Recently, the Supreme Court in India took a stand, calling on the government to justify its approval of the many clinical trials in that country. This came as a result of several organizations campaigning for tighter regulations and oversight on the trials.
“Clinical trials of NCEs are being conducted without following proper protocol, and companies are taking advantage of poor people,” explained Amulya Nidhi of the Health right Forum.
New chemical entities, or NCEs, are drugs that haven’t yet been approved for marketing and sale, but are being tested in Phase II and Phase III clinical trials in India. Most of these drugs, incidentally, are from Big Pharma, huge western corporations.
Between 2010 and 2012, 1542 deaths were reported in these clinical trials. Officials say only 54 could be definitively linked to the trials themselves, but either rate is too many.
So why has the Indian government allowed these corporations to come in and test on the poorest of their countrymen? As usual, it boils down to money.
The Indian clinical trial industry was valued at $450 million in 2010-11. It’s growing at an estimated 12% a year and predicted to pass $1 billion by 2016. The recent decision by the Indian Supreme Court, however, could derail its trajectory.
Nidhi, and others like her, say the loss Big Pharma may suffer as a result of the ruling and tighter regulations is inconsequential when balanced with the safety of Indians as a whole.
“We are concerned about and committed to the interests of people,” she said.
Better regulations could push Big Pharma trials right out of the country. A lack of such framework is what made these corporations so comfortable, perpetuating abuse by the “morally bankrupt pharmaceutical companies,” as Ethan A. Huff aptly characterizes them.
We can hope the Indian government is persuaded by the growing number of activists there that such trials must be tightly controlled if they are to continue. Without better controls, the corporations will continue to treat the Indian people as throw-away laboratory experiments.