In India, the safety of medicines, cosmetics, and medical devices is taken very seriously. If you are planning to manufacture, import, or sell such products, you must follow the rules laid down by the government. One of the most important approvals you need is a CDSCO license.

Many business owners often ask simple but important questions like:
How long is a CDSCO license valid?
When should it be renewed?
Can it be suspended or cancelled?

This blog explains everything in very simple words. Whether you are a startup, manufacturer, importer, or distributor, this guide will help you clearly understand CDSCO license validity, renewal, and suspension.

What is CDSCO?

The Central Drugs Standard Control Organization (CDSCO) is India’s national authority for regulating drugs, cosmetics, and medical devices. It works under the Ministry of Health & Family Welfare.

CDSCO ensures that:

• Medicines are safe and effective
  
  

• Medical devices meet quality standards
  
  

• Cosmetics do not harm consumers
  
  

Any business involved in these sectors must comply with CDSCO rules.

Why is a CDSCO License Important?

A CDSCO Online license is not just a legal requirement—it also builds trust. It shows that your product:

• Meets Indian safety standards
  
  

• Has been approved by a regulatory authority
  
  

• Is fit for public use
  
  

Without a valid CDSCO license:

• You cannot legally sell or import products
  
  

• Heavy penalties may apply
  
  

• Your business reputation may suffer
  
  

Types of CDSCO Licenses

Before understanding validity and renewal, let’s quickly look at the common types of CDSCO licenses:

1. CDSCO Online Registration

Most CDSCO applications are now filed through the online portal. This system makes the process transparent, faster, and trackable.

2. CDSCO Cosmetic Manufacturing License

This CDSCO Cosmetic Manufacturing License is required if you manufacture cosmetics like creams, lotions, shampoos, makeup products, or personal care items in India.

3. CDSCO Medical Device Import License

If you import medical devices such as diagnostic equipment, implants, or instruments into India, this CDSCO Medical Device Import License is mandatory.

4. CDSCO Medical Device Registration

This CDSCO Medical Device Registration applies to manufacturers and importers of notified medical devices to ensure they meet Indian regulatory standards.

CDSCO License Validity Explained

How Long is a CDSCO License Valid?

Earlier, CDSCO licenses were issued for a fixed time period. However, as per updated rules:

• Most CDSCO licenses are valid perpetually

• There is no fixed expiry date

• Validity continues as long as compliance is maintained
  
  

This means you don’t have to apply for renewal every few years—but compliance is key.

Is Perpetual Validity Really “Lifetime”?

Not exactly.

Although the license does not expire automatically:

• You must pay retention fees

• You must follow all CDSCO rules

• Inspections and audits can happen anytime
  
  

If you fail to meet these conditions, your license can be suspended or cancelled.

Retention Fees: A Very Important Point

Even though the license is perpetual, CDSCO requires license holders to pay a retention fee every five years.

Key Points About Retention Fees:

• Paid every 5 years from the date of issue

• Non-payment may lead to suspension

• Applicable to cosmetic and medical device licenses
  
  

Missing this fee is one of the most common mistakes made by businesses.

CDSCO License Renewal: Is It Required?

Do You Need to Renew a CDSCO License?

Technically, no renewal is required if:

• Retention fees are paid on time

• All conditions are followed
  
  

However, renewal-like actions are needed in some cases.

Situations Where Renewal or Revalidation is Needed

You may need to update or reapply if:

• There is a change in product composition

• Manufacturing premises are shifted

• Authorized signatory changes

• Product list is expanded

• Import source or manufacturer changes
  
  

In such cases, CDSCO approval is required before continuing operations.

CDSCO License Renewal Process (When Applicable)

Here is a simple overview of how the process works:

1. Login to CDSCO online portal

2. Select the relevant license

3. Submit updated documents

4. Pay applicable government fees

5. Wait for review and approval
   
   

The process is completely online and document-based in most cases.

Documents Required for Renewal or Updates

Common documents include:

• Existing CDSCO license

• Product details and specifications

• Updated manufacturing or import details

• Fee payment receipt

• Declaration of compliance
  
  

The exact list depends on the type of license.

CDSCO License Suspension Explained

A CDSCO license is a privilege, not a permanent right. It can be suspended if rules are not followed.

What is License Suspension?

Suspension means:

• Your license becomes temporarily inactive

• You cannot manufacture, import, or sell products

• Business operations must stop immediately
  
  

Reasons for CDSCO License Suspension

Some common reasons include:

1. Non-payment of retention fees

2. Violation of quality standards

3. Misleading or false information

4. Adverse inspection reports

5. Selling unsafe or substandard products

6. Operating beyond approved scope
   
   

Even a small compliance lapse can attract action.

CDSCO License Cancellation

If issues are serious or repeated, CDSCO may cancel the license completely.

Difference Between Suspension and Cancellation

Cancellation can cause long-term damage to your business.

How to Avoid Suspension or Cancellation?

Here are some practical tips:

• Pay retention fees on time

• Maintain proper records

• Follow Good Manufacturing Practices (GMP)

• Ensure product quality testing

• Respond quickly to CDSCO notices

• Update CDSCO about any changes
  
  

Compliance is always cheaper than penalties.

Role of Corpbiz in CDSCO Compliance

Managing CDSCO licenses can be confusing, especially for first-time applicants. This is where Corpbiz helps.

At Corpbiz, we assist with:

• CDSCO Online Registration

• CDSCO Cosmetic Manufacturing License

• CDSCO Medical Device Import License

• CDSCO Medical Device Registration

• Retention fee management

• Compliance tracking and updates
  
  

Our experts ensure that your license stays valid without interruption.

FAQs on CDSCO License Validity, Renewal & Suspension

1. Is a CDSCO license valid for a lifetime?

Yes, it has perpetual validity, but only if retention fees are paid and compliance is maintained.

2. What happens if I forget to pay the retention fee?

Your license may be suspended, and you may have to pay late fees or reapply.

3. Can CDSCO cancel my license without notice?

Generally, CDSCO issues a show-cause notice before suspension or cancellation.

4. Is CDSCO Online Registration mandatory?

Yes, all applications and updates must be filed through the online portal.

5. Can I sell products during license suspension?

No, all regulated activities must stop during suspension.

6. Is renewal required for CDSCO Cosmetic Manufacturing License?

No renewal is required, but retention fees and compliance are mandatory.

7. Can a suspended license be restored?

Yes, after corrective action and approval by CDSCO.

8. How often does CDSCO conduct inspections?

Inspections can happen anytime, especially after complaints or risk alerts.

Conclusion

Understanding CDSCO license validity, renewal, and suspension is crucial for running a compliant and successful business in India. While the concept of perpetual validity has reduced paperwork, it has also increased the responsibility on businesses to stay compliant at all times.

Timely fee payments, quality control, and proper documentation are the keys to avoiding suspension or cancellation. With expert guidance from Corpbiz, you can focus on growing your business while compliance experts handle the regulatory side.

Author Profile

Atul Shukla
Atul Shukla is a compliance and regulatory expert with extensive experience in CDSCO licensing, medical device regulations, and cosmetic approvals. He regularly writes informative and easy-to-understand content to help businesses stay legally compliant and confident in India’s complex regulatory environment.

Need help with CDSCO registration or compliance? Connect with Corpbiz today for reliable and professional assistance.

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