Imported cosmetics from USA are in high demand in India. Planning to venture in to imported cosmetics business? Well, this blog is curated just for you. In this blog, we have discussed how to secure the license to import cosmetics from USA to India.
CDSCO regulations for importing cosmetics from USA into India
Central Drugs Standard Control Organisation (CDSCO) heavily regulates all cosmetics being imported from USA into India. As of 1st April, 2013, all cosmetics imported into India will have to be registered with the CDSCO.
Furthermore, CDSCO has issued guidelines for registering imported cosmetics from USA. The registration of imported cosmetic products has to be done under Rule 21. For ease of application for cosmetics import license, CDSCO are 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 cosmetics product in India, you need to ensure the product is identified under the right category with the right components. The product imported from USA should comply with the guidelines for the registered category of your product.
Thus, to import cosmetics from USA into India, you have to mandatorily secure the CDSCO cosmetics import license.
License required to import cosmetics from USA to India
To import cosmetics from USA to India, you need to apply for the CDSCO cosmetics import license (import registration certificate).
- COS-1: The application for the imported cosmetics registration has to be filed under COS-1.
- COS-2: CDSCO grants the license to sell and distribute imported cosmetics in India under COS-2.
Restrictions for importing cosmetics from USA to India
There are some restrictions on importing cosmetics from USA into India:
- 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.
- Any cosmetics whose manufacture or development has involved animal testing at any point after 12th November 2014 cannot be imported into India.
- Cosmetics cannot be imported into India from USA, if the product is not registered per the rules set by the CLA.
- Cosmetics cannot be imported into India from USA, unless they comply with the specifications mentioned in the Ninth Schedule.
- Any cosmetic made with hexachlorophene, a mercury compound, or a compound containing lead and arsenic for colouring cannot be imported to India
Lab testing requirements for imported cosmetics products
All cosmetics products imported from USA need to conform to the Indian Standards. Hence, certain tests have to be performed to demonstrate compliance. We have listed some of the tests that have to be performed.
- Chemical stability tests
- Toxicology tests
- Performance tests
- Microbiology tests
- Safety tests
Regulation for labelling imported cosmetics products
Drugs & Cosmetics Act has laid down strict and clear guidelines for cosmetics product labels. Additionally, it has provided guidelines for packaging for overseas brands and importers. These regulations have to be followed for customs clearance. Furthermore, compliance with Indian cosmetics labelling guidelines is required to market your product in online and offline marketplaces per CDSCO requirements. Notably, 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. We have provided an overview of the labelling guidelines:
- 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.
- 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.
- In case the cosmetics product contains any possibly hazardous materials, the inner labels must mention the proper direction for safe usage of the cosmetics.
Notably, 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.
How to import cosmetics from USA to India?
India is witnessing a high demand for imported cosmetics products, especially those from USA. Hence, there are chances of spurious products entering the Indian market. Thus, CDSCO monitors and regulates all cosmetics products being imported into India to ensure consumer safety. Therefore, to import cosmetics from USA to India, you have to mandatorily secure the CDSCO cosmetics import license.
Who can apply for the COS-2 license?
The manufacturer himself, his authorised agent, importer, or subsidiary in India authorised by the manufacturer can apply for the COS-2 license.
Documents required to import cosmetics from USA to India
We have provided an overview of the documents.
- Cover letter from the applicant
- Application Form
- A valid Import Export Code (I.E.C.)
- Original copy of Power of Attorney
- Copy of the Label
- Specification and test method of the cosmetics product
- Package inserts, if any
- Fee receipt
- Information of the cosmetics product to be imported, including the chemical & safety data (Schedule D III)
- Marketing authorisation letter or Free Sale Certificate (F.S.C.)
- List of the name of countries where import permission or registration of the product has been granted
- Duly authenticated free sale certificate
- Declaration of non-animal testing
- Declaration mentioning the heavy metal and hexachlorophene content level
- Provide a soft copy of the details regarding the cosmetic products, brands, and the manufacturer.
- List of ingredients in the cosmetic product along with their percentage contents
- An undertaking that the product has not been subjected to animal testing on or after December 11, 2014 when the cargo is cleared at the port office.
Procedure to import cosmetics from USA into India: A step-by-step guide
Here is a step-by-step guide to secure the license to import cosmetics from USA to India
- Sign up/ Login the CDSCO online portal to register.
- All the necessary supporting documents have to be uploaded on the online registration portal.
- The 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 SUGAM dashboard online.
- The Central Licensing Authority (CLA) will grant the import registration certificate for importing cosmetics from USA.
Validity of the COS-2 license for imported cosmetics
The COS-2 license (import registration certificate) will remain valid for a period of 3 years from the date of issue, unless cancelled or suspended. Furthermore, a fresh registration will be required for any changes associated with the manufacturer or importer.
Are you are planning to import cosmetics from USA into India? Well, you have landed in the right place. We will leverage our regulatory expertise to help you import cosmetics products in a hassle-free manner. From document preparation, compilation to import registration certificate application, our service covers it all. Furthermore, we provide Indian authorized agent service for foreign manufacturers. Email at [email protected] or call/Whatsapp on 9996859227 to avail our services.
