The number of clinical trials registered with the Clinical Trial Registry of India (CTRI) has shown a marked increase during the last six months when the registration of clinical trial was made mandatory and a prerequisite by the Union Health Ministry for getting approval for the clinical trials in the country. During this six month period alone 373 trials were registered, against the 298 registrations during the last two years before that period.

Clinical trial industry was by and large an unregulated sector in India till early this year and the registration was voluntary till then. That the clinical trial organisations were not much interested in registration of trials for obvious reasons was clear from the fact that the total number of trials registered from July 2007, when the Registry was launched in the country, to December 2007 was just 11. In the year 2008, the number of registration went up to 137, still far from the desired level given the size of the clinical trials going on in the country. From January 1 to June 15, 2009, the total number of trials registered was just around 150.

But, there has been a substantial increase in the number of registration since June 15 this year when the Drugs Controller General of India (DCGI) Dr Surinder Singh made the registration mandatory for approval for clinical trials in the country, said Dr Abha Agarwal, coordinator of the Registry.

“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 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,” Dr Agarwal added.

The DCGI made registration of clinical trials mandatory as part of streamlining the clinical trials sector which remained largely unregulated in the country so far.

The Clinical Trial Registry of India (CTRI) was launched on July 20, 2007, and is being run by the National Institute of Medical Statistics (NIMS) which is an arm of Indian Council of Medical Research (ICMR) mandated with the responsibility of setting up and maintaining the Registry.