India's top medical facility will investigate the deaths of 49 babies in clinical trials, a hospital official said.
Hospital to conduct infant-death inquiry
NEW DELHI // India's top medical facility will investigate the deaths of 49 babies in clinical trials that took place from the beginning of 2006 to the present, a hospital official said yesterday. "An internal inquiry has been ordered," said Shakti Kumar Gupta, head of administration for the state-run All-India Institute of Medical Sciences. "We have constituted a committee to inquire into this."
The country's biggest hospital, where thousands go for free top medical treatment, has been in the spotlight after a non-profit health group publicised infant deaths that occurred during clinical trials over the past 30 months, some of them associated with foreign drug companies. Some 4,142 babies admitted in the hospital were in clinical trials since Jan 1, 2006, more than half of them under the age of one, the hospital told the group in response to a request under freedom-of-information laws.
The non-profit group's founder said it hoped to publicise the need for better regulation of India's booming outsourced clinical trial business, estimated at about US$120 million (Dh441m) last year and growing at 25 per cent annually. "When you are not able to afford a particular treatment in a private health care centre you look forward to getting free medication in something like this," said Rahul Verma, of the Uday Foundation for Congenital Defects and Rare Blood Groups, which filed the request.
"We wanted to know what are the socioeconomic condition of these people? Are they given consent forms and counselling?" Mr Verma said the hospital did not provide information on the incomes of the families in the infant trials. India has become a popular destination for clinical research because of its huge, varied population and low costs. Trials here cost 40 per cent to 60 per cent of what they would in developed countries.
Consulting firm Ernst and Young has said the outsourced clinical research market in India could grow to $2 billion by 2010. But with many of those who participate in trials poor and often illiterate, with few other options for care, questions persist over the ethics of doing the human testing of new drugs here. Mr Gupta, the hospital official, said the All-India Institute trials were cleared by an internal ethical committee and followed guidelines laid down by the government.
He also said the infants who died were in control groups and not among those receiving experimental medical intervention. "All these children were very seriously ill," Mr Gupta said. "No child has died which was in the intervention group." The health minister has backed the facility so far but also said better oversight was in the works. "Earlier we had guidelines on how trials need to be conducted," said Anbumani Ramadoss, the health minister, according to a report in the Times of India yesterday. "Soon we will have a law."
A five-member inquiry committee has been asked to submit its findings within a week. * Agence France-Presse