African pharmaceutical review understands that the Presidential taskforce in The Gambia has conclusively linked the death of 70 children in the country to four cough syrups. Additionally, the taskforce confirms that the syrups were fraudulently imported by Atlantic Pharmaceuticals from a manufacturer in Northern India.
What happened?
In October 2022, the WHO through its Global Surveillance and monitoring system, raised an alert on four substandard medical products identified in The Gambia.
These products, that failed to meet either quality standards or specifications included; Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough syrup and Magrip N Cough Syrup. All manufactured by Maiden Pharmaceuticals Limited based in Haryana, Nothern India.
These syrups contained unacceptable levels of diethylene glycol and ethylene glycol and WHO recommended their immediate removal from the market. Toxic effects of these elements include headache, abdominal pain, diarrhea, acute kidney injury or even death. In the case for Gambia, 70 children were suspected to have died as a result of consumption of the syrups.
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What was said?
In a pressor on 21st July 2023, a Gambian Presidential Taskforce confirmed that 70 children died directly as a result of consumption of the four cough syrups imported from India.
“All 4 of these products were manufactured by Maiden Pharmaceuticals in India and were imported to The Gambia by Atlantic Pharmaceuticals,” stated Health Minister Dr. Ahmadou Lamin Samateh.
“We have never lost sight of the fact that, sadly, 70 children died as a result of the products,”
Dr. Ahmadou Lamin Samateh
What is more?
It was noted that Altantic Pharmaceuticals had not followed due process when importing the syrups from India. The products had not been registered with the Medicines Control Agency (MCA), the key drug regulator in the country.
As a consequence to the offense, police investigations were launched on the operations of Atlantic Pharmaceuticals even as their licenses withdrawn and premises closed. The Gambian Government is also exploring ways on seeking legal redress against Maiden Pharmaceuticals which closed its plants when WHO raised the alert back in October 2022.
Bigger picture
Substandard and counterfeit medicines have far reaching implications in the African Pharmaceutical Market. The effects of these products can range from treatment failures to violent and even fatal adverse drug reactions as seen in Gambia.
Most countries in Africa including Gambia do not have a WHO pre-qualified quality control laboratory for medicines. This coupled with a lack of a vibrant pharmacovigilance unit has exposed the region and left it vulnerable to poor quality medication.
In response to this, The Gambia has decided to establish a Pharmacovigilance Department. The unit will includes a Medicines Safety Expert Committee, Regional Hospital Monitoring and Investigation Teams, and Focal Persons at the Regional Health Directorates and Health Facilities. It is hoped that with this new unit, their will be aversion of reoccurrences of such cases in future.
Other African countries should follow suit.
