Amendment under Rule 96 of Drugs Rules,1945

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-13072024-255425 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 361] NEW DELHI, FRIDAY, JULY 12, 2024/ASHADHA 21, 1946 4188 GI/2024 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 12th July, 2024 G.S.R. 391(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, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at [email protected]. DRAFT RULES (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. In the Drugs Rules, 1945, rule 96, in sub-rule (7): i. In particular no (vii) the words "date of expiry; and” shall be substituted with the words "date of expiry;”. ii. In particular no (viii) the words "manufacturing licence number." Shall be substituted with the words "manufacturing licence number; and". iii. After particular no (viii) the words “(ix) details of excipients.” shall be inserted. [F.No. X.11035/44/2024-DRS] RAJIV WADHAWAN, Adviser (Cost) Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st the December, 1945 and last amended vide notification number G.S.R 293(E), dated 28.05.2024