Q&A: Local pharmaceutical production for quality medicines

By Devex Editor 

A nurse looks over a prescription in Nigeria. Photo by: SIM USA / CC BY-SA

BARCELONA — From factory to pharmacy, medicines often endure long journeys before reaching a patient. A lack of locally produced medicines means imports from places such as India, China, and the United States are necessary. Complex supply-chains with fluctuating storage conditions can lead to a deterioration in quality and heightened opportunity for the infiltration of falsified products.

In a lower-middle-income country such as Nigeria, the lack of quality medicines remains a big issue. “While the prevalence of falsified medicines has dropped, it still remains high. This is because the majority of falsified medicines are imported,” said Mazi Sam Ohuabunwa, president of the Pharmaceutical Society of Nigeria.

One solution could involve the local production of essential pharmaceutical products. Ohuabunwa explained that localizing the source of essential medicines in-country, or closer to the patient, affords a number of potential benefits.

“By a combination of a law, regulatory agency, and technology, we can begin to have a handle on falsified medicines.”— Mazi Sam Ohuabunwa, president, Pharmaceutical Society of Nigeria

For example, in-country manufacturers may be more responsive to a local population’s needs, limiting risks of stockouts, and the regulatory authority can have increased access to assess quality at the source. “It’s easy to monitor local manufacturers because they are regulated by the country’s National Agency for Food and Drug Administration and Control and the Pharmaceutical Council of Nigeria,” Ohuabunwa said.

There are still significant barriers preventing local manufacturers from taking on the manufacturing of essential medicines. Speaking to Devex, Ohuabunwa listed the challenges, explained how they can be overcome, and what the development community can be doing to eliminate medicines that hinder rather than help improve global health.

This conversation has been edited for length and clarity.

What are the barriers preventing local manufacturers from entering the pharmaceutical market?

The critical thing is that the cost of entry is quite high because of the cost of establishing and meeting current global standards — for example, theGood Manufacturing Practice requirements. It’s also not easy to get to Nigeria, it’s very expensive, and while we have been doing our best to improve Nigeria’s global image, investments from external sources are not easily forthcoming.

For local manufacturers considering expanding their scope and capacities so that they can produce more, there is also the high cost of doing business, a high level of infiltration of the market by falsified medicines, and high cost to fuel the plants and laboratories. Due to limited enforcement capacity, there are all kinds of opportunities for poor-quality medicines to infiltrate the market and cause difficulties for the expansion of local drug manufacturers who are ready to adopt international standards.

But the barriers are not insurmountable, they are being addressed. We are seeing that some local manufacturers are expanding despite the challenges and efforts are continually being made to invite more foreign direct investment into the pharma industry.

What encouragement and support do local manufacturers need to start producing more essential medicines?

The first thing is to improve the operating environment, make it more inviting and more attractive by introducing some incentives to help investment in that area. In some African countries like Ghana and Kenya, governments are going out of their way to adopt policies that will encourage and incentivize local manufacturing — for instance, reduced tariffs, corporate tax exemption, and encouraging foreign direct investments. A coherent multisectoral pharmaceutical strategy with top-level commitment from the government is critical.Get development’s most important headlines in your inbox every day.Subscribe

One important aspect is that major buyers of medicines, including governments, are willing to invest in and commit to procuring high-quality medicines from local producers. Today, less than 50% of essential medicines are produced locally, so sometimes government agencies have to buy drugs from abroad. A coherent policy framework will help level the playing field so that local manufacturers producing high-quality medicines can compete with global players.  

Thirdly, I think if we can get specialized, low-priced, long-term loans to industry funding — which is what the government is currently looking at with the banks — I believe that will also encourage local production.

Promoting quality medicines

The work of the “Promoting the Quality of Medicines” program — funded by USAID and implemented by USP — is a good example of how donors can help advance the pharmaceutical sector in Nigeria. Through PQM, Nigeria has enjoyed the full technical capacity of USP to support more than 15 companies to adopt GMP standards for the manufacture of quality-assured essential medicines. Dozens of Nigerian manufacturers have been trained in GMP and dossier submission according to international standards.

The USP/PQM program is a major partner in strengthening regulatory systems supporting NAFDAC to strengthen capacity for inspections, dossier review and evaluation, and post-marketing surveillance.

There are two ways the development community can also help. The first is to allocate a portion of their investments to building strong systems that promote long-term, sustainable access to quality medical products, which will endure long after donor funding ends.

For example, investments in strong regulatory systems contribute to the development of robust local pharmaceutical production. A strong regulator is essential to ensure that high-quality manufacturers flourish and the bad actors improve or are rooted out.

Additionally, donors can invest in local manufacturing, either directly through loans or technical assistance provision, or indirectly by procuring essential commodities from high-quality local manufacturers, where feasible.

I also believe that there’s a need for a global commitment to support information sharing, best practices sharing, and the development of global best practices in dealing with this learning from the developed to less-developed countries.

Most countries have passed through this phase of dealing with falsified medicines or falsified products and then got to where they have with better regulation and better control. The global development community can help by creating better opportunities for information sharing and capacity building for people from lower-middle-income countries like ours.

Do you have advice for others working to tackle falsified medicines in their countries? How can they too build local capacity?

The first thing is to make sure they have a law. I remember when we didn’t have a law in Nigeria on fake medicines and they were just treated like intellectual property infringement, which was a civil matter, until we got NAFDAC in 1992.

Then trading, manufacturing, or importing falsified medicines became a criminal offense, so I think every country that wants to deal with it must have a law that criminalizes falsified medicines.

You also need to have a very strong and active regulatory agency that can really ring fence the country, especially those countries in Africa with porous borders.

Finally, you need technology, which is one of the things that is helping Nigeria right now. Some technology can help us identify falsified medicines at the point of purchase or in the stores. By a combination of a law, regulatory agency, and technology, we can begin to have a handle on falsified medicines.

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