Friday, 19 June 2009

“My Unending War With Drug Fakers”

Whenever she walks out of her office, dealers in fake and substandard food products scamper in different directions. Today, Professor Dora Akunyili is regarded as a life-saver and stands as the conscience of the nation with regard to her indefatigable resolve to run fake drug dealers out of town. But with her tenure coming to an end and her decision to quit her job due to family pressure, many fear the country may return to the dark days of the drug war. She spoke to Chukwunwikezarramu Okumephuna in Abuja on the achievements and challenges of NAFDAC. Excerpts.

On why the fight against the fake drugs and substandard food products is never ending!
The reason is that we have had these fake drugs in the system since the late 1960s. So when we are talking about a problem that has taken root for over three decades now, it is not something that you can clean up in one week or one year. I am even pleasantly surprised that we were able to bring down the level of incidence of fake drugs by over 80 percent in 2001. I believe we are moving at a reasonable speed. We still have fake drugs in the system but you can’t compare it with what we had in the 1990s and early 2000. Remember that in the 1990s, most of the multinational pharmaceutical companies left the country. We had Boringa, ICI, Meck, Boots etc. They all had to leave the country out of frustration. Made-In-Nigeria drugs were banned in other West African countries. Our local drug manufacturers were closing shops. But now, in addition to drastic reduction in the level of incidence of fake drugs, 16 new drug production factories sprang up in the last three years. Made-In-Nigeria drugs have been re-accepted in other West African countries. In fact, we have taken over the West African market. I think we are making a lot of progress. We can confidently celebrate the success even though it is not yet 100 percent.

On the sources of the illegal business and those behind it!
You cannot treat a disease without diagnosing it. You cannot eradicate fake drugs if you cannot identify where the drugs are coming from. Most of the fake drugs we have in this country come from Asia, specifically from India and China. And that is why we have one of our strategies for fighting drug faking as stopping the importation from the source. We have independent analysts in these two countries that re-certify drugs before they are exported to Nigeria. We also go to inspect factories anywhere in the world to establish that they have the right Good Manufacturing Practice(GMP) before we accept their drugs for registration and even after registration, drugs cannot still be imported into this country without first of all going through our independent analysts in China and India for double-checking. We also insist on pre-shipment information. We must get all necessary information on what a drug importer wants to bring into this country before the drugs are imported. We even use Nigerian banks. Banks do not prepare financial importation documents for drug importers without NAFDAC clearance. We are therefore tackling and battling it at the source. But local manufacturers, I must tell you, are doing very well even though we monitor them neck-to-neck. We do constant surveillance and once there is any problem, we issue a compliance directive and most of the time they comply. If they don’t comply, then we close them. When we got the report of an infusion killing people and causing a lot of adverse effects in 2002, we closed one of the infusion production factories. Last year, we closed four infusion factories until we got them to do the right thing. And not only getting them to do the right thing, we had to monitor them and their products thoroughly before we allowed them to resume production. We monitor local manufacturers properly and ensure that they are operating at internationally acceptable standard. We also carry out systematic sustained surveillance to mop up the fake drugs already in circulation and this has led to constant public burning of fake products worth over N8 billion.

On why NAFDAC has no strong teeth to bite!
The law is very weak indeed but we have found a way of getting round it. We use administrative guidelines allowed within the law. If we stick rigidly to the existing drug law, we will not be able to function. It is very weak. It is unimplementable and most of the time ambiguous. Even when we get people convicted, the punishment is very light and at the same time very annoying. At times, when we catch a fake drug dealer, the punishment is just three months imprisonment with an option of N10, 000 fine. It is very ridiculous. The highest we got was the one we got recently in Kano-a five year imprisonment-but even at that, he still had an option of fine. But it was better than what we got in the past.

