CDSCO Cosmetic Import Documents Checklist: Korea to India (2026 Complete Guide)

• The COS-1 application to CDSCO requires at least 12 core documents — missing even one can delay your import license by months.
• Korea's MFDS-issued Free Sale Certificate must be apostilled under the Hague Convention before submission to CDSCO in India.
• A manufacturer authorization letter, heavy metal test report, and non-animal testing declaration are mandatory for all Korean cosmetic imports.
• This checklist covers documents for both the import route (COS-1/COS-2) and the manufacturing route (COS-5/COS-8) with exact specifications.

Introduction

To import Korean cosmetics into India legally, you need to file Form COS-1 with CDSCO. The mandatory documents include: Free Sale Certificate (FSC) from Korea's MFDS (apostilled), GMP Certificate, Manufacturer Authorization Letter, complete INCI ingredient list with percentage content, product labels in English, Certificate of Analysis (CoA), heavy metal test report, non-animal testing declaration, and COS-1 application form with prescribed fees.

For Indian manufacturing of Korean formulations, the documents are filed via Form COS-5 to the State Licensing Authority. CDSCO processes COS-1 in 30–90 working days. All foreign documents must be apostilled or notarized before submission.

Why Getting the Documents Right Matters

If you are importing Korean cosmetics into India — whether you are a Korean brand, an Indian distributor, or a regulatory consultant — the documents you submit to CDSCO make or break your import license application. One missing paper, an apostille that was skipped, or an ingredient list that lacks percentage concentrations is enough to get your COS-1 application rejected or delayed.

India's Central Drugs Standard Control Organization (CDSCO) operates under the Drugs & Cosmetics Act 1940 and its Rules 1945. Every cosmetic import requires prior approval in the form of a COS-2 license — and that license only comes after CDSCO reviews your COS-1 application and all supporting documents.

This guide gives you the complete, verified document checklist for 2026 — covering both the import path (COS-1 → COS-2) and the manufacturing path (COS-5 → COS-8). It also explains what each document must contain, which authority issues it, and what the apostille requirement means in practice.

Regulatory Framework: Who Asks for What

CDSCO Cosmetic Import Documents Checklist: COS-1 Application (Import License — Korea to India)

The following is the complete, sequential checklist of documents required for a COS-1 application with CDSCO. Each document is mandatory unless marked 'Conditional'.

Pro Tip — Apostille Requirement for Korean Documents

India joined the Hague Apostille Convention on 14 July 2005. This means all public documents originating in Korea — including the Free Sale Certificate and GMP Certificate — must carry an apostille stamp before CDSCO will accept them. In Korea, the apostille is issued by the Ministry of Foreign Affairs (MOFA). The process takes 3–5 business days. Skipping apostillation is the single most common reason for COS-1 rejection.

Detailed Requirements for Each Critical Document

Free Sale Certificate (FSC) from MFDS Korea

The Free Sale Certificate (FSC) is the single most important document in your COS-1 application. It is the official proof that your Korean cosmetic product is legally manufactured and sold in Korea.

• Issued by: Ministry of Food and Drug Safety (MFDS), Korea
• Korean term: 수출용 제품 판매 증명서 (Export Sale Certificate)
• How to obtain: Apply at the MFDS integrated portal (nedrug.mfds.go.kr)
• Processing time: 5–10 business days in Korea
• Apostille requirement: Yes — apostille from Korea's MOFA is mandatory before submission to CDSCO
• Validity: CDSCO accepts FSCs issued within the last 2 years
• Common mistakes: Product name on FSC not matching the application exactly; expired FSC; apostille missing or incomplete

What the FSC must state:

• Name and address of the Korean manufacturer
• Product name (exactly as it will appear on the Indian label)
• Product category (e.g., moisturiser, toner, sunscreen)
• Confirmation that the product is legally sold in Korea
• Date of issue and MFDS seal

GMP Certificate (Good Manufacturing Practice)

The GMP certificate confirms that the Korean facility manufacturing the product operates to internationally recognised quality standards.

