Clinical Trials in India: 438 Died, 16 Compensated.
438 died during drug trials in 2011; only 16 compensated
In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during drug trials in India, but drug companies provided financial compensation in only 16 such cases.
The total amount paid in compensation in all the 16 cases adds up to Rs. 34.88 lakh with the highest amount being Rs. 5 lakh and the lowest being Rs. 50,000.
This makes 2011 only the second year, for which data are available, when any compensation was paid in cases of deaths caused during drug trials, the other being 2010, when 22 cases were compensated.
According to documents available with The Hindu, the largest amount in compensation was paid by Sun Pharma. The company paid Rs. 15 lakh in compensation in five cases (Rs. 3 lakh each).
Next in line was US-based Clinical Research Organization (CRO) ICON PLC, (6.52 lakh in three cases), followed by Pfizer Inc (6.5 lakh in two cases) and German pharma and medical-care giant Fresenius (Rs. 1 lakh in two cases).
Delhi-based CRO Apothecaries (Rs. 2.16 lakh), Multinational Clinical Research bigwig Lambda (Rs. 2 lakh), French firm Sanofi (Rs. 1 lakh) and Indian firm Veeda Clinical Research (Rs. 50,000) each paid compensation to one case of death.
The information was provided by the office of the Drug Controller General (India) to medical rights activist Anand Rai.
The information provided by the DCG(I) does not tell whether the compensation was paid by the foreign firms or their Indian subsidiaries.
According to official data, between January 2007 and January 2012, Serious Adverse Events (SAEs) during drug trials killed 2,193 people all over India.
The year-wise break-up of the deaths are: 132 (2007), 288 (2008), 637 (2009), 688 (2010), 438 (2011) and 30 (January, 2012).
However, compensation was only provided to 22 victims in 2010 and 16 in 2011.
“It is shocking that only over 3 percent of cases have been compensated. It is a mockery of the human rights of trial subjects in India. But sadly, the CDSCO's new draft guidelines on financial compensation only address part of the problem,” says Dr. Rai, who obtained the information under the Right to Information Act.
At present, financial compensation is not mandated by law in India and is only mentioned as a Good Clinical Practice (GCP) in para 2.4.7 of the Indian Council of Medical Research's GCP Guidelines for Clinical Trials in India.
The Central Drugs Standard Control Organization's (CDSCO) new draft guidelines for financial compensation seek to fill this major gap in the existing Drugs and Cosmetic Act, 1940.
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