Where do substandard and falsified drugs originate from?

By Your Health Magazine

Your Health Magazine

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Where do substandard and falsified drugs originate from?

Substandard and falsified drugs pose a significant global public health threat, jeopardizing patient safety and undermining the efficacy of healthcare systems. The origins of these substandard and falsified drugs are complex and multifaceted, stemming from various factors including inadequate regulatory oversight, weak supply chain management, economic motives, and the globalization of pharmaceutical production.

Inadequate Regulatory Oversight

One primary factor contributing to the proliferation of substandard and falsified drugs is the lack of effective regulatory oversight in certain regions. In many low- and middle-income countries, regulatory agencies may face challenges such as:

• Insufficient resources
• Limited technical expertise
• Inadequate infrastructure.

These factors impede their ability to effectively monitor and enforce quality standards in the pharmaceutical industry. Consequently, manufacturers may produce substandard or falsified drugs without fear of detection or significant consequences.

Weak Supply Chain Management

Weaknesses in the global pharmaceutical supply chain also play a crucial role in the origin of substandard and falsified drugs. The supply chain for pharmaceuticals is intricate and often involves multiple intermediaries, making it susceptible to various vulnerabilities. From the manufacturing of active pharmaceutical ingredients (APIs) to the distribution of finished products, each step offers opportunities for substandard or falsified drugs to enter the market. Counterfeiters may introduce substandard ingredients, engage in fraudulent labeling, or divert genuine products to illicit channels within the supply chain, compromising the integrity of the entire process.

Economic Motives

Economic motives are another driving force behind the production and distribution of substandard and falsified drugs. Counterfeiters are driven by the prospect of significant profits with minimal investment. The production of fake drugs is often less expensive than adhering to quality standards and regulatory requirements. Moreover, the low risk of legal repercussions in regions with lax enforcement further incentivizes criminal enterprises to engage in the production and distribution of substandard or falsified pharmaceuticals. As a result, consumers in these regions become unwitting victims of products that may be ineffective, unsafe, or even life-threatening.

Globalization of Pharmaceutical Production

The globalization of pharmaceutical production has further complicated the issue of substandard and falsified drugs. As the pharmaceutical industry becomes increasingly interconnected on a global scale, with manufacturing facilities, suppliers, and distributors spanning multiple countries, oversight becomes more challenging. The reliance on a global supply chain exposes vulnerabilities, making it easier for substandard or falsified products to infiltrate the market. Additionally, the complexity of supply chain logistics increases the difficulty of tracking and verifying the authenticity of pharmaceuticals throughout the entire production and distribution process.

Bureaucratic Influences

 Bureaucratic organizations within the healthcare system and regulatory agencies have also contributed to the persistence of substandard and falsified drugs. In some cases, political influences over policy decisions allow substandard products to evade scrutiny. This compromises the very institutions responsible for upholding the quality and safety of pharmaceuticals, exacerbating the problem and eroding public trust in the healthcare system.

Real-Time Intelligence

Obtaining real-time intelligence that directs remedial action is an essential component of strategies designed to discover and remove SF drugs from the supply chain. Robust solutions must incorporate the testing of products to determine their quality and safety. The targeted introduction of chemical analysis where these medicines are located in the supply chain – hospitals, pharmacies, warehouses, manufacturer inventories, and the like – provides actionable information for stakeholders to:

• Issue alerts
• Sequester questionable products for further testing
• Replace suspect shipments
• Purchase alternative medicines
• Monitor patient status, among other interventions.

ARTiFACTS Verify Platform

The ARTiFACTS Verify platform offers an integrated approach to identifying substandard and falsified drugs that have entered the pharmaceutical supply chain:

• Identification of suspect medicines through on-site testing at any point in the supply chain using paper analytical device technology that is cost-effective and requires minimal training. 
• Confirmation of the properties of medicines failing the initial test through further testing at specialist labs, using advanced scientifically recognized techniques, including high-performance liquid chromatography, mass spectroscopy, among others.
• Organisation of all data captured for managing workflows, analysing and reporting results.
• Coverage of over half of WHO’s 600 Essential Medicines.

Enhanced data security by recording results on a purpose-built blockchain provides an immutable record of test results, including active pharmaceutical ingredients, product origin, manufacturer and other data essential for effective intervention.

Conclusion

Addressing the issue of substandard and falsified drugs requires a comprehensive and collaborative approach. Strengthening regulatory frameworks, enhancing surveillance and enforcement capabilities, and promoting international cooperation are essential steps in combating this global challenge. Additionally, improving transparency within the pharmaceutical supply chain, investing in technology to trace and authenticate products, and raising awareness among healthcare professionals and consumers are crucial components of a multifaceted strategy to ensure the production and distribution of safe and effective medications. By tackling the root causes and implementing robust solutions, the international community can work towards safeguarding public health and mitigating the risks associated with substandard and falsified drugs.