By Jason Overdorf
A $400 million market for clinical trials puts desperate Indian patients at risk.
CHENNAI, India — India’s huge population, many of whom have hardly been exposed to medication, makes it one of the world’s most promising markets for drug research.
But as the $400 million business accelerates, critics say it is exposing the dark side of the country’s health-care sector.
“The regulations are weak, implementation is nonexistent, and ethics seem to be taken very lightly,” said Anjali Shenoi, a researcher with a New Delhi-based women’s health advocacy group called Sama.
“We feel like it is a growing problem, especially with India growing as a clinical trial hub, and more and more research being conducted by CROs [contract research organizations].”
Last week, the drug controller general of India — the top industry regulator — officially censured nine firms for failing to compensate the families of patients who died during clinical trials over the past year. But critics say the real story lies in the overall numbers, and the drug controller’s tardiness in taking action.
According to the official figures, more than 1,500 Indians have died in the course of clinical trials since 2008 — 670 last year alone. And even though few of those deaths were reported to be treatment-related, there is no independent audit system to investigate the fatalities that occur during clinical trials.
Some see the booming industry as a ticking bomb.