Maharashtra recorded the maximum number of deaths caused due to Serious Adverse Events (SAEs) during drug trials while Madhya Pradesh saw the least number of such deaths, latest official data reveal.
According to official data disclosed by the Drug Controller General of India, during the 49-month period, i.e., from January 2008 to January 2012, the country recorded 2061 drug trial related deaths.
However, the DCG(I) has provided death data for states only for 1603 of the total 2061 deaths.
An analysis of the death-data reveal that at 268, Maharashtra recorded the maximum number of SAE-related deaths and figures in the top five.
In the top five, Maharashtra is followed by Andhra Pradesh (153), Delhi/NCR (97), Gujarat (87) and Karnataka (78).
The States figuring in the bottom five are Tamil Nadu (46), Rajasthan (43), West Bengal (28), Uttar Pradesh (28) and Madhya Pradesh (26).
As the data show, the death toll for the top state (Maharashtra) was over 10 times that for the state lowest in the top-ten (Madhya Pradesh).
The data was obtained by medical rights activist Anand Rai under the Right to Information Act.
“ I had asked for the number of drug trial related deaths for the entire country, listed by state, trial site,drug name, investigator etc. However, the DCG (I) provided the full information for only 1010 deaths out of the total death figure of 2061,” Dr. Rai told The Hindu.
Among the drugs, trials of which saw the highest number of deaths during the 49-month period, were Rivaroxaban and Enoxiparin (both anticoagulants or blood thinners).
191 deaths occurred during trials for Rivaroxaban and 175 occurred during those of Enoxiparin.
However, these deaths occurred during the trials and therefore may have been caused by other factors besides the drug itself.