The Registrar/CEO of the Pharmacy Council of Nigeria (PCN), Ibrahim Babashehu Ahmed has explained that the newly introduced e-regulation framework is designed to protect access to medicines while preventing misuse and illegal supply.
In an interview with ARISE NEWS on Friday, Ahmed said that the launch of E-Regulation of pharmacists in Nigeria represents an important step in strengthening the regulation of pharmaceutical practice in Nigeria, particularly in response to the growing role of online platforms in medicine distribution.
“We had COVID-19 and there was a total disconnect; the supply chain was disrupted. People could not go out to buy their—in fact, e-commerce was generally activated, it became alive. And incidentally, in that space of e-commerce, medicines also were now beginning to travel or being distributed, being sold, being accessed online. That, of course, threw up a challenge.
“Now, when this started happening, what was even more worrisome was the fact that controlled medicines began to also find their way into this space. And of course, that was where we also started as an agency with the responsibility to regulate this space for the distribution, the sale, and the practice of those who are involved in all these processes. We felt that we also had to position ourselves, inasmuch as we’re already going through to ensure that all the physical facilities you see are duly registered, duly operated, and duly covered by licensed professionals. That space within the internet also needed to be safeguarded so that, one, certainly we will facilitate access to medicine through these facilities,” Ahmed explained.
Ahmed also explained that under the e-regulation framework, prescription-only medicines will only be dispensed when there is a valid prescription issued by a certified medical practitioner.
“Indeed, prescription-only medicines will not be dispensed to anybody unless and until there is a duly issued prescription by a certified medical practitioner. Over-the-counter medicine even has to go through the process of control. Having said that, the controlled medicine, under no circumstance will they go through this process because of their nature in terms of tendency of being abused and misused.”
Speaking on the impact of e-regulation on underserved communities, Ahmed said that the framework is designed to improve access to medicines for people in rural and hard-to-reach areas.
“Certainly. This even serves them more because a fisherman maybe in Bayelsa or a farmer in Zamfara can, through the process of e-health, go through this platform and access medicines through appropriately registered and licensed facilities. Believing the fact that such persons today all have phones; they do all kinds of things with the phones,” he said.
Ahmed also also disclosed plans for a National Electronic Pharmacy Platform that would connect all operators in the sector, ensuring only approved and compliant facilities were allowed to participate.
“We also have a platform. Of course, this administration must give it to the Coordinating Minister of Health, who has the agenda of bringing digitization into the health space, so there is going to be e-health. This is also going to be a facility. One thing I need to state is the fact that to drive this process, ultimately we are going to establish a National Electronic Pharmacy Platform so that anybody that is playing within this space has to be connected to this, and without you being connected, of course your medicine cannot go through because we are not doing this only as the Pharmacy Council,” he revealed.
The PCN Registrar underscored that the Council is in collaborations with other agencies to ensure a health space that is well-regulated and secure for the benefits of Nigerians.
“Let me inform you: in doing this, we are working with NITDA. We are working with NCC. We are working with the Nigeria Data Protection Commission. We are working with INTERPOL. So, it’s a space that is well-regulated, but ultimately for the benefit of the citizens.”
Ahmed expressed confidence in the Pharmacy Council of Nigeria’s capacity to implement and enforce the e-regulation framework.
“Certainly, I can say confidently that we do. But let me tell you what we’re doing now and where we’re going. As it stands now, we already have some of these players who have submitted themselves for regulation.”
Adding, Ahmed noted that permits have already been issued to some applicants who have submitted themselves for regulation, while others are still operating outside the system.
“I can say here confidently that we have issued some permits to those who have submitted themselves to regulation. There are some that are still playing out there and that is now the direction we are going through the setting up of the National Electronic Pharmacy Platform, working with NITDA, working with Data Protection Commission, and working with NCC,” he said.
Ahmed warned that some operators would not be able to access the online transaction space without integration between relevant agencies and the PCN platform.
“Some of these people will not be able to access the internet space to do transactions because there is going to be a handshake between these agencies and the Pharmacy Council of Nigeria platform. They will do their own first-level approval to ensure: does this person meet the criteria set by the PCN for them to do this? So, it’s something that is going to be highly integrated, not just from the health angle, but it’s also going to carry along the regulators within the system,” he explained.
Speaking on the validity of the permit after issuance, Ahmed said the permits issued under the e-regulation framework would be valid for one year and would require annual renewal after expiration.
“Of course, in fact, it’s going to be issued annually. Renewable after expiration.”
Ahmed further said that Nigeria remains import-dependent for medicines but is strengthening local manufacturing through government policy and NAFDAC’s 5+5 policy, which limits long-term imports and promotes partnership with local manufacturers.
“I will answer that question in two ways. Yes, we are import-dependent, but we must state here that currently, we are moving away greatly to having our local manufacturing improved upon, or manufacturing capacity improved. Through the deliberate policies of the current administration, which of course the Honorable Coordinating Minister of Health is driving. Today and again, supported by what NAFDAC is doing through the 5+5 policy.
“If you have imported a product for 10 years—I mean for 5 years, renewed for 5 years—you can’t bring that product for importation again. You must partner with a local manufacturer to do local manufacturing. So, the manufacturing capacity in-country has improved. In fact, it used to be 70/30; I think we have gone to the point of almost 50/50 now,” he explained.
Ahmed further stressed that no one is allowed to import or manufacture medicines in Nigeria without first being certified and licensed by the PCN before carrying out any transaction.
“I need to state here, nobody brings in drugs, nobody manufactures any drug in this country without first of all being certified and issued a license to do so by the Pharmacy Council. Nobody brings in any product into this country unless and until the person has been certified and licensed by the Pharmacy Council to do that transaction,” he stated.
Speaking on the circulation of fake drugs in the country, Ahmed said the circulation of fake drugs in Nigeria is largely driven by a previously disorganized drug distribution system, noting that efforts are now underway to organise and strengthen the distribution network to curb the spread of counterfeit medicines.
“That is now being supported by what we used to have as—I don’t want to use the word ‘chaotic’—but a disorganized distribution system. We are about to organize it,” he pledged.
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