The Gambia Bar Association (GBA) and the Female Lawyers Association (FLAG) are saddened to learn of the untimely deaths of 69 Gambian children from Acute Kidney Injuries (AKI) linked to the consumption of medicinal products imported from an Indian Company, Maiden Pharmaceutical Limited (Haryana, India). According to the World Health Organisation (WHO) Report Alert dated 5th of October 2022, the identified medicinal products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Couch Syrup and Magrip N Cough Syrup (the medicinal products).
The laboratory report of the samples further confirms that the aforementioned medicinal products contained unacceptable high amounts of Diethylene Glycol and Ethylene Glycol. Both diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. According to the WHO, the four medicinal products referenced in the alert are ‘‘unsafe, and their use especially in children may result in serious injury or death.” The Ministry of Health ( MOH ) has confirmed that the said medicinal products were imported into the country and have taken steps to withdraw the products from the market and homes across the country.
The importation of pharmaceutical products in The Gambia is regulated and administered by the Medicines Control Agency (MCA) in accordance with the Medicines and Related Products Act 2014. The primary responsibility of the MCA under the act is to regulate the quality and safety of medicines and related products.
The GBA and FLAG are gravely concerned that contaminated paediatric medicinal products were imported into the country from a manufacturer whose reputation and credibility according to widely available public records is dubious. We trust that it is the responsibility of the body charged with regulating the pharmaceutical industry to ensure that the quality and standard of drugs imported into the country are safe for human consumption. The general populace has the right to know how such dangerous/contaminated and unsafe products were allowed into the country and administered to children.
The GBA and FLAG are calling on the Government (as duty bearer) to take its responsibility as the primary protector of the citizenry to investigate this tragic incident and thereafter take steps to ensure appropriate measures are taken to hold those responsible accountable. We recommend the constitution of an independent inquiry with multiple stakeholders and experts, including the National Human Rights
Commission, to provide answers to the public and the bereaved families following the deaths presumably linked to the importation and consumption of the substandard medications. The inquiry should shed light on the following questions of public interest:
a) How were the substandard medications manufactured by Maiden Pharmaceutical imported and distributed in the country?
b) The role of the Ministry of Health, the Medicines Control Agency, and Pharmacy Council in the importation of the substandard medications in The Gambia?
c) Does the Medicines Control Agency have sufficient capacity to ensure quality and safety of drugs imported into the country? If not, what steps is the Government taking to increase the Agency’s capacity?
d) What steps will the Government take to re-examine the import license regime, the regulatory framework, and its efficacy in ensuring quality control and early detection of substandard products before its entry into the country?
e) What are the plans in place to prevent a reoccurrence of incidents such as the death of the 69 children? To ensure that the person(s)/entity(ies) responsible for the importation and distribution of the substandard medications are held accountable, The GBA and FLAG demand that the Government of The Gambia takes the following steps expeditiously:
1. Robustly pursue the Indian Manufacturer, Maiden Pharmaceutical Ltd using its bilateral ties with our sister republic of India to ensure that the manufacturers are held accountable, and the victims are adequately compensated.
2. Hold accountable any party or authority complicit in the importation, sale, and distribution of the substandard medications attributable to the deaths of the 69 Gambian children.
3. Leave no stone unturned to ensure there is accountability and justice for the victims of this travesty through the pursuit of legal action against the persons and institutions responsible for the importation and distribution of the substandard medicinal products.
The GBA and FLAG stand in solidarity with the bereaved families and demand justice and accountability. The GBA and FLAG are available to support the Government in its quest to ensure accountability, justice and safeguard the interest of Gambians. The GBA and FLAG extends its heartfelt condolences to the bereaved families. We join the entire population to mourn the loss of these innocent lives.
SALIEU TAAL ANNA A.B. NJIE
PRESIDENT GBA PRESIDENT – FLAG