Bioequivalence and Bioavailability Forum

Dear Mr Accutest,

❝ 1. Is this notice effective from 22 July 2015 or whether we need to done for all BENOCS had received in the past also.

Yes. It will be applicable for past BENOCs too.

❝ 2. If we had not initiated studies in six month after receipt of BENOCs, What will be the next step, after intimation of such BENOCs, whether such BENOCs get extra validity after intimation??

Its up to the DCGI office to decide . I hope that DCGI will extend the BENOC after seeing the reasons for not conducting the study within the period of 6 months.

❝ 3. The statement mentioned on notice order "without further communication would be initiated as per merit under Drugs and cosmetics Rules". Kindly explain??

I am too confused . What DCGI meant by that? Lets wait for next circular from DCGI for better clarity.