Cosmetics Registration (CDSCO)

Overview of Cosmetics Registration (CDSCO):

The cosmetic industry in India is witnessing significant growth, necessitating stringent regulation to ensure the quality, safety and efficacy of imported cosmetic products. To facilitate this, the Central Drugs Standard Control Organization (CDSCO) mandates a Cosmetic Import Registration Certificate from the Ministry of Health & Family Welfare as specified under Rule 21 of the Drugs and Cosmetics Rules 1945. This certification enables seamless import and sale of cosmetics in India, governed by the Drugs and Cosmetics Act 1940.

A cosmetic is defined as any substance intended to be applied to the human body for altering, cleansing or beautifying it’s appearance. This includes various articles associated with cosmetic products.

According to the Drugs & Cosmetics Act 1945, the following parties can apply for CDSCO Cosmetic Import Registration in India:

1. Authorized Agents: Agents appointed by manufacturers to import cosmetics on their behalf.
2. Manufacturers' Subsidiaries: Indian subsidiaries of foreign manufacturers can apply on their behalf.
3. Manufacturers: Direct application can be made by the manufacturers themselves.
4. Other Importers: Indian importers seeking to import cosmetics from foreign manufacturers.

Benefits of CDSCO Registration:

1. Ensures Safety and Efficacy: Guarantees that manufactured and imported drugs are safe and effective for consumers.
2. Quality Management: Regulates the quality of drugs and cosmetics available in the market.
3. User Safety: Promotes a safer environment for users in the drug and cosmetic sectors.
4. Enhances Goodwill: Strengthens the reputation of manufacturers and importers.
5. Builds Credibility: Increases the trustworthiness of manufacturers and importers.
6. Fosters Trust: Establishes reliability and confidence among consumers.

Licensing and Registration:

• Manufacturing: Regulated by State Licensing Authorities through a system of inspection and licensing.
• Importation: Requires registration with the Central Licensing Authority. Cosmetics must be registered before import along with details like packaging size and manufacturing premises. Compliance with the standards outlined in the Ninth Schedule of the Cosmetic Rules 2020 or any other applicable quality and safety standards is mandatory.

• Import Registration Certificate: The Central Licensing Authority issues an Import Registration Certificate under Rule 13 of the New Cosmetics Rules 2020. Applications can be submitted online using Form COS-1 on the SUGAM Portal accompanied by the required fee and documents. The application can be made by the manufacturer, their authorized agent or any importer in India.

  Additional Requirements:

• Labeling Requirements: Cosmetic product labels must adhere to prescribed labeling requirements to ensure compliance with regulatory standards.
• Required Registration under the Legal Metrology (Packaged Commodities) Rules 2011: Cosmetic products are considered packaged commodities and are regulated under the Legal Metrology (Packaged Commodities) Rules 2011 and they must be certified by the Director or Controller of Legal Metrology in New Delhi.
• Required Ingredient & Specification: To obtain approval for a cosmetic product in India, whether manufactured domestically or imported, it must adhere to the standards and acceptable limits set by the Drugs and Cosmetics Act and the Bureau of Indian Standards.

Documents of Cosmetics Registration:

The following documents are essential during the registration process:

1. Covering Letter: Clearly stating the purpose (e.g., Fresh Registration, Endorsement) and previous Import Registration Certificate details, if applicable.
2. Part-1 of Second Schedule: An undertaking from the manufacturer or authorized distributor, completed in Form COS-1.
3. List of Composition or Ingredients: Ingredients must be documented according to standard nomenclature including permissible limits for colors and heavy metals.
4. Labels of Proposed Products: Original labels must meet requirements outlined in the Cosmetics Rules including information about the manufacturer, expiry dates and a declaration of net contents.
5. Specification & Testing Methods: Documented testing protocols as per specified standards.
6. Manufacturing Licenses: Certified copies of manufacturing or marketing authorizations from the country of origin.
7. Free Sale Certificate: Issued by the national regulatory authority or the Indian embassy in the country of origin.
8. Declaration of Non-Animal Testing and Declaration for Heavy Metals & Hexachlorophene.
9. Application Form (COS-I) and TR-6 Challan (in original).

Note: All documents must be in English.

Fees:

For a customized and attractive quotation, please contact with your product details to Rekha Atri (+91 98118 03136) or Manju Laur (+91 9711994042).

Process for Registration:

• • • • Verify Cosmetic Classification: Manufacturers should confirm the regulatory status and classification of their products in accordance with the CDSCO Gazette Notification.
      • Appoint an Authorized Indian Agent: It is necessary to appoint an authorized Indian agent, providing them with Power of Attorney to facilitate the approvals and registration process.
      • Complete the Application Form: Fill out the Registration Form and submit it along with all required documents and the prescribed fee through the CDSCO website.
      • Receive Certificate: After submission, Department may send an inquiry letter requesting clarification. Once they are satisfied with the application, a Cosmetic Import License will be issued.