CDSCO Test License

The CDSCO test license is issued under the Drugs and Cosmetics Act, 1940, and the Rules, 1945, to authorize the import or manufacture of limited quantities of drugs solely for testing, analysis, or research purposes. The CDSCO Test License ensures that every medicine or product is safe and meets the required quality standards before it reaches the market. This license is given in Form-11 by the Central Drugs Standard Control Organization (CDSCO), which works under the Ministry of Health and Family Welfare.

This rule helps keep strong control over the quality of drugs tested in labs or used in clinical studies. It is an important requirement for all research centers, factories, and testing labs that work on developing or checking new medicines. The license ensures that every product tested in India follows the country's safety rules and meets the highest standards before it is used by people. It does not allow commercial sale or marketing of imported substances.

This rule helps the CDSCO ensure that all testing work is honest, safe, and in compliance with India's medicine laws. Any company, importer, or research lab that wants to test drugs must first get permission through the CDSCO SUGAM Portal. Only after getting this approval can they handle or test any drug samples. This process keeps drug research fair, safe, and fully under government control. The entire process promotes transparency, accountability, and high-quality pharmaceutical research practices in India.

What is the CDSCO SUGAM Portal?

The CDSCO SUGAM Portal is an online regulatory platform launched by the Central Drugs Standard Control Organization. The CDSCO SUGAM Portal makes it easy to apply for different types of drug approvals like test licenses, manufacturing permissions, and import approvals. It works as a single online platform where everything can be done in one place.

People can upload documents, pay the required fees, and check the progress of their applications anytime. This online system helps in faster work, clear communication, and smooth coordination between companies and the CDSCO officers. All CDSCO test license applications are handled through this portal in an organized and timely manner, ensuring that every step complies with India's drug safety and regulatory rules.

The following points highlight the importance of obtaining a CDSCO test licence. Each point shows how it ensures compliance, safety, and smooth pharmaceutical operations.

• Ensures Drug Safety: The test license ensures that drugs or raw materials are tested for quality, purity, and stability before public use.
• Supports Research & Development: It allows pharmaceutical companies and laboratories to conduct research and trials legally under controlled environments.
• Regulatory Compliance: The license ensures that all testing activities comply with the Drugs and Cosmetics Act and CDSCO certification standards.
• Prevents Misuse: It allows drugs to be imported into the country only for testing and research. This rule stops anyone from selling or using those drugs for business purposes. It helps keep the testing process safe, legal, and well-controlled.
• Facilitates Innovation: This allows safe, regulated testing, encouraging innovation and new drug development in India.

The CDSCO test licence is essential for laboratories, manufacturers, and research facilities to maintain lawful testing operations in India. It helps in upholding public health standards and strengthening India's position in global pharmaceutical research and production.

The following section explains how the CDSCO test licence supports the pharmaceutical industry and maintains regulatory discipline.

The CDSCO Test License helps make sure that new medicines and medical products are safe before people use them. It allows only a small, controlled amount of a drug to be made or brought into the country for testing, research, or study.

This process ensures that every product used in trials or lab tests meets the required quality and safety standards. It also helps improve medicines, biosimilars, and medical devices. With this license, the CDSCO ensures that no unsafe or poor-quality drugs reach the public. In simple terms, the test license helps scientists do their work safely while protecting people from harmful or untested medicines.

Circumstances under Which a Test License Will Not Be Issued

The following cases show when the CDSCO will not grant a test license.

• If the application involves banned or prohibited drugs.
• In cases where the products belong to herbal or agricultural categories.
• When the application includes starting materials or raw ingredients.
• When excipients or inactive substances are requested for testing.

In such cases, CDSCO rejects the application to stop anyone from misusing the test license. This ensures that only trained and approved companies or research groups can handle drugs intended solely for testing and research.

The following conditions must be met under Rule 33 of the Drugs and Cosmetics Rules to qualify for a CDSCO test licence.

• No drug shall be imported for any commercial purpose.
• The license holder shall maintain proper records and report activities to the licensing authority.
• The technical literature or package inserts for the drug must be submitted.
• The premises shall be inspected by a drug inspector authorized by the licensing authority, with or without prior notice.
• The substances imported under this license must be used strictly for testing, analysis, or research purposes only.

The following documents are necessary while applying for a test license CDSCO through the SUGAM portal. These ensure the authenticity and completeness of the application.

• Form-12: Application form for obtaining the CDSCO Test License.
• TR-6 Challan utilisation or justification: Proof of government fee payment or justification for its use.
• Free Sale Certificate (FSC): Certificate from the country of origin confirming the product is freely sold there.
• Covering Letter: Brief note stating the purpose of the application and testing requirements.
• Testing Protocol: Detailed testing procedure or study plan for the product.
• Product Brochures & Labels: Information and packaging details of the product for reference.
• Notarised Agreement: In cases where a firm uses another company's testing facility, a notarised and authenticated agreement between both parties must be submitted.

The following steps explain how to apply for a CDSCO test licence in India. Each stage must be completed carefully to ensure approval.

• Registration on the CDSCO SUGAM Portal: The applicant must register and create a user account on the official CDSCO SUGAM platform.
• Filling Form-12: The applicant must fill Form-12 to apply for a CDSCO test licence for testing or analysis.
• Uploading Required Documents: All supporting documents, including testing details, drug list, and premises proof, must be uploaded to the portal.
• Payment of Fees: The prescribed government fee must be paid through the online payment gateway available on the portal.
• Scrutiny by Licensing Authority: The CDSCO reviews the application and verifies documents and premises through inspection if required.
• Issuance of Form-11: Once approved, the licensing authority issues Form-11, granting permission to import or manufacture drugs for testing or analysis.

The Fees of a CDSCO Test License depends on several factors, including the type of drug or product being tested, the quantity involved, and the purpose of testing or research. The charges change depending on whether the license is for importing or making the product in India. Extra costs may arise from document checks, lab testing, or other approval steps. The final cost depends on the scope of the testing and the type of product being tested.

The CDSCO test licence remains valid for one year from the date of issue. Once this period ends, the authorization automatically expires. All testing, research, or study work must be finished within the time mentioned in the license. If more time is needed, a new application must be submitted. This rule helps the CDSCO carefully review each project and ensure that all testing is conducted safely and under proper control.

Renewal of Test License

The renewal process for the CDSCO test license is not available. After one year, a new Form-11 application must be filled out with the latest documents and payment proof. The CDSCO does not allow automatic or online renewal through the SUGAM Portal. Each time, the license is checked and approved again. This process helps the government closely monitor all testing work and ensure compliance with India's drug safety rules.

Corpseed is one of the top consulting firms, offering comprehensive assistance in medical device and pharmaceutical compliance, guiding businesses through every required process. Our team ensures that the entire CDSCO test license procedure becomes smooth, quick, and fully compliant with Indian drug laws. From document preparation to final approval, every step is managed with expert care and precision. Here’s how Corpseed can help:

• Document Preparation: We helps collect, organize, and verify all documents needed for the CDSCO test license.
• Application Filing: Submits the application through the CDSCO SUGAM portal correctly to avoid rejection.
• Regulatory Guidance: Provides complete guidance on CDSCO rules, forms, and procedures for test licenses.
• Coordination with Authorities: Communicates with CDSCO officials for queries or clarifications during the approval process.
• Follow-Up and Updates: Tracks the application status and gives timely updates until approval is received.
• Post-Approval Support: Assists with license renewal, modification, or compliance checks after approval.