Bringing a health supplement to India isn’t just about getting an FSSAI licence. The product should fit the applicable FSSAI category and comply with the applicable requirements. Further, businesses entering the country from the US, EU, or other markets must understand that compliance in another jurisdiction does not automatically make a product compliant in India.
Ingredients, labels, and everything else need to be assessed against Indian requirements before launch. For regulatory staff and product developers, these challenges can cause delays in approving products, reformulation expenses, and delayed product launches.
This guide will help you understand the essential criteria required to get an FSSAI licence along with the compliance procedure.
Regulatory Authority for Health Supplements in India
The Food Safety and Standards Authority of India (FSSAI) is India’s food safety as well as health supplements regulator. The FSSAI framework provides requirements covering product composition, labelling, ingredients, and claims for nutraceuticals and health supplements.
The principal notified framework currently identified by FSSAI is the following:
Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 + Applicable Amendments + Other FSSAI regulations
What are Health Supplements Under Indian Regulations?
In India, FSSAI defines health supplements as a product whose primary function is to supplement the usual diet of a person. It has concentrated sources of one or more nutrients that provide nutritional or beneficial physiological effects. Take a look at more details about it:
| Particulars | Description |
| When are they preferred? | When the existing diet isn’t enough to meet the nutrient requirements. |
| Nutrients covered |
|
| Age group | Applicable for 5 years and above |
| Target population | Healthy individuals |
| Purpose/Intended use |
|
| How to use? | Take orally |
| Duration of use | As given on the label of the pack |
| Format |
|
| Medical prescription required? | No |
| Health claims | Allowed |
| Medicinal claims |
Can’t label, present, or advertise itself as a prevention, treatment, or cure of diseases or having such properties
|
| Permissible nutrient limits | Less than one RDA |
| Steroid or psychotropic ingredients | No |
| Examples |
Protein supplements and vitamin and mineral formulations with food components intended for the general population.
|
| Ingredient Schedules Applicable | I, II, IV; only enzymes listed in VI, VII, VIII |
| Applicable Additive Schedules | VA, VE, and VF (only for tablets/capsules/syrups) |
FSSAI Compliance Checklist for Health Supplements
Before applying for an FSSAI license and importing products, please ensure the following:
- Product classification: Does the product fall within the health-supplement category?
- Ingredients: Are the ingredients and their forms permitted under the applicable FSSAI requirements?
- Composition: Are nutrient levels and other ingredient quantities compliant?
- Labelling: Does the label have the required category-specific and general food information?
- Claims: Are the proposed nutrition and health claims permitted and adequately substantiated?
- Manufacturing: Does the food business comply with applicable food-safety, hygiene and licensing requirements?
- Imports: If the product is imported, does the importer hold the appropriate FSSAI licence and meet the applicable import requirements?
Do Health Supplements Require Registration in India?
There’s no separate FSSAP product registration certificate for every health supplement. Instead, these businesses need to get an appropriate FSSAI licence. Their product must meet the regulatory requirements at this time.
FSSAI Health Supplement Licensing Process in India
FoSCos, the food safety compliance system is the online portal for FSSAI licence registration. Here is the step-by-step process to follow for the license:
Step 1: Verify Product Classification
Check ingredients, nutrient levels, purpose, and product claims to see if the product is a health supplement per the criteria. Follow this step for products containing unusual, new, or non-standardised ingredients. Where a food or ingredient is not covered by an applicable standard, the non-specified food framework may become relevant. FoSCoS specifically states that such products require product approval before the licence application.
Step 2: Review Ingredient Compliance
Ensure all ingredients are allowed under the relevant Schedules to FSSAI, and nutrient levels comply with the limits required. Observe the levels of vitamins and minerals, amino acids, botanicals and plant ingredients, other permitted substances, additives, nutrient levels, ingredient forms, purity requirements, and applicable usage conditions. Some ingredients uncommonly used or are new may need special approval.
Step 3: Prepare the Required Documentation
Here are the lists of documents companies should keep prepared:
| To Obtain FSSAI Licence | To Maintain Product Compliance |
|
|
Step 4: Hand over the Application via FoSCoS
The application is submitted online on the FoSCoS portal. The applicant must:
- Create a FoSCoS account
- Click on “Apply for New License”
- Complete Form B
- Choose the appropriate product category
- Upload supporting documents
- Fill out and submit your application, and pay the relevant fee
For application tracking purposes, a reference number will be generated.
