Mandatory Compensation for Clinical Trial Injuries in India

A lack of reasonable care and financial compensation has long been associated with clinical trials conducted in India, but this situation is set to change dramatically as the Indian government introduce stricter compensation laws & regulations for clinical trials.

Pharmaceutical firms conducting clinical trial of drugs in the country will be subject to a greater level of analysis throughout their trial processes, with particular attention attributed to instances of injuries or fatalities as a result of any medicines or treatment received on a research basis.

In addition, arbitrary compensation for such adverse events will be a thing of the past as the government is to set payment guidelines for patients – or their next of kin – that have suffered in this way. The decision to make compensation mandatory in these cases will provide trial participants with a modicum of security and arrives mere weeks after the Supreme Court rebuked the government for its haphazard regulation of clinical trials.

Improved procedures

Under the new proposals, the medic involved in the clinical research must inform the pharma company, the clinical research organisation (CRO) and the ethics committee of injury or death during a trial within 24 hours. It will also become mandatory for all clinical trial ethics committees to be pre-registered with the Drug Controller General of India (DCGI), replacing the current system whereby this registration has not been a requirement and the committee could be staffed by trial sponsors.

In turn, the pharma company and the CRO then have a window of 10 days in which to submit a detailed report on this particular adverse event to the ethics committee, which is allowed a further 10-11 days to communicate its evaluation on compensation to the independent expert committee (21 days from the time of the injury/death). The expert panel is then asked to advise the drug regulator of a fitting level of financial compensation within 30 days of receiving this report.

Appropriate compensation

Previously, when ethics committees set up by the sponsors of clinical trials were in place and given the responsibility of discerning the amount of compensation to be awarded in trial-related injuries or death, the figure arrived at would generally be completely unreasonable. In the past five years, according to Health Ministry data, 2,242 people have died during drug trials in India, with an average compensation per death standing at a paltry Rs 2.2 lakh.  Similar bias and inadequate remuneration is believed to be countered by the DCGI intention to recommend final payment, based on the independent probe panel's reports and the merits of each individual case. 

The tightened measures will be welcomed by the Indian media, which has been recently scathing in its reports of adverse events and a growing death toll in the nation’s clinical trials. However, investigators may be rather less receptive to the guidelines, which will entail a considerable amount of additional paperwork and bureaucracy. Furthermore, if affected CROs and pharma companies fail to pay the apportioned compensation in a timely manner, they may face trial suspension or even a permanent ban.