How to Start a CDSCO COSMETIC IMPORT REGISTRATION

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Overview of CDSCO Cosmetic Import Registration

The Indian cosmetics industry is growing rapidly, increasing the demand for imported cosmetic and personal care products. To ensure the safety, quality, and compliance of imported cosmetics, businesses must obtain a CDSCO Cosmetic Import Registration Certificate before importing or selling cosmetic products in India. The registration is issued by the Central Drugs Standard Control Organisation (CDSCO) under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. This registration is mandatory for the legal import, distribution, and sale of cosmetic products in the Indian market.

Who Can Apply for CDSCO Cosmetic Import Registration?

As per the Drugs and Cosmetics Rules, 1945, the following entities are eligible to apply for a CDSCO Cosmetic Import Registration Certificate in India:

  • Manufacturer: A foreign cosmetic manufacturer can apply directly for CDSCO Cosmetic Import Registration.

  • Authorised Agent: An authorised representative appointed by the foreign manufacturer can submit the application on their behalf.

  • Indian Subsidiary: The Indian subsidiary of a foreign cosmetic manufacturer is eligible to apply for the registration.

  • Importer: An Indian importer importing cosmetic products from a foreign manufacturer can also apply for the CDSCO Cosmetic Import Registration Certificate.

Documents required for CDSCO Cosmetic Import Registration

Following are some important documents required at the time of CDSCO Cosmetic Import Registration:

  • Covering letter: purpose (fresh or Endorsement of products or Pack Size or manufacturing site or Additional Sourcing Location or Re-Registration) must be mentioned along with guideline of earlier issued Import Registration Certificate and product category (whether registered or not).
  • Authorisation from the manufacturer (duly authenticated)
  • Filled in part-1 of the Second Schedule
  • List of ingredients along with their percentage contents
  • Specifications and testing methods: the specification of the document is required from the manufacturer's end. The protocol for testing Cosmetics & specifications is as per the standards specified in the Cosmetics Rules, 2020 for the applied product.
  • Manufacturing licenses/undertaking for no provision of manufacturing registration: the primary certified copy of manufacturing Registration or Marketing Authorisation regarding registered products issued by the Regarding Authority from the country of origin or undertaking.
  • Free sale Certificate (duly authenticated): this certificate is provided by the National Regulatory Authority of the Country for the appeal products or from the Indian Embassy of the country of beginning. List of products of free sale Certificate should be stamped & signed by providing authority. A Free Sale Certificate (FSC) should contain the declaration that the applied product is freely sold.
  • Pack insert (If any)
  • Non-Animal Testing Declaration
  • Declaration for Heavy Metal and Hexachlorophene content.
  • Other documents ( if any)
  • Application in form COS-1

Process for CDSCO Cosmetic Import Registration in India

Obtaining a CDSCO Cosmetic Import Registration Certificate involves the following steps:

Step 1: Product Classification
Determine the correct classification of the cosmetic product as per the applicable CDSCO guidelines and regulatory requirements before initiating the registration process.

Step 2: Appointment of an Indian Authorised Agent
Foreign manufacturers must appoint an Authorised Indian Agent through a valid Power of Attorney to represent them before CDSCO and manage the registration process in India.

Step 3: Application Submission
Submit the online application in Form COS-1 along with the required documents and prescribed government fee through the CDSCO SUGAM Portal for review by the licensing authority.

Step 4: Review & Grant of Registration Certificate
CDSCO examines the application and may seek additional information or clarification, if required. Once all requirements are fulfilled, the CDSCO Cosmetic Import Registration Certificate is issued, allowing the legal import and sale of cosmetic products in India.

Labelling of Proposed Products:

 Following are the original label for the proposed cosmetic product or item and their variant (if any) according to Chapter VI of the Cosmetics Rules, 2020.

  1. Cosmetic products name;
  2. Manufacturer name and proper address of the manufacturer's place where the Cosmetic has been manufactured, or the country name where it has been manufactured as “Made in (Country Name)” should be there on the label;
  3. A unique Lot Number or Batch Number;
  4. must be maintained. Date of expiry and date of manufacture
  5. Manufacturing registration Number, the number id preceded by the letter M or M.L. No or M. L. No. shall carry on outer or inner labelling;
  6. A memorandum of the net contents stated in terms of weight for solids, fluid measure/ weight for semi-solids, fluid measure for liquids, integrated with numerical count if the content is sub-divided;
  7. In the case of cosmetics, where a danger exists; every inner label must indicate enough directors for safe use, caution or any particular direction required to be observed by the customer;
  8. In imported Cosmetics to be marketed in India, CDSCO Cosmetic Import Registration no. shall be cited in the unit pack label denoted by the letter R.C. or Reg. Cert. No. or R.C. No., along with the name & address of the Importer;
  9. If any cosmetic pack has only one label, the label must contain all the details essential to be present on both inner and outer labels under the prescribed rules;
  10. All the Instances, the ingredients list, present in a concentration of more than 1%, in any order and preceded by the words “INGREDIENTS”,
  11. The Cosmetic must comply with all labelling requirements specified in the relevant Indian standard as set by the Bureau of Indian Standard (BIS) for the cosmetics covered under the Ninth Schedule;
  12. Cosmetic should not be imported unless it is packed & labelled in accordance with these rules & label of imported cosmetics shall carry the Registration Certificate Number of the product & name and address of the owner of CDSCO Cosmetic Import Registration for marketing the concerned products in India.

How CA Anytime Can Help You?

CA Anytime provides end-to-end assistance for obtaining the CDSCO Cosmetic Import Registration Certificate in India. Our experienced professionals simplify the registration process by handling documentation, application filing, regulatory compliance, and coordination with the concerned authorities.

With our expert guidance, you can ensure a smooth, accurate, and hassle-free registration process while meeting all CDSCO requirements for importing cosmetic products into India.