Fake drug traders deserve life imprisonment – Registrar, Pharmacy Council

The Registrar, Pharmacy Council of Nigeria, Babashehu Ahmed, speaks with LARA ADEJORO on efforts to curb the illegal sale of medicines, brain drain in the pharmaceutical sector among other issues

Medicines are part of many people’s everyday life, how easy or difficult has it been regulating that sector?

Regulating the pharmaceutical sector is a big responsibility, from the highest to the lowest level; including the manufacturers, importers, distributors, wholesalers, retailers, hospitals, pharmacies and the vendors. I said so because each of the departments that undertake these various responsibilities, based on the licence issued by the Pharmacy Council of Nigeria, have the responsibility of ensuring that standards are met, inspections are appropriately conducted and the facilities meet minimum standards. Also, we ensure that at the lowest level where people access these medicines, through retail facilities or the patent and proprietary medicine vendors, which are supposed to sell only over-the-counter medicines, they stock drugs that are registered by the National Agency for Food and Drug Administration and Control. We also ensure that the conditions in which these medicines are kept or stored are appropriate; that there are appropriate personnel to attend to clients or customers, as the case may be, and to ensure that they give out appropriate information. Some drugs require special storage conditions, like control medicines, which of course people abuse these days, meaning that when you must dispense them, it must be based on a prescription and you must also record it appropriately in accordance with the Poison and Pharmacy Act. This is an overview of our responsibilities in ensuring that drugs are available to the citizens and the drugs are of high quality, safe and obtained from facilities that are registered by the PCN. We have a lot of illegal facilities that are out there, and it is based on this that we go out for enforcement.

What are the short- and long-term implications of the proliferation of such stores?

The short-term implication is very clear because we are already seeing its effect. The proliferation of unregistered premises creates an opportunity for people to access medicines that ordinarily should not be accessed. I just spoke about the issue of controlled medicines. The issue of insecurity that we are seeing today, of course, is associated with access to these kinds of medicines, because these are medicines that promote crime. By the time people take them, they hallucinate. They use them as confidence-boosters and begin to do things their normal senses wouldn’t have been able to do. They feel on top of the world and do all kinds of dirty things.

What about the long-term effect of it?

The long-term effect of it, which we are working hard to avoid, is that you have a situation where population is increasing, settlements are increasing and these people will begin to have their way into the hinterland. We no longer have a situation where we can say with the highest level of confidence that the medicines we are buying are genuine, and what that means is that people lose confidence in the health sector because drugs are the cornerstone items that you get out of the health system; after everything, they end up with medicine. When the health of the citizens is not appropriately taken care of, it affects everything, including the wealth and the economy of the nation. Essentially, the long-term impact is that people will access medicines that will not only fail in delivering the expected outcome, but could also cause some injuries such as organ failure, which becomes a problem for the society. Morbidity also becomes very high leading to a tremendous increase in mortality.

Many Nigerians are not aware of the products that require prescription, and the practice has continued because some of the stores are manned by unlicensed persons, what is the PCN doing to educate the public on this?

On the issue of prescription, we are working with the Federal Ministry of Health so that we can have a prescription policy that is approved by the ministry, and which will specify the roles and responsibilities of different cadres within the health care team. Once that is achieved, I can assure you that nobody will prescribe medicines except the person that has been authorised. Nobody will dispense medicine or be involved in the sale, disposition, or disposal of medicine, except the person that is licensed to. I know the work started some time back, and I’m sure it will be concluded, such that when you walk into a facility or a pharmacy to buy medicines without a prescription, they will tell you categorically that the policy is that you must come with a prescription and there is no other place you can go to, including hospitals. I know with that delineation of roles and responsibilities, it will really bring to the fore what medicines we can access without prescription and those we can access only when they are prescribed.

Some years ago, the PCN lamented the scarcity of pharmacists in the health sector, does Nigeria have a sufficient number now, and what is the implication of this shortage for the health sector?

Certainly, we don’t have the numbers. As I’m talking to you now, the number on the register is about 33,000. When I say the number on the register, I’m talking about the number that is actually on the register from the creation of the council, which was 1936. From this number, we have a register that is called the register of deceased pharmacists, because you cannot reallocate their numbers; people who are also in other sectors of the economy, like those who are in banking, telecommunications, non-governmental organisations and even those who are outside the country but are pharmacists. But when you talk about those who are actively available to practice pharmacy now, there are about 19,000. I mean those who have been licensed to practice. So, you can see that there is a serious shortage. The World Health Organisation’s requirement is that for a population of 2,000, you should have one pharmacist. Now, what is the population of Nigeria? Over 200 million people. So, how do you want to put the ratio of that to 19,000?

