What Is CDSCO Certification for Other Skin Care Products? Requirements, Process & Cost

Although a skincare product may appear simple when on the shelf, it will have to go through a detailed regulatory framework if it is to be legally introduced into the Indian market.

Under India’s cosmetics framework, Other Skin Care Products can fall into a specific category that includes creams and lotions, along with special skin-care products that cannot be classified under conventional categories such as facial care, scrubbing, or bleaching products. If any product has to be imported to India, registration with the Central Drugs Standard Control Organisation (CDSCO) becomes essential.

As a foreign cosmetics manufacturer, exporter, trader, or brand owner, you need to understand CDSCO Certification for Other Skin Care Products if you plan to introduce such products in India.

The blog covers the relevant legal framework, who is eligible, the documents required, the process of registration, the government fees, the validity period, the timelines involved, the common difficulties, and the way in which UMSPCS can help to simplify the compliance process.

What does CDSCO certification for other skincare products entail?

In the case of imported cosmetics, the thing usually referred to as CDSCO Certification is the Import Registration Certificate issued under the Cosmetics Rules of 2020.

CDSCO requires that cosmetics imported into India be registered together with the relevant product details, the various variants, the pack sizes and the manufacturing premises before they are imported; an application for an Import Registration Certificate has to be filed online using Form COS-1, and the registration certificate itself is then issued in the form of Form COS-2.

Businesses which intend to import eligible Other Skin Care Products into India must evaluate their products in accordance with the Cosmetics Rules, 2020 and secure the relevant CDSCO registration prior to carrying out commercial imports.

Why is it Necessary to have CDSCO Certification?

The system of regulation in India is designed to make sure that any cosmetics entering the country comply with the required standards of quality and safety.

Under the Cosmetics Rules, 2020:

• Cosmetics that are imported have to be registered prior to being imported.
• It is necessary to provide the relevant product and the details of the manufacturing site.
• Products have to meet the relevant quality and safety requirements.
• Cosmetic claims have to be true and not misleading.
• Products have to meet the labelling and packaging requirements that apply to them.

The CDSCO also states that cosmetics must adhere to the specifications listed in the Ninth Schedule or to other relevant quality and safety standards. In the case where a cosmetic is not included in the Ninth Schedule, the applicable requirements and standards set out in the rules and, where appropriate, those of the country of origin must be taken into account.

What CDSCO Certification is Needed for Other Skin Care Products?

The registration procedure only becomes important in the case of cosmetic products being imported into India.

An applicant can include:

• The foreign manufacturer, where permitted and appropriately represented
• Authorised Indian Agent of the manufacturer
• Authorised subsidiary in India
• Other eligible importer

The guidance issued by CDSCO expressly allows applications to be made by the manufacturer, the authorised agent, the importer or the authorised subsidiary, on condition that the Cosmetics Rules, 2020, are met.

Foreign manufacturers therefore need to appoint an Authorised Indian Agent (AIA) and record the relationship as a key element of the compliance process.

Basic Requirements for Other Skin Care Products Registration

Before applying for CDSCO Registration for Cosmetics, businesses should evaluate the following:

• Correct Product Classification
• Compliant Formulation
• Manufacturing Site Details
• Product Variants and Pack Sizes
• Manufacturer Authorisation
• Compliant Labelling
• Supporting Regulatory Documents

Documents Required for CDSCO Certification

The exact document set can vary according to the applicant and product, but commonly required documentation may include:

• Cover Letter
• Application Form
• Authorization Letter
• Free Sale Certificate
• Manufacturing License from the place of origin
• Product Formula and Composition
• Product Specifications
• Artwork and Labeling
• Size and Variants of Packaging
• Certificate of Analysis
• Safety Information where applicable
• Declaration/Undertaking
• Details of Manufacturer
• Information about Manufacturer’s Manufacturing Facility
• Details of Authorized Agent
• Details of Brand Owner

The guidance issued by CDSCO states that the manufacturer’s authorisation must include relevant details regarding the manufacturer, the manufacturing premises, the authorised Indian agent, the products and the places where they are manufactured. It also lays down authentication requirements, these being able to involve execution before an appropriate authority, attestation by the Indian Embassy, or an apostille, according to the specific circumstances.

Step-by-Step Process for CDSCO Certification in India

Step 1: Product Classification & Regulatory Assessment

Check the product to see if it should be classified as an Other Skin Care Product and find the relevant requirements set out in the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020.

Step 2: Prepare Product & Technical Documents

Compile the required information, including:

• Product formulation and ingredient details
• Product specifications
• Manufacturing details
• Product labels and packaging
• Safety and quality information
• Test reports, wherever applicable

Step 3: Prepare the CDSCO Application

Make sure that the full application and all the supporting documents are prepared and checked, with attention to ensuring that the information regarding the product, the manufacturer, and the labelling is consistent.

