Needed: closer scrutiny of clinical trials

C M Gulhati

DOI: 10.20529/IJME.2004.002


How many people know that eight patients in Hyderabad who were administered recombinant streptokinase to test its efficacy and safety have died? According to the Genetic Engineering Approval Committee (GEAC), the trial was being conducted by the drug’s manufacturer Shantha Biotechnics without taking clearance. Not surprisingly, the company denies the allegation claiming that it had taken permission from the Drugs Controller General, India (DCGI). In this game of passing the buck, no one is shedding any tears on the lives lost or compensating the families of those whose loved ones have died. Without any independent enquiry, the death of ‘trial subjects’, as they are impersonally called, has been attributed to ’causes other than the use’ of the drug!

Full Text





There are currently no refbacks.

Article Views

PDF Downloads

Click here to support US