Cost of life lost in trials is Rs 2.2L

Cost of life lost in trials is Rs 2.2L

Despite a boom in India’s largely unregulated over Rs 8,000-crore clinical trial industry, ironically, the average cost of each life lost in drug trials declined. Compared to Rs 3.2 lakh in 2010, the average compensation doled out by the sponsors of the clinical trials in 2011 stood at a meagre Rs 2.2 lakh, as per the Government’s own data.

One of the main reasons for such miserly packages is due to the Government dragging its feet to frame the guidelines on compensation norms.

“The Government expects to finalise the guidelines on compensation for victims of clinical trials soon keeping in view the rights and well-being of trial subjects,” Health Minister Ghulam Nabi Azad conceded in a written reply in Lok Sabha on Friday.

The Minister said draft guidelines for determining the quantum of financial compensation to be paid in cases of clinical trial-related injury or death have been prepared and comments from public have been sought. However, he did not say when the guidelines will come into effect.

Presently, the compensation is being paid under the Good Clinical Practices Guidelines which are hardly adhered by the companies involved in clinical trials and those who dole out gives just a meagre amount.

For instance, some companies in 2011 paid as little as 50,000 as compensation to families of victims of the clinical trials as revealed by the Government data. Overall, a total of Rs 35.21 lakh has been paid in 16 cases by drug firms, ranging from a paltry Rs 50,000 to a maximum of Rs 5 lakh (still under process of payment).

In 2010, a total financial compensation of just Rs 70.33 lakh was paid in a total 22 cases with the maximum amount being Rs 20 lakh by and a minimum amount being Rs 1.08 lakh (See Box).

Though the total number of deaths in the country in 2010 and 2011 during clinical trials were 668 and 438 respectively, the Serious Adverse Events (SAEs) of death attributed only to clinical trials of drugs were found to be in 22 and 16 cases in these respective years.

In 2012, there have been 211 deaths till June during clinical trials, but the reasons of their deaths are being assessed, as per the data.

The Indian clinical research industry which was valued at Rs  1,200 crore in 2006 is expected to cross 10,000 crore in the next two years with global companies making a beeline to conduct clinical trials, pharmacovigilance studies and data management works in India.