The Ministry of Ayush on 23rd September 2021 has notified the Drugs and Cosmetics (Draft Amendment) Rules, 2021 to further amend the Drugs and Cosmetics Rules, 1945.The Ministry has invited objections and suggestions from the public which shall be addressed 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.
Through this amendment rule 30AA which deals with import of new Homoeopathic medicine has been substituted as follows:
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.
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.
Provided that the Licensing Authority shall, where the data provided or generated on the New Homoeopathic Medicine is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.