Step 5: Answer Regulatory Enquiries
The licensing authority may seek clarifications made in respect of ingredients, labels, product claims, and technical documents. Problems here may cause delays.
Step 6: Obtain the FSSAI Licence
The issued FSSAI licence is on the FoSCoS portal, which enables the business to produce, market, or import the health supplement within the scope of the licence. You can download a copy from the site itself.
Health Supplement Licensing Timelines in India
The FSSAI licensing framework provides a 15-day period for scrutiny of an application and a broader 60-day period for licence issuance once the application ID has been generated, subject to completion of the application and applicable regulatory requirements. Requests for additional information or inspection can affect the practical timeline.
FSSAI Licensing Costs for Health Supplements
Most health supplement manufacturers and importers need a Central FSSAI licence. A Central License is issued by the government for ₹7,500 per annum, valid for up to five years.
Also, companies need to allocate their finances for product testing, label compliance reviews, creating and maintaining quality and GMP documentation, import compliance requirements, and regulatory consulting support, where needed.
The licence fee is often a relatively small part of overall costs, as the reformulation, re-labelling, and regulatory enquiries constitute the bulk of them.
FSSAI Labelling Requirements for Health Supplements
All health supplement labels are required to include the following statements:
- “HEALTH SUPPLEMENT”
- Common name or description of the health supplement
- ‘Not for Medical Use’
- The amount of nutrients with nutritional or physiological effect in the product
- Recommended daily usage
- Warning: not to exceed the recommended daily usage
- This is a statement to the effect that the product is not meant to replace a variety of foods
- Warnings, precautions, or side effects/ contraindications/ published product or drug interactions, when applicable
- Instructions for storage and precautions against kids
There are no health claims that can be made for a health supplement, such as to cure, treat, or prevent any disease.
Claims & Advertising Regulations by FSSAI
FSSAI permits nutrition claims and health claims that are based on scientific evidence. Allowed claims include nutrient content claims, health maintenance claims, and mechanism of action or dysfunction—diseases of normal systems or organs.
Cures or treatments for diseases, drug-like efficacy claims, and any name, symbol, or picture suggestive of a disease being treated are not allowed. Uses that are greater or differ from the stated limits might need more clarification from regulators prior to use.
GMP Compliance Requirements in India for Health Supplements
The manufacturing facilities have to comply with Good Manufacturing Practices (GMP). Manufacturers should maintain documented quality controls, raw material specifications, batch manufacturing records, and records of product tests/quality records. Manufacturing facilities overseas may require GMP documentation as well for imported products.
Import Regulations for Health Supplements in India
The health supplements brought in from other countries must meet the same requirements for ingredients, nutrition, and claims as those in India. Importers typically need the following:
- Valid FSSAI Licence
- Labels that meet the Indian standard requirements for products
- Data regarding product specifications and quality documents
- As required, receive import documents (if applicable)
The authorities might also undertake a document review, inspection, sampling, or laboratory testing in order to obtain clearance in addition to the product.
Conclusion
Regulatory aspects of health supplements in India involve various factors such as ingredients, labelling, claims, licensing, and import requirements. Fulfilling these needs in the early stages can prevent expensive delays and hasten entry into the market.
At Artixio, we assist health supplement companies in India with FSSAI licensing and regulatory compliance, label reviews, import process, and market entry strategies. To discuss your product launch plans, contact us at info@artixio.com.
FAQs
Can the Same Supplement Formulation Sold in the US or EU Be Sold in India?
Not always. Ingredients and nutrient levels, as well as labelling and claims, in products need to meet FSSAI requirements. Products may need to be reformulated prior to launch.
What is the Difference Between FSSAI Licence and Product Registration?
FSSAI is a licence granted to sell, manufacture, or import health supplements in India. Unlike the case of every health supplement, India does not have a separate product registration requirement.
What Are the Most Common Reasons for Health Supplement Applications Delayed?
It is usually due to the presence of ingredients not allowed in the test food, incomplete documentation, non-compliant labelling, unsupported claims, novel ingredients, etc.
