Category: Features

  • Creams: NAFDAC tasks media officers on Bleaching dissemination of its effect-

    Creams: NAFDAC tasks media officers on Bleaching dissemination of its effect-

    By Aderogba George

    Abuja:.  The National Agency for Food and Drug administration and Control (NAFDAC) has tasked media officers to assist in disseminating to Nigerians the dangers associated with bleaching creams.

    The acting Director-General of the agency, Dr Monica Eimunjeze, made the plea at the flag-off of a nationwide media sensitisation workshop on the dangers of bleaching creams and regulatory controls.

    The News Agency of Nigeria (NAN) reports that the workshop was basically organised for journalists covering the health sector.

    The acting D-G cautioned Nigerians saying that there were so many bleaching creams in the market that are not regulated by the agency, and so, could cause harm to the body.

    “There are some of the bleaching creamsthat have also gone through the regulatory process on the list of licence items that are available in the record of the agency.

    “There are those who are clandenstally in the market in which the agency is yet to effect the regulatory control, and that Nigerians must be careful about those creams.

    “We see dangers inherent in using those creams products that are not in our regulatory process.

    “So, we are collaborating with health journalists to help us increase awareness on the products that have not gone through the regulatory process on the impact these could have on their health.

    “When you use a product that has chemicals that could affect the body in many ways or systemically cause reaction on the skin and could cause affection on the organ, there are many consequences such as kidney failure, liver damage from an accumulation of toxic chemicals within the system.

    “So, we want people to be aware of possibilities and try to modify their behavior.”

    According to her, though people have the right to make choices, they need to make informed choices that will guide and not the one that will hurt them.

    Eimunjeze stated that there was need for reasonable Nigerians, particularly social scientists, to examine and look at the reasons why people or why some men go for light complexioned women.

    According to her, this notion comes along with the way people perceive themselves to make them more “receivable or acceptable” in the society.

    She stated that the examination was necessary in order to make the peole who bleach to re-orientate themselves to the realities of life.

    She disclosed that the bleaching problem was not peculiar to Nigeria alone, but a global issue that needed to be discussed.

    She condemned the idea of bleaching totally.

    However, she said there were approved creams formulated to suit with one’s peculiar complexion and that this was more acceptable than bleaching the body.

    Eimunjeze stated that a lot of creams are produced that many don’t know the formulation knowledge in which the creams were made, adding that such creams are toxic to the body.

    She vowed that the agency would not allow that to continue to happen, saying that NAFDAC had the clear knowledge of formulation of those under the agency’s regulation.

    The D-G also talked about organic products which are perceived as natural, saying that not all organic products were good for the body they were not under regulation.

    She called on people to begin to make choices that would be more favourable to them. (NAN) (www.nannews.ng)/Flowerbudnews

  • NAFDAC warns bakers using potassium bromate, arrests offenders

    NAFDAC warns bakers using potassium bromate, arrests offenders

     

    The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned bakers who use potassium bromate as improvers, saying it is dangerous to health.

     

    According to it, as part of its efforts to curb the menace of importation, sales and distribution of counterfeit/fake regulated products and ensuring that only wholesome, safe, quality and efficacious products are imported, manufactured, distributed, sold and used by the Nigerians, it has stepped up efforts to raid defaulters.

     

    The Acting Director-General of NAFDAC, Dr Monica Eimunjeze, at a media briefing in Lagos on Tuesday explained that potassium bromate is a banned flour improver and a known cancer-causing agent.

     

    According to her, potassium bromate has been found to cause kidney failure among other ailments.

     

    “Potassium bromate, popularly known as tablets in the black economy, is always attractive to merchants of death who want to make outrageous profit at the expense of citizens’ wellbeing.

     

    “Bakers use potassium bromate because it helps to improve the texture of bread as well as increases its volume and it is relatively cheap.

     

    “NAFDAC wishes to state that there are recommended healthy flour improvers approved by the Agency.’’

