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Infant deaths: HR notice to AIIMS, health official

Posted Sep 22 2008 10:57am

New Delhi: Taking note of the deaths of 49 infants during clinical trials, the National Human Rights Commission (NHRC) issued a notice to the Indian Health Ministry and the All India Institute of Medical Science (AIIMS).

"This is a show-cause notice and we have sought comments from the Secretary of the Health Ministry and the AIIMS Director on a complaint filed with the NHRC," a Commission official said.

The Commission has sought replies within four weeks.

The notices were served following a petition by Non Governmental Organisation (NGO) Uday Foundation to the NHRC, bringing the matter to its notice and alleging violation of the right to life under Article 21 of the constitution, reports IANS.

"We are seeking the NHRC's intervention because we have no faith in any internal inquiry by the institute," an official of the NGO said.

In reply to a Right to Information (RTI) query, the AIIMS earlier this month admitted 49 babies had died during clinical trials over the past two and a half years.

The AIIMS Paediatrics Department conducted 42 sets of trials on 4,142 babies—2,728 of them below the age of one—since January 1, 2006.

AIIMS authorities said the deaths were not due to medicines used in the clinical trials but because of the diseases that the children were suffering from.

"We want to clarify that none of the deaths was due to the medication or interventions used in clinical trials," Paediatrics Department Head VK Paul had said.

Clinical research is the mandate of the AIIMS clinicians. Novel therapies are examined keeping in mind the utmost safety for all patients, he added.

"The research protocol undergoes intense scrutiny by the internationally recognised Institute Ethics Committee. Written informed consent is taken from parents and guardians," Paul said.

"Most of the 42 clinical trials have reported no deaths. The deaths are mainly due to inherent diseases and not due to medicines used," Paul said.
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