Is FSSAI Registration Required for Herbal Products?

Narendra Kumar

28 Jan, 2021

To manufacture the Ayurvedic/Herbal products in India, we need a license from AYUSH and not from FSSAI. AYUSH is an abbreviation for Ayurveda, Yoga, Unani, Siddha, and Homeopathy.

Below are 3 types of AYUSH Manufacturing License:

• Complete Manufacturing License.
• Loan License.
• Contract Manufacturing/Third party manufacturing/White label Manufacturing/Products to Products manufacturing.

Complete Manufacturing License

It is a full-fledged manufacturing license. In this, you will be doing both i.e. marketing as well as manufacturing the product. Thus you will have to set up your own manufacturing unit. You will have to fulfil all the requirements stated by the state authority of AYUSH^[1]. All the states of India have different requirements for the manufacturing license.

As per the AYUSH Delhi, there are some requirements for manufacturing license of Ayurvedic medicines which are given as under:

• Your manufacturing unit should be a minimum size of 1200 sqft. in the industrial area. This is just for 1 category of drug. If you want to add more categories, you have to add more space.
• The manufacturing unit should be GMP certified.
• You need 2 Ayurvedic experts and 2 Pharmacist.
• You should have all the manufacturing and packaging machinery.
• Drug inspectors come for regular inspection of your premises.
• Other paperwork
• Once the above requirements are done you can apply for FSSAI Registration

Loan License:

It is a manufacturing license, in it, you can finance loan to a manufacturing unit of a third party manufacturer to make your products and thus it is not a necessary requirement that you 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 registration. Then you will have to get 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, the manufacturer gives you a 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 of 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.

For example as per AYUSH Delhi, below are some requirements for Loan license of Ayurvedic medicines:

• 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.
• Loan License has to be renewed regularly
• Drug inspectors come for regular inspection of your premises.
• No Ayurvedic experts and Pharmacist are required.
• Your company should be registered in the same state as the manufacturer.
• Other paperwork.
• After all, the requirement has to meet then you can apply for FSSAI license for herbal products

Also, Read – Licenses Required for Banquet Hall Serving Food

Contract/Third-Party Manufacturing:

It is a License where you will use the manufacturing license of a third-party manufacturer to manufacture the product. You will only be just marketing the product, in this also it is not necessary that you have to own a manufacturing unit and have to get any license.  All the necessary requirements and formalities with AYUSH office will be done by the manufacturer itself.

Since you will be using the manufacturing license of the manufacturer, the manufacturer will have to get approval for your product from authorities. Either you have to provide the raw materials, packaging materials or manufacturer will arrange the same from his sources.  Finally, a manufacturer is going to give you the ready/final product. The label on the product will reflect the name of the company which has manufactured and marketed the product.

The manufacturer will charge the conversion charges for his service i.e. the cost of manufacturing the product, he will also charge the product approval fees. You will have to make a legal document stating that you own the product. The 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 a location of a 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 outsourced the manufacturing. Now Get in touch with Enterslice to get FSSAI license for herbal products.

Read our article: How to Get FSSAI License for Herbalife?