NAFDAC…. My Mission, My Challenges, By DG, Orhii
THEY are revered for their efforts in safe guarding the health of Nigerians. They are in charge of regulating the use and marketing of food, drugs, chemicals, cosmetics and medical devices in the country.
Officials of the National Agency for Food and Drug Administration and Control (NAFDAC) have received both local and international accolades and recognition for their efforts. But it seems the same feats that had endeared staff of the agency to the people have also made them endangered species to unscrupulous Nigerians.
Two months ago, NAFDAC officials went on routine check of bakeries across the country to make sure that they were not using potassium bromate — a substance banned because it has the capacity to cause cancer. They found that most of the companies were compliant. But in Osun State when they visited one of the bakeries, they found a bottle of potassium bromate about to be used. In their effort to retrieve the potassium bromate, the owners of the bakery descended on the officials, beat them until they became unconscious, bundled them into the car that they had brought, poured petrol on the car and were about to set it ablaze — with NAFDAC officials — inside when the police came to their rescue.
In another incidence, a staff from Port Harcourt office who went to spend the weekend at his own house in the village in Imo State was brutally murdered. Four NAFDAC officials from the Port Harcourt office went down to his house in Imo State on a condolence visit because his wife had told them the man had died. They were kidnapped on their way back. However, they were released few days later.
But these events have raised a lot of questions, which has left the Director General of the NAFDAC, Dr. Paul Orhii, worried.
Orhii assumed office over a year ago burdened by strong resistance from the Pharmaceutical Association of Nigeria (PSN), but he made several promises on how to better safeguard the health of Nigerians.
Orhii turns 50 years today, May 9. But as he said during this interview: “Unfortunately, I will be on official duty to India. I will be leaving on Saturday and I will just be arriving India on that day”.
Besides the issue of NAFDAC staff being marked for death or abduction, the agency has been accused of lowering standards that is going back to ‘business as usual.’
Some unconfirmed reports suggest that the incidence of fake drugs, which had hitherto gone down from over 80 per cent in 2001 to less than 16 per cent in 2007 is on the rise again.
Orhii in an exclusive interview with The Guardian spoke on the challenges he is facing in safeguarding the health of Nigerians, how he has met his targets, his plans for special life insurance for NAFDAC staff, and other issues.
Meeting NAFDAC’s mandate
I would say yes. To the best of our ability we are meeting our mandate. Fake drugs used to be a big problem in the early 2001 up to 2005. When NAFDAC paid lot of attention fighting fake drugs, it appeared as if NAFDAC was only fighting fake drug and doing nothing else.
But when I came I said it is okay, we can continue to fight fake drugs but let us be more balanced. I told you our efforts in regulating the food industry, chemical, bottled water, medical devices and instances where some of our staff got beaten. But we are not relenting in our fight against fake drugs. I told you that by my estimation, we have less than 10 per cent incidence of fake drugs right now.
Meeting targets and promises
I think I have delivered on all the promises that we made, but we are still moving forward. We now have new agenda. First and foremost, I said I was going to bring international standard to bear on our activities in NAFDAC and we are also going to adopt a more holistic approach to carrying out our mandate.
At a certain point, NAFDAC was seen exclusively pursuing fake drugs dealers but when I came in I decided that we have food to regulate, chemicals to regulate, cosmetics to regulate, medical devices and other industries to regulate. So we adopted a more balanced approach to carrying out our mandates. You know that food is seen to be more important in NAFDAC, it comes first even before the drugs. What we have done is… we have been inspecting the food industry. We invited the World Health Organisation (WHO) immediately to come and train our inspectors and also manufacturers of food together, so that they know good manufacturing practices in the food industry. We are more vigorous in inspecting the food eateries. We have punished some of them and gave them corrective measures. They have since been corrected. I think the fast food industry is safer right now. We have even been inspecting major restaurants and hotels and corrected some of the bad hygiene practices we saw there.
