New Delhi - As many as 49 children, many of them less than a year old, died during clinical trials of new drugs and therapies at a premier Indian medical institute over the past two and a half years, news reports said Monday.

"A total of 49 deaths corresponding to 1.18 per cent mortality among the enrolled patients were recorded during the studies," the Delhi-based All India Institute of Medical Sciences (AIIMS) said in response to a query filed under India's Right to Information Act, PTI news agency reported.

AIIMS said its paediatric department enrolled 4,142 children, of whom 2,278 were below the age of one, for clinical trials of various new drugs and therapies since January
1, 2006. It said five of the medicines were foreign-made.

Rahul Verma of the Uday Foundation, which works for people with congenital defects and rare blood groups, said his organization decided to file the query after hearing that several studies were being conducted on human babies in the country.

"I wanted to get factual information on such trials so we can press the government to formulate some specific policy to regulate it," Verma said.

AIIMS said the trials were funded by the Indian Council of Medical Research (ICMR), the federal Department of Biotechnology, the World Health Organization and John Hopkins Bloomberg School of Public Health based in the United States and AIIMS.

It said all the trials were conducted after clearance from the ICMR's ethical committee. Studies sponsored by international agencies were cleared by a panel of the federal Health Ministry.

An AIIMS official said strict protocols were followed while conducting the tests and all the deaths could not be attributed to the trials as some of the patients were in a condition where mortality was a "normal outcome."

Consent of the concerned parents or guardians was also given before conducting the trials, AIIMS said in its RTI reply.

Answering a query on the social status of the patients tested in the trials, the institute gave no specific details, but said: "No studies selectively target children belonging to low socioeconomic status."

Uday Foundation's Verma said he suspected that most of the children on whom the trials were conducted had poor and illiterate parents who were unlikely to comprehend the implications of a clinical trial.

Clinical trails are carried out on patients to test the efficacy and safety aspects of a new vaccine or therapy. A test on a patient is the last stage of a drug's development after it has been tested in a laboratory on animals and human volunteers.

The foreign medicines on trial at AIIMS included zinc tablets for treating deficiency, olmesartan and valsartan for treating blood pressure-related problems, rituximab for treating chronic focal hepatitis and gene-activated human glucocerebrosidase for treating liver-related ailments.

India's Planning Commission, in a document released in April, said India had become a top Asian destination for clinical trials with 139 new trials outsourced to the country recently, compared to 98 for China.

A Health Ministry reply in Parliament in November 2007 said the government gave permission to 190 multinational pharmaceutical firms to carry out trials of new drugs during that year, and said there had been no reports of any adverse effects on the health of patients.

India's diverse genetic pool, large numbers of patients, high quality professionals and hospitals as well as low cost of services make it an attractive destination for clinical trials by global drug companies. (dpa)