If you wish to sell or import under-eye creams, gels, or serums into India. You must understand that the products are regulated by the Central Drugs Standard Control Organization (CDSCO). This process is called CDSCO Approval for Eye Contour products.
In this blog, we will explain everything about how to get CDSCO approval, what documents are needed, and why this approval is important for eye contour products.
What Are Eye Contour Products?
Eye contour products are used as cosmetics around the eyes. These contouring products aim at diminishing skin bumps or puffiness known as bags, dark circles, wrinkles, along fine lines. Some of these products include:
- Under-eye creams
- Eye serums
- Eye gels
- Dark circle removers
As these products are intended for use on sensitive skin around the eyes, there is a need to obtain government permissions in order to ensure safety before selling them, which is why eye contour items need CDSCO approval.
Why CDSCO Approval Is Required For Eye Contour Products
CDSCO is India’s Office of Drug Control, and an eye contour product’s safety and medical claims must be verified by the CDSCO before being imported into India. Here are the following reasons why it matters:
- Compliance with Indian cosmetic law is mandatory.
- Safety and efficacy claims are substantiated.
- Business activities, including the importation or sale of the product in the Indian market, are permitted.
- Consumer and regulatory confidence is enhanced.
Step-by-Step Process To Get CDSCO Approval For Eye Contour Products
To get a CDSCO Cosmetic Approval for an eye contour product, it is mandatory to follow the step-by-step procedure as given below:Â
Step 1: Check If Your Product is Covered
Under the Drugs and Cosmetics Act, eye contour products are classified as a cosmetic and must comply with the CDSCO regulations before being marketed.
2. Appoint An Authorized Agent [If Required]
Foreign manufacturing companies need to appoint an authorized indian agent to get a CDSCO approval for eye contour products. Foreign manufacturers obtain this approval to ensure smooth access to the indian market.
3. Register on the SUGAM Portal
All the applications must be submitted using the SUGAM portal online. To submit these applications, you must create an account on csdco.gov.in.
4. Prepare Required Documents
Gather all the documents you will need to obtain a cosmetic license, as per the CDSCO guidelines. Make sure the provided documents are genuine and do not contain any false information. Below, we have attached the combined list of documents you may require for the cosmetic import and manufacturing license.
5. Pay the Fees and Submit the Application
Once the documents are aligned, apply and pay the governmental fees along with the application using Bharatkosh.
6. Get Your Registration Certificate
After verifying your application and documents, CDSCO will issue a registration certificate.
Documents Required To Obtain CDSCO Approval For Eye Contour Products
When applying for CDSCO registration for Eye Contour Products (as they are categorized under imported cosmetics). The following documents are generally required for Import Registration:
- Covering Letter
- Form COS-1: Duly signed by the authorized Indian agent/importer
- Authorization Letter/Power of Attorney: Issued by the manufacturer in favor of the Indian importer
- Free Sale Certificate: Issued by the regulatory authority in the country of origin
- Product Ingredient List: Complete list of ingredients with % composition
- Specifications and Testing Methods: For raw materials and final product
- Labeling Information: As per Rule 34 of the Cosmetics Rules, 2020
- Pack Insert/Leaflet (if any)
- Product Samples: For label review
- Manufacturing License/Certificate: Of the overseas manufacturer
- Product Details: Including product name, variants, and shade details
- Declaration: Regarding heavy metals and animal testing
- Undertaking by Indian Agent: Accepting regulatory responsibility
- Company Profile: Of both the manufacturer and the importer
Tips To Get CDSCO Approval Faster
The following are the tips to get CDSCO approval faster:
- Label cosmetic products according to India’s labeling regulations.
- Do not include any banned substances as identified by the CDSCO.
- Ensure that only clearly signed documents are submitted.
- To minimize lag time, consider using a regulatory consultant.
Who Should Apply For CDSCO Cosmetic Registration?
The following people or companies should apply:
- Foreign manufacturers who want to sell under-eye products in India
- Indian importers who bring in cosmetic items
- Brands planning to launch eye-care products in the Indian market
Benefits Of Getting CDSCO Approval For Eye Contour Products
Obtaining CDSCO approval for Eye Contour Products has many advantages, both commercial and regulatory:
- Legal Compliance: Avoids incurring penalties or bans by maintaining compliance with the India Drugs and Cosmetics Act of 1940 and its relevant rules.
- Market Access: Allows for legal importation as well as sale and distribution within the jurisdiction of India.
- Consumer Trust: India’s top drug authority boosts the credibility of Eye Contour Products to consumers through regulatory clearance, thereby enhancing trust.
- Competitive Edge: Gains an advantage over competitors who choose to operate in a grey market or do not follow regulations.
- Customs Clearance: Eases the process of customs clearance when it comes to imports.
- Marketing Leverage: Can be advertised as quality seals while being used on promotions as well as packaging, due to CDSCO acting as such a registration.
- Smooth Distribution: Makes it possible to register with demand e-commerce pharmacies, retail stores, and even without requiring regulatory approvals to sell them.
How ELT Corporate Pvt. Ltd. Can Help You Obtain CDSCO Approval Faster?
At ELT Corporate, we specialize in helping companies get their CDSCO approval for eye contour and other cosmetic products quickly and smoothly. Our team understands all the rules, paperwork, and online processes involved in CDSCO cosmetic registration.
Whether you are launching one eye-care product or an entire cosmetic range, we are here to make your CDSCO approval process hassle-free.
Contact us today [+91 85859 19582] to get started with your eye contour product registration in India.
FAQs
Is CDSCO Approval Mandatory For All Eye Contour Products?
Yes. All eye creams, serums, and gels imported for retail must have CDSCO approval before selling in India.
Can I Trade Under-Eye Products In India Without CDSCO Filing?
No. Trading imported cosmetics without a CDSCO filing is unlawful and may attract fines, refunding customers their money, seizing assets, or confiscating goods.
When Does One Get A Response From Application Submission?
In most cases, around 2 – 4 months, assuming there are no document errors or missing appendices that could slow things down due to needing more information.
