Cosmetic

COSMETIC REGISTRATION IN INDIA – COS-1 & COS-2

EXPEDITE YOUR COSMETIC PRODUCT ENTRY INTO THE INDIAN MARKET

Simplify your cosmetic product registration process with Shen Clinical Services LLP. Our expert team offers comprehensive support, from strategic product planning and testing to obtaining the COS-2 certificate (Form 43) for import licensing in India. Partner with us to ensure a smooth and hassle-free registration process, fully compliant with CDSCO regulations.

Fresh Registration (Cos-2) – Overview

Fresh Registration (Cos-2) – Overview

At Shen Clinical Services LLP, we assist you in navigating the cosmetic registration process with the Central Drugs Standard Control Organisation (CDSCO), the regulatory authority for cosmetic imports in India. To import cosmetic products for marketing in India, applicants or manufacturers must complete Form COS-2. The process begins with registration on the Sugam online portal, followed by uploading the required documents and payment of fees. After reviewing the application, CDSCO may request additional documentation or issue the import registration certificate (COS-2). Let us simplify the process for you with our expert guidance

Important Documents

What is Form COS-1 and COS- 2

COS-1:

The CDSCO grants license to import and market cosmetics in India through this form.

COS-2:

The CDSCO grants license to import and market cosmetics in India through this form.

Who Is Eligible to Apply for a Cosmetic Registration Certificate (COS-2) in India?

A cosmetic product intended for import into India must be registered online through the Central Government’s portal using Form COS-1. The application can be submitted by the manufacturer, their authorized agent, the importer in India, or an authorized subsidiary of the manufacturer operating in India.

How to Apply - Cosmetic Registration Certificate ( COS- 2 ) in India ?

Registration of importer on SUGAM

Document compilation for application filing

Upload essential documents online

Pay government fee and upload challan

Generate COS-1 and upload signed Form COS-1

The Process Of Registration Is As Follows:

Cos 1

COS-1 is a mandatory form provided by CDSCO for obtaining a Cosmetic Registration Certificate. It can be submitted online via the “Sugam” portal and requires detailed information about the manufacturing premises, product descriptions, brand names, pack sizes, and their variants. The application must also include all required supporting documents.

Submitted
The completed COS-1 form, duly signed and stamped, along with all relevant supporting documents, is submitted to the Drugs Controller General (India) at CDSCO, New Delhi. A challan reflecting the payment amount in INR and the importer’s details is also included to support the application.
Registered (Cos2)
COS-2, commonly referred to as the Registration Certificate, must be provided by the authorized importer, distributor, or Indian authorized agent upon request by the licensing authority. As per the updated Cosmetic Rules, 2020, the approval process is now set to 180 working days. The COS-2 certificate remains valid for five years. The government fees are $1,000 per category, $50 per variant, and $500 per manufacturing site
fee

Validity​

The validity of this license is five years.
Timeline to get ​

Timeline to get Form COS- 2 from Central Drugs Standard Control Organisation

The Government timeline for Cosmetic Registration is 180 days.
fee

Fees Involved

To obtain an import registration certificate for the import and market of cosmetic products in India, a fee of 1000 USD is charged per category, 50 USD per variants, and 500 USD per manufacturing site.
Important Documents

Important Documents Required To Get The Cosmetic Registration Certificate in India

The following documents are required for successful application for import registration certificate:

Authorization from manufacturer.
Product formulation, product label, and the certificate of analysis.
Free Sales Certificate.
Testing Method.

Essential Tips

To obtain an import license for the sale and distribution of cosmetics in India, an importer must ensure the following:
The validity of all legal documents must be checked.



The applicant must ensure consistency in the product names and names & addresses of manufacturers and importers across all documents.


 

All documentation must be in the English language.



The applicant must also provide other valuable information like heavy metal declaration and label claims of the product. In addition, the specifications of the cosmetic product must be as per the ninth schedule mentioned in the Bureau of Indian Standards.

