Propofol deaths: Central drug control body to get anaesthetic tested again

Naina Mishra

Chandigarh, December 5

The Central Drugs Standard Control Organisation (CDSCO) has sent samples of Propofol injection again for testing after the Himachal Pradesh-based manufacturing firm Nixi Laboratories challenged the Regional Drugs Testing Laboratory (RDTL), Chandigarh, report on the quality of the anaesthetic drug.

The report on quality check of the Propoven manufactured by Nixi Labs (batch No. PNL 220316), drawn by the CDSCO, Baddi sub-zone, received on September 27 had revealed the samples failed tests, including description, pH, propofol dimer, free fatty acid and bacterial endotoxin sterility, at the RDTL, Chandigarh.

However, the samples of the same batch drawn by the Himachal Pradesh Drugs Control Department were sent for testing to the Central Drugs Laboratory, Kolkata, and these failed only assay and free fatty acid, thereby showing contradiction from the CDSCO report.

Sources shared the samples of the same batch of the anaesthetic would be tested at the Central Drugs Laboratory, Kolkata, by a senior official who would determine the quality of the drug in question.

“The samples of the drug in question were seized from the PGI following complaints of five deaths. It will again be tested at the Central Drugs Laboratory to ascertain the quality of the drug. The investigation now depends on the grounds of the anaesthetic drug retest report as well as the PGI report in which the institute has stated the drug had caused the deaths. We will seek a detailed report from the PGI after the quality check is done,” said a senior official at the CDSCO.

There were eight serious adverse events over a period of 10 days (August 22 to September 1) in the PGI’s neurosurgical operation theatres. After being administered the anaesthetic, all patients reported unexplained hypotension (sudden drop in blood pressure), acute renal injury, followed by anuria/oliguria (production of no or abnormally small amounts of urine). Of the eight patients, five died, while the rest recovered.

Following the adverse events after the administration of Propofol, sealed vials of the anaesthetic were retrieved from operation theatres and sent for analysis to the PGI’s Department of Pharmacology and Department of Medical Microbiology as well as the Sophisticated Analytical Instrumentation Facility, Panjab University.

After testing, it was found the Propofol vials contained at least 26 impurities, some of which were highly toxic for human organs and had pH below the range recommended by the Food and Drug Administration.

The Department of Medical Microbiology reported the vials were contaminated with burkholderia contaminans (bacteria), known to cause septicaemia (blood poisoning). Septicaemia or sepsis is the body’s extreme response to an infection.

As the PGI’s laboratory is not certified with national accreditation board, it has no legal standing.

UT lab report challenged

• Propoven samples drawn by CDSCO, Baddi sub-zone, had failed on several parameters at the Regional Drugs Testing Laboratory, Chandigarh
• But samples drawn by HP Drugs Control Department and tested at Central Drugs Laboratory, Kolkata, failed on only two parameters
• Further, PGI’s tests by own depts & PU facility found vials contained at least 26 impurities, some of which were toxic, besides other anomalies

Tests failed at various labs

RDTL, Chandigarh

Description, pH, propofol dimer, free fatty acid, bacterial endotoxins sterility

CDL, Kolkata

Assay & free fatty acid

PGI’s internal testing

Bacterial contamination, 26 impurities, pH below FDA range, incorrect labelling, suboptimal physical appearance, non-uniform, heterogeneous particle size