India is to investigate the deaths of 49 babies who died during clinical drugs trials conducted in the capital New Delhi over the past two and a half years.
By Rahul Bedi in New Delhi
Last Updated: 1:55PM BST 20 Aug 2008
All the deaths occurred at the prestigious All India Institute of Medical Sciences, better known in the country by its acronym AIIMS.
It has now been forced by the federal health ministry to set up an internal five-member commission of inquiry, which will report on the deaths within a week.
The deaths were brought to the public's attention after a medical non-governmental organisation demanded information from the government. The figures released showed that 4,142 babies had been used for tests since the start of 2006 and 49 had died.
The institute has said this represented a normal mortality rate of 1.8 per cent and insisted that the deaths were not caused by the medicines, vaccines, instruments and new therapies ministered during the trials, but by the debilitating diseases afflicting the children.
"We want to clarify that none of the deaths was due to the medication or interventions used in clinical trials," said V K Paul, head of the paediatrics department. He said all new treatments were carried out safely.
India has recently overtaken China to become Asia's most popular destination to conduct clinical trials, many on behalf of overseas drugs and medical equipment makers.
According to India's federal planning commission, 139 new medical trials were outsourced to India in recent years compared with 98 to China.
The cost of conducting these trials in India was between 20-60 per cent cheaper than in developed countries.
Because of the increased number of trials, the health ministry has proposed new legislation to govern clinical trials including more safeguards and tougher penalties for lawbreakers.
"Earlier we had guidelines on how trials need to be conducted and soon we will have a law," said A. Ramdoss, the federal health minister.
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