What must be on a supplement label in India

Artwork gets designed, approved, printed in a run of twenty thousand, and then somebody notices the net quantity declaration is missing.

That is an expensive afternoon, and it happens often enough that this checklist exists.

This is general orientation, not legal advice. Labelling rules are amended periodically and interpretation varies. Confirm your specific product against the current regulations with a regulatory consultant or your licensing authority before you print.

First: which rules apply to you

This determines everything below, and it follows from your licensing route.

FSSAI route, your product is a health supplement or nutraceutical, and labelling follows the Food Safety and Standards packaging and labelling requirements, plus the specific provisions for health supplements.

AYUSH route, your product is an Ayurvedic medicine, and labelling follows the Drugs and Cosmetics Rules.

Legal Metrology rules apply to pre-packaged commodities in addition to either of the above. This is the set most often forgotten, and it governs things like net quantity, MRP and the consumer care details.

So a typical FSSAI supplement carries obligations from two separate frameworks, and missing the Legal Metrology ones is a common and avoidable error.

The core checklist

Product identity

• Name of the product
• Category declaration, the product must be identified as a health supplement or nutraceutical, as applicable, rather than left ambiguous
• Veg / non-veg symbol, the green or brown filled circle in a square. Mandatory, and its size and placement are specified. Gelatin capsules make a product non-vegetarian, which catches out brands who assumed otherwise
• Form, tablet, capsule, powder, liquid

Composition

• Full ingredient list, in descending order of composition
• Quantities of the actives per unit or per serving. A “proprietary blend” without quantities does not satisfy this
• Botanical names for herbal ingredients, which is both a requirement and good practice
• Standardisation, where claimed
• Additives and excipients, with their class names and INS numbers where applicable
• Nutritional information, where applicable

Quantity and price

These come from Legal Metrology and are the ones most often missed:

• Net quantity, weight, volume or number of units
• MRP, inclusive of all taxes, in the prescribed format
• Unit sale price, where applicable

Dates and batch

• Batch or lot number
• Date of manufacture
• Best before / use by / expiry, in the prescribed form

Who made it and who sells it

• Name and complete address of the manufacturer
• “Marketed by” details, where the brand owner is not the manufacturer, and this is the usual arrangement for contract-manufactured brands
• FSSAI licence number, or the AYUSH manufacturing licence number as applicable
• Importer details, for imported products
• Consumer care details, a working phone number or email. “Working” is the operative word; a dead number is a compliance problem and a customer service one

Directions and warnings

• Recommended dosage or serving
• Directions for use
• Storage conditions
• Allergen declarations, this one has teeth. Milk, soya, wheat, gluten, nuts, fish and other specified allergens must be declared
• Any mandatory statutory warnings applicable to your product category

The health supplement declarations

For FSSAI health supplements, specific statements are required, generally including:

• A statement that the product is a health supplement and not for medicinal use
• “Not for medicinal use” or equivalent, in the prescribed wording
• “Not to exceed the recommended daily dose”
• “Keep out of reach of children”
• A statement advising it should not be used as a substitute for a varied diet

Get the exact current wording from the regulations rather than copying a competitor’s pack. Competitors are frequently non-compliant, and copying is how an error propagates across a category.

The elements most often missing

From what we see coming through for approval:

1. Net quantity, or in the wrong format.

2. The veg/non-veg symbol, or at the wrong size, or in the wrong colour. The specification is precise.

3. Allergen declarations. Soya is the one most often missed, because soya-derived excipients are common and brands do not realise.

4. Quantities of actives, a blend listed without numbers.

5. Consumer care details, or a number that does not work.

6. The “not for medicinal use” declaration, which brands often leave out precisely because it undercuts their marketing, which is the reason it is required.

7. “Marketed by” details. A contract-manufactured product showing only the brand’s name with no manufacturer details is a compliance gap.

8. Date of manufacture, where only the expiry is printed.

9. Storage conditions.

10. Font size. There are minimum sizes for several declarations. A beautifully designed label with 4pt mandatory text is non-compliant.

The claims side, where the real risk is

Labels get pulled more often for what they say than for what they omit.

Three frameworks restrict claims, and they stack:

FSSAI, disease claims are not permitted on health supplements. Structure-function and nutrition claims are, within the permitted framework. Health claims need substantiation.

Drugs and Magic Remedies (Objectionable Advertisements) Act, restricts advertising for a schedule of conditions regardless of which licence you hold. This covers, among others, claims relating to sexual function and stamina, conception and fertility, and the improvement of the body’s structure or function in certain respects.

