Bangalore, The death of 49 babies in clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi may have opened a Pandora's box as two of the trial drugs have never been tried on patients below 18 years, an expert said.

How many of the children died because of the trial drugs will be known only when an enquiry committee submits its report this month, but doctors have already raised questions of ethics.

In reply to a Right to Information (RTI) query, the AIIMS said that 49 babies had died during clinical trials over the past two-and-a-half years.

The AIIMS paediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since Jan 1, 2006.

Two of the trial drugs - olmesartan and valsartan, meant for reducing blood pressure - have never been tried on patients below the age of 18 years, said Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties and a keen obserger of the clinical trials in India.

"The sponsors are trying to determine their efficacy and safety on children and adolescents" by conducting the trials in India at AIIMS, he said.

Gulhati asked: "Is hypertension in this age group (1-16 years) a problem in India? If yes, what is the incidence and prevalence? If it is not a major problem, why conduct a trial in India and put children at risk without any benefit?"

According to the US Food and Drugs Administration, the "pharmacokinetics" (what the body does to the drug) of valsartan has not been investigated in patients below 18 years of age.

Studies on another trial drug - rituximab for treating a type of cancer - have so far been done only on adult patients.

Gulhati said the phase III clinical trials are normally conducted as pre-approval requirement for marketing a new drug.

"If the company has not applied for marketing approval to use the drug on children, why were phase III trials permitted?"

Both olmesartan and valsartan are "off-patent" in India and are being marketed by local companies, said Gulhati.

"Why should foreign companies conduct phase III studies in India when they have not applied for marketing?

"Even if the trials establish the safety and efficacy of these molecules in children, the sponsors would not commercially benefit because of lack of patent," said Gulhati.

"It is obvious that these trials are being conducted to extend patent period in Western countries with no consequence or benefit for India using Indian children as guinea pigs."

Over 4,000 drug trial cases pertained to just one department in AIIMS - pediatrics.

"I shudder to think what this number would be in all the departments combined," said a senior scientist in the Indian Council of Medical Research (ICMR).

Although ICMR has established a registry for voluntary reporting of all clinical trials done in India, a search of the registry (www.ctri.in) does not show the AIIMS babies' trials.

However, AIIMS authorities had said the deaths were not due to medicines used in the clinical trials but because of the diseases that the children were suffering from.

"We want to clarify that none of the deaths was due to the medication or interventions used in clinical trials," V.K. Paul, head of the paediatrics department, had said.

"Clinical research is the mandate of the AIIMS clinicians. Novel therapies are examined keeping in mind the utmost safety for all patients," he added.

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