The agency charged with regulating the foods, drug and cosmetics sector in Nigeria is the National Agency for Food and Drug Administration and Control (NAFDAC). The agency’s Director General, Dr. Paul B. Orhii, joined the agency amidst some controversy about his qualification to hold such a sensitive brief. But, in this interview with editors, including LOUIS ACHI, Orhii shares insights into the challenge of policing his sector, his experiences and how he has been working behind the scene to transform the agency with the introduction of modern technology. He also speaks about NAFDAC’s endless battles with those involved in the counterfeit trade. Excerpts:
In contrast to Dora Akunyili’s tenure, the perception is that not much is being heard about NAFDAC since you took over as the Director General?
That is not correct. Maybe I have chosen to do things differently. First and foremost, when I came on board, I visited a lot of media houses to tell them about my plans for the agency. One of the things that I promised people was to sustain all the good things that had been done before. My major aim is to bring international standard to bear on what we are doing in NAFDAC and that is precisely what I have tried to do over the past two and a half years now. We have done a lot in the war against fake and counterfeit medicine.
It got to a point where people thought NAFDAC was exclusively about fighting counterfeit medicine. And so, there is no way you can talk about what we have done in NAFDAC without counterfeit medicine even though our activities are varied and include the regulation of food, bottle water, cosmetics, chemicals and many other things. Counterfeit medicine is at the center because it has been made a public issue at NAFDAC.
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It has been a problem this country has encountered and which this agency has fought to some extent with great success. You know counterfeit medicine was first discovered in Nigeria in 1968. By 2001, the situation had worsened and more than 40 per cent of medicine in the distribution chain was fake. People were buying corns starch and chalk thinking that they were buying anti-biotics. With the effort of my predecessor, Prof. Dora Akunyuli, the incident of counterfeit medicine drastilly reduced in 2005 to 15.7 per cent. That was a significant feat; from 40% to 15.7% and that was the last evaluation.
The other evaluation that was done was in 2008 when the World Health Organization decided to evaluate the quality of anti-malaria drugs that were in the circulation in 14 African countries including Nigeria, and that time it was discovered that Nigeria has the worse situation among all the countries that were evaluated. 64% or thereabout of the anti-malaria drugs that were in circulation in Nigeria at that time in 2008 were either fake or substandard, and you know, fake and substandard foods/drugs have great public health implication. So this was picture when I came on board in January 2009.
So what did you do to improve on the situation?
What we did was to, first and foremost, try to expand on those things Prof. Akunyili started that worked so well in helping to reduce the situation of counterfeit medicine to 15.7% from more than 40%. Probably, the only thing we did not do was to embark on massive public enlightenment campaign. We did every other things right. We got international collaboration; we expanded internationally, engaged countries where we discovered that most of our medicines were coming from in an effort to stop counterfeit medicine at the source. We found out that more than 70% of essential medicines consumed in this country were imported mainly from India and China. We thought it wise to engage these countries at the diplomatic level because it was our belief that most of the counterfeit drugs are likely coming from those countries.
We decided to immediately engage these two countries to see if they could help us to stop fake medicine from coming at all. We intercepted a consignment of fake drug anti-malaria drug that was purportedly coming from India, but when we checked, it actually came from China. So we picked up the matter with both countries and, in 2009, we were able to get the Chinese authority to sentence six of their own citizens to death for manufacturing and shipping that consignment of fake medicine to Nigeria. We also worked with the Indian parliament and that same year we got the Indian parliament to enact a law that makes it a crime punishable by life term jail and confiscation of the assets of the convict for manufacturing and distribution of inferior pharmaceutical product.
So these were some of the achievements we got at the international arena. And that earned us a respectable place at the International Medical Product Fighting Counterfeit Council where we have been very active. We called it INFAC and it is made up of 193 member states with the headquarters in Geneva. I am currently the vice chairman of that organisation. We have also been rated as one of the top 18 medical regulatory agencies in the world, the only four agencies on the African continent belonging to that lead group. They invited us to the meeting that is convened by the United States, Canada, Britain and Japan. In Africa, we are the only country that is invited to be at that meeting.
