New Delhi, Aug 18 (UNI) AIIMS today said the reports about the deaths of 49 children during clinical trials at the Institute, as ''misleading' and asserted that none of the deaths could be attributed to any new procedures or medicines.
Stating that the figures had been reported''out of context'', Dr V K Paul, Head of Pediatrics department of the Institute said, ''The figures refer to mortality cases over a period of time, all of whose causes have been reviewed. None of the cases can be attributed to new medicines or procedures. The whole effort is to reduce the causes for mortality and save lives.'' Elaborating, Dr Y K Gupta, the officiating spokesperson said the cases had been selected with due approval of the Drugs Controller of India, the regulating authority.
''The cases were selected after scrutiny and deliberations of Ethics Committee by experts in AIIMS and scientific community, members of public and judiciary. The Ethics Committee also monitors the progress of trials,'' Dr Gupta said.
''These deaths were definitely not due to any intervention and there was no question of anything going on,'' he said.
Earlier, reports quoting AIIMS' reply to a Right to Information (RTI) query, had said 49 children had died during the clinical trials of new medicines in the Institute since January 2006.
A total of 4,142 children, of whom 2,728 were under the age of one year, had enrolled for the clinical trials of new drugs by the Department of Pediatrics since January one, 2006.
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