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Tuesday, Nov 29, 2022

Drug fails lab test, DHS says central body to conduct final inquiry

On September 2, a high-level committee of PGI doctors had approached the UT health department for testing of the drug as a few deaths and its serious side effects were reported at the institute.

The lab report says the drug failed in sterility, free fatty acids, pH, Propofol dimer and bacterial endotoxin. (Representative/ AP)

The Regional Drugs Testing Laboratory, Chandigarh, has found Propoven (injection Propofol), an anaesthetic given to patients before surgery, not of standard quality.

The lab report, received on September 27, says the drug failed in sterility, free fatty acids, pH, Propofol dimer and bacterial endotoxin.

“After this report, the Central Drugs Standards Control Organisation will be conducting the final inquiry and we will await their report on further course of action,” said Dr Suman Singh, UT Director Health Services (DHS).

On September 2, a high-level committee of PGI doctors Chandigarh had approached the UT health department for testing of the drug as a few deaths and its serious side effects were reported at the institute. According to sources at PGI, these patients underwent surgery and were sedated with Propofol.

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On September 1, complications like unexplained hypotension (low BP) in the intra-operative period (during operation) with anuria (decrease in urine output) and/or jaundice in the post-operative period in a few patients and also some deaths were brought to the notice of the Medical Superintendent by two department heads. Taking note of the situation, the PGI director constituted a high-level committee under the chairmanship of Prof S K Gupta, head of the Department of Neurosurgery, to investigate the case.

According to Kumar Gaurav Dhawan, Deputy Director (Administration), PGI, the report on the issue from the PGI committee is awaited.

“The sub-standard drug clearly proves that it was the cause of the catastrophic events. Deterrent and appropriate action will be taken in due course,” said Dr Vivek Lal, Director, PGI.

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Listing the precautionary steps, the DHS said a joint investigation team comprising drug inspectors of Drugs Control Wing, Chandigarh, and Central Drugs Standards Control Organisation, Sub-Zone Baddi, drew samples of the drug on September 2 and sent the samples to the Regional Drugs Testing Laboratory, Chandigarh.

The retailers, wholesalers and distributors of the drug were asked to recall the drug or freeze the drug stocks, Dr Singh said. Further, State Drugs Controller, Haryana, and State Drugs Controller, Himachal Pradesh, were asked to take appropriate action as the distributor and manufacturer of the drug were in their area of jurisdiction respectively.

All four available injections of the particular batch were removed from the pharmacy. The distributor in Panchkula was told to ensure that injections of the particular batch are not sold/used till analysis is completed.

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According to the DHS, no more injections of the particular batch are available with any of the pharmacies in UT.
In view of the suspected adverse reaction of the drug, the PGI Administration had issued a show-cause notice to M/s Gupta Medicos, chemist shop at Emergency Block, PGI, from where the drug has been reported to be procured by the patients and attendants.

First published on: 30-09-2022 at 08:14:04 am
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