Despite Chandigarh report blaming drug, PGI mum on 5 deaths

Tribune News Service

Chandigarh, October 7

Despite UT’s report confirming the anaesthetic (propofol injection) used at the Postgraduate Institute of Medical Education and Research (PGI) was of “substandard” quality, the responsibility is yet to be fixed in connection with five deaths during operative procedure at the hospital over a span of few days.

Confirmation awaited

We haven’t received report from PGI confirming whether cause of deaths is linked to propofol. Nor have we got any recommendation for an FIR. Dr Suman Singh, Director, Health Services

While the PGI’s internal committee has investigated whether the cause of deaths was the anaesthetic, the UT report on the quality check of the drug received by the Central Drugs Standard Control Organisation (CDSCO) on September 27 had revealed “the drug sample failed in sterility, free fatty acids, pH, propofol dimer, bacteon tests”.

As per sources, the report has confirmed blood pressure fell in some patients after propofol injection was administered, leading to kidney failure and subsequent deaths.

On September 1, a matter regarding “unexplained” hypotension (sudden drop in blood pressure) in intraoperative (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 come to the fore.

After receiving the quality check report from the CDSCO, UT Administration had written to the Director Controller General of India (DCGI) to issue alert to state drugs controllers of the country, asking them to take immediate appropriate action. The internal committee of the PGI constituted on September 2 has looked into the details in the adverse events reported by the Department of Neurosurgery and Neuroanaesthesia over few days.

Nixi Laboratories, 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.

As per PGI authorities, the onus of registering the FIR against the manufacturing unit of the anaesthetic drug was on the UT Administration.

However, the Director Health Services, Dr Suman Singh, said: “We have not yet received the report from the PGI confirming whether the cause of deaths is linked to the propofol injection. Neither have we got any recommendation for an FIR from the hospital. As per the quality report of the drug, we have already raised the matter with the Centre and it is under their jurisdiction to get the FIR registered.”

The Deputy Director of PGI, Kumar Gaurav Dhawan, said: “The report has been received and is being examined. Appropriate action will be taken on the findings and conclusion of the report. We are trying to issue a detailed statement tomorrow.”

Onus of lodging FIR on Admn: Institute

• On Sept 2, PGI had formed internal panel to look into five deaths reported over few days
• On Sept 27, UT report sent to Central Drugs Standard Control Organisation said samples failed sterility, free fatty acids, pH, propofol dimer, bacteon tests
• Nixi Labs at Kala Amb, HP, was told to recall all batches of drug Propoven, including the batch found not of standard quality
• The PGI says onus of registering FIR against the manufacturing unit was on the UT. It may make detailed statement on Saturday

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