How to Start Nutraceutical Manufacturing Company in India?

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Nutraceuticals in India are regulated through Food Safety and Standards Act, 2006. Food Safety and Standards Authority of India (FSSAI) is the body to exercise the powers conferred on, and to perform the functions assigned to, it under this Act.

It’s criminal offence to manufacture nutraceuticals without having license from FSSAI. So, one must have to take license from FSSAI to manufacture nutraceuticals in India.

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Food Safety and Standards Act, 2006

Food Safety and Standards Act, 2006 is an Act to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto.

Food Safety and Standards Authority of India (FSSAI)

Food Safety and Standards Authority of India is a statutory body established under the Ministry of Health & Family Welfare, Government of India. The FSSAI has been established under the Food Safety and Standards Act, 2006, which is a consolidating statute related to food safety and regulation in India.

Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Purpose, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

Nutraceuticals wasn’t covered in Food Safety and Standards Act, 2006 when it was implemented. Later with power given to Food Authority in section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), Food authority published the draft of the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Food) Regulations, 2015 vide notification of the Food Safety and Standards Authority of India No. 1-4/ Nutraceutical/ FSSAI-2013, dated the 30th July, 2015, in the Gazette of India, Extraordinary, Part III, Section 4

Against this draft, Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Purpose, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 were implemented dated 23rd December, 2016

This comes into force on the date of their publication in the Official Gazette and Food Business Operators had to comply with all the provisions of these regulations by 1st January, 2018.

FSSAI License for Nutraceuticals and Food/Health Supplements

Before September 2021, there were two types of licenses issued by FSSAI i.e.

State License
Central License

State License:

FBOs having a production capacity of 2MT per day are issued with State License.

Central license:

FBOs having a production capacity of more than 2MT per day are eligible for Central license.

But now with order dated 16th September 2021, Considering the complexity and sensitivity of the products covered under the Nutraceutical regulations and of the products covered under it, it had been decided with the approval of the Food Authority to license food businesses manufacturing products covered through Central Licensing Authorities only.

Now only one type of license is applicable i.e.

Central License:

Irrespective of having any production capacity per day.

How to apply for Nutraceutical Manufacturing License?

Application is filled up online through FSSAI online Portal i.e. FoSCoS (Food Safety Compliance System) website.

Visit: https://foscos.fssai.gov.in/

The user – Food Business Operator (FBO) can log-in or sign up from homepage at top right corner of the portal

For signup (When the user is new): After clicking on signup, user will be redirected to signup page wherein the user has to fill in all details like Name, Email ID, Mobile No, Login ID and Password and click on “Signup” button.

A verification code will be sent to the registered email ID and Mobile number. Fill in the verification code and click “Submit” to verify the details

After successfully signing up, user can login to the system by entering the username, password and captcha code. If user is existing then s/he can simply login from this page by entering email ID, password and captcha code.

Select the location of Food unit i.e., regular premises etc

Selection of kind of business and eligibility for license and registration

Fill premises details and select appropriate food product Categories and products

A 17-digit user ID will be created based on application reference number

Fill communication details and upload requisite documents

Submission of Fee and the application

Useful links:

Identify the category of product as per regulation.

Health Supplements – Food Product Category 13.6
Nutraceuticals – Food Product Category 13.6
Food for Special Dietary Uses – Food Product Category 13.4, 13.5, as per ingredients/intended use
Food for Special Medical Purposes other than infants- Food Product Category 13.3, 13.4 as per ingredients / intended use
Food with added Probiotic Ingredients – Food Product Category 13.6
Food with added Prebiotic Ingredients – Food Product Category 13.6
Specialty Food containing plant/botanical ingredients with safe history of usage – Food Product Category 13.6

Mention a Common/Generic name of the product in the application in case of Health Supplements and Nutraceuticals and mention specific name of the product in remaining categories.

Mention the list of the ingredients along with FSSR according to the selected category of product as mentioned above

List of documents for Nutraceutical manufacturers

list of Directors/Partners/Proprietor/Executive Members of Society/Trust with full address and contact details with nomination of authorized signatory
Photo I.D. and address proof issued by Government authority of Proprietor/ Partner/ Director(s)/ Authorised Signatory
Proof of possession of premises. (Sale deed/ Rent agreement/ Electricity bill etc.
Partnership Deed/Self Declaration for Proprietorship/Memorandum & Articles of Association towards the constitution of the firm/ Copy of certificate obtained under Coop Act – 1861/Multi-State Coop Act – 2002 in case of Cooperatives
Form IX: Nomination of Person as per Clause 2.5 of FSS Rules, 2008 (Not applicable In case of Proprietor)
Blueprint/layout plan of the processing unit showing the dimensions in metres/squar metres and operation-wise area allocation
Production unit photograph
Name and list of Equipment’s and Machinery along with the number, installed capacity and horse power used
Analysis report (Chemical & Bacteriological) of water to be used as ingredient in food from a recognized/ public health laboratory to confirm the potability indicating the name of authorize representative of Lab who collected the sample and date of collecting sample. (Not applicable If water Is not being used Ingredient)
Recall Plan
Product specifications (Ingredients as per applicable schedule) of each product mentioning the purity criteria adopted for ingredients of nutraceutical and health supplement products as per the prescribed format
In case of extraction of ground water, NOC from CGWA as per FSSAI order dated 2^nd Jan 2018 and 11^th January 2021
Any document which is required by the licensing authority to ensure safety of food
Any document specified by FSSAI or commissioner of Food safety through a public order for any particular kind of business activity or in general

Documents to be enclosed for new application for license to State/Central Licensing Authority

Form-B duly completed and signed (in duplicate) by the proprietor/ partner or the authorized signatory
Blueprint/layout plan of the processing unit showing the dimensions in meters/square meters and operation-wise area allocation
List of Directors with full address and contact details (mandatory for companies only}
Name and List of Equipment’s and Machinery along with the number, installed capacity and horse power used (mandatory for manufacturing and processing units only)
Photo ld. and address proof issued by Government authority of Proprietor/Partner/Director/s)/Authorized Signatory. (optional)
List of food category desired to be manufactured.
Authority letter with name and address of responsible person nominated by the manufacturer along with alternative responsible person indicating the powers vested with them viz assisting the officers in inspections, collection of samples, packing & dispatch. (Wherever applicable)
Analysis report (Chemical & Bacteriological} of water to be used as ingredient in food from a recognized/ public health laboratory to confirm the portability (mandatory only for manufacturing and processing units only)
Proof of possession of premises. (Sale deed/ Rent agreement/ Electricity bill, etc.)
Partnership Deed/Affidavit/Memorandum & Articles of Association towards the constitution of the firm.
Copy of certificate obtained under Coop Act – 1861/Multi State Coop Act – 2002 in case of Cooperatives. (Optional wherever applicable}
Food Safety Management System plan or certificate (if any)
Recall plan wherever applicable, with details on which the product is distributed.
NOCs from Municipality or local body. (optional)

Conclusion

Food Safety and Standards Authority of India (FSSAI) is regulatory body for providing nutraceutical manufacturing license in India. So, you need to apply to FSSAI if you want to start manufacturing of nutraceutical products.

If pharma companies or distributors/chemists etc are engaged in sales and purchase or manufacturing of any product that fall under nutraceuticals, food supplements and dietary supplements, they have to apply for fssai license also according to basis of your business.

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