Bioequivalence and Bioavailability Forum

Dear All,

T-License is necessary to obtain for those drugs which are introduced in India within 4 years. For those drugs older than 4 years T-License is not required. But Ethics Committee permission is a must. If for those drugs older than 4 years in India need to be imported then you need to apply for T-License. This license comes along with the permission to conduct BA/BE or clinical trial. This application to be done using Form 12 as per Schedule Y.