By Sola Ogundipe
The war against fake and counterfeit medicines is one that the National Agency For Food & Drug Administration and Control, NAFDAC, has fought for several years. Counterfeit medicines were first discovered in Nigeria in 1968 but the situation progressively worsened.

By 2001, more than 40 percent of medicines in circulation nationwide were fake. Evaluations showed that by 2005, the incidence of counterfeit medicines dropped to 15.7 percent only to rise to an unprecedented 64 percent in 2008. This was the picture in January 2009 when Dr Paul Orhii took over the mantle of leadership as Director General of the Agency. Even then, the new Director General already had the war against fake and counterfeit medicines at the centre of the Agency’s agenda.

In this interview with Rotimi Ajayi and Sola Ogundipe, Orhii gives a rundown of the running battle NAFDAC has been having, tackling the “merchants of death” who perpetrate the menace of fake and substandard drugs in the country. Excerpts:

Since you became DG in January 2009, much of NAFDAC’s activities has been about tackling counterfeit medicine. Why the primary focus on counterfeit medicines?

BURNT: Fake drugs

There is no way you can talk about what we have done in NAFDAC without mentioning counterfeit medicines, even though NAFDAC’s activities are broad and include the regulation of food, bottled water, cosmetics, chemicals and many other things.

The war against fake and counterfeit medicines is at the centre because it has been made a topic at NAFDAC. It has been a problem this country has encountered and which NAFDAC has fought to some extent with great success. The was picture when I came on board in January 2009.

An evaluation in 2008 by the World Health Organization of the quality of anti-malaria that were in circulation in 14 African countries discovered that Nigeria had the worst situation among all the countries that were evaluated. It showed 64 percent of the anti-malarial drugs in the circulation in Nigeria at that time were either fake or substandard. To tackle this, what we did was first and foremost, to try to expand on those things that Prof. Akunyili started that worked so well in helping to reduce the situation of counterfeit medicine to 15.7 percent from more than 40 percent.

Dr Paul Orhii, DG, NAFDAC

The only thing we may not have done much was the massive public enlightenment campaign, but every other thing was done. We expanded and collaborated internationally, engaged countries where we saw that most of our medicines were coming from in an effort to stop counterfeit medicine at source.

We found out that more than 70 percent of essential medicines consumed in this country were imported mainly from India and China and then it made sense to know that most of the counterfeit were also coming from those countries, so what we decided to do was to immediately engage these two countries to see how they could help us to stop fake medicine from coming at all.

What synergies has NAFDAC built with sister agencies in tackling this menace?

We have synergies with sister agencies because we know that we cannot win this war fighting alone. We have been closer to the Nigerian Customs Service, Nigerian Immigration Service, Standards Organisation of Nigeria (SON), NDLEA and many others. For example, the Customs now have a system that enables them to know the content of any container before it arrives Nigeria.

The Customs have allowed us access to that system where we are able to view the contents of a container and if we believe that the container may have something that is of interest to us. We can insist that we want to inspect that container when it comes and the Customs never releases the container until we have inspected it. We want to build into their e-clearance system to help us clear goods within 24 hours.

What are your main challenges?

Financial problems are paramount among what we are encountering. Even the vehicles that we have are old Peugeot 504 cars and we have one or two for local government areas, and most of the time they are broken down.

If you take for example Kano with 44 local government areas, how are you going to cover it with two vehicles that are always breaking down? So we decided to engage the local government chairmen and asked that they they set up NAFDAC desks so that they can call us and report fake products that are in the system, especially drug hawking and illegal advertisement of herbal medicine.

We convened the meeting of all local government chairmen and we requested that each of them set up a NAFDAC desk because we are not present in every local government area. They have responded. Jigawa State for example has set up. All the local government areas have active NAFDAC desks.

Kano State has responded by setting up a mobile court to speedily try people who are caught hawking drugs. Edo State has also responded and set up NAFDAC desks and they are requesting us to conduct a workshop for them to educate the local government desks. So, we are going around and we want to be present at the grassroots.