     

    She disclosed that reiterating its resolve to reprimand offenders, operatives of NAFDAC raided and arrested suspects in connection with various fraudulent activities.

     

    “A warehouse containing potassium bromate tablets and unregistered imported EDC – 2000 BREAD IMPROVER was raided by NAFDAC operatives on Dec. 7, 2022.

     

    “ NAFDAC officers raided the warehouse located in Apongbon area of Lagos Island in Lagos where they found 115 cartons of potassium bromate tablets.

     

    “The tablets have a street value of twenty eight million seven hundred and fifty thousand naira (N28,750,000:00).

     

    “The seized tablets could be used with three hundred thousand (300,000) bags of 50kg flour to produce about thirty (30) million family-sized loaves of bread bread.

     

    “Also found in the warehouse were counterfeit EDC Bread Improver, packed in sachets with a fake NAFDAC registration number 01-4242, worth three hundred thousand naira (N300,000:00).

     

    “One Rapoluchukwu Joseph was arrested as the importer during the operation.’’

     

    She explained that apart from improving the texture of a loaf, potassium bromate also increases its volume and it is relatively cheap.

     

    Ejimunjeze said that other counterfeit products found in the warehouse included 400 cartons of counterfeit super delicious cooking margarine with fake NAFDAC registration number:- (a1-2508) and Manufactured date:- 25/01/2022, Expiry date:- 25/01/2024 with various batch numbers.

     

    She further disclosed that the NAFDAC had since Sept. 9, 2022, commenced an investigation which led its operatives to a long span of operations at states including Kano, Kaduna, Delta, Abia and Lagos States.

     

    “After rigorous and painstaking efforts, the Agency’s operatives traced and arrested one Owerekwe Obinna Michael ‘male’ 46 years of 12 Boundry Street, Aba, Abia State as the importer of the counterfeit product.

     

    “At the point of his arrest, the suspect upon sighting the operatives completely destroyed his mobile phone so that the evidence will not be traced to him. He also fought the operatives but was instantly overpowered, arrested and taken into custody.

     

    “He confirmed that he actually imported four hundred (400) cartons of the product with the above details from Dubai through groupage and cleared at Onne Port, Port Harcourt.

     

    “He claimed that the shipment was delivered to him by a clearing Agent, whose name he did not yet disclose He also admitted to distributing the product to markets across the country.

     

    “Preliminary examination of the product showed that the actual manufacturer’s name was not written, but produced for a company in Indonesia.”

    2508) and Manufactured date:- 25/01/2022, Expiry date:- 25/01/2024 with various batch numbers.

     

    She further disclosed that the NAFDAC had since Sept. 9, 2022, commenced an investigation which led its operatives to a long span of operations at states including Kano, Kaduna, Delta, Abia and Lagos States.

     

    “After rigorous and painstaking efforts, the Agency’s operatives traced and arrested one Owerekwe Obinna Michael ‘male’ 46 years of 12 Boundry Street, Aba, Abia State as the importer of the counterfeit product.

     

    “At the point of his arrest, the suspect upon sighting the operatives completely destroyed his mobile phone so that the evidence will not be traced to him. He also fought the operatives but was instantly overpowered, arrested and taken into custody.

     

    “He confirmed that he actually imported four hundred (400) cartons of the product with the above details from Dubai through groupage and cleared at Onne Port, Port Harcourt.

     

    “He claimed that the shipment was delivered to him by a clearing Agent, whose name he did not yet disclose He also admitted to distributing the product to markets across the country.

     

    “Preliminary examination of the product showed that the actual manufacturer’s name was not written, but produced for a company in Indonesia.”

     

    Ejimunjeze enjoined Nigerians to watch out for these injurious products anywhere in the country and report same or any suspected fake/counterfeit or unwholesome product to any nearest NAFDAC Office.(NAN

  • NAFDAC confiscates counterfeit antiseptics products, nabs three suspects in Onitsha

     

    By Carol V. Utulu

    Asaba:  The Taskforce on Counterfeit of the National Agency for Food, Drug Administration and Control (NAFDAC), has confiscated hundreds of counterfeit liquid antiseptics and bleaching agents in a raid in Onitsha, Anambra state.

