Drug- Test License

Drug- Test License

Test licence is issued for the purpose of examination, test or analysis of a drug in small quantities which is otherwise prohibited under section 10 of the Drugs and Cosmetics Act and Rules, 1945. This licence is issued in form 11 and form 29 for the said purpose and is issued by Zonal offices and State licensing authority respectively.

Test licence or form 11 licence is given for the import of small quantities of drugs, for the purpose of examination, test or analysis.

An application for a licence for examination, test or analysis shall be made in Form 12 and shall be made or countersigned by the head of the institution in which, or by a proprietor or director of the company or firm by which the examination, test or analysis will be conducted. Other supportive documents would be required with the application.

Currently there is a notice issued by CDSCO stating that all the test licences shall be issued by respective zonal offices, which were earlier issued by CDSCO. However for import of new drugs including biological products and medical devices for the purpose of clinical trials, the test license is granted by CDSCO HQ.

The Form 29 is a license to manufacture drugs for the purpose of examination testing and analysis. An application for a license in Form 29 shall be made to the licensing authority appointed by the State Government for the purpose of examination testing and analysis. Application filed in form 30 shall be made by or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured.

Reference

  1. Guidance document on grant of licence in form 11(test licence) for the purpose of examination testing and analysis as per rule 33 of drugs and cosmetics acts and rules 1945. Central Drugs Standard Control Organization, Directorate General of Health Services Ministry of Health And Family Welfare Government of India. Available at-http://www.cdsco.nic.in/writereaddata/GUIDANCE%20DOC%281%29.pdf, Accessed on 12th March 2016.

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