Drugs and Cosmetics (Draft Amendment) Rules, 2021; consultation launched

The Ministry of Ayush has notified the Drugs and Cosmetics (Draft Amendment) Rules, 2021 on 23rd September 2021. The draft Rules amend the Drugs and Cosmetics Rules, 1945 by substitution of Rule 30AA. The key points under Rule 30AA are:

  • No New Homoeopathic medicine shall be imported without the permission in writing by the Licensing Authority.
  • The importer of a New Homoeopathic medicine when applying for permission 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.
  • The New Homoeopathic Medicine shall continue to be considered as New Homoeopathic Medicine for a period of four years from the date of its first approval.
  • The Licensing Authority after being satisfied that the drug shall be effective and safe for use in the country shall issue approval subject to the conditions stated therein.


The Ministry has launched the consultation inviting objections and suggestions from the public which shall be addressed to the Secretary, Ministry of AYUSH, AYUSH Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023 or emailed at dcc-ayush@nic.in. within 30 days.


*Tanvi Singh, Editorial Assistant has reported this brief.

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