CDSCO Cosmetic Import Registration: 2026 Step-by-Step Guide

CDSCO Is Tightening Cosmetic Import Scrutiny in 2026 — Here’s What Importers Must Know

Importing cosmetics into India without a valid CDSCO Import Registration Certificate (Form COS-2) is not just a compliance gap — it is grounds for outright seizure of goods at the port of entry. As India’s cosmetic market expands rapidly, the Central Drugs Standard Control Organisation (CDSCO) has shifted toward sharper digital scrutiny: applications are now validated automatically on the SUGAM portal, reviewer tolerance for incomplete submissions has dropped, and the Bureau of Indian Standards (BIS) is expected to introduce mandatory quality control orders (QCOs) for select cosmetic categories before the end of 2026. If you are a foreign brand, importer, or Indian subsidiary planning to bring cosmetics into India, this guide maps every step you need to take — and every pitfall you need to avoid.

Legal Foundation: Cosmetics Rules, 2020 and GSR 763(E)

The import of cosmetics into India is regulated by the Drugs and Cosmetics Act, 1940, read with the Cosmetics Rules, 2020. The Drugs Controller General of India (DCGI) functions as the Central Licensing Authority (CLA) who grants Import Registration Certificates, as notified under Gazette Notification GSR 763(E). No cosmetic may be imported unless it is registered along with every pack size, variant, and manufacturing premise under Rule 21 of the Cosmetics Rules, 2020. State Licensing Authorities handle domestic manufacturing licences; CDSCO exclusively handles import registrations.

A critical compliance signal for 2026: CDSCO’s online MD portal activated a new provision for submitting Risk Classification applications for IVDs with effect from 18 February 2026, and a Special Code submission provision went live on 15 May 2026 — signalling CDSCO’s broader push toward structured, pre-classified digital dossiers across all regulated product categories, including cosmetics.

Who Must Register — and Who Can Apply

Every cosmetic manufactured at a foreign site and intended for commercial sale in India must carry a valid COS-2 registration before a single shipment clears customs. Eligible applicants under the Cosmetics Rules, 2020 include:

• The overseas manufacturer directly
• The manufacturer’s authorised agent in India
• An Indian subsidiary authorised by the manufacturer
• The importer in India

Where the brand owner is a company registered in India, its name and registered office address must appear on the registration application and, ultimately, on the product label.

Step-by-Step: The COS-1 to COS-2 Registration Pathway

Step 1 — Identify the Correct Cosmetic Category

CDSCO has classified imported cosmetics into approximately 80 product families, based primarily on intended use and body region of application. Correct categorisation is non-negotiable — placing a product in the wrong family is one of the most common reasons for query cycles and delays. Review the CDSCO guidelines column carefully before filing.

Step 2 — Appoint an Authorised Indian Agent

Foreign manufacturers must appoint an authorised agent in India before the application can be submitted. The authorisation must be duly authenticated — either before a First Class Magistrate in India, before the Indian Embassy in the country of origin, by an equivalent authority, or via Apostille for Hague Convention member countries. This document travels with every application and cannot be self-attested.

Step 3 — Compile the Documentary Dossier

The following documents must be submitted along with Form COS-1 on the SUGAM portal:

• Covering letter stating the purpose of the application
• Authenticated authorisation from the overseas manufacturer
• Complete ingredient list with percentage concentrations
• Labels of all proposed products (compliant with Rule 34 of the Cosmetics Rules, 2020)
• Free Sale Certificate (FSC) from the country of origin — required for every variant, not just the lead product
• Manufacturing licence or an undertaking that no such provision exists in the country of origin
• Declaration for heavy metal content and absence of hexachlorophene
• Original Bharatkosh e-receipt confirming fee payment

Important labelling check: Under Rule 34, imported cosmetic labels must display product name, manufacturer details, the RC registration number, ingredient list in descending order of percentage, batch number, date of manufacture, expiry date, net contents, and applicable special warnings (e.g., “For external use only”). Labels carrying false, misleading, or therapeutic claims will result in immediate rejection under Rule 39.

Step 4 — Pay the Fee via Bharatkosh

All fees are paid exclusively through the Bharatkosh gateway under Head of Account “0210041040000-00-1 – Import and Registration”. The applicable fee structure is:

• USD 1,000 per category for the primary registration
• USD 500 per variant under the registered category
• Adding an extra category post-registration: USD 1,000 per additional category
• Adding an extra manufacturing site: USD 500 per additional site

Step 5 — Submit Form COS-1 on the SUGAM Portal

The complete application — signed, stamped, and with all documents uploaded — is submitted through the CDSCO SUGAM online portal. No physical files are accepted. CDSCO officers review the dossier; if the information is incomplete or inconsistent, a query is raised. Post-query, applicants must respond within the stipulated window or risk the application being treated as withdrawn.

