Starting a business in the health and wellness sector in India—whether it’s manufacturing medical devices, selling drugs, or producing cosmetics—requires various approvals and licenses. One of the most important is the CDSCO Registration in India. This registration is issued by the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority for drugs and medical devices in the country.
In this blog, we will explain what CDSCO is, who needs it, and how to obtain licenses like Medical Device Registration in India, Cosmetic Manufacturing License, and Drug License Registration. Whether you're a startup or an established company, understanding these registrations is essential for running a legal and successful business in this sector.
What is CDSCO?
CDSCO (Central Drugs Standard Control Organization) is the primary regulatory body under the Ministry of Health and Family Welfare. It oversees the quality, safety, and effectiveness of drugs, medical devices, and cosmetics in India.
The organization works under the Drugs and Cosmetics Act, 1940, and is responsible for granting approvals, conducting inspections, monitoring quality, and ensuring public safety.
Why is CDSCO Registration in India Important?
If your business deals with health-related products like medicines, medical devices, or cosmetics, you need to ensure that these products meet Indian safety and quality standards. Without CDSCO registration or the necessary licenses, you cannot legally manufacture, import, or sell such products in India.
CDSCO registration helps in:
Legal authorization to operate your business
Compliance with government standards
Customer trust and credibility
Avoiding legal penalties or business shutdown
Types of Registrations under CDSCO
Let’s look at the key licenses and registrations under CDSCO for medical and cosmetic businesses:
1. Medical Device Registration in India
If you want to manufacture, import, or sell medical devices in India, you need to register with CDSCO.
Examples of Medical Devices:
Syringes
Thermometers
X-ray machines
Heart monitors
Surgical gloves
Categories:
Medical devices are classified into four categories based on risk:
Class A (low risk)
Class B (low-moderate risk)
Class C (moderate-high risk)
Class D (high risk)
Registration Process:
Check the classification of your medical device.
Prepare documents such as manufacturing license, ISO 13485, Free Sale Certificate, and Device Master File.
Apply online through CDSCO’s SUGAM portal.
Pay the fees and submit documents.
Inspection may be conducted for certain classes.
Get the registration certificate, usually valid for 3 years.
2. Drug License Registration
A Drug License Registration is mandatory to manufacture, distribute, or sell drugs and pharmaceutical products in India.
Types of Drug Licenses:
Manufacturing License – For producing drugs
Wholesale License – For selling drugs in bulk
Retail License – For selling drugs directly to consumers (e.g., chemist shops)
Import License – For importing drugs from other countries
Documents Required:
Company registration documents
Premises details and ownership proof
Pharmacist qualification and registration certificate
Affidavit of non-conviction
Site plan and blueprint
Proof of refrigeration (for temperature-sensitive drugs)
Process:
Apply online via the state drug controller’s website or CDSCO SUGAM portal.
Attach all required documents and pay the applicable fee.
Inspection of premises by drug inspector.
Grant of license within 30-60 days if all is in order.
3. Cosmetic Manufacturing License
If your business is into making beauty or personal care products like creams, lotions, soaps, or shampoos, then a Cosmetic Manufacturing License is needed.
Types of Cosmetic Licenses:
License to Manufacture Cosmetics for Sale (Form 32)
License to Distribute/Wholesale (Form 41)
Loan License (If you use another manufacturer’s facility)
Documents Required:
Proof of premises (minimum space requirement is 100 sq. ft.)
List of cosmetic products and formulations
Equipment and machinery details
Qualification of technical staff (must have a pharmacy or chemistry background)
Company incorporation certificate
Process:
Apply to the state drug authority along with the required documents.
Inspection of your premises and verification of staff and machinery.
License issued if you meet all standards.
Note: Imported cosmetics must also be registered under CDSCO before they are sold in India.
Common Mistakes to Avoid
Not classifying medical devices correctly
Submitting incomplete or incorrect documents
Not hiring qualified staff (especially for drug licenses)
Trying to sell/import products before getting the license
Ignoring regular compliance and inspections
Benefits of Getting Proper Licenses
Builds customer trust
Prevents legal troubles
Enhances brand reputation
Makes your product eligible for exports
Helps in getting government tenders
How Can Corpbiz Help?
Getting CDSCO registration or any health-sector license can be complex. The application process involves technical documents, compliance with strict norms, and coordination with government departments.
At Corpbiz, we help simplify the entire process for you:
✅ Expert guidance on classification and eligibility
✅ Complete documentation support
✅ Online filing and follow-up
✅ Timely updates and reminders for renewal
✅ Assistance with inspections and audits
Frequently Asked Questions (FAQs)
Q1. Is CDSCO registration mandatory for all medical devices?
Yes, CDSCO registration is mandatory for all medical devices classified under Class A to D. Non-compliance may lead to legal action.
Q2. How long does it take to get a drug license?
It typically takes 30–60 days, depending on the type of license and completeness of your documents.
Q3. What is the validity of the Cosmetic Manufacturing License?
The cosmetic license is generally valid for 5 years and must be renewed before expiry.
Q4. Can I sell imported cosmetics without CDSCO registration?
No, imported cosmetics must be registered with CDSCO before being marketed in India.
Q5. Is ISO certification required for Medical Device Registration?
Yes, ISO 13485 is often required for Class B, C, and D medical devices. It shows your company follows international standards for quality management.
Conclusion
Whether you're a startup or an existing manufacturer in the healthcare or beauty industry, obtaining the proper licenses from CDSCO is not just a legal requirement but also a mark of quality and trust. CDSCO Registration in India, along with Medical Device Registration, Cosmetic Manufacturing License, and Drug License Registration, opens the door to a compliant and profitable business.
It may seem complicated at first, but with expert help from Corpbiz, the process becomes smooth and stress-free.
Author Profile
Atul Shukla
Legal & Regulatory Expert | Corpbiz
Atul Shukla is a seasoned legal advisor with over 8 years of experience in Indian regulatory compliance. He specializes in CDSCO Registration, Medical Device and Drug Licensing, and Cosmetic Business Licensing. Atul is passionate about helping startups and healthcare businesses navigate India’s complex licensing landscape with ease. At Corpbiz, he offers end-to-end support to entrepreneurs looking to grow their businesses legally and responsibly.
