COS-1 Import Registration Certificate

Rule 12(1) of the Cosmetics Rules 2020 is unambiguous: no cosmetic from a non-SAARC country enters India without a Registration Certificate granted by the Central Licensing Authority. Form COS-1 is the prescribed application for that certificate. Filing is exclusively through CDSCO's SUGAM portal. There is no offline route.

The legal definition of a cosmetic under Rule 2 draws from Section 3(aaa) of the Drugs and Cosmetics Act, 1940 — any article applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance, including components of cosmetics. Products making therapeutic or drug claims fall outside this definition. Rule 36 governs that boundary; such products cannot be registered under Chapter III.

Who Can File COS-1

The application may be filed by the foreign manufacturer directly or by an Authorised Agent in India appointed by the manufacturer. Rule 3(d) defines the Authorised Agent as the person in India who assumes full legal responsibility for the manufacturer's business activities and compliance with the Act and all rules thereunder.

For foreign manufacturers without an Indian legal entity, appointing an Authorised Agent is the mechanism through which a compliant presence is established for the purposes of the Cosmetics Rules 2020. The agent is not a passive intermediary — under Rule 65(1), the agent is responsible for initiating market recall procedures if imported cosmetics pose a health risk to users.

Documents Required

From the foreign manufacturer:

- Letter of Authorization in the form prescribed in the First Schedule, duly authenticated

- Product composition — INCI names with exact percentages for each variant

- Manufacturing site details

- Labelling details for each product

- Free sale certificate from the country of origin

- Undertakings on animal testing compliance and heavy metal limits

From the Indian applicant (manufacturer or Authorised Agent):

- Covering letter on company letterhead

- Completed and signed Form COS-1

- Import Export Code (IEC)

- GSTIN

- Payment proof (Bharatkosh challan)

Names, addresses, and product particulars must be consistent across every document in the file. CDSCO's scrutiny team treats internal consistency as a first-pass filter; mismatches trigger deficiency notices regardless of the quality of individual documents.

Second Schedule — Part I Requirements

The Second Schedule (Part I) is the core information document accompanying every COS-1 application. It requires:

- Full particulars of the manufacturer and manufacturing premises: name, address, telephone, email, and names and addresses of all partners or directors

- Name and address of the authorised importer, distributor, or agent in India, including partners and directors

- A brief profile of the manufacturer's business activity

- Product particulars: names, brand names, categories, pack sizes, and all variants

- Copies of manufacturing licenses, marketing authorizations, or free sale certificates from the country of origin

- List of countries where marketing authorization or import permission has been granted

- Chemical information: INCI names of all ingredients with exact percentages, specifications, testing methods, labelling details, and package inserts

- Four mandatory undertakings: compliance with Chapter III; conformity to BIS standards per the Ninth Schedule; confirmation that products have not been tested on animals on or after 12 November 2014; adherence to heavy metal and hexachlorophene limits

The INCI name requirement admits no deviation. Ingredients submitted under trade names or common names without corresponding INCI nomenclature constitute a standard rejection trigger under CDSCO's non-compliance list.

Letter of Authorization — Rule 12(3) and First Schedule

The Letter of Authorization is the document most frequently cited in CDSCO deficiency notices. Rule 12(3) and the First Schedule set out its requirements precisely.

The document must be:

- Signed by the foreign manufacturer

- Accompanied by an undertaking signed by the Authorised Agent in India

- Authenticated in one of three ways: before a First Class Magistrate in India, by the competent authority in the country of origin, or via apostille

The authorization must explicitly state that the agent is the official representative for obtaining the Registration Certificate, submitting all required documents, and assuming legal responsibility for compliance. It must list the specific products, brand names, variants, pack sizes, and actual manufacturing premises covered.

A generic authorization that does not name specific products or manufacturing premises fails First Schedule requirements. Authentication by a notary public where apostille is required is a fatal deficiency and results in rejection.

SUGAM Portal — Application Process

All COS-1 applications are filed at sugam.gov.in. The workflow:

1. Create or log into your SUGAM account

2. Select the Cosmetics registration module

3. Complete Form COS-1 online

4. Upload all required documents: Second Schedule, First Schedule Authorization, free sale certificate, IEC, GSTIN, and all supporting documents

5. Pay the applicable fee via Bharatkosh — challan is generated within SUGAM

6. Submit the application

7. Monitor status; respond to any deficiency or discrepancy notice within the specified window

8. Receive Form COS-2 (Registration Certificate) on approval

Deficiency notices pause processing. The application does not restart from the original filing date — it advances from the point of resubmission.

Fee Schedule — Third Schedule, Rule 12(5)

Fees are denominated in US Dollars under the Third Schedule (Item 1) and paid at the applicable rate via Bharatkosh:

Item | Fee (USD)
Registration Certificate — per category of cosmetic | 1,000
Additional category in the same application | 1,000
Per variant (one formulation across all pack sizes) | 50
Per manufacturing site | 500
Permission for new cosmetic post-registration | 500
Overseas manufacturing site inspection | 5,000
Duplicate Registration Certificate | 200

Retention fees — due before the end of the fifth year from the date of issue — are equal to the original grant fees. Rule 14(2) imposes a late fee of 2% of the applicable retention fee per month for up to 180 days. Non-payment beyond 180 days results in deemed cancellation of the Registration Certificate.

Processing Timeline — Rule 13(1)

Rule 13(1) sets the statutory outer limit at six months from the date of application. CDSCO's operational target for complete, deficiency-free applications is 90 days.

Deficiency notices issued during scrutiny pause the application; the clock does not run while the file awaits correction from the applicant. Incomplete applications — specifically those where the information in Part I of the Second Schedule is not in order — are liable to rejection under Rule 13(1).

Validity and Retention — Rule 14

Under Rule 14(1), the COS-2 Registration Certificate has no expiry date. It remains valid in perpetuity provided the retention fee is paid before the end of every five-year period from the date of issue.

Rule 15 requires a fresh COS-1 application in the event of any change in the constitution of the applicant — for example, a change in the composition of the firm. Rule 15(3) requires notification to the Central Licensing Authority within 60 days of such a change.

Eligibility Restrictions

The following products are ineligible for COS-1 registration:

- Products whose manufacture, sale, or distribution is prohibited in their country of origin — Rule 18(1)

- Products containing hexachlorophene, with limited exceptions for soaps under Rule 39(4) — Rule 18(3)

- Products tested on animals on or after 12 November 2014 — Rule 18(4)

- Products containing raw materials listed in Annex A of IS 4707 Part 2 — Rule 39(2)

- Products using lead or arsenic as colouring agents, or containing mercury above 0.007% in eye products or 1 ppm elsewhere — Rules 39(5) and 39(6)

- Products making drug or therapeutic claims — Rule 36

Common Rejection and Deficiency Triggers

CDSCO's published non-compliance patterns and First Schedule requirements identify the following as the most common causes of deficiency notices and rejections:

- Inconsistent product or manufacturer details across the application file

- Letter of Authorization failing authentication requirements under Rule 12(3)

- Missing or incomplete free sale certificate from the country of origin

- Ingredient list using trade names instead of INCI nomenclature

- Fee underpayment caused by incorrect variant or site count

- Bharatkosh challan not matching the application reference

- Missing IEC or GSTIN

- Second Schedule Part I undertakings incomplete or unsigned

- Products containing restricted ingredients under Rule 39

Conclusion

COS-1 registration under Rules 12 to 14 of the Cosmetics Rules 2020 is the statutory prerequisite for all non-SAARC cosmetic imports into India. Contact us to assess your application before filing.