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The Government of India, Ministry of Health and Family Welfare 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 Notifications 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.
Department of Health, Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi dated 2nd March, 2005.
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EK/MK.
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