The Central Drugs Standard Control Organisation (CDSCO) has made it mandatory the registration of all clinical trials in the ICMR Trial Registry with effect from June 15, as part of streamlining the trials sector which has been largely unregulated.
"It has been decided to make registration of clinical trial mandatory with effect from June 15, 2009, which will be applicable for clinical trials initiated after June 15, 2009. Accordingly, while granting permission for clinical trials, applicants are now being informed that registration of clinical trial in ICMR Clinical Trial Registry www.ctri.in before its initiation will be mandatory from June 15, 2009," the notice from the DCGI office said.
The DTAB had approved a number of proposals including incorporation of a new Schedule Y1 to the Drugs and Cosmetics Rules 1945 to specify all aspects regarding trials. The DTAB has also given green signal for proposals like announcing guidelines, penalty provisions for defaults, registration of ethics committees and on-site audits of trials, which the DCGI office will now be carrying out with the help of specially assigned teams, sources said.
While granting permission for conducting trials, the DCGI office henceforth will advise the applicants to register them in the web-based registry. The registration of trials has been voluntary so far and among the hundreds of ongoing trials, not even 25 per cent of them have registered so far. Besides, the DCGI office have also prepared guidelines for registration of ethics committees so that some uniform pattern can be worked out and they can be made more effective.
Another proposal is to ask the trial companies to get the finger-prints of all volunteers in phase-III trials and share the data between the CROs. This will ensure that the same man is not going for another trial by another company, after being a subject in one trial.The number of trials that a principal investigator also will be limited for more effective end results, sources said.
