Cosmetics — India
Do I need an import registration or a manufacturing licence — and who issues it?
Cosmetics & personal care
What does it take to put this cosmetic on the Indian market?
How this sector is regulated
Cosmetics in India are regulated under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. Imported products need a registration certificate from CDSCO as the Central Licensing Authority — applied for in Form COS-1, granted in Form COS-2. Products manufactured in India are licensed instead by the State Licensing Authority, in Form COS-5 and COS-8, where the premises are assessed as well as the product.
The Rules govern composition, labelling and claims. Ingredient restrictions and heavy-metal limits apply, standards for particular product types sit in the schedules to the Rules, and some categories carry Bureau of Indian Standards specifications on top.
India also prohibits testing cosmetics on animals, and prohibits importing cosmetics that have been tested on animals. For a brand entering from a market where that testing is routine, this is a supply-chain question rather than a paperwork one, and it is better answered early.
Where programmes usually lose time
Cosmetic, or drug by accident
The line between a cosmetic and a drug is drawn by intended use, and claims are how intended use gets expressed. Language about repairing, restoring or treating the skin can move a product across that line, taking it out of the cosmetic route and into a licensing pathway that was never budgeted for.
Your route
Regulatory routes that apply here
Which one governs your product depends on its composition, its intended use and what you intend to claim.
BIS certification
Does my product need a BIS licence, and against which Indian Standard?
Delivery
The services behind that work
The route sets what has to be produced. These are the teams that produce it — the same functional capability we have run for CROs and sponsors for years.
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Medical Writing
Protocol/IB, CSR, narratives and statistical sections aligned to TA context.
Quality Assurance & Audits
Internal/vendor/site audits support, TMF health, deviation/CAPA tracking, inspection readiness.
Biostatistics & Programming
SAP, SDTM/ADaM mapping, TLF programming & QC; submission-ready outputs.
When people call us
Typical situations
Importing an existing range
A brand sold elsewhere needs COS-1 registration before anything can enter, and the dossier has to answer Indian requirements rather than the ones it was originally assembled for.
Manufacturing in India
You are producing locally and need the State Licensing Authority route — where the premises are assessed alongside the formulation.
Labelling that will not clear
Artwork is approved and in production, and nobody has checked it against the mandatory particulars the Indian Rules require. Caught late, this is a repackaging cost.
A claim that may not be cosmetic
Marketing has written something about repairing or restoring, and you need to know whether it keeps the product a cosmetic or turns it into a drug.
Animal-testing exposure
Part of the range was tested on animals in another market, and you need to understand what that means for what can be brought into India.
The limits of what we cover
Regulatory strategy, registration and licensing dossiers, labelling review and claims assessment are done by our own team. Safety assessment and analytical testing are carried out by qualified laboratories under our scope and review — the same way we handle testing across every category — and we name the laboratory before work starts.
Other sectors we work in
Nutraceuticals
FSSAI category and claims work for supplements, functional foods and foods for special dietary use.
Medical Devices
Classification, risk management, technical documentation and quality systems for CDSCO and EU routes.
Pharmaceuticals
Clinical trial approval, study execution and the full functional stack — our longest-running capability.
Working on a cosmetic product?
Send us the product, the claims you want to make and the market you are going to. We will come back on the route and the evidence it needs — before anyone commissions a test.