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India's clinical trial industry shrivels in wake of safety controversy

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With its huge population and a savvy mix of drug development experts on the ground in India, analysts had once estimated that the clinical trial business on the subcontinent could be worth up to a billion dollars a year by 2016. Now, with new regulations in place following a hullaballoo over the number of deaths recorded in drug studies, it appears as if the once-thriving clinical trial business is barely registering a heart beat.

The Hindu reports that sources in the government confirm that only about 12 drug studies have been OK'd by regulators so far this year, with about 70 applications pending. It appears that the number of global clinical trials in India peaked in 2010, with about 500 approved. That number dropped to 325 in 2011 and 262 last year.

The plunge in approved trials came after the Indian government responded to an outcry over the number of deaths being recorded during clinical studies. New rules were adopted to force trial sponsors to pay more than the meager compensation amounts recorded earlier, and independent ethics committees were required to monitor the trials.

Indian officials appear to have no problem with the slowdown, saying that the safety of its citizens comes first.

"The safety and well being of Indian subjects participating in clinical trials is the foremost in our minds," says the Drug Controller General of India, G.N. Singh, according to The Hindu. "This is why the government has tightened the norms putting the onus of safety of participants on firms conducting the trials. It is for the first time that such norms have been put in place."

It also may be the last time a significant number of clinical trials are undertaken in India, where Big Pharma companies are already complaining bitterly over the loss of patent protection for some of their biggest blockbusters. 

- here's the story from The Hindu
- get more from FierceCRO

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