Indian
activists say pharmaceutical companies should be held accountable for deaths
caused by unauthorized clinical trials of drugs on human beings.
Prabha
Devi's son Manish is yet to fully recover after developing white spots on his
skin which he developed after undergoing a clinical trial in a private hospital
in the northern Haryana state of India.
"Medical
workers came to our village and spoke of a new vaccine for newborn babies. What
was tempting about it was that the vaccine was free, which otherwise would have
cost us 6000 Rupees (80 Euros)," Devi's husband Jagan Das told DW. Manish,
he said, was now being treated by doctors so that his spots could be removed.
In another
incident in the southern Andhra Pradesh state, some 35 women, all limekiln
workers from Guntur district, were allegedly put through clinical trials to
test a breast cancer drug. The women were paid money to undergo these tests.
But the doctors had to abruptly stop the tests after the women complained about
nausea, joint and chest pains.
“Unfortunate”
Experts say Indian health sector needs treatment |
The Indian
Supreme Court has recently asked the Madhya Pradesh state government to explain
its position on why it allowed large-scale illegal drug trials in the state.
"Human
beings are being treated as animals. This is unfortunate," Justice R M
Lodha told DW.
Experts
blame the lack of proper laws and regulations to hold multinational
pharmaceutical companies accountable for the deaths allegedly caused by
unauthorized clinical trials.
“Things are
getting worse. Between 2004 and 2006, many pharmaceutical companies carried out
clinical trials on patients and repeatedly violated the prescribed guidelines
and regulations. Sadly, no hospital or doctor was ever penalized,” Puneet Singh
of the Swasthya Adhikar Manch (Health Rights Forum) told DW.
According
to the World Health Organization (WHO), in India, on an average 10 people have
died every week in clinical trials since 2006.
Between
2008 and 2011, 2,031 deaths were reported during these trials, forcing the
Indian government to set up a committee to review clinical trial approval
procedures in the country. However, the number of deaths remained high despite
the public outcry with 438 deaths reported in 2011 - preceded by 668 in 2010;
637 in 2009; and 228 in 2008.
“The lack
of supervision by Indian health officials has created a culture of impunity for
drug research companies and the doctors who work for them,” said Dr Lalit
Kumar.
International
standards
Drug
companies say they conduct trials on people suffering from serious ailments
with limited or no cure, and that they should not be blamed for the deaths.
“The
standards applicable to clinical trials in India are no different from those in
the US, the EU, or elsewhere in the world,” a spokesperson of a multinational
company told DW on conditions of anonymity.
But it is
not enough to convince the Indian activists who demand that a committee of
experts consisting of members of civil society and the All India Drug Action
Network be formed to examine existing legal provisions related to clinical
trials in India and abroad.
Author: Murali Krishnan
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