Herbal Supplements in India: AYUSH (Ayurvedic) Route vs FSSAI Nutraceutical Route

In India, a herbal product built on ingredients such as ashwagandha, turmeric or moringa can follow either the AYUSH route, as an Ayurvedic product regulated under drug law, or the FSSAI route, as a health supplement or nutraceutical regulated as food. Which route applies depends on the formula, its basis in classical texts or food science, the dose form and above all the claims, so classification should be settled with a regulatory check before formulation and label design.

Ayurveda brands, wellness start-ups and importers sourcing Indian botanicals often assume a herb's identity decides its category. It does not. The same plant can appear in an Ayurvedic proprietary medicine and in a food supplement, under different rules, licences and labels. As a nutraceutical manufacturer in India whose facility is both FSSAI licensed for nutraceuticals and AYUSH licensed, we see both routes, and this guide explains the general principles. It is not legal advice; confirm classification for your specific product with a regulatory adviser.

The two routes in outline

Factor	AYUSH (Ayurvedic) route	FSSAI (nutraceutical) route
Legal framework	Ayurvedic, Siddha and Unani drugs under the Drugs and Cosmetics Act, 1940 and its rules	Food law, including the FSSAI regulations for health supplements and nutraceuticals
Nature of product	A medicine within the Ayurvedic system	A food that supplements the normal diet
Basis of formula	Classical texts or proprietary formulations using ingredients from authoritative Ayurvedic texts	Permitted ingredients from FSSAI schedules, within limits
Licensing	Manufacturing licence from the state licensing authority for AYUSH drugs	FSSAI licence covering nutraceutical manufacture
Claims	Indications consistent with the Ayurvedic system and relevant texts, subject to the rules on advertising	No disease or medicinal claims; only permitted, substantiated wellbeing or nutrient-function statements
Label identity	Ayurvedic medicine labelling requirements	"Health Supplement" or "Nutraceutical" with food label requirements, including a not-for-medicinal-use statement

What decides the classification

1. Claims and intended use

This is usually decisive. If the product is presented as treating, mitigating or preventing a disease or condition, it is moving into medicine territory, and in India that points to the AYUSH route for an Ayurvedic product. A food supplement must not make such claims at all. If your marketing plan depends on talking about specific conditions, a food supplement is the wrong category.

2. Basis of the formulation

Ayurvedic products draw on classical texts and the Ayurvedic understanding of ingredients, processing and dose. A formula built on that basis, with Ayurvedic preparation methods or nomenclature, fits more naturally into the AYUSH framework. A formula built on standardised extracts selected for nutritional or physiological reasons, and described in food terms, fits the nutraceutical route.

3. Ingredients, parts and forms

FSSAI's schedules list permitted plants and botanicals by name, plant part and form, sometimes with conditions. An ingredient, part or extract type that is not listed cannot simply be used in a food supplement. Equally, some substances used in Ayurvedic practice have no place in a food product at all.

4. Dose and dose form

Both routes use capsules, tablets, powders and liquids, so dose form alone rarely decides. But a level of an ingredient that goes beyond what food rules permit can push a product out of the food category.

5. Presentation

Product name, imagery, Ayurvedic terminology and the overall impression all matter. A product labelled as a food supplement but marketed with medicinal language sends mixed signals that regulators may resolve against you.

Worked examples, in general terms

• Ashwagandha. Widely used in Ayurvedic formulations and also listed among botanicals used in supplements. As a supplement, the permitted part and extract type matter, claims must stay within food rules, and there have been regulatory discussions about which plant parts are acceptable, so check the current position closely. As an Ayurvedic product, it follows AYUSH licensing and labelling.
• Turmeric. A common culinary ingredient and an Ayurvedic herb. In a food supplement, turmeric or curcumin extracts must be permitted forms within limits, with no disease claims. In an Ayurvedic proprietary product, it follows the AYUSH framework.
• Moringa. Often positioned as a nutrient-dense plant food, which suits food supplement and greens-powder formats, provided the part and form are permitted and claims stay nutritional.

Rules on individual botanicals change, and export markets have their own views; for example, some botanicals familiar in India need separate authorisation in the EU. See our guide to exporting supplements from India.

The common thread is that the herb alone never settles the question. Two products with the same headline ingredient can sit in different categories because one is described in food terms and the other is presented as an Ayurvedic medicine.

Choosing the right route for your brand

1. Start with what you want to say. Write your intended claims and positioning first, then see which framework permits them.
2. Check each ingredient. Confirm the plant, part and form are permitted in the chosen route and in each target market.
3. Consider your channels. Retail, pharmacy, marketplaces and export partners may treat the two categories differently.
4. Consider export plans. Overseas markets classify products under their own rules, not India's.
5. Get a regulatory check before formulation is locked and before artwork is drawn.

Our overview of FSSAI rules for health supplements covers the food route in more detail.

Quality matters on both routes

Botanical ingredients vary with source, harvest and processing, so identity, quality and contaminant checks on raw materials matter whichever route you choose. Standardised extracts help give batch-to-batch consistency. Learn about our testing and quality approach and our certifications.

Common mistakes with herbal products

• Labelling a product as a health supplement while marketing it with Ayurvedic disease indications.
• Using a plant part or extract type that is not on the permitted list for the chosen route.
• Assuming that a traditional use automatically supports a food claim.
• Designing packaging before classification is confirmed, then having to reprint.
• Forgetting that export markets will classify the same product under their own rules.

Most of these are avoided by deciding the route, the claims and the ingredient list together at the start of the project.

Herbal products at Harrods Health

Harrods Health manufactures nutraceuticals and health supplements in-house under an FSSAI licence for nutraceuticals, and the facility is also ISO certified, GMP-compliant, Halal certified, AYUSH licensed and US FDA registered. We offer ready formulas and custom herbal formulation in capsules, tablets, powders, gummies, liquids, syrups and drops, with packaging and label design, samples before you order and a single account manager. We will discuss the likely route for your product, and recommend independent regulatory confirmation before launch.

Frequently asked questions

Can ashwagandha be sold as a food supplement in India?

It can be used in food supplements where the plant part, form and level meet the current FSSAI schedules and claims stay within food rules. Check the latest position, as rules on botanicals are reviewed from time to time.

Can a nutraceutical make Ayurvedic claims?

No. A food supplement cannot make medicinal or disease claims, including those framed in Ayurvedic terms. If those claims are essential, the AYUSH route may be more appropriate.

Which route is faster to market?

It depends on the product, the licences already in place and the claims. A food supplement using only permitted ingredients avoids product-level approval in many cases, but every product still needs full compliance.

Does the same facility need different licences for each route?

Yes. Food supplements need an FSSAI licence covering nutraceuticals, while Ayurvedic products need an AYUSH manufacturing licence.

Developing a herbal range? Talk to our private label supplement manufacturing team.