As many as 49 children have died during clinical trials of new medicines in the premier All India Institute of Medical Sciences in Delhi during the last two-and-a-half years.
A total of 4,142 children, of whom 2,728 were under the age of one year, enrolled for the clinical trials of new drugs and therapies by the Department of Pediatrics since January 1, 2006.
Replying to a Right to Information application filed by an NGO, the institution said a total of 42 clinical trials of various medicines, of which top five medicines were foreign-made, were conducted during the given period.
In its reply to the Uday Foundation for Congenital Defects and Rare Blood Groups, the AIIMS said, "A total of 49 deaths corresponding to 1.18 per cent mortality among the enrolled patients were recorded during the studies."
Rahul Verma from Uday Foundation said, "As our organisation is working for the welfare of children facing medical challenges, we used to hear or read that several studies are being conducted on human babies in the country.
I wanted to get the factual information on such trials so we can press the government to formulate some specific policy to regulate it."
The institute said the studies were funded by the Indian Council of Medical Research, Department of Bio-technology, World Health Organisation and John Hopkins Bloomberg School of Public Health in USA and by AIIMS itself.
The practice of clinical trials, a method of checking the efficiency and other safety aspects of a drug, vaccine or
therapy, has been prevalent in foreign countries until recent time. But of late, several foreign medicines are being sent to India for such trials.
The AIIMS has said all the clinical trials, sponsored by national agencies such as ICMR, were conducted after getting clearance from the institute's ethics committee, whose approval is a pre-requisite for such studies.
Additional clearances from the Health Ministry Steering Committee were obtained for the studies sponsored by international agencies like WHO.
The institution has said the consent of concerned parents and guardians was also taken before conducting such studies as per the direction of its ethics committee.
On a query related to the socio-economic condition of the patients on whom the trials were conducted, the hospital, while maintaining that the children enrolled represented a mix of patients attending the out-patient and in-patient services, said, "No studies selectively target children belonging to low socio-economic status."
However, no specific details have been provided by the hospital on the number of children belonging to the below poverty line category.
Among the 42 clinical trials conduced for different drugs were foreign-made medicines like zinc tablets for treating zinc deficiency, Rituximab treating for chronic focal encephalitis, olmesartan and valsartan for treating blood pressure related problems and Gene-Activated Human Glucocerbrosidase for liver related ailments.
