CDSCO Registration for Antiperspirant Products in India

Antiperspirants are among the most widely used personal care products worldwide. In India, these products are in the cosmetics category as per the Drugs and Cosmetics Act, 1940 and Cosmetic Rules, 2020. The Central Drugs Standard Control Organization is a Central Licensing Authority responsible for regulating the import, registration and compliance of antiperspirant products before marketing in India.

It ensures product safety, quality and alignment with global cosmetic standards.

Why Do Antiperspirants Require CDSCO Registration?

Unlike regular cosmetic products, antiperspirants are classified as drugs in India as they change the normal function of the skin by reducing sweat. This makes them subject to security, efficacy and quality rules under CDSCO.

Key reasons for CDSCO oversight:

• Body sprays contain active ingredients like aluminium salts that connect with sweat glands.
• They have a pharmacological effect outside fragrance or cosmetic enhancement.
• To ensure consumer safety, the CDSCO regulates their import, manufacture, labelling, and sale.

Governing Laws and Regulations

Antiperspirant in India is ruled by the registration of products:

• Drugs and Cosmetics Act, 1940
• Drugs and Cosmetics Rules, 1945
• CDSCO Guidelines for Import/Construction of Drug Yogas

Step-by-Step Process for CDSCO Registration of Antiperspirants

1. Check Applicability: Since antiperspirants are a recognised cosmetic category (Column 3 lists them under “Correction of body odour and/or perspiration”), registration is required before import.
2. Prepare and Submit the Application

Forms required:

• Form COS‑1: Application for registration.
• Form COS‑2: Registration Certificate issued upon approval.
• Form COS‑3: If the product is a “new cosmetic,” prior permission must be sought under Form COS‑3 before applying for registration

Applicant Profiles: Applications may be submitted by:

• Manufacturer with a registered office in India.
• Authorised Agent in India.
• Subsidiary of the manufacturer based in India.
• Other importers

3. Required Documentation

According to CDSCO guidelines, a typical import registration dossier must include:

• Completed application form (Form COS‑1).
• Proof of fee payment (Treasury Challan).
• Power of Attorney authorising the Indian representative (must be duly notarised, attested, or apostilled
• Schedule D‑III, listing product details, ingredients, manufacturing site, brand, variants, and undertaking
• Covering letter, English translations of non-English documents, and relevant label or artwork submissions

4. Labeling Requirements

Imported antiperspirants must bear:

• The Registration Certificate (RC) number.
• Name and address of the registrant.
• Manufacturer’s details and country of origin (or actual facility if different)

In some cases, stickering post-import may be permitted at an approved location upon application

5. Fees & Application Management

• A fee of USD 250 (or equivalent in INR) is charged per brand category (brands include any variants—size, shade, etc.)
• Adding another variant under an already registered brand typically doesn’t require extra fees, but a fresh application must be submitted for endorsement
• If product specifications change post-registration (e.g., ingredient or variant modifications), the authority must be informed with an updated Schedule D‑III at least 30 days before the intended import

6. Review, Approval, and Issuance

Once CDSCO is satisfied with compliance, the Import Registration Certificate (Form COS‑2) is granted. Absent compliance, the application may be rejected or sent back for corrections

Timeline and validity

• The Registration Certificate (Form COS-2) is valid for 5 years from the date of issue, unless:
• It was suspended or cancelled earlier due to non-compliance.
• Product specifications/ingredients change without informing CDSCO.
• Renewal: Must be applied for at least 6 months before expiry with updated documents and fees.

Labelling Requirements for Antiperspirants

According to CDSCO rules, labels must include:

• Name of the product and active ingredients
• Manufacturer’s details and country of origin
• Import license/registration number
• Batch number, manufacturing date, and expiry date
• Storage conditions and cautionary warnings

Challenges in CDSCO registration

• Detailed technical documents are mandatory.
• Differences between cosmetic deodorants and drug-based antiperspirants often create confusion.
• Prolonged approval deadline compared to cosmetics.
• If you are a foreign manufacturer, then an Indian authorised agent is required.

How ELT corporate can help

In ELT Corporate, we are experts in helping businesses navigate the complex regulatory structure of CDSCO. Our experts help:

• Full application preparation and submission
• Coordination with CDSCO officials
• Ensure that the labelling and testing requirements ensure
• Accelerate the approval process

Whether you are importing or manufacturing antiperspirant products in India, our team ensures a smooth and hassle-free registration process so that you can focus on increasing your business.

Conclusion

Getting CDSCO registration for antiperspirant products in India is a mandatory legal requirement that is due to their functional role in controlling sweat. By complying with the strict guidelines of CDSCO, manufacturers and importers can ensure that their products are safe, effectively and legally marketed in India.

If you are planning to launch antiperspirant products in India, start early with your registration process and partner with regulatory experts to avoid delay.