- SPC yet to clear meropenem for use
The State Pharmaceuticals Corporation (SPC) is yet to clear the antibiotic meropenem for use, while two batches of another antibiotic – co-amoxiclav – have been recalled by the Medical Supplies Division (MSD) after glass particles were discovered in them, The Sunday Morning learns.
Speaking to The Sunday Morning, MSD Deputy Director General (DDG) Dr. G. Wijesuriya said that the MSD had recalled two batches of co-amoxiclav from the Lady Ridgeway Hospital (LRH) after glass particles had been discovered in them earlier this month.
Meanwhile, SPC General Manager D. Dasanayake said that an issue had also arisen with a shipment of meropenem.
“A pre-shipment sample test of meropenem initially failed. The manufacturer disputed that and it was then decided to conduct another test through an independent laboratory. However, before the second test results were obtained, the manufacturer had already dispatched the shipment to us,” Dasanayake said.
Dr. Wijesuriya noted that both medicines had been manufactured by the same manufacturer while the shipment of meropenem had been imported by the SPC under the Indian credit line.
According to Dasanayake, as the shipment of meropenem had been dispatched before the second pre-shipment sample test results had been obtained, the SPC had been unable to clear the shipment for the past four months and as a result the medicines had been in storage at the Colombo Port.
“The medicines passed the second test conducted by the independent laboratory, but since the medicine was in storage for the past four months, we need to conduct another quality test to determine whether it is suitable for use. Therefore, it has only been conditionally cleared so far. We have requested the National Medicines Quality Assurance Laboratory (NMQAL) to provide an analytical report on the shipment. If it is unable to do so, we will have to get it checked by an accredited laboratory, likely in India,” said Dasanayake.
He further said that a payment had not been made for the shipment yet.
It is learnt that the SPC had not been involved in importing the two batches of co-amoxiclav that were recently recalled. The Sunday Morning learns that it is likely that the local manufacturer, which was supposed to supply the medicine, had been unable to supply it and had thus sourced the medicine from another manufacturer (as per their agreement).
Sri Lanka has been haunted by a series of low-quality medicines reaching patients since the economic crisis in 2022. Key amongst them is the consignment of fake immunoglobulin that the Health Ministry cleared for use last year, which, when injected, caused adverse reactions in patients.
Former Health Minister Keheliya Rambukwella, along with seven other suspects including former Health Ministry Secretary Janaka Sri Chandraguptha, have been accused of being involved in the scam. When the matter was called before court last week, all eight were further remanded until 29 February.