New GPC implicated in another defective drug scandal

May 03, 2017 News

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– GPHC complains of fungus on Paracetamol tablets, “foul-smelling” replacements
– Company calls complaints deliberate ploy to malign and discredit it

The New Guyana Pharmaceutical Corporation [NGPC] has found itself at the centre of yet another defective drugs controversy. This time around, the defective product in question is a significant quantity of Paracetamol supplied to the Georgetown Public Hospital Corporation [GPHC].
Just yesterday this publication reported that the company was instructed to recall and replace a quantity of soda lime from the GPHC. Soda lime is a type of sodium hydroxide used to help patients breathe while under anaesthesia.
The company had, however, asserted that it was not responsible for the defective product as it was not the manufacturer, and it was already making arrangements to have the recalled quantity replaced within weeks. This development has left the GPHC without soda lime and dependent on a private hospital should the need for the sodium hydroxide arise.
However, the company cannot use this argument in the case of the 500 milligram Paracetamol supplied to the GPHC, since sources close to the Ministry of Public Health have confirmed that the New GPC was in fact its manufacturer.
“They are making it themselves and they had to replace it because it had fungus…the batch that they replaced that with seems to have a foul smell, a very bad odour,” said the source, who pointed out that the manufacturer’s address is New GPC Inc. of A 1 Farm, E. B. D., Guyana.
The New GPC, this publication understands, delivered a quantity of 249,000 Paracetamol to the GPHC over the period April 19 – 20, 2017. The batches delivered include: Batch Number: 508421 – Quantity: 33000; Batch Number: 508420 – Quantity: 23000; Batch Number: 509422 – Quantity: 45000; Batch Number: 509424 – Quantity: 85000 and Batch Number: 509423 – Quantity: 63000.
Based on information from the Public Health Ministry, 186,000 of the tablets have thus far been quarantined at the Ministry of Public Health’s bond. It was revealed that the notice of quarantine was sent out April 25, 2017 at 11:00 hours, and a reliable source informed that “the pharmacist at the GPHC is maintaining that this is a manufacturing flaw and not a storage problem at the hospital.”
This publication was privy to information that an additional 45,000 of the tablets were also returned by the Kitty, Campbellville and Industry health centres and the Enmore Polyclinic. “These health centres also complained about the Paracetamol …they [the company] are maintaining that nothing is wrong with the [fungus covered] drugs but they have replaced them… but still replaced them with foul smelling ones,” asserted a senior health official.
Meanwhile, in a statement last night, the New GPC revealed that on April 19 it received a complaint from the GPHC that there was an issue with paracetamol tablets which the company had supplied. It was revealed that this stock was imported from another manufacturer who, when contacted by NEW GPC to respond to the complaint, communicated that there were no anomalies observed in their retention samples. The company said that “These batches were earlier recalled and subsequently replaced.”
However, it was revealed that “further, on April 25 another complaint was received from the Georgetown Public Hospital Corporation regarding the replacement batches of paracetamol amounting to 186,000 units or 186 bottles. The NEW GPC immediately requested the Georgetown Public Hospital Corporation to quarantine the tablets and the company subsequently initiated a recall.”
The complaint, according to the Company, was investigated on the same day and a response was provided to the GPHC indicating that testing and inspection were conducted on retention samples for each of the batches and were all found to be in compliance with the US Pharmacopoeia’s acceptable criteria for microbiological quality. It added, “Testing and inspection were also carried out on the raw materials and no problems were found.”
However, the company said that it has since supplied an additional 80,000 units of paracetamol to the hospital from new batches manufactured at NEW GPC.
In commenting on the Soda Lime issue, the company said that “upon investigation it was found that the same product was also supplied to a local private hospital in February. The local hospital when contacted indicated that they have no complaints with the Soda Lime, which was recently used last weekend.”
As such, the New GPC said that it “wishes to put on record that it has supplied pharmaceuticals manufactured locally and procured from reputable companies internationally to the Georgetown Hospital for decades without any major issue. Suddenly there are three complaints on three products from three different manufacturers within a matter of days.”
Added to this, the company said in its statement that the hospital has chosen to go to select media houses that have always been critical of the company with sensitive information which suggests a determined ploy to malign and discredit the company as a manufacturer and pharmaceutical supplier.

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