New Delhi: Nearly Rs 5 crore has been paid as compensation to clinical trial victims who died in India since 2015, according to government data tabled in parliament.
The deaths of 88 clinical trial victims are said to be related to serious adverse events (SAE) they suffered due to the trial. So far, 66 of them have been paid compensation.
This puts the average compensation received by the 66 victims at Rs 7.46 lakh each.
In the same period – between 2015 and 2018 – 8,117 trials were registered in India.
Compensation is paid only to those whose deaths are attributed to an SAE from the trial. This is decided by various committees which review all cases of adverse events suffered during or after trials.
Also read: Compensation Clause for Clinical Trial Participants Should Remain: Health Observers
A total of 1,443 patients suffered serious adverse events of death, but only 88 of them have been linked to the clinical trial. Moreover, only 66 of them have received any compensation.
2015 saw the highest payment – at Rs 2 crore – and every year subsequently has seen about Rs 1 crore being paid as compensation to patients who suffered an SAE. Last year, about Rs 5 lakh was paid out as compensation.
In nine years – between 2008 and 2017 – 4,604 cases of death in clinical trials were reported, including those related to the trial.
Adverse events other than death
Serious adverse events are counted for deaths, but also injuries and disabilities which may occur in a clinical trial.
While in 88 cases, the patient’s death was attributed to the clinical trial, there are hundreds of other deaths which happen during and after the trial where doctors are not always able to link it to the trial itself.
This means that those patients won’t be eligible for any compensation either.
According to government data, only one case of permanent disability was reported between 2016 and 2018. This case was established as related to the clinical trial and the person was paid a large sum of Rs 47,49,996 as compensation.
Also read: A Scrapped Clinical Trial Shows How a Drug Might Work While the Trial Fails
Many trials but few ethics committees
A total of 8,117 trials were registered in India between 2015 and 2018. This number has been increasing drastically. While India saw 859 trials in 2015, this number has increased nearly four times since then. In 2018, India saw 3,869 clinical trials.
While these numbers are high, there is a disproportionately small number of ethics committees registered for these trials.
Only 1,183 ethics committees were registered in India between 2015 and 2018 – going up from 130 committees in 2015 to 330 in 2018.
According to the Drugs and Cosmetics Act, 1945, ethics committees are mandated to review and give approval to trial protocols. They are also supposed to maintain records and details of the trials. But the Central Drugs Standard Control Organisation does not keep detailed information about the ethics committees themselves.
Government data from 2015 also shows that Karnataka and Maharashtra continue to lead in the number of trials conducted every year. Last year, Karnataka registered 1,037 trials and Maharashtra had 802. In 2017, the two states had 786 and 914 trials respectively.