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Core Purpose

Ministry of AYUSH notification of the Drugs (Fourth Amendment) Rules, 2024, further amending the Drugs Rules, 1945 by omitting rule 170 and certain forms in Schedule A.

Detailed Summary

Vide G.S.R. 360(E) dated 1st July 2024, the Ministry of AYUSH, after considering objections/suggestions received on the draft published as G.S.R. 98(E) dated 2nd February 2024 (made available to the public on 5th February 2024) under section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, made the Drugs (Fourth Amendment) Rules, 2024 under sections 6(2), 12, 33 and 33N of the Act, omitting rule 170 of the Drugs Rules, 1945 and omitting FORM 26 E4 and FORM 26 E5 in SCHEDULE A, effective on publication in the Official Gazette; the principal rules (notified vide F. No. 28-10/45-H(1) dated 21st December 1945) were last amended vide G.S.R. 293(E) dated 28th May 2024; signed by B.K. Singh, Joint Secretary.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-02072024-255091 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 337] NEW DELHI, TUESDAY, JULY 2, 2024/ASHADHA 11, 1946 MINISTRY OF AYUSH NOTIFICATION New Delhi, the 1st July, 2024 G.S.R. 360(E).—Whereas the draft of certain rules further to amend the Drugs Rules, 1945, was published as required under section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940) (hereinafter referred to as the said Act), vide notification of the Government of India in the Ministry of Ayush, number G.S.R. 98(E), dated the 02nd February, 2024, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And Whereas, the copies of said Official Gazette were made available to the public on the 5th February, 2024; 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 6(2), 12, 33 and 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:- 1. Short title, and commencement: - (1) These rules may be called the Drugs (Fourth Amendment) Rules, 2024. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules,- (a) rule 170 shall be omitted. (b) in SCHEDULE A, FORM 26 E4 and FORM 26 E5 shall be omitted. [F. No. T-11011/05/2019-DCC(AYUSH)] B.K.SINGH, Jt. Secy. Note: The principal rules were published in the Gazette of India, vide, notification No. F. 28-10/45-H(1), dated the 21st December, 1945 and last amended, vide, notification number G.S.R. 293(E), dated the 28th May, 2024.

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