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MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health)

NOTIFICATION

New Delhi, the 13th December, 2004

*G.S.R.  810 (E).– Whereas the Central Government is satisfied that the use of drug formulations containing Rofecoxib are likely to involve risk to human beings.

And whereas safer alternative to the drug are available;

And whereas the Central Government is satisfied that it is necessary and expedient to prohibit the manufacture, sale and distribution of this drug in public interest.

Now, therefore, in exercise of powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale and distribution of the following drug, with immediate effect, namely:-

 "Rofecoxib and its formulations for human use".

[F. No. X-11014/7/2004-DMS & PFA

RITA TEAOTIA, Jt. Secy.

 

 

_______________________________

*Published in The Gazette of Inda, Part II-Section 3- Sub section (i) dated DECEMBER 15, 2004 on No.551

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