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CDSCO Certification for Products Without Antiperspirant Activity

CDSCO Certification for Products Without Antiperspirant Activity

Navigate CDSCO registration certification for products without antiperspirant activity with UMSPCS. Our regulatory experts support cosmetic registration, documentation, compliance, and approval requirements in India.

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CDSCO Certification for Products Without Antiperspirant Activity in India - Requirements & Process

A cosmetic may appear uncomplicated when it is in stock, but the process it has gone through for approval is very complex.

Every body spray, deodorant, refreshing body product, or personal care formulation that does not possess antiperspirant properties fulfills the Indian cosmetic criteria like all other cosmetics that are legally marketed in India. The 2020 Cosmetics Rules mention "Product without antiperspirant function" in Category 23 in the Fourth Schedule.

Product classification, the review of formulations, documentation, testing, labelling, and the submission of regulatory filings are all important things for companies that intend to import or manufacture such products.

At UMSPCS, we assist businesses in understanding these requirements and in dealing with the CDSCO Certification for Products Without Antiperspirant Activity, covering everything from regulatory assessment and documentation to providing application support and coordinating compliance.

What Is CDSCO Certification for Products Without Antiperspirant Activity?

Typically, the term 'CDSCO Certification for Products Without Antiperspirant Activity' refers to the regulatory registration or compliance procedure for products belonging to Category 23 mentioned in the Fourth Schedule of the Cosmetics Rules, 2020.

The category is officially listed apart from "Products with antiperspirant activity", which is classified as Category 22.

Nevertheless, it should be understood by businesses that 'Products without antiperspirant activity' is a product category and not a separate standalone certificate known as a 'CDSCO Certificate for Products Without Antiperspirant Activity'.

When importing cosmetics, the regulatory requirement is to obtain the Import Registration Certificate in the form of COS-2, which is obtained by filing an application in the form of COS-1 with the Central Licensing Authority. As per the CDSCO's office, importing cosmetics is prohibited until registered under the Cosmetics Rules, 2020.

In the case of cosmetics produced in India, the route for regulation is different since the manufacturer has to apply to the State Licensing Authority for a manufacturing or loan licence pursuant to the Cosmetics Rules, 2020.

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Who is in charge of what regarding CDSCO certification for cosmetics?

A very common error that businesses commit is to think that every cosmetic approval in India is granted directly by CDSCO. The regulatory structure is even more specific.

For imported cosmetics

The Central Licensing Authority is in charge of import registration; the application has to be filed online using Form COS-1, and the registration certificate is then issued in the form of Form COS-2 after the necessary regulatory examination has been carried out.

For cosmetics manufactured in India

A manufacturer who wishes to produce cosmetics for sale or distribution should apply to the State Licensing Authority for a manufacturing licence using Form COS-5 or for a loan licence using Form COS-6.

The CDSCO certification in India for cosmetics must always be regarded as depending on whether the product is imported or produced locally.

Key Regulatory Requirements

The application for CDSCO Certification of products without antiperspirant activity succeeds for reasons other than just filling in a form.

  • Correct product classification
  • Complete formulation information
  • Product specifications
  • Compliant labelling
  • Safety and quality compliance
  • No misleading claims

Applicable Tests for Products Without Antiperspirant Activity

There is no single universal test known as the "Products Without Antiperspirant Activity Test" that is prescribed on its own just because a product falls into Category 23.

The programme for carrying out the tests will vary depending on the product's formulation, its ingredients, its dosage form, its intended use and the applicable standards.

A regulatory testing assessment may include, as applicable:

  • Physical and appearance parameters
  • pH
  • Viscosity
  • Specific gravity
  • Microbiological quality
  • Microbial limits
  • Stability-related parameters
  • Heavy-metal assessment where applicable
  • Ingredient identification or verification
  • Preservative-related testing where applicable
  • Product-specific safety parameters
  • Packaging compatibility
  • Claim-supporting data where required

The Cosmetics Rules specify that IS 4011:2018 should be referred to for the methods of test concerned with the safety evaluation of cosmetics.

The regulations also include requirements relating to prohibited or restricted substances; for instance, with respect to permitted synthetic and natural organic colours there are specified limits for arsenic, lead and other heavy metals, and it is prohibited to use lead and arsenic compounds for colouring cosmetics. Furthermore, animal testing of cosmetics is banned.

Benefits of CDSCO Compliance

Proper regulatory compliance can help businesses:

  • Legally place applicable imported cosmetics in the Indian market
  • Establish regulatory credibility
  • Reduce documentation-related delays
  • Improve product traceability
  • Support smoother import operations
  • Maintain consistent product information
  • Reduce risks associated with misleading claims
  • Build consumer confidence
  • Maintain long-term regulatory compliance

For cosmetics that are imported, the registration certificate must be kept, and it will remain valid indefinitely as long as the required retention fee has been paid before the five-year period ends, unless it is suspended or cancelled.

Step-by-Step Process for CDSCO Certification

Step 1: Registration on CDSCO SUGAM Portal

The applicant must first register on the CDSCO SUGAM Portal by providing accurate details of:
  • Applicant
  • Indian Authorised Agent
  • Foreign Manufacturer
  • Manufacturing Facility
  • The information must be kept consistent throughout the application process.

    Step 2: Prepare and Submit the Application

    The applicant must prepare the applicable cosmetic registration application as per the Cosmetics Rules, 2020, including:
  • Product category and intended use
  • Product and brand details
  • Formulation and ingredients
  • Product specifications
  • Variants and pack sizes
  • Manufacturing details
  • Product claims
  • Step 3: Submit Supporting Documents

    The required documents may include:
  • Product formulation and specifications
  • Test reports, where applicable
  • Proposed labels and artwork
  • Manufacturer's authorisation
  • Free Sale Certificate, where applicable
  • Manufacturing licence
  • Manufacturing-site details
  • Indian Authorised Agent details
  • The documents must be complete and consistent.

