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Propofol drug incident: Have no further role in investigation, says Chandigarh health department
A few days after the Post Graduate Institute of Medical Education and Research (PGIMER) submitted an internal committee’s report on the death of five people, suspected to have been caused by the Propofol drug, to the UT administration, health department authorities claimed that they do not have any further role in investigating the matter and the Centre will now take required action
A few days after the Post Graduate Institute of Medical Education and Research (PGIMER) submitted an internal committee’s report on the death of five people, suspected to have been caused by the Propofol drug, to the UT administration, health department authorities claimed that they do not have any further role in investigating the matter and the Centre will now take required action.
Director health services, Chandigarh, Dr Suman Singh in an official note, said, “There is no further role of the Drug Control Authority, Chandigarh, and required actions are being taken by the Central Drugs Standard Control Organisation.”
The matter of health complications in a few patients during the postoperative period over the past few days due to “Propoven” (Inj. Propofol IP 10 mg/ml) had been brought to the notice of the institute’s medical superintendent by two department heads on September 1, following which the institute director Dr Vivek Lal had constituted a high-level committee to investigate the incident.
The high-level internal committee of the PGIMER had submitted its final report to the director on October 4, but the institute is yet to reveal its findings and ascertain the cause of death of the five patients.
As per the sources, PGIMER’s internal committee report included the Propofol injections used were of substandard quality, but the investigation could not establish a direct link between the drug and the deaths. As per senior doctor, autopsy of the patients, who had been suspected to have died due to the adverse effects of the injections, was not done by the institute.
“Without the autopsy, the findings cannot establish any connection between deaths and the drug. The report said that patients got adverse effects after Propofol was administered but did not ascertain it as the ‘cause of death’. The report only concluded that the drug was of substandard quality,” a senior official said.
UT health department’s official note further said, “Being an internal matter of PGIMER, they would be the best to comment on findings/report of the committee”.
Since the drug was suspected to have killed the five people who had undergone orthopaedic and neurosurgeries, a joint investigation team comprising drugs inspectors drew samples on September 2 — which were then sent to the regional drugs-testing laboratory in Chandigarh.
As per the CDSCO report, which was received on September 27, the drug has been declared as ‘not of standard quality’ by the laboratory, as it failed various parameters.
Drug’s stock recalled
“After getting the reports of substandard drugs, the drugs control wing of Chandigarh administration had ensured that the whole stock of both the drugs was recalled from the market. Also, the drugs inspector, CDSCO, sub-zone Baddi being the investigating officer, has started the investigation from retail chemist to the manufacturer’s level under provisions of Drugs and Cosmetics Act/Rules,” Dr Suman said.
