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In this exclusive interview, Dr. Paul B. Orhii, Director-General, National Agency for Food and Drug Administration and Control (NAFDAC), discusses with Jide Akintunde, Director, Nigeria Development and Finance Forum, the surveillance of the food industry and the reform that has raised the institutional profile of NAFDAC.          

Jide Akintunde: NAFDAC has recently intensified its activities on safeguarding the public from consumption or use of unregistered food, drug and medical products. Are these activities routine in nature or they have arisen from concerns over breaches in the control and administration of food and drug in the country?

Paul B. Orhi: It is both routine and as a result of our increased efforts to safeguard public health. I say it is routine because we routinely want to make sure that products that are in circulation meet the required standards for consumers at all times.
    
Recently, we created what we call the Post-marketing Surveillance Directorate. We reasoned that when you require people to come and register products – of course they know we are going to test these products before we register them – they will bring the best samples that meet the requirements. But what we really want to find out is that the consumers are getting the right products. So the easiest way to do this is to go to the market, buy the same products that the consumers are also buying, and test them. Sometimes even good products that were registered, due to poor storage, might deteriorate and no longer meet the standard. That is why we have increased our surveillance.

You also know that the Nigerian market has increased in size. When NAFDAC was created in 1993, there were fewer food products that were available. For example, most people used to cook and eat at home. But now you see fast-food restaurants everywhere; much of the corporate community do not have time to eat at home. So we want to make sure the food that is sold in those places is of good quality and wholesome. Also, because of the influx of processed foods into our market, we have stepped up our surveillance activities.

JA: There have been recent media reports of a number of deaths arising from consumption of locally brewed gin; but other than that, it would appear that there is an appreciable level of public protection from consumption of harmful products. What assurance would you like to give the public with regard to the effectiveness of the statutory functions of NAFDAC?

PBO: You are right. Ogogoro, or the different names that it is called, has been around in Nigeria as a locally brewed gin for a long time. But recently, it became the centre of attention because of the deaths that it caused in Ondo State and Rivers State. At about the same time, we also heard that a local gin caused the deaths of some 100 people in India. So it means there is something happening in that industry that has changed the quality of the product.

Ogogoro can be brewed from so many different raw materials, including cassava, banana and sugar cane; but we don't know which of the products is causing these deaths. However, we have established that methanol intoxication is what caused these deaths. The samples that we tested from the two states showed there were high levels of methanol in the drinks.

When you ferment these products, it could go through two pathways: one could go to production of ethanol, and another could go to methanol. Maybe depending on the process, you are having more methanol being produced. In the meantime, we have decided to go to the locations and stop the production of the locally brewed gin, temporarily. Then we will inform those who want to produce it that they must apply for NAFDAC's approval. Once that is done, it triggers the review of their production processes. Before, we did not regulate it because there was no problem, even though locally brewed gin is usually intoxicating and addictive.

We have decided to take a holistic look at the alcohol industry. There is something that is popularly known as alcohol fraud. When you want to import absolute alcohol – that is, full-grade alcohol – they say the import duty is as high as 20 per cent. But if you bring denatured alcohol, then the duty is as low as 5 per cent. Normally, you denature alcohol by adding, sometimes, methanol to make it unfit for human consumption. People who want to import full-grade alcohol sometimes denature it and then when they clear it through customs, they try to purify it to absolute alcohol. In most cases, they are never entirely successful. Sometimes when the use a chemical like Bitrex, its traces are left in the alcohol even after purifying it. We are looking into all of that.

We are going to visit beverage manufacturing companies to find out their sources of alcohol, how they cleared it in, whether they imported it as denatured or absolute alcohol and we are going to regulate that too. All this should give the public the assurance that we are going to safeguard their health and only good quality beverages are going to be available for public consumption.

JA: NAFDAC has undertaken certain reforms within the institution. What is the dimension and purpose of the reforms, and how effective have they proved to be?

