Fake medicines kill almost 500,000 sub-Saharan Africans a year: UNODC report.
(Ref: From Africa Renewal: 1 February 2023. By: UN News Accessed on August 13, 2024)
In sub-Saharan Africa, an estimated 267,000 deaths annually are attributed to falsified and substandard antimalarial medicines, according to a transnational organized crime threat assessment. Additionally, up to 169,271 deaths are linked to the use of counterfeit and substandard antibiotics for treating severe pneumonia in children.
The trafficking of these products also imposes a significant economic burden on affected countries. The World Health Organization (WHO) estimates that the cost of treating individuals who have used counterfeit or substandard malaria medications in sub-Saharan Africa ranges from $12 million to $44.7 million annually.
Africa's counterfeit drug market is as intricate as its distribution networks and the individuals involved in operating them. The World Health Organization reports that one in every 10 medical products in low-income countries, including those in Africa, is either substandard or fake. Additionally, the organization noted that 42 percent of all counterfeit drugs reported between 2013 and 2017 originated in Africa.
As the situation intensifies, so do efforts to combat the effects of the illicit drug trade. Young Africans and startups across the continent are spearheading a wave of innovations, such as apps, barcoding technology, and scanners, designed to detect counterfeit drugs.
Motivated by personal encounters with fake medications and a desire to develop homegrown solutions to local challenges, these innovators are thriving amid a technology boom and an increasing pool of creative young talent on the continent.
Serialization has become a mandatory measure in many African countries, including South Africa, Nigeria, Rwanda and Zambia, to combat counterfeit medicines and enhance the security of the pharmaceutical supply chain. By creating a closed distribution system that tracks the movement of drugs, serialization plays a crucial role in saving lives. Under the guidance of the African Medicines Regulatory Harmonization (AMRH) and the New Partnership for Africa's Development (NEPAD), delegates from national and regional economic communities (RECs) spanning Africa have endorsed a Call to Action for the "Africa Strategy for Pharmaceutical Traceability." Through this endorsement, they have affirmed their dedication to implementing measures aimed at enhancing the accessibility of high-quality medicines, ensuring enhanced tracking of products throughout the supply chain, and facilitating improved patient care. Embracing established global standards for pharmaceutical traceability in supply chains is envisioned to advance these objectives by fostering stronger regional regulatory alignment and facilitating global and national interoperability among supply chains and associated information systems.
In South Africa, the government initiated the serialization process in December 2018, aiming for full implementation by June 30, 2022. The requirements mandate the use of a 2D DataMatrix code containing a GTIN, batch or lot number, expiration date, and serial number. These standards apply to both local manufacturers and importers of pharmaceutical products. The government introduced these requirements gradually to provide healthcare manufacturers with sufficient time to adapt.
In Zambia, the strategic plan for 2022-2026 has been devised by ZAMRA to enhance the effective and efficient execution of the Authority's regulatory functions both domestically and internationally. Additionally, Zambia Medicines Regulatory Authority (ZAMRA) has released a preliminary Guideline on Identification and Labelling of Medicines and Allied Substances as well as Master Data Sharing for public review and input. This guideline aims to outline the criteria by which the Authority will mandate product labelling in support of their forthcoming pharmaceutical traceability system aligned with GS1 standards. It marks a crucial progression towards establishing pharmaceutical traceability systems.
In March 2023, ZAMRA released a Guideline outlining the implementation of GS1 standards for traceability of medicines. Furthermore, alongside these guidelines, Zambia is actively establishing its master data platform, which will serve as the centralized repository for all product information within the country. This initiative is led by the Ministry of Health.
In Nigeria, NAFDAC is striving to attain comprehensive oversight of all products circulating within Nigeria's pharmaceutical supply chain. To realize this goal, it intends to establish and enforce regulations and guidelines. The agency anticipates that traceability will be fully operational throughout the Nigerian pharmaceutical supply chain by the conclusion of 2024.
The strategy adopted by NAFDAC (NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL) for implementing traceability aligns with the Nigeria National Traceability Strategy Policy document, which was issued by the Federal Ministry of Health in May 2020. Additionally, it corresponds with the "Africa Strategy for Pharmaceutical Traceability" initiative, endorsed by 25 African regulatory agencies and six health financing and donor organizations.
NAFDAC has formulated a five-year traceability implementation plan to enhance supply chain visibility and bolster its pharmacovigilance efforts against substandard and falsified medicines and medical devices by the end of 2024.
Compliance:
It is important for pharmaceutical companies to work closely with their supply chain partners and technology vendors to ensure that their serialization solutions comply with respective African country regulations and meet the required deadlines. Non-compliance with serialization requirements can result in penalties and delays in product registration and market access.
Reference:
https://originall.com/content-hub/article/3-figures-to-illustrate-the-urgency-to-fightthefakes-in-africa/
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe. We are well versed with the compliance regulations for various markets and can help you with implementing the respective African country’s pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
Disclaimer:
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
Please write to us on info@cosmotrace.com for more details.