DRUG TRIALS IN 2012
(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. Medical research, Clinical trials, Compensation, volunteers
Prof.
John Kurakar
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