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Explain or withdraw order to ‘corrupted’ antibiotic supplier
View(s):By Nadia Fazlulhaq
The Health Ministry has decided to remove the entire consignment of ‘cloxacillin’ antibiotic, if the Indian pharmaceutical firm fails to give a credible explanation on the glass particle found inside an antibiotic vaccination vial at the Colombo South Teaching Hospital (Kalubowila), last week.
Cosmetic Devices and Drug Regulatory Authority (CDDA) head Dr. Hemantha Beneragama said this was a serious violation of drug manufacturing process, and at a meeting with Health Minister Maitripala Sirisena, it was decided to revoke its registration, if a proper explanation was not forthcoming.
“If the explanation is unsatisfactory, a team of experts will visit the manufacturing plant to inspect their manufacturing process, including its hygiene practices and standards followed,” Dr. Beneragama said.According to the CDDA, up to November 2012, 99 incidents of quality failures have been reported, out of which, 19 are on the presence of foreign particles including glass and insect body parts.
On December 27, a glass particle inside a sealed vial containing cloxacillin was found in a ward, when it was to be used on a patient, Kalubowila Hospital Director Dr. Asela Gunewardena said.Dr. Gunewardena said the Health Ministry was informed immediately and samples were sent to the National Drug Quality Assurance Laboratory (NDQAL) for confirmation. Also, as a precautionary measure, the batch of 600 vials was withdrawn and disposed.
He said the drug was a commonly used antibiotic for both adults and children.On December 31 (Monday), hospitals including private hospitals were issued a circular to suspend administering the drug, and remove the relevant batch from use.
National Drug Quality Assurance Laboratory Director Ajith Priyadarshana said the sample sent to the laboratory confirmed the vial contained a piece of glass, which had taken place during the manufacturing process.Meanwhile, Health sector trade unions charge the Ministry for not taking strict measures against companies that send low quality drugs or those with defects.
Health Services Trade Union Alliance (HSTUA) President Saman Ratnapriya said the ‘corrupted’ batch was found on a Friday, but the withdrawal order to hospitals islandwide was given on Monday.“The Ministry should have announced immediately, then, by Monday, the circular would have reached all hospitals, and nurses in wards notified. These inquiries should lead to strict action against low-quality drug manufacturers, and blacklisting of pharmaceutical firms that issue sub-standard medicines, which happens rarely, “he said.
According to him, priority should be given to prevent corruption and strengthen the Health Ministry’s Investigation Unit so that random sampling could be conducted more regularly. Last year, 12 such expert teams were sent to India and another team sent to Thailand, after the companies failed to provide credible explanations on quality failures.
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