It took me a while to figure out what licenses i need and from which authority to manufacture Ayurvedic Medicines. Thus I have compiled this blog to give an overview of Licenses required for manufacturing ayurvedic drugs in India.
To manufacture Ayurvedic / Herbal Products in India, we need a license from AYUSH and not from FSSAI. The Ministry of AYUSH is located at INA and The AYUSH Department of Delhi is located in Tibbia college, Karol Bagh.
Below are 3 types of manufacturing licenses issued by AYUSH :
1. Complete Manufacturing License.
2. Loan License.
3. Contract Manufacturing / Third party manufacturing / White label Manufacturing / Product to Product manufacturing.
Complete Manufacturing License is a full fledged manufacturing license. In this case you will be both marketing and manufacturing the product. Thus you will have to setup your own manufacturing unit. You will have to fulfill all the requirements stated by state authority of AYUSH. All states in India have different requirements for the manufacturing license. – Below is the detailed requirement for a complete manufacturing license from AYUSH for Delhi : http://www.delhi.gov.in/wps/wcm/connect/doit_health/health/home/directorate+of+ayush
For example as per AYUSH Delhi, below are some requirements for manufacturing license of Ayurvedic medicines :
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Your manufacturing unit should be of minimum size of 1200 sqft in industrial area. This is just for 1 category of drug. If you want to add more categories, you have to add more space.
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The manufacturing unit should be GMP certified.
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You need 2 Ayurvedic experts and 2 Pharmacist.
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You should have all the manufacturing and packaging machinery.
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Drug inspectors come for regular inspection of your premises.
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Other paper work
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Example:
Marketed & Manufactured by:
My Company Pvt Ltd
My address, New Delhi, 110001
Loan License is a manufacturing license where you loan a manufacturing unit of a third party manufacturer to make your products. Thus you will not have to own a manufacturing unit. You will have to apply for a Loan license with a GMP certified manufacturer and it will be issued to your company. Then you will have to get an approval for your product from authorities. Post that you can manufacture your products in the factory of the manufacturer. Either you can provide the raw materials and packaging material or manufacturer can arrange it from his sources. Finally manufacturer gives you the ready product.
In case you like to change the manufacturer, you will have to apply for a Loan license again with a new GMP certified manufacturer.
The manufacturer will charge you the conversion charges i,e.. the cost for manufacturing your product in his facility. The Product label will say that the product is both manufactured and marketed by your company. It will not mention anything about the manufacturer you liasioned with. Below is the detailed requirement for a Loan license from AYUSH for Delhi : http://www.delhi.gov.in/wps/wcm/connect/doit_health/health/home/directorate+of+ayush
For example as per AYUSH Delhi, below are some requirements for Loan license of Ayurvedic medicines :
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You need to have a premise with 3 min rooms. 1 room for raw material storage, 1 for finished material storage and 1 for office.
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Loan License has to be renewed regularly
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Drug inspectors come for regular inspection of your premises.
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No Ayurvedic experts and Pharmacist is required.
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Your company should be registered in same state as the manufacturer.
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Other paper work.
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Example:
Marketed by:
My Company Pvt Ltd
My address, New Delhi, 110001Manufactured by:
My company Pvt Ltd
Manufacturing company address, Noida, UP.
Contract / Third-Party Manufacturing is a License where you will use the manufacturing license of a third-party manufacturer to manufacture the product. You will be just marketing the product. Thus you dont have to own any manufacturing unit and dont have to get any license. All liasoning with AYUSH office will be done by the manufacturer.
Since you will be use manufacturing licence of the manufacturer, the manufacturer will have to get approval for your product from authorities. Either you can provide the raw materials and packaging material or manufacturer can arrange it from his sources. Finally manufacturer gives you the ready product. The Product label will say that the product is manufactured by the XYZ manufacturer and marketed by your company.
The manufacturer will charge you the conversion charges i,e.. the cost for manufacturing your product in his facility. The manufacturer will also charge you the product approval fees. You will have to make a legal document stating that you own the product. Legal document should also say that in case of any dispute, your company remains the owner of the product.
Also for Contract Manufacturing, the marketing company can be in any state irrespective of location of manufacturing company. Many big companies are doing Contract manufacturing. For example 5 or 6 big brands are getting their chyawanprash manufactured by one manufacturer. The brands just market it and have outsource the manufacturing.
Example:
Marketed by:
My Company Pvt Ltd
My address, New Delhi, 110001
Manufactured by:
Manufacturing company Pvt Ltd
Manufacturing company address, Noida, UP.
Special thanks to :
– Dr.Surendra Chaudhary (https://in.linkedin.com/in/dr-surendra-chaudhary-4ab70511)
– Dr. Thaprial, Retd. Professor, Tibbia College, Karol Bagh.