It’s alleged that there is no love lost between NAFDAC and other agencies responsible for the fight against drugs like the NDLEA and others? Does your agency have a good working relationship with them?
Back in the country, we decided to build synergy with other sister agencies because we know that we can not fight this war alone. We work closely with the Nigeria Customs Service, Nigeria Immigration Service, Standard Organisation of Nigeria, the NDLEA and many other sister agencies. For example, the Customs now has a system that enables them to know the content of a container and they have allowed us assess 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 we want to inspect that container when it comes and the Customs never releases it until we have inspected it. Also, we want to build in to their e-clearance system to get more cleared goods within 24 hours.
We have worked very closely with the Customs service and we have built closer relationship with traditional rulers and local government chairmen, realising the fact that most of the people that reside in these areas are largely uneducated and very poor and therefore potential marker for the counterfeiters. They may want to take advantage and market their fake products there. We decided to partner with the traditional rulers because we realise that whatever we do in Abuja or Lagos would be tantamount to nothing if we are not stay in touch with the rural area. And that informed the stakeholders meeting that we have been holding around the country. Just the other week, we were in Sokoto.
We just came from Owerri and we have been going around the country holding stakeholders meeting to explain to the people what we require and more importantly listening to the people who are on the ground because they will tell us what they see on ground. These are some of the things we have done. 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 areas. Currently, we are only present in the state capitals but not in the local government areas.
What stops you from being everywhere?
Basically, it is finance. Even the vehicles that we have are the old model Peugeot 504. We have only two of them for local government areas and, most of the time, they break down. How do you intend to cover these local government areas with just two vehicles? So we decided to engage the local government chairmen and asked them to 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. And I can tell you that the response had been encouraging. Jigawa State, for example, has set up NAFDAC desk in all the local government areas; they are calling us to report fake products. Kano state has responded in one way where they have set up a mobile court to speedily try people who are caught hawking drugs. I also learnt that Edo State has set up NAFDAC desk and they are requesting that we should come and conduct a workshop for them to educate them, at least two of them that will be manning it. There are many other requests pouring in. So, we are going around and we want to be present at the grassroots and we are involving the traditional rulers, local government chairman to help us police the incident of counterfeit medicine and other ones – the wholesome of unregulated products, expired food products, food product not manufactured according to good manufacturing practices in the local government areas.
In what ways have you improved on the use of technology in the detection of fake drug and food products?
That is an area where we have excelled. We decided on the use of cutting edge technology to fight counterfeit medicine and other unregulated products. Before, it used to be that if you look at the packaging you can infer whether the product is fake or genuine. There was a time when NAFDAC would tell you that if you want to buy a product just look at the packaging and see if there is NAFDAC number, buy it, and if there is none, don’t buy it. But now, with the sophistication in packaging including technology, people fake the product complete with the packaging and NAFDAC number on. That may not necessarily be an indication that the product is registered by NAFDAC. If they can copy a tablet, I don’t why they cannot copy NAFDAC number. We have intercepted such products before.
Even we attempted, at a time, to use hologram, the hologram that worked elsewhere did work in Nigeria. In fact, we intercepted products that the original did not have a hologram but the fake had a hologram and everybody was thinking that the fake one was the good one. The most experienced hand that we have at NAFDAC cannot walk into a door and take a tablet and tell you immediately whether the tablet is genuine. Most of the time, they look exactly the same and the packaging looks exactly the same unless you do chemical analysis in the laboratory that takes, sometimes, months before you can find out that they contain different ingredients. Sometimes you find out that anti-malaria drug that suppose to take a certain dose of anti-malaria pharmaceutical ingredients has just one part. The worse thing is that some of them have half the strength. Half the strength is worse than nothing because, at least, you know that you still have malaria and you can go for further treatment.
With half strength, the malaria sometimes is subdued and then develops a resistance for the micro-organism. And it became imminent for us to find a way to quickly scan these products, release them on time without compromising the quanlity. We found out that in the United States of America, there is a new invention by the US military called the Tru-scan which can quickly tell whether the product is genuine or fake. We got in touch with the only pharmaceutical company using it to evaluate the quantity of their active pharmaceutical ingredients. So, we got that Tru-scan and, as a medicine regulatory agency, we have become the first in the world to use the Truscan to detect the quality of the medicine.
