Human clinical trials must be registered

BANGALORE: In a significant move aimed at making clinical trials on human beings more ethical and transparent, the Drugs Controller of India has ruled for the first time that all clinical trials taking place across the country in all areas of health — new drugs, treatments, therapies, surgical procedures and new medical devices — must be compulsorily registered. The rule will come into effect on Monday.

Simply put, clinical trials and research conducted on human beings can now be accessed by the general public too. Hitherto, research institutions and companies obtained permission from the regulatory authorities and registration of the trials was voluntary.

Now, the Drugs Controller General of India (DCGI) has asked the Indian Council of Medical Research to ensure that while granting permission for clinical trials, the applicants are advised to get the trial registered before initiation of the study. The new rule mandates that trials should be registered before the enrolment of the first patient. Not just fresh human trials but even ongoing trials must be registered, the DCGI has said.

“Over the last five years there has been accelerated growth in the number of clinical trials in India. There is a need to improve transparency and accountability in this field both for ethical and scientific reasons. In a way, it promotes greater trust and public confidence in clinical research. Primarily, it has been found that some research populations are particularly vulnerable and cannot give or refuse consent for themselves. The mandatory registration will avoid coercion or undue influence, sources told TOI.