The implication is exactly what we are seeing, whereby some of those available are not working in systems or structures where medicines are directly offered to the public. Some of us are working in the regulatory set-up, some are in the administrative set-up like the ministries, some are in the NGOs. What that means is that you now have other people who are not pharmacists coming to occupy positions pharmacists are supposed to be primarily, and that is establishing facilities for people to access medicine from, but even as establishing manufacturing facilities, importations and what have you. So we have other people, especially at the retail end, you have people doing all sorts of things, establishing premises that are illegal or unregistered.

How worried are you about the brain drain challenge?

I am very worried. I can tell you that the brain drain is of serious concern to us, because if I’m to give you the statistics in terms of brain drain, you will be concerned too. From January to July this year, 270 pharmacists left the country. Last year, we had 472 who left the country. In 2021, 783 left the country. In 2020, maybe because of Covid-19, only 300 left. In 2019, 550 left. In 2018, 480 left. So, by the time we deduct this from the number of registered pharmacists, from the 19,000, almost 3,000 are out. That is a big problem.

But what is the council doing about it?

The issue of brain drain is an issue that affects virtually every profession, especially within the health sector, maybe because of what they see as greener pastures out there. So, the best we can do is to continue to improve our environment, provide an enabling environment, and this we can only do through sanitising the space through enforcement, largely, so that the environment, as it were, can be good enough for people to remain so they can also take advantage of available opportunities.

For many drug manufacturers, it was learnt that it is cheaper for them to import than manufacture locally because of the harsh business environment, is the government aware of this situation?

Yes, the government is aware and a lot of things are happening to change that. The Federal Government is partnering with M&B to promote vaccine production locally. Also, on the project called IMPACT, they are working with the Federal Ministry of Health to strengthen five local manufacturers to make them have the WHO qualification. When that happens, it means you will have people from outside the country or WHO partners and UN agencies coming here to buy drugs. However, one of the critical things affecting local manufacturers here is what is affecting the industrial sector generally – the issues of power and infrastructure. In addition to that, in the pharmaceutical industry, we also have the problem of access to funds and the fact that we don’t have an industry that specialises in the production of active pharmaceutical ingredients. So, I’m sure the ministry is currently working with the pharmaceutical manufacturers group in the Manufacturers Association of Nigeria to see how that can be improved upon. Of course, access to forex is also key for manufacturers to be able to survive. So, we will appreciate it if that can be made easy for them so that they can be able to access it easily, and at low rates, because if they get it at a high rate it is going to affect the input, and the price of the goods at the end of the day. So, we want easy access to forex for the manufacturers. It will go a long way to reduce their challenges.

The vision of the PCN, according to your website, is to create an enabling and regulated environment for the provision of quality pharmaceutical services for sustainable healthcare delivery. In what ways can pharmaceutical companies be supported for them to be more efficient?

One way we can support them is through regulatory mechanisms, one of which is undertaking routine inspections, monitoring inspections and capacity building. Recently, we sent out notices for capacity building for pharmaceutical sales representatives and medical sales representatives, and we are doing this in conjunction with the Nigerian Association of Industrial Pharmacists. Apart from that, other ways we can support them is by sanitising the pharmaceutical industry, because even if you are in the process of production, and somebody is faking your medicine, that fake product can compete with the genuine one because the cost will be low and people will patronise the fake one than the genuine one. So, we will continue to talk about enforcement to provide an enabling environment just as you have seen in our mission statement.

A law was passed in 2022 to check quackery, to what extent has the law helped to check the menace because it is a problem till date?

We must give credit to the National Assembly for the law passed in 2022. We must also give credit to the last administration led by President Muhammadu Buhari, who signed that bill into law on August 16, 2022. Also, we must give credit to all the leaders within the pharmacy sector; who stood firmly and many organisations like the Nigerian Law Reform Commission and the National Drug Law Enforcement Agency, NAFDAC, who all came together to support the passage of this law. With the Act, we are now known as the Pharmacy Council of Nigeria and no longer the Pharmacists Council of Nigeria, where people used to think that the council was for Pharmacists. Now, it is a council that regulates the pharmaceutical sector. It has brought on board the Director-General of NAFDAC as a member, and that has strengthened the collaboration between the two agencies. The PCN is also represented on the board or council of NAFDAC. Also, with the passage of that law, there is a regulation of the online sale of drugs because that has been existing without any regulation. So, the law brings all the stakeholders on board, including those who operate in the open drug market like Onitsha overhead bridge, Kano Sabon-Gari market and Idumota in Lagos. Everybody has now been brought under the regulatory body, and with that I can assure you that gradually, the law will catch up with everybody and the entire sector will be effectively sanitised and you can be sure that quackery will be taken off.

NDLEA has consistently lamented the extent of drug abuse in the country. What is the PCN doing about this challenge?

