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- India becomes a global hub for clinical drug trials
This story is from November 28, 2005
India becomes a global hub for clinical drug trials
Dangerous terrain to get into.
It is alarming that the government has decided to promote India as a hub for clinical trials. In January this year, it enacted an amendment to the Drugs and Cosmetics Rules, doing away with the requirement of a phase lag in trials between India and the rest of the world.
Phase I, mercifully still not permitted in India, concerns trials on healthy persons, while Phase II and III are conducted on patients.
Untrammelled Phase II and Phase III trials, without the information benefits of a lag, will unleash havoc in India, which has no regulatory apparatus to cope with legal and ethical violations.
India's recent experiences do not inspire confidence. The Supreme Court pulled up Shanta Biotech and Biocon India for allegedly conducting clinical trials on unsuspecting patients.
In 2003, an anti-cancer drug, letrozole, was tried on 400 women for its effects on ovulation, without their knowledge. These cannot be seen as aberrations; the larger reality is that life comes cheap in India.
After the Bhopal gas tragedy, the government allowed precious time to lapse before seeking to establish that methyl isocyanate was the cause of the deaths and injuries. Criminal proceedings on the case have run into sand.
Given this backdrop, what should we expect? The view that clinical trials could be used to throw up effective remedies for common ailments such as leprosy, kala-azar, tuberculosis and malaria is misplaced.
Historically, a mere fraction of the drugs discovered have dealt with tropical diseases. Besides, remedies for tropical killers have long been in existence.
People still succumb to these diseases because of inadequate health infrastructure. The medical establishment conceals information out of callousness or contempt.
Add to this the social and cultural hierarchies inherent in any engagement, and the recipe for disaster ��� trials without legal or ethical basis ��� is complete.
Phase I, mercifully still not permitted in India, concerns trials on healthy persons, while Phase II and III are conducted on patients.
Untrammelled Phase II and Phase III trials, without the information benefits of a lag, will unleash havoc in India, which has no regulatory apparatus to cope with legal and ethical violations.
India's recent experiences do not inspire confidence. The Supreme Court pulled up Shanta Biotech and Biocon India for allegedly conducting clinical trials on unsuspecting patients.
According to the petitioners, the two companies carried out trials of a clot-dissolving drug used in heart attacks without obtaining the necessary clearances. As a result, eight people reportedly died.
In 2003, an anti-cancer drug, letrozole, was tried on 400 women for its effects on ovulation, without their knowledge. These cannot be seen as aberrations; the larger reality is that life comes cheap in India.
After the Bhopal gas tragedy, the government allowed precious time to lapse before seeking to establish that methyl isocyanate was the cause of the deaths and injuries. Criminal proceedings on the case have run into sand.
Given this backdrop, what should we expect? The view that clinical trials could be used to throw up effective remedies for common ailments such as leprosy, kala-azar, tuberculosis and malaria is misplaced.
Historically, a mere fraction of the drugs discovered have dealt with tropical diseases. Besides, remedies for tropical killers have long been in existence.
People still succumb to these diseases because of inadequate health infrastructure. The medical establishment conceals information out of callousness or contempt.
Add to this the social and cultural hierarchies inherent in any engagement, and the recipe for disaster ��� trials without legal or ethical basis ��� is complete.
End of Article
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