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Core Purpose

Draft notification G.S.R. 375(E) under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, proposing further amendments to the Drugs Rules, 1945 to insert references to Schedule G drugs in Rules 74, 74A, 74B, 78 and 78A, inviting objections within 45 days.

Detailed Summary

Ministry of Health and Family Welfare (Department of Health and Family Welfare) notification G.S.R. 375(E) dated 10 July 2024 publishes, in exercise of powers under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and after consultation with the Drugs Technical Advisory Board, a draft of the Drugs Rules (....Amendment), 2024, further amending the Drugs Rules, 1945 (principal rules published vide notification No. F.28-10/45-H(1) dated 21 December 1945, last amended vide G.S.R. 293(E) dated 28 May 2024); the draft would insert the words 'Schedule G,' after 'the drugs specified in' in clause (p) of Rule 74, clause (i) of Rule 74A, clause (7) of Rule 74B, clause (q) of Rule 78, and clause (8) of Rule 78A; objections and suggestions are invited within 45 days of the Gazette copies being made available to the public, addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Room No. 414A, D Wing, Nirman Bhavan, New Delhi-110011, or by email to [email protected]; signed by Rajiv Wadhawan, Adviser (Cost).

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-11072024-255341 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 352] NEW DELHI, WESNESDAY, JULY 10, 2024/ASHADHA 19, 1946 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 10th July, 2024 G.S.R. 375(E). The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, 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), 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 or after the expiry of a period of forty five days from the date on which the copies of the Gazette of India these draft rules are made available to 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. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at [email protected]. DRAFT RULES 1. (1) These rules may be called the Drugs Rules (......Amendment), 2024. (2) They shall come into force on the date of their final publication in the Official Gazette. 2. In the Drugs Rules, 1945, — (i) in rule 74, in clause (p), after the words "the drugs specified in", the words "Schedule G," shall be inserted; (ii) in rule 74A, in clause (i), after the words "the drugs specified in", the words "Schedule G," shall be inserted; (iii) in rule 74B, in clause (7), after the words "the drugs specified in", the words "Schedule G," shall be inserted; (iv) in rule 78, in clause (q), after the words "the drugs specified in", the words "Schedule G," shall be inserted; (v) in rule 78A, in clause (8), after the words "the drugs specified in", the words "Schedule G," shall be inserted. [F.No. X.11035/47/2024-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.

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