• Monday, May 27, 2024
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From N3.2bn debt, NAFDAC became solvent in one year – Moji Adeyeye, DG/CEO

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Moji Adeyeye has never faced any shortage of life’s challenges. Although from the south west, in 1971, she braved odds to head east of Nigeria, with the civil war still fresh in people’s memories, to study pharmacy at the University of Nigeria, Nsukka, graduating in 1976. She had her internship in 1977 at UCH.

In this exclusive interview with the BusinessDay team, led by Bashir Ibrahim Hassan, GM, Northern Operations, Adeyeye, who was appointed the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC) in 2017, explains how her experience as professor of pharmaceutics, manufacturing science, and drug product evaluation at the College of Pharmacy at Roosevelt University in Schaumburg, Illinois, prepared her with the right tools to grapple with the challenge of running NAFDAC.

What did you find when you assumed duties as NAFDAC boss? What was working and what was not?

When I got appointed, I never knew that things were bad—very, very bad. The only thing that was on at NAFDAC was the roof. I met a N3.2 billion debt, staff that were stunted in their careers, and also a divisive environment. I will call it a toxic environment; I was told that there was always one schism or the other. When I got here, there were three or four things that I needed to fix. One of them was the prevalence of substandard or falsified medicines. I had a friend who came home a few years earlier for Christmas, and their son almost died because they bought an antibiotic that wasn’t working. That I knew was a problem, but you cannot do anything without money. I met N3.2 billion in debt, and there was another N500 million they couldn’t account for. I couldn’t believe it. In the US, NAFDAC would have been designated as bankrupt, and a financial house would be managing the account, but we don’t even have money to hire a financial house. I decided to manage my account and pay the debt in one and a half years.

We started plugging holes. One of the major things we did was start Zoom meetings because a lot of money was being wasted on unnecessary travel. We started to zoom in March 2018—even before the pandemic. My staff didn’t like it then but embraced it later, more so during the pandemic. On my first international trip, I went to Thailand by myself. A group of our inspectors were also inspecting in Thailand. They were really surprised to see me alone. But I went alone because I couldn’t go with a team when we were in debt! So, there were a lot of challenges that I turned into opportunities.

What is your vision and plan for NAFDAC? And what have you been able to accomplish so far?

NAFDAC, a regulatory agency, had five strategic plans: governance, good leadership, and ensuring the mitigation of substandard, falsified, and counterfeit medicines. After seven years of absence, the agency faced challenges such as a photo of staff working at ports with umbrellas, a shortage of tramadol, and the Office of National Security Adviser (ONSA) finding tramadol residue. To address these issues, the agency started a quality management system and trained itself for a year and a half.

The agency became customer-focused and agency-minded, focusing on improving the overall quality of their operations. Despite ISO 9001 certification, the agency continues to train and become audit-conscious in preparation for the WHO global benchmarking tool (GBT). By March 2022, they had cleared all the indicators and satisfied the recommendations, demonstrating the agency’s commitment to improving its regulatory framework and ensuring its sustainability.

Everywhere, people are talking about the proliferation of fake drugs. How have you been able to deal with it, and what progress have we made?

The global problem of substandard or falsified medicines is a multifaceted issue, with Africa having a 25-30 percent prevalence. To reduce this, several measures have been implemented, including pre-shipment testing, which has been found to have loopholes and inadequate equipment. The WHO has signed agreements with laboratories and agents to ensure they have the right equipment and accreditation. Since March 2020, 140 products have been stopped due to daily reporting from laboratories.

The implementation of Good Distribution Practice (GDP) has also been initiated, starting with the legal framework and developing a regulation. NAFDAC, which is responsible for monitoring the quality of medicines, has been working on this since its inception 25 years ago. The Pharmacy Council of Nigeria (PCN) has been working on professional practice and monitoring the quality of medicines.

The GDP inspection was delayed due to the pandemic, but the organisation has inspected almost 1000 distribution sites, categorising them as low-risk, medium-risk, and high-risk. Regular visits are made to ensure corrections are made for high-risk sites, while annual visits are made for low-risk patients.

Do we have the capacity to test the standards of these drugs?

When I got in, there was little or nothing in the lab. There’s what we call high-performance liquid chromatography; we had only one and a half in the lab. And we have thousands of products to test. Now we have 17 pieces of that equipment. If you cannot manage your finances, there’s no way you can equip the lab, there’s no way you can equip ICT, and there is no way you can equip vehicular transportation. So, we started saving money and putting money into equipment or needed tools. When you talk of testing, that is part of the mitigation of substandard or falsified medicines, but if you don’t have the equipment, what do you test? So many products were being approved without testing in this country because there was no equipment.

How risky is this?

It is life-threatening, not risky. Two weeks into my tenure here, I went to our food lab in Oshodi, Lagos, and I was stone-shocked at the lab. That was when I knew our work was cut out for us. So, we started saving money. It is tedious because the approval of a memo, which should take five to 10 minutes ordinarily, may take one hour because I will inquire about the importance of the approval. I don’t want people to cook numbers for me. That is another approach to mitigating substandard or falsified medicines: saving money to buy needed laboratory equipment. For the Central Drug Control Lab (CDCL) in Yaba and the Food Lab in Oshodi, we have bought billions of naira worth of equipment; the labs are functioning very well! In fact, the CDCL Lab in Yaba got the enviable WHO Prequalification Certification in September 2023. Only a few regulatory agencies in Africa have this certification. Our citizens can rest assured that products coming from our laboratories are well tested for quality and safety.

