Omission of Glyceryl Trinitrate and Isosorbide Dinitrate from Schedule P1 and modification in Rule 105.

6107 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. 545] NEW D ELHI, TUESDAY , SEPTEMBER 26, 2023/ ASVINA 4, 1945 CG-DL-E-27092023-249002 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 2 5th September , 2023 G.S.R. 687(E).— The follow ing draft of certain rules, which the Central Government proposes to make, in exercise of the powers conferred by sections 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules will be taken into consideration on or after the expiry of a period of forty -five days from the date on which the copies of th e 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, Room No. 437, 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. 2. In the Drugs Rules, 1945, (hereinafter referred to as the said rules), in rule 105, in sub -rule (2), in clause (i), the words, letters and figures, “multiples of 5”, following words, Letters and figures shall be substituted namely. - “multiples of 5 or 7.” 3. In the said rules, in Schedule P1, in the table, the following entries under the Name of the Drug and respective Dosage form and Pack Size, shall be omitted. “Glyceryl Trinitrate Sapnsules (Long Acting) 25 Isosorbide Dinitrate Sapnsules (Long Acting) 25” [F.No. X.11035/108/2023 -DRS ] ARADHANA PATNAIK , Jt. Secy . Foot note: The Drugs Rules, 1945 were published in the G azette 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. 410(E), dated the 2nd June, 2023. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, N ew Delhi -110064 and Published by the Controller of Publications, Delhi -110054.