THE Food and Drugs Authority (FDA) has taken delivery of two anti-counterfeiting medicine verification devices to assist its efforts to prevent the importation of counterfeit and substandard medicines into the country under the Canadian Government supported Government of Ghana Capacity Development Mechanism (CDM).
The Raman TruScan Handheld Spectrometer which can sample 5,000 medicines within an hour, rapidly investigates the components of medicines and also differentiates counterfeit medicines from the genuine ones.
The devices, valued at $160,000, would facilitate the authority’s work in the control of substandard, spurious, falsely labelled and falsified medicines (SSFFC) on the Ghanaian market.
Additionally, it can conduct raw material verification, chemical dispensing and secondary operations, as well as finished product inspection.
As handheld analysers, the devices were purposely designed to provide manufacturers with a portable solution to achieving quality production standards.
One of the devices will be detailed at the Tema Port, which is a major entry point for medicines and raw materials imported by the local manufacturing companies. A huge chunk of medicines passing through that port could, therefore, be tested to ensure they meet the required specifications.
WHO on counterfeit medicines
According to the Chief Executive Officer of the FDA, Mr Hudu Mogtari, the World Health Organisation (WHO) estimate that counterfeit medicines constituted up to 25 per cent of total medicine supply in less-developed countries.
In Africa and East Asia , the world body said a more detailed sampling had revealed that 30 and 60 percent of medicines were substandard. “The equipment would facilitate regulatory decisions on the importation of pharmaceutical raw materials and products”, Mr Mogtari told the Daily Graphic, when he handed over the equipment to the Drug Enforcement Unit of the FDA.
“With increasing regulatory pressures and the drive towards lean manufacturing, the FDA needs efficient ways to perform its tasks to ensure incoming raw material and medicines would not pose threats to public safety”, Mr Mogtari said.
Mr Mogtari was also optimistic that the equipment would serve the interest of the Ghanaian public by reducing the negative impact of SSFFC products.
How the spectrometer works
In seconds, the Raman Spectrometer delivers reliable analyses of raw materials and finished products at the point-of-need.
It is also able to analyse sealed packages to minimise contamination and exposure and offers other enhanced compliance features for regulated environments, thus decreasing sampling costs on products.
Source: Daily Graphic