The Central Drugs Standards Control Organization, which is part of the Ministry of Health and Family Welfare, regulates all medical goods and imports of cosmetics in India. Under CDSCO, the Drugs Controller General of India is responsible for issuing a license for Allopathic Drugs, Veterinary Medicines, Medical Devices, Homeopathy, Cosmetics etc. The primary goals of CDSCO are to protect and promote public health. The Drugs & Cosmetics Act 1940 and rules 1945 have given various responsibilities to central and state regulators for regulating drugs & cosmetics.
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:
- Authorized Agents: Agents appointed by manufacturers to import cosmetics on their behalf.
- Manufacturers' Subsidiaries: Indian subsidiaries of foreign manufacturers can apply on their behalf.
- Manufacturers: Direct application can be made by the manufacturers themselves.
- Other Importers: Indian importers seeking to import cosmetics from foreign manufacturers.
Benefits of CDSCO Registration:
- Ensures Safety and Efficacy: Guarantees that manufactured and imported drugs are safe and effective for consumers.
- Quality Management: Regulates the quality of drugs and cosmetics available in the market.
- User Safety: Promotes a safer environment for users in the drug and cosmetic sectors.
- Enhances Goodwill: Strengthens the reputation of manufacturers and importers.
- Builds Credibility: Increases the trustworthiness of manufacturers and importers.
- 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.
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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:
- Covering Letter: Clearly stating the purpose (e.g., Fresh Registration, Endorsement) and previous Import Registration Certificate details, if applicable.
- Part-1 of Second Schedule: An undertaking from the manufacturer or authorized distributor, completed in Form COS-1.
- List of Composition or Ingredients: Ingredients must be documented according to standard nomenclature including permissible limits for colors and heavy metals.
- 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.
- Specification & Testing Methods: Documented testing protocols as per specified standards.
- Manufacturing Licenses: Certified copies of manufacturing or marketing authorizations from the country of origin.
- Free Sale Certificate: Issued by the national regulatory authority or the Indian embassy in the country of origin.
- Declaration of Non-Animal Testing and Declaration for Heavy Metals & Hexachlorophene.
- 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:
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- 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.
Frequently Asked Questions
CDSCO Cosmetics Registration is the mandatory process of registering cosmetic products and their manufacturing sites with the Central Drugs Standard Control Organization (CDSCO), India's national regulatory body for pharmaceuticals and cosmetics. This is essential to:-
* Ensure the safety and quality of cosmetics entering Indian markets.
* Protect consumer health and well-being.
* Comply with the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020.
* Legally import and sell cosmetic products in India.
The following entities are required to obtain CDSCO Cosmetics Registration for their products intended for import into India:-
* Cosmetic Manufacturers (Foreign).
* Authorized Agents of Foreign Manufacturers.
* Importers of Cosmetics in India.
* Authorized Subsidiaries of Manufacturers in India.
All cosmetic products intended to be imported and sold in India require CDSCO registration including:-
* Skin care products (creams, lotions, cleansers).
* Hair care products such as conditioners, shampoos, styling products etc.
* Color cosmetics (makeup).
* Personal hygiene products.
* And products which fall under the definition of "cosmetic" as per the Drugs and Cosmetics Act, 1940.
It is important to classify your products correctly according to CDSCO guidelines.
iKargos offers comprehensive support to streamline your CDSCO registration process, providing benefits such as:-
* Guidance: Our team of experts has in-depth knowledge of CDSCO regulations and procedures.
* Simplified Documentation: We assist in preparing and compiling all the necessary documents.
* Efficient Process Management: We manage the entire registration process, minimizing delays.
* Liaison with CDSCO: We act as your point of contact with the regulatory authority.
* Reduced Chances of Rejection: Our team of experts helps in ensuring accurate and complete submission of documents.
* Time and Cost Savings: We optimize the process, saving you valuable time and resources.
The typical process involves the following key steps:-
1. Classification: Determining the correct cosmetic category as per CDSCO guidelines.
2. Documentation Preparation: Gathering and compiling all the required documents.
3. Authorized Indian Agent Appointment: If required, assisting with the appointment of an Authorized Indian Agent.
4. Online Application Filing: Submitting the application in Form COS-1 through the SUGAM portal.
5. CDSCO Query Handling: Addressing any queries or requests for clarification from CDSCO.
6. Registration Certificate Issuance: Obtaining the Import Registration Certificate (Form COS-2) from CDSCO.
The specific documentation may vary, but generally includes:-
* Covering Letter.
* Application Form COS-1.
* Authorization from the Manufacturer.
* List of Ingredients and their concentrations.
* Product Labels (as per Indian regulations).
* Product Specifications and Testing Methods.
* Licenses of manufacturing from the country of origin.
* Free Sale Certificate (FSC).
* Non-Animal Testing Declaration.
* Heavy Metals Declaration.
* Other documents as specified by CDSCO.
iKargos will provide a detailed checklist tailored to your specific product portfolio.
The fees for CDSCO Cosmetics Registration are prescribed by the CDSCO and may vary. These fees typically include:-
* Application fees per product category.
* Fees for additional manufacturing sites.
* Fees for variants of a product.
* Service Fees by iKargos.
iKargos will provide you with a clear breakdown of the applicable fees. Contact us for a customized quotation.
The processing time for CDSCO Cosmetics Registration can vary depending on factors such as the completeness of the documentation, the number of applications being processed by CDSCO and any queries raised by the authorities. It can typically take several weeks to months. iKargos strives to expedite the process by ensuring accurate and timely submissions.
The validity period of the CDSCO Cosmetics Registration Certificate is typically five years. Renewal is required to continue importing and selling cosmetics in India.
iKargos stays updated with the latest amendments and guidelines issued by the CDSCO regarding cosmetic regulations. Our team ensures that your application and practices adhere to the current requirements, minimizing the risk of non-compliance.
iKargos can provide guidance on the specific labeling requirements for cosmetics in India, ensuring your product labels comply with the Drugs and Cosmetics Rules, 2020.
To initiate the CDSCO Cosmetics Registration process with iKargos, please contact our dedicated team of experts:
* Rekha Atri: +91 98118 03136
* Manju Laur: +91 9711994042
