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Industry specific-Medical Central Ministry of Ayush Drugs and Cosmetics Act, 1940

Issuance of Drugs (4th Amendment) Rules, 2021 introducing e-AUSHADHI portal and amending the rules under Part-XVI and Part-XVI A

01-Oct-2021 | G.S.R. 716(E)

Ministry of Ayush has issued Drugs (4th Amendment) Rules, 2021 and following are its key highlights: 1. Application for Licence and Loan Licence to be made through e-AUSHADHI portal as per format prescribed on the portal. It will not be applicable to licence obtained prior to the date of commencement of the this amendment rules and licence holder having a Good Manufacturing Practices Certificate. For the period of 6 months either of online and offline application will be accepted. 2. Application for Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing unit shall be made through e-AUSHADHI portal. 3. Licence will be issued within a period of 2 months instead of 3 months. 4. Certificate of Good Manufacturing Practices to manufacturers of Ayurveda, Siddha or Unani drugs shall be issued in Form 26 E-1 and duration of 5 years has been omitted. 5. Licence issued in Form 25 D will remain valid perprtually instead of 5 years validity. For further details, please refer to the attachment.

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