Spurious Drugs: No FIR yet, onus on Chandigarh drug authority, says PGI

Tribune News Service

Chandigarh, December 3

Even as the PGI report concluded that the Propofol injection contained bacterial contamination that was toxic for human organs and eventually led to five deaths, there is no headway yet in lodging an FIR against the manufacturer of the anaesthetic drug.

Centre investigating matter: Admn

The report is observatory in nature as they have failed to establish any direct link between the deaths and the injection. The investigation is going on at the central level and a decision will be taken by them. Dr Suman Singh, Director, Health Services, Chandigarh

The PGI authorities claim they cannot lodge an FIR against the manufacturer as it is for the UT Drug Authority to do it. The Director, Health Services, Chandigarh, Dr Suman Singh, said, “The report is observatory in nature as they have failed to establish any direct link between the deaths and the injection. The investigation is going on at the central level and a decision will be taken by them.”

The Department of Medical Microbiology (PGI) had reported that the injection was contaminated with burkholdaria contaminant (bacteria), which is known to cause septicemia (blood poisoning by bacteria). Septicemia or sepsis is the body’s most extreme response to an infection. According to the committee, which prepared the report, the injection was also found to have incorrect labelling and its physical appearance on storage was of suboptimal quality, and it also appeared uniform and broken. It also had heterogeneous particles. The committee reported that there were eight serious adverse events over a period of 10 days (from August 22 to September 1) in neurosurgical operation theatres of PGI. All patients had unexplained hypotension, acute renal injury after the induction of anaesthesia, followed by anuria/oliguria. Of these eight patients, five died and the rest recovered.

The committee had concluded that the drug was the “most probable cause of serious adverse reactions including deaths in the patients reported”.

PGI findings

A PGI report had concluded that the Propofol injection contained bacterial contamination that was toxic for human organs and eventually led to five deaths.

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