The decision of Indian Council of Medical Research to establish a Clinical Trials Registry of India (CTRI) is a timely initiative. Although it was formed in last July, many features of the registry are under development and it would be a fully operational platform with a range of services shortly. The Registry is expected to record not only the prospective clinical trials but also the ongoing trials in the country. The key objective of forming CTRI is to provide all information relating to any trial at a single point to the public and researchers. Registry may also help to curb the practice of suppressing negative and unfavourable trial reports. As many as 300 drug trials are going in India for various chemical compounds at multi locations. And the office of DCGI receives about 30 applications every month for conducting clinical trials. As of now, there is no single agency or source from where information about ongoing trials in the country is accessible. The DCGI routinely gives permissions for trials after submission of toxicological reports, pre-clinical data and other relevant documents of the chemical entity. But monitoring of clinical trials at various sites is hardly done once the permission for clinical trials is granted.

By placing data of on-going clinical trials with CTRI, clinical research should become more transparent and accountable. Conducting clinical trials has been a matter of concern for the regulatory authorities in India for some time now. Usually the phase I trials are done in utmost secrecy as the sponsors and CROs know that this activity, if not done ethically, amounts to human right violations. There are agents, operating in close coordination with large companies and CROs, procure illiterate and uninformed subjects and parade them before the so-called investigators. With the offer of a few thousands of rupees, these healthy volunteers agree to undergo trials without understanding the consequences of such experiments. Many of these subjects die or face serious health problems during or after the trials. Deaths or chronic ailments on account of such trials are not recorded or accounted for as there is no machinery to track this activity. Despite having a fairly effective drug regulatory system in place, the clinical trials are not effectively monitored or regulated in India yet. There is no practice of providing the names of trial centres, investigators and human subjects to the DCGIs office. Now, with Clinical Trial Registry in place, the government can direct companies seeking permission for new drugs approval to compulsorily register all trials with the new body. Enactment of the clinical trial rules without any further delay will be of great support in this regard.