• Issued by: MFDS Korea or an internationally accredited certification body (ISO 22716)
• Apostille requirement: Yes — required for MFDS-issued GMPs
• Validity: CDSCO accepts GMP certificates valid within the last 3 years
• Scope: Must explicitly name the manufacturing site address and cover the product category
• ISO 22716: The international GMP standard for cosmetics — widely accepted by CDSCO

CDSCO may request an inspection of the manufacturing facility for high-risk categories or novel ingredients. In practice, this is rare for standard cosmetic categories but common for hair dyes and sunscreens.

Manufacturer Authorization Letter

This letter is the legal instrument through which the Korean manufacturer authorises the Indian importer to import, distribute, and market their products in India.

• Must be on the manufacturer's official company letterhead
• Must name the Indian importer specifically — a generic letter ('to whom it may concern') is not acceptable
• Must list the specific products authorized for import — product-wise and SKU-wise if possible
• Must include the authorization period (typically 1–3 years)
• Must be signed by an authorised signatory of the Korean manufacturer (CEO, Director, or authorised officer)
• Must be apostilled or notarized — CDSCO officers may reject letters without notarization

If the Korean brand has a subsidiary in India, the letter must still be issued by the Korean manufacturing entity

INCI Ingredient List with Percentage Content

This is the most technically demanding document in the checklist. CDSCO requires not just the INCI names but also the actual concentration of each ingredient.

• All ingredients must use INCI (International Nomenclature of Cosmetic Ingredients) names — not trade names, Korean names, or chemical abbreviations
• Listed in descending order of concentration (highest first)
• Percentage (%) content must be declared for each ingredient
• Ingredients present at less than 1% may be grouped and listed in any order after those above 1% — but each must still have a % declared
• Must be on the manufacturer's official letterhead and signed by the QC/R&D head
• This document is treated as confidential by CDSCO and is not published publicly

Why % concentration matters: CDSCO cross-checks concentrations against Schedule S (restricted substances list). For example, hydroquinone is restricted to 2%; if your product contains more than this, it cannot be imported.

English Product Labels (Label Specimen)

A printed specimen of the proposed English label must be submitted with the COS-1 application. This label must be compliant with both CDSCO and Legal Metrology requirements.

Label elements that CDSCO checks:

• Product name and generic description
• Full INCI ingredient list (in descending order, without % — % is in the separate document)
• Net quantity in metric units (ml or g)
• Manufacturing date and expiry date / PAO symbol
• Batch number
• Country of origin: 'Made in Republic of Korea'
• Importer's name, full Indian address, and customer care contact
• MRP (Incl. of all taxes) — can be left blank on label draft if not yet fixed, but slot must be visible
• Directions for use (for functional products like sunscreens, hair dyes)
• Any required warnings or precautions

Label rejection is common. The most frequent reason is missing importer contact details or INCI names not matching the ingredient list submitted separately.

Heavy Metal Test Report

Since 2018, CDSCO has consistently required heavy metal test reports for cosmetic import applications, especially for skincare, colour cosmetics, and lip products.

• Test must be performed by a NABL-accredited laboratory in India, or an ISO 17025 accredited laboratory internationally
• CDSCO may request fresh Indian lab testing even if a Korean lab report is submitted
• Report must include the batch number tested, methodology used (typically ICP-MS), and detection limits

Non-Animal Testing Declaration

• India banned cosmetic animal testing in 2014 under the Drugs & Cosmetics (Fifth Amendment) Rules. This means no cosmetic product — or any ingredient used solely in cosmetics — can be imported into India if it was tested on animals after the ban date.
• The declaration must be signed by the Korean manufacturer's authorized signatory
• It must state: (a) the finished product was not tested on animals, and (b) the cosmetic ingredients were not tested on animals specifically for cosmetic purposes
• The declaration should cover the specific product(s) listed in the COS-1 application
• Internationally recognized cruelty-free certifications (Leaping Bunny, PETA) can be attached as supporting evidence
• This is a self-declaration — CDSCO does not independently verify, but false declarations attract legal liability

Important Clarification

The animal testing ban applies to testing for cosmetic purposes. If an ingredient is used in both a drug and a cosmetic, the testing prohibition covers only cosmetic-specific testing. Korean manufacturers supplying both pharmaceutical and cosmetic markets must document this distinction carefully in their declaration.