On the situation in Aba, Onitsha and Kano as the greatest headache of the agency!
Our greatest problem is Onitsha. Aba is a little bit sanitised because when we closed the Aba market in 2002 for about six months, they learnt a lesson. Right now, they are doing a lot of self-regulation among themselves. From the information we are getting, anybody who bring in fake drugs or unregistered products into Aba market will have problem with the traders. This is because they know that if we find fake or unregistered drugs again in their market and close it again, it will be indefinite. We agreed on this before we opened the market. Onitsha is a disaster but we are planning a new strategy for it which I would not want to divulge because if you disclose your strategy, it won’t work again. But I don’t think there is any other drug market in this country that can be compared with Onitsha in terms of selling fake drugs, fraudulent re-labelling and repackaging of spurious drugs, despite the fact that we have been combing Onitsha, closing different lines, different shops, carting away drugs in that market. NAFDAC staff and I still have plans to checkmate them; and I think I will stop at that. Kano is a little bit sanitised too because we closed it for about three months last year. We didn’t close Kano for up to six months as we did Aba because when we went to Kano to close the market, the traders co-operated. We went to Aba, they threw pure water sachets on our staff and that was why we closed it for six months. And if they did not come out to apologise using all media, coming to our office etc, we would have closed it for a longer period. So these three markets have constituted a stumbling block to the eradication of fake drugs in this country but I must tell you that Aba is sanitised to some degree. Kano is sanitised to a good degree. Onitsha is sanitised a little because what we have in Onitsha today if it is bad, then it was terrible about three years ago. We are still going to do more work in Onitsha. There is nothing traders have not done. Can you believe that when we planned to carry out enforcement actions on unregistered drugs, the Onitsha traders tried to circumvent it? There is no country in the world where a company is allowed to market unregistered or unauthorised drugs or foods. In developed and most developing countries, foods and drugs must be certified by the drug regulatory agency before a go-ahead is given for their sale and use. When we issued a warning that if a drug is unregistered, it would be seized by NAFDAC; do you know what Onitsha people did? They went and cleaned numbers in their shops to create confusion for NAFDAC, so that when we went on inspection, we won’t be able to identify individual shops. How can you identify a shop from thousands of shop when they are not numbered? So when we got the information, I called their executive members and gave them two weeks within which to replace the numbers or have all the shops closed and all the drugs evacuated; and we were ready to do it. But within 10 days all the shops were re-numbered. They comply when we give instructions. They’ve not been obstinate when we issue directives. But we think we still have to do something radical, but we have to plan properly.

On consumer’ right to report fake drugs or substandard food products that fall below their expectation!
They have a right and they have been exercising it. When we discovered problems with infusion in 2002, it was as a result of consumers’ report. The problem with infusion last year was also reported by some hospitals. So, in most of the time actually, outside our routine surveillance where we pick vegetable oil, or flour or water or injection or cream etc, it is the people who report and then we have to follow it up with investigations, collect samples and test. We don’t ignore any report because it can help us save millions of lives. It is better for us to investigate and find out that there is nothing than not taking any action.

On NAFDAC’s surveillance capacity!
We cover all of the entry points and government also helped us a lot by approving that we have what is called Special Designated Ports for drug importation. In the past, drugs were imported from anywhere and any border, land or sea. But right now, government graciously and kindly approved that drugs can only be imported through Calabar or Apapa Sea Ports or through Murtala Mohammed or Aminu Kano International Airports. So if fake drugs are imported through these designated points of entry, it would be easier for us to monitor. That means that if anybody brings in drugs through Port Harcourt, Customs will seize it because it is illegal in the first place and hand them over to us. So these designated points of entry have really helped us. We have also beefed up surveillance in these designated points and at the same time, have been making a lot of seizures too. In the seaports, we have a very strong surveillance too but on the land borders, though we still have some presence of NAFDAC officials, nobody is allowed to import any NAFDAC regulated products through the land borders. Importers are complying. If they fail to comply, we seize their goods.

