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Core Purpose

Notification amending the Drugs Rules, 1945 to insert Oseltamivir and Zanamivir into Schedule H1 of the Rules, under sections 12 and 33 of the Drugs and Cosmetics Act, 1940.

Detailed Summary

Notification G.S.R. 95(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, dated 5th February 2024, finalises the Drugs (Amendment) Rules, 2024, further amending the Drugs Rules, 1945, under section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board. The draft rules were earlier published for objections via notification G.S.R. 686(E) dated 25th September 2023 (Gazette copies made available to the public on 25.09.2023), and objections/suggestions received have been considered. In Schedule H1 of the Drugs Rules, 1945, after serial number 48, two new entries are inserted: serial number 49, Oseltamivir, and serial number 50, Zanamivir. The rules take effect from the date of final publication in the Official Gazette. The principal rules were originally published vide notification F.28-10/45-H(1), dated 21st December 1945, and were last amended vide notification G.S.R. 922(E), dated 28th December 2023. The notification is signed by Rajiv Wadhawan, Advisor (Cost), under file number X.11014/10/2016-DRS.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-05022024-251806 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 86] NEW DELHI, MONDAY, FEBRUARY 5, 2024/MAGHA 16, 1945 740 GI/2024 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi the 5th February, 2024 G.S.R. 95(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945, was 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 Ministry of Health and Family Welfare, Government of India, number G.S.R. 686 (E) dated 25th September, 2023 published in the Gazette of India, Extraordinary, Part II, Section 3, Sub- section (i), inviting objections and suggestions from the 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 Gazette were made available to the public on 25.09.2023; And, whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), 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 (Amendment) Rules, 2024. (2) They shall come into force on the date of their final publication in the Official Gazette. 2. In the Drugs Rules, 1945, in Schedule H1, after serial number 48 and entries relating thereto, the following serial number and entry shall be inserted, namely:- "49. Oseltamivir 50. Zanamivir". [F. No. X.11014/10/2016-DRS] RAJIV WADHAWAN, Advisor (Cost). Note: The principal rules were published in the Gazette of India vide notification number F.28-10/45-H(1), dated the 21st December, 1945 and last amended vide notification number G.S.R. 922(E), dated the 28th December, 2023. 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. MANOJ KUMAR VERMA

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