We are involving the traditional rulers, the local government areas to help us police the incidence of counterfeit medicines and other unwholesome regulated products, expired food products, food products not manufactured according to good manufacturing practices and good hygiene programme in the local government areas.

Which technologies have worked for you?

One of the technologies is the Truscan. With this, we can quickly scan imported products at the Ports and release them on time without compromising their quality. It is a new invention by the US military; it can quickly tell whether the product is genuine or fake. The pharmaceutical companies were using it to evaluate the quality of their active pharmaceutical ingredients. So we got the Truscan and as a medicine regulatory agency, we have become the first in the world to use it to detect the quality of medicines. Recently, we were at meeting in London and we found out that the US Food and Drug Administration had started using it too.

Germany, Sweden, Canada, and most advanced countries have also started using the Truscan now to check the incidence of fake medicine in their systems.

People often claim they bought fake drugs from a genuine pharmacy. How is this possible?

We found out that sometimes, genuine distributors will get a certain consignment of the good medicine and then take a sample of that and go to another country and order a counterfeit of that to be manufactured and then mix them together and start selling to unsuspecting pharmacies.

So, all we do is to close down such pharmacy and the owners would tell us where they purchased this medicine. We would then follow all the way to the last person who can tell us where they got the medicine from. Now, pharmacies are more careful in trying to get their medicine.

How much has the incidence of fake drugs in Nigeria reduced?

Within a year, we have been able to reduce, especially in the major cities, the incidence of fake medicine to just about 5 percent in Lagos, in Abuja, in Kano and in Kaduna. That does not mean that fighting counterfeit is such that once you reduced it, you can go back and lie-down that it has been reduced.

Counterfeiting is like a balloon filled with water; you push it on one side, it goes and waits for your hands, and if you want to take the hands, it can bounce back even stronger. So, that is what we saw when NAFDAC fought counterfeiting and reduced it to 15.7 percent, but by 2008, we found out that more than the 64 percent of the anti-malaria drugs in the circulation were either fake or substandard. So, you cannot celebrate that you have gained some victory, especially now that it is even more dangerous.

Is it true that you also wage war against hard drugs?

We have waged war against cocaine; most of the drug barons now are diverting their income into manufacturing counterfeit drugs.

It is more lucrative, less risky, even when you are caught, the punishment is very light. They engage in it and they have made it more sophisticated, internationalised the business. It has been more global and more militarized. Even Europe which was thought didn’t have counterfeit medicine, they have found the market of counterfeit medicine worth more than 10.5 million Euros. So, counterfeit medicine is a global phenomenon.

What is NAFDAC’s model achievement to date?

The model achievement we have seen here is huge when you consider that globally, the problem of counterfeiting has worsened and that is why Nigeria is now looked at as the global leader in the fight against counterfeit medicine. Many countries are coming to share our experience when they see what we have been able to achieve in the current counterfeit medical business.

Even as we speak, we have four Sierra Leoneans working in our laboratories right now and studying how we do what we do. Ghana and Uganda have requested to come, many other countries want to come and understudy us and we have been called to make presentations at many international fora. That is about the Truscan.

NAFDAC recently acquired an instrument called “Black Eye”. What does it do?

The Black Eye is a technology manufactured in Israel – a country which is very good in security instruments and it works like Truscan.

It will compare the tablet that you are trying to check and tell you whether it is genuine or fake and if you ask from the machine, it will break it down into its component and tell you what it contains; active pharmaceutical ingredients or it contains so much inactive pharmaceutical ingredients. The Black Eye now allows us to work faster. We can put 100 tablets, or even 1,000 tablets at the same time and it will break them down and tell you which one is good or bad. So it makes the work faster.

We are working with the Israeli manufactures to tailor it to our need and very soon, we hope that they can manufacture something like a conveyor which you just put a carton inside. We don’t have to even remove a tablet and check it.

It can also even go and evaluate the packaging itself separately and tell you if the package is from the original company that manufactured it or not, using the packaging material. We are working on that, we are doing experiment with that and again it was tested in Singapore. But we are the first medical regulatory agency that Israel has trusted based on our experience with the Truscan to carry this system through.

