In recent years, the demand for Ayurvedic medicine has risen due to its natural origins. Also, Ayurveda medicine has no adverse effects, which has resulted in high demand rise even further. Assuring everyone has equal and unbiased access to medicaments is the primary concern of any government. But the right to manufacture and sell medicines, including the Ayurveda license, has to be given carefully. Hence the Government has strict rules for granting Ayurveda licenses too, that’s why the Government has made the application process for Ayurveda drug licenses entirely online. In this write-up, We will discuss how the application process for Ayurveda drug license goes online by the Ministry of Ayush.
Government decision for issuing Ayurveda Drug License Online
The Government has decided to make the Ayurveda, Siddha, and Unani Drug permanent, i.e., with a one-time registration fee, the Ayurveda drug license will be valid for a lifetime based on submission of self-conformity declaration every year or unless suspended or canceled by the Government.
The process of granting a ASU (Ayurveda, Siddha, and Unani drugs) license to the manufacturer has been made ready, paperless, and more transparent by the Ministry of Ayush. The ministry decided to bring the application system online as the manufacturers can now apply for an Ayurveda drug license on the ministry’s portal.
The applicants of Ayurveda, Siddha, and Unani drugs will have to get their Good Manufacturing Practice certification is authenticated every five years to keep their license in function. Also, the GMP certificate can be maintained by submitting the online maintenance fee of Rs 1000. The manufacturing unit of the ASU drugs will be determined by random inspections every five years. Since the validity period of ASU drugs increased, the fee has been altered from ₹1,000 to ₹2,000 for any number of collective ASU drugs and ₹3,000 for up to 10 proprietary drugs.
Also, the Ministry of Ayush has lessened the maximum time taken for granting licenses from three months to two months. For six months from the issue of gazette declaration, both the online and offline application process of ASU drugs will exist side-by-side before it becomes completely online.
The decision taken by the Government to make the application process online was to bring uniformity to the whole process. For the online ASU drug license, the Ministry of Ayush will act as a facilitator in the process. Further, the authority has taken specific measures to reduce the ASU drug manufacturers’ regulatory adherence burden. Also, the government’s actions have helped ease of doing business while ensuring the quality, safety, and effectiveness of the Ayurveda Siddha Unani drugs.
How will Ayurveda Drug Licenses Online process help the Manufacturing unit?
The launch of the Online portal is the initial step toward the Digitalization of the documentation, quick approvals. It will help the Ayurvedic industry to work better in competitive markets. Also, The Ministry of Ayush has introduced new by-laws to strengthen the Ayurveda Drug license and created an online licensing portal. The rules amended by the Government have enhanced several fees significantly and added regulations on Good Manufacturing Practices.
As per the amendment, all the procedures have to be moved through a the-Aushadhi portal, including payment of fees, submission of inspection forms, and others.
Earlier, for the grant of a license to manufacture/sell any Ayurvedic, Siddha, or Unani drugs, the fee of Rs 1000 is to be submitted. As per the amendment, the price to be offered for manufacturing for sale of any Ayurvedic, Siddha, or Unani drugs is Rs. 2,000. Further, the applicant must also submit a price 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.
The rules initiated do not apply to the license obtained under Form 25D before the commencement date of the laws amended by the Government. Also, the permit holder with a Good Manufacturing Practices Certificate has to deposit a one-time license fee of Rs. 1,000 on the date of its renewal for existing licensed drugs falling under Clause (a) of Section 3 of the Act. The FEE of Rs. 1,000 is charged for the first ten products and a fee of Rs. 1,000 per product in addition to the ten products for existing ASU licensed drugs.
Every state has its own Ayurvedic website, and the person applying for the online Ayurveda drug license must visit the AYUSH website for the respective state in which they are starting the business. This online ASU Drug License will help in strengthening existing research institutions and ensure a time-bound research activity.
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