FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
BIS certification and Indian Standards conformity
Does my product need a BIS licence, and against which Indian Standard?
What this route requires
The Bureau of Indian Standards publishes Indian Standards and runs certification schemes against them. For some products certification is voluntary; for others it is mandatory, and the product cannot lawfully be sold without it.
Which standard governs a product is not always obvious, and testing has to be carried out in a laboratory BIS recognises for that standard — so the standard determines the laboratory, not the other way round.
Where a mandatory scheme applies, leaving certification late is expensive: the testing and the factory assessment both sit on the critical path to launch.
Applies to
Manufacturers and importers placing products in India that fall under a BIS certification scheme.
Our scope
How Prequel supports it
- Determine whether the product falls under a mandatory or voluntary scheme
- Identify the applicable Indian Standard or standards
- Build the testing plan and place it with a recognised laboratory
- Prepare the licence application and supporting documentation
- Support the factory assessment and query responses
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.
AYUSH — ASU products
What licence does an Ayurvedic or herbal product need, and who issues it?
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
Not sure BIS certification 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.