49 Babies die in Drug trials in India!

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 per cent for all patients treated at the hospital.

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 subsidised 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 billion-a-year industry in India by 2010. According to the Indian Pharmaceutical Alliance, GlaxoSmithKline, the London-listed pharmaceutical giant, and Johnson & Johnson, its US-based peer, are the two leading groups engaged in testing new drugs in India, each conducting 22 trials over the past year.

The country’s regulatory infrastructure has been found to be weak and the office of the Drugs Controller, which has to approve drugs trials, including those at AIIMS, is understaffed.

A spokesman for AIIMS, which has a strong international reputation, said that it was important to note that it was not yet known how many of the deaths occurred among babies given drugs and how many among those in control groups, who received placebos. “Many of these babies were very ill,” he said.

It is understood that an inquiry into the deaths ordered by Anbumani Ramadoss, the Indian Health Minister, will focus on two trials carried out at AIIMS funded by the World Health Organisation and the Indian Government. It is not known what treatments were being tested.

Experts said that the entry of large Western drugs developers into India has raised safety and ethics standards but admit that India’s regulatory systems are failing to keep pace with a boom in clinical trials.

Rashma Cama, of the Indian Institute of Clinical Research, said: “Informed consent is now the norm and regulations have become stricter but there is a need for savvier investigators.”

Trial and error

£500m Average cost of bringing a new drug to market. Human clinical trials are the most expensive phase of drug development

60 Percentage by which costs can be cut by holding trials in India

400 The approximate number of trials under way in the country

£1bn Predicted value of the industry to India by 2010

Source: Times archive