Regulating Use of Chemicals
Recently, we started a programme we called NAFDAC and Your Health, an educational programme, which educates people on all the products we regulate, starting from food to chemicals. Not many people know that NAFDAC regulates chemicals. Chemicals are vast, including the fertilisers the federal government expends hundreds of billions of Naira to procure, all the way to large amount of chemical used in the oil industry in manufacturing and other industries.
We have intensified our efforts in chemicals, in educating the masses about chemicals. We have sampled fertilisers. We believe that some fertilisers are not good for the soil. Substandard fertilisers are imported into this country, sometimes they are of good standard elsewhere but do not match our soil here. Some of these fertilisers were releasing lot of acids, even chemicals being incorporated into the crops that we eat.
We are saying that this inappropriate use of chemicals by Nigerians might be responsible to some extent for the increase rate of cancer and kidney failure that we have observed in this country. So we are monitoring the chemical industry very closely. We have been conducting workshops for farmers to educate them about the appropriate use. In collaboration with Crossline International we have been educating farmers. We held the workshop in Kano for the North West zone, another one in Yola for the North East and we are planning another in Ekiti State to educate cocoa farmers on the appropriate treatment of cocoa with pesticides, taking into cognition that some of their seeds have been rejected at the international market for high level of pesticides. So that is what we are doing in the food industry. Also, for the chemical industry, we are educating the farmers.
Timeline for Product Registration
We have intensified our efforts in the area of medicines registration. First and foremost, we have streamlined our guidelines for the registration of products. It used to be that somebody would submit an application and it would be there for two years. There were no timeline, nobody could hold anybody accountable for not approving the products on time.
When I came, I looked at it and said we have to keep timeline to this our application. Somebody who is trying to register a product might want to negotiate a loan with a bank. They should have a timeline to be able to tell the bank approximately when they should expect response. It does not matter whether it is 10 years that it is going to take us. But the person should know at the beginning how long it is going to take. We were able to come up with 90 days turnaround time when if somebody submit a completed application form and pay all the required fees, should get a response to whether it has been approved or not.
It is already in effect. Anytime the time is not met, I give the person administrative approval to start producing his products if the laboratory analysis proved to be satisfactory, every other thing we can finish later.
Incidence of fake drugs
Let me put it straight. Fake drugs were first discovered in Nigeria in 1968. By 2001, a survey showed that the incidence of fake drugs went up for more than 40 per cent. Due to concerted effort of my predecessor, Prof. Dora Akunyili, the incidence of fake drugs by analysis in 2005 that was done by NAFDAC and WHO went down to 16.7 per cent. But then another survey was done in 2008 just before Prof. Akunyili left. In 2008 a survey of anti-malaria drug was done for African countries and you know the drugs that are mostly intercepted are anti-malaria and anti-biotics. But this one was for anti malaria by WHO and NAFDAC. The result was just released a month ago. It showed that at that time, 2008, almost 50 per cent of anti malaria drugs did not meet the specified standards. They were either fake, substandard or not of good quality. That was the picture when I came in. You remember that was the time we had the problem of My Pikin teething mixture. That was what I inherited.
As of now, what we did was we brought in Truscan, a fake drug detecting device. This is a hand-held equipment that can instantly determine if a drug is genuine or fake without the need to send samples to the laboratory. Each unit cost about 50,000 US dollars.
We are making efforts internationally, in collaboration with China and India to stop the fake drug from coming into the country. I do not believe that you can ever stop fake drug coming to Nigeria by intercepting them and destroying them. That is not sustainable because our borders are vast and porous and those that are manned, are poorly manned. So I think the culture of intercepting them at the border and destroying is not sustainable. So we have engaged them at the source. We have realised that out of the medicines that we consume in this country, more than 70 per cent are imported. And out of the import, China and India are the major exporter of medicines to Nigeria. We went to China and tried to convince the Chinese to make sure that drugs coming into this country are of good quality. We went to India and tried to convince to make sure that they produce quality medicine leaving India for this country. Apart from that, we adopted more measures in the country and then we looked at the result.
