Forty-nine babies have died in drug tests at one of India’s top hospitals, raising concerns that ethical standards are being compromised as the country becomes the world’s leading destination for clinical trials.
The deaths occurred over a period of 30 months at the Delhi-based All India Institute of Medical Sciences (AIIMS), an elite medical college and public hospital renowned for providing low-cost treatment to the poor.
The victims were among the 4,142 infants who were used in a total of 42 clinical trials — one of the final stages of developing a new drug — at AIIMS since January 2006, many for Western companies. Of the children used in the trials, 2,728 were aged under a year old.
The mortality rate among the babies, many of whom were seriously ill before they became part of the clinical trials, was 1.2 per cent — significantly below the 4 percent for all patients treated at the hospital.
However the age of those selected for testing has shocked many in India and there are fears that the increasingly lucrative drug-testing industry may be cutting corners because of a shortfall of staff trained in medical ethics and best practice.
Manish Tiwari, a spokesperson for the Congress party, which heads India’s coalition Government, said: “The practice of using infants like guinea-pigs for drug testing must end.”
Campaign groups have voiced concerns that the poor, often illiterate, parents who make use of the publicly subsidized healthcare that is available at institutions such as AIIMS do not understand the implications of putting forward children to test new drugs.
Rahul Verma, of the Uday Foundation for Congenital Defects and Rare Blood Groups, which exposed the AIIMS deaths after a request under freedom of information laws, said: “If you are rich in this country you go to a private doctor. You certainly don’t put your child up to be experimented on.”
India has become the leading destination for international pharmaceutical companies to outsource clinical trials, largely because of the diverse genetic pool offered by its population and the low cost of doing business.
Clinical trials on human beings are forecast to become a $1.8 billion-a-year industry in India by 2010.