In its first move to resolve the uncertainties surrounding clinical trials in India, an expert committee set up by the Drugs Controller General of India has proposed compensation in the range of Rs 4 lakh to Rs 73.6 lakh.
However, where a terminally-ill patient, with a life-expectancy as low as 30 days, on drug-trial dies, the panel has proposed that Rs 2 lakh be paid to the family.
The formula for compensation developed by the panel takes into account two crucial factors — the age of the volunteer and the risk factors.
On the basis of this formula, the compensation that has to be paid by the trial sponsors can range from Rs 4 lakh (for patients in 65 and above age bracket and a life expectancy of up to six months) to a maximum of Rs 73.6 lakh (for a healthy volunteer of not more than 16 years).
This is significantly higher than the compensation paid by companies sponsoring drug trials till now.
According to a Health Ministry response to Parliament questions earlier this year, compensation paid in clinical trial-related deaths, from 2005 till early this year, was in the range of Rs 50,000 to Rs 5 lakh. In some cases, compensation of up to Rs 20 lakh has also been paid.
According to a DCGI paper, the prescribed factors (based on age) for calculation of reparation under the Workmen Compensation Act have been used in the new formula.
G. N. Singh, Drugs Controller General of India, said, “Our intention is to ensure safety of the patients and their rights first. It is a fair, transparent mechanism based on a scientific mathematical formula that will ensure that justice is done by the patients.”
He said this (formula) will be a trend-setter and hoped many countries will follow.
aesha.datta@thehindu.co.in