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CDSCO Approval For Cosmetic Bleach

CDSCO Approval For Cosmetic Bleach | A Complete Guide

Cosmetic bleaching products have become more popular in the Indian market because of their skin-lightening effects. There is growing consumer demand for safer bleach products to sell legally in the market. These increasing demands put a greater emphasis on getting CDSCO approval for cosmetic bleach. CDSCO regulates all beauty products sold in India, as they all fall under the Drugs and Cosmetics Act of 1940, and it will consolidate and compile explanations about the mandatory cosmetic license to sell cosmetic bleach, and all subsequent processes, including registration process assistance, required documents, timelines, and validity.

Definition Of Cosmetic Bleach Under CDSCO Guidelines

Concerning CDSCO, if it alters the appearance of the skin and whitens or lightens the skin, it is a cosmetic bleach. Cosmetic bleach may have acceptable ingredients, including hydrogen peroxide, ammonia, or plant-based lightening materials. Therefore, cosmetic bleach products may not have prohibited active ingredients and must comply with the general criteria of BIS formulations and labeling.

Understanding The Role Of CDSCO In Cosmetic Regulation

The Central Drugs Standard Control Organization (CDSCO) is a national drug regulatory authority (FDA) in India for pharmaceuticals and cosmetics. The CDSCO defines the regulations relating to the importation, manufacture, distribution, and sale of cosmetics through the Cosmetic Rules, 2020, and is responsible for and by these rules protect the health of the people. 

Cosmetic bleaches can be thought of as looking like noxious chemicals and are active in the skin; therefore, they are prescribed as active ingredients of cosmetic bleaches under the rules. This is why getting CDSCO Approval for Cosmetic Bleach is necessary to legally sell in the country.

Why Is CDSCO Approval For Cosmetic Bleach Important?

Obtaining CDSCO Approval for Cosmetic Bleach is more than just a regulatory necessity; it also symbolizes product credibility. Here’s why it is important:

  • Compliance: Ensures your product complies with Indian cosmetic law.
  • Safety: Minimizes the risk for consumers developing harmful skin reactions to your product or if you receive product recalls.
  • Market Acceptance: Retailers and online platforms like Flipkart and Amazon prefer to sell products that show compliance.
  • Import License: Needed for customs clearance.
  • Brand Credibility: A strong asset for your credibility with consumers and professionals in the beauty industry.

When Is CDSCO Approval Required for Cosmetic Bleach?

CDSCO Approval is mandatory under the following circumstances:

  • When importing cosmetic bleach from foreign manufacturers into India.
  • When introducing a new cosmetic bleach formulation in the Indian market.
  • If there is any change in product composition, manufacturer, or brand name.
  • Before launching a product under a new brand or variant.
  • During the renewal of the registration certificate, if the previous approval is about to expire.

Step-by-Step Process for Obtaining CDSCO Approval for Cosmetic Bleach

Here’s a step-by-step guide to applying for CDSCO Approval for Importing Cosmetic Bleach: 

Step 1: Appoint an Authorized Indian Agent 

The importer must appoint an Authorized Indian Agent (AIA) who has a valid Indian address. The AIA will make the application for the applicant, along with the coordination of the CDSCO. 

Step 2: Classify the Product 

Ensure that your product is classified as a cosmetic and does not fall under drugs or medicated cosmetics. Verify that your product meets the BIS standard for bleach-type cosmetics. 

Step 3: Filing of Form COS-1 

Complete and file Form COS-1 provided by CDSCO online at the SUGAM CDSCO portal with supporting documents and schedule of fees for registration of the cosmetic bleach product. 

Step 4: Supporting Documents 

Gather the supporting documents and file them with the application of COS-1 for the import registration certificate. Ensure the supporting document is accurate. If CDSCO, upon review, finds that any information is false, the application may be rejected. 

