Bioequivalence and Bioavailability Forum

Dear Suchit Bhavsar
First of all I have to point out that I do not know the regulations of DCGI. In theory there is no expiry date for a positive ethics vote or an approval of a regulatory authority unless other specified in their regulations/rules. However you should consider that during the time period from 2011 to 2013 new scientific knowledge about the drug could have been gained. According to ICH-GCP the investigator should provide current knowledge to the IEC in order to get an approval for a study. In addition the investigator is obliged to keep the IEC updated during the clinical conduct. In case there is no relevant new literature published I suggest to inform the IEC and DCGI about the delayed study start and to submit a statement that no new information about the study drug exists which would change the risk/benefit evaluation. Furthermore you should confirm that all information of the study protocol remained uneffected by the study delay, otherwise you need to submit an amendment.
I hope this helps
Kind regards
Dan