Gazette Tracker
Gazette Tracker

Core Purpose

Draft notification proposing amendment of the Drugs Rules, 1945 to add Oseltamivir and Zanamivir to Schedule H1, inviting public objections and suggestions.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) published draft notification G.S.R. 686(E) dated 25th September 2023, in exercise of powers under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), and in consultation with the Drugs Technical Advisory Board, proposing the Drugs (......Amendment) Rules, 2023. The draft rules amend the Drugs Rules, 1945 by adding, after serial number 48 and its entries in Schedule H1, two new entries: serial number 49, Oseltamivir, and serial number 50, Zanamivir. Objections and suggestions may be submitted within thirty days from the date the Gazette copies containing the draft are made available to the public, addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Room No. 434, C Wing, Nirman Bhavan, New Delhi-110011, or emailed to [email protected]. The principal Drugs Rules, 1945 were published vide notification F.28-10/45-H(1) dated 21st December 1945. Signed by Aradhana Patnaik, Joint Secretary, under file number X.11014/10/2016-DRS.

Full Text

6106 GI/202 3 (1) रजिस्ट्री सं. डी.एल.- 33004/99 REGD. No . D. L. -33004/99 EXTRAORDINARY PART II —Section 3 —Sub-section ( i) PUBLISHED BY AUTHORITY No. 544] NEW DEL HI, TUES DAY , SEPTEMBER 26, 2023/ ASVINA 4, 1945 CG-DL-E-26092023-248998 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 2 5th September , 2023 G.S.R. 686(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 an d Cosmetics Act, 1 940 (23 of 1940) and in 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 conside ration 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 public; Objections and suggestions which may be received from any person within the period specified above w ill 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, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv [email protected]. DRAFT RULES 1. (1) These rules may be called the Drugs (......Amendment) Rules, 2023. (2) They shall come into force on the date of their final publication in the Official Gazette unless otherwise specified. 2. In the Dr ugs Rules, 1945 , in Schedule H1 after serial number 48 and entries relating thereto, the following serial numbers and entries shall be added, namely: - “49. Oseltamivir 50. Zanamivir”. [F.No. X.11014/10/2016 -DRS] ARADHANA PATNAIK , Jt. Secy . Note : The prin cipal 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. ……(E), dated ……. Uploaded by Dte. of Printing at Government of India P ress, Ring Road, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.

Never miss important gazettes

Create a free account to save gazettes, add notes, and get email alerts for keywords you care about.

Sign Up Free