NAFDAC says 10% of anti-malarial drugs fake, sub-standard
•Procures $2.4m device to test active ingredients in medicines
All is set for Nigeria to begin local production of vaccines by the end of this year, according to Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Christianah Adeyeye.
Adeyeye, yesterday, at a media parley with Health and News Editors, in Lagos, also said a survey carried out in 11 states showed that nine to 10 per cent of anti-malarial drugs in circulation were fake and substandard.
She, however, said the agency had begun a bigger study and procured a $2.4 million device to detect the quantity and quality of active ingredients in medicines.
Adeyeye submitted: “We are working day and night to make sure that by the end of the year, we start manufacturing of vaccines. That doesn’t mean that we will produce completely developed vaccine.”
The DG said the Minister of Health, Dr. Osagie Ehanire, had gone through different pathways and still on the process for the project to see light of day.
“But the Federal Government also has a Public Private Partnership (PPP) arrangement with Biovaccines or with May and Baker rather to form Biovaccines. The government has 49 per cent and May and Baker has 51 per cent. The goal is to be able to manufacture vaccines and this arrangement started long time ago. So, it not just because of COVID-19 pandemic,” she added.
Adeyeye, who is also a pharmacist, said Nigeria is upbeat about manufacturing of local vaccines because NAFDAC had achieved Maturity Level 3.
The World Health Organisation (WHO), last week, announced that Nigeria and Egypt have joined Ghana and Tanzania as effective regulatory systems in Africa.
It explained that the two new entrants’ medical products regulatory agencies had achieved Maturity Level 3.
Maturity Level 3 means that these national bodies have been found to function well and could be eligible for inclusion into the transitional WHO Listed Authorities, a list that comprises the world’s regulators of reference – that is regulatory authorities – that should be globally recognised as meeting international standards.
WHO said Nigeria attained Maturity Level 3 for medicines and imported vaccines, even as several other regulators on the continent are undergoing assessment.
On fake antimalarials, Adeyeye said: “Antimalarials are the most used and you find out that they are the most falsified. From the survey we did in 11 states across the North and South, we found out that we have about 10 per cent, actually nine per cent plus falsification. I will not take that to the bank, in the sense that we are doing even a bigger study, but that is the latest that we have now, not the 70 per cent fake news that pervaded the news about a month plus ago.”
“For antimalarials, we have about nine to 10 per cent, but we are going to expand the study to involve border towns because a lot of activities take place near our borders, and that is where smuggling of bad products takes place,” the NAFDAC boss clarified.
On the way out, she observed: “We did a survey with WHO in terms of quality of our medicines and we found some companies compromising. We shut down their lines. It cost them lots of money not to produce for about three months. But it is good to set a deterrent so that they will not repeat it.”
Regarding the production of the vaccines, Adeyeye said: “Yes, we are working on local manufacture of vaccines. NAFDAC is part and parcel of it, and we are looking forward to a very bright future in terms of starting manufacturing. Whether we are using modular laboratory to begin with, which is Good Manufacturing Practice (GMP) ready. It is like a mobile home that is already fitted to be able to start quickly. Whether we are using that or the traditional that will take longer time, but I am thinking that very likely, we will start with the modular vaccine lab.
She explained that WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool’ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators – covering core regulatory functions such as product authorisation, testing of products, market surveillance and ability to detect adverse events to establish their level of maturity and functionality.