A Cosmetic License is a mandatory approval issued by the Central Drugs Standard Control Organization (CDSCO) and State Drug Control Authorities for manufacturing, importing, or selling cosmetic products in India. It ensures compliance with the Drugs and Cosmetics Act, 1940, and its associated rules.

Importance of a Cosmetic License

• The production as well as distribution and import/export of cosmetics requires legal approval for conducting operations.

• Ensures product quality and safety standards.

• The expansion of markets becomes possible through legal operation in national and international market territories.

• Avoids penalties and business shutdowns due to non-compliance.

Types of Cosmetic Licenses in India

Manufacturing License (Form 32 & Form 32-A)

• Required for manufacturing or packaging cosmetics.

• Issued by State Drug Control Authorities.

• Form 32: For manufacturing cosmetics for sale.

• Form 32-A: For loan licenses (third-party manufacturing).

Import License (Form 42 & Form 43)

• Required for importing cosmetic products into India.

• Issued by CDSCO.

• Form 42: Application for import.

• Form 43: Issued as an import registration certificate.

Process for Obtaining a Cosmetic License

Manufacturing License Process

• Identify a GMP-compliant manufacturing unit.

• Prepare the necessary documents.

• Submit an application to the State Licensing Authority.

• Inspection by a Drug Inspector.

• Grant of Manufacturing License.

Import License Process

• Submit an online application on the CDSCO portal.

• Provide necessary documents and product details.

• CDSCO reviews and verifies the application.

• Approval is granted with a Form 43 Import License.

Documents Required for a Cosmetic License

• Company Incorporation Certificate.

• MOA & AOA (for companies).

• List of Directors/Partners.

• Manufacturing Site Layout Plan (for manufacturing license).

• Product Formulation & Ingredients List.

• Labeling Details as per BIS Standards.

• Quality Control & Safety Data.

• Import Registration Certificate (for imports).

• GMP & ISO Certificates (if applicable).

Validity & Renewal of Cosmetic License

• A cosmetic license is typically valid for 5 years.

• Renewal must be applied before expiration to avoid penalties.

Penalties for Non-Compliance

• Life-threatening consequences can affect businesses that operate without cosmetic manufacturing or sales licenses because they can face criminal sanctions and major financial penalties.

• The manufacturing or selling of unsafe products will result in product recalls together with market bans.

• Cancellation of license for repeated violations.

Conclusion

A Cosmetic License represents a fundamental requirement for any organization selling cosmetics throughout India. CDSCO and State Drug Authorities monitoring policies lead to the distribution of safe high-quality products to consumers.

To acquire assistance with Cosmetic License Registration contact a regulatory expert or a legal advisor.

Disclaimer

The information provided in this blog is purely for general informational purposes only. While every effort has been made to ensure the accuracy, reliability and completeness of the content presented, we make no representations or warranties of any kind, express or implied, for the same. 

We expressly disclaim any and all liability for any loss, damage or injury arising from or in connection with the use of or reliance on this information. This includes, but is not limited to, any direct, indirect, incidental, consequential or punitive damage.

Further, we reserve the right to make changes to the content at any time without prior notice. For specific advice tailored to your situation, we request you to get in touch with us.