The All India Institute of Medical Sciences (AIIMS) has reported 49 infants have died in clinical trials over the past two and a half years, but denies these were caused by investigational drugs, according to FDAnews.
The institute's Department of Pediatrics reportedly enrolled a total of 4,142 subjects since 2006, of whom 2,728 were younger than 12 months. The institute claims the deaths occurred due to pre-existing disease causes, although an Indian nongovernmental organization is calling for an investigation to gain further information about the trials.
The full FDAnews report can be found here.