Step 4: Submit Application on SUGAM Portal

When applying for imported cosmetics, you must submit your application via the CDSCO SUGAM Portal in the required form together with the relevant government fee and the supporting documents.

Step 5: CDSCO Review & Query Resolution

The CDSCO will examine the application and might submit questions or ask for more information. Any observations must be responded to with the necessary clarifications or documents.

Step 6: Grant of Registration

The competent authority grants the Cosmetic Import Registration Certificate (Form COS-2) once it has satisfactorily reviewed and found that the relevant requirements have been met.

Estimated Cost of CDSCO Certification for Other Skin Care Products

The amount that has to be paid for CDSCO Certification of other skin care products will depend on the range of products and the specific requirements of the application. The main factors affecting the cost are:

• Number and type of cosmetic products
• Product formulation and testing requirements
• Documentation and authentication
• Government fees
• Consultancy charges
• Number of variants and manufacturing facilities

As each application is unique, there is no set fee for CDSCO Certification in India, and the cost can be estimated by carrying out a product-specific assessment.

Timeline for CDSCO Certification

The general timeline will vary according to how complete the documents are, the complexity of the product, and the review by CDSCO.

Delays may happen if documents are missing, product information does not match, or CDSCO asks more questions.

Important Compliance Rules After Registration

Getting registration is not the final stage of the compliance process. Businesses should note:

• Product labels: Imported cosmetics must follow the relevant labeling rules.
• Expiry period: According to CDSCO, is such that cosmetics cannot be imported if the”Use Before'” or “Use By'” date is more than six months away from the date of import.
• The products cannot have claims that are false or misleading.
• With regard to animal testing, the restrictions that apply must be followed.
• Changes to products: If further products, variants, or manufacturing sites are involved, regulatory action such as endorsement may be required.

The retention fee has to be paid within the required time frame in order to keep the Form COS-2 registration.

How UMSPCS Can Help With CDSCO Certification for Other Skin Care Products

At UMSPCS, we assist businesses in meeting the regulatory requirements concerning cosmetics and other regulated products in India.

For CDSCO Certification for Other Skin Care Products, our support can include:

• Product classification and regulatory assessment
• Identification of the applicable CDSCO category
• Documentation checklist preparation
• Manufacturer and Authorised Indian Agent documentation support
• Formulation and product information review
• Label and claim review
• SUGAM application preparation
• Application filing support
• CDSCO query and clarification assistance
• Endorsement/additional product support
• Post-registration compliance guidance

The aim is to cut down on documentation errors that can be avoided and to enable manufacturers and importers to tackle the CDSCO Certification process in India by using a well-structured compliance strategy. Also, get to know more about MTCTE Certification for PON-ONT.

Conclusion

The Indian market for skincare is expanding quickly, but to enter it it is necessary to have not only a good formulation and attractive packaging but also for other skincare products to be specifically listed in the Fourth Schedule of the Cosmetics Rules, 2020, and for imported products to meet the relevant CDSCO registration requirements.

At every stage, from product classification and documentation through to SUGAM filing, CDSCO scrutiny, labelling, and post-registration compliance, the success of your application can be affected.

When you intend to import or introduce other skin care products into India, it is important to get your regulatory classification and the necessary documentation correct right at the start in order to save a great deal of time and prevent unnecessary compliance problems.

What about planning the CDSCO registration for other skin care products? 

Connect with UMSPCS now and talk to our compliance team about your product, the location of your manufacturing, and your registration requirements.

Read more also: How to Get BIS ISI Certification for Flashlight as per IS 2083:2024

FAQs

1. Is it necessary to have CDSCO registration for other skin care products?

Cosmetic products that are imported into India must register with the Central Licensing Authority pursuant to the Cosmetics Rules, 2020 before they are imported, and the relevant product category together with the requirements should be evaluated prior to submitting the application.

2. What form is required for registering with CDSCO Cosmetics?

The application for an Import Registration Certificate is made on Form COS-1 and the Import Registration Certificate is then issued on Form COS-2.

3. Can a foreign manufacturer of cosmetics apply for registration with the CDSCO?

Yes, the Cosmetics Rules offer ways for an overseas manufacturer, an authorised agent, an authorised subsidiary or an eligible importer to make applications, provided that the relevant requirements are met.

4. Does each skincare product come within the category of Other Skin Care Products?

On the contrary, the Fourth Schedule includes a number of distinct skincare categories, and before choosing the right category, the formulation, intended use, and method of presentation of the product should be evaluated.

5. Is it necessary to carry out product testing before registering with the CDSCO?

The CDSCO FAQ makes it clear that cosmetic products are not required everywhere to be tested before they are registered under the Cosmetics Rules, 2020; it is still necessary to meet the relevant requirements regarding quality, safety, and regulation.