Usha Sharma – Mumbai
An expert committee set up by the Drug Controller General (India) (DCGI) has recommended a compensation formula to determine the quantum of compensation in the cases of clinical trial related serious adverse events (SAEs) of deaths.
As per this formula, compensation amounts could vary from a minimum of Rs 4 lakhs to a maximum of Rs 73.60 lakhs depending on the age of the deceased and the risk factor. In case of patients whose expected mortality is 90 per cent or more within 30 days, a fixed amount of Rs 2 lakhs is recommended.
The DCGI had constituted three Independent Expert Committees in pursuance of sub-clause (6) of appendix XII of the Schedule Y to the Drug & Cosmetics Rules 1945 on March 14 ,2013 under the chairmanship of Dr AK Agarwal, Maulana Azad Medical College to examine the SAE of deaths occurring during clinical trial and to recommend the cause of death, and to determine the quantum of compensation, if any, to be paid by the sponsor or his representative, who ever had obtained permission from the DCGI.
After a detailed deliberation, the committee prepared a formula to decide the quantum of compensation in case of SAE of death related to clinical trial based on three factors viz; age, risk and base amount.
According to the notification, the committee decided that base amount should be such that if the nominee of the subject keeps that amount of compensation in bank by way of fixed deposit, he or she will get a monthly interest amount which is atleast approximately equivalent to the minimum wages of unskilled workers in Delhi. It was also decided that this base amount should refer to the age of 65 years which corresponds to the factor of 99.37 of the table of Worksmen Compensation Act. It is evident that the base amount will increase /change with the revision of minimum wage.
Commenting on the recent notification, Dr Arun Bhatt, President, Clininvent Research said, “The notice provides clarity on the compensation issue to the industry so that accordingly sponsors can budget for it and discuss it with the insurance companies before initiating a clinical trial.”
Apurva Shah, Chairman, Association of Contract Research Organisations (ACRO) and Group Managing Director and Veeda Clinical Research welcomes the move and commented, “ACRO welcomes the regulators’ view of having guidelines for compensation to be paid to patients and volunteers to stop the abuse of our people who are poor and vulnerable.”
He points out, “However, the new guidelines provide for a very large amount and we fear that it might almost become an inducement for people to participate in trials. We would prefer to have the regulators introduce measures and enforce them to curb illegal trials and ensure that the right informed consent process is carried out by the people who conduct the trial to counter the problem.”
Shah added, “The compensation shouldn’t be a factor to induce participation or deter research from being carried out in India. We need to develop the expertise to develop new drugs in India and that is a slow and complex process. I hope these new compensation guidelines do not put India at a disadvantage and we do not lose the valuable expertise we have gained in the past decade or so.”