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Cosmetics Registration

Cosmetics
Regulatory Services

The Regulatory Authority that governs the regulations of import of Cosmetics into India is “Central Drugs Standard Control Organization” (CDSCO) HQ, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, FDA Bhawan, ITO, Kotla Road, New Delhi – 110002. 

In India, cosmetics are regulated under the Drugs & Cosmetics Act, 1940 and The Cosmetics Rules, 2020, requiring mandatory registration before import or sale. Manufacturers and importers must obtain approval from the Central Drugs Standard Control Organization (CDSCO) by submitting detailed product information, including pack size and manufacturing premises. This process ensures that cosmetic products meet safety and quality standards before reaching consumers, protecting public health and maintaining the integrity of the cosmetic market.

What is a Cosmetic in India?

As per Section 3(aaa) of the Drugs and Cosmetics Act, 1940, “Cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic.

Who Can Apply / Import Cosmetics into India?

The Manufacturer Himself

The Authorized Agent of the Manufacturer

The authorized subsidiary of the manufacturer in India

Any other importer in India

Are Imported Cosmetic Regulated in India?

Import of cosmetics is regulated in India under the provisions of the Drugs & Cosmetic Act, 1940 & the Cosmetics Rules, 2020.

  • New Brand having multiple products and variants (Shades / Flavour / Fragrances) shall apply for Fresh Application
  • New Products / Variants (Shades / Flavour / Fragrances) Addition shall apply for Endorsement Application.
  • Pack Size or Net Wt. addition for already registered products / variants shall apply for Additional Pack Size Application.
  • Renewal of already registered products shall apply for Re-Registration before the expiry of Fresh Registration Certificate.
  • Validity – Permission / Approval / Registration Certificate received is valid for a period of 5 years

Rule 12

Import of Cosmetics

Rule 18

Prohibition of import of certain cosmetic

Rule 17

Import of cosmetics already registered for import

Rule 16

Suspension and cancellation of Registration Certificate

Rule 15

Fresh application in case of change in constitution

Different Rules
Applicable in Imported Cosmetic Registration

Rule 12 sub-rule (2)

Application Form COS-1

Rule 13

Import Registration Certificate Form COS-2

Rule 14

Validity of import registration certificate

Various Forms as per the Cosmetic Rules, 2020

Form COS-1
Application Form

Form COS-2
Registration Certificate

Form COS-3
New Cosmetic Permission

Form COS-4
Already Registered Cosmetics Application Form

Form COS-4A
Import Registration No

Form COS-12
New Cosmetic Application Form

Labelling Guidelines:

The labelling requirements for cosmetic products in India are specified in the under Rule 34 of Cosmetic Rules, 2020, under the Drugs and Cosmetics Act, 1940. The key labelling guidelines are as follows:

  • 1. Name of the cosmetics
  • 2. Name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured
  • 3. Use before or date of expiry (month and year)
  • 4. Batch Number
  • 5. Manufacturing Licence Number
  • 6. Net Contents
  • 7. Directions for Use
  • 8. Warning / Caution
  • 9. Registration Certificate Number
  • 10. Name and address of the Importer
  • 11. Ingredients
  • 12. Instruction in English language

Step By Step Process

The cosmetic registration process follows a structured approach, starting with importer registration and document preparation. After submitting the necessary forms and government fees, the application undergoes CDSCO review. Upon approval, the registration certificate (Form COS-2) is issued, ensuring compliance with regulatory standards.

Step 1

SUGAM Portal Registration for Importer

Step 2

Document Collection

  1. Product List (Product Brand, Product Category, Product Name, Variants (Shade / Flavour / Fragrances / Pack Size)
  2. Actual Manufacturer and its premises
  3. Kit Name
  4. Artworks
  5. Formula / INCI Sheets
  6. Specification Sheet / Certificate of Analysis
  7. Testing Methods 

Step 3

Documents Preparation

  1. First Schedule
  2. Free Sale Certificate
  3. Heavy Metal Compliance Letter
  4. Non-Animal Testing Letter
  5. Microbeads Declaration
  6. No Provision for Manufacturing License Declaration

Step 4

Dossier Compilation

Step 5

Government fee payment on Bharatkosh

Step 6

Essential Documents Uploading As per Checklist

Step 7

Upload Government Fee Challan

Step 8

Form COS-1 generation

Step 9

Submission of Signed, Stamped Form COS-1

Step 10

CDSCO Processing

Step 11

Clarification Raised (Optional)

Step 12

Approval / Registration Certificate in Form COS-2 received

Government Fees

Government fees is calculated based on the products intended use. The categorisation of these products available for registration is to be done as per the Fourth Schedule – Sub – Rule 6.

  • Each Category USD 1,000
  • Each variant (Shade / Flavour / Fragrances) of cosmetic USD 50
  • Each Actual Manufacturer
    USD 500
  • Inspection of each overseas manufacturing site of cosmetics USD 5000