How NAFDAC has saved millions of lives – Akunyili
By AZOMA CHIKWE
Tuesday, May 15, 2007

•Dora Akunyili PHOTO The Sun Publishing

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The Director-General of the National Agency for Food and Drug Control (NAFDAC), Prof (Mrs) Dora Akunyili has declared that the agency has sanitized the food and drug industry in the country, created a well regulated environment that has saved the lives of millions, and created a level playing field for industries to grow.

She told Daily Sun that local industries that were just 70 in number and were moribund when she came into NAFDAC, are now 150. Multinationals that left Nigeria out of frustration are now coming back.

Equally, share prices of pharmaceutical companies in the stock exchange are rising, and Nigerian drugs banned in other West African countries are now unbanned, she said.

New NAFDAC
When the new NAFDAC came on board in April, 2001, we had about two decades of failed regulation which resulted in massive importation of copy of original brands of regulated products, and when I say regulated products, I mean the products that NAFDAC is regulating. And NAFDAC was actually established by decree 99 of 1993, and this decree regulates and controls the production, the importation, the exportation, the advertisement, the use, the sale of all drugs, processed food, cosmetics, medical services, all drinks including our popular pure water, chemicals and so on.

So, this copying of original products we had, dumping of expired products we had, even pure water produced in every street unregulated, we had rampant outbreak of water-borne diseases, especially cholera, we had soft drinks that were supposed to be of the same quality with similar products in other parts of the world because they are the same brand, but they were giving us something different because there was no regulation. We had juices that are not naturally very sweet, but you find them being as sweet as honey. That’s why I call them fraud on people’s health.

We had beer and other alcoholic beverages that did not bear date before now, and most of them contain nitrosamin. Nitrosamin is a natural bye-product of brewery, but it takes a lot of refining to remove it from beer, but they were not doing it for beer consumed in this country, but they were doing if for export. In fact, one of the brewers that was in Premier brewery confessed to me that they were exporting in the past but at a time they stopped, because they were going through a lot of trouble to refine beer for export. But they were giving these to our brothers and sisters, you and I.

We also had a lot of poison put in our food in one way or the other like bromate in bread. They were using bromate to bake in this country, it just enhances the bread abnormally. It enhances very well, much more than the usual healthy enhancers and is very cheap, but they know that this bromate causes cancer, kidney failure, loss of hearing, breakdown of vitamins in bread and other deleterious effect. We had over 95 per cent of bakery, using bromate in this country.

In fact, we started enforcement in early 2002, I was watching television at night of bread being burnt, I couldn’t sleep, I called my directors up in the midnight and said from tomorrow no more enforcement, let us start public enlightenment campaign so that the number of miscreants will reduce because I don’t want people to say we are hungry, what is wrong with these people.

I didn’t want us to get into that, we needed to be sensitive, that’s when we started public enlightenment campaignment and all.

But the worst form of unwholesome food we encountered in the process of our regulation and control in the past six years was when we caught somebody who for many years was mixing baby milk, cassava flour and sugar. So, only God knows how many babies have died of being poisoned by cyanide. This case is currently in court.

Also, in the area of cosmetics, we have the so-called designer perfumes. We intercepted so many people puffing empty bottles and packets of designer perfumes and diluting and filling them with diluted concentrates here in Nigeria. Especially the ladies were using these things containing mercury, hydrophenol which not only destroys the skin but targets the kidney.

We also have copies of genuine food products, but never contained the level of protein they were supposed to contain.

In our regulation for chemicals, we’ve noticed a lot, people were massively importing chemicals that were banned or restricted, that could be used in developing explosives or refining hard drugs. We had to monitor them from port to industries, and monitor how much they use, how much they requested and how much is left. And that has actually reduced the quantity that is brought in and the misuse of it, especially in splashing their enemies with acid and so on.

In the area of drugs, the situation is even worse because we had substandard drugs in this system for over two decades, drugs that did not contain any active ingredient. When a drug contains neither taste nor smell, it contains nothing but chalk.

Like Supradyn capsules, we burnt hundreds of cartons containing olive oil, because they know that there is no way of knowing. When a drug contains chemicals that have characteristic taste or smell, they add a little. Out of all the chloroquine, amobiciline, and ampicillin we destroyed, we never found up to 20 per cent active ingredient. They were re-labelling expired products, they could even be declared as agents of waste disposal by these Asians who are their collaborators. They were copying original brand. They were also labelling drugs totally what they are not.

Two years ago, a senator called me, and said he is dying, I asked what is going on? He said: Can I send somebody to come and collect the Novak in my house? Eventually, he told me that when he started taking the Novak, he was collapsing and sweating, we rushed the Novak from Abuja to Lagos laboratory, do you know that this Novak was simply re-labelled anti-diabetic. These criminals are only interested in money. They can re-label any drug, any name.

Because Novak was scarce, and in this same way if anti-diabetic becomes scarce, they re-label anti-hypertensive, anti-diabetic. And that explains why some people just die like that and they tell you, they had no problem, they are just on their normal medication. And when we took the sample of Novak, we went to the shops and markets.

Because that is our system, when we get fake drugs, we go to the shops and markets and we scream and bring them out. Not only bringing them out from the system to burn, we also use receipts and invoices to find out, where the retailers buy them from. Then from retailers to distributors, from distributors to importers, from importers to the factory that made it. That was how we were able to ban 30 Indian and Chinese companies and one Pakistani company, total of 31, from importing drugs into this country.

