India announces new standards to compensate victims of clinical trials

Activists have earlier raised concerns that volunteers who end up with injuries after trials are not compensated properly

By Jyotsna Singh
Published: Friday 26 December 2014

Reena Yadav’s son developed mental illness after he was made to participate in a drug trial in Indore, Madhya Pradesh

The Union Ministry of Health and Family Welfare has for the first time computed a standard formula for compensation of adverse effects due to clinical trials. Though a formula for deaths due to the trials already existed, there was no standard for injuries and other severe adverse events (SAE). It was decided on a case by case basis.

"We did not have any standard formula. The ethics committee used to give initial observation, which was analysed by the expert committee. Finally, the Central Drugs Standard Control Organization (CDSCO) used to decide on the compensation. Now, all of them will work according to the formula," said Shilpa Garg Agrawal, founder and CEO, SenseCR, an organisation working in clinical research.

How the formula was computed

The formula was arrived at by a committee formed by health ministry's drugs regulatory body CDSCO and was released on December 15. It draws on the already existing one in case of death due to clinical trial. SAE have been divided into four categories—permanent disability, chronic life-threatening disease, reversible effect and birth defect in child due to clinical trials on parents.

For 100 per cent permanent disability, 90 per cent of the compensation that is given in event of death will be given. In case of less than 100 per cent disability, the extent of disability will be an important component in deciding the compensation.
In case of chronic life-threatening disease and reversible SAE, the compensation will depend on the number of days of hospitalisation and minimum wage for unskilled labour in Delhi.

For birth defects, the compensation will be a lump sum of Rs 4 lakh. "People were not getting any compensation before. Now at least something has started," said Mira Shiva, director of non-profit Initiative for Health, Equity and Society. Shiva, also a member of CDSCO's committee, said that many people needed compensation in clinical trials, but did not know how much to get. She, however, informed that the committee meetings were very short and no detailed deliberations were held before arriving at the formula.

Formula for computation of compensation:
1) In death cases:
C = (B * F * R)/99.37

C = Compensation
B = Base amount = Rs 8 lakh
F = Age factor
R = Risk factor

2) SAE causing permanent disability to the subject:
C = (C * D * 90) / (100*100)

C = Compensation
C = Quantum of compensation which would have been due for payment to the subject's nominee in case of death of the subject
D = Percentage disability the subject has suffered.

3) SAE causing life-threatening disease and reversible SAE in case it is resolved

C = 2 * W * N

C = Compensation
W = Minimum wage per day of the unskilled worker (In Delhi)
N = Number of days of hospitalization

3) SAE causing congenital anomaly or birth defect:

Compensation shall be a lump sum amount such that if that amount is kept by way of fixed deposit or alike, it should bring a monthly interest amount which is approximately equivalent to half of minimum wage of the unskilled worker in Delhi. Considering the base amount as Rs 8 lakh, the quantum of compensation is Rs 4 lakh

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