Starting a healthcare business in India comes with a lot of responsibility, especially when it involves drugs, cosmetics, or medical devices. One of the most important legal requirements in this space is getting approval from the Central Drugs Standard Control Organization (CDSCO).
In this blog, we’ll explain everything healthcare entrepreneurs need to know about the legal side of CDSCO approval—what it is, why it's important, and how to get your CDSCO Certificate Registration done the right way.
What is CDSCO?
CDSCO (Central Drugs Standard Control Organization) is India’s national regulatory authority for pharmaceuticals and medical devices. It works under the Ministry of Health and Family Welfare and ensures that drugs, cosmetics, and medical devices are safe, effective, and of high quality.
If you're planning to manufacture or import any healthcare product in India—such as drugs, cosmetics, or medical devices—you must follow the rules laid out by CDSCO.
Why CDSCO Approval Matters
CDSCO approval is not just a formality; it’s a legal requirement. Without it, your business could face:
Heavy penalties or fines
Product recalls
Loss of credibility
Complete shutdown of operations
It also builds trust with customers, hospitals, pharmacies, and even foreign buyers. CDSCO ensures that your product meets safety standards, making your brand more reliable in the healthcare market.
Key CDSCO Approvals for Healthcare Entrepreneurs
Here are the major CDSCO approvals and licenses you might need:
1. CDSCO Certificate Registration
This is the basic regulatory approval for manufacturers and importers of drugs, cosmetics, and medical devices. You need this CDSCO Certificate Registration before you can legally sell your product in India.
The application process involves:
Product classification
Application submission
Testing and evaluation
Final approval from CDSCO
Depending on your product type, CDSCO may ask for additional safety data and quality testing.
2. Medical Device Registration in India
If you're planning to manufacture or import a medical device (like syringes, diagnostic kits, stents, or surgical tools), CDSCO must approve it.
Here’s how the Medical Device Registration process works:
Classify your device (Class A, B, C, or D)
Apply on the CDSCO Sugam portal
Submit technical and safety documents
Wait for inspection and approval
For Class A and B devices, a state licensing authority may be involved. For Class C and D (higher risk), CDSCO itself will handle the registration.
3. Cosmetic License Registration for Product Manufacturing
Thinking of launching a skincare or beauty brand? You’ll need a cosmetic manufacturing license under the Drugs and Cosmetics Act, 1940. CDSCO monitors the safety and labeling of all cosmetic products sold in India.
Steps include:
Apply for Form 32 (license to manufacture cosmetics)
Submit product details and safety information
Set up a GMP-compliant (Good Manufacturing Practices) unit
Get your products tested at an approved lab
This license ensures your product is free from harmful chemicals and meets labeling norms.
4. Drug License Registration
If you're manufacturing or selling pharmaceutical products like tablets, syrups, or vaccines, you’ll need a Drug License Registration.
There are two main types:
Manufacturing License – for drug producers
Retail/Wholesale License – for pharmacies or distributors
You must have proper infrastructure, qualified staff (like a registered pharmacist), and follow GMP guidelines. CDSCO or the State Drug Control Department will inspect your premises before granting the license.
Legal Framework Behind CDSCO Approvals
All CDSCO activities are governed by these legal rules:
Drugs and Cosmetics Act, 1940
Drugs and Cosmetics Rules, 1945
Medical Device Rules, 2017
New Drugs and Clinical Trials Rules, 2019
Failing to comply can lead to legal consequences, including suspension of your license.
How Corpbiz Can Help
Getting CDSCO approval can be complex, with multiple forms, inspections, and documentation. At Corpbiz, we simplify the process by:
✅ Helping you classify your product
✅ Preparing and submitting applications
✅ Coordinating with CDSCO officials
✅ Managing legal compliance
✅ Tracking your approval status
Whether it's CDSCO Certificate Registration, Medical Device Registration in India, or Drug License Registration, our team ensures quick, hassle-free service.
FAQs – CDSCO Approval
Q1. How long does it take to get CDSCO Certificate Registration?
It usually takes between 3 to 6 months, depending on the product and completeness of documents.
Q2. Is CDSCO approval required for Ayurvedic products?
Not always. Ayurvedic products are regulated under AYUSH, not CDSCO. But if they contain modern drug ingredients, CDSCO approval may be needed.
Q3. Can I apply for CDSCO approval online?
Yes. CDSCO uses the Sugam Portal for all online applications related to drugs, medical devices, and cosmetics.
Q4. What is the cost of Drug License Registration in India?
It depends on the type of license (manufacturing, wholesale, retail). Government fees range from ₹5,000 to ₹50,000, excluding consultant charges.
Q5. Is it mandatory to have a GMP-certified unit for cosmetic manufacturing?
Yes. CDSCO requires GMP compliance to ensure product safety and hygiene.
Final Thoughts
If you're entering the healthcare market in India, CDSCO approval is your legal gateway to success. Whether you're making a new drug, importing a medical device, or launching a cosmetic line—compliance is not optional. It's the foundation of trust and business longevity.
With expert support from Corpbiz, you can focus on building your brand while we handle the paperwork. Let’s ensure your healthcare venture is legally strong, compliant, and ready for growth.
Author: Atul Shukla
Legal Consultant | Healthcare Compliance Expert
Atul Shukla brings years of experience helping startups and businesses with regulatory approvals in India. He specializes in CDSCO, drug licensing, and product compliance.
