India’s cosmetic industry is rapidly expanding, and both local manufacturers and international brands are entering the market. But before any product can be sold legally, businesses should understand whether it requires cosmetic registration in India or a cosmetic manufacturing license.
This difference is important because the wrong point of view may result in customs seizures, product recall or punishment. In this blog, we clarify which cosmetic products require registration or a license under the Drugs and Cosmetics Act, 1940 and Cosmetic Rules, 2020, with examples of the real world.
What Is Cosmetic Under Indian Law?
A cosmetic is defined as:
Any article intended to be rubbed, poured, sprinkled, sprayed on, or applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.
Examples of cosmetics:
- Lipsticks, lip glosses, and balms
- Creams, lotions, moisturisers, and serums
- Perfumes and deodorants
- Hair dyes, shampoos, conditioners
- Nail polish, mascara, kajal, eyeliner
Example: A fairness cream marketed for “beautifying skin” is a cosmetic. But if the claim is “cures skin disease,” it becomes a drug requiring a different approval.
Cosmetic Registration vs Licence – The Key Difference
| Scenario | Requirement | Authority |
| Manufacture of cosmetics in India | Cosmetic manufacturing licence | State Licensing Authority |
| Import of cosmetics into India | CDSCO cosmetic registration certificate (Form 42 → Form 43) | CDSCO (Central Drugs Standard Control Organisation) |
When Does a Cosmetic Require a Licence?
If you create cosmetics in India, you will have to get a manufacturing license from the State Licensing Authority.
Key conditions for the licence:
- Manufacturing sites should follow good manufacturing practices (GMP).
- Products should meet the standards in the Ninth Schedule of 2020.
- Packaging and labelling should follow legal metro (packaged commodities) rules.
Example: A Delhi-based company producing herbal shampoo should secure a cosmetic manufacturing license before sale.
When Does A Cosmetic Require Registration?
If a cosmetic is imported into India, it requires CDSCO cosmetic registration before import.
Key points for CDSCO cosmetic registration:
- Each variant, shade, pack size, and manufacturing site must be registered.
- Application filed in Form 42; approval is issued in Form 43.
- Documents required include the ingredient list, Free Sale Certificate, and manufacturer’s licence.
Example: A Korean sheet mask or a US brand lipstick must get an imported cosmetics registration before customs clearance in India.
Exemptions from Registration/Licence
Certain scenarios do not require cosmetic registration in India:
- Small quantities imported for R&D, testing, or stability studies.
- Cosmetics imported in bulk for 100% export (repackaging only), with proper undertakings to CDSCO.
- Non-commercial samples for trials and demonstrations.
Special Note on Sunscreens and BIS
- In India, sunscreens are generally regulated as cosmetics, unless they make therapeutic claims like “cures sunburn.”
- BIS certification is not mandatory for most cosmetics. It only applies if specifically notified (e.g., some hair dyes).
Common Mistakes to Avoid
- Wrong classification – treating a drug-like product as a cosmetic.
- Non-compliant labelling – missing expiry date, MRP, or importer details.
- Ignoring ingredient restrictions – using banned chemicals such as mercury.
- Skipping pack-size registration – each SKU needs separate approval.
International Comparison
- USA: Cosmetics do not require pre-market approval; The FDA has voluntary registration programs.
- EU: Compulsory CPNP notification before sale; Safety assessment report is required.
- India: Licence for local manufacture + registration for imports.
Thus, India’s system is stricter than the US but closely aligned with the EU.
Conclusion
To summarise:
- Manufactured in India? → Apply for a cosmetic manufacturing licence.
- Imported into India? → Obtain a CDSCO cosmetic registration certificate.
- For R&D or export-only? → May be exempt with CDSCO permission.
Staying compliant ensures smooth market entry, protects your brand reputation, and avoids legal issues.
At ELT Corporate, we provide end-to-end support for cosmetic registration in India, dossier preparation, CDSCO approvals, and compliance audits.
Need help with a cosmetic licence or registration? Contact us +91 85859 19582 today to simplify your compliance journey.
