CDSCO Import Registration for Eye Cream in India: IS 6608 and the Complete Process

Eye creams and eye gels are a premium anchor of most skincare ranges, and they must be registered with CDSCO under the Cosmetics Rules, 2020 before import. Registration is product-level and tied to the specific formulation and factory.

Unlike a toner or serum, an eye cream does have an applicable Indian Standard — IS 6608 for skin creams — and because it is used around the eye, it also picks up the tighter eye-area controls on colourants and mercury.

Is CDSCO Registration Mandatory for Eye Cream?

Yes. Eye cream is a Fourth Schedule skin-care preparation and needs CDSCO registration before the first consignment. The IS 6608 Certificate of Analysis and the anti-ageing claim review are the two pivots of the filing.

Applicable Standard for Eye Cream

The applicable Ninth Schedule standard is IS 6608 for skin creams, and the Certificate of Analysis must report against its parameter set: pH, non-volatile matter, water content, freedom from grittiness and rancidity, and stability at elevated temperature. Freedom from grittiness matters for a product applied to the delicate eye area.

Because the eye area is a sensitive zone, an eye cream also inherits the eye-area rules that apply to eye cosmetics generally: any colourant must be one permitted for use in the eye area under IS 4707 (Part 1), and mercury is permitted only as a preservative in eye-area products and only up to 70 ppm (0.007%). An ophthalmological safety or eye-irritation assessment strengthens the file for a leave-on eye product.

Anti-Ageing Claims and the Eye Area

An eye cream stays a cosmetic when it makes appearance-level claims — “reduces the look of fine lines”, “brightens the under-eye area”. It edges toward a drug where it promises to “treat” dark circles as a medical condition or contains an active at a therapeutic strength. Rule 36 prohibits misleading claims, and therapeutic claims convert a cosmetic into a drug.

Documents Required for Eye Cream CDSCO Registration

• Certificate of Analysis against IS 6608 — pH, non-volatile matter, water content, freedom from grittiness and rancidity, and stability at elevated temperature.
• Microbiological limits report.
• Heavy-metals report or manufacturer undertaking (Pb, As, Hg and other heavy metals).
• Colourant declaration limited to colours permitted for the eye area under IS 4707 (Part 1), where the cream is tinted.
• Ophthalmological safety / eye-irritation assessment.
• Claim-substantiation dossier for any anti-ageing, firming or dark-circle claim.

Label Requirements Specific to Eye Cream

• Directions for safe use and a caution to avoid direct contact with the eye.
• Address of the actual manufacturer, or “Made in ____” where contract manufactured.
• For containers of 30 g or less (solid / semi-solid), manufacturer name and principal place of manufacture with PIN code is sufficient.
• Any anti-ageing claim supported by the substantiation on file.

Step-by-Step: CDSCO Import Registration Process

The CDSCO cosmetic import registration route is the same for every product category, and we explain each step in our complete CDSCO cosmetic registration guide. For eye cream, these are the points that need the most attention:

Confirm the product is a cosmetic rather than a drug, test it against the applicable Indian Standard, and keep the labelling claims consistent with the formula you file.

Common Mistakes That Trigger a CDSCO Query

• Anti-ageing or dark-circle claims that stray into therapeutic territory.
• Colourants in a tinted eye cream that are not on the eye-area permitted list.
• A CoA that omits stability at elevated temperature or the microbiological limits.
• Variants under-declared for the USD 50 variant fee.

Related Approvals to Plan Alongside CDSCO

• DGFT Importer-Exporter Code — every importer of record needs one before the first consignment.
• LMPC registration (Legal Metrology) — eye cream is a pre-packaged commodity requiring MRP, net quantity, importer details, country of origin and consumer-care details on the pack.
• Wholesale licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
• Drug import licence (Form 10) — needed if a therapeutic claim or a pharmacologically active ingredient makes the product a drug instead of a cosmetic.

Frequently Asked Questions

Is CDSCO registration mandatory for imported eye cream?

Yes. Eye cream is a Fourth Schedule skin-care preparation and cannot be imported until registered under Rule 12(1) of the Cosmetics Rules, 2020, with the certificate issued in Form COS-2.

Which Indian Standard applies to eye cream?

IS 6608 for skin creams. The CoA reports pH, non-volatile matter, water content, freedom from grittiness and rancidity, and stability at elevated temperature.

Are there special rules because it is used near the eye?

Yes. Any colourant must be one permitted for the eye area under IS 4707 (Part 1), and mercury is permitted only as a preservative in eye-area products and only up to 70 ppm.

Can I claim my eye cream removes dark circles?

A cosmetic can claim to reduce the appearance of dark circles with substantiation. A claim to treat or cure them is therapeutic and moves the product to the drug route.

Why Choose PCN India Global

• Claims triage — we confirm upfront whether your eye cream is cleanly cosmetic or at risk of drug reclassification.
• Category mapping — the correct Fourth Schedule category and test scope confirmed for your formulation.
• Dossier assembly — the full core document set prepared and cross-checked against the CDSCO checklist.
• Label compliance — a Chapter VI review to correct any non-compliant or therapeutic wording before you print packaging.
• End-to-end SUGAM filing — application, query response and the Form COS-2 grant managed for you.
• Adjacent approvals — LMPC, DGFT/IEC and, where relevant, PESO/AYUSH coordinated alongside your CDSCO registration.

PCN India Global manages the complete CDSCO import registration process for eye cream — from claims triage and category mapping to dossier assembly, SUGAM filing and the Form COS-2 grant. WhatsApp or call +91 80109 05029, or email bdm@pcnindiaglobal.com, to get your import registration underway.

Related Compliance Guides

• Legal Metrology (LMPC) Registration
• DGFT License Services (Importer-Exporter Code)
• CDSCO Registration for Skin Cream & Lotion

Related Guides

• CDSCO Import Registration for Face Mist & Setting Spray in India
• CDSCO Import Registration for Facial Cleanser & Face Wash in India
• CDSCO Import Registration for Face Serum & Ampoule in India
• CDSCO Import Registration for Cleansing Oil & Micellar Water in India

Need expert help? See our CDSCO registration services.