In India, most people wish to have a whiter and healthier smile, and the market for cosmetic teeth whitening products is rapidly growing. Are you a business that is planning to import these products into India? Then you need to know the governing laws. One of them is a cosmetic import license for tooth whitening products. This article will provide you with all the details that you require regarding the import license procedure, regulations, and important details you must meet.
What is a Cosmetic Import License for Tooth Whitening Products?
Acquiring the import license for tooth whitening cosmetics means that you have received a business license from the relevant agency to import tooth whitening cosmetics.In India, approvals would be made through the Central Drugs Standard Control Organization (CDSCO) (Ministry of Health and Family Welfare). There is an interesting idea in that tooth whitening products are cosmetic products in India (Cosmetics Act 1940), but it can also be a drug if it is claimed to have a therapeutic function.
Why Do You Need A Cosmetic Import License?
Under Indian law, it is illegal to import cosmetic products, including teeth whitening products, without a license. Obtaining a cosmetic import license provides:
- Safety of Products: It is. A guarantee that the product meets (safety) standards and, thus, does not include danger.
- Quality Control: It considers the processes that include production and ingredients.
- Consumer Protection: It ensures that an inundation of unsafe products is not introduced to the markets and consumers.
- Compliance: It avoids fines, seizure of products, and litigation.
How To Get a Cosmetic Import License For Tooth Whitening Products
Below is a complete procedure for you to obtain a Cosmetic Import License for Tooth Whitening Products in India. Compliant with the CDSCO regulations by following these steps:
Step 1: Product Classification
You will need to ensure that your tooth whitening product is classified as a cosmetic (specifically as oral hygiene products under Category 21 but not dentifrices) under the Cosmetic Rules, 2020. It should not have any therapeutic claims, or else it will probably fall into the definition of a drug or medical device.
Step 2: Appoint an Indian Authorized Agent
If you are a foreign manufacturer you must appoint an Indian Authorized Agent with a Power of Attorney. The agent will apply and be the responsible Country representative for regulatory purposes.
Step 3: Register on the CDSCO SUGAM Portal
You can create an account on the CDSCO’s SUGAM portal (https://cdsco.gov.in). You must register as either an importer or agent and complete the registrant’s profile to gain access to the online application forms.
Step 4: Collect all Required Documents
Collect all the required documents, including the Free Sale Certificate, Power of Attorney, product composition, manufacturing license, test reports, label artwork, photos of the product, etc. The documents must be in PDF format and duly signed.
Step 5: Submit on Line Form COS-1
Log in to the SUGAM portal and complete and submit online Form COS-1, the cosmetic import registration certificate application, with uploaded documents and all product details using the format specified by CDSCO.
Step 6: Payments Of the Fees
Pay for the appropriate fees – USD 1,000 for every brand/category, USD 50 for every variant, and USD 500 for every site of manufacture. Payments must be made via the specified banks (Bank of Baroda) or by the indicated way in SUGAM.
Step 7: Review by CDSCO
Once you register your application, CDSCO will review it. If there are any inadequacies regarding documentation or need clarification, they will raise queries. You must respond to queries promptly to avoid any delays. If there are no queries, you will receive a decision in a few months. The review process can take between 2 – 6 months.
Step 8: Acquire your Import Registration Certificate (Form COS-2)
Assuming the application you submitted is successful, you will be issued a Form COS-2 document from the CDSCO as an official Import Registration Certificate. Form COS-2 is valid for three years and constitutes a requirement for customs clearance, and also allows for legal sale.
Step 9: Obtain your Importer Exporter Code (IEC) from DGFT.
You will also need to either secure an Importer Exporter Code (IEC) from the Directorate General of Foreign Trade (DGFT) during the application process or if you don’t have one already.
You will need to obtain an IEC for customs clearance and business purposes. Â
Step 10: Ensure Labeling Compliance
Before distribution, check that your product labels fulfil the relevant Indian requirements (i.e., Product Name, Ingredients, Net Content, Manufacture and Expiry Dates, Batch No., details of Importer, reasonable warnings, etc.).
Step 11 – Clearing Customs and Record-Keeping
Present the COS-2 certificate and IEC code for import clearance to customs. Keep proper records of all your imports, distribution, and lab testing. CDSCO may perform random inspections on your products.
Documents Required for Cosmetic Import License for Tooth Whitening Products
Following is the list of documents required for obtaining a Cosmetic Import License for Tooth Whitening Products from CDSCO:
- Covering Letter (addressed to DCGI)
- Form COS-1 (filled and submitted on CDSCO’s SUGAM portal)
- Power of Attorney (notarized and apostilled/legalized)
- Free Sale Certificate (FSC) from the country of origin
- Product Specifications and Test Methods
- Certificate of Analysis (CoA) for each product/variant
- Valid Manufacturing License or GMP Certificate
- Schedule D(III) Undertaking (signed by manufacturer)
- List of Ingredients with % Composition
- Labeling Information (proposed product labels – inner & outer)
- Product Artwork/Images
- List of Products/Variants (Excel format – brand-wise)
- Safety and Efficacy Data (if applicable)
- Manufacturing Site Details
- Proof of CDSCO Fee Payment (challan or online receipt)
Validity Of Cosmetic Import License For Tooth Whitening Products
The license will be valid for 3 years, after which a renewal will be required.
Who Issues A Cosmetic Import License In India?
In India, the Central Drugs Standard Control Organization (CDSCO) is the government authority that issues the import licenses for cosmetics. The CDSCO operates under the Drugs and Cosmetics Act, of 1940, and the Drugs and Cosmetics Rules, 1945.
Why Choose ELT Corporate?
ELT Corporate makes the CDSCO licensing for your cosmetic imports as easy as possible. We can provide you with expert guidance, document assistance speedily, and assist you with the process from Product classification to License. We would help you from start to finish. Leading brands usually select us for our speed and precision, and we can guarantee that we have followed statutory obligations concerning the sale of all your tooth whitening products in India.
FAQs
Is an import license classified as a cosmetic compulsory for tooth whitening products?
Of course, if you wish to import tooth whitening products that are categorized as cosmetics into India, you will need to acquire a cosmetic import license from CDSCO.
What happens if the whitening product has an excessive amount of hydrogen peroxide?
It’s classified as a drug if it contains over 6% hydrogen peroxide, meaning it will need a drug import license, which has more stringent rules.
Could a foreign manufacturer apply for the import license on his own?
No, foreign manufacturers need to appoint an Authorized Indian Agent to submit the application on their behalf.
