A Delhi-based non-governmental organisation (NGO) has asked the National Human Rights Commission (NHRC) to investigate the clinical trials by All India Institute of Medical Sciences (AIIMS) on 4,142 babies since January 1, 2006.
The Uday Foundation for Congenital Defects and Rare Blood Groups approached the NHRC today asking it to probe the details of all clinical trials, including the 49 deaths that happened at AIIMS.
Rahul Verma, managing trustee, Uday Foundation, has also sought NHRC’s intervention to understand the role of the Drugs Controller General of India in approving such clinical trials.
"The socio-economic condition of all the 4,142 babies used for clinical trials conducted by the department of pediatrics and 71 babies used by pediatric surgery should be made public," Verma said. The status of the same clinical trials in other countries and the outcome have also been sought.
Uday Foundation had, through a Right to Information plea, found that of the 4,142 babies that underwent clinical trials at AIIMS, 2,728 babies were aged less than 12 months.
Following the disclosure, AIIMS had clarified that none of the deaths happened due to the medicines administered during the clinical trials. According to the institute's Head of Paediatric Department, Vinod Paul, the babies who died were not those who took the trial drugs. On the other hand, these were babies who were in the control group which were not given the new drugs.
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Reacting to the AIIMS’ stand, several doctors and medical experts had called for investigations for identifying possible human right violations. Doctors and experts say that the fact that the babies who did not take trial drugs died makes it all the more alarming.
Dr Anup Saraya, who heads the All-India Institute of Medical Sciences Front for Social Consciousness, which has so far been fighting the doctors over caste discrimination, said in a statement last week that AIIMS had followed procedures related to the conduct of trials. "Also, some children inducted into the trials were very sick. They would have had a comparatively high rate of mortality even under the best existing treatment (which is in the range of 20-40 per cent as reported in various studies)" Saraya said.
As per the reply of AIIMS to the RTI application, the children were subjected to trials od zinc tablets of World Health Organisation, Rituximab, Olmesartan, Valsartan of Novartis and gene-activated human glucocerebrosidase.