Doctors say ICMR guidelines are followed by the trial-conducting agencies.
To keep a further check on the trials, a Central Data Safety Management Board (DSMB), which comprises independent experts, is formed. “Their work is data safety. The DSMB can stop the trials anytime if they see any problems,” added Dr Paul.
The 42 clinical trials were conducted for different drugs like zinc tablets for treating zinc deficiency, rituximab, olmesartan and valsartan for treating blood pressure-related problems and gene-activated human glucocerbrosidase for liver-related ailments.
However, the doctors conducting the trials claimed the intervention of some of these drugs had turned out to be effective. “The study using rituximab has been conducted amongst children between 3-16 years of age for kidney diseases. Results have been very good. The study was conducted on 22 children, and no death has occurred so far,” said Dr Arvind Bagga, Department of Paediatrics, AIIMS.