Baby Deaths After Indian Drug Trials Sparks Ethical Debate

An inquiry has been launched after 49 babies died in an Indian hospital after clinical trials involving foreign drug companies.

A non-profit health group discovered the deaths, which occurred within a period of 30 months, after a freedom of information request to the All-India Institute of Medical Sciences.

Now the state-run institute, which is billed as India’s top medical facility, will conduct an inquiry into the fatalities.

Some 4,142 babies have been involved in clinical trials at the hospital since January 1, 2006. More than half of them were under the age of one.

They were all ill and were admitted for free treatment under the banner of testing new drugs.

Indian’s clinical trial business was valued at US$120 million last year and is growing at a rate of 25 per cent annually. However rights groups have called for better regulation of the growing industry.

“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 Rahuk 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?” he told AFP. “Are they given consent forms and counselling?”

He added that the hospital had not provided the group with details of the incomes of the families involved in infant trials.

Foreign drug companies have flocked to India in recent years to conduct clinical trials because of the huge population and the low costs. Trials in the country cost 40–60 per cent less than they would in a developed country.

Consulting firm Ernst and Young has said the outsourced clinical research market in India could grow to $2 billion by 2010.

But many of those who participate in drug trials are illiterate and below the poverty line and questions remain over the ethics of the treatment.

The hospital has defended its reputation and stated that the trials in question were conducted with the oversight of an internal ethical committee and followed guidelines laid down by the government.

A five-member inquiry committee will submit its results within a week.