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Indian Express
09 August 2010
By Teena Thacker
New Delhi,India

DESPITE the Union Health Ministry’s insistence that deaths occurring during clinical trials may be due to unrelated health reasons, according to data available with the ministry, the number has been steadily increasing.

In 2010 alone, as many as 462 people, who were a part of clinical trials, died (till June).

According to data, there were 132 deaths in year 2007, 288 deaths in the year 2008 and 637 deaths in year 2009.

Officials maintain that deaths occurring during clinical trials could be due to a variety of reasons ranging from disease–related ones to side effects of an unrelated cause.

"Such deaths are investigated for casual relationship by investigator and by medical experts of sponsor," ministry officials said.

India has recently become a favoured destination for organisations to conduct clinical trials.

In 2010 till now, permission has been obtained for about 117 global clinical trials (international companies) and 134 local (Indian) trials. In 2009, 258 global and 195 local trials took place in India. 2008 was no different with approximately 246 global and 275 local trials obtaining permission.

The companies approaching the Central Drugs Standard Control Organisation (CDSCO) include names like GlaxoSmithKline, Johnson and Johnson, Sanofiaventis, Novartis among others and clinical research organisations like Quintiles, ICON, GVK and many more.

Though officials say that deaths occurring due to negligence of the company during trials is rare, such instances have come to light. The most recent case being the trial of a human papilloma virus (HPV) vaccine in Andhra Pradesh, where four girls died after being vaccinated. While, the Indian Council of Medical Research (ICMR) halted the trials, experts are still investigating the cause of the deaths.

According to ministry officials, conducting trials in India is easier than in North America or Europe, where many clinical trials get tangled in litigation as the patients are very aware of their rights. Tr ials for a standard drug in the US may cost up to $150 million but could be tested in India for 60 per cent less.

With the industry growing fast, the Drug Controller General of India (DCGI) proposes to add penal provisions for fraud and misconduct in clinical research soon.

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