A personal care product doesn’t have to be anti-sweat to be a cosmetic. A deodorant that’s for odour control, a body spray for fragrance, and a roll-on for refreshing the skin may all look the same on the shelf. The actual purpose and claims of the product will determine how it’s assessed in terms of compliance.
This raises a very pertinent question for cosmetic brands, importers and manufacturers: can a product which has no antiperspirant claims still be CDSCO certified in India?
The answer is yes, subject to the product meeting the relevant regulatory requirements. The mere absence of an antiperspirant claim does not in itself remove a product from the scope of cosmetic regulation or automatically entitle it to registration. The formulation, the intended use, the product as presented, and the claims made must all be considered in the context of one another.
For any business looking at launching deodorants, body sprays, underarm creams, etc., the importance of understanding this distinction cannot be overstated, as it can help to avoid registration problems that could otherwise be completely avoided. At UMSPCS, we assist businesses in understanding the CDSCO certification for Product Without Antiperspirant pathway for cosmetics, including those products which do not make any claim to have antiperspirant activity.
What Does ‘Without Antiperspirant Claims’ Actually Mean?
An antiperspirant is of course designed to reduce or control perspiration. A product which makes no claims as to being an antiperspirant may be one which is simply designed to provide fragrance, mask body odour, cleanse the skin or improve the user’s personal care.
To understand the meaning of the concept, let’s look at some instances:
- Deodorant: formulated for the purpose of masking or eliminating unpleasant smell associated with the body.
- Body spray: creates a pleasant aroma.
- Underarm cream: can hydrate, soften, and condition skin.
- Antiperspirant roll-on: limits the sweating process depending on the composition and informational claims made.
These are examples of descriptions but not necessarily legal definitions. The overall marketing material must be analyzed above all before a classification can be made.
Products with antiperspirants are determined as a separate category according to the Fourth Schedule of the Cosmetics Rules, 2020. This is significant for import registration purposes but does not mean that every deodorant or underarm product with no antiperspirant claims is not a cosmetic product.
Does a Product that Makes No Antiperspirant Claims Qualify for CDSCO Certification?
Yes, the CDSCO can classify a product without antiperspirant claims as a Product without Antiperspirant according to its intended use, formulation, category, and compliance with regulations.
The key difference is between product classification and regulatory eligibility. Taking the antiperspirant claim off the label doesn’t automatically remove the product from the CDSCO’s regulatory remit.
As per section 3(aaa) of the Drugs and Cosmetics Act, 1940, entities that are meant for cleaning, beautifying, enhancing appearance, and modifying the appearance are included in the definition of cosmetics. The Cosmetics Rules, 2020 provide for the conditions of production and import of cosmetic products.
Basic Conditions for Compliance with the Cosmetics Rules
Before applying for CDSCO certification for cosmetics, businesses must check the following requirements:
- Product Classification: Determine the type of product according to the nature and purpose of the product formulation.
- Requirements for Ingredients of the Product: Compare the ingredients of the product with the list of acceptable and unacceptable ingredients.
- Product Safety and Quality: Meet the safety and quality standards.
- Correct Labelling: The product’s label, advertisement, and description should be truthful concerning the functions of the product.
- Technical details: identify and locate the place of manufacture.
- Regulatory documentation: prepare the relevant declarations, authorisations and supporting records.
These checks will establish whether the product is eligible to proceed down the appropriate compliance route.
Documents Required for CDSCO Cosmetic Registration
For imported cosmetic products, the application is submitted on Form COS-1 for the import registration certificate (Form COS-2). The guidance provided by CDSCO explains the documentation needed, which consists of an authorization letter from the manufacturer, product details, and information about its ingredients.
Commonly required documents may include:
- Identity proof
- Rental agreement
- Master file of plant
- Building plan
- ISO 13485 certificate with past audit report
- Technical manpower for manufacturing and testing
- Device Master File
- Testing license, if applicable
- Environment compliance
- Analysis report of 3 consecutive batches
- Translation of documents in English, if submitted in a foreign language
- Other applicable documents
How to Apply: The CDSCO Compliance Process for Product Without Antiperspirant
For imported products, the following is the general process for CDSCO cosmetic registration.
Step 1: Register on the CDSCO SUGAM Portal
Register on the CDSCO SUGAM portal and enter the requisite applicant and manufacturer details.
- Applicant and authorised agent details
- Foreign manufacturer information
- Manufacturing site details
Step 2: Prepare and Submit the Application
Complete the application in accordance with the Cosmetics Rules, 2020 and ensure that all product information is correct.
- Product category and intended use
- Ingredient composition and specifications
- Product variants and pack sizes
Step 3: Submit the Required Documents
Upload the requisite technical and regulatory documentation to support the application.