On the pharmacovigilance strategy to protect the consumers!
NAFDAC did not invent the pharmacovigilance. Pharmacovigilance has been in existence internationally for many years. In fact, we are the 74th country in the world to join the pharmacovigilance system. It is a system by which when people have any adverse reactions to drugs, they report. Drugs are poisons; they have both positive and negative effects. It is when the positive effects outweigh the negative effects that we allow people to take it. What it means is that even though you are being cured of something by these drugs, it also destroys something in your system and if what it destroys in your system gets to a point that you feel uncomfortable or alarmed, that is when we call it an adverse effect. You have to report conditions like this immediately to the doctor or pharmacist for onward transmission to our pharmacovigilance centre. Adverse Drug Reaction can depend on the individual. For instance, some people take Chloroquine and it itches them a lot; it is an adverse effect. Some people take drugs and they can’t see well. Some can even be more terrible. Recently, we had reports of Analgin injection that caused severe skin necrosis (decay) in some patients. When you have such reactions, no matter how mild it is, you have to report back to whoever gave or sold that drug to you. NAFDAC distributed pharmacovigilance forms to doctors and pharmacists and we are still distributing. It has a free prepaid stamp on it so that nobody will complain of not having money to buy stamp. So they just fill the form and send to us. We collect and collate and send to Uppsala in Sweden, which is an international pharmacovigilance monitoring centre. Uppsala collates such adverse effects of drugs and when they have enough number, they will send a signal for this drug to be banned all over the world. And the Nigerian food and drug regulatory agency known as the NAFDAC can also, based on what we collate, ban the use of a drug in this country. So pharmacovigilance is so beautiful that I wish we started it earlier. If we started pharmacovigilance in the early 1990s, fake drugs wouldn’t have gained root in the system because it also allows people to report when a drug has no effect at all. So when you take a drug and it has an adverse effect you have to report and if it has no effect at all you have to report. But what happened in the past that actually encouraged counterfeiting was that some of our doctors when they prescribed Paractamol, it doesn’t work; they come back and see the patient and ask if he is still having fever. If the answer is yes, he will prescribe Novalgine. Next time he will prescribe Piroxicam etc without asking why the patient did not respond to Paractamol or Novalgine, not even to a little degree. Pharmacovigilance is therefore a good system that will enable us track counterfeit drugs and ban all drugs that need to be banned in the system. It will also help us to restrict the use of certain drugs, which is our work as a regulatory agency. So pharmacovigilance is actually a beautiful thing and I wish we can mount more public enlightenment to get our people more informed. Unfortunately, some people are even feeling uncomfortable that NAFDAC has too much campaign. Haven’t you heard that? So if we put up another campaign about this pharmacovigilance, somebody will surely say ‘oh! They have too much campaign’. Are they talking about another campaign? It is not that NAFDAC enjoys these campaigns, but we are doing it as a matter of necessity. Without awareness, people just perish for nothing. It is awareness that is making people patronise fake products. Even old women, who cannot read these days ask for NAFDAC number, expiry dates or ask others to read for them. It is what awareness has done. Today, if you tamper with expiry date in this country, nobody will buy it from you. Not only on drugs but also on other related products like foods, cosmetics etc. People are always looking for expiry date. In fact, awareness is our first strategy because it tackles the fundamental issue at stake. A problem is half solved when people are knowledgeable about it. If not for limited resources, I tell you we need more awareness especially on this pharmacovigilance, salt iodization and Vitamin A fortification of flour, sugar and vegetable oil and margarine.

On her passion about the war against fake drugs!
I am passionate about it because I know that if we even had awareness in the 1980s, my sister would not have died; there was no awareness and we were buying nonsense, even as a pharmacist. You know what I mean; it was a terrible thing and my sister died of fake drugs. It is something that pains me all the time and I also believe that I am doing this job as opportunity to help mankind.

1 comment:

  1. The original of this interview with the same title was first published by the Guardian Newspapers of Nigeria on Sunday April 17, 2005.