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CDSCO Certification for Chemical Depilatories

UMSPCS - CDSCO Certification for Chemical Depilatories

CDSCO Certification for Chemical Depilatories

UMSPCS provides CDSCO registration certification support for chemical depilatories in India, including regulatory documentation, cosmetic compliance.

  • BIS Registration Guidance
  • Application Filing Support
  • BIS Authority Coordination
  • Cost & Timeline Clarity
  • Complete Documentation Help
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CDSCO Certification for Chemical Depilatories: Classification, Documents & Approval

While a chemical depilatory could resemble any beauty care product at first sight, its nature makes it different from other beauty products due to its ability to chemically decompose hair. That is why the composition, safety, labeling, and regulation of the product should be taken into account.

Companies that are planning to produce, import, or sell these products on the Indian market should know about the regulatory pathway for that.

According to the Cosmetics Rules, 2020, Chemical Depilatories have been specifically mentioned in the Cosmetics category as cosmetics imported into India.

Importation of cosmetics in India is governed by the CDSCO as the Central Licensing Authority, while manufacture of cosmetics in India is governed by State Licensing Authorities.

CDSCO certification for Chemical Depilatories becomes one of the compliance requirements.

With UMSPCS, companies can learn about the right regulatory pathway, compile necessary documentation, organize testing, and apply for CDSCO certification in India.

Chemical Depilatories Under India's Cosmetic Regulatory Framework

Is my hair removal product considered a cosmetic?

As stated in the Drugs and Cosmetics Act, 1940, a cosmetic means any substance which is applied on a human body whether through rubbing, pouring, sprinkling, spraying or by any other mode with the intention of cleansing, beautifying, promoting attractiveness or altering one's appearance of the human body and the ingredients of cosmetics.

Cosmeceuticals are depilatories which, although they contain chemicals, are purpose- and formulation-compliant to the cosmetic definition.

Specifically, the Fourth Schedule of Cosmetics Rules, 2020 classifies chemical depilatories separately from categories of cosmetics for import.

Thus, companies must not take a product to be exempt from CDSCO guidelines merely on the basis of being a personal care product.

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What Exactly Are Chemical Depilatories?

Chemical depilatories refer to cosmetic products used for the purpose of removing unwanted hair chemically rather than by mechanical means.

They may be available as follows:

  • Hair removal cream
  • Hair removal lotion
  • Hair removal gel
  • Certain depilatory pastes
  • Or any other formulation used for the removal of hairs chemically

Depending upon its purpose, form of preparation, claims, contents, package, and applicable specifications, regulatory classification can vary.

The important Indian Standard for such products is IS 9636:1988 - Specification for Chemical Depilatories. According to BIS, this standard relates to chemical depilatories which have an alkaline-thioglycolic acid formulation. The standard lays down the requirements and methods of sampling and testing.

The coverage of this standard needs to be verified in relation to the actual formulation since IS 9636:1988 covers only certain types of depilatory formulations.

Which Chemical Depilatory Products May Require Compliance?

Some products to be considered by businesses include:

  • Hair Removal Creams
  • Depilatory Lotions
  • Depilatory Gels
  • Other Chemical Hair Removal Products

This is especially critical for cases where there are other claims on the marketing of the product, which could influence the regulatory status of the product.

The Indian Standard You Should Know: IS 9636

In respect to chemical depilatories, IS 9636:1988 - Specification for Chemical Depilatories, is a relevant product-specific Indian Standard.

IS 9636:1988 is stated by BIS as the specification for chemical depilatories, and this Indian Standard deals with requirements, sampling, and test procedures for alkaline-thioglycolic-acid composition depilatories.

The aspects covered by this Indian Standard are:

  • Product description
  • Requirements related to formulation
  • Ingredients
  • Safety
  • Packaging and labeling
  • Sampling
  • Testing

Moreover, it mentions that formulations of chemical depilatories must meet certain safety-related requirements. Nevertheless, companies need to ascertain the most recent Indian Standard related to their products.

