Pharm. Lekan Asuni is the President, Association of Nigerian Representatives of Overseas Pharmaceutical Manufacturers (NIROPHARM). He is also the founder and CEO of LEFAS Pharmaceuticals Limited. In this interview with PharmaTimes Correspondent, GABRIEL IFINNWA, he reveals how drugs manufactured locally can meet international standards, and why the pharma industry still needs government support. Excerpts:
What are your major achievements as chairman, Association of Nigerian Representatives of Overseas Pharmaceutical Manufacturers (NIROPHARM)?
As you are aware NIROPHARM represents multi-national pharmaceutical manufacturing companies locally. The Association sets and operates on a very high standard. We ensure that the international best practices are met locally. This we do through every company that represents the multinational pharmaceutical companies or through their representatives. Since, assumption of office, we have had some modest achievements. Principally, one major achievement is in the area of bridging capacity gaps – making sure that the international best practices are implemented locally.
So there has been heavy investment, in both material efforts and monetary resources to ensure an upscale, especially in the training of personnel in the relevant areas. Still, on the issue of capacity building, we have held several of this for some of our regulators like NAFDAC and other local agencies in different areas just to see how the global best practices can be implemented locally. We have also held capacity building for diverse stakeholders outside the pharmaceutical industry. Also, we have been able to champion the innovative deployment of technology in the fight against counterfeit and unwholesome medicine/drugs. We were the first to embrace technology in the fight against fake and substandard drugs. Another achievement is that we have played significant role in ensuring effective collaboration and harmony across various other trade groups and professionals within and outside the sector. In addition, we have expanded the membership strength of the Association to a very large extent. Under my tenure we have been able to organise different fora where stakeholders in the industry converge to talk on a number of topical issues.
What can be done to regulate the challenge of open drug market in Nigeria?
In the early colonial days, things were more structured. We had about 2 to 3 drug stores distributing products across Nigeria. But we started getting it wrong with the crisis in the late 80s when we had recession. The government started issuing import permits and lots of people used this import permit to do whatever they liked. That is how it started. Ideally, there should not be an open market. But going forward, I believe that it is important for those in the industry to practice in an environment where there is adequate regulatory oversight. What is lacking in the open market is that there is no access to regulation. We don’t know exactly in what conditions the drugs are being stored. Once there is no regulation, you find sub-standard drugs in circulation. I believe that those that operate in the open market have their reasons.
Some of them believe they will get more patronage and all that. But, this can still be achieved through what government is proposing with the national drug distribution guideline. This guideline will show underserved areas where people will be encouraged to set up their practice. The issue we have in Nigeria is the lack of appropriate data. I think the critical element of this guideline is the ability to map existing practice outlets with population. It can be able to tell people that there are some un-served population. It will detail the areas where the market is sizeable for you to cater for. So, I believe that once people get to know about some of the benefits of having effective regulation, through enlightenment, education, provision of adequate facilities needed, it will make it easy for those in the industry to imbibe the change. Ideally, let people practice in an environment where there could effective regulatory oversight. When this happens, the issues we have with our distribution system will be minimised as this will enable all the regulatory bodies like NAFDAC, PCN, and Nigeria Customs among others, to have access to these places. Sincerely, I think the way the industry is evolving with the deployment of technology in drug distribution it will help to curb some of the challenges in the industry.
Firstly, before a product is released into the market you need to go through the regulatory body, NAFDAC. And NAFDAC ensures that the products meet the required standard. NAFDAC also ensures that the facility meets the minimum required standard for it to operate, especially in regards to its capacity to meet good manufacturing best practices. But you know after the first batch of that process, I am not sure if there is subsequently, a follow-up after the initial stages. This is not an indictment on NAFDAC because there is so much that the regulatory body can handle. In some developed countries, they have bio-equivalent centres to run tests on some of the drugs and their compositions to determine the effects on the body. There are so many other measures put in place to check aside the chemical constituents. More importantly, for imported products, coming into the country, we need to have a proper process to ensure that they conform to standards.
