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Core Purpose

Notification under section 26A of the Drugs and Cosmetics Act, 1940 prohibiting the manufacture, sale and distribution of Ketoprofen and Aceclofenac formulations for animal use.

Detailed Summary

The Ministry of Health and Family Welfare, Department of Health and Family Welfare (S.O. 3448(E), dated 31st July 2023), being satisfied that drug formulations containing Ketoprofen and Aceclofenac are likely to involve risk to animals and that safer alternatives are available, and in exercise of powers under section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, prohibits, with immediate effect, the manufacture, sale and distribution of Ketoprofen and its formulations for animal use and Aceclofenac and its formulations for animal use; the notification is signed by Aradhana Patnaik, Joint Secretary (F. No.X.11035/65/2023-DRS).

Full Text

4957 GI/202 3 (1) रजिस्ट्री सं. डी.एल.- 33004/99 REGD. No . D. L. -33004/99 EXTRAORDINARY PART II —Section 3 —Sub-section ( ii) PUBLISHED BY AUTHORITY No. 3298] NEW DEL HI, TUES DAY, AUGUST 1, 2023/ SHRAVANA 10, 1945 CG-DL-E-01082023-247766 MINISTRY OF HEALTH A ND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi the 31s t July, 2023 S.O. 3448 (E).—Whereas the Central Government is satisfied that the use of drug formulations containing Ketoprofen and Aceclofenac are likely to involve risk to animals; And whereas, safer alternatives to the said drugs are available; And whereas, the Central Government is satisfied that it is necessary and expedient i n the public interest to prohibit the manufacture, sale and distribution of –– (i) Ketoprofen and its formulations; and (ii) Aceclofenac and its formulations, for animal use; Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Co smetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, the Central Government, hereby prohibits the manufacture, sale and distribution of the following drugs, with immediate effect, namely: - “(i) Ketoprofen and its formulations for animal use (ii) Aceclofenac and its formulations for animal use”. [F. No.X.11035/65/2023 -DRS] ARADHANA PATNAIK , Jt. Secy . Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapuri, New Delhi -11006 4 and Published by the Controller of Publications, Delhi -110054.

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