G.S.R 732 (E) dated 29th October, 2002

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health)

NOTIFICATION

New Delhi, the 29 th October 2002

*G.S.R. 732 (E).– WWhereas the Central Government is satisfied that the use of drug formulations containing Astemizole and / or Terfenadine are likely to involve certain risks and whereas safer alternatives to these drugs are available;

And whereas the Central Government is satisfied that it is necessary and expedient to prohibit the manufacture, sale and distribution of these drugs in public interest;

              Now, Therefore in exercise of the powers conferred by Section 26 A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby [Prohibits the manufacture of the following drugs for human use with immediate effect and sale and distribution thereof with effect from 1^st April 2003]¹,namely: -

          1. Astemizole
          2. Terfenadine

Deepak Gupta, Jt. Secy.

Note: Published in the Gazette of India (extraordinary) Part-II, section 3, sub-section (i) vide GSR No. 732 (E) dated 29th October 2002

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1.Amended vide GSR 191(E) dated 5^th March 2003