Other regulatory agencies across the world have copied the use of this technology. The Germans have started using it. Sweden, Canada and most of these advanced countries have started using the Truscan to check the incidents of fake medicine in the system. We started using it at the Murtala Mohammed Airport. This is because there used to be consignments of face drugs, of fake medicine carried from China. So we checked it and found out that it actually contained corn starch. We took the medicine to the laboratory and, after chemical analysis, we found out it was only corn starch that was being shipped as anti-malaria drug.
Of course, we did announce our findings immediately. We waited to break the syndicate. They used to send it in small small packs and when we intercepted them, the clearing agent would come forward to claim them. If we did not intercept it, they will carry it to their warehouse. So when we found out how they operated and we entered into information sharing arrangement with other countries and the INTERPOL. We went to China and found out how they operated and we waited for them. Somehow they loaded some of the product and bypassed the airline operators, came all the way to Nigeria and when we intercepted them at the Murtala Mohammed Airport, we saw them coming we did not search them, they cleared and we followed them to their warehouse and we arrested the final people that came to pick it up. We intercepted the medicine worth millons of naira. Now we have slowed down on that and we have not seen it for a long time. They have stopped to operate that way.
Have you been using the Tru-scan in the rural areas?
When we saw the success of this Truscan at the airport, we started going from store to store to check them from state to state. We just finished Imo now. We have combed 19 states. We can go into a pharmacy, point a tablet and within a minute, it will tell you whether it is genuine. If there are counterfeit, we close it down. We did not arrest immediately because we found out that some people selling medicine, the pharmacist themselves, they do not know that they were being supplied fake medicine.
It is interesting that some of them buy from a genuine distributor of the company. We found out that some genuine distributors of a good medicine and they will take the sample of that and go to other country and order a counterfeit of that exactly to be manufactured like that and mixed up together and started selling them to unsuspecting pharmacists. So all we did was, we would close it down and you will tell us where you purchased these medicine from and then we follow all the way they came to the last person. Now, pharmacists are more careful with where they get their medicine. Within a year, we found out that we have been able to reduce the incident in the major cities. Incident of fake medicine is just about 5% in Lagos, Abuja, Kano and Kaduna.
So an evaluation by the international pharmaceutical security institute and the world customs service shows that the counterfeit and medicine product business annually and globally, even Euro which was taught that they don’t have counterfeit medicine, they have found the market of counterfeit medicine worth more than 10.5 million Euro. So, counterfeit medicine is a global phenomenon. The model achievement we have seen here is huge when you start looking at it that globally the problem has worsen and that is why Nigeria now looked at as the global leader in the fight against counterfeit medicine because many countries are coming to share our experience when they see what we have been able to achieve.
Tell us more about the text messaging system of detecting fake drugs.
We realised that 70 million Nigerians use cell phone and we thought that if every Nigerian who has a cell phone enters a pharmacy store, he is a potential informant for NAFDAC. The pharmacists will seat up any time you walk in with a cell phone because they will suspect that you might be calling NAFDAC to report a fake drug. The truth is, with cell phone, you have the capacity in your hand to check whether the product is authentic or not. What we did with the text messaging system is that 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, has something like a scratch recharge card on it and we are relying on this technology because it has proved to be effective.
As we speak now, if you go to a pharmacy and buy a drug, you will see something like a scratch card on it. When you scratch it you will see a pin number and you will put that pin number in to your cell phone and text it into a short code. We have the same short code for all the medicines so that the customer will not be confused. If the drug is fake or genuine, you will get an instant response and the service if free. It is free and that is how the thing works. You will scratch and text and within a minute, you will get your response back.
It will tell you whether the drug has been approved by NAFDAC; the NAFDAC registration number that is supposed to be on that product. You will the look at it and compare if with the one on the drug. If it does not merge, then you have the counterfeit. It will also tell you the company that manufactures this batch; when is it going to expire and all that. It will also give you a number to report if you have a problem. So these are some of the things that are there to fight counterfeiting and now we have not required every medicine to be on it.
