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"Availability of substandard, falsified medical products on markets endanger lives of public" - FDA

Chief Executive Officer (CEO), Food and Drugs Authority (FDA), Dr. Delese Mimi A. A. Darko has hinted that the availability of Substandard and Falsified (SF) medical products on the Ghanaian market endangers the health of the general public.


The CEO made these known while speaking at a stakeholder engagement on draft pharmaceutical traceability guidelines in Accra on Wednesday.


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


Dr. Darko stressed that 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.


She also mentioned that the lure of huge profits from this venture has enabled all manner of unscrupulous persons into this business.


"No doubt the implementation of traceability of medical products will enable the FDA rid  the country off /  minimise incidence of SF medical products Ghanaian market"


"I am very delighted at our collective efforts to ensure quality, safe and efficacious medical products are available to the Ghanaian public. Track and trace system for medical products enable one to identify any item’s current and past locations in the supply chain"


She hinted that track and trace system for medical products will enable the FDA have 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, identify legitimate medical products in the supply chain and gather reliable data to inform policy formulation on medical products"


Dr. Darko explained that the FDA Ghana is currently listed as a 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, she noted, will enable the FDA to meet these requirements through serialization of the product packaging.


"These codes will serve as a unique identifier for each single package of the medical product"


"The FDA Ghana is grateful for the support provided by the United States Pharmacopoeia (USP) Ghana through the Promoting the Quality of Medicines Plus (PQM+) program in drafting this guideline"


"We will also want to show our appreciation to the WHO for sponsoring this stakeholder engagement. To surmount the challenges posed by SF medical products, I wish to appeal to all stakeholders present to support the efforts towards the implementation of track and trace in Ghana to help us rid the market of SF Medical products"


The CEO showed her appreciation to the Minister of Health, Kwaku Agyemang-Manu for the leadership and support he has provided in FDA's journey to implement pharmaceutical track and trace  in Ghana.


Present at the event were; The Directors of Ministry of Health, Members of the National Technical Working Group on Pharmaceutical Traceability, Representatives of the Pharmacy Council, Pharmaceutical Society of Ghana, The Chamber of Pharmacy, Pharmaceuticals Manufacturers Association of Ghana (PMAG), Pharmaceutical Importers and Wholesalers Association (PIWA), Representatives of the WHO and USP Ghana, Chemonics.


Story by: Joshua Kwabena Smith

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