Cosmetic or Ayurvedic medicine: start with the licence
In India the word "Ayurvedic" on a pack can mean two different legal products. A cosmetic is made under a licence granted by the State Licensing Authority in Form COS-8 under the Cosmetics Rules, 2020 (applied for in Form COS-5; a loan licence to make at another maker's plant is applied for in Form COS-6 and granted in Form COS-9), with named technical staff. An Ayurvedic medicine, including many medicated hair oils, is licensed separately under the Drugs and Cosmetics Rules, 1945, usually in Form 25-D. The same factory may hold both.
The importing country decides what the product is in your market, not the Indian licence. A hair oil made as an Ayurvedic medicine in India can still be sold as a cosmetic abroad if its formula and claims fit, and a product licensed as a cosmetic in India becomes a drug abroad if its label makes drug claims. The inspector asks to see the licence and checks that your product appears on it, because it shows which rules the plant works under and who signs off its batches.
Rule 34(10) of the Cosmetics Rules also applies to exports: labels follow the importing country's law, but the inner and outer packs must still show the product name, a batch number preceded by "B", any use-before date, the manufacturer's name and premises and the licence number, unless the buyer asks for a code number approved by the State Licensing Authority instead of the maker's name.
The claim line between cosmetic and drug
Herbal products are sold on their benefits, and that is where they cross the line. In the US, FDA classes a product by its intended use: cleansing, beautifying or changing appearance is cosmetic; treating or preventing disease, or affecting the structure or function of the body, is a drug. FDA names "restore hair growth" as a drug claim, and a scent claimed to help sleep is a drug too. In the EU, claims must meet the six common criteria in Regulation 655/2013, from truthfulness to evidential support, and a product presented as treating disease is regulated as a medicine.
| Wording on the pack | Why it needs review |
|---|---|
| "Stops hair fall", "regrows hair" | Hair growth and hair loss claims are drug claims in the US |
| "Heals acne", "cures dandruff", "treats eczema" | Treating a condition is a drug claim; in the US an anti-dandruff shampoo is a drug as well as a cosmetic |
| "Relieves headache", "helps you sleep" | Effect on the body, not on appearance |
| "Chemical-free", "100% natural" | Must be truthful and supported by evidence under the EU common criteria |
| "Approved by", "certified" with a government logo | EU claims rules bar suggesting authority approval |
The inspector does not judge the law. We compare each pack with the wording your regulatory adviser approved for that market and report any difference, including on inserts, cartons and stickers.
What we check on herbal and Ayurvedic cosmetics
| Check | How it is checked | What fails |
|---|---|---|
| Hair oil fill and leaks | Net weight on a calibrated scale; bottles inverted and squeezed; flip-top and pump function | Short fill, oil at the cap, flip-tops that do not close |
| Herb sediment | Bottles held to the light; sediment against the sample | Heavy or uneven sediment, floating plant matter where none is specified |
| Creams and balms | Jars opened on a sample: fill, surface, separation, odour | Oil separation, dry or cracked surface, mould spots, rancid odour |
| Powders and face packs | Pouch weight, seal strength, colour and lumps against the sample | Caked powder, open seals, insects or foreign matter |
| Tamper evidence | Induction seals, shrink bands, sealed cartons | Missing or loose seals |
| Dates and codes | Batch code, manufacturing date, expiry or period-after-opening symbol on unit and carton | Missing or illegible dates, codes that differ between unit and carton |
| Labels and claims | Every panel against approved artwork per market, including the ingredient list | Unapproved claims, missing warnings, wrong responsible person |
| Licence and retained samples | Licence copy checked for the product; factory's retained samples for the batch confirmed | Product not on the licence; no retained sample kept |
Heavy metals and the tests that matter
FDA warns that some unapproved Ayurvedic products have contained harmful levels of lead, mercury or arsenic, which are not shown on the label. Those warnings concern medicines taken by mouth, but buyers of Ayurvedic cosmetics test for the same metals because herbs, minerals and mined colours can carry them. Rules to know:
- US. FDA guidance recommends no more than 10 ppm lead as an impurity in lip products and externally applied cosmetics. FDA states that kohl, kajal and surma are not approved colour additives, so they cannot legally be sold as cosmetics in the US.
- EU. Lead, arsenic, cadmium and mercury and their compounds are listed as prohibited substances in Annex II of the Cosmetics Regulation, with narrow exceptions for two mercury preservatives in eye products. Article 17 tolerates only traces that are technically unavoidable in good manufacturing practice and do not make the product unsafe.
- India. The Cosmetics Rules limit unintentional mercury in finished cosmetics, other than eye products, to 1 ppm and ban lead and arsenic compounds as colourants.
Samples drawn at random and sealed with numbered tape go to an accredited lab for heavy metals by ICP-MS, microbiology and, where your safety assessor asks, preservative efficacy, through lab testing coordination.
Common herbal and Ayurvedic cosmetics defects and how they are classed
| Defect | Typical cause | Class |
|---|---|---|
| Drug claim on a pack sold as a cosmetic | Indian-market artwork reused for export | Critical |
| Lab result over the agreed heavy-metal limit | Contaminated herb or mineral ingredient | Critical |
| Kajal or kohl in a US order | Product range not screened per market | Critical |
| Leaking hair oil bottles | Cap liner missing, neck finish mismatch | Major |
| Mould or separation in creams | Weak preservation, hot storage | Major |
| Missing expiry or batch code | Coding machine skipped units | Major |
| Label slightly off-centre | Hand labelling | Minor |
Your defect list decides the final class.
Packing and your purchase order
Hair oils travel best with an induction seal or inner plug under the cap and in divided cartons; creams with herbal extracts need protection from heat in the container. The inspector checks seals, upright packing and carton marks, and that no stock from an earlier batch is mixed into the lot.
- Formula reference and the licence under which it is made.
- Claims approved per market, and the full artwork set, including inserts.
- Expiry or period after opening, and batch code format.
- Heavy-metal, microbiology and other lab limits, and the lab.
- Pack, closure and seal specification; fill and tolerance.
- Number of sealed samples per batch and retained samples at the factory.
Herbal hair colours are covered on the henna and mehndi page. Book an inspection.
Sources
- CDSCO: Cosmetics Rules, 2020
- FDA: Is it a cosmetic, a drug, or both? (Or is it soap?)
- FDA: Heavy metal poisoning and certain unapproved Ayurvedic drug products
- FDA: Lead in cosmetics
- FDA: Kohl, kajal, al-kahal, surma, tiro, tozali or kwalli
- Regulation (EC) No 1223/2009 on cosmetic products (EUR-Lex)
- Commission Regulation (EU) No 655/2013, common criteria for cosmetic claims (EUR-Lex)