PGI deaths: 11 of 75 had reacted 'adversely' to Propofol made by Himachal firm, 'six' died

Naina Mishra

Chandigarh, November 21

As many as 75 patients, who had undergone surgeries at the Post-Graduate Institute of Medical Education and Research (PGI) in the last week of August, were administered Propofol injection, of whom 11 had suffered from “adverse reactions” from the use of anaesthetic from the same manufacturer — Kala Amb (HP)-based Nixi Laboratory, says a PGI source. Four patients had recovered from the adverse reactions, while “six” had died. Earlier reports had suggested only “five” deaths.

“There is no denying the fact that the drug was responsible for the deaths and that all adverse reactions happened in the batch of the same manufacturer only. In all 75 surgeries, Propofol of different companies were used, but the problem was faced in the drug of one manufacturing unit only. We had even sampled Propofol from other companies, but no problem was found in others,” said a top official privy to the matter at the PGI.

Three months on, no action

• Even three months after deaths of ‘five’ patients were reported from the anaesthetic at the PGI, no action has been initiated against the manufacturer
• The matter came to light when on Sept 2, Neuroaneasthesia Professor, in an email, complained about unexplained complications in patients during surgery
• The PGI conducted in-house testing of the drug and found as many as 25 impurities, including some lethal substances as well

Drug from single unit behind fatalities

There is no denying the fact that the drug was responsible for the deaths and all adverse reactions happened in the batch of same manufacturer only.— PGI source

Up to drug authority to act against firm

The report about reported adverse reactions of the drug has been submitted to the Drug Control Authority. Required action on the firm has to be taken by them.— PGI statement

“Even though post-mortem was not conducted, data speaks volumes. Those who suffered adverse reactions were given anaesthetic from the same manufacturer,” said the source.

The PGI had conducted in-house testing of the drug in question and found as many as 25 impurities, including some lethal substances as well. The samples were sent to Panjab University as well, where it was found the drug was not of “standard quality”. The internal committee’s report of the PGI has pointed to the anaesthetic as the cause of deaths during the procedure.

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

The matter of anaesthesia inducing adverse event on patients came to light when on September 2, Dr Nidhi B Panda, Professor Neuroaneasthesia, in an internal email, complained about unexplained complications in neurosurgical patients undergoing surgery. According to the email, the complainant had ruled out all the causes of adverse reactions except “drug-induced hypersensitivity reaction”.

The complaint read: “In the past 5-7 days, there have been a few cases (7-9 in number) of unexplained hypotension in intra-operative period with anuria and/or jaundice in the postoperative period. We have ruled out all causes of hypotension, except drug-induced hypersensitivity reaction to some routinely used drug in neurosurgery OTs. We have not used any new drug or anaesthetic technique in the recent past.

Standard anaesthesia technique with proper haemodynamic monitoring was done in all cases. The head of the department (HOD), Pharmacology, was informed and the department is participating in the drug tests. The HOD, Neurosurgery, Medical Superintendent, HOD, Nephrology, were also informed about the serious life-threatening problem.”

Even three months after the deaths of “five” patients were reported from the anaesthetic at the PGI, no action has been initiated against the manufacturer to date.

The PGI, in a statement to Chandigarh Tribune, said: “As soon as the information pertaining to adverse drug reactions was reported, the same was brought to the notice of the Drug Control Authority, UT. The sample of the drug in question was sent for testing. A high-powered committee was constituted by the Director, PGI, to look into the matter. The report on reported adverse reactions of the drug in question has been submitted to the Drug Control Authority. Needed action on the manufacturing firm has to be taken by the Drug Control Authority itself. Death certificates have been issued by the departments concerned to the respective families.”

The Chandigarh Administration has maintained there is no further role of the Drug Control Authority, Chandigarh, and the matter was already brought to the notice of the Director General Controller of India.