Aiming to secure the safety of people involved in drug trials in the country, the Government is in the process of framing guidelines for awarding compensation in cases of death during these trials.

The hallmark of the new guidelines would be the fixing of minimum mandatory compensation to be paid by pharma companies for deaths in clinical trials.

Sources in the Health Ministry indicated that the minimum proposed compensation could be around Rs 2 lakh for each case of Serious Adverse Event (SAE) of drug trial-related death.

The move is also being taken to ward off the perception that Indian volunteers in clinical trials of drugs are considered as “guinea pigs”.

As many as 211 deaths in clinical trials have been reported during this year (till June). Last year, 438 volunteers died during drug trials across the country but compensation was awarded only in 16 cases. Similarly, 668 deaths were reported during drug trials in 2010 but compensation was paid only in 22 cases. Over the past four years, 10 persons have died every week in such trials.

“The safety and well being of human beings volunteering for clinical trials is the foremost and the kin of victims of trials should be awarded suitable financial compensation by the sponsors. We are in the process of finalising a good compensation formula for the victims and hope to notify it soon,” a top Health Ministry official told PTI .

“The minimum quantum of compensation to be paid in each case of death would also be fixed to guarantee basic protection,” the official said.

The Government is also finalising an independent mechanism for review of deaths taking place due to the adverse effects of drug trials, the official said. At present, drug companies appoint their own auditor for ascertaining the deaths and fixing monetary claims.

The new formula would calculate the total compensation amount in each case depending on various factors, including the income, age, family background and the extent of disease suffered by the victim.

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