Although a product designed for personal hygiene purposes may seem to be a regular item available on the market, from people’s perspective, a product is regulated based on its claim and formula, and it depends on the country of manufacture as well as the marketing strategy.
In the case of India, the class of External Intimate Hygiene Products has been classified as belonging to the cosmetic category in Schedule 4 of the Cosmetics Rules 2020; thus, the process of getting regulatory approval from the Central Drugs Standard Control Organization becomes one of the most important elements of the market-entry strategy of companies supplying these goods.
It is mdzxs CDSCO Certification for external intimate hygiene products comes into play. Nevertheless, it is necessary to realise that the regulatory pathway will vary according to whether the product is being imported into India or is manufactured in India, as well as depending on whether its intended use and claims are covered by the definition of a cosmetic.
In this blog post, UMSPCS sets out the regulatory framework, requirements, documents, procedures, timelines, validity, common difficulties, and compliance issues that businesses dealing with external intimate hygiene products in India have to consider.
What are External Intimate Hygiene Products?
Products used for external intimate hygiene serve the purpose of maintaining hygiene or cleaning the external intimate part of the body,y and such products may fall under the cosmetic definition as per the intended use and the claims made about the product.
In accordance with Section 3(aaa) of the Drug and Cosmetic Act,ct 1940, cosmetics are defined as any article that is applied on the human body or any of its parts for cleansing, beautifying and changing the appearance of the body and any such products classified as cosmetics.
External Intimate Hygiene Products have been classified in the Fourth Schedule of the Cosmetics Rules, 2020 for imported products.
Depending on the formulation and intended claims, businesses may deal with products such as:
- External intimate cleansing products
- Intimate hygiene washes
- External intimate cleansing gels
- Personal cleansing products for external intimate use
- Other cosmetic products specifically intended for external intimate hygiene
The product’s classification should always be evaluated in light of its formulation, intended use, mode of presentation, and the claims made rather than depending solely on the product name.
Is CDSCO Certification Mandatory for External Intimate Hygiene Products?
Cosmetic products that are imported have to be registered before they are imported into India.
The CDSCO says that any cosmetics which fall within the regulatory definition must be registered together with the relevant product details, the different pack sizes, the various variants, a nd the manufacturing premises before they are imported; Rule 12 of the Cosmetics Rules, 2020 is the regulatory basis for import registration.
The application for an Import Registration Certificate is made on Form COS-1 and the Import Registration Certificate itself is then issued on Form COS-2.
Hence, those businesses in India looking to obtain CDSCO Certification for imported external intimate hygiene products should generally regard the requirement as that of CDSCO cosmetic import registration rather than seeing it as a separate certification scheme.
Why Does the CDSCO Regulate These Products?
Intimate hygiene products are used on a sensitive part of the human body and, as a result, regulatory requirements centre on product quality, safety, composition, labelling, and accurate representation.
The CDSCO states that the purpose of regulating imported cosmetics is to ensure that those cosmetics entering India meet the required standards in terms of safety, quality, and performance.
For businesses, adherence to compliance rules sets up a proper regulatory framework prior to the product entering the Indian market.
It can also help companies:
- Meet applicable Indian regulatory requirements
- Establish product and manufacturing-site compliance
- Prepare appropriate product documentation
- Reduce documentation-related queries
- Support lawful import and distribution
- Maintain consistency between formulation, claims, and labels
- Legal Framework for CDSCO Certification for External Intimate Hygiene Products
- The primary regulatory framework includes:
- Drugs and Cosmetics Act, 1940
- Cosmetics Rules, 2020
- Fourth Schedule
- Second Schedule
- Ninth Schedule and applicable standards
- Cosmetics (Amendment) Rules, 2025
Instead, businesses should look at the most up-to-date requirements rather than relying just on the older registration checklists.
