FSSAI vs AYUSH: which licensing route for your product?

This is the first real decision in launching a herbal product in India, and a surprising number of brand owners make it by accident, whichever route their manufacturer happens to use.

It deserves a deliberate choice, because the two routes differ in what you can claim, who regulates you, how long approval takes, and where you can sell.

This is general orientation, not legal advice. Rules change and interpretation varies by state. Confirm your specific product with a regulatory consultant or your state licensing authority before committing to artwork or a launch date.

The two routes

The FSSAI route. Your product is a food, specifically a nutraceutical, health supplement, or food for special dietary use. Governed by the Food Safety and Standards Act and the regulations made under it, administered centrally by FSSAI.

The AYUSH route. Your product is an Ayurvedic medicine. Governed by the Drugs and Cosmetics Act and its rules, administered by state AYUSH or drug licensing authorities.

The same tablet, say ashwagandha, shallaki and guggul, can go either way depending on how it is formulated, licensed and labelled. That is not a loophole; it reflects a genuine overlap between food and traditional medicine that both frameworks acknowledge.

The core difference: what you may claim

This is the decision driver, so take it first.

Under FSSAI, you may make structure-function and nutrition claims within the permitted framework: a nutrient’s recognised role in normal body function, general wellness, and health claims where substantiated and permitted. You may not claim to treat, cure, prevent or mitigate any disease. Food supplements are not medicines and cannot be presented as such.

Under AYUSH, you may reference the therapeutic indications of classical formulations, within what the authoritative Ayurvedic texts say, and consistent with your licence. If you manufacture a classical formulation as given in an authoritative text, the traditional indications come with it.

So, bluntly: if your product needs to reference a condition, AYUSH is the route that permits it. If general wellness positioning is sufficient, FSSAI is simpler.

And one constraint that overrides both: the Drugs and Magic Remedies (Objectionable Advertisements) Act restricts advertising for a schedule of conditions regardless of which licence you hold. It covers, among others, claims relating to sexual function and stamina, conception and fertility, and the improvement of the human body’s structure or function in certain ways. An AYUSH licence does not authorise advertising those claims to the public. This catches a large number of brand owners who assume a licence settles the question.

Classical versus proprietary, the distinction inside AYUSH

Within the AYUSH route there are two quite different situations, and conflating them causes most of the confusion.

Classical formulations are those appearing in the authoritative texts listed in the First Schedule of the Drugs and Cosmetics Act, the Ayurvedic Pharmacopoeia and recognised classical works. Chyawanprash, Triphala Churna, Ashwagandha Churna, Arjunarishta and so on.

For these, the formulation and its traditional indications are established in the text. Licensing is comparatively straightforward because you are not asking anyone to evaluate a new formulation, only to confirm you can make a known one properly.

Proprietary Ayurvedic medicines are your own formulation, built from ingredients listed in the authoritative texts but combined in a way the texts do not give.

Here you must justify the formulation, the rationale for each ingredient, with textual references, and in some cases safety and other data. Expect more scrutiny, more documentation, and a longer timeline. This is where most modern products sit, and where brand owners most often underestimate the work.

Side by side

	FSSAI	AYUSH
Legal basis	Food Safety and Standards Act	Drugs and Cosmetics Act
Regulator	FSSAI, central	State AYUSH / drug licensing authority
Product is	Food supplement / nutraceutical	Ayurvedic medicine
Disease claims	Not permitted	Traditional indications, within the licence
Dosage form language	Food-style serving guidance	Medicinal dosage
Typical timeline	Faster	Longer, especially proprietary
Vitamins and minerals	Permitted, with limits	Restricted
Modern nutrients	Easier to include	Harder to justify
E-commerce	Straightforward	Platform policies vary
Export	Food framework, widely recognised	Varies considerably by destination
Per-product approval	Generally not needed for compliant products	Yes, product-wise licence

Where FSSAI genuinely wins

Speed. Both licence and launch. For a product you want selling this quarter, this is often decisive.

Vitamins, minerals and modern nutrients. If your formulation includes vitamin D3, B12, zinc, collagen, probiotics, omega-3 or amino acids, FSSAI is the natural home. The nutraceutical regulations provide for exactly this; fitting them into an Ayurvedic licence is awkward at best.

E-commerce. Marketplace onboarding for food supplements is a well-trodden path. Medicine categories attract additional platform requirements and, periodically, additional restrictions.

Export. The food supplement framework maps reasonably onto how most countries regulate supplements. “Ayurvedic medicine” maps onto very little outside India and can complicate entry.

