The CDSCO License is considered one of the most important regulatory approvals for a business who is dealing in drugs, medical devices, or cosmetics in India. The product becomes a stamp of safety and quality as it is certified by the Central Drugs Standard Control Organisation (CDSCO) in India.
Without this license, manufacturing or importing these items is illegal. In this guide, we simplify the entire CDSCO Licence registration process, breaking down the essential documents, government fees, and steps to help you stay compliant and market-ready.
Why Does Your Business Need a CDSCO License?
The Central Drugs Standard Control Organisation is India’s main drug control body. It works under the Ministry of Health and Family Welfare. It ensures that organisations follow the provisions of the Drugs and Cosmetics Act for drugs, medical devices, and cosmetics.
A CDSCO License in India gives a company permission to make, import, or sell regulated products. It is illegal to sell these products without this license, you can face product seizure, heavy fines, and a market ban.
Types of CDSCO Licences
Different businesses need different types of licenses from CDSCO:
Drug and cosmetic related licenses
- Drug manufacturing license – You need this to make medicines for sale. It shows your factory follows good practices and quality rules.
- Import license for drugs and cosmetics – You need this to bring in finished products, raw materials, or cosmetic items from other countries. It proves the foreign factory and products meet Indian safety standards.
- Registration certificate – This lets you register and sell a specific product in India.
- GMP certificate and COPP – You often need these when you export products from India or want to show you follow quality rules.
Medical device related approvals
- Medical device registration – All medical devices in Class A, B, C, and D need registration with CDSCO before you can sell them.
- Manufacturing and import licenses – The fees change based on device risk class and whether you make it in India or bring it from abroad.
Who Must Apply for CDSCO Registration in India?
- Indian companies that make drugs, medical devices, and cosmetics
- Companies that import regulated products into India
- Foreign companies that work with Indian agents
- Companies that do clinical trials or research with drugs or devices
- Testing labs that work on studies for exports
You may require CDSCO Registration if your business imports, manufactures or sells any goods under the Drugs and Cosmetics Act. Contact Advisou experts if you experience difficulties.
Step-by-Step Guide to the CDSCO Online Registration Process
The full CDSCO Registration process happens online through the SUGAM portal:
Account creation on the portal
Go to the official CDSCO portal[1] and click “Login/Sign Up.” Pick the right “Registration Purpose” from the list. Fill in details like your type, username, and email. Upload your ID proof, a signed statement, and address proof. You will get a link in your email. After CDSCO officials approve your account, you can log in and apply for licenses.
Product and license planning
Before you apply, find out your correct product type always verify the classification as a drug, cosmetic, or device. Determine whether you are required to obtain a license to manufacture, import or register the product. It’s important to get this right because it affects the papers you need and how much you pay.
Document preparation and application filing
- Device Master File or Plant Master File: Details about how you make the product.
- Technical Data: Documents about product use and risk.
- Quality Certification: Certificates like ISO 13485.
- Regulatory Status: Permission from the home country for imports.
- Clinical Evidence: Test data for new or risky products.
Review and Final Approval
CDSCO officials will check your application and may ask for more details or extra papers. Once they are satisfied with everything, they issue your license or certificate through the portal.
Mandatory Documents Required for CDSCO License
Compulsory documents you may need include:
- Government ID proof and address proof
- Making or selling license from your State Licensing Authority
- Company papers like incorporation certificate
- Technical file with product details and use
- Quality certificates
- Free Sale Certificate or permission for imported products
- Test data for new or risky products
- Sample labels with all required information
Official Fees and Approval Timelines for CDSCO Licenses
For Medical Devices
- Class A and B Making: ₹5,000 per factory and ₹500 per device
- Class C and D Making: ₹50,000 per factory and ₹1,000 per device
- Class A Import: $1,000 per factory and $50 per device
- Class B Import: $2,000 per factory and $1,000 per device
- Class C and D Import: $3,000 per factory and $1,500 per device
For Cosmetics
Registration costs ₹10,000 (or $250) for up to 10 items in one category. Additional items will cost ₹500 each.
Low-risk devices can get approval in a few months if all papers are correct. High-risk products take longer because officials do deeper checks. Missing or wrong papers can add weeks or months to the wait time.
Conclusion
A CDSCO license is required for healthcare and cosmetics business under Central Drug Standard Control Organisation. Understanding the necessary approvals for your projects, the required documents and their costs results in better planning.
With proper preparation and expert guidance, your business can get the right permits and comply. If you have any queries related to business compliance, you can trust Advisou for reliable guidance.
Also Read: Complete NBFC License Registration Process in India as per RBI
