Guyana is not immune from the threat of substandard or falsified pharmaceutical drugs, says Director of the Food and Drugs Department, Marlon Cole.
He made the remarks as he addressed a drug importers form at the Marriott Hotel this morning, where he also announced that the Department has partnered with a leading US-based pharmaceutical company, AnsaZenica, in an effort to curb this issue.
“We at the Food and Drug Department would benefit directly from the capacity building by the manufacturers themselves as it relates to product security and stability data on the very products,” he stated.
“While we operate in a global supply chain it is important that as regulators we know that there is no acrimonious relationship between the regulators and manufacturers. We regulators are to regulate the manufacturers but still there must have opportunity for dialogue and communication and the exchange of information to insulate ourselves from the threat of substandard products,” he added.
Ansa Zenica is a manufacturing company with over 100 years of experience in the production of pharmaceuticals and boasts over 50000 staff globally with 30 manufacturing sites across 19 countries.
Cole explained that in the 2017 World Health Organisation (WHO) Report, it is stated that 10 percent of pharmaceuticals that are used in low and middle income countries are substandard or falsified with the market share of drugs and pharmaceuticals recorded between low and middle income countries to be US $300B.
“If you factor that 10 percent in then you would see that substandard drugs that are, we are exposed to in this part of the world is actually US $30B annually. I say that to say we in Guyana we are not immune or remote from such a threat and it is a clear and present danger for us.”
This means that every one in 10 drugs is substandard or falsified because of unavailability in accessing quality medication.
He noted that the Report suggested too that there is weakness in governance in those countries that would affect or cause the proliferation of substandard or falsified (drugs) in the market.
“We here in Guyana are currently looking at legislative review to ensure that when we issue a marketing authorization same as is done under the backdrop of solid regulatory oversight or we have a good regulatory framework to ensure that we insulate ourselves from such a threat,” he said.