Grooming Products Online: Cosmetic or Drug
A beard oil is a cosmetic, a beard growth serum may be a drug, and an Ayurvedic oil is a third thing. The claim on the pack decides which statute, which licence and which form you are filing.
- Classification runs on the claim, not the formulation. CDSCO's cosmetics FAQ states that a product carrying a drug claim on its label or literature falls outside the section 3(aaa) definition and cannot be registered as a cosmetic, and rule 36 of the Cosmetics Rules, 2020 separately bars any claim that is false or misleading.
- Manufacture is a state licence and import is a central registration. Form COS-5 or COS-6 goes to the State Licensing Authority and is granted in Form COS-8 or COS-9. Form COS-1 goes to the Drugs Controller General of India and is granted in Form COS-2. Both run in perpetuity subject to a retention fee paid before five years.
- The Ninth Schedule names thirty seven finished cosmetics against BIS standards, including shaving creams IS 9740, shaving soap IS 5784, aftershave lotion IS 9255 and hair oils IS 7123. Beard oil, face wash, body wash and deodorant are not named, so rule 39(1) sends them to the other standards applicable to them.
- Form COS-8 is granted and priced per item within a category, at Rs 10,000 for up to ten items of a category and Rs 500 for each additional item. A licence that covers your category but not your newest SKU is the most common marketplace audit failure in this lane.
A beard oil that conditions, a beard serum that claims to grow hair, and a herbal beard oil sold as an Ayurvedic preparation are three products under three licensing regimes. Nothing on the shelf tells them apart. The claim on the pack does.
The AYUSH track is set out in selling Ayurvedic products online and the advertising prohibitions in Ayurvedic product claims and advertising. This post takes the cosmetic door and the line that separates it from a drug.
The definition does the work
Section 3(aaa) of the Drugs and Cosmetics Act, 1940 defines a cosmetic as an article intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance, including any article intended for use as a component of a cosmetic.
The Cosmetics Rules, 2020 were made under sections 12 and 33 of that Act and notified as G.S.R. 763(E), and rule 2 applies them to a cosmetic as so defined. The Drugs, Medical Devices and Cosmetics Bill drafted in 2023 to replace the Act has not been enacted.
CDSCO’s position on the boundary is flat. Its cosmetics FAQ says a product carrying a drug claim on label or literature cannot be registered as a cosmetic, because cosmetic and drug are defined separately under section 3, which puts a drug claim outside the cosmetic definition. Rule 36 adds the second gate: no cosmetic may claim or convey any idea false or misleading to the intending user. Your formulation does not decide your regime, your claim does.
A beard oil that conditions sits inside section 3(aaa). A serum promising to regrow hair asserts something about a body process, and that claim closes the cosmetic door before anyone reads the ingredient list.
Where the Fourth Schedule draws its own lines
The Fourth Schedule, referred to in rule 12(6), lists the categories of cosmetics for import and is the most useful classification map in the rules. Entry 24 is shaving products, entry 25 pre-shave and after-shave products, entry 18 chemical depilatories. Entries 22 and 23 split deodorants by antiperspirant activity. Entry 47 is scalp and hair roots care, entry 48 anti hair loss products, entry 50 antidandruff products.
That last pair is the one operators misread. Anti hair loss and antidandruff are named cosmetic categories in CDSCO’s own list, but a category existing does not license the claim. Rule 36 and the section 3 drug definition still police what the pack says the product does.
Manufacture is a state licence, import is a central registration
Under rule 23, anyone intending to manufacture cosmetics applies to the State Licensing Authority in Form COS-5 for a licence or Form COS-6 for a loan licence, and rule 25 grants them in Form COS-8 and Form COS-9. Rule 3(p) defines a loan licence as one to manufacture on another licensee’s site, the structure most Indian grooming brands are in.
Rule 23(4) requires a self declaration in Form COS-7 on good manufacturing practices and the Seventh Schedule premises requirements. Rule 23(5) gives forty five days to grant, and rule 23(8) deems the licence valid if the inspection rule 23(7) requires within thirty days does not happen. Rule 24 requires a separate licence per premises, and rule 30 makes it perpetual subject to a retention fee paid before five years. Under the Third Schedule a Form COS-8 licence is Rs 10,000 for up to ten items of each category and Rs 500 for each additional item.
Import runs on a different authority. Rule 12(1) bars import unless the product is registered by the Central Licensing Authority, identified at rule 3(f) as the Drugs Controller General of India. The application is Form COS-1, filed by the manufacturer, an authorised agent, the importer or an Indian subsidiary. Rule 13(1) gives six months to grant the certificate in Form COS-2 or reject with written reasons, and rule 14 makes it perpetual on the same five year retention fee. The Third Schedule prices it in dollars: USD 1,000 per category, USD 50 per variant and USD 500 per manufacturing site.
The Ninth Schedule names your product, or it does not
Rule 39(1) requires a cosmetic to meet the Ninth Schedule specification, and where it is not in that schedule, the rules and the standards applicable to it in the country of origin. The schedule lists thirty seven finished cosmetics against Indian Standards. Shaving creams are IS 9740, shaving soap IS 5784, aftershave lotion IS 9255, hair oils IS 7123, hair creams IS 7679, shampoo IS 7884, pomades and brilliantines IS 9339, skin creams IS 6608.
Now read it for absences. Beard oil, beard balm, face wash, body wash, deodorant, hair serum and hair wax are not named. A beard oil is a hair oil in substance, which makes IS 7123 a live question, and the answer changes the test panel your contract manufacturer runs. The schedule also notes that a new or amended BIS standard becomes mandatory six months after publication.
Rule 39 carries the composition limits. Hexachlorophene is barred except in soaps up to one per cent by weight with the prescribed caution. Lead and arsenic compounds are prohibited as colourants and no animal may be used for testing. Rule 37 puts a prescribed patch test caution on both labels of any hair dye containing paraphenylenediamine, in English and local languages, which catches every beard colour.
What a marketplace reviewer actually opens
The general audit file is covered in product safety documents for a marketplace audit, the onboarding list in the marketplace document checklist, and pack declarations in legal metrology labelling. What is specific here is small.
For a domestic SKU the reviewer wants the Form COS-8 in the manufacturer’s name with your item inside a category it covers, and the manufacturing licence number on the pack preceded by M or M.L. No. under rule 34(2)(b) matching it. For an import they want the Form COS-2 and the registration certificate number on the unit pack preceded by RC or RC No. under rule 34(5). Rule 34(9) allows India specific labelling to be stickered at a bonded warehouse.
The common failure is not a missing licence. It is a licence that covers your category but not your newest item, because Form COS-8 is granted and priced per item within a category. Rule 34(2)(a) adds batch marking, preceded by B or Batch No., with the month and year of manufacture instead on soaps. Tracing that back is covered in batch code traceability.