AYUSH — ASU products
What licence does an Ayurvedic or herbal product need, and who issues it?
FSSAI licensing and claims for nutraceuticals and health supplements
Can I sell this as a health supplement, and what am I allowed to claim on the label?
What this route requires
FSSAI regulates health supplements, nutraceuticals and foods for special dietary use under the Food Safety and Standards Act, 2006 and the 2016 regulations made under it. Those regulations define the permitted product categories, which ingredients may be used in each, and the limits that apply.
Most of the commercial risk sits in the claim rather than the formulation. Claims must be substantiated before they are made, and a claim that strays into preventing, treating or curing a condition takes the product out of food regulation and into drug regulation — a different authority, a different evidence bar, and a different timeline.
Which licence you need depends on scale, and on whether you manufacture, import, or only market the product.
Applies to
Manufacturers, importers and marketers of health supplements, nutraceuticals and foods for special dietary use in India.
Our scope
How Prequel supports it
- Confirm the product category and whether the formulation sits within permitted ingredients and limits
- Assess intended claims, and flag any that would reclassify the product as a drug
- Build the substantiation plan for the claims you intend to keep
- Prepare the licence application and product dossier
- Coordinate responses to FSSAI queries
Delivered by Prequel. Where a step needs a specialist partner — laboratory testing in particular — we define the scope and review the output, and we say so rather than implying it is in-house.
Other routes
Many programmes target more than one market. Evidence generated for one route can often support another, which is worth planning before testing starts rather than after.
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
Not sure FSSAI — Nutraceuticals is your route?
That is what the Readiness Assessment settles. Tell us the product, its intended use and your target market, and we will confirm the pathway before you commit to evidence.