Modification in Rule 105 and Schedule P1 of Drugs Rules, 1945

2090 GI/202 4 (1) EXTRAORDINARY PART II —Section 3 —Sub-section ( i) PUBLISHED BY AUTHORITY No. 202] NEW DELHI, MON DAY , MARCH 1 8, 2024 /PHALGUNA 28, 1945 CG-DL-E-18032024-253209 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 18th March , 2024 G.S.R. 216(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945, was published, as required by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Ministry of Health and Fam ily Welfare, Department of Health and Family Welfare, number G.S.R. 687 (E) , dated the 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 forty -five 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 said Gazette notification were made available to the public on 2 6th September, 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.Short title and commenc ement (1) These rules may be called the Drugs ( Second 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, (hereinafter referred to as the principal rules), in rule 105, in sub -rule (2), in clause (i), after the words, and figure, “multiples of 5”, the word and figure “or 7” shall be inserted. 3.In the principal rules, in Schedule P1, under the heading “PACK SIZES OF DRUGS”, the drugs “Glyceryl Trinitrate” and “Isosorbide Dinitrate” mentioned in column 1 and entries relating thereto in column s 2 and 3 shall be omitted. [F.No. X.11035/108/2023 -DRS] RAJIV WADHAWAN , Advisor (Cost) . Foot Note: The Drugs Rules, 1945 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. 95(E), dated the 5th February, 2024. Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.