OPINION: 436 deaths in Clinical trials in 2012; India needs better regulation to look after victim’s family

OPINION: 436 deaths in Clinical trials in 2012; India needs better regulation to look after victim’s family

The information given in the Lok Sabha about the clinical trials in India is a cause of concern for India. The most surprising factor is that not a single case of death has been investigated yet and what to say about the compensation to any victim’s family?

The death toll in drug trials in the country stands at 1,542 over the past three years.  It was 668 in 2010 where only 22 cases were attributed to deaths on account of clinical trials.  In 2011, 438 deaths happened in drug trials, but companies paid compensation to just 16 persons

The Health Ministry had changed the procedures governing compensation and the Drug Controller General of India will now be the final authority to determine compensation

The clinical trials claimed 436 lives in 2012 which needs serious consideration by the government. No doubt without the clinical trials, we cannot play with the lives of the people but Pharmaceutical industry has now become a powerful industry, driven only by profit. The MNCs conduct clinical trials of new drugs, on the people who are economically weak and underprivileged. The poor, who has become a trial subject in lieu of a meager amount of money.

In fact, the commercial interests prevail over ethical concerns. The safety of human life cannot be compromised at any cost. It is time the government woke up for better regulation.

The improper clinical trials not only put the patients in danger on which the trials are conducted but would create havoc for all those patients who are given the medicines after its sanction.  No doubt, such trials were also being conducted in the past but using the citizens of an independent and democratic country, is a blot on our system.

Since the cost of testing in India is 80 per cent less than in the developed world, firms come here, there is need to adopt safety standards in the case of the drug trials and Indian citizens are not reduced to the level of laboratory animals.

The rules should also be framed to specify that trials will be allowed only in cases where the firm in question undertakes to make the drug available to Indians at affordable prices.

Presently, different companies continued to pay different compensations. The government should fixing minimum compensation in cases of deaths and injuries during drug trials. It would be more appropriate if the family member of victim is given appointment by the pharmaceutical company to look after the family members.

(Disclaimer: The views expressed by the author in this article are his own and do not necessarily reflect the views of City Air News.)