Bioequivalence and Bioavailability Forum

Dear Experts,

We have some queries in notice order published on CDSCO site dated on 22 July 2015 (File No.DCG(I)/Misc./2015(132), could you please help us on same.

1. Is this notice effective from 22 July 2015 or whether we need to done for all BENOCS had received in the past also.
   
   
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??
   
   
3. The statement mentioned on notice order "without further communication would be initiated as per merit under Drugs and cosmetics Rules". Kindly explain??

Thanks in Advance.

Your comments are highly appreciated.

Regards
Bharat N.