FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
Cosmetic registration and manufacturing licence (India)
Do I need an import registration or a manufacturing licence — and who issues it?
What this route requires
Cosmetics in India are regulated under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. Which approval you need turns on one question: whether the product is imported or made in India. The two routes go to different authorities and produce different documents.
Imported cosmetics need a registration certificate before they can enter. The application is made in Form COS-1 to the Central Licensing Authority — CDSCO — through its online portal, and the certificate is granted in Form COS-2, held against the brand and covering the products and variants listed on it.
Cosmetics manufactured in India are licensed by the State Licensing Authority instead, applied for in Form COS-5 and granted in Form COS-8. Here the premises are assessed, not only the product.
Two requirements catch importers repeatedly. India prohibits testing cosmetics on animals and the import of cosmetics that have been tested on animals. And Indian labelling carries mandatory particulars that a product compliant in its home market will usually not already display — which is a packaging problem, and therefore a lead-time problem.
Applies to
Brand owners, importers and manufacturers placing cosmetics or personal care products on the Indian market.
Our scope
How Prequel supports it
- Establish whether you need import registration or a manufacturing licence, and which authority applies
- Assemble the Form COS-1 dossier: composition, specifications, manufacturer authorisation and supporting documentation
- Review labelling against the mandatory particulars the Rules require
- Assess claims and flag any wording that would move the product into drug licensing
- Coordinate the submission and manage queries through to grant
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 Cosmetics — India 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.