By Omar Bah
At the end of several weeks of investigations into the death of 70 children from Acute Kidney Injury, the National Assembly committee on health has recommended government take legal action against Maiden Pharmaceutical for exporting the contaminated syrups to Gambia. The committee said Maiden Pharmaceuticals Ltd is culpable and should be held accountable for exporting the contaminated medicines.
“The government should pursue legal action against Maiden Pharmaceuticals for exporting contaminated drugs to The Gambia with the Atlantic brand name,” the report stated.
The committee also recommended Medicines Control Agency to blacklist Maiden Pharmaceuticals products and ban all their products in the Gambian market.
The committee said it was informed by the MCA that they approved the import clearance permit for Atlantic Pharmacy which contained the suspected four syrups on 17 June 2022, namely Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup manufactured by Maiden Pharmaceuticals in India.
It concluded that all the cases of AKI are linked to the consumption of the contaminated medical products imported by Atlantic Pharmacy and Manufactured by Maiden Pharmaceuticals Ltd India.
However, the committee added that the actual cause of the children’s death is still under scientific investigation as causality tests are currently being undertaken by the Ministry of Health and partners.
According to the committee’s findings, Atlantic pharmacy in The Gambia, had followed all regulations for importation of medicines including the batch that had the contaminated syrups.
The committee recommended for the MCA to operate as an autonomous agency for effective and efficient regulation, increase background checks on companies from which pharmacies or importers buy medicines and for government to strengthen the hospitals with the required medical products/supplies for the effective and efficient management of patients.
The committee also recommended for onsite visits to 39 manufacturing drugs companies by MCA before granting permit to any importer and that pharmacies should be encouraged to buy medicine jointly so that they have a higher buying power.
“This will ensure that they can purchase from the high-quality companies, and they could also get a certificate of analysis for the products,” the committee added.
The government has been criticised for failing to establish a laboratory for the testing of medicines imported into the country which is a requirement under section 50 of the Medicines and Related Product Act 2014.
But according to the committee, the World Bank is funding the construction of one modern QC Lab.
The committee also stressed the need for an urgent establishment of a functional Pharmacovigilance (PV) unit at the MCA and hereby recommend for its immediate establishment in January 2023 and that the MCA should involve countries such as Nigeria and Ghana and others for on-the-spot assessment.
The Committee also recommended that the government, through the Ministry of Higher Education, Research, Science and Technology, establish a School of Pharmacy at the University of The Gambia to train more pharmacists and strengthen regulatory and health care delivery institutions.
The committee said its engagement with stakeholders has exposed fundamental inadequacies in the country’s health care delivery system.
The findings revealed that all importers of pharmaceutical products (wholesale and retail) into The Gambia are following MCA regulations but added that the MCA is confronted with inadequate human and institutional resources.
The committee said the Pharmacy Council of The Gambia (PCG) which is responsible for quality control, inspection of pharmacy premises, and overseeing related regulations is faced with huge logistics and staffing constraints.