Basic Requirements for Cosmetic Registration from the CDSCO
Before applying for CDSCO Certification for External Intimate Hygiene Products, businesses should review the following areas:
- Product classification
- Product formulation
- Product claims
- Manufacturing site
- Labelling
- Safety and quality information
Documents Required for CDSCO Certification for External Intimate Hygiene Products
The exact documentation needed will depend on the product, the manufacturer, the applicant, and the type of application. The CDSCO registration checklist and guidelines list the documents and information such as:
- Proof of identity of organization
- Rent deed for the premise
- Master file of plant/site
- Building layout plan
- ISO 13485 certificate and past audit report
- Technical manpower capable of producing and testing devices
- Device Master File
- License to conduct tests, if available
- Environmental compliance
- Analysis report for three consecutive batches
The official checklist issued by CDSCO specifically calls for information on the ingredients, the proposed labelling, the specifications and the testing methods, together with a manufacturer’s authorisation in the prescribed format.
Foreign manufacturers may also have their documents appropriately authenticated, attested to, or apostilled depending on the nature of the document and the relevant requirements.
How to Obtain CDSCO Certification for External Intimate Hygiene Products?
The registration process can best be understood by referring to the following stages.
Step 1: Registration on the CDSCO SUGAM Portal
The first step is for the applicant to register on the CDSCO SUGAM Portal by providing the details required relating to themselves, their business, and the overseas manufacturer. Once this registration has been carried out, the applicant will be able to begin the process of obtaining CDSCO Registration for External Intimate Hygiene Products.
Step 2: Preparation & Filing of the Application
The CDSCO application relevant to the case is filled out with all the necessary information about the product and the manufacturer, including the product category, its intended use, the formulation, the manufacturing details, the various product variants, the pack sizes, and any other information required by the Cosmetics Rules, 2020. The application, once completed, i s then submitted via the SUGAM Portal.
Step 3: Submission of Required Documents
The applicant is required to prepare and submit the supporting documents needed, including the ingredient list, the Free Sale Certificate, the manufacturing licence, the product specifications, the test reports, the proposed labels, the manufacturer’s authorization, and all other relevant regulatory documents.
Step 4: Payment of Applicable Government Fees
The government fees prescribed are paid according to the relevant cosmetic category, the number of product variants, the number of manufacturing premises, and other provisions specified in the Cosmetics Rules, 2020.
Step 5: CDSCO Review & Grant of Registration
The Central Licensing Authority examines the application, the details of the product, and the supporting documents; and if the requirements are met, it issues the CDSCO Import Registration Certificate enabling the import of the eligible cosmetic products into India.
How Long Does it Take to Get CDSCO Registration?
The time taken to obtain CDSCO registration for external intimate hygiene products will depend on both the completeness of the application and the regulatory review. According to Rule 13 of the Cosmetics Rules, 2020, the Central Licensing Authority carries out the processing of the application within the prescribed regulatory framework.
The actual timeline may vary due to:
- Documentation or technical dossier gaps
- Free Sale Certificate availability
- Apostille/attestation requirements
- Label corrections
- Product classification issues
- Regulatory queries or deficiencies
UMSPCS suggests that the full technical and regulatory documentation should be prepared before submission in order to avoid unnecessary delays.
CDSCO Certification Cost for External Intimate Hygiene Products
The total cost will vary according to the relevant regulatory pathway, the product’s requirements, the testing involved, the documentation needed, and the consultancy obtained. For reference, the fees for a medical-device manufacturing licence are:
- For classes A and B, the licence fee is ₹5,000 plus ₹500 for each extra apparatus.
- For classes C and D, the licence fee is ₹50,000 plus ₹1,000 for each extra apparatus.
The additional costs could be things like laboratory testing, audits, documentation, authentication, and consultancy fees, according to the application.
Labelling Requirements: An Important Compliance Check
Labelling ought not to be regarded as a design task that is carried out after the registration documentation has been completed.
The suggested label is included in the regulatory documentation, and CDSCO’s checklist requires the method of labelling as well as the proposed label to be provided as part of the registration information.
