In the past, there have been several attacks, especially on social media, directed at the National Drug Authority (NDA) in regards to its role and how it conducts its regulatory mandate.
In an interview with the Nile Post, Public Relations Manager at the National Drug Authority (NDA), Abiaz Rwamwiri, explained that there are a number of factors that need to be taken under consideration before approving a certain product.
Excerpts below.
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Why did you close private pharmacies in government facilities?
We took action on March 4 2022 to implement the directive from the president. The president in 2019 December issued the directive to the minister of Health saying all private pharmacies within government hospitals should close. Before we could implement that he wrote to the minister to stay the directive until he consults with the stakeholders.
We didn’t hear from the president until the minister wrote to us last week saying that his [president’s] first directive stands and should be implemented. The background here is that before the presidential directive, there was no law that would stop NDA from licensing these pharmacies. The pharmacies that were within government hospitals had had a memorandum of understanding with the administration of these hospitals which NDA was not party to.
We have guidelines when licensing hospitals or the pharmacies and we don’t interest ourselves on how you negotiate the contract but when the president issued the directive, these had just acquired their licenses. If he didn’t tell us to stay the implementation we would have cancelled their licenses as the new government policies.
Did NDA face any resistance while implementing this directive since some of the owners are believed to be highly connected?
That didn’t happen. By Saturday every pharmacy within the government hospitals had closed and I can confirm to you they all closed .They were five pharmacies, so by Saturday the two pharmacies in Mulago were closed, another one in Hoima was closed, Kiruddu was closed, Hoima and Mbarara closed .The illegal one was that of Kawempe hospital because that one didn’t have a license.
We wrote to the administration of all government hospitals not to enter a memorandum of understanding with private drug outlets because we would not give them the license. When we are dispensing our duties we don’t look at big or small fish because our role is very clear. So we take the task before us seriously and we know there is nobody above the law.
There are many people selling herbal concoctions in different trading centers across the country, are they really cleared by NDA?
As NDA, we have been supporting and promoting the development of herbal medicines, working with several innovators, researchers and herbalists. If you are aware of our board we actually have one of the board members who is a herbalist. According to the statistics from the ministry of Health over 60% of Ugandans seek their first medication through herbal medication and as NDA we know traditionally that Ugandans, Africans generally have relied on herbal medicines to mitigate symptoms of different ailments.
The law mandates the NDA to regulate herbal medicine. What people need to know is we only come when the product is leaving a community setting. When you start producing massive and promoting these drugs for commercial purposes, you need clearance from NDA because we want to look at the issue of safety, efficacy and quality as a way of protecting public health.
There is no product which is risk free. There are several products on the market that claim to be treating different conditions such as cancer, diabetes, pressure and many others, As NDA we have been encouraging people not to buy products from the street vendors, hawkers.
Why have you frustrated the effort of David Ssenfuka, the man behind diabetes herbal remedy who came out with a lot of testimonials and Ugandans had hoped that his medicine would help them overcome certain conditions?
What you don’t know is that NDA has been engaging David Ssenfukua and his team since 2019. It is coming to three years now. David Ssenfuka claims that he has two products. The one that treats diabetes and the other one that treats cancer. We have asked him to bring his products so that we can analyze it. We asked Ssenfuka to bring his products to be notified so that we look at how safe they are and their quality because we must guard Ugandans even when we need solutions of treatment.
You don’t want to risk public health by allowing testimonials that you have not looked into. I don’t think there is anywhere you will go where they will give you a blanket approval of a product to be on the market without minimum standards.
When we asked him [Ssenfuka] to present his formulations, he brought his worries of copyright thinking that someone could steal his formulation. We gave him all the assurance. Any product in the Ugandan market is called a drug. We have its formulation and our teams signed confidentiality clauses, they cannot disclose information of our clients.
He was also concerned that when he puts his product on the market and puts on the label its content, people will snatch his products and we gave him assurance that when we approve it, we will give him a waiver of not including the content which is a special pass we have not even given to anyone.
In January this year we again met him with his lawyers at NDA, we gave him the things he needed to do, he has not come back to us. The last time we saw him was when he told journalists that he wants to leave the country because he feels threatened .We don’t know who is threatening him but also as NDA we don’t get involved in security issues.
Why do we still have few locals manufacturing drugs in the country?
Drug development and even drug business itself is highly specialised field but most importantly very expensive. I told you about the clinical trials, if you are going to go into clinical trials alone ,you need insurance, you need patience, you need specialised doctors who are going to do all these and all that cost a lot of money .
If you look at conventional drugs as simple as paracetamol from its discovery throughout the entire development to when it is introduced in the market, it can cost between $3 million to $5 million ,so that tells you why we have very few firms that are involved in drug development within Uganda.
There are a number of drug outlets and pharmacies in the country. Do you have enough capacity to regulate and monitor all these outlets?
Absolutely, we have a presence in every region in the country but also we work with the districts across the country. At every district we have a drug inspector who works very closely with regional offices to provide supervisory inspection.
We have a dedicated team of enforcement which comes from our head office to keep an eye on the entire supply chain. We also have a team of surveillance who work with our intelligence network to curb any leakage that would compromise our supply chain.Yes, we have the capacity, we have the resources and we are dedicated to protecting the drug supply chain across the country.
What is the difference between NDA and National Medical Stores (NMS) in mandate?
NDA is mandated to ensure that Ugandans have access to good quality, safe and efficacious drugs. Our role is to regulate the importation, the local manufacture, the entire supply chain of drugs within Uganda both for private and government .We are regulators and the drugs we look at are both human and veterinary drugs including health care drugs that is NDA. NMS is the government agency that is mandated to procure and to distribute government drugs to all government health centres and hospitals. NMS is part of our clients; we regulate the drugs they import.
NDA have closed several unlicensed drug outlets across different parts of the country but there is an issue of accessibility to drugs in some areas. Aren’t you making the situation worse for citizens in some parts of the country where accessibility of these products is an issue?
As NDA we are very concerned and we care about the availability and this comes with accessibility. Drugs should be there and should be easily accessed. We have been putting guidelines and mechanisms of ensuring that there is accessibility of essential drugs across the country. When you see how we regulate, we put up discouraging fees of people who want to out up pharmacies within Kampala so that they can go and establish it in other places. We don’t stop you but we charge a little higher than if you are going to go outside Kampala so that we have equitable distribution.
Whereas we want people to access drugs, like I mentioned drugs are very sensitive, they can easily deteriorate along distribution channels given how they are stored, handled and who dispenses them. That cannot compromise the key things of having the right people dispensing the drugs, having the right premises and where these drugs are stored.
What are some of the challenges NDA encounters as it carries its mandate of regulating drugs in the country?
As NDA we would love to have our presence to be in every village, we are still relying on our regional offices. The other big challenge we are facing is the porous borders we get people sneaking in or taking out drugs. People use porous borders to steal government drugs and take them across borders.We are working with security agencies to ensure that we curb that. We still have a challenges of drug misuse. There are some farmers that have become doctors to their animals yet they give wrong dosage.
