TEST LICENSE TO IMPORT DRUGS | FORM 11 / FORM CT -17

A Test License in Form 11 is for import of small quantities of drugs for the purpose of examination, test or analysis or in Form CT – 17 for import of new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis.

1000+

Satisfied Clients

3000+

Project Completed

10+

Years in Business

Book a Free
Consultation Call!

Invalid Name
Invalid Mobile
Invalid Email

Any Indian importer or Indian manufacture who wants to import small quantities of drug samples for the purpose of testing or analysis shall apply for a Test License. The applicant shall make an application in Form 12 or Form CT – 16 to Central Licensing Authority for the purpose examination, test and analysis. The validity period of Form 11 and Form CT – 17 is three years for the date of issue. A total of only 10 drugs can be imported in a single test license.

The licensing authority may revoke a license for examination, testing, or analysis if any of the conditions under which the licence was issued is violated.

Procedure for Obtaining a Test License to Import Drugs in Form 11 / Form CT - 17 in India:

  • check icon Obtaining Login credentials: To obtain a Import License for the purpose of examination, test or analysis in Form 11 / Form CT - 17, the applicant must first register in an online portal and create a Login ID and Password.
  • check icon Documentation: The applicant must produce all necessary documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
  • check icon Fees: The applicant must pay the required fees online as per The Drugs And Cosmetics Act, 1940, The Drugs And Cosmetics Rules, 1945 or The New Drugs and Clinical Trial Rules, 2019
  • check icon Document Verification: Following the submission of documentation, the licensing authority will authenticate all the documents submitted.
  • check icon Issue of Import License for test, examination and analysis: Post authentication and verification of all the documents the licensing authority will grant the Import License in Form 11 or Form CT - 17 as per the requirement.

Pre - Requisites / Documents required for Test License to Import Drugs in Form 11/ Form CT - 17 :

  • check icon Covering Letter: The covering letter should clearly specify the purpose of the application, list of documents attached. It should be signed by authorised signatory including his name and designation and address of the firm.
  • check icon Authorisation Letter: A signed authorisation letter from the Director, Company Secretary, or Partner of the Indian Agent firm is required, which should include the name and title of the authorised person who is authorised to sign documents on the company's behalf.
  • check icon Form 12/ Form CT - 16: The applicant has to fill the application Form 12 or Form CT -16 as per their requirement of license
  • check icon Drugs Imported: The form shall capture all the details of the small quantities of the drugs to be imported in India.
  • check icon Challan: The original and detail challan of the fees paid has to be uploaded
  • check icon Manufacturing / Wholesale Drug License: Drug License: The applicant who wish to import drugs in India for the purpose of examination, test or analysis has to have a valid manufacturing / wholesale drug license in India.
  • check icon Undertaking: The CDSCO may ask for any other documents to be furnished during the verification of the application.

The importer or manufacturer applying for a Test License to Import drugs in India in Form 11 will remain liable to pay a license fee of five thousand rupees for a single drug and two thousand rupees for subsequent drugs in the same application. For Form CT – 17 the applicant is liable to pay five thousand rupees per drug.

Obtaining a Test License to Import Drugs for test, examination and analysis can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the certificate. We reduce the likelihood of application rejection and ensure that licenses are issued quickly and without complications.

You can apply for a Fresh Test License in Form 11 or Form CT – 17 / Renewal of Test License / Amendment in Test License / Change in Constitution / Surrender of Test License through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com

Book a Free
Consultation Call!

Invalid Name
Invalid Mobile
Invalid Email

TEST LICENSE TO IMPORT DRUGS Registration Procedure

Registration Procedure