PBO: Institutional reforms have been on since I came to NAFDAC. When I came here, the infrastructure was not that great. So I started massive infrastructural development, building of new laboratories, refurbishing and upgrading laboratories, getting laboratory accreditation, and so on. Two of our laboratories – one in Oshodi and the other in Yaba – have international accreditation.

Apart from infrastructure development, we embarked on massive training of staff to meet international standards. Now, NAFDAC staff can stand shoulder-to-shoulder with counterparts anywhere in the world. In fact, we have NAFDAC staff jointly working with WHO (World Health Organization) inspectors to conduct inspections on factories in different countries all over the world.

We also looked at some of the activities of the agency. For example, food takes about 30 percent of NAFDAC'S entire regulatory activities. Water alone is, at the minimum, a N10 billion-per-day business. As we wake up this morning, by the time we go to bed at night, Nigerians would have consumed water worth more than N10 billion. And then you look at alcoholic and non-alcoholic beverages; all these are under the food industry. We regulate products that constitute more than one-third of the Nigerian economy. And yet food did not have a directorate of its own.

So one of the reforms we did was to create five new directorates. One was Food Safety and Applied Nutrition Directorate to focus on food issues. I was in Geneva at a meeting of the Codex (Codex Alimentarius Commission), which decides the global standards of food. For two days, the meeting was dedicated to talking about the use of ractopamine in feeding cows. Some of the western countries were saying that meat from animals fed with ractopamine – which makes the animals grow fast – is dangerous and so should not be consumed by humans. But the Americans were saying “No, we use this; we have tested it and the meat is safe.” See how complicated these issues can be. Here in Nigeria, we may have thought that was not a big problem. So when I saw how cow feeds can be so serious a business, we came back and said we need a veterinary directorate to monitor the drugs that are used to treat these animals, and the feeds that go into them.

And then I told you about post-marketing surveillance. Even good drugs do have side effects. Most of these drugs are manufactured in different countries under different climatic conditions and some of the people there have different genetic compositions. A drug can induce a robust immune system in the West where the people do not have some other factors that might compromise their immunities. But that same drug may not produce such a robust immune response here. So we have to look at how the drugs act in our own environment.

We ensure that before we approve a drug, clinical trials are done in a professional environment. But that is on a small scale. When you begin to administer these drugs on a large scale, what are you seeing? We still have to monitor the drugs after we have approved them to see what effects they have on the population. That is why we created a Pharmacovigilance and Post-marketing Surveillance Directorate – a full directorate that monitors what happens to a drug after it has been approved to be used on a large scale and also to monitor the quality of other products that are in circulation, whether or not they are meeting the standards that were approved. I believe these reforms have significantly impacted on our activities in the agency and on the Nigerian population at large.  

JA: It is globally established that there is usually resistance to implementation of institutional and market reform. What has been the experience within NAFDAC in this regard?

PBO: Niccolo Machiavelli once said somebody who embarks on reforms is embarking on a very difficult task. You have very strong opposition from people who are benefiting from the system, and sometimes, the strongest opposition is from within the agency.  

You must have heard of the publications in the newspapers accusing me of all sorts of things because of the reforms that I have embarked on. Before I came to office, NAFDAC was generating N2.5 billion annually. We increased it to N6 billion, and then to N7 billion. Now we are targeting N9 billion, as opposed to the false report that we were generating N9 billion already. I significantly plugged the holes and raised the internally generating revenue (IGR) profile of the agency. But the money is not sitting there in the bank. The paradox is that people forget that to generate this money, you have to spend a lot more money. If we want to approve more companies, we have to send more people to go for inspections. We have to do more laboratory analysis and buy more equipment for laboratory analysis. You raise the IGR profile, but you spend so much to increase the IGR generation.

We are generating the IGR because we want to build the infrastructure and develop the laboratories to be competitive at the global level. We have been able to make NAFDAC one of the top 20 medicine regulatory agencies in the world. We sit on the same table with the U.S. Food and Drug Administration. On the African continent, we were the only agency until now that South Africa has joined us.     

