FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
AYUSH licensing for Ayurvedic, Siddha and Unani products
What licence does an Ayurvedic or herbal product need, and who issues it?
What this route requires
Ayurvedic, Siddha and Unani medicines are regulated under the Drugs and Cosmetics Act, 1940 and the rules made under it, with the Ministry of AYUSH setting policy and State Licensing Authorities issuing manufacturing licences.
Whether the formulation is classical — appearing in an authoritative text listed in the Act — or a patent or proprietary medicine changes what evidence the application must carry, and what may be claimed for the product.
Premises and processes are assessed against the Good Manufacturing Practice requirements in Schedule T, which is frequently where an otherwise sound application stalls.
Applies to
Manufacturers and marketers of Ayurvedic, Siddha, Unani and other AYUSH products in India.
Our scope
How Prequel supports it
- Establish whether the formulation is classical or patent/proprietary, and what that implies for the application
- Assess premises and processes against Schedule T GMP
- Compile the licence application and supporting formulation evidence
- Prepare label and claim wording consistent with the approved basis
- Coordinate with the State Licensing Authority through to a decision
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 AYUSH — ASU products 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.