Form 11 or Test License is granted to import small quantities of drugs or medical devices, which is otherwise banned under section 10 of the Drugs and Cosmetics Act and Rules, 1945, for the purpose of examination, test or analysis.

  • The Test License in Form 11 is required for import of New Drugs for Testing or Clinical Trial purpose in India.
  • Test license for Narcotic drugs is obtained by procedure that the company has to apply for form 11 then the company  has to approach CBN Gwalior to get (NOC) for import of narcotic drugs.

PROCEDURE FOR OBTAINING FORM 11

For obtaining Test License in Form 11, an application in Form 12 is required. Since 1st April 2016, all applications should be made through the CDSCO’s SUGAM portal.

As per Rule 33 of Drugs and Cosmetics Acts and Rules the following conditions to be considered by the applicant:

  • No drug shall be imported for any other commercial purpose.
  • The licence shall use the substances imported for the purpose of test analysis.
  • Drug Inspector authorized by the licensing authority will inspect the premises with or without prior notice.
  • The licence shall keep a record and will report to the licensing authority.
  • Technical literature /package inserts of drugs.

DOCUMENTS REQUIRED FOR FILLING THE FORM 11 APPLICATION

  1. Covering letter
  2. Form 12
  3. TR 6 challan utilization/justification
  4. Testing protocol
  5. Product labels and brochures
  6. Free sale certificate in the country of origin
  7. Notarized agreement- in case, when firm applied for grant of license in form 11 and use testing facility of another company then company should submitted copy of notarized agreement between the two firms duly authenticated by the applicant.
  8. Ethics committee approval – if applicable

VALIDITY OF TEST LICENCE

The validity period of Test License is one year from the date of its issue.

RENEWAL OF TEST LICENCE

The Company has to apply for new Form 11 license with the relevant documents and challan. Renewal Facility is not available for test license.

REJECTION

Application for grant of test licence in form 11 for Examination Testing and analysis cannot be considered in following cases:

  • No test licence will be issued in case of banned drugs
  • No test licence will be issued in case of starting material
  • No test licence will be issued in case of Herbal/agricultural products
  • No test licence will be issued in case of Excipients

 


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