Draft Drugs and Cosmetics (Amendment) Rules,2021

The Ministry of Ayush on September 23, 2021 has issued Draft Drugs and Cosmetics (Amendment) Rules, 2021 to further amend the Drugs and Cosmetics Rules, 1945. In Rule 30AA which specifies “Import of New Homoeopathic medicines”, has been inserted in the Drugs and Cosmetics Rules, 1945, namely: (1) No New Homoeopathic medicine shall be imported except under and in accordance with the permission in writing by the Licensing Authority as defined in clause (b) of rule 21. (2) The importer of a New Homoeopathic medicine when applying for permission under sub-rule (1) shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the safety, therapeutic efficacy of the medicine including the minimum homoeopathic provings carried out with it.

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