The recent report of deaths of 49 infants while conducting clinical trials during the period of 2006 to 2008 at India's prestigious All India Institute of Medical Sciences sounds quite shocking. The report based on the facts provided in response to a Right To Information query raised by one of the Delhi based NGOs throws some light at the horrors taking place in the name of clinical trial business in the country. AIIMS admitted that in all, 4142 babies were enrolled for clinical trials by the Institute's department of paediatrics since January 1, 2006 and out of that 2728 were below the age of one. Now, after the report appeared in the print media, AIIMS has been desperately trying to downplay the deaths but with no convincing explanations. The Institute says that it has taken informed consent from the parents of these infants. But the question is whether the parents were fully aware or were told that their children were to be subjected to such deadly experiments. Just obtaining signatures on the consent forms by offering some paltry amounts is patently unethical. Such system of taking informed consents by CROs is widely prevalent in the country today. The fact that none of the parents of the dead children neither protested nor approached the court of law clearly shows that they were made to believe that the deaths occurred due to natural causes. This is a matter to be investigated by the country's Central drug authorities.
The infant deaths at AIIMS is only a tip of an iceberg. There are over 600 clinical trials going on in the country for various untested and potentially dangerous drugs involving several thousands of illiterate and innocent subjects. Just two years ago, there were only about 250 clinical studies being conducted in the country. For the trials, large number of patients need to be recruited from various parts of the country. There are agents, operating in close coordination with large pharma companies and CROs, who procure illiterate and uninformed subjects and parade them before the so-called investigators. With the offer of a few thousands of rupees, healthy volunteers and parents of children agree to undergo trials without understanding the consequences of such experiments. Many of these subjects die or face serious health problems during or after the trials. Deaths or chronic ailments on account of such trials are not recorded or accounted for by the government as there is no machinery to track this activity. Despite having a fairly effective drug regulatory system in place, the clinical trials are not effectively monitored or regulated in India yet. What is shocking is the extreme slow pace at which the Union health ministry is moving to enact the law for clinical trials in the country. Ethical Guidelines for Biomedical Research on Human Subjects drafted by ICMR has been with the health ministry since the year 2000.