License to Import New Drugs or Investigational New Drugs Procedure in India

Aryan Panwar

Aryan Panwar

Published on: May 27, 2026

Shatakshi Sharma

Updated on: May 27, 2026

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Introduction

A person, institution or organisation that is desirous to import any New Drugs or any Investigational New Drugs for the purpose of Clinical Trial or Bioavailability or Bioequivalence Study or for Examination, Test and Analysis shall mandatorily hold a license in Form-17 issued by the Central Licensing Authority.

Applicable Provisions

Essential Requirements

Licensee shall fulfil the following conditions for the grant of license in Form CT-17:

• New drugs have been manufactured in accordance with the provisions of the Act, these rules and principles of Good Manufacturing Practice.
• Make use of a new drug or substance relating thereto imported on the basis of Licence granted in Form CT-17 only for the purposes of a clinical trial, bioavailability or bioequivalence study or for examination, test and analysis and no part of such new drug or substance relating thereto shall be sold in the market or supplied to any other person or agency, institution or organisation.
• Maintain records of imported new drug or substance relating thereto to indicate the quantity of drug imported, used, disposed of in any manner and other matters related thereto.
• Where the imported new drug or substance relating thereto is left over or remains unused or gets damaged or its specified shelf life has expired or has been found to be of sub-standard quality, the same shall be destroyed, and details of action taken in such cases shall be recorded.

Process For Obtaining License

Any person/organisation having a valid wholesale license for the sale and distribution of drugs under the Drugs and Cosmetics Rules, 1945, who intends to import a new drug or any such substance for clinical trial or BA/BE study or for examination, test and analysis shall make an application in Form CT-16 to the Central Licensing Authority. The application shall be accompanied by fees as specified below and such other information and documents as specified in Form CT-16.

In case of import of such drugs only for examination, test and analysis and not for any CT, BA/BE study, the application in CT-16 should be submitted to the respective Zonal/Sub-zonal offices of CDSCO.

Validity of License

License granted in Form CT-17 shall remain valid for a period of 3 years from the date of its issue, unless suspended or cancelled by the Central Licensing Authority. In exceptional circumstances, the Central Licensing Authority may extend the period of the license granted under Form-17 for a further period of 1 year.

Cancellation or Suspension of License

In case the Licensee violates the Act or rules, the Central Licensing Authority may, after giving an opportunity to show cause and after affording an opportunity of being heard, by an order in writing, suspend or cancel the licence for such period as considered appropriate either wholly or in respect of some of the substances to which the violation relates and direct the imported new drugs to be disposed of in the manner specified in the said order.

Frequently Asked Questions