10 die per week in drug trials in India


The government will be analysing mortality figures during drug trials in India following WHO data showing that 2,031 people died between 2008 and 2011 in such trials in the country. That amounts to about 10 people per week, or more than one person a day.

At the same time, the data shows that only 1.5 per cent of clinical trials held across the world so far (2,770 of 1,76,641) have taken place in India — belying the perception of India emerging as the hub of such experiments.

"There are some diseases like cancer where mortality is high so a blanket statement about the number of deaths cannot convey anything. We have no figures to compare this (2,031 deaths in four years) with world statistics... So we are starting a project to get people to analyse these deaths, find out the causes, find out what effect the trial had on subjects and see from a scientist's viewpoint," said Secretary, Health Research, Dr V M Katoch.

The data showing that India has hosted only a minuscule amount of global clinical trials at least makes it clear that the country is not as big a centre as is being made out, he added.

Mortality rates in clinical trials in India have remained consistently high despite intermittent public outcry. While 438 deaths were reported in 2011, 668 died in 2010, 637 in 2009 and 228 in 2008, as per the World Health Organisation's international clinical trial database.

Cautioning against jumping to any conclusions, Dr Katoch pointed out that data available with the clinical trial registry of India also shows that only 25 per cent of all trials in India are global trials. The others are for indigenous products.

"It is not as if we are a banana republic that is putting our people at risk. We have a transparent system of registry and a comment about deaths is not valid without analysing the circumstances," he said.

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