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The Medicine Quality Research Group focuses on substandard and falsified medicines, critical issues often overlooked in LMICs. Recent tragic incidents underscore the urgent need for better regulatory oversight. The group explores portable screening technologies to empower regulators in identifying and preventing such medicines, potentially mitigating widespread harm and economic strain on health systems.

My name is Céline Caillet, I am the Deputy Head of the Medicine Quality Research Group here in Oxford. My area of research is the quality of medicines.

The Medicine Quality Research Group is one of the only dedicated research groups globally to work exclusively on this topic. We work on substandard and falsified medicines. Substandard medicines are medicines that are produced by authorised manufacturers, and they can contain low or high active ingredient amounts or have dissolution problems. Falsified medicines on the other hand are medicines that are made by criminal intents, usually by criminal organisations, and they can contain no active ingredients, or wrong active ingredients. One very recent example is the heart-breaking outbreak of children below five dying because they consumed paediatric syrups containing very toxic ingredients, and hundreds of children died in The Gambia, in Indonesia and other countries in the last two years.

Let me give you a little bit of context. Medicines regulatory authorities like the MHRA in the UK, or NAVDAK in Nigeria are the safeguards of the quality of medicines in the supply chains. Currently very few regulatory authorities in low- and middle-income countries have laboratory capacity or devices like portable devices to check the quality of medicines. But there's a key activity and that is called post-market surveillance that the regulators need to do to safeguard the quality of their medicines in the market. In our group we work on portable screening technologies. There are many portable screening technologies available to test the quality of medicines, but these devices haven't been developed for this purpose, they've been developed for example to identify explosives on crime scenes, but they could potentially work for medicine quality. What we are doing is we are looking at the available evidence, the scientific evidence on the performance of these devices for medicine quality, and we gather this information together (because there is some information but not a lot) on a visualisation tool that we call a dashboard that is available as a guidance tool, for regulators to choose the right device for their purpose of post-market surveillance. We also work on testing some devices, existing devices that can be repurposed for testing the quality of medicines, including tablets, capsules but also more recently vaccines that we started during the pandemic, and even more recently the problem I mentioned with the kids dying because of these toxic ingredients.

There are many big questions, I would say challenges and many gaps of evidence in this field of research. First, we don't really understand what the problems are related to the quality of medicines, what are the issues, where are they. But regarding portable screening technologies, which are the main projects we're doing at the moment, there is also a lot of gaps of evidence. For example, we don't know if devices can accurately identify substandard medicines containing low amounts of active ingredients or high amounts of active ingredients, or we don't know if this device, there's very limited evidence that they can detect degradation. If medicines have been poorly stored or transported, they can degrade. So there is not a lot of evidence regarding devices for identifying those.

I believe that everybody should have access to quality medicines. Empowering regulatory authorities with portable screening technologies will not only allow them to timely identify and take action on potential occurrence of substandard or falsified medicines to prevent the medicines to reach the patient, but also it will do similar as speed limit control radars on the roads for cars, it will likely decrease the occurrence of substandard or falsified medicines.

I believe that no one should suffer the tragedy that happened to the kids dying because they used contaminated syrups. This is likely to be only the tip of the iceberg. Many cases will go unseen, especially in low- and middle-income countries, and substandard and falsified medicines will not only affect health but also the economic systems and the trust in health systems and in pharmaceutical systems. When antibiotics are affected, it will likely be a driver of antimicrobial resistance. By having portable devices, regulators will not only be able to do more routine activity of surveillance of their quality of medicines, but also, they will understand better what the problems are, where they are and find solutions to fight them.

This interview was recorded in July 2024

Céline Caillet

Dr Céline Caillet, Deputy Head of the Medicine Quality Research Group, NDM Centre for Global Health Research, University of Oxford, tells us about her research detecting substandard and falsified medical products.

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