The Indian Council of Medical Research decided to have a Clinical Trial Registry of India in July 2007 after reports of lack of transparency while conducting trials by contract research organizations and pharmaceutical companies in the country. The purpose of forming CTRI is to provide all information relating to any drug trial at a single point to the public and researchers. The Registry has to record not only the prospective clinical trials but also all the ongoing trials in the country. It was expected that the Registry would curb the practice of suppressing negative and unfavourable trial reports. Currently, more than 700 drug trials are going in India for new chemical entities of mostly multinational companies at multi locations. On an average, the office of the DCGI receives about 30 applications every month for conducting clinical trials. And, there is no single agency or source from where information about ongoing trials in the country can be accessed. After the formation of the Registry, the expectation was that all the CROs and pharma companies will voluntarily record their ongoing and prospective trials in the Registry. But that has not happened yet as there is some resistance on the part of most CROs to register the trials.
Almost two years after the Registry was established, hardly 150 trials have been registered with ICMR. Such response of the CROs and pharma companies is not very encouraging. Conducting clinical trials has been a matter of concern for the regulatory authorities in India for some time now as it used to involve injuries and deaths to the trial subjects. And usually subjects or their relatives are not properly compensated by the companies for the injuries. For this reason, human trials are being done with utmost secrecy in the country by large number of CROs and pharma companies. The decision of the Central Drugs Standard Control Organisation to make the registration of all clinical trials in the Trial Registry mandatory with effect from June 15 is therefore a right step in the right direction. While granting permission for conducting trials, the DCGI office henceforth will also advise the applicants to register the trials in the web-based Registry. The office of the DCGI has also prepared guidelines for registration of ethics committees so that a uniform pattern for monitoring trials can be worked out and they can be made more effective. Ethics committees do have a key role to play in producing best possible results of a trial. Now that the rule is in place and what ICMR has to do is to strictly enforce the same with adequate penalty provisions.