The stakeholders are seeing the impact of the reforms. For example, the mobile authentication service (MAS) we introduced has helped companies to redress losses of market share and market integrity as a result of faking of their products. Sometimes, pharmaceutical companies lose up to 40% of their market share to product faking. Although some of the companies had initially resisted the authentication technology we introduced, today they voluntarily submit their products for authentication. We brought the technology to Nigerians at no cost to the taxpayer. The businesses are using less than 5 percent of what they have regained to pay for the technology. Now it has become more difficult to fake antimalarial drugs. We are waiting to have the antibiotics MAS implemented by the end of July. The two categories of drugs are the most faked in Nigeria.

We also got the pharmaceutical industry to reform. When we told them we could start manufacturing medicines in Nigeria that have approved international standards, they didn't believe it. Somebody wrote in America that I am a day-dreamer. But Eleanor Roosevelt once said “the future belongs to people who believe in the beauty of their dreams.” Today, we are a living testimony to that. Four Nigerian companies have gained WHO approval to market their products globally.

We are proud to say that when we go to the WHO procurement centre in Copenhagen, Nigeria stands out. The WHO held a session to welcome Nigeria into the league of countries that manufacture products that have international acceptance.

When we started the United Nations Commission on Life-Saving Commodities for Women's and Children's Health, it was noted that there were high maternal and neonatal deaths in Africa. Nigeria's indices were very disturbing. The Commission identified 13 commodities for the 50 countries that participated. It was said if we could produce these commodities and teach midwives their appropriate usage, we would drastically reduce deaths in children and in mothers. At that time (in 2012), Nigeria was not producing any of these commodities. Out of the 50 countries, only Nepal was manufacturing chlorhexidine used for management of umbilical cord. (Infections to umbilical cords is one of the causes of neonatal deaths.) Within three years, Nigeria now manufactures chlorhexidine as well as some of the life-saving commodities for women and children; we also export them.

When we said we could manufacture Amoxicillin dispersible tablets – one of the best drugs for management of pneumonia in children, which is the cause of about 17 percent of deaths among children – people laughed at us. Today, we have two companies manufacturing this product.

In the management of postpartum hemorrhage – bleeding during labour (including after the baby has come out) – if you cannot stop the bleeding, it can lead to death. Oxytocin is used to help contract the uterus and stop the bleeding. But because oxytocin is unstable, it can disintegrate with heat. So we now use a tablet called misoprostol. We have started to manufacture misoprostol tablets in Nigeria. Very shortly, we should be able to decrease maternal and neonatal deaths.

JA: It is interesting to note that NAFDAC has instituted a framework for clinical trial in the country. What capabilities do we currently have for this and what additional capabilities do you want the country to have in clinical trial, and perhaps more generally, interfacing R&D with the market?

PBO: NAFDAC is the agency that is charged with the responsibility of regulating clinical trials in Nigeria. I just came back from a meeting on nanomedicine and target medicine in Basel, Switzerland, where they are talking about personalized medicine. We believe that medicine should be tailored to the individual. This would ensure you have the maximal treatment effects of that medicine with minimal side effects.
    
We have not reached there yet, but we want to insist that medicines that are sold in Nigeria should be tested on Nigerian population so that we can know what to expect from these drugs before people take them on a large scale.

Other benefits from clinical trials can be in research and development. Our universities, students and professors can begin to research into new molecules for management of different conditions and develop drugs that suit our environment.

We are partnering with the Association of Good Clinical Practice in Nigeria. Clinical trials can bring Nigeria more money than most other investments. Pharmaceutical companies spend a lot of money in any country where they are doing clinical trials and we want that to be spent in Nigeria, apart from making medicines that are suitably tailored for Nigerians. The aim is to make Nigeria the choice destination for good clinical trials on the African continent and we hope it would be realized soon.

JA: You have done your work at NAFDAC without strutting for personal media limelight. Would you like to shed some light on your professional profile and your leadership philosophy?

