The Food and Drugs Authority (FDA) has received a notification through the World Health Organisation (WHO) Global Surveillance and Monitoring System for substandard and falsified chloroquine in the WHO region of Africa.
These chloroquine products with different presentations are confirmed as falsified on the basis that they deliberately or fraudulently misrepresent their composition or source.
A statement issued in Accra by Mrs Delese A. Darko, the Chief Executive Officer, FDA said it was noted that either the products do not contain the correct amount of the active pharmaceutical ingredient, based on the result of preliminary or full compendial analysis.
“And or the products were not by the manufacturer, whose name was stated on the product labels and varied data (batch number and dates) of the above products do not correspond to genuine manufacturing records,” it said.
It said it was either the manufacturer name was not stated on the product label does not exist.
The statement said Chloroquine phosphate or sulfate was referenced on the WHO Model List of Essential Medicines for the treatment of Plasmodium vivax infection (Malaria).
It said large clinical trials were underway to generate the robust data needed to establish the efficacy and safety of Chloroquine in the treatment of COVID-19.
It said these medicines were currently for the treatment of rheumatoid arthritis and lupus diseases and it was important that they were dispense on prescription only.
The statement assured the public that their officers in the regions were working to ensure that these products do not enter the supply chains.
GNA
