Early this month, a leading financial daily reported that Drug Controller General of India ordered an inquiry into one of the clinical trials conducted at Bhopal Memorial Hospital and Research Centre during which three subjects had died. The trial was conducted by Quintiles Transnational Corp., a leading CRO, for the drug, telavancin. The sponsor of the drug trial was US-based Theravance Inc. Permission to conduct telavancin trial was granted by the DCGI office sometime in April 2006 for testing it for hospital-acquired pneumonia. The trial of telavancin was completed by Quintiles in June 2007 with enrollment of just eight subjects whereas only four completed the trial. It is during this one year period of the trial, three deaths occurred. The drug was approved for marketing in the US only in September 2009 for skin infections. The financial daily also reported that seven other drug trials were conducted on Bhopal victims at BMHRC during 2004 and 2008. Following this and other media reports stating that patients in BMHRC were being subjected to clinical research of banned drugs by multinational drug firms, Madhya Pradesh government has also initiated an investigation. The government-funded BMHRC was set up in 2000 after the 1984 Bhopal gas disaster to provide speciality treatment to the victims and to carry out research on the long term effects of MIC, the chemical that caused the holocaust.

This is not for the first time reports of deaths and injuries occurring to the subjects during the conduct of clinical trials in India. In August 2008, Indian media reported the death of 49 infants during clinical trials conducted by All India Institute of Medical Sciences during the period of 2006 to 2008. Again in November 2008, DCGI ordered to stop the trial of a pneumonia vaccine by Wyeth after the death of an infant in Bangalore who had a pre-existing cardiac disorder. There are many such instances which are not being reported in various parts of the country. As per the government records, 700 trials are currently going on in the country for various chemical and biotech compounds. Apart from having the figures of the number of trials taking place in India and the names of the compounds, the Union health ministry does not have much details about the trial sites, subjects, progress of trials and working of ethics committees. The DCGI routinely gives permissions for trials after submission of toxicological reports, pre-clinical data and other relevant documents of the new drug. But, monitoring of clinical trials at various sites is hardly done once the permission for clinical trials is granted. This is a critical area of neglect on the part of the government. All trial sites are expected to have ethics committees to oversee the trials. But hardly the ethics committees have any control on the trial centres or the sponsors. A set of comprehensive rules for effectively governing clinical research is already there with the government for a long time now. It is high time now the Union health ministry is notified and enforced these rules to avoid recurrence of such avoidable deaths and injuries during trials.