ISLAMABAD, May 21: Pakistan's pharmaceutical industry looks in for more trouble as the death of two pregnant women in Pakistan Institute of Medical Sciences (Pims) last year has been traced to a manufacturing defect in the antibiotic that was injected to them, Dawn learnt on Monday.
A federal drug testing laboratory which was sent the batch sample of the suspected Macronid injection in June 2011 has reported now that “the drug had failed the sterilisation process during its manufacturing,” Pims executive director Professor Mahmood Jamal confirmed to Dawn. But he wouldn't name the manufacturer.
“That it took a year for the report to land at my desk is a matter of concern,” said the official who had to face much criticism when Fauzia, 25, and Safia, 27, died of infection that has been traced to the injections they were given.
It would be the second scam to hit the pharmaceutical industry of the country this year since more than 100 cardiac patients of the Punjab Institute of Cardiology in Lahore died from the reaction of a faulty drug.
However, the pregnant women coming to Pims escaped such ghastly end as Pims authorities immediately sealed the entire stock of the suspected Macronid injection in its pharmacy and sent it for testing.
Initially, the Pims management had attributed the death of Fauzia and Safia to infection, which the lab test now traces to faulty injection.
“Both of them may have died of some virus which might have been infected with an E. coli virus,” suggested one physician who had attended the unfortunate women. “When the laboratory report reached Pims a year later it caused a stir and anger among its staff,” said a medical officer.
According to web definition, Escherichia coli, abbreviated as E. coli, is a gram negative rod-shaped bacterium that is commonly found in the lower intestine of warm-blooded organisms (endotherms). The Pims executive director regretted that the two pregnant women died because of spurious drugs. “It's very sad and tragic,” he told Dawn.
Every single drug coming into the Pims’ pharmacy passes through the strict ‘standard operating procedures’ of the hospital, he said.
“We had immediately stopped using the suspect injection and sealed all its consignments to save other patients from possible harm,” he said. “All the batches of Macronid drugs were removed from the store and we stopped prescribing the drug”.
Prof Jamal gave the generic name of the drug as metronidazole and said a lowest bidder was supplying the drug with the locally registered Macronid.
A medical expert at Pims said metronidazole drug is used to treat trichomoniasis, a sexually-transmitted infection caused by the parasite trichomonas vaginalis, and giardiasis, that is diarrhoeal infection.
“We will convey the facts to the federal government (Capital Administration and Development Division) by Tuesday,” he said when asked about follow-up action on the lab test report.
About the purchase of the drug, he clarified that “all the PPRA Rules (procurement rules) were followed by the management and every fact is available with our management”.