Request for approval to publish the Import Checklist related to shelf life below 60 percent and Overprinting Snickering Stamping as per Rule 104 A of the Drugs and Cosmetics Rules 1945

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-25062026-273833 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 454] | NEW DELHI, MONDAY, JUNE 22, 2026/ASHADHA 1, 1948 4612 GI/2026 | (1) 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 22nd June, 2026 G.S.R. 505(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]. [PART II—SECTION 3(i)] | THE GAZETTE OF INDIA : EXTRAORDINARY | 3 DRAFT RULES (i) These rules may be called the Drugs (...... Amendment) Rules, 2026. (ii)These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette. In the Drugs Rules, 1945, in Rule 31, the second proviso shall be substituted as follows:- "Provided further that the licensing authority shall not allow the import of any drug having less than one year residual shelf-life period as on the date of import. However, in the case of Biological drugs and Radiopharmaceuticals, 60% of the labelled shelf-life may be allowed." [F. No. X.11014/08/2026-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 December, 1945 and last amended vide notification number G.S.R......(E), dated the....... 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. SRIVASTAVA | SARVESH KUMAR by SARVESH KUMAR