Central Drugs Standard Control Organisation (CDSCO) stringently regulates all cosmetics being imported into India. Cosmetics cannot be imported into India without the cosmetics import registration certificate (COS 2 license). Only cosmetics products satisfying the cosmetics import regulations can be imported into India. As per Drugs & Cosmetics Act, 1940 and Rules, cosmetics imported into India is regulated by the Central Licensing Authority (CLA). Furthermore, the CLA grants the import registration certificate. Are you planning to import cosmetics into India? The cosmetics import regulations can be overwhelming to understand. We have prepared this guide to help you easily navigate the regulations for importing cosmetics into India.
CDSCO regulations for importing cosmetics into India
CDSCO has issued guidelines for registering imported cosmetics. Stringent regulations for importing cosmetics are in place to ensure consumer safety. The registration of imported cosmetic products has to be done under Rule 21. For ease of application for cosmetics import license, CDSCO has categorised cosmetics into approximately 80 product families. Furthermore, the CDSCO has issued “Guidelines to Registration of Imported Cosmetics”. The Column 3 of the guidelines present the categories of cosmetic products. The classification is based mainly on the intended use of the product and the region where the product will be applied. Accordingly, regulatory guidelines for import and registration of cosmetics have been formulated. Thus, for registering your imported cosmetics product in India, you need to ensure the product is identified under the right category with the right components. The product imported should comply with the guidelines for the registered category of your product.
License required to import cosmetics into India
To import cosmetics into India, you need to apply for the CDSCO cosmetics import license or the import registration certificate.
- COS-1: COS-1 form is used to file the application for the imported cosmetics registration.
- COS-2: CDSCO issues the COS-2 license for selling and distributing imported cosmetics products in India.
Who can apply for the CDSCO cosmetics import license (COS-2)?
- The manufacturer
- The authorised agent of the manufacturer
- Any other importer
- A subsidiary agent of the manufacturer
Top 7 restrictions for importing cosmetics
- Cosmetics cannot be imported, unless they comply with the specifications mentioned in the Ninth Schedule.
- Any item that violates the Drugs and Cosmetics Act, 1945, is strictly prohibited
- Cosmetics of subpar quality cannot be imported
- Cosmetics with straight-up false claims cannot be imported into India.
- If the product is not registered per the rules set by the CLA, it cannot be imported.
- Any cosmetic made with hexachlorophene, a mercury compound, or a compound containing lead and arsenic for colouring cannot be imported to India.
- Any cosmetics whose manufacture or development has involved animal testing at any point after 12th November 2014 cannot be imported into India.
Regulations for importing cosmetics: Labelling imported cosmetics products
Drugs & Cosmetics Act has laid down strict and clear guidelines for cosmetics product labels, which even imported products have to comply with. Compliance with Indian cosmetics labelling guidelines is required to market your product in online and offline marketplaces per CDSCO requirements. Additionally, some cosmetics labelling requirements are also mentioned in the Indian standards, such as BIS for cosmetics products. All cosmetics product labels need to adhere to Rule 129-H along with Part XV of Drugs and cosmetics Rules, 1945. We have discussed some of the labelling requirements as per the regulations for importing cosmetics.
- Specify the cosmetics product’s name along with the manufacturing address on both the inner and outer labels. In case the container is small in size, then the principal place of manufacturing and the pin code should be mentioned at least.
- The ingredients should be displayed on the outer label of the cosmetics products.
- The inner label should contain the ‘directions for use’ along with any warning and caution.
- A separate batch number preceded by the letter ‘B’ should be mentioned on the label. Additionally, a manufacturing batch number preceded by the letter ‘M’ must be specified on the label.
- In case the cosmetics product contains any possibly hazardous materials, the inner labels must mention the proper direction for safe usage of the cosmetics.
- If the packaging contains only one label, then the label must provide all necessary information that would otherwise be mentioned on the inner and outer labels of the product.
Specific labelling guidelines for imported cosmetics products
- The original product labels need to be submitted to the CDSCO while applying for the COS-2 license. However, applicants maybe allowed to submit a copy of the original label, only if it mentions all the necessary details.
- When importing registered products, India-specific requirements can be incorporated into the label after arrival in India at a customs warehouse or place approved by the CDSCO. This has to be done prior to release of the product into the Indian market.
- Guidelines for packaging for overseas brands and importers have to be followed for customs clearance.
List of supporting documents required to secure CDSCO cosmetics import license
We have provided an overview of the documents required per regulations for importing cosmetics into India.
- Cover letter clearly stating the purpose of the application
- Application in Form COS-1
- Duly authenticated authorisation letter from the cosmetics manufacturer
- List of ingredients in the cosmetic product along with their percentage contents
- Product formulation and the certificate of analysis
- Labels of proposed cosmetic products
- Filled in Part-I of second schedule D
- Fee receipt
- Specifications and testing methods
- Duly authenticated free sale certificate
- Declaration of non-animal testing
- Heavy metal declaration
- Pack inserts
- Duly authenticated free sale certificate
- Declaration of non-animal testing
We have listed some of the documents required for securing the CDSCO cosmetics import license. For a detailed checklist of documents required, feel free to get in touch with us. Additionally, we will help you prepare and collate all the documents required for securing the COS-2 import license for cosmetics.
How to secure the CDSCO cosmetics import license COS-2?
- Sign up/ Login on the CDSCO online portal.
- The application for the imported cosmetics registration or CDSCO cosmetics import license has to be filed under COS-1. Details regarding the cosmetics manufacturing premise, product description, brand name, pack size and their variants, etc. have to filled in the application form.
- All the necessary supporting documents have to be uploaded along with the duly signed and stamped COS-1 application on the online registration portal.
- Application fee challan along with the details of the importer has to be submitted.
- The cosmetics import license application will be reviewed by the regulatory officials. Additionally, the submitted documents will be verified for regulatory compliance.
- After the application is successfully verified, it will be approved. The approval letter for satisfactory application will be posted on the applicant’s online SUGAM dashboard.
- The license to sell and distribute imported cosmetics in India will be granted under COS-2 or the import registration certificate.
COS-2 license application fees
To apply for the COS-2 license, you need to pay the COS-2 license application fees. A fee of 1000 USD per category, 50 USD per variants, and 500 USD per manufacturing site is charged.
Validity of the COS-2 import license
Per regulations for importing cosmetics, the COS-2 license will remain valid for a period of 5 years from the date of issue, unless cancelled or suspended.
Timeline for COS-2 license approval
The timeline for COS-2 license approval is 180 working days according to the new Cosmetic Rules, 2020.
We have curated this blog to help you easily navigate the CDSCO regulations for importing cosmetics. For any queries on CDSCO cosmetics import regulations or to easily secure the COS-2 license, email at [email protected] or call/Whatsapp on 9996859227.
