Report: 438 died in Indian clinical trials last year

The debate over the safety of clinical trials in India continues, as Business Standard reports that 438 people died in studies there last year, a number some attribute to lax regulations in the country.

Novartis ($NVS) saw the most fatalities in its trials, according to the paper, with 57, while U.S.-based CRO Quintiles came second with 32. Bayer and Pfizer ($PFE) had 20 each, while Bristol-Myers Squibb ($BMY) reported 19 to Indian regulators.

The number is a decline from 2010's 668 deaths, but experts attribute that not to safer trials but to flagging demand for studies in India. Furthermore, drugmakers and CROs in India rarely pay compensation to the families of patients killed in trials, doing so in only 22 cases in 2010, Business Standard reports.

The companies in question argue that they adhere to the law when enrolling and conducting trials, but critics say those laws allow for too much leeway. In India, there are no minimum clinical standards for trials, and the only requirement is medical supervision, meaning any doctor can administer a legal trial in a private clinic. This lack of oversight makes it impossible for regulators to ensure that trials are safe, experts say.

However, some companies argue that the raw number of deaths doesn't necessarily speak to the quality of trials. As Quintiles pointed out to Business Standard, patients who participate in trials already suffer from pre-existing conditions that could be severe or acute. "Therefore, the death of a patient in a clinical trial could occur due to a variety of reasons, including those unrelated to the trial," Quintiles India's Chief Medical Officer Shoibal Mukherjee told the paper.

- read the Business Standard report
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