Fake drugs were first noticed in Nigeria in 1968, and the situation continued to deteriorate. By 2001, Nigeria was rated as about the country with the highest incidence of take drugs. And consequently, made-in-Nigeria drugs were banned in other West African countries. Some researchers like Kool in 1989 said that 25 per cent of drugs in Nigeria were infected, 25 per cent genuine, 50 per cent inconclusive, Lambo in 1990 said we have 54 per cent fake and that the figure will rise to 80 per cent the following year, Osekpe et.al reported that we had 41.4 per cent fake and Osolo et.al reported in 2001 that we had 48 per cent of drugs in circulation as fake. We took a conservative average of 41 per cent, that means we have 41 per cent of drug in circulation as fake.

And we looked at the level of compliance with registration and found out that 68 per cent of drugs in circulation were actually unregistered, and when drugs are unregistered, it means they are not supposed to be sold in the country. And most fake drugs are actually unregistered.

The evil of fake drugs are too many, but let me just point out a few. People were dying like rats, we had treatment failures, we had resistance for antibiotics and anti-malaria. Before 1970, as a child, whenever I was ill, my grandmother would give me a few coins to go and buy chloroquine, and they give you two tablets of chloroquine, you drink it and go to school, by noon you are sweating and you are fine.
By the 80s, we developed resistance to chloroquine because we were taking sub-standard. What is resistance? Resistance is when you are taking little, little quantities of a chemical, the organisms in the body or parasite will get so used to that chemical it becomes like food.

When you eventually take the standard dose, the organisms would not react. We moved from chloroquine to Fansidar and Halfan. These people counterfeited this second line. And we developed resistance. We moved to artesunate, we developed resistance again. And we moved to Artemisinin Combiration Therapy (ACT). The question is, if ACT fails, where do we go from there? Are we going to use magic or witchcraft to treat malaria?

So as people were dying, our local industries were going under, multinationals left us out of frustration, we had about 70 manufacturers, they were producing little or nothing, just about 20 per cent of our drug need. We just went on and on, we were actually drowning, and then we decided to wage a war.
We started this war, the counterfeiters could not believe it, they thought it was a joke or like any other Nigerian story, they felt we will make noise and it will soon be over, but it was not over. We employed many strategies, and our most effective strategy in fighting these criminals, merchants of death and blood suckers is through public enlightenment campaign.

That is the reason each time we talk about what we have done, I say it is Nigerian press that will get the award. Because it was so aggressively reported that the level of awareness got very high, not only in the area of fake drugs and even in the area of expired products. Because some of these multinationals were dumping expired products into this country or one product that is about to expire, but not anymore.
After public enlightenment campaign, our next strategy is actually to tackle them from those countries where these fake drugs are imported.

Most of the fake drugs circulating in this countries are imported from India and China. I have told you how we identify the places. And consequently, we go to any country to inspect facilities of production before we register any product. In fact, before we put up that guideline in January 2002, most of the people that submitted their fruit juices for registration disappeared, because we wanted to see that unlimited orchards and production lines where they were producing the fruits.

Again, we have put independent analysts in India and China that re-certify drugs before they are imported into Nigeria. So, we don’t just depend on what the manufacturers are telling us. And we are so strict that any drug that is not re-certified by independent analysts is collected and destroyed. And they know, so they are complying and we’ve made more success in India than in China. China is still a problem. In fact, when you have meetings with Chinese officials, you get more frustrated after the meeting than before the meeting.

Because even if you don’t understand the language, and look at the faces of the people and the interpreter, you see body language, so you discover that what you are saying is different from what the interpreter is saying and they pretend not to understand a word of English. But we have at least made an in-road for the fact that we have an independent analyst in China.

We also have a system where we insist on pre-shipment information, from the drug importers before the drug is accepted. You have to tell us what you are bringing in, every detail down to conveyance vessel, we are also working with Nigerian banks, they do not allow anybody get financial document for purchase until the person clears from NAFDAC. And we also very importantly, insist that before any drug is registered in this country, we must ensure that drug is used in the country of production.
And we do that by getting certificate of pre-sales signed by Minister of Commerce or Trade or Industry of that country authenticated by Nigerian embassy. And if we don’t have Nigerian embassy in any country, we use commonwealth mission or any other African mission.

I don’t want to go on and on with our strategies because I have already given you the highlights.
Well, it is not all bad news, we have some good news. The good news is that we have sanitized the food and drug industry in this country.

And we have created a well regulated environment that has saved the lives of millions of Nigerians and created a level playing field for industries to grow. The local industries that were just 70 in number and were moribund, they are now 150. Multinationals that left Nigeria out of frustration, are now coming back. Share prices of pharmaceutical companies in the stock exchange are rising.

Our drugs that are banned in other West African countries are now unbanned. We have secured 45 convictions, we destroyed over 104 billion dollar worth of fake products.

We are not only working in the area of drugs, we regulating food and cosmetics very strictly. Both food and cosmetics industries are springing up. Nigeria has been celebrated as the first country in the world to achieve universal salt-iodization, and we have been celebrated in many countries, 2003 in Beijing, 2005 in Senegal and so on. Nigeria is an example for all developing countries.

And our sanitization of table water has greatly reduced incidence of cholera and other water-borne diseases. In the bakery industry, we’ve recorded a great success rate. We had over 95 per cent of bread containing bromate in the past, but right now we have 0.01percent. I cannot go on and on and on.