schedule H1 of the Drugs Rules, 1945, after serial number 50. The draft rules are published for public information, and objections and suggestions are invited for a period of thirty days from the date the Gazette is made available, to be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, New Delhi, 110001 or via email to drugsdiv-mohfw@gov.in. The final rules, once published, shall come into force after three months. The principal Drugs Rules, 1945, were originally published vide notification No. F. 28-10/45-H(1) dated December 21, 1945.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-27012026-269587 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 54] NEW DELHI, THURSDAY, JANUARY 22, 2026/MAGHA 2, 1947 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. GORAKHA NATH YADAVA

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