Recently India Ministry of Health & Family Welfare published the notice regarding partial amendment to “Drugs and Cosmetics Rules, 1945”.
The amendments are relating to animal toxicity studies and encourage the use of OECD (Organisation for Economic Cooperation and Development) validated non-animal alternatives.
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Current rules |
Amendments |
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Dermal toxicity study |
Daily topical (dermal) application of test substance in its clinical dosage form should be done |
The initial toxicity study shall be carried out by non-animal alternative tests as given in Organisation for Economic Cooperation and Development Guidelines |
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Ocular toxicity studies (for products meant for ocular instillation) |
need to include a recovery group |
Such initial toxicity studies shall be carried out by non-animal alternative tests as given in Organisation for Economic Cooperation and Development Guidelines. |
The amendments shall come into force on the date of their publication in the Official Gazett.
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