When we bought the Truscan, we deployed it to the airport and caught some fake Lonart (antimalaria drug). We confirmed in the laboratory that the fake Lonart contained only corn-starch. Based on that result, we went to all the stalls in Onitsha, Lagos, Kaduna, Zaira, Abuja and Kano and recovered all the medicines that were in the market. Using this Truscan, the preliminary result showed that out of the more than 1000 medicine tested, we found that less than 10 per cent were substandard. And the important thing here is that we are not just talking about counterfeit medicines, but we are also talking about substandard medicines. I am very pleased with what we heard. But we are fighting to reduce it much lower.
Dismantling open drug markets
There is no advanced country in the world that has open drug market, where drugs are bought in open market. We are finding ways to regulate that. The registration of drug outlets is under the Pharmacy Council of Nigeria (PCN). What we have tried to do is to encourage states to dismantle open drug markets for regulated drug marts. Ekiti is a typical example that has bought its own drug mart. For example, to control the quality of drugs or medicines that go into this place and the kind of qualified staff or pharmacists that work in these facilities and the drugs that go out. I think that is what will save this country from this open drug market.
We are also encouraging private partners like UAC, which has started one of these drug marts in Abuja. They have a storage facility that is under a stringent environmental condition, well controlled and approved by WHO; only qualified pharmacists work in there and the quality of medicine that come in is controlled; only quality medicine can come in there. So we are encouraging them to build similar drug mart in other states, especially around Onitsha Bridge Head market.
Plans to dismantle Onitsha and Sabogeri drug markets
We do have plans in Onitsha. We were working with Governor Peter Obi. He told us that he would help us to build something like that where drugs coming in would be controlled and only quality drugs will be allowed in. Then drugs that cannot make it in, we know that this is fake drug. So we can dismantle those drugs, dislodge them.
The same thing we plan to do in places like Kano. The plan was stalled due to elections. Now that elections are over, we will resume the plan or effort and would see how we can move into that programme.
Legislation and punishment for offenders
We have finished the draft. I assembled a team of the most brilliant legal minds in this country — professors of Law, Senior Advocates of Nigeria (SAN) and we also got a professor from the Institute of Advanced Legal Studies – and they came out with a draft. In that draft, we are asking for lifetime jail term. Personally I had wanted death penalty because I believe that fake drug dealers are worse than armed robbers. We have come out with lifetime jail term, confiscation of assets and in cases where we can prove that a fake drug caused death or a severe body injury to the victim, we are asking that some of the assets confiscated be used to compensate the victim. We are also asking that a whistle blower system be built in the new law such that people who give us tips that lead to interception of some of these products can be legally rewarded. We intend to hold a stakeholder meeting to review the draft, where members of the media also would be invited. A broader stakeholders meeting would be held and we would clean up the draft and finally hand it over to the National Assembly.
Recent hostilities against NAFDAC officials
We have been working towards having a special Life insurance because they are exposed to increased risk. We are taking our staff very seriously and we are working not just the insurance, we are also working ways of response to some of these people who try to harm NAFDAC officials as they go about their duties.
The Port Harcourt kidnap issue is a little bit different. I think that was not peculiar to NAFDAC staff. It was just a general issue in that area.
That man was murdered in his village. Our staff just happened to be where kidnappers were kidnapping other people and they kidnapped them too. So, that was not peculiar to NAFDAC.
Thank God we worked with the security agents. The Inspector General (IG) of Police and the Special Security Service (SSS) were very helpful; they helped me a lot and we secured their release.
Perceived falling of standards in NAFDAC
It is not true that NAFDAC has lowered standard. If anything, we have set high standards, we are trying to get to international level. People work in different ways. We may not be talking much, but we are building internally.
We have NAFDAC and Your Health that is shown on four different TV channels. We want to educate the masses about our activities. It is very easy for me, if I want to be seen to be very active, I could go down and close down a big company and Nigerians would cheer me; but that is not the style. The style is that we are working more closely. If registration is easier, it is one of the reasons that have made it more straight forward.
It used to be that people were afraid of coming down to NAFDAC, they would go and find touts who will come and liaise between them and NAFDAC. We have tried to educate these people that NAFDAC is not a monster; that NAFDAC wants to work with you if you want to develop your business and you want to do the right thing. We understand you and want to help you do the right thing. So if you have a problem doing it right, we try to educate you.