    Dr. Christiana Esenwah, the Deputy Director, NAFDAC Directorate of Investigation and Enforcement, told the News Agency of Nigeria (NAN) on Thursday in Asaba that officials of the taskforce also nabbed three suspects during the raids.

    “These products you are seeing here are counterfeits. These three suspects were arrested with the products in Ochanja and Relief markets in Onitsha on Dec. 14, 2022.

    “The raid followed a petition from the makers of the original products.

    “The brand owners sent a petition to NAFDAC that their products are being counterfeited in the markets so we moved in and got these three suspects with the products.

    “The exhibits recovered from them include over five cartoons filled with the counterfeit products and the suspects are here with us.

    “The suspects are undergoing interrogation and after that, they will be prosecuted,” she said.

    One of the suspects, who gave his name simply as Emma, said he regretted going into the illicit business.

    He said he was compelled to venture into the business in order to take care of his father who is very sick and bedridden.

    “I knew what I was doing was wrong but I didn’t have an option. I learnt a trade but after my service year, I didn’t have anyone to help me establish.

    “When I returned home, I met my father down with sickness, with no help anywhere. So I approached one of my friends who taught me how to produce these products.

    “I have only been in the business for about three months now. I need help to take care of my father’s medical bills,” Emma said.

    However, the other two suspects told NAFDAC officials that they were not the producers of the product, but only selling them in the market to make ends meet.

    One of them, who gave his name as Okey, aged 26, said he buys the products in the market and in turn, sells them off to buyers to make profit.

    “I don’t produce these products; I only sell to buyers in the market. I have been doing the business for a long time because I make profit from it,” he said. (NAN) (www.nannews.ng) /Flowerbudnews

  • NAFDAC Warns Public Against Counterfeit COVID-19 Antigen Test Kits

     

    By Biola Lawal

    Abuja: (Flowerbudnews): The National Agency for Food and Drug Administration (NAFDAC) has warned Nigerians against use of counterfeited BTNX Incorporated’s COVID-19 rapid antigen test kits.

    NAFDAC Management said in a public notice obtained by Flowerbudnews that the product was confirmed by Canadian Authorities to have been produced without licence.

    The public notice confirmed that The genuine manufacturer BTNX Inc. has confirmed that the devices were counterfeit.

    The notice listed the features of the fake Covid-19 test kits against the original products of BTNX.

    It disclosed that the counterfeited test kits were being sold online in 25-pack boxes by a distributor called Healthful Plus without the required licence.

    The National Agency for Food and Drug Adminis (NAFDAC) is notifying healthcare providers of a safety communication by Health Canada following the discovery of counterfeit BTNX Incorporated COVID-19 rapid antigen test kits in Ontario, Canada.

    The counterfeit test kits were sold online in 25-pack boxes by a distributor called Healthful Plus without the required licence.

    NAFDAC said in the notice entitled;
    Public Alert No. 048/2022 – Warning Against Counterfeit Covid-19 Antigen Rapid Test Kits, that the counterfeit kits were labelled as manufactured by “Health Advance Inc.” instead of BTNX Inc.;

    Below is the Full Alert:

    NAFDAC is notifying healthcare providers of a safety communication by Health Canada following the discovery of counterfeit BTNX Incorporated COVID-19 rapid antigen test kits in Ontario, Canada.

    The counterfeit test kits were sold online in 25-pack boxes by a distributor called Healthful Plus without the required licence.

    The packaging of the counterfeit kits resembles the authentic (licensed) BTNX Inc. products in colour and typeface and uses the BTNX Inc. device identifier “COV-19C25”, but also has several key differences.

    The counterfeit kits: are labelled as manufactured by “Health Advance Inc.” instead of BTNX Inc.; lists Health Advance as an “Official Canadian Distributor”; and includes the text “Health Canada Approved”. Claims of endorsement by government authorities, such as Health Canada, are not permitted.