We cannot stop talking about enforcement. Now, when you talk about drug abuse, what are the sources of the drugs? Where are they coming from? In fact, specifically, they mostly come from unregistered facilities. One of the most contributing centres is the open drug market. That is why we are making every effort and reinforcing our commitment to ensure that we get the national drug distribution guideline fully implemented, wherein these markets and all unregistered facilities would be closed down.

It seems the unregistered stores keep springing up across the country, does that bother you?

We are also getting more committed, and I can assure you that we will win this.

To laymen, Nigeria has a lot of natural herbs that can be developed and converted into safe medicines, why has this not been sufficiently explored for the benefit of the citizenry?

You are right, and I can say that it has not been explored. I think it is because people are not aware of what the government is doing. That was what necessitated the establishment of the Traditional Complementary and Alternative Medicine department in the ministry. I can also tell you that the National Institute for Research and Development has been working with the Nigerian Association of Pharmacists and the academia to explore a lot of herbs and to see those that have medicinal value so that they can bring them to the fore. So, a lot of work is ongoing. There is this component of pharmacy training that is called pharmacology. It is a field of pharmacy training, which of course, focuses on what is called phytomedicines; medicines sourced from plants. So, it is a full-fledged field in pharmacy, right from undergraduate. You can also specialise in it at the postgraduate level and even become a professor in it. So, one of the checklists that we look out for when we go for accreditation is to ensure that each faculty of pharmacy has a herbarium and a farm where students are taken to learn basic plants that have some medicinal value in our environment. I can tell you that we already have some schools who through this process have even produced some medicines from these plants and are ready for use.

If they are ready, what’s stopping the use of those medicines?

Well, the issue is to be able to do it in commercial quantity, and you know it goes through processes. It has to go through the validation of NAFDAC. It has to go through clinical trials. We have some that NAFDAC has already listed and I’m sure that in no distant time, we will have many more, because there are many more on the line that are being explored. We will get to the level of listing and registration and become available on the shelf for use.

From your activities, would you say the proliferation of illegal and unlicensed stores in any way aids the distribution of illicit drugs and substances?

You have just said it rightly. The answer is yes. Registration essentially means that a facility has been certified to have what it takes to offer quality effective service delivery. So, once there is no registration, anything goes in there, and why is there no registration? It is because the person wants to evade the process of policing. That is essentially why they exist. And of course, one of the top things they look out for in terms of attempts to evade policing is economic empowerment, I mean, using those facilities to sell medicines, especially the drugs they abuse, which have become commonplace these days.

There have also been incidences of fake and expired drugs, who is to blame for the importation of such drugs into Nigeria?

I think the issue of products squarely lies with NAFDAC and I do know that NAFDAC has introduced what we call track and trace, and they are working with PCN now. NAFDAC is also in the process of activating the task force which has gone moribund for some time, to improve the oversight in this particular area of fake and counterfeiting, because you know the task force comes under the law of fake and counterfeit medicines and unwholesome processed food. So, it is entirely a task that deals directly with the issue of fake and counterfeit, and by the time it is activated and energised, we can be sure that they would be able to do a lot.

What do you make of suggestions that sellers of fake and expired drugs deserve the death penalty or stiffer penalties because their activities could lead to death or cause serious damage to people?

Certainly, I recommend stiffer penalties. Before now, the sanctions were very watery, but now they have been strengthened. But even in a court of law, if it is possible, for somebody who is found trading in fake and counterfeit drugs, we will want the person to face stiffer penalties like life imprisonment.

At the moment, how many pharmacies and patent medicine stores are licensed in Nigeria?

As of last year, we licensed 18,431 pharmacists. It is an annual activity. So, for this year, I can say it is still ongoing, but as of today, we have crossed 11,000 licenses so far.

What is the latest on the open drugs market relocation in Kano, which the PCN is insisting must be relocated to the Coordinated Wholesale Centre?

The so-called stakeholders took us to court after the commissioning, with the hope of trying to withdraw that particular process. They were waiting for the court to enforce their ‘fundamental human right’ they should not be moved out of the market. But good enough, the court has said fundamental human right does not apply to individuals who want to stay in the markets to sell medicines. The project was commissioned on February 10, but because elections were around the corner, we decided to wait for the elections to take place for the swearing-in to be done. By May 29, everything about the election was over, and swearing-in was conducted. They quickly rushed to court to stop us from the enforcement, and by June 30, the court made a pronouncement and threw away their case. In August, they went to court again to institute another case. The court has fixed October for the ruling. Let’s wait for that ruling, and then we will take it from there.

Since the PCN does not have armed personnel to enforce its rules and guidelines, to what extent has this hampered your operations?

You know we work effectively with the office of the IG as well as the Director-General of the NSCDC, so any time we need security cover for our operations, they are always ready to make men available for us, so we don’t have problem with security cover for our operations.

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