Step 5: Scrutiny and Query 

CDSCO will review your application and may ask questions or request clarifications. Make sure you respond quickly, and if CDSCO wants any additional information, make sure to get that to them promptly. 

Step 6: Grant of Registration Certificate (Form COS-2) 

Upon approval, you will receive a Registration Certificate in Form COS-2. The registration certificate is valid for 5 years unless suspended.

Documents Required To Apply For CDSCO Approval For Cosmetic Bleach

Here is the combined list of documents required for getting CDSCO approval to import and manufacture cosmetic bleach.

  • Covering Letter
  • COS-1 Form (Import)
  • COS-2 Certificate (Post-approval)
  • TR-6 Challan (fee payment)
  • Power of Attorney (for import)
  • Product Labels & Pack Inserts
  • Ingredient List with % composition
  • Free Sale Certificate / Manufacturing License
  • Non-Animal Testing & Heavy Metals Declaration
  • Plant Master File & Layout (for manufacturing)
  • Company Incorporation Docs
  • Equipment & Machinery List
  • Importer’s Drug License (20B/21B)
  • IEC Certificate (for import)
  • CPCB NOC (if applicable)

For better understanding, refer to these blogs: Documents Required for Cosmetics Import License

Labeling Requirements For Cosmetic Bleach In India

The packaging for your cosmetic bleach must adhere to the labeling requirements established by CDSCO, including:

  • The name of the product and category (e.g., “Skin Bleach Cream”)
  • Manufacturer’s name and address
  • Batch number and date of manufacture
  • Expiry date
  • Net content (weight or volume)
  • Directions and warnings for safe use
  • “Imported by” details (if imported)
  • Country of origin (if imported)
  • Ingredient statement in descending order of weight/volume

Key Compliance Tips to Ensure Approval

To improve your chances of securing CDSCO Approval for Cosmetic Bleach, keep the following points in mind:

  • Avoid banned or restricted ingredients listed in IS 4707 Part 1 and Part 2.
  • Submit only authentic documents with proper notarization.
  • Use high-resolution images for labels and product artwork.
  • Follow all BIS and ISO standards for safety and efficacy.
  • Maintain consistent product claims across all documents and marketing materials.

Timelines and Costs for CDSCO Approval of Import License for Concealer

Government fees and time requirements for CDSCO approval to obtain an Import license for concealers involve several fees. Understanding government fees will allow importers, sellers, and manufacturers to better plan when to prepare and launch their products in India.

Timeline
Step / ItemDuration / Cost (INR)
SUGAM Portal Registration3–7 working days
Application Review (Form COS-1)10–15 working days
Query Resolution (if applicable)7–10 working days
Final Approval & License Issuance (Form COS-2)5–7 working days
Total Time to Approval4–6 weeks

Note: The cost of obtaining CDSCO approval varies for different product variants. To know in detail, contact ELT Corporate at [+91 85859 19582]

Benefits Of Hiring A CDSCO Consultant

Due to the complexity of the regulatory process, it’s advisable to hire a cosmetic regulatory consultant. Here’s how a consultant helps:

  • Evaluate product eligibility and BIS compliance
  • Prepares and reviews documents
  • Coordinates with laboratories for testing and safety reports
  • Manages online submission and query resolution
  • Acts as liaison with the CDSCO

For expert assistance, you can reach out to ELT Corporate Private Ltd., a leading consultancy with proven experience in CDSCO cosmetic registration.

FAQs

How Long Does It Take To Get CDSCO Approval For Cosmetic Bleach?

The average processing time is 60–90 working days, excluding document preparation and query resolution.

Is Cosmetic Bleach Considered A Drug Or A Cosmetic By The Cdsco?

Cosmetic bleach is classified as a cosmetic under the Cosmetics Rules, 2020 unless it contains active pharmaceutical ingredients.

Can A Foreign Manufacturer Apply Directly To The CDSCO?

No. A foreign manufacturer must appoint an Authorized Indian Agent (AIA) who is responsible for applying.

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