Introduction: CDSCO Cosmetic Import

Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under Rule 21 or by any person to whom such powers may be delegated under Rule 22.

Any article falling within the definition of cosmetic (Section 3aaa of D&C Act, 1940) is required to be registered along with pack size and manufacturing premises before import into the country.

An application for the issue of a Registration Certificate for cosmetics intended to be imported into India shall be made online in COS I Form on the SUGAM Portal of CDSCO either by the manufacturer himself or by his authorized Consultants or importer in India or by the subsidiary in India authorized by the manufacturer to the Licensing Authority under the Act i.e. Drugs Controller General (I), CDSCO (HQ).

Role of CDSCO Cosmetic

• Amendment of the Cosmetic Rules, 2020 with respect to registration and import of Cosmetic products.
• Examining applications for registration of cosmetic items for import into the nation in accordance with the requirements of the Drugs and Cosmetics Act 1940 and its Rules. 
• Scrutiny of various applications for NOC /Clarification relating to the import of cosmetic products.
• Preparation of draft replies to RTI, court cases, VIP references, and Parliament Questions related to cosmetics.
• Replying to Government correspondences/ BIS as and when required.
• Handling of PMOPGs/public inquiries/hearings related to the cosmetic import registration process and providing guidance thereto.
• Handling of public/NGOs/Consumer forums complaints/grievances regarding standards of cosmetic products

Scope of Applicant for CDSCO Cosmetic Import

As per the Drug and Cosmetic act, 1945, the Central Drugs Standard Control Organization (CDSCO) has listed the applicants who are eligible to apply for a CDSCO Cosmetic import license in India.

• Manufacturer: The manufacturer himself can apply for the grant of a CDSCO cosmetic import license.
• Authorized Consultant: In case the manufacturer has authorized an importing Consultant on his behalf to import cosmetics. In the said scenario, the authorized importer needs to apply for the license.
• A subsidiary of manufacturer: For any foreign manufacturer of cosmetics. The Indian subsidiary firm can apply on behalf of the manufacturer for the import of cosmetic licenses with CDSCO.
• Any other Importer: Any Indian importer willing to import cosmetics to India from a foreign manufacturer can apply for the CDSCO Cosmetic import license.

Documents Required For CDSCO Cosmetic Import

Guidance Documents for Submission of Application for Grant of Registration Certificate in Cos I form to Import Cosmetics

• Covering Letter: Corpseed will provide the necessary filled format after details are received from the client.
• Power of Attorney: Executed & authenticated either in India before a First-class Magistrate or in the country of origin before such an equivalent Authority or attested by the Indian Embassy of the said country or Apostilled from Hague Convention member countries. Power of Attorney including product list duly apostilled and authenticated from the country of origin. All the pages of Power of Attorney including the product list should be signed by both authorized Indian Consultants and the manufacturer before authentication. (Customer will provide)
• Second Schedule Part I: Corpseed will provide the necessary filled format after details are received from the client.
• List of Ingredients: Corpseed will provide the necessary filled format after details are received from the client.
• Labels of proposed products: Corpseed will provide sample labels and labeling instructions as per the CDSCO guidelines.
• Specifications and testing methods: The specific document is required from the manufacturer's end. Test Protocol for testing of cosmetics and specification as per the standards specified in the Cosmetics Rules, 2020 for the applied product.
• Pack insert, if any
• Manufacturing Licenses: Authenticated copy of manufacturing licenses/registration/marketing authorization in respect of applied products issued by the Regulatory Authority from the country of origin. or undertaking.
• Free Sale Certificate: Original Free Sale Certificate issued by the National Regulatory Authority of the Country of Origin for the applied products or from the Indian Embassy of the country of origin. The product list of free sale certificates should be signed and stamped by issuing authority. Free sale certificate should contain the statement in which country the applied products are freely sold.
• Non-Animal Testing Declaration: The Manufacturer either legal or actual /brand owner of the products/ Indian subsidiaries can submit a one-time self-declaration that the applied products have not been tested on animals on and after 12.11.2014 along with import registration dossiers to CDSCO. The acknowledgment copies for submission of this undertaking as received by the applicants from CDSCO can be produced at port offices in the future for clearing their future consignments. The necessary draft template will be provided by Corpseed.
• Declaration for Heavy Metal and Hexachlorophene content:  Corpseed will provide the necessary filled format after details are received from the client.
• Other documents (If any).
• Application (Cos I Form): The application COS I Form is generated post-submission of the application online
• Fee: TR-6 Challan (In Original) 

**If the documents are not in English language, the English version of the documents will be provided by the customer, and translated by a qualified translator.

Procedure for CDSCO Cosmetic Import Registration

Determine the cosmetic category as per cosmetic rules 2020.

The CDSCO authority has provided a list of 88 cosmetic categories that need to compulsorily obtain registration under the Drugs and Cosmetics Act 2020. The applicant firm needs to identify the cosmetic category under which its final product and its variants fall. Once the category is finalized, the applicant further needs to identify all the variants as well.

The identification of categories and variants is necessary as the same will define the fee structure of the application.

Appoint an Authorized representative (in case of a Foreign Entity)

For a foreign business manufacturer entity, it shall be necessary to appoint an authorized business entity in India, who shall be the contact person for the inspection authorities during the process, assist in cosmetic approvals, and registrations process, and vigilance adverse event reporting.

Fill out the application form for Cosmetic Import Registration

In the next step, the manufacturer/importer of cosmetics shall be required to submit the registration form of a regulatory dossier, along with all the prescribed documents along with the prescribed fee on the CDSCO portal to the DGCI (Drugs Controller General of India) by logging on to the online CDSCO   portal and signing into the portal.

Obtain a Certificate of Registration in the Prescribed form 

Once the application is submitted on the CDSCO portal, the DGCI registration authority may send a query through an inquiry letter to the manufacturer or from the authorized representative of the importer, along with the timeline within which the query should be answered and sometimes, may also ask for a technical presentation On satisfaction the authority may issue a license in such form as provided in the above list. 

Applicable Fees of CDSCO Cosmetic Import