Expert Advise

The categorization of the cosmetic products must be as per their intended use.

The applicant must ensure that the product-related and other details shared are consistent across all the documents.

The labeling of the cosmetic product should be as per the rules of the CDSCO. Also, the label should not contain any non-cosmetic claims.

Compliance and Evaluation Analysis for Cosmetic Registration in India

When registering your cosmetics products in India, it’s crucial to ensure that your products are correctly categorized, contain compliant ingredients, and align with local regulatory standards. At Shen Clinical Services LLP, we offer expert assistance in product analysis, compliance verification, and categorization to ensure a seamless and successful registration process.

PRODUCT AND INGREDIENT ANALYSIS

Your cosmetic products must comply with the Bureau of Indian Standards and the Drugs & Cosmetics Rules, 1945. This includes meeting specific regulations regarding product ingredients, labeling, and coloring. Our team performs thorough checks to ensure your product adheres to these standards, streamlining the registration process and ensuring regulatory compliance.

PRODUCT CATEGORIZATION

Cosmetics and personal care products in India are divided into a broad range of categories based on their intended use, application area, and other factors. The Indian regulatory body has established over 80 product categories, including skincare, haircare, oral hygiene, and nail care products. We assist you in correctly categorizing your product to ensure it is compliant and eligible for registration.

Important Documents

COMPLIANCE

All products and accompanying documentation must adhere to CDSCO’s regulatory guidelines, including the appropriate labeling requirements for the registered product category. We support you throughout the compliance process, ensuring every step is covered to guarantee a smooth registration and market entry in India.

Authorized Agent Support/ Registration Holder

Shen Clinical Services LLP can serve as your Authorized Indian Representative, acting on your behalf in accordance with Indian regulatory requirements. We ensure that all processes are handled with integrity, without any commercial conflicts of interest related to product distribution, marketing, or sales activities.

Distributor Identification

Successful market entry in India requires finding the right distribution partners. We help identify ideal distributors and e-commerce partners to ensure your products have the right channel for success in India’s competitive market. Our network connects you with the right platforms to build your brand’s reach across the country.

Market Research And Price Research

The Indian cosmetics market is expected to reach $20 billion by 2025. Understanding local consumer behavior and market trends is critical. Our in-depth market research will help you identify consumer preferences, inform your product positioning, and develop the optimal pricing strategy to appeal to the Indian market

Joint Venture With Indian Manufacturers

Entering the Indian market is often more effective with a local partner. Through a joint venture, you can tap into the existing distribution networks, benefit from local expertise, and streamline your entry into the market. We can assist you in identifying suitable Indian manufacturers and forming strategic partnerships to strengthen your market presence.

At Shen Clinical Services LLP, we provide end-to-end support for registering and launching your cosmetics products in India, ensuring full compliance with regulatory requirements and facilitating your success in one of the world’s fastest-growing markets.

Distributor Identification
Successful market entry in India requires finding the right distribution partners. We help identify ideal distributors and e-commerce partners to ensure your products have the right channel for success in India’s competitive market. Our network connects you with the right platforms to build your brand’s reach across the country.
Market Research And Price Research
The Indian cosmetics market is expected to reach $20 billion by 2025. Understanding local consumer behavior and market trends is critical. Our in-depth market research will help you identify consumer preferences, inform your product positioning, and develop the optimal pricing strategy to appeal to the Indian market.
Joint Venture With Indian Manufacturers

Entering the Indian market is often more effective with a local partner. Through a joint venture, you can tap into the existing distribution networks, benefit from local expertise, and streamline your entry into the market. We can assist you in identifying suitable Indian manufacturers and forming strategic partnerships to strengthen your market presence.

At Shen Clinical Services LLP, we provide end-to-end support for registering and launching your cosmetics products in India, ensuring full compliance with regulatory requirements and facilitating your success in one of the world’s fastest-growing markets.

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