By Biola Lawal
…NAFDAC Can Now Produce Vaccine
ABUJA – The World Health Organization (WHO) has certified Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) as a maturity three regulatory agency.
”With this, we (NAFDAC) can manufacture our own vaccines,” DG, Prof. Moji Adeyeye announced happily at a press conference on Wednesday in Abuja.
Flowerbudnews reports that Prof. Moji Adeyeye disclosed that this major feat made Nigeria the third African country and few globally to attain this status.
The NAFDAC Boss said that the process of local vaccine production has started with the construction of a vaccine laboratory in Oshodi, Lagos.
She said that this feat could have been achieved without the tremendous support of President Muhammadu Buhari who magnanimously gave seven hundred and thirty-six million to equip our laboratories.
According to her,” When I came on board, 70 to 80 per cent of our laboratories equipment were not working and President Buhari intervened and gave us seven hundred and thirty-six million (736 million) to equip our laboratories.
” President Buhari also gave us four billion to buy more equipment and build a vaccine laboratory which is almost completed. it is the tools that earn us this, and I thank President Muhammadu Buhari for his kind gestures.
“We are already working on Maturity Level four which will enable any products we approved as a regulatory agency to be traded globally.
Since we don’t produce, the pharmaceutical companies that produce will have a larger market
” There is no fear on our side getting certification for maturity four because we have our template and we have been recertified by WHO since 2019, once we get recertified by November this year, we start self-auditing, which is going to keep us on our toes. This has to be sustained because they will be coming every three years”, she said.
Adeyeye said that the journey of attaining the status all began January 2018, five weeks after her resumption as the director-general of the agency, and that the agency went through a lot of tasks before it could attain maturity level three.
He said that she got to know about the news at about 1 a.m on Wednesday and she immediately broadcast the news via e-mail to some relevant government personalities.
“The agency has earlier been told sometime in 2018 that it needed to meet up with 868 recommendations before it can get to maturity level three, and the agency immediately step-up work on the process.
“WHO Global benchmarking is all about comparing regulatory agencies that work to carry out tasks pertaining to the best health regulatory agency in the world, it is not about comparing ourselves with ourselves but with the best.
“And, they told us that we need to meet up with 868 recommendations before we can get to maturity level three, it sounded impossible but my directors stood by me all the way,” she said.
According to her, there is a group of people in NAFDAC, we call them the Global Benchmarking team, and they have sacrificed a lot, they are the one that were marking whichever recommendations we have met.
“In June 2019, WHO came to NAFDAC physically to start the benchmarking process and out of the 868 recommendations, we were able to make over 600 and we have 147 left up till June 2019, but those 147 that were left were the most difficult ones.
“We started working at it with retreat, with training because it is all about training, one thing we also did in parallel making sure NAFDAC is built on a quality system is `quality management system’, it was it that got us to the 147 recommendations left in 2019.
“We continue in that direction, but in July 2021, WHO met us virtually and we were able to reduce the 147 to 33, the 33 were the most difficult, our staff work endless hours, I thank them, may I also use this medium to thank the council for recommending regulations, they work tirelessly,’’ she said.
Adeyeye said that with 33 tasks of recommendations left, WHO came back in October 2021, and by then the agency was able to clear all the remaining recommendations, and was waiting for it to re-bench mark the agency.
She said that WHO also came between Feb. 21 and Feb. 25 for re-bench marking the agency, and the information was finally broken to the agency today (Wednesday).
According to her, global benchmarking requires about eight functions that must be performed to the satisfaction of WHO among which is licensing and inspection.
She stated that through-out the journey of attaining this present status, the Pharmacists Council of Nigeria (PCN) was rightly behind the agency because it stood a prime position in ensuring the licensing of pharmaceutical companies before they can start operating.
She said that without NAFDAC and PCN, Nigeria would be filled with substandard and falsified medicine, adding that PCN did a lot of downstream functions in checking for substandard.
Adeyeye stated that the agency would work further to ensure it attained level four (4) maturity status, and thanked President Muhammadu Buhari for the confidence reposed in her to work for her mother land.
Mr Yusuf Suleiman, Chairman, NAFDAC Governing Board, also appreciated the impact played by the government, adding that government support had made the agency to strengthen its regulatory capacity.
He said that the level three maturity status bestowed on Nigeria meant that the country would be recognized worldwide, and that whatever the agency approved as NAFDAC would be certified worldwide.A
lhaji Yusuf Suleiman also acknowledged the hard work of the DG and staff of NAFDAC.
“The certification to Maturity level 3 by WHO is an indication that NAFDAC is well functioning and global agency,” Alhaji Suleiman stated.
“We gave ourselves a target, to cross the last huddle, I made a commitment that the DG see us through maturity level four, once we get to this level, everything we approved will get global acceptability”, the NAFDAC Chairman said. (Flowerbudnews)