Central administration. One regulator with published regulations, rather than state-by-state variation.

The modern wellness positioning. If your brand is built on gut health, immunity, energy and sleep rather than on classical therapeutics, the food framework matches your copy anyway.

Where AYUSH genuinely wins

Claims that reference conditions. Subject to the Magic Remedies Act, this is the only route that permits therapeutic indications at all.

Classical formulations. If you are making Chyawanprash or Triphala Churna, this is the correct route and licensing is comparatively clean. Selling a classical formulation as a food supplement forfeits its traditional standing for no gain.

Practitioner and pharmacy channels. Vaidyas prescribe Ayurvedic medicines. If your channel is practitioners, dispensaries or Ayurvedic pharmacies, the medicine framework is what that channel expects.

Credibility with the traditional customer. A substantial Indian audience reads “Ayurvedic medicine, licensed by the State AYUSH department” as more serious than “food supplement”. That perception has commercial value.

Classical dosage forms. Asava, arishta, bhasma, guggulu, taila, avaleha, these do not fit the food framework. Fermented asavas and arishtas in particular have no sensible FSSAI home.

AYUSH-specific schemes and export promotion exist for the sector and are worth knowing about.

Where the difference does not much matter

A single-herb powder or capsule, plain ashwagandha, plain triphala, plain moringa, sold on general wellness positioning to retail customers, works adequately under either route. Most brands in that position choose FSSAI for speed, and nothing is lost.

And here is what matters more than the route, in practice: the claims you actually make. We have seen AYUSH-licensed products whose advertising breaches the Magic Remedies Act, and FSSAI products whose copy makes clear disease claims. The licence does not protect bad copy. Enforcement, when it comes, looks at what you said.

How to decide, a practical sequence

1. What is in it? Vitamins, minerals, probiotics, amino acids, collagen, modern extracts → FSSAI. Only classical herbs, in a classical dosage form → AYUSH. Mixed → the balance decides, and ask a consultant.

2. Is it a classical formulation? If yes, AYUSH. Do not sell a classical formulation as a food supplement.

3. What does the copy need to say? Needs to name a condition → AYUSH, and then check the Magic Remedies Act for that specific condition. General wellness is enough → FSSAI.

4. Which channel? Practitioners, dispensaries, Ayurvedic pharmacies → AYUSH. E-commerce, modern trade, D2C → FSSAI.

5. Export? Yes → FSSAI, usually.

6. How fast? Launching this quarter → FSSAI is more likely to make it.

7. What is the dosage form? Asava, arishta, bhasma, guggulu, taila → AYUSH; there is no choice here.

Practical notes

Running both. Many established brands hold both licences and place each product on the route that suits it. For a contract-manufactured brand this costs you little, since the licences sit with the manufacturer. This is the usual arrangement for a growing range.

Loan licence versus own manufacturing. Most new brands manufacture at a licensed facility under a loan licence or on contract rather than building their own. That gets you to market without the capital and the GMP obligations, and the manufacturer’s licences cover the production.

Do not switch routes after printing artwork. Label requirements differ substantially, and a route change means new artwork, new approvals and written-off stock.

State variation is real. AYUSH licensing is administered by states and both interpretation and timelines vary. Your manufacturer’s state matters.

Get the licence before the artwork. The route determines mandatory label elements, declarations, warnings and how the product may be described. Designing first and licensing second produces expensive reprints.

What we ask of clients either way

We manufacture under both routes, and our position on claims does not change with the licence.

We decline artwork claiming to cure or treat disease where the licence does not support it, anything within the Magic Remedies Act’s restricted schedule, and before-and-after imagery that makes a claim the words avoid. Regulators read pictures.

We require the mandatory declarations for the route, a real name and address, batch and expiry, and a referral line where the category warrants one.

This occasionally costs us an order. It is the trade we have chosen, partly because enforcement in this sector has been tightening and a brand built on claims it cannot defend is a brand with a deadline.

The short version

FSSAI if your product contains vitamins, minerals or modern nutrients, sells through e-commerce or modern trade, needs to launch quickly, or is headed for export. General wellness claims only, no disease claims.

AYUSH if it is a classical formulation, uses a classical dosage form, sells through practitioners, or needs to reference a condition. Longer timeline, state-administered, more documentation for proprietary formulations.

And either way: the Drugs and Magic Remedies Act restricts advertising for a schedule of conditions regardless of licence, and the licence does not protect copy that overclaims. Decide the route before you design the label.

Detail on the licences themselves: licences for Ayurvedic manufacturing and supplement label compliance in India.