Key Safety & Formulation Considerations

Chemical Depilatories need special consideration because of their direct application on the skin. These aspects must be considered when doing a compliance assessment:

  • Ingredient Compliance
  • Concentration
  • pH
  • Skin Safety
  • Instructions for Use
  • Packaging

Thioglycolates and Current Ingredient Restrictions

In BIS's revision of IS 4707 (Part 2) in 2025, it is stated that thioglycollic acid and its salts are included in the list of substances that have specific restrictions. According to the document, the maximum authorised concentration of thioglycollic acid and its salts for depilatories is 5%, while the ready-to-use pH is 7 to 12.7.

Since ingredient standards and regulations could be changed, it is recommended that the manufacturer make sure what the latest version is before proceeding with product formulation or submission.

It is particularly important for depilatories containing thioglycolate or other chemically active depilatory ingredients.

Applicable Tests for Chemical Depilatories

Tests vary depending on the formulation, standard applicable, and regulatory approach to the product. Some of the aspects that can be covered by the technical tests include the following:

  • Appearance and Physical Properties
  • pH Tests
  • Active Ingredient/Assay Tests
  • Safety Tests
  • Skin Safety Tests
  • Microbiology
  • Stability Tests
  • Package and Label Tests

Tests should not be selected based on the cosmetic generic test checklist alone.

New Cosmetic? A Different Approval Route May Apply

According to Section V of the Cosmetics Rules, 2020, if one plans to either import or manufacture a new cosmetic, he or she has to submit an application to the Central Licensing Authority in Form COS-12 along with the fee and data on the safety and efficacy of the cosmetic. Upon approval, the authority can grant prior permission in Form COS-3.

Furthermore, it is stated that the safety testing methodologies for a new cosmetic shall conform to IS 4011:2018, as amended from time to time.

Hence, it is important for the company to find out whether its depilatory product falls under the category of an existing cosmetic or a new one.

CDSCO Approval Process for Chemical Depilatories

Step 1: Registration on CDSCO SUGAM Portal

The applicant needs to register at the CDSCO SUGAM Portal by furnishing information regarding the business, Indian authorized agent/importer, and foreign manufacturer in order to start the CDSCO Certification for Chemical Depilatories procedure.
Points to Consider:
  • Details of the applicant or business
  • Details of the Indian authorized agent/importer
  • Details of the foreign manufacturer
  • Validity of the contact and registration information

    • Step 2: Preparation & Filing of Application

    File the relevant CDSCO application form having complete product and manufacturing information according to the Cosmetics Rules, 2020.
    Points to Consider:
  • Product category and use
  • Formulation of the product and its composition
  • Manufacturing information
  • Variants & pack sizes
  • Specifications of the product

    • Step 3: Filing of Relevant Documents

    Submit all necessary documents along with the application form for further processing.
    Points to Consider:
  • Formula and specifications of the product
  • Free Sale Certificate
  • Manufacturing License
  • Test reports
  • Labels of the product
  • Manufacturer authorization
  • Undertaking & other relevant documents

    • Step 4: Payment of Government Fee

    Pay the relevant government fees depending on the type of cosmetic, manufacturing location, variants, etc., that have been defined under the Cosmetics Rules, 2020.
    Points to be Considered:
  • Relevant fee for cosmetic type
  • Fee for manufacturing location
  • Fee for variants
  • Validation of payment information

    • Step 5: CDSCO Assessment & Registration

    Central Licensing Authority examines the application, the product, and documents for compliance with the relevant requirements. After the relevant requirements have been met, CDSCO issues the Import Registration Certificate for Chemical Depilatories.
    Points to be Considered:
  • Application and document examination
  • Product compliance check
  • Regulatory query resolution, if any
  • Import Registration Certificate issuance
  • Compliance for import into India

    • Documents Required for CDSCO Certification for Chemical Depilatories

    In case of imported products, the documentation process would need the following information.

    The major documents would include:

    • Identity of the organization
    • Rent document for the premise
    • Master File of plant
    • Plan drawing of the building
    • ISO 13485 certificate along with past audit report
    • Technical manpower capable of manufacturing and testing devices
    • Device Master File
    • License for testing if available
    • Environment compliance
    • Analysis report of three successive batches
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    CDSCO Certification Cost for Chemical Depilatories

    However, there cannot be any general fee for CDSCO certification for Chemical Depilatories since the total cost will depend on the nature of the product and its structure of application.