We have conducted Good Manufacturing Practice (GMP) inspection directly between NAFDAC staff and staff of the industry. We invite their staff to come and train with our own staff to know exactly what our expectations are. Not that they are bribing their ways through registration.
The guidelines on registration were not straightforward, timelines were not given. If NAFDAC staff did not like your face, you could come here up to two years and not get your registration. Now we have designed the guidelines and give specific time lines of 90 days, if you submit the completed application form and pay all the required fees, you should be able to get a response.
We realised that people were negotiating loans with banks and they should be able to give the banks approximately when they would begin operations and begin to make payment. So we are making registration easier. We also do post market surveillance after registration. That is why you see us deploying different gadget, new equipment to help us detect bad products in the market. Post market surveillance is even more important than what you do when you scrutinise before you register a product. So we are paying more attention to post market surveillance on the product in the market, while the registration process is going on. But we try to make it easier for Nigerians who want to do business legitimately who want to do the right thing, not to be afraid to approach NAFDAC.
I do not believe that getting easier registration means they are bribing their way through.
Strategy to ensure sustained progress
We are making lot of progress. You see how we encouraged some hospitals that have by reporting adverse drug reaction recently, even some people won awards for reporting adverse drug reaction in products to us. We are improving on pharmaco-vigilance and we are intending to even expand it to other products just for post marketing surveillance.
Apart from that we are planning to make the country a hub for clinical trials. Recently, we invited some experts from the FDA, the medicine regulatory authorities in Canadia and the United Kingdom for a review of our programme for five days — almost one week. We are adopting a more clear guideline for clinical trials in Nigeria. We want to make Nigeria a choice in clinical trial.
Challenges on the job: threats to staff, fund…
The challenges are many. I just told you about the hostile regulatory environment; some of our staff were beaten, we have received threats. These are big challenges.
Another challenge is funding. For the vast territory that we are called to protect and the kind of population, almost 150 million Nigerians, that we are called to serve, we are grossly underfunded and grossly understaffed. By way of comparison, the Chinese regulatory authority like ours, has 70,000 employees; we have less than 2,000 officials serving the whole territory of Nigeria.
Poor funding has had a negative impact in our activities. For example, a state like Kano State with 44 local government areas, we have just about two vehicles, with only one operational. How are you going to cover all these local government areas in Lagos? Even our Directorate for Inspection and Regulation has just a few vehicles. Yet they need to inspect all the thousands of companies we have in Lagos. This is a big challenge and major concern.
First and foremost, you can see that we are refurbishing our laboratories, to be world standard. They would be approved by WHO. We noticed that more than 70 per cent of the medicines we consume in this country are imported. This culture is not sustainable in the long run because it does not ensure the availability of quality medicine at affordable prices to Nigerians. We consider it to be a national security matter. We want to reverse the trend a situation where more than 70 per cent of medicines that are consumed in this country are manufactured locally. We know that this is a major challenge because the banking industry is not giving loans now. So even our local pharmaceutical companies are having a problem.
Last year, Global Fund expended more than $4.7 billion acquiring medicines for donations to developing countries and you know that Nigeria is one of the major recipient of those kind of medicines. None of those drugs were sent here. We want to be able to capture a significant portion of funds in Nigeria here.
Another condition they gave us was that our industry is not WHO-prequalified. We want to be able to prequalify at least five to 10 per cent of our industry. This will help us to capture some of those funds not just the fund it self. It will increase the confidence of made in Nigeria pharmaceutical drugs. It will increase the number of Africans giving quality job to our teeming graduates of pharmacy, biochemistry, and even people in marketing. It will make funds available. If our pharmaceutical industry is that strong, then they will have money available for research and development.
In the United States, where I worked as a scientist, more than 50 per cent of our budget came from pharmaceutical companies who are giving us money for research. We want a situation where the pharmaceutical industry in Nigeria is so robust, they are so much involved in the raw materials we have here, they are doing research and development and they are giving lot of money to universities to help them do research and development for their products.