    Genuine COVID-19 Antigen test helps detect certain proteins in the virus.

    Rapid antigen tests are designed to tell in a few minutes whether someone is infectious or not.

    It is recommended as a high performing test for individuals with symptoms, high-risk populations, and healthcare or casual workers.

    Counterfeit health products are imitations of authentic products. The safety and effectiveness of these counterfeit test kits have not been assessed.

    The genuine manufacturer BTNX Inc. has confirmed that the devices were counterfeit.

    The table below shows the difference between the counterfeit and authentic COVID-19 rapid antigen test kit;

    Image Counterfeit BTNX test kit (25-pack)Counterfeit BTNX test kit (25-pack)Image Authentic BTNX test kit (25-pack)Authentic BTNX test kit (25-pack)

    Counterfeit box (top)

    Health Advance name and phone number along with text “Official Canadian Distributor” and unauthorized text “Health Canada Approved” appear on box.

    Authentic box (top)

    Authentic boxes are sealed with a clear sticker with blue lettering that says “QC APPROVED”.

    Counterfeit box (side)

    Health Advance name and phone number appear on box.

    Authentic box (side)

    BTNX Inc. name, address and symbol appear on box.

     

    Counterfeit kits – three open boxes

    Each box has varying contents, including varying test cassettes and assay buffers.

    Authentic kit – open box

    Shown here: test cassettes, tube stand, assay buffer, swabs, procedure card and package insert.

    Note, assay buffer may come in bottles (shown here) or 25 single-use vials (not shown here).

    Not shown here: extraction tubes and nozzle filters

     

    Counterfeit kits – cassette pouch found in some kits

    Expiry date and lot number may not match the box. Pouches are not green.

     

    Authentic kit – box and cassette pouch (back)

    Lot number and expiry date on cassette pouch should match the lot number and expiry date on the box. Lot numbers start with the letter “I”.

    NAFDAC advice wholesalers, distributors, pharmacies and consumers to ensure that products are obtained from authentic and reliable sources.

    Increased vigilance is hereby encouraged within the supply chain to avoid the importation, distribution, sale or use of the counterfeit COVID-19 rapid antigen test kits and to prevent the administration of the product to unsuspecting patient by healthcare providers.

    The products’ authenticity and physical condition should be carefully checked.

    Anybody in possession of the counterfeit product should immediately discontinue sale or use and submit stock to the nearest NAFDAC office.

    Healthcare providers and consumers are encouraged to report any suspicion of counterfeit drug product to NAFDAC on 0800-162-3322 or email: sf.alert@nafdac.gov.ng, report adverse events experienced with the use of the counterfeit product to the nearest NAFDAC office, via pharmacovigilance@nafdac.gov.ng, E-reporting platforms available at www.nafdac.gov.ng or via the Med- safety application for download on android and IOS stores.(Flowerbudnews)

  • NAFDAC seizes wines, spirits worth N8m from Apogbon market

    NAFDAC seizes wines, spirits worth N8m from Apogbon market

     

    By Augusta Uchediunor

    Lagos:   Enforcement Officers of the National Agency for Food and Drug Administration, and Control (NAFDAC) and its Federal Task Force (FTF) team have raided the popular Apongbon market in Lagos seizing drinks valued at eight million naira (N8,000,000).

    The operation was part of its efforts to eradicate fake, unwholesome, and counterfeit alcoholic and non-alcoholic wines and drinks from circulation.

    Anita Dabor, Head of Unit, NAFDAC, told the News Agency of Nigeria (NAN) in Lagos that many of the offending products were sold by merchants underneath the bridge.

    ?
    National Agency for Food and Drug Administration, and Control (NAFDAC) at Apogbon market, Lagos. Confiscates fake, unwholesome, and counterfeit alcoholic and non-alcoholic wines and drinks from circulation. December 2022,

    “ They were mopped up and include very popular brands of wines and spirits.

