Last Updated on November 18, 2021 by The Health Master
Download Drug Rules notification No. 716(E) dated 01-10-2021 Following its move to amend rules on the manufacturing of Ayurveda, Siddha and Unani (ASU) drugs through a notification in October this year, the Ministry of Ayush has clarified to the State Licensing Authorities (SLAs) that there will be no further retention or renewal fees after the one time registration of products, as specified in the notification.
In a clarification to the SLAs this month, the Ministry said that the manufacturing units of the ASU drugs will be subjected to inspection in a randomised manner every five years, whereas previously this duration of inspection was twice a year.
The amendments, under the Drugs (4th Amendment) Rules, 2021, notified vide notification No. 716(E) dated 01-10-2021, are aimed to reduce the compliance burden and facilitate ease of doing business.
Through the notification, the Ministry has fixed a one time registration fee as Rs. 2,000 for any number of classical or generic ASU drugs and Rs. 3,000 for the first ten proprietary products; after the said ten products, an additional fee of Rs. 2,000 per product will be charged.
For existing license holders, this fee for one time registration is Rs. 1,000 for any number of classical/generic ASU drugs and Rs. 1,000 for the first ten proprietary products and after that, an additional fee of Rs. 1,000 per product.
“It is to be noted that there will be no further retention or renewal fees thereafter,” said the letter from the Ministry to the SLAs.
“The license of the ASU drugs have been made perpetual i.e. with one time registration fee the license of the product will be valid lifetime subject to online submission of self compliance declaration every year or unless suspended or cancelled. While prior to the notification, it had a validity period of five years,” it said.
The mode of online payment is not at present integrated on the e-aushadhi portal and all submission of fees is through the existing challan system and the receipt of the same is uploaded on the portal for further processing of the application.
“Under Form 25D and 25E, it is mandatory for the licensing authority to mention the names of drugs categorised as per Schedule T (each item to be separately specified) with a specific Product Code/QR Code for each approved drug,” it added.
The fees over and above the first 10 products of patent and proprietary category under the relevant rules will be accordingly calculated for approvals on or after October 1, 2021, said the clarification.
The Ministry has made the process of granting a license to manufacture ASU drugs swift, paperless, and more transparent by making the license application system online.
However, for six months from the date of gazette notification, both online and offline application process will co-exist before it turns completely online.
The amendment also inserted a form for the application for the Certificate of Good Manufacturing Practices (GMP) for Ayurvedic, Siddha or Unani drug manufacturing units with a fee of Rs. 5,000.
The applicants will only have to get their GMP certification validated every five years to keep their license in force. The GMP certificate can also be retained with submission of retention fee of Rs. 1,000 every year.
The maximum time in granting the license to manufacture ASU drugs has been reduced from three months to two months, through the amendment.
Issuance of free sale certificate has been made online and non conviction certificate also moved online with submission of notarised affidavit. The validity of non conviction certificates has been increased from six months to one year.
The notification has no retrospective effect and is applicable prospectively. Those who have applied for the licence before October 1, 2021, along with the old fee structure, may be considered according to the rates/retirements prevalent on the date of applications. In such cases, while issuing a license, the date of application may also be mentioned prominently.
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