Bioequivalence and Bioavailability Forum

❝ In a BA/BE study is it required to obtain import license for the molecule

Yes, it is required. You need to fill Form -44 and form-11 for getting the license

❝ tested in the trial and when should we obtain the import license for the molecule and for all the molecule obtaining import license is mandatory?

You can apply for this license along with BE-NOC (if required) or you can apply separately.

For further details read Drugs and Cosmetics act of rules 23, 27, 33, 33A, 122A, 122B, 122D and 122 DA.

Import license is mandatory for the products that are imported to INDIA, irrespective of whether it is for BA/BE, Clinical trail, analysis or self administration

Regards
Raghavender.Chenna