How to Renew the CDSCO Drug Registration Certificate Digitally in 2025?

Medical drugs are used to treat human illnesses, manage chronic conditions, and enhance overall health. This is important to give them a healthy and quality life. Have you ever wondered what would happen if the medicines don’t meet the quality standards or are supplied with expired drugs? This not only damages the chain of the pharmaceutical industry but also has a profound impact on consumer health. To keep the quality and the safety of drugs high, the Central Drugs Standard Control Organization (CDSCO) mandates the use of a drug license. It means that all manufacturers and importers are required to register with the regulatory authorities. 

In addition, the renewal of the CDSCO drug certificate is crucial. The renewal of a drug license ensures that the manufacturers and distributors are adhering to regulatory standards and also following safety standards. On the other side, the digital developments made the drug registration renewal more seamless. In this comprehensive guide, we will explore how you can renew your CDSCO certificate for a drug with the online portal, the process, benefits, and much more.

Why Do Manufacturers Need a Drug License in India?

Under the Drugs and Cosmetics Act, 1940, securing a license for the drug business is important. The drug certification ensures the pharmaceutical products’ quality, safety, and efficacy standards. The license rules were published to protect the health of the public by manufacturers, sales, and distributors’ working activities. With license registration, the authority gets access so they can confirm whether the manufacturing process of the drug is accurate or not. 

The licensing is not only a formality, but it is one of the most vital steps to safeguard the health of consumers. If you are operating a pharmacy business in India, you can register with the Central Drugs Standard Control Organization, which serves as the regulatory authority. 

The importance of Drug Certificate Renewal

For the manufacturers and distributors, renewing the drug safety certification is crucial to managing the legal and ethical operations. These operations ensure the consumer’s safety and uplift business credibility to the next step.

Here is why you need to renew your registered drug license:

Drug Certificate Validity for a Specific Period

Drug safety certifications are valid for a specific period, and the validity depends mostly on the jurisdiction. The variety of licenses and the guidelines further define how long a certificate can be used in the market. Several nations, including India, allow a drug license to be used by the manufacturer for 5 years. It means that, before the coming of the expiry date, businesses are required to apply online for their renewal.

However, if the manufacturers and the distributors fail to meet the license renewal standards, it can raise a serious concern that there can be strict legal actions or seizure. 

Step-by-Step: Process for Drug Safety Certification Renewal Digitally

For the safety drug license renewal, the business needs to follow a comprehensive process. Interestingly, the online renewal registration made the process easier. The digital steps are increasing the document’s security. In addition, the steps start from registering on the online portal to submitting the application form. The steps are

Start Early: Begin the renewal process at least 30-60 days before the license expiry. It saves time processing.

Online Application: For the drug license application, log in to the official CDSCO online portal.

Registration: If you are new to the portal, create an account for application submission. 

Application Form: As per the type of license, fill out Form 19, Form 19A, Form 19B, or Form 19. Most review the application form before its submission to avoid errors or rejection.

Document Submission: Attach the necessary documents with the application form.

• A copy of the existing drug certificate
• Evidence of ownership or lease of the premises
• Technical staff education with proof of experience
• The other major certificate reflects the license type and the regulatory rules.

Fee Payment: Pay the mandatory license drug renewal through the online portal.

Inspection: To ensure compliance, the authority may conduct the inspection. 

Final Approval: After a successful verification, the authority will issue the renewed drug safety license. 

User Query: All About New Drug Approval by CDSCO in India

Final Words | Drug Renewal Licence in India

The license renewal is the core part to continue the operations in the pharmaceutical industry. The renewal identifies that the drug operator meets the regulatory standards and rules. 

This process is further vital to protect the health of the general public from substandard products. Understanding the importance of certificate renewal encourages the business to take a protective step. Overall, applying digitally for the renewal ensures legal compliance, manages the license privileges, and gives access to work without the fear of legal penalties. The online procedure is cost-effective and efficient. This further reduces the physical paper submission, which is beneficial to improve accessibility. The digital steps offer real-time updates and notifications related to authority guidelines. Meanwhile, to complete the application accurately, connect with the Legal Raasta experts who help businesses apply for their license for renewal. Reduce the burden and processing period with our professionals’ guidance and support. 

Frequently Asked Questions

1. What is the name of the CDSCO online portal?

Ans. To obtain the license or renew it, visit the SUGAM portal.

2. What is the fee for renewing a drug license?

Ans. The registration fee depends on the type of drug license and certain rules. In Delhi, the retail drug license renewal fees range from Rs 1,500 to Rs 3,000. It can be increased if the applicant applies for renewal late.

3. What is the online fee for renewing a drug certificate in Uttar Pradesh?

Ans. For the drug certificate renewal, the applicant needs to pay Rs 3000, which must be paid online.

4. What are Forms 20B and 21B?

Ans. Under the Drugs and Cosmetics Act, 1940, these forms act as the drug license in India for wholesalers.

5. Who is the head of CDSCO?

Ans. In India, the CDSCO head department is the Drugs Controller General of India (DCGI).