The directive by the DCGI to get all new clinical trials registered with the Clinical Trial Registry-India (CTRI) as a pre-requisite for obtaining permission has made a notable impact. Around 100 trials were registered during last one month alone after it was made compulsory from June 15 by the CDSCO, the sources said.
As many as 342 trials have been registered in the site so far. Interestingly, the total number of trials registered from July 2007, when it was launched by the Indian Council of Medical Research (ICMR), to December 2007 was just 11. During 2008, the number went upto 137, still far from the desired level given the size of the clinical trials going on in the country.
From January 2009 to July 16, the total number of trials registered was 194. Interestingly, around 100 of them came during the last one month alone, indicating a reasonable compliance to the DCGI directive aiming at streamlining the trial sector in the country, sources in the ICMR said.
"The impact is tremendous. All these trials in the site were registered after quality check. Every day we are getting 20 to 30 applications. Some may not be having all required information and we want to put them only after all clearing all doubts and it takes time. We are in the process of upgrading the software to make it automatic, instead of manual checking of the quality parameters," ICMR official in-charge of the CTRI told Pharmabiz.
The CDSCO had made registration of all clinical trials mandatory in the ICMR Trial Registry with effect from June 15, as part of streamlining the trials sector which has been largely unregulated. Accordingly, while granting permission for clinical trials, applicants are now being informed that registration of clinical trial in ICMR Registry www.ctri.in before its initiation will be mandatory from June 15, 2009.
ICMR sources said site had implemented all required norms set by the WHO. But, more things should be done with regard to the speed of the internet and software which would be taken care soon. Then every month, it would be reviewed and status report would be made. However, there is no mechanism at present to submit regular reports to the CDSCO or the DCGI office was not asking for the same.