The integrity and morality of India’s clinical trials boom are under question following revelations about the deaths of babies during studies at a prestigious public hospital and medical school in New Dehli.

The non-governmental organisation (NGO) whose Right to Information (RTI) request to the All India Institute of Medical Scientists (AIIMS) sparked the uproar over what critics claim is the exploitation of poor and illiterate Indians to furnish guinea pigs for low-cost trials of internationally-sourced drugs has asked the National Human Rights Commission to intervene in the case.

An internal panel at AIIMS is already looking, at the request of the Indian Health Minister, into the infant death rates publicised by the NGO, the Uday Foundation for Congenital Defects and Rare Blood Groups. However, the Foundation sought an external inquiry after it further emerged in Indian press reports that foreign-manufactured pharmaceuticals tested on babies at AIIMS over the past two-and-a-half years included two that had not previously been studied in patients under 18 years of age.

As things stand, details of the trials in which the infants died, the specific drugs involved and whether any causality can be inferred remain patchy, although this has not prevented calls from Congress for all clinical trials to be suspended in India until the circumstances have been fully investigated.

The RTI request revealed that 4,142 children, of whom 2,728 were below the age of one year, had been enrolled in clinical trials at AIIMS since the beginning of January 2006. A total of 49 deaths were recorded during these studies, corresponding to a mortality rate of 1.18%. According to a report in the UK-based Times newspaper, this was well below the mortality rate of 4% for the hospital overall.

Moreover, AIIMS has pointed out that many of the babies involved in the trials were already very ill and that the distribution of deaths among active and placebo groups is as yet unclear. The Institute insists the trials went through all the necessary ethics approvals, that informed-consent procedures were followed and there is no evidence linking the deaths recorded with the drugs taken.

AIIMS also denies the trials targeted people of low economic status, although the Uday Foundation claims most patients at the Institute are poor and illiterate, making it unlikely they would understand the implications of taking part in clinical trials.

The Institute’s response to the RTI query showed there were the five “foreign-manufactured” drugs among the various interventions used in the AIIMS trials. Local press reports identify these as zinc tablets, the antihypertensives olmesartan and valsartan, the monoclonal antibody rituximab for chronic focal encephalitis, and human glucocerebrosidase for Gaucher’s disease.

While no causality has been established between these drugs and the infant deaths reported during trials at AIIMS, the revelation that two antihypertensives (olmesartan and valsartan) previously confined to adult use were potentially tested on very young children has further stoked suspicions that trials in India are stretching ethical boundaries.