Step 6 — CDSCO Review and Issuance of Form COS-2

The CDSCO review of COS-1 applications may take a maximum of 180 days from the date of submission. Upon satisfactory review, CDSCO issues Form COS-2 (the Import Registration Certificate), and the approval letter is posted directly to the applicant’s SUGAM dashboard. If CDSCO identifies a need for overseas site inspection, additional inspection fees are levied separately.

The “New Cosmetic” Prior Permission Track — Form COS-12 / COS-3

If your product contains an ingredient not previously used in cosmetics in any country, or one not recognised in national or international literature, it qualifies as a New Cosmetic under the Cosmetics Rules, 2020. Prior permission from the DCGI in Form COS-3 is mandatory before applying for an import registration. The prior permission application is submitted offline in Form COS-12 with the required documents under Chapter V of the Cosmetics Rules, 2020. Only after obtaining Form COS-3 can the applicant proceed with the COS-1 import registration application.

The COS-4 Route: Importing an Already-Registered Cosmetic

If a cosmetic is already registered in India (Form COS-2) by another entity, any other person or entity may import it by applying separately in Form COS-4 for an Import Registration Number (issued in Form COS-4A) through the SUGAM portal, along with an undertaking as per the Sixth Schedule. The Import Registration Number (COS-4A) is valid for three years from the date of issue, unless suspended or cancelled earlier. All COS-4 applications must be submitted to the DCGI at FDA Bhawan, ITO, Kotla Road, New Delhi – 110002.

Key Restrictions — What Cannot Be Imported

Businesses must be aware of the absolute restrictions that apply to cosmetic imports:

• Animal-tested cosmetics are banned: Any cosmetic that involved animal testing at any point after 12 November 2014 cannot be imported into India.
• Prohibited substances: Products containing hexachlorophene, mercury compounds, or lead/arsenic-based colourants are strictly prohibited.
• Minimum shelf life: Only products with a minimum expiry period of six months from the date of import are permitted entry.
• False or misleading claims: Any cosmetic whose label purports to convey a false, misleading, or therapeutic/drug-like claim is barred under Rule 39.
• Ninth Schedule compliance: Products must meet the specifications under the Ninth Schedule of the Cosmetics Rules, 2020 or, where not listed, the standards applicable in the country of origin.

Post-Approval Compliance: What Happens After COS-2 is Issued

Obtaining Form COS-2 is not the end of the regulatory journey. Importers must actively manage their registration to avoid cancellation:

• Retention fee: The COS-2 certificate remains valid indefinitely, but a retention fee must be paid every five years. Failure to pay within the retention cycle attracts a late fee of 2% per month. If unpaid beyond 180 days, the registration is deemed cancelled.
• Address/name amendments: Changes to the name or address of the registration holder or the overseas manufacturer require an amendment application within 60 days of such change.
• Change of constitution: Any change in the constitution of the registration holder (e.g., merger, acquisition) requires a fresh registration application under Rule 12 within 180 days of the change.
• Adverse event reporting: Importers must promptly report any market withdrawals, regulatory restrictions, or “Not of Standard Quality” actions taken by any foreign regulatory authority for a registered product, and must stop dispatch immediately upon such notice.

Upcoming Regulatory Development: BIS Quality Control Orders for Cosmetics

Businesses should begin preparing for a material shift on the horizon. The Government of India is actively considering mandatory BIS certification for specific cosmetic categories under Quality Control Orders (QCOs). Testing has already been initiated in the toiletries, hair dye, and sunscreen segments, with an expected rollout before the end of 2026. Importers should now begin aligning their product specifications with BIS standards to avoid market disruption when QCOs come into force.

Practical Checklist for Importers in 2026

1. Confirm product category from CDSCO’s list of ~80 cosmetic families
2. Check if the product qualifies as a “New Cosmetic” requiring Form COS-12/COS-3 first
3. Appoint and authenticate the Authorised Indian Agent
4. Collect FSC for every variant (not just the lead SKU)
5. Verify labels comply with Rule 34 — no therapeutic or misleading claims
6. Confirm the product has not been animal-tested after 12 November 2014
7. Pay fees via Bharatkosh and retain the e-receipt before filing
8. File Form COS-1 on SUGAM portal and monitor the dashboard for queries
9. Diarise the 5-year retention fee deadline post-COS-2 issuance
10. Begin BIS specification alignment for hair dye, sunscreen, and toiletry categories

ACPL’s regulatory experts can help you navigate CDSCO cosmetic import registration from category identification and dossier preparation to SUGAM submission, query responses, and post-approval compliance management. Contact us at info@acplgroupindia.co.in or call +91-9266665201 for a consultation.