The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy on 17th March 2021 has published the Draft Drugs and Cosmetics (Amendment) Rules, 2021 to further amend the Drugs and Cosmetics Rules, 1945.
The Amendment is brought under Part XVI which deals with manufacturing for sale of ayurvedic, siddha or unani drugs in which the application for the grant of a licence to manufacture for sale of Ayurvedic, Siddha or Unani drugs shall be made in Form 24D to the licensing authority along with a fee of rupees five thousand.
The application shall be made through portal e-AUSHADHI (www.e-aushadhi.gov.in) as per the format provided in the said portal, pertaining to the license for manufacture for sale of Ayurvedic, Siddha or Unani drugs.
An application for the grant of a loan licence to manufacture for sale Ayurvedic, Siddha or Unani drugs shall be made in Form 24E to the licensing authority along with a fee of rupees five thousand.
Further, an application for the grant of a Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing unit shall be made in Form 24E-1 to the licensing authority along with a fee of rupees five thousand and inspection fee of rupees one thousand.
A license issued in Form 25D shall remain valid perpetually, Provided that the licensee shall submit a self-declaration of adherence to the conditions of the license and the provisions of the Drugs and Cosmetics Act and the Rules, every three years from the date of issue of license in form 25 D or from the date of submission of the last self-declaration as the case may be.