What are you doing to restore the authenticity of the NAFDAC number?

We have the text messages system. We realise that 70 million Nigerians use cell phones. We thought since we don’t have enough staff it will be a beautiful idea that every Nigerian who has a cell phone and enters a pharmacy is a potential informant for NAFDAC.

Any time you walk in with a cell phone you, have the capacity in your hand to check whether the product is authentic or not. We decided to give the NAFDAC number the meaning that it has lost. Right now, any product that we approve, apart from the NAFDAC number, it will have something like a scratch/ recharge card on it. We are relying on this technology because it has proven to be effective.

Cell phone companies have been in this country for 10 years now and have been using this recharge card system and nobody has copied them. If it was easy to copy, Nigerians would be making more money from copying cell phone recharge cards than from trying to fake medicines. The most counterfeited medicines are anti-malaria drugs, antibiotic, and anti-hypertensive, anti diabetic drugs. So we decided to try using them.

How does this system work?

If you go to a pharmacy and buy, say ampiclox, which is very often counterfeited, you will see something like a scratch card on it, and when you scratch it, you will see a pin number which you put into your cell phone and text it into a short code. We have the same short code for all the medicines so that customers will not be confused. The same thing is with Glucophage, an anti-diabetic drug, and Lonart, a very popular anti-malaria drug which lost its market because of counterfeiting.

The makers were losing almost 40 percent of their market here to counterfeiters and even more importantly, they were losing their brand name, because if people bought it and it didn’t work, they began looking for something else. So these companies volunteered to try out the system, and because they are going to gain their market and their brand name back, NAFDAC decided not to pay for it with the tax payer’s money. The consumer is not going to pay for the text message, but the companies will finance it.

They agreed. That is how the thing works. You will scratch and text and within a minute, you will get a response. It will tell you whether the drug has been approved by NAFDAC, what the NAFDAC registration number on that product is, the company that manufactured the product, the batch number, when is it supposed to expire and the address of the manufacturer. The message will also give you a number to report if you have a problem.

Why have you not requested every medicine to be on this system?

We have not required every medicine to be on it yet because the text rate is still coming at about N10.00 per text message. It is still expensive. We asked the phone companies to reduce the cost of the text message. They said if we can bring them enough volume, then they will reduce it.

We asked the pharmaceutical manufacturers and importers to give us the volume so that we can reduce the cost, they said if we can reduce the cost, we give you the volume because it doesn’t make sense to them to put a text message that would cost N10.00 on a satchel of Panadol that may cost N5.00. Right now, we require that only the most openly counterfeited medicines and essential medicine should apply the technology and then, when we generate enough money, we’ll extend it to other medicines.

What other security measures are you utilizing to safeguard NAFDAC’s activities?

We have started with the radio frequency identification technology that will help us to authenticate NAFDAC documents. Sometimes, to import some of these things, people need letters from NAFDAC to the banks to allow them transfer money for import. People forge those letters. They would just print NAFDAC letter-headed papers; write to a bank and the bank gives approval to bring their money.

But with the radio frequency identification technology, there will be a microchip on every NAFDAC document. The bank just scans it and if it responds to the bank scanner, they will know it is an authentic NAFDAC document. It is utilized in some other countries now. Like in India, before you export pharmaceutical products to Nigeria officially, you have to show that you have approval from NAFDAC. People forged those letters too. So this will take care of that. But more importantly there are some food products that will be taken care of. Different products will now carry that chip.

Very soon, we hope that you will be able to go to a store and if you want to check whether it is fake or not, all you just do is to scan it. The way we have designed it is going to be very easy for even my grandmother in the village to be able to verify it. The stores will have what we call a magic trail. If you scan, it will show red or green. Red means don’t buy it, because it is not registered by NAFDAC.

If it is green, then go ahead and buy it. Even my grandmother can tell if it is red or green. She doesn’t have to be literate to read anything like a text message. These are some of the things we intend to do in the future.