Bringing a health supplement to India isn’t always straightforward. Even products sold in the US or Europe, or other markets, can come across an issue with ingredients, claims, labeling, or import requirements with Indian regulations. For regulatory staff and product developers, these challenges can cause delays in approving products, reformulation expenses, and delayed product launches.
This guide has been created to understand the essential criteria required for registration of health products in India and make it easy for you to launch a compliant health product in India.
Regulatory Authority for Health Supplements in India
The Food Safety and Standards Authority of India (FSSAI), under Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, regulates health supplements in India. These regulations apply to composition and labeling, claims, manufacturing, imports, and sales.
What are Health Supplements Under Indian Regulations?
In India, FSSAI represents the health supplements as a product whose primary function is to supplement the usual diet and to supplement the regular intake of nutrients or other substances that can support normal body functions. They contain:
- Vitamins and minerals
- Amino acids
- Proteins
- Botanicals (herbs & plants) and plant extracts
- Other permitted nutrients
Health supplements cannot mention the prevention, cure, or treatment of any disease. Special requirements may apply to products claiming medicinal benefits.
FSSAI Compliance Checklist for Health Supplements
Prior to applying for an FSSAI License and importing a product, please ensure that:
- The product is suitable for a health supplement.
- All the ingredients and nutrient content are suitable according to FSSAI Guidelines.
- All required statements are included in the labels.
- Claims are supported and do not suggest disease treatment.
- Manufacturing conforms to GMP Standards.
- Technical and quality documents are provided.
Health Supplements Registration Process in India
To sell a health supplement in India, Companies have to make sure that the product attains the regulations framed by FSSAI and gets the relevant FSSAI License via the portal of FoSCoS.
Here is the step by step approval process.
Step 1: Verify Product Classification
Check the following to see if the product is a health supplement per the criteria in Nutra Regulations:
- Ingredients
- Nutrient levels
- Intended use
- Product claims
Medicinal products or products containing unapproved ingredients may not be considered health supplements.
Step 2: Review Ingredient Compliance
Ensure all ingredients are allowed under the relevant Schedules to FSSAI, and nutrient levels comply with the limits required.
The following should be observed:
- Vitamins and minerals
- Amino acids
- Botanicals
- Probiotics and prebiotics
- Novel ingredients
Some ingredients that are not commonly used or are new may need special approval.
Step 3: Prepare the Required Documentation
Organize the documents to be licensed and reviewed, such as:
- The formula and constituents of a product
- Ingredient specifications
- Certificate of Analysis (CoA)
- Product label artwork
- Manufacturing license
- Certifications for GMP (or quality) as applicable
Step 4: Hand in the Application via FoSCoS
The application is made 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 Inquiries
The licensing authority may seek to have clarifications made in respect of:
- Ingredients
- Labels
- Product claims
- Technical documents
There are frequent problems with documents and ingredients, which are sources of delay.
Step 6: Obtain the FSSAI License
The issued FSSAI License is in the FoSCoS portal, which enables the business to produce, market, or import the health supplement within the scope of the License.
Documents Required for Health Supplements Registration in India
Companies should prepare:
- Formulation and ingredient information
- Product label artwork
- Certificate of Analysis (CoA)
- Manufacturing License and GMP Documentation
- If required, move documents into the import folder, if any are available
FSSAI may require further safety and/or scientific evidence for any botanical, novel ingredients, or alternative formulations.
FSSAI Labeling Requirements for Health Supplements
All health supplement labels are required to include the following statements:
- “HEALTH SUPPLEMENT”
- Medical Use is not intended
- The amount of nutrients that are produced 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/ interacting drug/drugs, 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
- Mechanism of action or dysfunction—diseases of normal systems or organs
These items are not allowed:
- Cures or treatments for diseases
- Drug-like efficacy claims
- Any name, symbol, or picture suggestive of a disease being treated
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 used to create health supplements have to comply with Good Manufacturing Practices (GMP). Manufacturers should maintain:
- Documented quality controls
- Raw material specifications
- Batch manufacturing records
- Record of product tests and 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 brought in from other countries.
Importers typically need:
- Valid FSSAI License
- Labels that meet the Indian standard requirements for products
- Data regarding product specification and quality documents
- As required, receive import documents (if applicable)
The authorities might also undertake a document of review, inspection, sampling, or laboratory testing in order to obtain clearance in addition to the product.
Health Supplement Registration Timelines in India
Within 15 days of application, FSSAI reviews all license applications and can request further information if needed.
Applications that include timelines may be extended when:
- Innovative and alternative ingredients
- Incomplete documentation
- Non-compliant labels
- Unsupported claims
Approval time will vary according to the complexity of the product and the extent to which it is completed.
FSSAI Registration Costs for Health Supplements
Most health supplement manufacturers and importers need a Central FSSAI License. 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
- Regulatory consulting support, where needed
The license fee is often a relatively small part of overall costs, as the reformulation, re-labeling, and regulatory inquiries constitute the bulk of them.
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 License and Product Registration?
FSSAI is a license 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.