    Step 4: Pay The Applicable Government Fees

    The applicant is required to pay the government fee which is prescribed in the Third Schedule to the Cosmetics Rules of 2020.
    Further costs could be involved in the areas of testing, documentation, authentication, legalisation and professional fees.

    Step 5: CDSCO Application Review

    The CDSCO examines the application, the product information, the formulation, the documents, the manufacturing details, and the labels and claims.
    The applicant will have to respond to any questions that CDSCO may put forward or to any further documents that it may request.

    Step 6: Grant of Cosmetic Import Registration

    Once the applicable requirements have been carefully examined and satisfied, the CDSCO issues the Cosmetic Import Registration Certificate in the prescribed format, which allows the Products Without Antiperspirant Activity to be imported into India in accordance with the Cosmetics Rules, 2020.

    Documents Required for CDSCO Certification in India

    For imported Products Without Antiperspirant Activity, the documentation package may include:

    • Identity proof
    • Rental agreement
    • Master file of the plant
    • Building plan
    • ISO 13485 certificate with previous audit report
    • Technical manpower for manufacturing and testing
    • Device master file
    • Testing license, if any
    • Environment compliance
    • Analysis report of 3 consecutive batches
    • Translation of documents, if any, in English, in case of any other foreign language
    • Other documents, as applicable

    The online checklist provided by CDSCO specifically calls for documents including the covering letter, the manufacturer's authorisation, details of the ingredients, the proposed labelling, the specifications and the testing methods.

    CDSCO Certification Cost for Products Without Antiperspirant Activity

    The amount one has to pay in order to get CDSCO Certification for products lacking antiperspirant activity in India varies according to the number of cosmetic categories, the number of product variants, the number of manufacturing sites, the testing requirements, the documentation needed and the consultancy involved.

    According to the Third Schedule of the Cosmetics Rules, 2020, the applicable government fees for imported cosmetics are:

    Particular

    Government Fee

    Registration Certificate for each cosmetic category

    US$1,000

    Each additional cosmetic category

    US$1,000

    Each cosmetic variant

    US$50

    Each manufacturing site

    US$500

    The additional costs associated with product testing, documentation, translation, authentication, legalisation, consultancy and other professional services (where applicable) are not included in the above government fees.

    How long does it take to get CDSCO registration?

    The extent to which the timeline varies will depend on the quality of the documentation, the complexity of the product, and the number of regulatory queries, together with the time taken by the authority to process them.

    In practical terms, the overall project timeline can be affected by:

    • Availability of manufacturer documents
    • Apostille requirements
    • Completeness of technical information
    • Testing requirements
    • Label corrections
    • Product classification issues
    • Regulatory queries
    • Application deficiencies
    • Number of products and variants

    The State Licensing Authority must, in accordance with Rule 23, either grant a manufacturing or loan licence application or indicate the deficiencies within 45 days, provided that the relevant requirements are met.

    Common Challenges Businesses Face

    • Incorrect category selection
    • Confusing deodorant with antiperspirant
    • Incomplete formulation information
    • Non-compliant labels
    • Foreign documents
    • Unsupported claims

    What makes UMSPCS the choice for CDSCO certification?

    It is easier to achieve regulatory compliance when the product classification, the documentation, the testing, and the application strategy are all dealt with together.

    UMSPCS has more than six years of experience and provides support to businesses regarding over 600 product compliance requirements, assisting manufacturers, importers, and brands in dealing with the complicated regulatory procedures.

    Why businesses choose UMSPCS
    • Product-category assessment
    • Regulatory requirement identification
    • Ingredient and formulation review
    • Documentation support
    • Label compliance review
    • Testing requirement assessment
    • Application preparation
    • CDSCO portal support
    • Query and deficiency support
    • Regulatory coordination
    • Post-registration compliance guidance

    Our method does not stop at submitting an application; instead, we first get a good understanding of the product and then construct the compliance pathway based on its real regulatory requirements.

    Conclusion

    Looking at the possibility of importing or manufacturing a cosmetic product that does not have antiperspirant properties in India?

    Start with the product classification, the formulation, and the regulatory assessment, not with the application form.

    UMSPCS can assist you in determining if your product belongs in Category 23 - Products without antiperspirant activity, identify the CDSCO certification requirements for use in India, arrange the necessary documentation, assess the testing requirements, and provide support for the regulatory application process.

    Connect with UMSPCS now to have a product-specific CDSCO compliance assessment and choose the correct regulatory path before you enter the Indian market. Explore detailed information about

    Frequently Asked Questions (FAQs)

    Any cosmetics imported that fall under the coverage of the Cosmetics Rules must be registered prior to such import into India, and Category 23 is specifically stated in the Fourth Schedule.

    Category 23 is more popularly referred to as “Products without antiperspirant effect” as per the Fourth Schedule regarding cosmetics importation.

    Not at all; those products with antiperspirant effects have been included under Category 22 as per the Fourth Schedule, while the ones which don’t possess antiperspirant activity have been categorized in Category 23.

    he import registration application is made using Form COS-1, and the Import Registration Certificate is issued on Form COS-2.

    Testing requirements will vary according to the formulation, the ingredients, the intended use, and the applicable standards, and a test evaluation specific to the product should be carried out.

     

    No, generally Indian cosmetic manufacturers obtain their manufacturing licences through the State Licensing Authority, employing either Form COS-5 or Form COS-6 as the case may be.

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