The Ministry of Ayush on 2nd July 2021 has published the draft Drugs and Cosmetics (Amendment) Rules, 2021 and has invited objection/suggestions from the public which shall be addressed to Secretary, Ministry of AYUSH, AYUSH Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023 or emailed at dcc-ayush@nic.in. within 30 days.
The Amendment is brought under rule 67A which deals with sale of homoeopathic medicines in which the Application for the grant of a licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines shall be made in Form19-B to the Licensing Authority and shall be accompanied by a fee of rupees two thousand.
The application shall be made through portal e-AUSHADHI (www.eaushadhi.gov.in) as per the format provided in the said portal, pertaining to the sale license of Homoeopathic Medicines.
Provided that this rule shall not be applicable to licence obtained under Form 20C or 20D prior to the date of commencement of this Amendment Rules, 2021. Such licence holders have to deposit a license retention fee of rupees one thousand for perpetuity of existing licence.”
Further the license to sell, stock or exhibit or offer for sale or distribute] Homoeopathic medicines by retail or by wholesale shall be issued in Form 20C or 20D as the case may be and it shall remain valid perpetually.
The licence to manufacture for sale of Homeopathic medicines shall be issued in Form 25-C. The licence shall be issued within a period of two months from the date of receipt of the application or from the date of fulfilment by the applicant of any shortcomings highlighted by the licensing authority as the case maybe.