COS-1 Application: Step-by-Step Filing Process

• The COS-1 form is available on the CDSCO Sugam portal. Here is how to file it correctly in 2026.
• Create or log in to your account on the CDSCO Sugam portal (sugam.gov.in). The Indian importer must hold the account.
• Select 'Application for Import License — Cosmetics' and choose Form COS-1.
• Enter importer details: company name, GST number, Import-Export Code (IEC), registered address, and customer care contact.
• Add product details for each product: product name (as on label), category, manufacturer name and address, country of origin, shelf life, and label description.
• Upload all supporting documents in PDF format. Each document must be clearly named and under the file size limit specified on the portal.
• Calculate the fee based on the number of products. Pay online through the Sugam portal's payment gateway.
• Download and keep the fee payment receipt (challan). This is part of the application.
• Submit the application. Note the application reference number.
• Monitor the portal for queries from CDSCO reviewers. Respond to all queries within the specified timeline (typically 30 days).
• Upon approval, download the COS-2 license from the Sugam portal.

Form COS-2 — Grant of Import License: What You Receive

Once CDSCO approves your COS-1 application, they issue Form COS-2 — the actual Import License for Cosmetics. This is the document that makes your import operation legal in India.

Form COS-5 — Application for Manufacturing License

If your Korean brand or its Indian partner wants to manufacture cosmetics in India — either from Korean formulations or locally developed K-beauty inspired products — you need a COS-5 application and the resulting COS-8 manufacturing license.

Who Needs COS-5?

• Indian companies manufacturing Korean-formulated products under a license or technology transfer agreement
• Contract manufacturers (CMOs/CDMOs) in India who will produce products for a Korean brand
• Korean companies that have set up Indian subsidiaries with manufacturing facilities
• Businesses shifting from importing to Indian manufacturing to reduce duty costs

Documents Required for COS-5 Application

COS-5 is filed with the State Licensing Authority (SLA) — not CDSCO centrally. Each Indian state has its own Drug Controller who handles COS-5 applications. The process, fees, and timelines vary by state.

Form COS-8 — Grant of Manufacturing License

COS-8 is the manufacturing license issued by the State Licensing Authority once the COS-5 application is approved and the manufacturing premises have been inspected.

Import vs Manufacturing Route: Document Comparison

Apostille Process for Korean Documents: Step-by-Step

Korea is a member of the Hague Apostille Convention. India joined in 2005. This means Korean official documents — primarily the Free Sale Certificate and GMP Certificate — must carry a Korean apostille before they are legally valid in India.

Note: If any document has been translated from Korean to English, the translated version must also be apostilled or certified by a notary. CDSCO officers verify the apostille chain for Korean-language originals.

MOFA Korea Apostille portal: apostille.go.kr (Korean language; use a Korean regulatory consultant for guidance).

Fees for CDSCO COS-1 Application (2026)

Fees are prescribed under the Drugs & Cosmetics (Fees) Rules. Always confirm current fees on the CDSCO Sugam portal before filing, as revisions may occur. The following are indicative 2026 figures.

All CDSCO fees must be paid through the Sugam portal's online gateway. Do not make cash payments or bank transfers outside the portal — these are not accepted.

End-to-End Timeline: Korean Cosmetics Import License India

Fast-track or priority processing is not a formal CDSCO programme. However, complete applications with no deficiencies are processed faster. Engaging a CDSCO-experienced regulatory consultant significantly reduces query rates and delays.

Validity and Renewal: COS-2 & COS-8

Common Reasons for COS-1 Application Rejection or Delay

Frequently Asked Questions