PGI deaths: 3 months on, victims’ identity not revealed

Tribune News Service

Chandigarh, November 26

While the Central Drugs Standard Control Organisation (CDSCO) has claimed that an FIR could not be lodged against the drug manufacturing firm with the PGIMER, Chandigarh, failing to provide a detailed report on the death of six persons following the administration of Propofol injection, the hospital authorities say that the inquiry report was submitted to the Drug Control Authority, Chandigarh, for further course of action.

The blame game continues even as the victim’s identity remains in dark. No compensation has been promised to the families of those who died due to adverse events after being given the anaesthetic drug. The UT Administration had maintained that there is no further role of the Drug Control Authority, Chandigarh, and the matter was already brought into the notice of the Drug Controller General of India.

The UT Drug Controller, Dr Suman Singh, said it was the PGI authorities who had to send the report to the CDSCO and “we are in no position to share their internal report with any other authority”.

A PGI source privy to the development said, “We had submitted the report to the Drug Control Authority in which we held the manufacturer accountable for the adverse events. FIR cannot be lodged from the institute’s end as it is for the drug authorities to initiate proceedings under the Drugs and Cosmetics Act. The investigation is going on at the central level.”

On September 1, a matter regarding “unexplained” hypotension (sudden drop in blood pressure) in intra-operative (occurring or performed during the course of a surgical operation) period with anuria (failure of the kidneys to produce urine) and/or jaundice in post-operative period in a few patients over the past few days had surfaced. Following this, the PGI authorities constituted a committee to look into the adverse events of the anaesthetic drug.

The report on the quality check of the anaesthetic drug by the Central Drugs Standard Control Organisation (CDSCO) on September 27 had revealed that the drug sample failed in sterility, free fatty acids, pH, Propofol dimer, bacteon tests.

Nixi Laboratories Private Limited, the manufacturing firm of the anaesthetic drug situated at Kala Amb (Himachal Pradesh), was directed to recall all batches of drug Propoven, including the batch of drug found not of standard quality.

6 fatalities, but no FIR

No FIR has been registered against the manufacturer of the anaesthetic drug, which was administered to the six patients who died at the PGI nearly three months ago, neither the investigation into the incident has gained momentum.

Drug failed quality test

The report on the quality check of the anaesthetic drug by the Central Drugs Standard Control Organisation (CDSCO) on September 27 had revealed that the drug sample failed in sterility, free fatty acids, pH, Propofol dimer, bacteon tests.

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