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An Overview of CDSCO Test License

CDSCO Test License is issued by respective Zonal Offices, which were earlier issued by CDSCO. However, for the import of new drugs, including biological products, for the purpose of clinical trials, the CDSCO Test License is granted by CDSCO HQ. This License is issued for the purpose of test, examination, or drug analysis in small quantities which is otherwise prohibited under Section 10 of the Drugs & Cosmetics Act & Rules made there under. This License is issued in Form 11 or CT-17 and Form-29 for the said purpose and is issued by the zonal offices and State License Authority respectively. Also, all such applications should be made through the CDSCO’s SUGAM Portal.

A Brief on CDSCO SUGAM Portal

This portal was first introduced in November 2015 by the CDSCO (Central Drugs Standard Control Organisation). CDSCO introduced the module under the SUGAM portal for updating & uploading the data on its website related to the licensed Drug Manufacturing facilities & approved or licensed drug formulations for having updated information on drugs manufactured in India. The implementation of SUGAM has brought accountability, reliability, transparency, and simplicity to the business. It’s a major reform in the pharma industry of India and it directly refers to the Government Digital India initiatives.

CDSCO SUGAM is an e-governance system to discharge various functions of the CDSCO. It’s a software developed for an online portal where an applicant applies for NOCs, Permissions, Licenses, Registration Certificates, and Approvals. This portal provides an online interface to track the applications, respond to queries and download the permissions issues by the CDSCO. It is also helping the CDSCO officials in processing the online applications & generating the online permissions and the MIS reports.

Conditions to be considered by the applicant for obtaining CDSCO Test License

According to Rule 33 of the Drugs & Cosmetics Acts and Rules, the following conditions should be considered by the applicant:

  1. No drug shall be imported for any other commercial purpose;
  2. The License shall keep a record & will report to the licensing authority;
  3. Technical literature pf package inserts of drugs;
  4. A Drug Inspector authorised by the Licensing Authority will inspect the premises with/prior notice;
  5. The License shall use the substances imported for the purpose of test analysis.

Vital Necessary Papers Required for Filling the Form 11 Application for CDSCO Test License

Following are some vital necessary papers required for obtaining CDSCO Test License:

  1. Form-12;
  2. TR-6 Challan utilisation or justification;
  3. Free Sale Certificate (FSC) in the country of origin;
  4. Covering letter;
  5. Testing protocol;
  6. Product brochures & labels;
  7. Notarised Agreement – in the case when a firm applied for the grant of the CDSCO Test License in Form-11 and used the testing facility of another firm or company should submit a copy of Notarised Agreement between the 2 firms duly authenticated by the applicant;
  8. Ethics Committee Approval (if applicable).

Procedure for Obtaining CDSCO Test License in Form 11

For obtaining a Test License in Form-11, the application in Form-12 is required. Following is the step-by-step procedure for CDSCO Test License:

Step 1: Filing of the Application: First, the applicant needs to fill out the application form and fill in all the vital details correctly, as mentioned in the application form.

Step 2: Prepare Necessary Papers: After filling out the application form for the License, the applicant needs to arrange all the necessary papers; our experts will help you in filling and preparing all the vital necessary papers as mentioned above and submit them to the concerned authority.

Step 3: Scrutiny: Once our experts submit the application form along with all the necessary papers, then the authority will scrutinise them.

Step 4: Issuance of License: Once all the above steps are completed, you will get a Test License.

Note: The validity of the Test License is 1 year from the date of its issue. For the renewal of this License, the company must apply for a new Form-11 License with relevant necessary papers & challan. The facility for the Renewal is not available for Test License.

In What Conditions the Issuance of a Test License is not considered?

Application for the issuance of Test License in Form-11 for examination testing & analysis cannot be considered in the following cases:

  1. No Test License will be issued in case of banned drugs;
  2. In the case of Herbal or Agricultural products, no Test License will be issued;
  3. In the case of starting material, no Test License will be issued;
  4. In the case of Excipients, no Test License will be issued.

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Frequently Asked Questions

According to Rule 33 of Drugs & Cosmetics Acts & Rules, Form-11 is granted for the import of small quantities of the drug for the purpose of examination testing/analysis.

Only 10 drugs can be imported under Single Form-11 License.

For animal studies, the firm has to submit an IAEC Approval/CPC SEA permission copy of the subject drug.

There is no provision for the renewal of this License once it is expired; the firm has to apply for a new or fresh License with Challan and all other relevant necessary papers.

No, drugs imported under Form-11 License will be used for analysis & testing purposes only it will not use for any commercial activity.

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