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FDA introduces guidelines to secure pharmaceutical supply chain in Ghana

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The Food and Drugs Authority (FDA) has launched guidelines on pharmaceutical traceability to secure medicines supply chain of the country.

The track and trace system for medical products enables one to identify any item’s current and past locations in the supply chain.

The system allows for visibility and data on medical products intended for the Ghanaian market by authorized manufacturers, easily track product suspected to be defective along the supply chain, facilitate effective recall of non-conforming products from the market.

It also helps identify legitimate medical products in the supply chain, and gather reliable data to inform policy formulation on medical products

Mrs Mimi Delese Darko, the Chief Executive Officer of the FDA, speaking at a two- day stakeholder meeting to provide input into the draft guidelines developed by the FDA said this was in line with the National Pharmaceutical Traceability strategy.

The National Pharmaceutical Traceability Strategy (PTS) is a global standard document to track and trace the originality and source of all medicines and consumables.

The FDA CEO said the guidelines would therefore help in the effective implementation of the PTS as there were availability of Substandard and Falsified (SF) medical products on the Ghanaian market, which endangers the health of the public.

She said the FDA in the past years had expended a lot of resources in combating SF medical products in Ghana.

“Despite these efforts, the war on SF medical products is far from over since the production and trafficking of SF medical products is a multimillion-dollar business. The lure of huge profits from this venture has enabled all manner of unscrupulous persons into this business,” she stated.

Mrs Darko said there was no doubt the implementation of traceability of medical products would enable the FDA to rid the country off or minimise incidence of SF medical products on the Ghanaian market.

She said the FDA Ghana was currently listed as a World Health Organization (WHO) “Maturity Level 3” Regulatory Agency, one of the few countries in the WHO African Region to attain this level in the four-tier WHO classification of National Medicines Regulatory Systems.

“As part of the sub-indicators for Market Surveillance and Control function to attain maturity level 4, it is required for National Regulatory Authorities to have legal provisions and regulations that place a unique identification code on the outer packages of medical products.

“The implementation of the pharmaceutical traceability guidelines will enable the FDA to meet these requirements through serialization of the product packaging,” She noted.
Mrs Darko said this would serve as a unique identifier for each single package of the medical product.

The CEO while expressing gratitude to the WHO and the United States Pharmacopoeia (USP) for the support called on stakeholders to support efforts towards the implementation of track and trace in the country to surmount the challenges posed by SF medical products.

Mr Festus Korang, the Coordinator of the Pharmaceutical Traceability Secretariat at the Ministry of Health, in his presentation gave highlights on the progress made so far in the development of the strategy.

He urged stakeholders to accept the guidelines to help rid the market of SF Medical products, which costs the country huge sums of money.

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