Anyone dealing with herbal or ayurvedic products must acquire a license given by the AYUSH ministry which was established in 2014 on 9th of November. This ministry is responsible for issuing and regulating the AYUSH licenses.
Table of Contents
Types of Licenses
- AYUSH manufacturing license
This license is availed by someone who wants to manufacture herbal or ayurvedic products in India. A licensee here must be establishing a manufacturing facility complying with the rules of their respective state governments.
- The factory must be an industrial area.
- Must be at least 1200 square feet.
- In case there is more than one drug, then more space is required.
- Needs to be GMP (Goods manufacturing Practice) certified.
- 2 Ayurvedic experts and 2 Pharmacies should be a part of the team.
- Regular inspection shall be done.
- AYUSH Loan License
Here unlike the previous license the manufacturing unit is not owned by the licensee. Such Loan license is applied with GMP certified manufacturer. So an approval for the product is also required for this kind of license.
- AYUSH Retail License
This license is availed by someone who wants to retail herbal or ayurvedic products in India. A licensee doesn’t need a manufacturing facility, they buy from a wholesaler.
- AYUSH Wholesale License
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This license is availed by someone who wants to wholesale herbal or ayurvedic products in India to further retailers. A licensee doesn’t need a manufacturing facility, but they buy the products from a third party manufacturer and sell it to a retailer.
- Details of the applicant. ( PAN, adhar and etc.)
- Details of company (MOA or AOA). If applicable.
- Manufacturing License copy as issued by the state government.
- List of products applied for.
- Issuance of Certificate of a Pharmaceutical Product (CoPP)
- CoPP composition.
- Site Plan Master file.
- Master manufacturing formula and the manufacturing process.
- List of approved products.
- Stability study evaluation batch wise, along with the Date of manufacturing, Date of Expiry, stability study condition, the name of Drug etc
- Process validation report for 3 batches. (Herbal Products)
- Validation report of the analytical method.
- List of technical staff along with their qualification, experience and approval status.
- List of equipment .
- Manufacturing Plant layout.
- Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
- Any other rules prescribed for a particular product.
Process of Application
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- The license must be applied on the state website of AYUSH. Can be found at this link : http://e-aushadhi.gov.in/login#gsc.tab=0
- Download the form and affidavits and other certification such as GMP and CoPP as the case may be and fill them.
- Apply for Goods manufacturing Practice and Certificate of a Pharmaceutical Product if applicable.
- Submit the particulars to the local Directorate of the AYUSH.
- How to get AYUSH license?
Need to apply according to the state govt requirements, check http://e-aushadhi.gov.in/login#gsc.tab=0
- How to get AYUSH license and certification?
Refer to the process above.
- How to get AYUSH license for manufacturing herbal products?
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http://e-aushadhi.gov.in/login#gsc.tab=0 as stated above has all the details.
- How can I get ayurvedic medicine manufacture license?
You need to apply to the directorate.