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Issue dated - 10th March 2005

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Tetanus toxoid gets extended shelf life

EPP News Bureau - New Delhi

The Ministry of Health and Family Welfare, Government of India, has proposed to amend provisions of the Drugs and Cosmetics Rules, 1954 to amend the shelf-life of tetanus toxoid from 24 months to 36 months under Schedule P to bring it at par with the shelf-life prescribed in Indian Pharmacopoeia.

It has also been proposed to create provisions under rule 75, 76 and Forms 26 H, 27 D and 28 D for licensing of recombinant DNA (r-DNA) drugs which are now required to be licenced by Central Licence Approving Authority (CLLA).

A Gazette Notification GSR No.36(E), dated 20th January, 2005 has been published inviting objections and suggestions from public within 45 days for the consideration of the Government.

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