Substandard, falsified pharmaceuticals a threat to Guyana, other developing countries

– Food & Drug Department partners with US-based leading company to counter threat

Guyana is not immune of the threat of substandard or falsified pharmaceuticals and in light of this, the Food and Drug Department is now partnering with a US-based leading pharmaceutical company, Ansa Zenica, to address the issue.

FDD Director Marlon Cole

Director of the FDD, Marlon Cole, at a drugs importers meeting on Tuesday, stated that such a collaboration is both timely and opportune relative to the threat that countries in the developing world, particularly low and middle-income countries, face in terms of the quality and safety of medicinal drugs and medical supplies being released for sale in the market.
He explained that in the 2017 World Health Organisation (WHO) report, it is stated that 10 per cent 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$300 billion.
“If you factor that 10 per cent in then you would see that substandard drugs that are, we are exposed to in this part of the world, is actually US$30 billion 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 one in every 10 drugs is substandard or falsified because of unavailability in accessing quality medication.
“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 authorisations, 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. Lastly, I must say that the report suggested that capacity-building or lack thereof in terms of technical capacity operative in middle and low-income countries contributed to the proliferation of substandard or falsified drugs in societies,” Cole further stated.
According to the FDD Director, with the collaboration between the Food and Drug Department and US company, Ansa Zenica, strides are expected to be made in securing the country from such a threat.
“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. 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 said that during this period amidst the backdrop of threats that are associated with substandard or falsified medication, the FDD is happy that Ansa Zeneca actually accepted the invitation whereby the FDD can be exposed to presentations on product security and this also has to do with substandard and falsified products, how you would detect them and capacity-building.
Cole added that the FDD can benefit tremendously from information shared by Ansa Zenica, a manufacturing company with over 100 years of experience in the production of pharmaceuticals.
Ansa Zenica boasts over 50,000 staff globally with 30 manufacturing sites across 19 countries. Also in attendance at the drug importers meeting were representatives from the Public Health Ministry and staff from various sections of the Georgetown Public Hospital Corporation and its pharmacy. (Kristen Macklingam)