Guinea pigs

Theres need for strict monitoring of drug trials.

The high number of deaths during drug trials in India, as reported by the WHO’s clinical data base, should cause concern. According to this data, 2031 people died during such trials in the country between 2008 and 2011. The government has said that it would analyse the figures. It has also been suggested that the mortality rates may be high in the case of diseases like cancer and that may have accounted for the high number. There is also another view that all the deaths may not have been the result of the trials and may have been caused by other reasons. But these arguments should not be allowed to gloss over the serious problems and malpractices that go with drug trials.

The Supreme Court had earlier this year issued notices to the government over the permissive state of clinical field trials. The National Human Rights Commission is seized of the matter and there is a specific enquiry going on into a charge relating to grant of permission for clinical trials. There have also been some cases of action against doctors who were involved in illegal and unethical trials but punishments were trivial. There  were recent reports of tests on mentally ill persons in Madhya Pradesh and two years ago vaccine trials were conducted on tribal girls in some states without their knowledge and consent. Though the matter has been hotly debated in the country there still are no safeguards against turning people into guinea pigs. There is still no clear law on the matter.

At present, the share of India in global clinical trials is not known to be high and those conducted by multinational pharma companies do not account for a high percentage of them. But it is recognised that the country is more vulnerable than many others because of its high, genetically diverse and poorly informed population, low costs of trials, lax laws and their bad implementation. Unscrupulous doctors and pharma companies form a nexus and very often there is no informed consent for the test. The result is that  the companies and others involved in the trials are not held responsible for deaths and after-effects of testing. It is also reported that compensation even in the case of deaths is poor and often not paid at all. There is an urgent need to put in place stringent laws and a good regulatory and monitoring mechanism that ensures complete safety and freedom from exploitation.