1,725 Deaths During Drug Trials in India in Four Years
For the first time since 2010 when six tribal girls from Gujarat and Andhra Pradesh involved in the clinical trials of anti-cervical cancer HPV vaccine died, the government has admitted that 1,725 persons have lost their lives to drug trials in the last four years …
Currently, 1,868 clinical trials are going on as per the Clinical Trial Registry of India maintained by the office of the Drug Controller General of India (DCGI). Many of the drugs being tested are not even of specific relevance to the country and could have been tested anywhere. Equally shocking is the fact that the rules, under the Drugs and Cosmetics Act, entirely trust the trial investigator with the reason attributed for the death of a subject. This is resulting in gross under-reporting of actual deaths during clinical trials.
Dr Chandra Gulhati, a leading medical practitioner, who led several clinical trials in the UK, says the number of deaths would be much more than we will ever know. "We have no system of independent auditors to investigate the cause of death of subjects involved in clinical trials. Whatever the investigator says is believed even if he attributes the death to a prior disease. Such investigators are always hired by the firm conducting the trial. How can we expect them to be objective all the time?", he asks …
Dr Amit Sengupta, who helped expose loopholes in the HPV trial conducted by the US NGO PATH, says India must drastically reduce the number of trials happening here. "Why should we allow trials of drugs for medical conditions that prevail elsewhere in the world? Trials for diarrhoea, malaria etc are understandable, but why should foreign firms come to us to test anti-cancer drugs? Cancer is prevalent in their countries also. Let them test there," he says. The reason is: since the cost of testing in India is 80 per cent less than in the developed world, firms come here.
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