Propofol deaths: PGI submits report, says Chandigarh Administration to decide on filing FIR

Naina Mishra

Chandigarh, October 11

The Post-Graduate Institute of Medical Education and Research (PGI) on Tuesday submitted its report on the recent propofol injection-related deaths to the UT Administration, even as anaesthetic samples of another firm have failed the quality check.

PGI Deputy Director Kumar Gaurav Dhawan stated the report was submitted to the UT Administration for further action today. However, UT Director Health Services Dr Suman Singh said the Health Department was yet to receive it.

The PGI administration has not yet recommended an FIR against the manufacturing firm to the administration. “We want the UT Administration to look at the report first before we recommend any action against the firm,” said Dhawan.

The report of the internal committee of the PGI, constituted on September 2, has looked into the “adverse events” reported by the Department of Neurosurgery and Neuroanaesthesia over a period of a few days. Sources say the PGI’s internal committee report confirmed blood pressure fell in some patients after propofol injection was injected that led to kidney failure deaths. This comes as propofol injection samples of a Mumbai-based firm, Neon Laboratories Ltd, have been found to be “substandard”. As per the report, the samples failed bacterial endotoxins, fatty acid, propofol dimer tests.

The Central Drugs Standard Control Organisation (CDSCO) report of ‘Neorof’ injection (propofol from Neon Labs) was received the same day as that of Nixi Labs, anaesthetic ‘Propoven’ manufacturer situated at Kala Amb (Himachal Pradesh).

‘Neorof’ is being sold by almost all chemist shops at the PGI. While the source of the drug samples collected has not yet been confirmed, there is apprehension over the quality of anaesthetics being used at the PGI. Amid the concerns, the PGI said it was “looking into the matter”.

The UT Administration has so far only alerted the Drugs Controller General of India about the anaesthetic manufactured by Nixi Labs.

On September 1, a matter was reported 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.

The report on the quality check of the anaesthetic drug received from the CDSCO on September 27 had revealed the drug sample had failed the sterility, free fatty acids, pH, propofol dimer, bacteon tests.

The manufacturer, Nixi Laboratories, was directed to recall all batches of drug Propoven, including the one found not of standard quality.

Yet to receive it, says Admn

While the PGI claimed the report had been submitted to the UT Administration for further action, UT Director Health Services Suman Singh said the Health Department was yet to receive it

Now, Mumbai firm in the dock

• Samples of Mumbai-based Neon Labs’ propofol drug ‘Neorof’ have also failed quality test and have been found “substandard”
• Central Drugs Standard Control Organisation’s report on injection was received the same day as that of Nixi Labs
• As per the report, the samples failed the bacterial endotoxins, fatty acid, propofol dimer tests
• In the September 27 CDSCO report, Nixi’s samples had failed sterility, free fatty acids, pH, propofol dimer, bacteon tests