Dr Margaret Ilomuanya is the acting dean of the Department of Pharmaceutics and Pharmaceutical Technology at the Faculty of Pharmacy, University of Lagos. She is the chief investigator in the collaboration between Population Council, New York; Jaiven Pharmaceuticals Consulting, New Jersey; and the University of Lagos—a project that resulted in the establishment of the General Manufacturing Practice (GMP) laboratory, housed in the Faculty of Pharmacy, University of Lagos. In this exclusive interview with Patrick Iwelunmor, she discusses the significance of the GMP laboratory and how academia can collaborate with industry to maximise the potential of local manufacturers in Nigeria. Excerpts:
Kindly tell us about the MED-AFRICA GMP laboratory. How did it come about?
The GMP laboratory came about as a result of collaboration between Population Council, New York, Jaiven Pharmaceuticals Consulting, New Jersey and the University of Lagos with me being the Principal Investigator. With the long-standing collaboration I have with Population Council, New York, I secured research funding from Jaiven Pharmaceuticals. They established the MED-AFRICA Foundation Fund, which financed the construction of the GMP laboratory. The GMP laboratory is designed to produce clinical trial batches for HIV prevention products.
What is the significance of academia-industry collaboration?
The bedrock of innovation lies in academia. If we can foster a cohesive academia-industry synergy, we can achieve translational research. This means that innovations developed in academic settings can be scaled up in facilities like the MED-AFRICA GMP laboratory. Once we demonstrate the feasibility of manufacturing on a pilot scale, we can scale up to larger productions, where big pharma can get involved. This pathway allows us to develop home-grown solutions, making university-developed products available for Nigerians.
Do you believe that maximizing local manufacturing could address challenges regarding access to quality medicines in Nigeria?
Local production might be expensive initially, but it will become more affordable as we reduce dependency on imports and manufacture everything locally. For example, currently, 99% of APIs used in Nigeria are imported. Imagine a Nigeria that manufactures its APIs and finished pharmaceutical products. This would lower overall product prices, increase availability, and ensure that locally produced medicines meet high regulatory standards, given the proximity of manufacturers and regulators.
With Nigeria’s abundant flora and fauna, why aren’t we producing our own APIs?
We can produce APIs, but the government needs to support manufacturers with the costs of machinery and power. Power is a primary challenge in local manufacturing. Without power issues, production would be more seamless.
Do you think the challenges you’ve identified pose a serious threat to producing our own APIs?
We shouldn’t let today’s challenges stop us from starting. The GMP facility at the University of Lagos is the first of its kind in Nigeria and the only one in West Africa housed in a university. We should begin and address challenges as they arise.
What major challenges do researchers in academia face?
Innovation in cutting-edge technology and pharmaceutical products requires funding for materials, equipment, infrastructure, personnel, and principal investigators. If the government is serious about innovation, it should fund our universities and educators at all levels. This would nurture capable, brilliant minds who can become innovators.
Where there is a funding gap, two things happen. The first is brain drain, where we have people taking knowledge outside. You can see how Nigerians are being innovative and making their marks everywhere around the globe. The second thing is that those who remain in the system would decide to work with foreign entities who fund their research; or they may choose to be redundant, giving the system just as much as what the system is giving to them. If we are serious about innovation, education has to be prioritised. If we want cutting-edge technology, our laboratories must be cutting-edge. If you come into our GMP laboratory and see cutting-edge research, it is because someone has funded a cutting-edge facility for us.
There are many research institutes in Nigeria, yet we still struggle with access to quality medicines. Why is that?
While some research institutes, like NIPRD, have products, we need to make these products more mainstream. The issue isn’t the number of research institutes but proper regulation and utilisation of their research. Collaboration with universities could improve outcomes.
Do you think NAFDAC is focusing more on revenue generation than its core regulatory role?
As an academic, I don’t have a specific perspective on this. While NAFDAC is aware of our GMP laboratory, we have yet to formally invite them as a regulator. We need more synergy to move forward, creating rules that cater to our needs, and the need of the Nigerian pharmaceutical industry right now is the provision of quality medicines at affordable prices. Anything that would hinder a company from providing good quality medicines at affordable prices should be looked into, to ensure the Nigerian populace get benefits.
Is NAFDAC meeting expectations as a regulator?
The issue often lies in balancing regulatory and business needs. As a government agency, NAFDAC operates within certain constraints. The current administration has taken steps, like waiving taxes on imported items, to reduce medicine costs. I hope similar issues within the pharma sector and NAFDAC will be addressed. NAFDAC is doing its best, and like everything, there’s room for improvement.
What motivates you in your pursuit of better outcomes for Nigeria’s pharmaceutical sector?
I graduated from the University of Lagos at a time when the laboratories were very good, when the classrooms were not crowded, and when the living accommodation was optimised and comparable to those of other universities around the world. My motivation stems from the desire to bring such facilities to the younger ones we are training.
It was the impact of the kind of training I had that is enabling me do the kind of research I am currently doing. During my PhD, I had the opportunity to work in the UK and the US, where such facilities abound and that also fuelled my motivation that if this can happen, then there must be something, no matter how little, I can do to replicate same in Nigeria.
What challenges did you encounter in realising the GMP laboratory project?
I faced challenges but focused on possibilities and the unexpected champions who supported my vision. Dwelling on challenges won’t get us anywhere, so I chose to focus on positive aspects and supporters.
How did you balance family commitments with your professional responsibilities, especially during travel for your fellowship?
My family has been my backbone, especially my husband, who is my biggest champion. He is the one that encourages me when I am faced with difficult situations. Without him being there to help out, it would have just been impossible to achieve some of these things. He runs his own company and when he needs to travel, I am available to take care of the home. Sometimes, when the need arises, we even travel together. It is more like a tag-team. We have found a way to make things work and I think it is all about understanding.
What are your most urgent needs to sustain the GMP laboratory?
We need collaboration with big pharma for contract manufacturing and clinical trials. We also require regulatory agency support to test for quality. We are open to collaborations at all levels of drug development.
Then, we can also look at collaboration with the regulatory agencies where they can give us some equipment that we can use to test. So, this point will be a point for testing for quality. We are open to collaboration at all levels of drug development.
What advice would you give the government to create an enabling environment for local manufacturers?
For local manufacturers to thrive, government must provide power. They must also provide security. Once these two are sorted out, every other thing will sort itself out.
