State of Emergency Looms in Pharmaceutical Sector

18.06.2013 02:58:08 | Webadmin
Source: Nigerian Tribune, June 6, 2013 An interview granted the Nigerian Tribune by Mr. Olakunle Ekundayo, MD Drugfield Pharmaceuticals Ltd.

Mr. Olakunle Ekundayo - Managing Director, Drugfield Pharmaceuticals LtdAll countries aspire to be self sufficient and self reliant in medicine to cater for their health needs while at the same time monitoring what the populade consumes. However, Mr Olakunle Ekundayo, the Group Managing Director, Drugfield Pharmaceuticals Ltd, in this interview with Sade Oguntola expresses fear on Nigeria achieving this.

The Nigerian Pharmaceutical Development Fund (NPDF) was put in place to boost local production of medicines. How far has this guaranteed quantity and quality of available drugs, including those produced by Drugfield Pharmaceuticals Ltd?
The NPDF is made available to help Nigerian companies to modernise their facilities, ensure they become GMT compliant and meet current GMP practices. Although this will impact their efficiency, it is not really meant to make Nigerian pharmaceutical companies to be World Health Organisation (WHO) prequalified.

Most of the facilities are very old. For instance, Pfizer has a factory that was built in 1976 in Ikeja, which now metamorphosed into Neimeth pharmaceutical. You can imagine how old a facility that was built in 1976 is. It really needs to be modernised.

Even companies that are purely indigenous, like Emzor pharmaceuticals which were built years ago need to be modernised because the standards in pharmaceutical industry are always changing. They are always going up. But access to funding is a major constraint to increased and improved capacity.

Unfortunately, Drugfield Pharmaceuticals has not ventured into this fund. The way we structure our business and the way we approach issues is such that we like to inject our own funds. Even when we are expanding or building new ones, we factor current GMP practices into it.

What is the WHO’s prequalification standard all about and why the common notion that it is meant to help meet the standard?
That is not the original intention of this fund. Of course, if a company has a product or two, it wants WHO‘s prequalification for it to be able to compete in international tender. This fund will help start the process of meeting the current requirements for such products.
WHO prequalify products, it does not prequalify companies. They do this because the donor agencies have a list of drugs for diseases they put their money into such as HIV/AIDS, malaria, tuberculosis and of course some vaccines. These agencies approach WHO to help them select companies that can make products that will meet WHO’s standard.

Can you appraise the pharmaceutical sector in Nigeria, against the backdrop of insecurity, lack of access to funds and power problems?
What companies in business do for quite a while now is to daily improve on what they do, meet current standards despite all these challenges and remain in business.

That is why companies are always looking for avenues for increased funding so that they can do what they are supposed to do. Nonetheless, the truth is that for manufacturing, these are the toughest times that you can ever imagine.

For pharmaceuticals, it is even worse because this sector is highly technologically-driven. Processes for making drugs are very complex. You need the right equipment and materials that meet the highest standards because drugs are meant to take care of ailments, not to cause more problems.

Unfortunately, infrastructure development in this part of the world is so poor. Despite all these, a lot of finished products, especially drugs, are allowed in from different parts of the world in an unbridled fashion.

Aside the fake and substandard products, we are beginning to see products that are manufactured in Nigeria that are cloned in China and India, being brought in.

Cloned products, what does this mean?
Take the neurogesics, for instance, which is made by our company, Drugfield Pharmaceuticals in our name and colours. You can imagine another company in China producing it, putting our name that we are the manufacturer, putting our Nigerian address, our logo and then shipping it to Nigeria. When you take a sample and analyse it, you discover that it is all rubbish.

When did this start?
It started for some years ago. We have been battling this for three to four years. Recently, there was a big catch by NAFDAC. The importer brought in two of our major products-neurogesic and microten cream, which were produced in China. The quantity seized filled two 4-foot containers.

They also fake products of other companies such as Greenlife Pharmaceuticals. All these products came in through our seaports.

One of our products, Becotin cream, contains cortimazole as its active ingredient. This is a chemical substance whose importation has been banned by the Federal Government because Nigeria has more than enough capacity to make them.  Although this is in the tariff books, they are still allowed into the country. So many pharmaceutical manufactures cannot even sell their products.

Given that disposable income is very low, people are always looking for cheap products. Unfortunately in a lot of cases, they end up buying fake products, which are offered to them as genuine, but at very low prices.

What happens to expired drugs and how are they supposed to be handled?
When a pharmaceutical company sends its products out, they can become short-dated if they are not moving fast. But there must be a recall system the moment the product becomes short-dated, maybe six months to expiry, such products should come back to its manufacturer. That is normal thing. Short-dated products are supposed to be recalled and sent back to the company.

Drugfield Pharmaceuticals LtdWhat is the company supposed to do with such products?
Depending on the product, the pharmaceutical company is allowed by law to recheck the potency of the product, if it is not a generic application.

