Import of New drug/Investigational drug for clinical trials

Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or The application under sub-rule (2) shall be accompanied by a fees specified in the Sixth Schedule and such other information and documents as specified in Form CT-16.

Validity period of licence

The licence granted under rule 68 in Form CT-17 shall remain valid for a period of three years from the date of its issue, unless suspended o cancelled by the Central Licencing Authority.

In exceptional circumstances, where the Central Licencing Authority is satisfied about the necessity and exigency, it may, on the request of the applicant made in writing, extend the period of the licence granted under rule 68 for a further period of one year.