The cosmetics industry in India is witnessing remarkable growth, fueled by changing consumer preferences and increasing demand for beauty and personal care products. With this surge in demand comes the need for stringent regulations to ensure the safety and quality of cosmetic products entering the Indian market. One such CDSCO regulatory requirement in India is the Import Registration Number (IRN) for cosmetics, which plays a crucial role in facilitating the importation process.
What is an CDSCO Import Registration Number (IRN) for Cosmetics in India?
An Import Registration Number (IRN) is a unique identifier issued by the Central Drugs Standard Control Organization (CDSCO) to importers of cosmetics in India. This number is mandatory for importing cosmetics into the country and serves as proof of compliance with regulatory standards.
Why is an CDSCO Import Registration Number (IRN) for Cosmetics Required?
The Import Registration Number (IRN) is required to ensure that imported cosmetics meet the safety and quality standards set by the CDSCO. It helps regulatory authorities track and monitor imported cosmetics, ensuring that only safe and compliant products enter the Indian market. By obtaining an IRN, importers demonstrate their commitment to adhering to regulatory requirements and safeguarding consumer health and safety.
How to Obtain an CDSCO Import Registration Number (IRN) for Cosmetics?
According to the Cosmetics Rules, 2020, cosmetics manufactured at foreign sites and already registered under Rule 13 for import and sale in India can be imported by any person or entity. The process begins with the submission of an application through the online portal of the Central Government in Form COS-4. Along with the application, an undertaking specified in the Sixth Schedule must be provided. The application in Form COS-4 shall include the details of Cosmetic Name, Name and address of the manufacturer, pack sizes of cosmetics intended to be imported into India and Registration Certificate Number under which the cosmetics are approved under Form CoS-2
Granting of Import Registration Number (IRN) for Cosmetics in India
Upon receipt of the application, the Central Licensing Authority examines the documents furnished. If satisfied, the authority may grant an Import Registration Number in Form COS-4A. However, if the application is rejected, the reasons must be recorded in writing within six months from the date of application.
Validity of CDSCO Import Registration Number (IRN) for Cosmetics
An IRN issued under this process remains valid for a period of three years from the date of its issue, unless suspended or canceled due to non-compliance. Importers are required to comply with the conditions specified in the Import Registration Number. Failure to do so may result in suspension or cancellation of the IRN after providing the importer with an opportunity to show cause.
Prohibited Imports and Reporting Requirements
Certain prohibitions exist regarding the importation of cosmetics, such as those prohibited in the country of origin, cosmetics containing hexachlorophene, and those tested on animals after November 12, 2014. Additionally, cosmetics must have a "Use Before or Use By" date later than six months from the date of import.
Compliance Obligations for CDSCO Import Registration Number (IRN) for Cosmetics
Importers granted an Import Registration Number (IRN) under Form COS-4A are subject to various compliance obligations to ensure adherence to regulatory standards and maintain transparency in the importation process. In addition to the conditions specified for obtaining the IRN, importers have additional responsibilities as outlined below:
Annual Reporting: Importers must provide an annual statement to Central Licensing Authority (CLA) detailing the cosmetics imported into India. This statement should include information such as the number of consignments, imported quantities, total costs, warehouse details, and more. Compliance with these reporting requirements ensures transparency and accountability in the importation process.
Production of IRN: The Import Registration Number must be produced by the importer whenever requested by the Licensing Authority or regulatory authority. This ensures that importers can demonstrate compliance with regulatory requirements at any given time.
Notification of Administrative Actions: Importers are required to promptly inform the Licensing Authority in the event of any administrative action taken, such as market withdrawal, deletion of products from the original Registration Certificate holder's portfolio, or any regulatory restrictions affecting the cosmetics covered by the registration. This proactive notification ensures that regulatory authorities are kept informed of any changes or developments that may impact the importation or sale of the cosmetics.
The Import Registration Number (IRN) plays a crucial role in facilitating the importation of cosmetics into India while ensuring compliance with regulatory standards. By adhering to the prescribed procedures and compliance obligations, importers contribute to maintaining the safety and quality of cosmetics available in the Indian market.
By adhering to these compliance obligations, importers contribute to maintaining the safety, quality, and integrity of cosmetics imported into India. This not only ensures compliance with regulatory standards but also helps to build trust and confidence among consumers in the cosmetics available in the Indian market.
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