Last Updated on October 8, 2021 by The Health Master
Download notification: The Union Ministry of Ayush has notified amendment of Drugs Rules, 1945 related to issuance of manufacturing licence and renewal for Ayurvedic, Siddha or Unani drugs, including provisions to move the procedure online. The amended rules have increased various fees significantly, and added rules on Good Manufacturing Practices.
Ayurveda, Siddha and Unani
According to the Drugs (4th Amendment) Rules, 2021, notified on October 1, vide notification No. GSR 716(E) dt 01-10-2021, which amended the Part XVI of the Rules, all the procedures have to be moved through the e-Aushadhi portal as per the format provided in the said portal, including payment of fees, submission of inspection forms and others.
While the Rules of 1945 mandated application for the grant or renewal of a licence to manufacture for sale of any Ayurvedic, Siddha or Unani drugs to be submitted along with a fee of Rs 1,000, the amended Rule says that the fee to be submitted at Rs. 2,000.
According to this, the applicant must also submit a fee of Rs. 3,000 for the first ten products and after that an additional fee of Rs. 2,000 per product through the portal e-Aushadhi as per the format provided in the portal.
This rule shall not be applicable to license obtained under Form 25D prior to the date of commencement of the amended rule, and such licence holder having a Good Manufacturing Practices Certificate on the date of its renewal has to deposit a one time licence retention fee of Rs. 1,000 for existing licences drugs falling under Clause (a) of Section 3 of the Act and Rs. 1,000 for first ten products and a fee at the rate of Rs. 1,000 per product over and above these ten products for existing licenced drugs.
Till the portal e-Aushadhi shall come to effect within six months from the commencement of the amended rules, either online or online process of licence application shall be accepted. The amendment has also substituted the words ‘(including Siddha)’ in the principal rule to ‘Siddha’.
For Ioan licence also, the fee has been fixed at Rs. 2,000 and Rs. 3,000 for first 10 products and additional fee of Rs. 2,000 per product after that. This rule is not applicable for licences obtained under Form 25E prior to the date of commencement of the amended rules, for whom the rules have fixed another fee structure.
For the Certificate of GMP for Ayurvedic, Siddha or Unani drugs manufacturing unit, the form 24E-I shall be submitted with a fee of Rs. 5,000.
The period for issuance of manufacturing licence and loan licence has been fixed as two months from the date of receipt of the application or from the date of compliance by the applicant of shortcomings, as against the previous duration of three months from the date of receipt of the application. The rules regarding certificate of renewal for both manufacturing licence and loan licence have been omitted under the amended rule.
While earlier the validity of the licence was fixed as five years from the date of issue, the amended rule states that a licence issued in Form 25D shall remain valid perpetually, provided the licence shall submit a self declaration of adherence to the conditions of licence and the provisions of the Drugs and Cosmetics Act and the rules, every year from the date of issue of licence in For 25D or from the date of submission of last self declaration.
If the event of non submission of such self declaration within the stipulated time, the licence of the product shall be suspended temporarily and if the licensee fails to submit the self declaration within a further period of three months, the licence of the product shall be deemed to have been cancelled, it added. Under similar conditions, the duration of loan licence has also been made valid perpetually.
Under Rule 156, the amendment also added a set of rules related to the GMP certification, inspection of licence and verification of compliance, report by inspector and procedure of licensing authority following the enquiry, and provisions for further application after rejection.
The certificate of GMP, issued in Form 26E-I shall remain valid unless it is cancelled by the licensing authority subject to deposit of a certificate retention fee of Rs. 1,000 before the expiry of a period of every succeeding five years from the date of its issue. All these processes have to be moved through the online portal and the inspector shall also submit the record online through the portal as per the amended rules.
The draft of these rules was published on March 17, 2021, with a period of thirty days to submit objections and suggestions. The Ministry of Ayush has considered the objections and suggestions from the public, it added in the notification.