Eleven of India's leading medical journals will now consider publishing the results of clinical trials only if the trial in question has been registered with the Indian Council of Medical Research (ICMR) in New Delhi or any primary clinical-trial register.
The move follows the 2005 decision by the International Committee of Medical Journal Editors to publish only the results of registered trials. According to Kanikaram Satyanarayana, deputy chief of the ICMR, the delay was partly due to reluctance by the journal editors and pressure from industry. In addition, the ICMR had hoped that a bill it drafted in 2006 to regulate human trials would become law.
Trials that start in or after June of this year must be registered before enrolling their first participant; those beginning before this must register retrospectively. The ICMR says mandatory registration will ensure transparency and honesty, and discourage unethical trials.
An estimated 250 drug trials are under way in India, with applications for 30 more received on average each month.
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