For instance, the potency of a product at the point of its going out from the factory should be a minimum of 99.5 per cent. If it comes back to the company six months to expiry and such is analysed and its potency was still 99.5 per cent, by law, the company can extend its shelf life by six months maximum.  And then in terms of physical deterioration, it must still be intact.

But there are certain products that will not fall into this category such as antibiotics. Once they expire or are short-dated, you do not want to take that risk. If they come back to the company, you replace such with fresh products because that builds confidence.

So, pharmacy outlets should not wait till any medicine expires. Rather, such should be returned the moment they become short-dated to the sales representative of the drug manufacturer who will give a form to the person to fill and a kind of credit note.

That is the more reason it is best to stock products that are manufactured in Nigeria. If, for instance, the products were made in India, China or Germany, they cannot be returned.

If you have problems on this, can you report to NAFDAC?  Will they take such a case up?
Of course, that is why there are regulatory bodies. No company likes to be taken up on such issues because that is on the wrong side of the law. This is a requirement that all pharmaceutical companies must fulfil.  

Can individuals return such short-dated medicines, even though they are not pharmacists or medical doctors?
This is going to be hard because once medicines are brought from the shelf, the seller is not going to take it back. But people must understand that if they buy one to two packs and they have complaints, they have a right to complain about the quality of what was brought to the pharmacy shop where they purchased it.

That is why it is good to patronise registered pharmacies. But if you are not getting the expected response, then you can walk up to NAFDAC. Even as an individual, they will listen to you.

How have tariffs of materials for drug manufacturing as well as trade liberalisation imparted the pharmaceutical sector?
The issue of tariff in Nigeria is such that one will want to ask whether this country knows what it is doing when it signed the ECOWAS trade liberalisation policy, which also include tariffs.  Of all the ECOWAS countries, this is the only country where tariffs are highest on materials that are used to produce locally.

Some of the ingredients that are used for medicine manufacturing, including packaging materials that cannot be made in Nigeria, attract as much as 20 per cent import duties. But another company that brings in the same finished product into the country will be asked to pay 10 per cent import duty for bringing the same product.

Take, for example, our eye drop for treating glaucoma. Its bottles, including its tips and caps, are made of a special material and pre-sterilised by gamma radiation. We have to pay 20 per cent duty on these special eye drop bottles, and another 5 per cent VAT.

But in importing this eye drop as a finished product, I will probably pay about between five and 10 per cent. So you then ask yourself if it makes sense to manufacture locally or just import.  So, these days, quite a number of Nigerian manufacturers are now importing finished products to come in to sell.

Actually, this is a sector in which they should declare a state of emergency. Do you know why? Drugs are so important in the life of every person, whether young or old. If you are not able to produce most of what you consume, then you will always be at the mercy of other countries.

Of what significance is this?
The world has become more and more a dangerous place in that a large percentage of a country can be wiped off through someone putting something terrible in medicines that will be shipped into that country and which you know people will consume.  

So it is always good for a country to be self sufficient and self reliant as well as to be able to monitor what it consumes. There is a risk where  there is very little control over what goes on in the system.

The warfare that people fight these days does not involve guns and grenades. It is a biological warfare and this can wipe out large populations of a country without lifting a finger. So we need to be more self reliant, look more inwards and make sure that we produce more of what we consume.

How self reliant is Nigeria?
Certainly, there is no country that is totally self-sufficient. But as we speak, Nigeria imports about 70 to 80 per cent of what it consumes and only makes about 30 per cent here.

What determines the choice of drugs that you manufacture right from inception?
When we started about 20 years ago, we noticed that products to fight skin infections were imported mostly. This was to give us an opportunity to render some services in this area and that paid off.

Over the years, we have always been looking for opportunity areas and making products to fill in the gaps. For instance, we ventured into eye drops because we discovered that most of the eye preparations that were in use were being imported.

We are also into some small volume injections and intravenous fluid manufacture. This has helped us in so many ways to stay alive and in business.

The SMS –authentication system, how effective has it been?
The mobile authentication system, which is called MAS, is the latest technology that NAFDAC has introduced to help the end users identify a product that is genuine from that which is not.

After buying a pack of medicines, the code on it is scratched open and the numbers seen are sent by SMS and there comes an instant answer to authenticate whether it is genuine or not.

The first set of products which they have chosen are the arthemisin-based antimalarials (ACT). From January this year, no pharmaceutical company is allowed to produce or import into Nigeria any ACTs without this mobile authentication in their individual packs. This is a very great step forward.

Although it is a little bit expensive, it is desirable.

So what does Drugfield Pharmaceuticals Limited do? What are its areas of interest and emphasises?
For us, it has been a phenomenal growth in terms of out therapeutic coverage areas where we try to make the difference in the lives of our Nigerians, trying to make available to them products that they can trust.

We have been doing our own bit to make sure that Nigerians are always healthy so as to contribute to the development of not only Nigeria, but the world we live in at large.