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

Hi Suchit,

as you know DCGI’s requirements changed since 2011 (e.g., videotaping the informal process, registration of the IEC/IRB,…). If (!) your 2011 protocol and procedures are compliant with current requirements, fine. Please check everything twice!

Hi Suchit

❝ We want to conduct bioequivalence study on a IEC approved protocol (in 2011) and DCGI approved protocol (in 2011) now.

Recently (in 2013) CDSCO-DCGI has issued guidance on following

SAE reporting
Compensation related to clinical trial related injury/death
Ethics Committee registration etc

As we have to capture all of the above in the protocol and ICD, you have to update the protocol and ICD, obtain the registered EC approval and then notify the Protocol to the DCGI.

❝ So is there any criteria of IEC approval and DCGI approval window period

Is it necessary to send protocol for reapproval