- Product formula and specifications
- Applicable test reports and product labels
- Manufacturer authorisation
- Free Sale Certificate, where applicable
Step 4: Pay the Applicable Government Fees
Pay the required registration fees in accordance with the relevant requirements.
- Cosmetic category fee
- Manufacturing site fee, where applicable
- Product variant fee, where applicable
Step 5: CDSCO Review and Registration
CDSCO will review the application and may ask for further documents or clarification. Once the application satisfies the applicable requirements, the Cosmetic Import Registration Certificate in Form COS-2 may be issued.
These steps are in accordance with the import registration framework under the Cosmetics Rules, 2020 and the relevant CDSCO guidance.
CDSCO Registration Cost for Products Without Antiperspirant Claims
The cost of CDSCO certification for products without antiperspirant claims will vary depending on the relevant regulatory route, the number of cosmetic categories and variants, the number of manufacturing sites, and any additional testing or professional assistance required.
For imported cosmetics, the Third Schedule to the Cosmetics Rules, 2020, specifies the following statutory fees:
| Fee Component | Amount Specified in the Rules |
| Registration certificate for each cosmetic category | US$1,000 |
| Each additional manufacturing site | US$500 |
| Each variant | US$50 |
| Permission for a new cosmetic | US$500 |
| Inspection of each overseas manufacturing site, where applicable | US$5,000 |
These are the fees relating to the applicable import registration requirements and should be checked against the current rules for that particular application. The fact that there is no antiperspirant claim does not in any way alter the prescribed fee.
Timeline for CDSCO Registration for Products Without Antiperspirant Claims
The timeline for CDSCO certification will vary depending on whether the cosmetic is being imported or is being manufactured in India and on the regulatory pathway that is in effect.
For imported cosmetics, Rule 13 of the Cosmetics Rules, 2020 gives the Central Licensing Authority up to six months in which to either approve or reject an application. For cosmetics manufactured in India, the time frame will be dependent on the requirements and processing of the relevant State Licensing Authority.
Delays can arise for a number of reasons, including incomplete documentation, inconsistencies in labelling, questions arising from the ingredients, or requests for further information from the Authority. The actual timeframe will therefore have to be assessed on a case-by-case basis.
Benefits of Getting the Classification Right
A correct regulatory assessment offers practical advantages:
- Reduces the risk of submitting an application in the wrong category.
- Helps to maintain consistency between the formula, the label and the intended use.
- Supports smoother documentation and regulatory review.
- Helps importers to plan product launches and distribution.
- Reduces the risk of making misleading claims or of incurring avoidable compliance corrections.
How UMSPCS Can Help with CDSCO Certification for Product Without Antiperspirant
UMSPCS supports businesses working through the product compliance and certification requirements in India.
With 6+ years of experience and over 600 product compliance cases to their name, UMSPCS can provide a structured form of assistance in relation to the product and the applicable regulatory requirements. The final classification and registration of the product will of course be subject to the applicable law and the decision of the competent authority.
Our team can assist with:
- Reviewing the product description, the intended use and the proposed claims.
- Identifying the likely cosmetic category and the applicable regulatory route.
- Preparing and reviewing the supporting documentation.
- Engaging in the process of managing applications and addressing doubts related to documentation.
- Evaluating compliance matters involved in labeling and ingredients.
- Assisting businesses that import or produce in the knowledge of regulations regarding the requirements before they are ready to launch their products in the market.
Conclusion
Although a product does not need to possess antiperspirant properties, it may be eligible for cosmetic registration depending on different aspects, including its formulation and classification.
Make sure you know to check all the requirements in order to choose the proper method of registration and import of deodorants and other underarm products.
Are you looking to introduce your cosmetic items in the Indian market?
Contact UMSPCS for help in getting all classification, registration, and documentation done correctly.
Read more also: Do Taiwan Furniture and Electrical Appliances Need BIS Certification
FAQs
- Is it possible for deodorants that do not claim to be antiperspirants to be accepted by CDSCO?
Yes, it will be possible as long as it complies with the required guidelines.
- Is CDSCO registration mandatory for every imported deodorant?
Any imported products that fall within the definition of cosmetics as per the law will, in general, be required to be registered before import (subject to any applicable rules and exemptions).
- Does the removal of an antiperspirant claim remove the requirement for registration?
No, a product can be a cosmetic without any claim to reduce sweating. The classification has to be considered on its own.
- What forms are used for registration of imported cosmetics?
Form COS-1 is the form used to apply for registration, and Form COS-2 is the Import Registration Certificate issued under the Cosmetics Rules, 2020.
- Can a foreign manufacturer register a cosmetic product in India?
Yes, the manufacturer can apply via the approved route or via an authorised Indian agent, importer or eligible subsidiary as appropriate.
- Can misleading claims affect cosmetic registration?
Yes, Rule 36 of the Cosmetics Rules, 2020 prohibits any cosmetic claim which is false or misleading to the intended user.
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