There has to be constant testing and data gathering, even if the data they submit possess the relevant Quality Certificate (QC); the regulatory agency must ensure these things are in order. For the local manufacturers, the drugs can meet international standards. And some of the local companies in Nigeria are already doing this. A few years ago no factory in Nigeria was WHO accredited, but nowadays we have 3 to 5 companies coming up, and more others are coming up. What this shows is that anybody that wants to set up a drug factory should ensure from the onset that it meets the international best practices, especially WHO certification. That is the only way you can be sure of the quality and it makes them competitive in the international market to be able to partake in tenders for relevant products.
As I mentioned earlier, the Pharma industry in Nigeria is still heavily import dependent. The machineries, raw materials and the addictives are still imported. So my point is that, the quality of the products starts from the quality of the manufacturers input. The big multi-national companies audit those they source their raw materials from, because they want to be sure. So, over here we should do the same. Apart from this we need to consider how these raw materials can be sourced locally. If we cannot source the active raw materials, what about sourcing the additives? The availability of machinery still needs to be resolved too. Next is the manpower, which is making sure that the personnel that will work in the industry are well trained. The university training those to work in the industry and the industry itself must work together to ensure that the quality and quantity of people employed can deliver on the role and what is required. Again, we must ensure that the quality of the processes and procedures are strictly adhered to. The manufacturers need to be diligent to follow through on this.
Again, the manufacturers still need to have access to cheap funds. Majority of the manufacturers source their funding through the banks. The banks sometimes charge high interest rates on the loans. This is still a big issue. This prevents a lot of the manufacturers in investing heavily on the quality of their products. The other element is to also ensureconstant monitoring of the industry by the various regulatory bodies. In other advanced countries, they do this. So, we should do same here in Nigeria. Nigeria has a huge population, so we can be a huge player in the West African sub-region.We need to build on our image not only locally but internationally. This will obviously help.
How do you think the Government can help pharmaceutical manufacturers in the country?
I think the pharmaceutical industry is still not considered a key sector in Nigeria. If the government could have a bank of Agriculture, what stops them from having bank of Health or Pharmaceutical industry? This issue should not be diluted with other various sectors. Funding through a proper mechanism is very important. This will help to drive focus and convergence of efforts in all that we are doing. I have nothing against the Bank of Industry (BOI). But I think we need to have a bank of health or pharma industry to drive forward our agenda. If you look at what the Asians are doing for instance, we should learn from them. For instance, they have dedicated cluster development parks. In India, they have this. In Nigeria, we are all aware that getting a parcel of land is not easy, in terms of the monetary aspect. If you bring in the issue of roads, power, and the rest, it is really a challenge. Imagine, if we have a pharma park in Nigeria, all of the issues of associated with infrastructure will be addressed there. There will be concentration on skills and expertise.The land will be on lease. When we have such places, global developers can come in and build structures along the line.
How do you see the fight on fake drugs and what strategy do you think should be employed to effectively tackle the menace?
Counterfeiting is an illicit trade. It is like blood money. People will always try to circumvent whatever the government is doing because of financial benefits. So many efforts have been made to fight substandard medicines. And these efforts need to be sustained. The regulators need to be proactive all the time. The regulators need to be steps ahead of the counterfeiters. Firstly, I am of the opinion that the penalties to deal with those who deal in counterfeit drugs is like a slap on the wrist. I think the penalty is not stringent enough. Another way to fight this is adoption of the drug distribution guideline. This guideline if effectively implemented with transparency and leveraging on technology, will go a long way in minimising fake drugs. Another issue is speedy dispensation of justice. Most of these cases stay too long in the law courts. Even when you apprehend and decide to prosecute, it takes so long before the case is completed. Some people do not have that length of time to wait for court judgement, so they give up and will rather move on.