As more shoppers watch hygiene and skin-care trends develop, almost every Indian shop front now has a line of creamy, velvety hand creams next to shiny bottles of alcohol-rich sanitiser. Anyone looking to manufacture, import, or make a sale of either of these product lines in India must first pass a registration check run by the Central Drugs Standard Control Organisation, or CDSCO. This simple step-by-step guide leads you through that process, including what documents to compile, how long to allow, and, finally, the regulation link that supports every form you compile.
Introduction To CDSCO Cosmetic Registration
The Central Drugs Standard Control Organisation (CDSCO) regulates drugs, cosmetics, and medical devices in India. The CDSCO is regulated by the Drugs and Cosmetics Act 1940, as well as the CDSCO and Cosmetic Rules 2020. This law states that all apparel that is imported as a cosmetic must have CDSCO approval before it can be sold. The hand cream, a cosmetic, is required to be approved by the CDSCO, so that anyone selling such a product must receive approval from the CDSCO. However, sanitiser can fall into a different category, depending on the ingredients used and the suggested use.
Why Hand Creams And Sanitizers Need CDSCO Registration
Hand creams mostly soothe dry hands, but Indian regulations view them as mere cosmetics rather than as medicines.
During the lockdown, alcohol gels were flying off the shelves since almost everyone needed a fast solution for fighting germs. Because they contain powerful ethanol or isopropanol that can kill germs, they move from being a cosmetic to a drug, meaning manufacturers then must register with a drug licence, specifically Form 41 or Form 10, rather than having a much simpler approval system for cosmetics.
Is Hand Sanitizer A Cosmetic Or A Drug In India?
It’s easy to sort products like hand cream: lather it on to look nicer, and it’s a cosmetic. Hand sanitizers, though, often blur the line:
- Alcohol-rich versions usually around 60% or more fall squarely in drug territory, so they need the full drug licence.
- Varieties promoted as herbal or purely cosmetic could, in theory, sit under the cosmetics rule, but that route hardly ever gets used.
- Heads-up: this note talks about the CDSCO cosmetic path for hand cream; it doesn’t dive into the drug side for sanitizers.
Step-by-Step Process Of CDSCO Cosmetic Registration For Hand Cream
Here are the following steps you need to follow while applying for a cosmetic import license for hand cream:
- Register on SUGAM Portal: Create an account at cdsco.gov.in.
- Prepare Documents: prepare the necessary documents required forÂ
- Submit Application Online: Fill out details, upload documents, and submit via SUGAM.
- Pay Govt. Fee: Pay the required fee online.
- CDSCO Review: Respond to any queries or requests for more info.
- Get Registration Certificate: Download the COS-2 certificate once approved.
Documents Required For CDSCO Cosmetic Registration For Hand Cream
The following documents are required to obtain CDSCO import registration for hand creams:
| Document | Purpose |
| Form COS-1 | Application form for cosmetic import registration |
| Power of Attorney | Authorizing an Indian Agent by the foreign manufacturer |
| Ingredient List | To ensure compliance with banned/restricted substances |
| Label/Artwork | As per CDSCO labeling rules |
| Product Specifications | Includes pH, microbiological tests, etc. |
| GMP Certificate | From the manufacturing country |
| Free Sale Certificate | From the country of origin |
Note: If you are a manufacturer, the document requirements for a manufacturing license are different from comparison for the cosmetic import license.Â
CDSCO Registration Fees
The application fee is USD 250 per variant of hand cream. Multiple SKUs require separate fees. Payment must be made online through the Bharatkosh portal.
Timelines for Approval
The average processing time for CDSCO Cosmetic Registration for Hand Cream is:
| Stage | Timeframe |
|---|---|
| Documentation & Submission | 2–3 weeks |
| CDSCO Review & Query Resolution | 1-2 months |
| Certificate Issuance | 3-4 months (total) |
Note: Timelines may change depending on how quickly queries are answered, current backlog, and product complexity.
How ELT Corporate Can Help?
At ELT Corporate, we specialize in CDSCO Cosmetic Registration for Hand Cream, offering end-to-end support including:
- Regulatory guidance and classification
- Preparation of COS-1 & COS-5 applications for importers and manufacturers, respectively.
- Assistance with the SUGAM portal
- Power of Attorney & documentation drafting
- Timely follow-up and query resolution
- Post-registration assistance
Our specialists ensure that the product meets India’s regulatory requirements to support your ability to import a product and market it with full compliance and peace of mind.
FAQs
Are Hand Creams Required To Be Registered With CDSCO For Import?
Yes, registration under CDSCO is required for all imported cosmetics, including hand creams.
How Long Is The Validity Of CDSCO Cosmetic Registration?
COS-2 & COS-8 are valid for 5 years from the date issued.
Can I Register Multiple Hand Creams Under One Application?
No, you would need to register each variant (based on composition, shade, and scent) separately.
Do Indian Manufacturers Also Need CDSCO Cosmetic Registration For Hand Cream?
YES, a COS-8 license is required for hand cream manufacturing under the CDSCO. They also need to comply with local GMP and state licensing requirements.
