The Central Government after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, notifies Drugs (4th Amendment) Rules, 2021 to amend the Drugs Rules, 1945.
The amendment modifies the following provisions:
- Rule 153 dealing with Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs. The fee has been revised from one thousand to two thousand.
- Inserted a new provision Rules 153 B dealing with Application for Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing unit.
- Rule 154 dealing with Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs has been amended to make modifications in the period in which a licence to manufacture for sale of any Ayurvedic, Siddha or Unani drugs shall be issued in Form 25D from the date of receipt of the application or from the date of compliance by the applicant of shortcomings. Earlier, the period was 3 months but now the period has been modified to two months.
- Rule 154 A dealing with Form of loan licence to manufacture for sale of Ayurvedic, Siddha or Unani drugs has been modified to insert the period within which a loan licence to manufacture for sale of any Ayurvedic, Siddha or Unani drugs shall be issued in Form 25E. The Loan License shall be issued within a period of two months from the date of receipt of the application or from the date of compliance of shortcomings.
- Rules 155 dealing with Certificate of renewal and 155A dealing with Certificate of renewal of a loan licence of the principal rules, shall be omitted.
- Rule 156 dealing with duration of license has been amended to modify the vaildity period from 5 years to remain perpetually valid.
Provided that the licencee shall submit a self declaration of adherence to the conditions of licence and the
provisions of the Drugs and Cosmetics Act and the rules made thereunder, every year from the date of issue of licence in form 25 D or from the date of submission of last self declaration, as the case may be .