Campaigners criticise India’s new system for compensating clinical trial deaths

The decision by a medical expert committee to award compensation for 21 of the 370 deaths that occurred since January 2013 in clinical trials conducted in India has reignited debate about the transparency of drug trials.

Even though this is the first systematic attempt by the Indian drug controller to compensate the families of people who have died during clinical trials, public health campaigners told The BMJ that the process of compensation was still neither fair nor transparent.

Because trial investigators may have links with drug firms, campaigners have said that the data provided by such investigators are not legitimate. Therefore, using these data as the basis for awarding compensations was problematic, they said.

Clinical trials by foreign firms have come under fire in India in the past few years. A 2013 parliamentary committee report found that the Seattle based health charity PATH had committed gross violations while carrying out trials for two cervical cancer vaccines in India.1 The report also pointed out that the Indian drug controller had remained silent while rules for conducting trials were being violated, a problem not restricted to the PATH trial.

To allay such concerns, India’s drug controller set up an expert committee this year to establish whether deaths during clinical trials were caused by the drugs being tested. The committee has been charged with calculating the compensation payable, based on the age and life expectancy of the trial volunteer at the time of enrolment. The final compensation under the new system can vary between Rs4 and Rs7.4m (£75 000; €95 000; $115 000), higher than any compensation paid out in India between 2005 and 2012.2 So far, 220 of 370 deaths have been examined, and drug adverse effects have been established as the cause of death in 21 cases.

However, Chandra M Gulhati, a public health advocate and editor of the Monthly Index of Medical Specialities, argued that the new compensation system was not suitable for India because of the inherently high levels of corruption in India’s medical fraternity. Gulhati also pointed out that the drug controller had borrowed this system from countries such as the United Kingdom and the United States. The reason it worked in the United Kingdom, he said, was because most trial investigators there are government employees and do not have any interest in promoting drugs on the behalf of pharmaceutical companies. On the other hand, Indian trial investigators typically consult in private hospitals, which also happen to carry out a large number of trials. This introduces a conflict of interest, Gulhati said, because “one of the income sources for private hospitals and private medical colleges is clinical trials. So, it is not research for them; it is business.”

Samiran Nundy, a gastroenterologist at Sir Ganga Ram Hospital in Mumbai, also expressed his reservations about the new system of awarding compensation. “It’s very difficult to tell if a person has died of the disease or the drug during a trial,” he said. While other countries have better systems of calculating the risk of a person dying of a disease during a trial, India doesn’t yet, he added.

However, Ranjit Roy Chaudhary, a clinical pharmacologist who authored a report on overhauling the clinical trial regime in India,3 said that these concerns were overblown and that the new Indian system had enough safeguards built in to ensure the interests of patients.

Chaudhary said that the decision by a trial investigator of whether a death was due to the drug being tested was reviewed by three other groups of experts. First, the data monitoring committee—a committee of trial investigators—examines the data, followed by an independent ethics committee. Only after this do the data go to the drug controller’s expert committee, which can question the investigator if it finds evidence of manipulation. “I think the system has to be given a chance. We can’t just write it off, saying doctors are corrupt,” said Chaudhary.

Chaudhary also added that one of the recommendations in his report, which was subsequently accepted by the government, would go some way in dealing with the problem of ineffective ethics committees. According to the recommendation, all trial investigators and ethics committees now need to be accredited by the government before they can conduct any trial. Among other factors, the accreditation process will check whether ethics committees meet frequently, follow standard operating procedures, and take action when presented with evidence of ethical breaches. These steps will ensure that trials were conducted in a competent and transparent manner, said Chaudhary.