I read the news on The Economics Times that Indian government is going to make mandatory the registration for clinical research organisations (CROs) and Clinical Trials. Registration guidelines are under review and once guidelines will be at place, only those CROs will be registered who meets these guidelines. Non registered CROs will not be allowed to conduct trials in country. 

 According to Drug Controller General of India (DCGI) Dr. Surinder singh, registration guidelines are already framed and now will be sent to review committee comprising of experts from CROs, academics and health ministry. After committee review it will be sent to Drug Technical Advisory Board (DTAB) for approval.

Clinical Trial registry has already been established in India (www.ctri.in) by Indian Council of Medical Research (ICMR) in collaborative effort with WHO but at present it’s voluntary process. 

 Government is planning to make registration mandatory by December 2008. 

News did not confirm that what about current clinical trials which are on going in the country. Will it also be mandatory to get registered current trials or will it apply only on those trials which will be starting after december 2008?

At present clinical trial registration in India is supposed to done either by PI or primary sponsor but now CROs are also going to be brought in the circle with this enforcement.