Businesses should carefully review:
- Product name
- Manufacturer details
- Importer/Indian registration-holder details, where applicable
- Net contents
- Batch/lot information
- Manufacturing information
- Use-before/expiry information
- Relevant warnings and directions
- Ingredient information where required
- Registration-related information applicable to imported cosmetics
The 2025 amendment also made clear the meaning of ‘use before’ and ‘date of expiry’ within the Cosmetics Rules.
Common Challenges in CDSCO Registration
The trouble that businesses often experience is not due to the registration process being unclear, but rather because their various technical and commercial documents have to be consistent.
- Incorrect product classification
- Inconsistent manufacturer information
- Incomplete ingredient information
- Labelling discrepancies
- Authentication issues
- Overstated marketing claims
- Multiple variants
What Makes UMSPCS the Choice for CDSCO Certification in India?
It is easier to deal with regulatory registration when product classification, technical documentation, coordination with the manufacturer, and filing on the portal are carried out as a single coordinated process.
We provide support to businesses that have regulatory compliance requirements relating to cosmetics and other regulated products.
UMSPCS, having gained more than six years of experience in the field of compliance, offers support in relation to the regulatory requirements of its products and has dealt with over 600 product compliance requirements in a number of different industries.
For CDSCO Certification for External Intimate Hygiene Products, UMSPCS can assist with:
- Product and regulatory classification
- Applicable cosmetic category identification
- Documentation checklist preparation
- Manufacturer document coordination
- Ingredient and product-information review
- Label and claim review
- Application preparation
- SUGAM portal filing support
- Regulatory query and deficiency support
- Registration documentation
- Post-registration compliance guidance
The aim is to assist companies in developing a compliance process based on their real product rather than viewing registration as a single instance of completing paperwork.
Conclusion
To launch an external intimate hygiene product in India, it is necessary to do more than just complete a registration form; all aspects of the product, such as its classification, formulation, claims, labelling, information regarding the manufacturing site, and the supporting documentation, have to be consistent.
It matters very much that, whether you are a foreign manufacturer looking to enter the Indian market or an Indian importer who is about to launch an intimate hygiene brand, you should understand the relevant cosmetics regulations before you begin commercial operations.
UMSPCS can assist your business with product assessment, providing the necessary documentation, preparing the application, submitting the SUGAM filing, and dealing with regulatory queries.
Looking at the prospect of launching an external intimate hygiene product in India?
Connect with UMSPCS and have your product’s CDSCO compliance pathway evaluated prior to starting the registration process.
Read more also: BIS Certification in Europe for Furniture and Electrical Appliances
FAQs
- Is it necessary to have CDSCO registration for external intimate hygiene products in India?
When a product is classified as a cosmetic and is being imported into India, the CDSCO’s import registration requirements relevant to that product must be met prior to the import; external intimate hygiene products are specifically included in the Fourth Schedule of the Cosmetics Rules, 2020.
- What CDSCO form is needed for intimate hygiene cosmetics that are imported?
The application for import registration is made on Form COS-1, and the Import Registration Certificate is issued on Form COS-2 in accordance with the Cosmetics Rules, 2020.
- Is it possible for an Indian manufacturer to get CDSCO certification for intimate hygiene products?
For cosmetics produced in India, the regulatory procedure concerning manufacturing is usually carried out by the State Licensing Authority and not by the CDSCO import-registration route. The specific requirements will vary according to the product and the method of manufacturing.
- Does each intimate hygiene product fall within the category of cosmetics?
It is not automatic; classification is determined by the product’s intended use, its formulation, how it is presented,e d and the claims it makes. Products that make therapeutic or disease-related claims may then need a different regulatory assessment.
- Is it necessary to carry out product testing in order to register a cosmetic product with the CDSCO?
Testing and the specifications of the product are included in the regulatory documentation, with specific requirements varying according to the product and the applicable standards. The CDSCO checklist specifically requests the product specifications and the testing methods.
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