PBO: I was born in a village called Lesel in Oshongo Local Government Area of Benue State. I went to St. Frances College, Otukpo, and had a brief stint at the University of Jos. I was fortunate to win a highly competitive scholarship and was chosen as one of the 23 candidates out of 168,000 applicants to go and study medicine in Russia. That was in 1982. I graduated in 1989 with a distinction and was immediately offered an opportunity – the first foreigner to be offered such opportunity— to do a 5-year PhD programme at the Stavropol State Medical University. I finished two years ahead of schedule. While I was in medical school, I was already a research scientist and had publications. So it was easy for me to put everything together and defend my thesis.

I came back to Nigeria to do my NYSC at the University of Jos, teaching pharmacology to medical students. I was to stay back and work in Nigeria but the school was closed down for one year.

When I was leaving Russia, about six countries had offered me chances to continue my research work, including Japan, U.S., France and Australia. My topic of research was a hot topic at that time. I was trying to look for a new pill to induce more natural sleep. We found something that seemed to have the potential in pineal melatonin. But I refused the offers because I wanted to come back home. But when schools in Nigeria were closed for one year, I called the U.S. and told them I was available. They told me to come. So I packed my luggage and left for the University of Texas Health Science Center in San Antonio, Texas. I worked there as a Biomedical Scientist, first on that melatonin research and then when women health issues became very prominent in the States, I changed my research interest to postmenopausal osteoporosis. Osteoporotic bone loss was causing fractures in women. I did that for some time and then went on to do work on Fetal Alcohol Syndrome. Then I did work on prostate cancer. I thought that by changing the genes of a human being, you could prevent them from having prostate cancer. We were successful in manipulating the genes in a mouse that does not have prostate hyperplasia to induce prostate cancer in them. We thought if we could identify that gene and enhance it in humans, we could prevent them from having prostate cancer.

My father had told me to become a lawyer. But my uncle, who later became Chief Justice of Nigeria, told me to study medicine. But my interest in law never went away. So when I watched the O.J. Simpson's case, I became interested. The lawyers were trying to communicate with the medical experts, but they could not understand each other. The lawyers did not know the relevant questions to ask the medical experts. The medical experts did not know what was relevant in law. It was like the blind trying to communicate with the deaf. I watched this whole drama and I got up and told my wife I was going back to study law.
 
I resigned my job, moved to Houston, got admission into Thurgood Marshall School of Law and studied law full time. I graduated in 2006, got called to Texas Bar. I was practicing in Texas when I was offered this job. Within three years of my arrival here, I was given a national honour – Officer of the Order of the Niger (OON) – because of the innovations we have been able to bring here.

Before I came to NAFDAC, people were predicting a downfall because my predecessor had performed very well. I promised I would not only sustain her achievements but I will also build on that foundation; and we are here today. I think if she were alive, she would be proud of what NAFDAC has become.

JA: What is your outlook for Nigeria in terms of investment and growth in the food and drug sector of the economy?

PBO: I believe the biggest potential for Nigeria lies not in the oil sector. I believe it lies in the agricultural sector. Maybe because I come from a state that is considered the food basket of the nation. When I go to Benue State, I see money on the ground. Nigeria should not only be self-sufficient in feeding its own people but should be a major exporter of food products. That is where the future of this country lies.   

If you see the wisest investor in the Nigerian economy, that is, Aliko Dangote, his main investments are in the food sector. That is why at NAFDAC, we have a policy of promoting that industry. We now have at NAFDAC, a small business support desk at the Registration and Regulatory Affairs Directorate in Lagos for people who want to manufacture value-added agricultural products.

We are working with Bank of Industry and the Nigeria Customs Service. We tell anybody who wants to export value-added agricultural products, “bring it to NAFDAC, we will do a free analysis for you. Tell us which country you want to export to, then we will check the quality that is required in that country and advise you on how to meet that quality so that your product is not rejected.” Still many people bypass us and try to carry their products to the U.S. and Europe and sometimes they are rejected at the ports of entry because they do not meet the quality. It may just be labelling.

We believe that food processing can play a significant role in the Nigerian economy; give good quality jobs, provide food and exports to other countries.