RTI revelation - clinical trial deaths occurred in private hospitals too
As per the data provided by the Drug Controller General of India (DCGI) following the directions of the Central Information Commission (CIC) to furnish information, it has been revealed that 1,010 deaths took place between 2008 and January 2012 during clinical trials in the country. The state-wise data of clinical trials shows that Maharashtra reported 268 deaths, followed by Andhra Pradesh (153), NCR (97), Gujarat (87) and Karnataka (78).
The state of Madhya Pradesh reported 26 deaths, 13 of which occurred in different private hospitals of Indore and Bhopal like Aurbindo Institute of Medical Sciences, CHL Hospital, Dr Mehta Allergy and Asthma Care and Research Centre, Gyanpushp Research Centre for Chest and Allergy, Dr Ashok Sethia Clinic of the city and in Global Liver and Gastroenterology in Bhopal. In MP, the deaths were reported from government hospitals like Cancer Hospital and Research Institute, Gwalior, the Jawahar Lal Nehru Cancer Hospital and Research Centre and MGM Medical College and MY Hospital.
It has come to light that the maximum numbers of deaths were reported during the drug trial of two drugs - Rivaroxaban (sponsored by Bayer) and Enoxiparin (sponsored by Sanofi Aventis). They were related to deaths of 191 and 175 patients respectively.
The appellant has filed a complaint with the CIC that the details of investigators, trial sites and sponsor of 593 cases have not yet been provided by the DCGI.