Thursday, July 19, 2012


Clinical trials are still rampant

The Supreme Court of India most recently rapped the Union Government and the Madhya Pradesh Government over the knuckles for failing to save lives corroborated by clinical trials of drugs carried on rampantly and sometimes illegally. The data revealed by Directorate General of Health Services (DGHS) under RTI shows some shocking statistics. According to the DGHS, 1,600 people have died over the span of only two years between 2008 and 2010 by the clinical trials conducted by the multinational companies.

Between January and June 2010, as many as 117 clinical trials by global companies and 134 Indian companies took place in India. In 2009, the figure stood at 258 and 195 while in 2007, it was 246 and 275. The stark figure of 2,031 deaths between 2008 and 2011 have raised our government’s heckle, compelling it to install review committee to oversee the permission granting mechanism for the clinical trials. Sanjay Parikh, an advocate, who appeared in the court for petitioner NGO, Swasthya Adhikar Manch, accused the MP government for easing off the accused, which carried out the trials mostly on women, children and mentally retarded, with a paltry Rs.500 fine! The government is under pressure as eye brows are being raised from all quarters, which will validate the total ineffectiveness of their regulatory mechanism as spree of deaths continue to rise! The stark figure was pegged at 132 in 2007, 288 in 2008, 637 in 2009 and finally rising to 668 in 2010. What is even more disconcerting is the pharmaceutical companies’ apathy to generously compensate the deceased families and bring about a prudent end to the unfortunate occurring! Out of the 668 death cases in 2010, with all government’s urging, the pharma firms could only compensate 22 families in all! In the $400 million sector, the pharmaceutical firms manage to provide compensation that averages around Rs.1.5-2 lakhs per family with a total cost of Rs.53.30 lakhs.

India is fast developing as one of the hottest destinations for clinical trials, even for medicines that has got demand anywhere in the world. It is devious to test drugs for diseases like cancer (it is understandable to test India-specific drugs like anti-malaria or anti-diarrhea) as it is as common in the West as it is here. But it is going on regardless because conducting clinical trials in India will be 80 per cent cheaper than in the West. Equally appalling is the fact that these companies themselves appoint the investigator and the Drugs and Cosmetics Act allows them to have the final say! Th at means there is no counterbalance to the obvious underreporting by the company appointed investigators in case of deaths and health hazards.

To conduct clinical drug tests, it is mandatory to obtain approval from the Drug Controller, which many believe, is fraught with negligence and corruption. In Indore, an 800 page protocol for clinical tests was placed before DCGI seeking approval, which was granted in just 4 days! The question remains how an 800 pages protocol can be examined in such a short period?

The only solution here is to have complete transparency and a nation-wide awareness campaign. I can bet that 80 per cent of us have no clue on whether we are being used as Guinea Pigs during hospitalisation or not! A central portal is needed to make sure that all complaints and grievances are addressed!


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