The press briefing, which was moderated by the government spokesperson and presidential adviser on Diaspora, Ebrima G. Sankare, also witnessed the launch of two other reports: Acute Kidney Injury Outbreak and Causality Assessment Report.
“All 4 of these products were manufactured by Maiden Pharmaceuticals in India and were imported to The Gambia by Atlantic Pharmaceuticals,” Health Minister Dr. Ahmadou Lamin Samateh confirmed.
The taskforce report also confirmed that the deaths could be conclusively linked to the four cough syrups imported by Atlantic Pharmaceuticals from Maiden Pharmaceuticals in India.
The report also investigated how these syrups were imported from India and distributed in the country.
The affected medicines were not registered with the Medicines Control Agency, even though the Regulation requires all medicines to be registered before importation, according to the report. “The MCA has the legal responsibility to ensure all medicines and related products are submitted through an application for registration prior to importation.”
According to Minister Samateh, amid the outbreak of AKI, the government has immediately banned Atlantic pharmaceuticals, and had their licence withdrawn and their premises closed. This was followed by police investigations into their activities.
“We have never lost sight of the fact that, sadly, 70 children died as a result of the outbreak,” Dr. Samateh said, describing the AKI outbreak as a “national tragedy.”
“This was a very difficult moment for all of us and we wish to emphasise to the bereaved families His Excellency President Barrow’s resolve and that of his government to addressing this issue. However, it was very important to establish the cause of the Acute Kidney Injury in a scientific way.”
The Minister said that the World Bank is helping The Gambia in establishing a Food and Drug Quality Control Laboratory in Brusubi.
“The architectural design and the development of the BOQ is currently going on and construction work will start soon thereafter. Government has already tasked MCA to get support from partners. This is already ongoing with support from WHO and the Pakistani Drug Regulatory Authority. This step will continue and will be enhanced.”
The Presidential Taskforce Report has urged the need for the MCA to establish a fully functional Pharmacovigilance Department to include: a Medicines Safety Expert Committee, Regional Hospital Monitoring and Investigation Teams, and Focal Persons at the Regional Health Directorates and Health Facilities as required by the Regulation to avert reoccurrences of such cases in future.
However, Minister Samateh said the MCA has already started this process and is instructed to ensure the expansion of the scope for increase coverage and efficiency.
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