Unethical drug trials on gas victims, DGCI fumes
Sep 21 2011 by Web Editor
Bhopal: This comes straight from the highest authority. Victims of the Bhopal gas tragedy were subjected to drug trials that violated several norms, a letter written by the Drug Controller General of India (DGCI) reveals.
While the Madhya Pradesh government is yet to furnish its report on illegal drug trials conducted on gas victims by the doctors at Bhopal Memorial Hospital and Research Centre (BMHRC), the DGCI has issued a strict warning to the hospital authorities for exploiting the unsuspecting patients.
A Central Drug Standard Control Organsiation (CDSCO) team which inspected BMHRC in August 2010 on DGCI’s directive has reported severe irregularities on part of the BMHRC doctors.
Referring to a multinational trial of intravenous Telavancin versus another drug for treatment of hospital acquired pneumonia, the CDSCO reported that the hospital authorities had not only concealed facts but also submitted false statements to the inspecting team.
The BMHRC doctors, CDSCO reported, failed to adhere to the guidelines while trying the drug. They did not report adverse effects to the sponsor or the ethics committee within the stipulated time.
“There was no proper correspondence of serious adverse events (side affects of under trail drug) reporting by the principal investigator to the sponsor” CDSO reported.
The BMHRC also failed to maintain trial records in accordance with established rules.
The inspection team also reported to DGCI several other violations during the trial.
Source: Daily Bhaskar