Even as Union Health Minister Anbumani Ramadoss on Monday asked the director of AIIMS to order a high-level inquiry into the deaths of 49 children during clinical trials, the premier institute claimed the children did not die due to any new drugs tried on them.

Head of the Department of Paediatrics Dr V K Paul said all 49 kids were mortally sick and died naturally, not due to any drugs used in the trials. “The trials would have been stopped in between if the children had died due to the drug intervention. The data safety management board, which comprises experts, keeps a regular check on the trials,” he added.

In reply to an RTI application filed by Udyog Foundation, an NGO, the AIIMS administration said as many as 49 children had died during clinical trials of new medicines in the premier institute during the past two-and-a-half years.

A total of 4,142 children, of whom 2,728 were aged below a year, had been enrolled for clinical trials of new drugs and therapies by the Department of Paediatrics since January 1, 2006. However, the total number of deaths includes both the kids who were on standard drug management and those who were given new intervention along with the standard medication. “This doesn’t mean that all those children who were tested for new drugs have died,” added a doctor.

Before conducting any human trial, a comprehensive exercise is done. A research questionnaire is formed, defining the criteria of the study. The proposal is then sent to the sponsoring agency, which could be World Health Organisation (WHO), Indian Council of Medical Research (ICMR), or UNICEF. The funding agency then gets it reviewed independently and gives the go-ahead.

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