Ayush License Overview
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.
Ayush full form
The full form of Ayush is Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy.
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.
Ayush licenses Requirements
- The factory must be an industrial area.
- 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.
- Must be at least 1200 square feet.
- Regular inspection shall be done.
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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
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.
Ayush products list
- Dabur Pudin Hara Pearls Capsule 10’S
- Himalaya Liv.52 Tablet 100’S
- Galact Granules – Elaichi Flavour 200 gm
- Himalaya Confido Tablet 60’S
- Himalaya Liv.52 HB Capsule 10’S
- Himalaya Septilin Tablet 60’S
- Dabur Chyawanprash Awaleha 500 Gm
- Dabur Shilajit Gold Capsule 20’S and more.
- Hapdco Aqui Plus Cream 25 Gm
- Allen A84 Lipoma Drops 30 Ml
- Dr. Reckeweg R9 Jutussin Drops 22 Ml
- Dr. Reckeweg R19 Euglandin-M Drops 22 ml
- Dr. Reckeweg R13 Prohaemorrin Drops 22 ml
- Dr. Reckeweg R42 Haemovenin Drops 22 ml
- Dr. Reckeweg R85 Cephabol Drops 30 ml
- Dr. Reckeweg R7 Hepagalen Drops 22 ml and many others.
- Dr. JRK 777 Oil 100 ml
- Dr. JRK 777 Oil 200 ml
- Dr. JRK Eve Fresh Cream – HyperPigmentation & Darkened Skin 25 gm
- Dr. JRK Psorolin Medicated Bathing Bar 75 gm
- Dr. JRK Dano Anti Dandruff Oil 100 ml,
- Dr. JRK Lumina Herbal Shampoo 100 ml,
- Dr. JRK Tolenorm Oil 100 ml
- Dr. JRK Tolenorm Ointment 75 gm and others.
- Hamdard Safi Syrup 500 ml
- Hamdard Joshina Syrup 200 ml
- Hamdard Joshanda Herb 33 Gm, Hamdard Sualin Tab 60’S
- Hamdard Rogan Surkh 50 ml
- Hamdard Roghan Baiza Murgh 25 ml
- Hamdard Itrifal Kishneezi 150 gm and more.
Documents Required
- 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.
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Ayush licence apply online
There are different types of Ayush licence like AYUSH Manufacturing License, AYUSH Wholesale & Retail License, AYUSH Loan License, AYUSH Third-Party Manufacturing License. One can get these licences completely online as they are application based, the interested candidate can fill the Ayush licence form with required documents. Reachout to Ayush by clicking http://www.e-aushadhi.gov.in/
FAQ’S
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?
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.
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