On April 04, 2022, the Central Government has notified the Drugs (4th Amendment) Rules, 2022 to further amend the Drugs Rules, 1945. This has come into force on April 4, 2022.
Key points:
- In Rule 153 and 153 A which deals with ‘Application for licence to manufacture Ayurvedic (including Siddha) or Unani drug’ and ‘Loan Licence’, the maximum period of renewal has been substituted with 18 months.
Rule 153 : Application for licence to manufacture Ayurvedic (including Siddha) or Unani drug
“Provided further that the applicant may apply for renewal after the expiry of one month but within Eighteen months of such expiry in which case the Fee payable for renewal of such licence shall be rupees one thousand and two hundred plus an additional fee of rupees six hundred.”
Rule 153A which specify “Loan Licence” the second proviso has been substituted:
“Provided further that the applicant may apply for renewal after the expiry of one month, but within Eighteen months of such expiry in which case the fee payable for renewal of such licences shall be rupees six hundred plus an additional fee of rupees three hundred.”
- Form 26D and 26E which specify ‘Certificate of renewal of licence to manufacture for sale of Ayurvedic/Siddha or Unani drugs’ and Certificate of renewal of loan licence to manufacture for sale of Ayurvedic/Siddha or Unani Drug respectively has been omitted.