3 min de lecture
India has emerged as one of the world's fastest-growing Cosmetics markets, creating significant opportunities for both domestic and international brands. However, importing cosmetic products into India requires compliance with the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940, the Rules, 1945, and the Cosmetics Rules, 2020. Cosmetics manufactured in India are regulated through inspection and licensing by the State Licensing Authorities (State FDA) appointed by the respective state governments. This Regulatory framework is designed to ensure consumer safety and product quality.
Whether you're a manufacturer, importer, or brand owner, understanding the Regulatory pathway for Cosmetic registration in India is essential for smooth market entry.
Here's a step-by-step guide to help you navigate India's cosmetic compliance requirements.
1. Confirm Product Classification cum Compliance
The first step is determining whether your product qualifies as a cosmetic under Indian cosmetic regulations and reviewing the product formula, labels, and claims to ensure the product falls within the applicable regulatory framework. Proper product classification is critical because products classified under other categories, such as drugs or medical devices, follow different Regulatory pathways. An accurate classification helps avoid delays during registration and ensures the correct compliance process is followed.
The label review should also confirm compliance with the Cosmetics Rules, 2020, including applicable mandatory declarations such as the ingredient list, importer details, batch number, manufacturer information, and country of origin.
2. Review Formula Compliance
Before submitting any application, manufacturers must verify that the Cosmetic product formulation complies with Indian ingredient regulations. The Bureau of Indian Standards (BIS) defines and maintains lists of permitted, restricted, and prohibited ingredients through Indian Standards, primarily IS 4707 Part 1 and Part 2.
A thorough formulation review early in the process helps identify compliance issues before Regulatory submission.
3. Understand Licensing and Registration Requirements
Regulatory obligations differ depending on whether the cosmetic is manufactured locally or imported.
- Domestic Manufacturing License:
Domestic manufacturers must obtain a manufacturing license from the respective State Licensing Authority subject to submission of the prescribed documents, fees, and GMP self-declaration, followed by site inspection and compliance verification. The license is generally granted within 45 days, followed by site inspection within 30 days and ongoing compliance requirements. - Import Registration Certificate:
Imported Cosmetics require an Import Registration Certificate before they can be sold in India. The registration process is done through the SUGAM Portal, and each product must pass CDSCO’s scrutiny. Foreign manufacturers must appoint an Authorized Indian Agent to represent them throughout the process in India.
4. Dossier compilation
This process involves compiling detailed information about the product, including its formula, labels with acceptable claims, a free sale certificate, a letter of authorization, and other declaration documents etc.
5. Application Submission
Once the documentation is complete, the registration application is submitted for imported cosmetics using Form COS-1 through the SUGAM Portal. CDSCO reviews the submitted documents. Upon successful review, the CDSCO issues Form COS-2, the Import Registration Certificate, which is valid for 5 years. This certificate is mandatory for importing cosmetic products into India and should be retained for customs clearance and Regulatory inspections.
- To import or manufacture a novel cosmetic product, the applicant must apply to the Central Licensing Authority in Form COS-12, along with the prescribed fee and required safety and efficacy data. Upon approval, prior permission is granted in Form COS-3. This permission must then be submitted with the Form COS-1 application for import, leading to the issuance of an Import Registration Certificate in Form COS-2, or with the manufacturing license application.
Recent Regulatory Developments
India’s CDSCO has issued a circular on 22nd July 2026 directing State Licensing Authorities (SLAs), Zonal Heads of CDSCO, and Port Officers to enhance vigilance against the sale of imported cosmetic products without a valid Import Registration Certificate.
This means:
- Increased market surveillance and inspections by SLAs and CDSCO field formations to identify imported Cosmetics lacking valid registration.
- Enhanced vigilance at ports to prevent the entry of imported Cosmetics without a valid import Registration Certificate.
Manufacturers, importers, authorized agents, and brand owners must ensure that imported cosmetic products hold a valid Import Registration Certificate before importation and sale in India.
Dernières réflexions
Navigating India's cosmetic Regulatory landscape can be complex, particularly for companies entering the market for the first time.
Freyr provides end-to-end Regulatory support from product classification, formulation reviews, claims and label assessment, Indian Authorized Agent services, and Cosmetic product registration in India, helping brands achieve seamless market access.