This is the one brands most often get wrong, because they assume a licence authorises the claim. It does not. The licence says what you may manufacture; this Act says what you may advertise to the public.

Consumer Protection Act, misleading advertisement provisions, with liability extending to endorsers.

What will not survive on a label:

• Cures, treats, prevents or heals any disease
• “Guaranteed” anything
• Specific quantified outcomes, “8 kg in 15 days”, “increases count by X%”
• Claims about conditions in the Magic Remedies schedule
• Comparisons implying medicinal superiority
• Anything suggesting prescribed medication can be stopped

And images make claims too. A before-and-after photograph, a cracking stone, a silhouette slimming down, a muscle outline, regulators read pictures, and so do marketplace compliance teams. Artwork that avoids a claim in words and makes it in imagery is not compliant; it is just less honest about it.

Practical sequencing

The order that avoids reprints:

1. Decide the licensing route before any design work. Mandatory elements differ.
2. Get the composition finalised with quantities and standardisations.
3. Draft the label copy, all mandatory text first, marketing copy second. This is the opposite of how it usually happens, and it is why mandatory elements get squeezed out.
4. Have the claims reviewed against all three frameworks above.
5. Then design, fitting the design around the mandatory content rather than the reverse.
6. Check font sizes and symbol specifications.
7. Get the manufacturer’s sign-off, they will catch things, and they have seen more labels than you have.
8. Print a small run first. Artwork almost always changes after the first market contact.

That last point is practical rather than regulatory. The most common reason for wasted label stock is not non-compliance; it is a brand changing its mind about the design after seeing it on a shelf.

For e-commerce specifically

Marketplaces impose their own requirements on top of the law, and they enforce them faster than regulators do.

What gets listings pulled:

• Mandatory declarations not visible in the product images
• Claims in the listing title or bullet points that are not on the label
• Claims in the A+ content or the product description that would not be permitted on the pack. Brands routinely keep the label clean and then write whatever they like in the listing, and the listing is an advertisement
• Missing FSSAI number
• Missing manufacturer or importer details
• Expired or near-expiry stock
• Customer complaints about efficacy claims

A useful rule: if it cannot go on the label, it cannot go in the listing. The listing is advertising and the same law applies.

Export

If you intend to export, the destination’s rules govern, and they are frequently stricter.

Common differences:

• Permitted ingredients differ, some Indian herbs are restricted or novel-food-regulated elsewhere
• Permitted claims differ substantially
• Allergen rules differ
• Language requirements
• Nutrition panel format differs
• Some markets require registration before sale

Do not assume an India-compliant label works abroad. It usually does not, and consignments get held for labelling reasons more often than for product reasons.

What we check before printing

Our own pre-print checklist, offered because it is useful to anyone:

• All mandatory elements present, in the right format and font size
• Veg/non-veg symbol correct in size and placement
• Composition with quantities matching the approved formulation and matching the licence
• Allergens declared, including from excipients
• FSSAI or AYUSH number correct and current
• Manufacturer and “marketed by” details complete
• Batch, date of manufacture, expiry fields present
• Required statutory declarations in current wording
• Claims reviewed against FSSAI, Magic Remedies and consumer law
• Imagery reviewed for implied claims
• Consumer care number tested
• Barcode correct

And one we insist on in several categories: a referral line directing the customer to a doctor where the category warrants it, urinary symptoms, rectal bleeding, headache red flags, a child not gaining weight. It is not a regulatory requirement. It is the thing most likely to prevent the real harm in those categories, and it costs nothing on the artwork.

What we decline to print: disease treatment claims, anything in the Magic Remedies schedule, quantified outcome promises, before-and-after imagery, and a composition that does not match what is actually in the batch.

The short version

1. Two frameworks usually apply, your licensing route plus Legal Metrology. The Legal Metrology items are the most often missed.
2. Most commonly missing: net quantity, veg/non-veg symbol specification, allergen declarations, quantities of actives, working consumer care number, “not for medicinal use”.
3. Do not copy a competitor’s pack. Competitors are frequently non-compliant.
4. Three claim frameworks stack, and the Magic Remedies Act applies regardless of your licence.
5. Images make claims. Before-and-after and outcome imagery is not a loophole.
6. Write mandatory text first, design around it, not the reverse.
7. Check font sizes. There are minimums.
8. If it cannot go on the label, it cannot go in the listing.
9. Print a small first run. Artwork always changes.
10. An India-compliant label does not work for export.

More detail: supplement label compliance in India and licences for Ayurvedic manufacturing. On choosing the route: FSSAI vs AYUSH.