Indian Manufacturer
Manufacturing cosmetics in India is licensed at the state level under Rule 32, with Schedule M setting the mandatory GMP standard for your premises and processes. CDSCO does not issue manufacturing licenses for domestic cosmetics production.
Your compliance journey
Apply to State Licensing Authority
The COS-8 application is filed with the State Licensing Authority (Drugs Controller of your state), not with CDSCO; filing with CDSCO is a procedural error that will not result in a valid license.
Achieve Schedule M GMP Compliance
Your manufacturing premises, equipment, processes, and quality systems must meet the requirements of Schedule M under Cosmetics Rules 2020 before inspection; non-compliant premises fail the licensing inspection.
Complete BIS Testing for Notified Products
Products notified under BIS—including shampoos, skin creams, and hair oils covered by IS 4707 series standards—require BIS certification before sale; this is separate from the COS-8 process.
Verify INC Nomenclature on Labels
All ingredients on the label must be declared in INCI nomenclature as required by IS 4707 and Cosmetics Rules 2020 Second Schedule; trade names or chemical names are not compliant.
Confirm Rule 36 Classification
Before manufacturing any product with active claims—depigmenting, anti-hair loss, anti-dandruff—confirm it is not reclassified as a drug under Rule 36 of the Drugs and Cosmetics Act 1940, which would require a Drug License instead.
Comply with Legal Metrology on Pack
All pre-packed cosmetics must declare net quantity, MRP, and manufacturer address per Legal Metrology (Packaged Commodities) Rules 2011 Rule 6; domestic manufacturers are not exempt from these requirements.
Apply to State Licensing Authority
The COS-8 application is filed with the State Licensing Authority (Drugs Controller of your state), not with CDSCO; filing with CDSCO is a procedural error that will not result in a valid license.
Achieve Schedule M GMP Compliance
Your manufacturing premises, equipment, processes, and quality systems must meet the requirements of Schedule M under Cosmetics Rules 2020 before inspection; non-compliant premises fail the licensing inspection.
Complete BIS Testing for Notified Products
Products notified under BIS—including shampoos, skin creams, and hair oils covered by IS 4707 series standards—require BIS certification before sale; this is separate from the COS-8 process.
Verify INC Nomenclature on Labels
All ingredients on the label must be declared in INCI nomenclature as required by IS 4707 and Cosmetics Rules 2020 Second Schedule; trade names or chemical names are not compliant.
Confirm Rule 36 Classification
Before manufacturing any product with active claims—depigmenting, anti-hair loss, anti-dandruff—confirm it is not reclassified as a drug under Rule 36 of the Drugs and Cosmetics Act 1940, which would require a Drug License instead.
Comply with Legal Metrology on Pack
All pre-packed cosmetics must declare net quantity, MRP, and manufacturer address per Legal Metrology (Packaged Commodities) Rules 2011 Rule 6; domestic manufacturers are not exempt from these requirements.
What you need
Avoid these pitfalls
Submitting the COS-8 application to CDSCO instead of the State Licensing Authority (State Drugs Controller), which has no jurisdiction to issue COS-8 under Cosmetics Rules 2020 Rule 32.
Presenting premises for licensing inspection before achieving Schedule M GMP compliance, resulting in a failed inspection and requiring a re-inspection after corrective action.
Manufacturing a product with claims that trigger Rule 36 drug reclassification—such as anti-hair loss or fairness actives at therapeutic concentrations—without first confirming cosmetic classification, exposing the manufacturer to prosecution under the Drugs and Cosmetics Act 1940.
Declaring ingredients on the label using trade names or chemical nomenclature instead of INCI names as required by IS 4707 and Cosmetics Rules 2020, resulting in non-compliant labelling across the entire production run.
Omitting mandatory net quantity or MRP declarations from domestic pack labels, in violation of Legal Metrology (Packaged Commodities) Rules 2011 Rule 6(1)(d) and Rule 6(1)(e).
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Free resource
India Cosmetics Import Checklist 2025 — free download