Despite its details being published in the local Press, the Madhya Pradesh Government is refusing to comment on the investigation report submitted by the Economic Offences Wing on alleged illegal drug trials conducted by Government doctors in Indore.
The EOW submitted its investigation report on irregularities in trials conducted by six doctors of the Maharaja Yashwantrao Government Hospital, Indore to the State Government (Department of Medical Education) three weeks ago. A draft copy of the report was subsequently leaked to the media.
“I cannot speak about the matter to you except say that we submitted the report to the Department of Medical Education (DME) three weeks ago. If you need any further information, speak to the Principal Secretary DME,” EOW Director General Ramesh Sharma told The Hindu.
When contacted, Principal Secretary DME I. S. Dani said the Department had not received any report. On pressing further, however, he checked with his deputy secretary and admitted to having received the report.
Neither the EOW nor the DME is ready to endorse the leaked report. However State Minister of Health and Family Welfare Mahendra Hardia confirmed to The Hindu several findings of the report.
Also, articles based on the report have appeared in two prominent local dailies and were not denied by either department.
According to the report, during 2006-2010, the six doctors together performed 76 clinical trials on 3307 subjects and reported 81 deaths. Together they received Rs.5,10,00,000 from pharmaceutical companies for conducting these trials.
It also finds the doctors guilty on nine counts including failure to pay compensation in case of death or Serious Adverse Events (SAE), failure to ensure insurance of subjects for the full duration of the trials, failure to obtain proper informed consent of the subjects, of using government facilities and taking in patients for trials in their personal capacities.
Further, none of the doctors had the required endorsement from the Dean of the MGM medical college, to which the MY hospital is affiliated, of their Clinical Trial Agreements with the pharmaceutical companies.
The doctors also failed to inform either the hospital or the State Government about the huge financial remuneration they received from pharmaceutical companies or about foreign trips sponsored by these companies.
Mr. Hardia confirmed that the report found 81 deaths and several other irregularities and said action would be taken based on the findings of the report once the Government was done studying it.
Keywords: Indore illegal drug trials