Are you planning to start a face-mask business? Then, understand how to register cosmetic face mask with the CDSCO in India. As the Indian cosmetic industry is experiencing rapid growth, with increasing demand for skincare products like face masks. So, whether you are a manufacturer, importer, or distributor, obtaining a valid registration under the Central Drugs Standard Control Organization is a must.
In this guide, you will get the complete procedure for registering a face mask under CDSCO, including the list of required documents, & labeling guidelines.
What Is CDSCO & Its Role In The Cosmetic Industry
The Central Drugs Standard Control Organization (CDSCO) is a regulatory authority that was established under the Ministry of Health and Family Welfare of India. CDSCO is the regulatory authority responsible for approval, registration, and quality control of cosmetics, drugs, and medical devices in India.
What Qualifies As A Cosmetic Face Mask?
A cosmetic face mask is a topical skincare product intended for application to the face for a period of time for the benefit of the condition and/or appearance of skin. Cosmetic face masks are generally regarded as a cosmetic (as opposed to a drug or medical device) because it cleanse, beautify, or otherwise enhance attractiveness (with no effect on skin structure and function).
Who Needs To Register Cosmetic Face Mask With CDSCO?
All entities must register their face masks with the CDSCO before marketing products in India, which includes:
- Foreign manufacturers are importing face masks for use in India.
- Indian subsidiaries or distributors of foreign brands.
- Indian brands are using foreign vendors for their manufacturing.
Process Of Cosmetic Import Registration For Face Mask with CDSCO
The cosmetic face mask Import registration process with CDSCO involves several steps:
Step 1: Appoint An Authorized Indian Representative (AIR)
If you are a foreign Manufacturer and want to sell beauty products in the indian market, then you must appoint an Authorized Indian Representative (AIR).Â
Step 2: Create A Sugam Portal Account
The AIR must register on the CDSCO’s SUGAM portal to submit applications online. This involves providing company details and uploading required documents.
Step 3: Prepare Form COS-1
The application form for cosmetics import is Form COS-1. This form requires product information, manufacturer information, and declarations. It is important to ensure that the details have been properly filled out.
Step 4: Obtain Support Documents
The applicant will be required to obtain support documents – Power of Attorney, Free Sale Certificate, ingredients listing, product labels, good manufacturing practices (GMP) certificate, and hazardous data.
Step 5: Submit Application and Payment
The application and payment must be submitted at the same time via BharatKosh, through the SUGAM portal.
Step 6: CDSCO Review
The CDSCO will review the application and may request further clarifying documentation. The CDSCO can either approve or deny the application. If approved, the CDSCO will then issue a Cosmetic Import Registration Certificate (Form COS-2).
Step 7: After Registration
Once you have approval, you must comply with labeling requirements and keep good documentation. The registration is valid for three years and must be renewed before it expires.
Documents Required For CDSCO Registration Of Cosmetics Face Mask
Here is the list of documents required to register cosmetic face mask with CDSCO:
- Covering Letter: Addressed to the Drugs Controller General of India (DCGI), summarizing the application.
- Form COS-1: Duly filled and signed application form for cosmetic import registration.
- Power of Attorney (PoA): Empowerment of the Authorized Indian Representative (AIR) to act on behalf of the foreign manufacturer. The document must be notarized and apostilled/legalized.
- Free Sale Certificate (FSC): Certification issued by the regulatory authority of the exhibiting country confirming the product is being routinely sold or freely sold on the market of the exhibiting country.
- Manufacturing License / GMP Certificate: Documentation giving evidence that the product manufactured is made using GMP Good Manufacturing Practice.
- Product Ingredient List: Full declaration of ingredients (composition in percentage to be included).
- Product Specification and Test Methods: Physical, chemical, and microbiological specifications, along with test methods used.
- Label & Artwork for Each Product: Final product labels in compliance with Indian labeling regulations, including: Product name, Ingredient list, & Net content, etc.
- Pack Insert or Leaflet (if applicable): Refers to any usability information or promotional information accompanying the product.
- Safety and Stability Data (optional but highly recommended): May contain any reports and studies that demonstrate the safety and shelf-life of the product in case of inspection.
- Product Sample Invoice or Airway Bill (if applicable): May be necessary during the application process or the inspection process.
Legal Framework For Cosmetic Product Registration In India
The rules to register cosmetic face mask with CDSCO are as follows:
- Drugs and Cosmetics Act of 1940Â
- Drugs and Cosmetics Rules of 1945Â
- CDSCO Guidelines on Import and Registration of Cosmetics
Rule 129 of the Drugs and Cosmetics Rules of 1945 states that all cosmetic products imported into India have to be registered in the CDSCO by completing Form COS-1.
Labeling Guidelines For Cosmetic Face Masks
To comply with Indian regulations:
- The product name must match what’s registered
- The label must include the manufacturer’s details, expiry date, and batch number
- Use INCI names for ingredients
- Avoid therapeutic or misleading claims
Labels must also show the registration certificate number granted by CDSCO.
Timelines To Register Cosmetic Face Mask With CDSCO
Here’s a table showing the estimated timelines for registering a cosmetic face mask with CDSCO:
| Step | Estimated Timeline | Remarks |
| Appoint Authorized Indian Representative (AIR) | 1–2 weeks | Includes execution of Power of Attorney (PoA), may take longer if notarization/apostille is needed. |
| SUGAM Portal Registration | 2–5 working days | After the submission of the required documents. |
| Document Preparation & Form COS-1 | 2–3 weeks | Depends on the availability of documents like FSC, GMP, artwork, etc. |
| Application Submission & Fee Payment | 1–3 days | Done via SUGAM and BharatKosh portals. |
| CDSCO Review & Approval | 3–4 months (typical) | Time varies depending on the completeness of the application and the CDSCO workload. |
| Registration Certificate Issuance (Form COS-2) | Immediately after approval | Sent digitally via the SUGAM portal. |
Key Benefits Of CDSCO Cosmetic Registration
Registering your face mask products with CDSCO ensures:
- Legal Compliance with Indian LawsÂ
- Allows you to access retail and e-commerce platforms like Amazon, Nykaa, and so on.
- Consumer Trust/Credibility
- Eligible for institutional/government tenders
Renewal And validity Of Cosmetic Registration
CDSCO registration certificates for cosmetics are valid for three years, and applications for renewal need to be made at least 6 months before expiry.
FAQs
Is It Mandatory To Register A Cosmetic Face Mask With CDSCO before Selling In India?
Yes, if the face mask is imported or falls under a new product line, it must be registered with CDSCO under Form COS-1.
Can Indian Manufacturers Sell Face Masks Without Registration?
NO, Indian manufacturers are not required to apply for COS-1 registration for domestic manufacturing, but must apply for COS 8 to comply with the cosmetic regulations.
What Are The Fees To Register A Cosmetic Face Mask With CDSCO?
According to CDSCO, the fee is USD 250 per category or equivalent in indian rupees. Variants within a category do not have to pay for a full registration, but must be declared.
How Long Should It Take To Register A Cosmetic Face Mask?
Generally, it takes about 4-6 months to register a cosmetic, depending on the completeness of your documents and replies to the questions asked by the CDSCO.
