In India, every drug, cosmetic, and medical device must go through a strict approval process before it reaches the market. Two major government bodies regulate this process: CDSCO (Central Drugs Standard Control Organisation) and State Drug Authorities. Both these bodies play essential roles in ensuring the quality, safety, and effectiveness of products related to health.

At Corpbiz, we help manufacturers, importers, and traders navigate the complex drug approval process smoothly. In this guide, we explain the key differences between CDSCO and State Drug Authority approvals to help you understand where to apply, when, and why.

What is CDSCO?

CDSCO (Central Drugs Standard Control Organisation) is India's national regulatory authority under the Ministry of Health and Family Welfare. It is responsible for regulating drugs, cosmetics, and medical devices at the central level.

CDSCO handles:

• Approval of new drugs
  
  

• Medical Device Registration Process in India
  
  

• Import and export of drugs and cosmetics
  
  

• Clinical trials
  
  

• CDSCO Registration Process in India for manufacturers and importers
  
  

If you're a manufacturer or importer looking to launch a new drug, medical device, or cosmetic in India, you’ll most likely need CDSCO approval first.

What is the State Drug Authority?

Each state in India has its State Drug Control Department. These State Drug Authorities work under the guidelines of CDSCO and the Drugs and Cosmetics Act, 1940.

State Drug Authorities handle:

• Granting retail and wholesale drug licenses
  
  

• Apply Drug License for sale and distribution
  
  

• Apply Cosmetic Manufacturing License for state-level units
  
  

• Monitoring drug and cosmetic quality sold within the state
  
  

• Inspection of manufacturing and storage premises
  
  

They mainly regulate drug sales and local manufacturing units operating within their respective states.

Key Differences Between CDSCO and State Drug Authority

When Do You Need CDSCO Approval?

You need CDSCO approval when:

• You’re introducing a new drug in the Indian market
  
  

• You want to import medical devices
  
  

• You want to launch a new cosmetic product from outside India
  
  

• You’re registering as a manufacturer/importer of medical devices
  
  

• You want to conduct clinical trials
  
  

The CDSCO Registration Process in India involves submitting an online application via the SUGAM portal, along with safety data, technical documents, and testing results.

When Do You Need State Drug Authority Approval?

You need State Drug Authority approval when:

• You are a chemist or pharmacy looking to sell medicines
  
  

• You want to manufacture drugs or cosmetics within a state
  
  

• You are planning to open a wholesale or retail drug store
  
  

• You need a drug sale or storage license
  
  

The application is submitted to the State Drugs Control Department, along with documents such as site layout, staff details, premises ownership documents, and proof of qualification.

A Simple Example

Let’s say you are a company that wants to:

1. Import a medical device – You’ll need to go to CDSCO.
   
   

2. Open a chemist shop in Delhi – You’ll need to apply to the Delhi State Drug Authority.
   
   

3. Manufacture face cream in Maharashtra – You must Apply Cosmetic Manufacturing License through the Maharashtra FDA (State Drug Authority).
   
   

4. Develop a new antibiotic – You must take permission from CDSCO for testing and launch.
   
   

How Corpbiz Helps

At Corpbiz, we simplify the entire approval and registration process for you:

✅ Help you understand if you need CDSCO or State Drug Authority approval
✅ Support you in the CDSCO Registration Process in India
✅ Guide you through the Medical Device Registration Process in India
✅ Assist in how to Apply Drug License for your retail, wholesale, or manufacturing unit
✅ Help you Apply Cosmetic Manufacturing License without delays

FAQs: CDSCO vs State Drug Authority

Q1. What is the major difference between CDSCO and State Drug Authority?

Ans: CDSCO handles central-level approvals such as new drug approvals, medical device registration, and import licenses. State Drug Authorities regulate local sale and manufacturing.

Q2. Do I need CDSCO approval to sell medicines locally?

Ans: No. For selling medicines locally, you only need a drug license from the State Drug Authority.

Q3. How can I register a medical device in India?

Ans: You must apply through the Medical Device Registration Process in India managed by CDSCO. It involves submitting forms, fees, safety documents, and test data.

Q4. Can I get both CDSCO and State Drug Licenses?

Ans: Yes. Many businesses need both. For example, import approval from CDSCO and local sale license from the State Authority.

Q5. How long does it take to get a drug license?

Ans: It depends on your business type and the state. Generally, it takes 15–60 days. Corpbiz can help you speed up the process.

Conclusion

Understanding the difference between CDSCO and State Drug Authority approvals is key for anyone in the pharma, cosmetic, or medical device industry. While CDSCO looks at the national and global level compliance, State Drug Authorities ensure public safety at the local level. Both bodies together help maintain India’s high standards in health-related products.

If you need help with CDSCO registration, drug license, or cosmetic manufacturing approvals, our experts at Corpbiz are just a call away.

Author: Atul Shukla

Regulatory Compliance Expert at Corpbiz
Atul is passionate about helping businesses meet legal and compliance requirements in the healthcare, medical, and cosmetic sectors in India. With years of experience, he ensures every registration and approval process is smooth, fast, and reliable.