Draft Drug amendment Rules, 2026

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-21082026-275641 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 679] NEW DELHI, WEDNESDAY, AUGUST 19, 2026/SHRAVAN 28, 1948 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II-SEC. 3(i)] 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 [email protected]. 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.