In what way is NAFDAC assisting the local pharmaceutical industries?
We evaluated about 70 per cent of essential medicine that we import in this country come from other countries and then you begin to ask yourself if, for some reasons, we cannot get medicine from other countries, what are we going to do with 150 million people? So, when you ask that question, you come to the inescapable conclusion that the availability of this pharmaceutical product at affordable prices is a national security issue, because we have to find the way for Nigeria to be self sufficient in the supply of essential medicine for Nigerians. Since I came in, we have decided to encourage the pharmaceutical industries to go back and expand and upgrade their facilities.
Right now, you can not insist that Nigerians buy medicine from local pharmaceutical industries so that they will expand. If we say Nigerians should buy from the local manufacturer alone, the international community will blackmail us that we are forcing Nigerians to take substandard medicine in Nigeria and that is a big problem, because once they develop resistance to micro organism like malaria they don’t need to get international passport or visa. They can be flown to any country around the world. It is the concern of the entire world Nigeria, first and foremost, before we begin to do that we have to upgrade the facility to make sure that they conform with the international standard.
We have decided to make it in such a way that NAFDAC is not just waiting to supervise your company and close it down. What we do is we work with you and show you how to do it. Sometimes, we even invite experts from outside the country to come and show us how they do it. We realize that it takes a lot of money and the company can not get good running with the current rate and the short term loan. So, we went to the National Security Adviser and told him the situation and he told me to work with relevant bodies like bank of industry, CBN and come up with a plan. We came up with a request for 200 billion naira intervention fund in pharmaceutical industry so that, as a deliberate policy like other countries had done; Nigeria can now become headquarters of medicine.
We met with the president who received it very well. The president was happy and said a fund should be sourced, between the minister of finance and bank of industry they should find a way to source for find and the fund should be made available to pharmaceutical industries at affordable rate. The gains are enormous. If that happens, we are going to get about 250,000 quality jobs from pharmacist, micro-biologists, marketers etc in the expanded pharmaceutical industry; the World Health Organisation will help us get a qualification for our products which we can even export to other countries. We have porous boarders and we cannot keep on chasing counterfeiters around their boarders. If we become self sufficient, some of these things will die by themselves.
What do you think can be done to dissuade people from engaging in the deadly trade of drug counterfeiting?
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We are asking for a review of the law as it stands now. I told what happened in India and China to those who fake medicine to Nigeria. Our law says 15 years jail term or N500, 000 fine. These people are rich people and N500,000 is nothing to them. So we found out that, paradoxically, we who at the receiving end when it comes to punishing offenders, we hardly give them harsh punishment. And so we reviewed our law. We had a committee made up Senior Advocates of Nigeria, professors of law and the Institute of Advanced Legal Studies. In the new law, we are requesting that it should be life time jail, confiscation of assets of the convict.
We found out that, with the confiscation of their assets, they will be left with nothing and if we can proof that from their fake drug it led to death or severe injury, we are saying that some of the confiscated assets should be used to compensate the victims. We also want in the law for us to legally reward people who come forward to give information that lead to seizure of these fake products. We want also make the law non-bailable or alternatively a designated court that try our cases. We also want to create more emphasis on post-marketing surveillance of products.
Could you explain why your appointment generated so much controversy?
If you look at it, anybody who is bringing change into society has been criticized and if you don’t want to be criticized then you must be above Jesus Christ. You have to expect that. It is always like that. An agency like NAFDAC is very critical to the lives of Nigeria. It is something that Nigerians are very interested in. So don’t expect people to be different; people should be concerned about who is coming at the helm of NAFDAC. I understood the Pharmaceutical Society of Nigeria’s concern, they did not know me I just came back from USA and entered into the system, they don’t know where I come from, and some of them even thought I was only a lawyer. The law that established NAFDAC doesn’t say that you must be registered with Pharmaceutical Society of Nigeria. But we thank God that all that is in the past now. We have moved on.