July 8, 2012 9:58:33 pm
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 during such trials in the country. That comes 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 scientists 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 Organisations 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.
The component of globally driven trials being held in India is also on the decline. While before March last year,the trials held in India constituted 27.7 per cent of the internationally driven trials involving global drug developers and testers,this share is now down to 20 per cent.
Incidentally,an expert committee is already probing irregularities in functioning of the Central Drugs Standard Control Organisation (CDSCO) that grants approvals to hold clinical trials in India.
The committee was formed after the Parliamentary Standing Committee on Health,in its last report,alleged a nexus among drug makers,CDSCO officials and experts who grant opinions on use of drugs. The panel had found that the CDSCO had approved 33 drugs (out of a randomly selected sample) for use in India without any country-specific clinical trials.
Experts believe government data on deaths during clinical drug trials in India is underestimated.
The Supreme Court has also expressed concern over safety of people being used as subjects in clinical trials of drugs,while the National Human Rights Commission too is reviewing the matter. It has sought detailed responses from the Central and state governments on regulations to approve clinical trials and to ensure safety of volunteers involved therein.
(with PTI inputs)
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