FDAnews Drug Daily Bulletin

The Drugs Controller General of India (DCGI) is increasing inspections of clinical trial sites rather than imposing new regulations in the wake of two recent incidents in which infants died in studies sponsored by multinational drug companies. The stricter oversight follows the death of a child in a trial of Wyeth’s pneumonia vaccine Prevnar and last year’s deaths of 49 infants in trials at the All India Institute of Medical Sciences. Saurendra Das, India country head and director of operations for Excel Life Sciences, said this marks the first time the DCGI has actively inspected a trial site.
Clinical Trials Advisor