Clinical Trials in India: At the cost of human lives?

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I recently came across this article that had me quite bewildered, to be honest. What is happening to a country like India? It's hardly surprising when we follow in the footsteps of countries like America. With their ignominious FDA unapproved trials, clinical trials in India are being taken for granted at the cost of human lives.

If we intend to create better drugs, diagnostic apparatuses and therapies to help the multitude, we're in turn only using hundreds of others as guinea pigs. Don't they have the right to be protected as well? How can the conscience of clinical trial units approve of us inhuman methods?

What's worse is, the people who have risked their lives for the sake of these trials are treated no better than junk to be disposed if they have been injured or lost their lives in the process. The idea of human life being reduced to a number is bad enough in the first place, but to pay a glaringly small amount as less as Rs. 50,000 or in some cases Rs. 2 lacs, is beyond my comprehension. Who are we to put a price on another human being? By doing so, does it bring back the dead person back to life?

In the name of pharmaceutical development and clinical trials for the so-called betterment of the nation, we are no less than selling our souls to the devil himself. If compensation guidelines have not been formulated, it is solely the inefficient Government to be blamed. Human lives need to be respected and should not be treated as experimental objects. If the drugs need to be tested, they should be thoroughly approved first so as to ensure minimum risks. By being subjects to unknown drugs, we are exploiting the lives of innocent people and their naivete.

Although clinical trials cost a sizable amount, it is their responsibility to adequately compensate for the lives lost, even though it may be immeasurable to the families in question. If the sponsors can take care of the drug administration and the other related paraphernalia, then why not provide adequate and rightful compensation as well? It is surely an outrage.

News says, that a recent research report estimates the CRO (Clinical Research Organization) to cross the $1 billion mark by the year 2016, as opposed to the figure $485 million last year. If this estimation is accurate, then surely lost lives should be much better compensated.

Why should there be a case where people are injured or lose their lives in the first place? The lesser lives lost, the more successful a clinical trial is. The CRO market boasts of 11-13% growth rate due to easy access of treatment-naive population, which in itself is a term that degrades human lives.

It is some of the companies who dole out poor compensation that are to be blamed and held responsible. 438 lives were lost in 2011, out of which only 16 lives were found to be SAEs (serious adverse events) and the compensation was as less as Rs. 2.2 lacs. A point to be noted is that compensation rates have significantly dropped since 2010. 668 lives were lost in the year 2010, out of which 22 were found to be SAEs. Does that mean the others died in vain? It's a question that should haunt all drug trial companies. As opposed to Rs. 3.2 lacs being paid as compensation, the price for human lives hit an all time low in 2011.

The Union Health Minister, Ghulam Nabi Azad noted that poor compensation was due to improper compensation rules. After the loss of how many more lives is the Government planning to revise its laws? The Health Minister acceded that the Government expects to finalise the compensation guidelines in keeping with the rights and well-being of trial subjects. He also added that a draft has been prepared with comments from the general public. Let's hope it's not too late.

The compensation amount is paid in keeping with the Good Clinical Practices Guidelines, but most companies take these rules for granted and are responsible for grave injustices towards the unsuspecting common man. Compensation amounts varied from Rs. 50,000, to Rs. 5 lacs in 2011 and from Rs. 1.08 lacs to Rs. 20 lacs in 2010.

The domestic CRO market is monopolised by MNCs who look into global trials, while domestic drug trials are conducted by local companies. The Frost & Sullivan report declares that diagnostic research is also expected to thrive in the domestic CRO market. The downside to this expected growth however, is increasing competition and lack of quality infrastructure in smaller cities. Due to excessive and almost cut-throat competition in the CRO market, consumer confidence in clinical trials has been shaken; not the least bit surprising. The report states that clear guidelines should be emphasised on the types of international trials that can be performed on Indians, for the market growth. Looking at only the growth and development of the domestic market, less importance is being given to rules of compensation being brought to the forefront at the earliest.

This year, clinical trials have seen 211 deaths and we can only hope that the families are well compensated. Hoping to cross 10,000 crores in the next two years, India is surely going to see a boom in the CRO market thanks to pharmacovigilance studies and data management works.

Suggested Reading :

  1. Worst Clinical trials : Part 2: Worst Nazi Human Experimentation in Twins

  2. Worst Clinical Trials : Part 3 - Nazi Experimentation on humans

  3. Worst Clinical Trials : Part 4 - Nazi experimentation on humans

About the Author

Shloka Shankar's picture
Author: Shloka Shankar


Ph. Bhagavan P S RPh's picture

Here is piece of how the clinical trials used to happen:

Bhagavan P.S. B Pharm

Rtd. Dy Dir.(Pharmacy),Govt of Karnataka, India

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