India is in uproar over the deaths of 49 babies over 30 months in clinical trials run by the All India Institute of Medical Sciences hospital in Delhi.

Over 4,000 infants were involved in the trials, putting the death rate at about 1.18% (WSJ’s Live Mint). The London Times says the average mortality rate for all cases at the hospital is 4%. Some of the babies were in control groups.

V K Paul, head of the AIIMS paediatric department, said on Monday, “After a faculty review meeting of all available data, we found that none of the deaths can be attributed to drugs” (Times of India).

However the fact that around 2,700 of the infants were under a year old is not going down well in the country and an investigation has been started by the institute.

Rahul Verma, of the Uday Foundation for Congenital Defects and Rare Blood Groups, responsible for obtaining the figures under freedom of information rules was livid.

“If you are rich in this country you go to a private doctor,” he said (Times of London). “You certainly don’t put your child up to be experimented on.”

However the Indian health minister A Ramadoss told the Times of India, “AIIMS is a renowned research institution. The children must have died because they were already very ill.”

Communist politician Brinda Karat, has told Ramadoss the inquiry is not enough. “According to me this (inquiry) is inadequate and skirts the main issue, namely the liberalisation of procedures for granting permission for the conduct of clinical trials putting at risk the lives and health of Indian citizens,” she says (Hindustan Times, more on this from The Hindu).

Congress party spokesman Manish Tewari went even further (from The Hindu story 2): “There are 139 ongoing trials on human beings in the country,” he/she said. “Pending the probe into the AIIMS trials, let all clinical trials be stopped.”

Any halt to Indian clinical trials would be bad news for the pharma industry, which has been steadily increasing the amount of work is does in the country.

Previously on Nature

Outsourcing clinical trials to India rash and risky, critics warn – Nature Medicine, 2004

India’s drug tests – Nature, 2005