    Regarding the imported cosmetics, the CDSCO FAQ clearly indicates that the Third Schedule fee comprises the following:

    • US$1,000 or equivalent for the grant of the Registration Certificate for each category of cosmetics
    • US$500 for the registration of each manufacturing site
    • US$50 for each variant
    • US$1,000 for the grant/ retention of an additional category

    It is important to check the current government fee with the help of the current Cosmetics Rules.

    UMSPCS can evaluate the product cost after the review of the product formula, manufacturing site, variants, and market route.

    Common Challenges in Chemical Depilatory Approval

    • Incorrect Classification of Products: A product could have an incorrect classification since its claims, uses, or composition have not been evaluated properly.
    • Restrictions on Ingredients: Active ingredients present in chemical hair removal products could have restrictions such as concentration, pH, warnings, and others.
    • Incomplete Formulations Information: Incomplete or inconsistent formulation information could raise issues.
    • Non-conformity with Labeling Regulations: Labeling regulations must comply with the relevant requirements, and they cannot contain false or misleading claims. CDSCO specifically stipulates that cosmetics must not represent an idea which is false or misleading to the intended user.
    • Inconsistent Manufacturing Documents: The name of the manufacturer, manufacturing sites, and product information need to be consistent in the application file.
    • New Cosmetic Evaluation: In case the product falls under a new cosmetic category, the prior permission pathway would be applicable.
    • Foreign Documentation: It would require certain procedures to be followed according to the relevant document and the country.

    Key Benefits of CDSCO Compliance

    Getting the right regulatory approval or registration offers many benefits.

    • Legal Entry into the Market
    • Safety for Consumers
    • Increased Credibility of the Product
    • Simplifies Regulatory Processes
    • Helps International Brands

    Why Choose UMSPCS for CDSCO Certification for Chemical Depilatories?

    For a chemical depilatory, an ordinary application form will not do. The formula, the ingredients used, claims, testing, and the product category must be aligned.

    With UMSPCS, you will get comprehensive regulatory assistance specifically tailored to your product. With our 6+ years of experience managing more than 600 product compliance requirements, we help businesses comply with the regulatory processes systematically and specifically for their products.

    • Product Category Assistance
    • Ingredients and Compliance Assistance
    • Documentation Assitance
    • Testing Assitance
    • SUGAM Application Assistance
    • Query and Clarification Assistance
    • Foreign Manufacturer Assistance

    Conclusion

    A chemical depilatory can be a cosmetic product, but it must go through a lot more than an application to be regulated. Product classification needs to dovetail with ingredient compliance, applicable testing, labelling and manufacturer documentation, as well as the proper CDSCO route.

    In case of imported products, the Cosmetics Rules 2020 have laid down the central registration pathway, whereas for Indian manufacturers there are applicable requirements of the State Licensing Authority. Chemical depilatories are a special group of cosmetics and are recognised in the cosmetic classification, so it is important to have early regulatory assessment.

    Considering introducing or importing a chemical depilatory into India?

    Talk to UMSPCS today for product classification, documentation review, guidance for testing, and end-to-end support for CDSCO compliance. Also, get to know more information about CDSCO Certification for Other Skin Cleansing Products.

    Frequently Asked Questions (FAQs)

     

    Chemical depilatories have been specifically mentioned as a cosmetic category for import in the Cosmetics Rules, 2020. Cosmetics brought in from outside the country for import into India are required to be registered with the Central Licensing Authority.

     

    Yes, imported cosmetics need to be registered before importation into India if it falls under the Cosmetic Products category. The import registration application is submitted in Form COS-1.

     

    The importation of cosmetics is done under Form COS-1, and the Import Registration Certificate (IRC) is issued under Form COS-2.

    Typical documents consist of product information, formulation, manufacturing details, test reports, labels, manufacturer approval, and other supporting documents. The checklist will vary depending on the product and regulatory pathway.

    The length of time depends on documentation, testing and regulatory review. It takes up to six months for the Central Licensing Authority to approve or refuse an application for import-registration under the Cosmetics Rules.

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