The Nigerian pharmaceutical industry is facing challenges due to the lack of a strong regulatory system for quality medicine. The “five plus five” directive, which requires companies to provide an architectural blueprint to ensure flow and prevent contamination, has led to a 12 percent increase in new companies and a significant decrease in companies making substandard or falsified medicines. The directive also allows companies to shut down companies producing bad medicine within two hours, a significant step towards mitigating the issue.

To combat substandard medicines, the Pharmacy Council of Nigeria (PCN) is collaborating with the government to close open drug markets and relocate marketers to coordinated wholesale centres. However, the PCN has faced court challenges in cases involving former Governor Abdullahi Ganduje and the Pharmacy Council of Nigeria. Justice Simon Amobeda ordered the relocation, locking up 487 shops and closing over 1,300. The court dismissed cases in March, citing the devastation of drugs on young people’s lives.

Over 70 percent of our drugs are imported, while 100 percent of our vaccines are also imported. What is NAFDAC doing to change the narrative?

The manufacturing of vaccines is already at our doorstep because NAFDAC has reached maturity level 3. Without maturity level 3, no country can produce vaccines. We have been in Level 3 since 2022, and we are going to Level 4. It is a lot of work, but we are already working. We had to meet up with over 800 recommendations to get to level 3, or about 276 indicators. When I got here, we were at -1. Now we are going to 4 for both medicines and vaccines. There’s lots of work, but we’ll get there.

No country can manufacture vaccines without reaching maturity level 3. Why is this so important?

You must have a good regulatory system, a good clinical trial system, a good regulatory inspection system, and a good laboratory testing system. NAFDAC is the only agency that has an in-house laboratory in sub-Saharan Africa for vaccines and biologics; one or two regulatory agencies have theirs contracted out. We are the only one in Sub-Saharan Africa that has in-house vaccine biologics.

How can Nigerians help the work you do to protect all of us?

First, they must know the nature of the regulatory agency. For our funding, again, we are not alone. What do other regulatory agencies do? They get funding from the government. There are what are called user fees; these are fees that are paid for inspection, laboratory testing, pharmacovigilance, and post-marketing surveillance. It is deliberately designated for that. Those user fees are supposed to be untouchable; we have not realised this fact as a country! What I’m craving the most is more staff and recognition of what our staff does. We work around the clock, faced with hazards every day. I have two policemen living in my house 24/7 in Lagos and Abuja. I have five policemen and three drivers in a convoy. I don’t have a normal life. I cannot go anywhere and just be myself. That is the nature of our job.

Our pay is ridiculously poor, and it is not just NAFDAC; it is many of the regulatory agencies in Sub-Saharan Africa. I cannot tell you what I get; you will be shocked. Another fact is the hazards that come with our work. One of our staff was attacked many years ago, and she has scars on her body. Some staff went for inspection, and they attacked her. Some staff get death threats, just to be sure that our people get the right medicines for the populace.

What are you doing about people taking drugs without a prescription?

The Ministry of Health and the Medical Association must have a prescription policy and enforce it to change the narrative. There must be enforcement. I was volunteering at the University of Florida when I first went to the US in the early 1980s. I volunteered 24 hours a week, and I couldn’t take one paracetamol tablet without a prescription, and I was part of the workforce.

What are you doing about those hawking medicines on the streets?

Those involved got violent against NAFDAC operatives one month ago, but we cannot stop. We will join hands with PCN to combat the menace. There is going to be a point when there will be no hawkers at all. My brother, who lives in Ijesa, Lagos, died about two and a half years ago from kidney failure. About a year before he died, he called me and said he had malaria and couldn’t walk when he took medicines. I thought he had a stroke, but no. I asked him what medicine he bought, and he mentioned one of the falsified drugs that we were running after; that was what he bought on the street.

So, we are going to curtail this through sensitization, sensitization, and sensitization! In our first year, we didn’t have money for publicity, and I couldn’t borrow money for that. But once we got out of our debt, we started doing “NAFDAC and Your Health,” a twice-a-week programme on television (TVC and NTA).

Sachet water producers are complaining about licensing pack size. How do you support those small businesses as they grow?

We have about 35,000 MSME products, and we support MSMEs a lot, giving one palliative or the other. But pack size extension is an issue. It is the same registration; nothing has changed. It is just the pack size. But if the material that is used to increase that size is not the same, we will have to assess it. But if it’s just size, we use a risk-based approach to expedite the process.

What type of NAFDAC would you like to leave behind?

I want to see a NAFDAC in 10 years with three times the current staff strength and better emoluments—a NAFDAC that is so technologically driven. The interaction between man and man will be reduced, and corruption will be reduced. But digitization should also mean quality. You cannot digitise them unless they are of high quality. When a company submits an approval today at registration, the directorate that will do a good manufacturing practice inspection in a few months already knows from day one. I want to see a NAFDAC that has no silo mentality. I instituted focus groups to foster team efforts for problem solving. I modified the focus groups to become coordinating directorships to align with global benchmarking auditing functions such as market authorization and market control. That is NAFDAC, which will be more transparent and results-driven, where quality product approval will be faster.

Are you satisfied with the success of NAFDAC under your leadership?

So far, so good, but we are not there yet.