Bioequivalence and Bioavailability Forum • Approval from Independent EC

sparsh
☆

India,
2013-05-16 08:10
(4771 d 22:53 ago)

Posting: # 10588
Views: 3,266

Approval from Independent EC [Regulatives / Guidelines]

Dear Sir,
As per the recent amendment to Schedule Y an Independent ethics committee has to be registered with the DCG(I). ok now we have registered Independent EC but not received the approval letter from DCGI, Question is shall I apply for the BE NOC to DCGI now.

meanwhile I also come to know that DCG(I) is approving only Institutional EC not independent EC is it true. And is there any timeline given by DCGI for approval of Independent ethics committee/ Institutional EC from DCGI.

Regards,
Sparsh

suds4u
☆

India,
2013-05-22 11:22
(4765 d 19:41 ago)

@ sparsh
Posting: # 10615
Views: 2,648

Approval from Independent EC

Post reply

Dear Sparash

Please visit the following link and check, the DCGI office has started the approval process for independent ethics committee's now. The letter numbers are as follows ECR/13/Indt/DL/2013

:cool:

http://cdsco.nic.in/ethiccommittee3.htm

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Irukulla Shravan Kumar
★

India,
2013-05-23 15:29
(4764 d 15:35 ago)

@ sparsh
Posting: # 10629
Views: 2,516

Approval from Independent EC

Post reply

❝ As per the recent amendment to Schedule Y an Independent ethics committee has to be registered with the DCG(I). ok now we have registered Independent EC but not received the approval letter from DCGI, Question is shall I apply for the BE NOC to DCGI now.

Dear,
u can approach the DCGI with the acknowledgement received for registration of EC

❝ meanwhile I also come to know that DCG(I) is approving only Institutional EC not independent EC is it true. And is there any timeline given by DCGI for approval of Independent ethics committee/ Institutional EC from DCGI.

The DCGI is giving approval not only for IRB but also for Independent Ethics Committee. For more info go through CDSCO website.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]