Government of the Gambia exploring possibilities of legal action against Indian manufacturer related to death of children

Monday, July 24, 2023, 

The Government of the Gambia has said that it is in advanced stage of exploring avenues for potential legal action against Indian manufacturer Maiden Pharmaceuticals and its local partner Atlantic Pharmaceuticals in the Gambia, in connection with the incidents of acute kidney injury (AKI) outbreak which resulted in death of around 70 children in the country in the year 2022.
 
Dr Ahmadou Lamin Samateh, the Minister of Health, Government of the Gambia, while releasing the Presidential Task Force Report on the inquiry into the acute kidney injury outbreak that led to the death of Gambian Children in 2022, on July 21, said that the report suggested that the  Government of the Gambia through the Ministry of Justice and the Ministry of Foreign Affairs, should forthwith explore the possibility of instituting for legal action against Atlantic Pharmaceuticals and Maiden Pharmaceuticals and should engage with the Government of India to seek criminal and civil redress on behalf of families of the victims of the AKI outbreak.
 
The Minister said in the news conference, “The government is far advanced in exploring avenues for potential legal action against Atlantic Pharmaceuticals and Maiden Pharmaceuticals as well as potential redress-full engagement with the Government of India. The Government of Gambia is currently benefiting from legal advise from a top tier legal law firm that will support us in carrying out this.”
 
He added that the Task Force confirmed that the deaths can be conclusively linked to the four cough syrups imported by Atlantic Pharmaceuticals from Maiden Pharmaceuticals in India. The Task Force also investigated how the syrups were imported from India and distributed in the country. They learned that the affected medicines were not registered with the Medicines Control Agency (MCA) even though the regulation requires all medicines to be registered before importation.
 
“The MCA has the legal responsibility to ensure all medicines and related products are submitted through an application for registration prior to importation. The task force found that there is an urgent need for the Quality Control Laboratory to conduct proper testing on all medicines and related products imported into the country. Although the statute authorised a national laboratory years ago, the MoH failed to establish the national laboratory. One of the fundamental requirements of registration  is that the applicant should submit a copy of a certificate of a qualified Pharmacist and that failure to submit the requirement would render the application invalid,” he quoted the Task Force report which was later released to the public.
 
While the Government of India has been on the stand that there is no direct causal relation established between the cough syrup consumption and the deaths, Dr Samateh told reporters that there are three reports, including a Causality Assessment Report on the AKI outbreak in children in Gambia, published between June and October, 2022, and a task force report by the government this year confirming the causality.
 
To a recommendation from the Task Force that the government should with immediate effect dismiss the executive director and deputy executive director and consider prosecuting them in line with the relevant laws for the abdication of their official duties, he said that for the purpose of strengthening the MCA and building public confidence the executive director of MCA has been dismissed with immediate effect and the contracts of the deputy executive director is terminated with immediate effect. The report will also be forwarded to the Gambia police for further action.
 
The Government is in the process of setting up a Food and Drug Quality Laboratory and a fully functional pharmacovigilance department to include a medicines safety expert committee, regional hospital monitoring and investigation teams among others, as recommended by the Task Force, he added.
 
The recommendation that the Government of the Gambia through the MoH should review the laws and regulations surrounding granting importation license and instill stringent conditions so as to ensure that importers are approved based on their qualifications, operating with a sense of accountability and responsibility rather than principally driven by profit is also being addressed with the MoH roping in an experienced law firm that is currently carrying out a review of all the health related legislations in Gambia, this will be carried out as a part of its ongoing review, he added.
 
It may be noted that Gambia has earlier this year tightened the scrutiny on the imports of drugs from India.
 
The issue started with the reporting of several adverse reactions and ultimately a death of around 70 children in Gambia, allegedly associated with four cough syrups manufactured by Haryana-based Maiden Pharmaceuticals and imported in the Gambia by Atlantic Pharmaceuticals. The WHO issued an alert on these drugs and the Indian drug regulator and the State drug regulator asked the Maiden Pharmaceuticals to stop manufacturing in the plant. However, according to reports, a committee set up by the Government of India to look into the issue observed that it does not find any substantial evidence for establishing the causality between the drug and the deaths.

PHARMABIZ.com