    “During the mop-up operation, a transport vehicle containing an array of drinks including JAPATA (a herbal drink that failed laboratory tests) was found hidden in the vehicle.

    “The offending products were confiscated and evacuated.’’

    “Attempts to apprehend the supplier of the Japata in the market proved abortive.

    “The products mopped up from the market are valued at N8,000,000.’’

    “However, the investigation is ongoing,’’ she said.

    According to her, NAFDAC is fully alive to her responsibilities of assuring the safety, wholesomeness, and quality of foods and other regulated products offered for sale to the public.

    Consumers are hereby advised to be vigilant and exercise discretion when making purchases, especially during this festive season, and report suspicious activities to the nearest NAFDAC office across the Federation. (NAN)www.nannews.ng (Flowerbudnews)

     

  • NAFDAC alerts Nigerians on existence of fake COVID-19 test kits

    By Aderogba George

    The National Agency for Food and Drug Administration and Control (NAFDAC) has notified Nigerians about counterfeit Covid-19 Antigen rapid test kits in circulation.

    The notification is contained in a NAFDAC public alert released to newsmen on Sunday in Abuja.

    The counterfeit BTNX Incorporated COVID-19 rapid antigen test kits was communicated to NAFDAC by Health Canada.

    NAFDAC quoted Health Canada as saying that the fake test kits were sold online in 25-pack boxes by a distributor called Healthful Plus who had not the required licence.

    NAFDAC said the packaging of the counterfeit kits resembles the authentic BTNX Inc. products in colour and typeface and uses the BTNX Incorporated.

    It said that the device identifier has “COV-19C25”, but also has several key differences, adding that it was labelled as manufactured by “Health Advance Inc.” instead of BTNX Inc.

    NAFDAC stated that on the packaging Health Advance was identified as the  “Official Canadian Distributor of the counterfeit products.

    It pointed out that the products had a claim of endorsement by government authorities, such as Health Canada.

    “Genuine COVID-19 Antigen test kit helps detect certain proteins in the virus. Rapid antigen tests are designed to tell in a few minutes whether someone is infected or not.

    “It is recommended as a high performing test for individuals with symptoms, high-risk populations and healthcare or casual workers.

    “Counterfeit health products are imitations of authentic products. The safety and effectiveness of these counterfeit test kits have not been assessed.

    “The genuine manufacturer BTNX Inc. has confirmed that the devices were counterfeit,” NAFDAC said.

    The agency advised wholesalers, distributors, pharmacies and consumers to ensure that their products are obtained from authentic and reliable sources.

    It also encouraged healthcare providers to Increase vigilance within the supply chain to avoid importation, distribution, sale or use of the counterfeit COVID-19 rapid antigen test kits.

    It advised healthcare providers to prevent the administration of the product to unsuspecting patients, adding that the products’ authenticity and physical condition should be carefully checked.

    NAFDAC said that anybody in possession of the counterfeit product should immediately discontinue sale or use and submit stock to the nearest agency office.

    Healthcare providers and consumers are encouraged to report suspected counterfeit health products to NAFDAC on 0800-162-3322 or email: sf.alert@nafdac.gov.ng.

    NAFDAC also advised the public to report adverse effects via pharmacovigilance@nafdac.gov.ng, and e-reporting platforms www.nafdac.gov.ng or via the Med- safety application for download.

    NAN

  • Breaking: Pres. Buhari Re-appoints Prof Moji Adeyeye as NAFDAC Director-General

    Breaking: Pres. Buhari Re-appoints Prof Moji Adeyeye as NAFDAC Director-General

     

    By Biola Lawal

    Abuja: (Flowerbudnews): President Muhammadu Buhari (GCFR) has reappointed the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Moji Christianah Adeyeye for a second tenure of five years.

    The Secretary to the Government of the Federation, Mr. Boss Mustapha (CFR) conveyed the approval of the President to Prof. Adeyeye whose tenure renewal took effect from 1st December, 2022.

    This was disclosed in a statement by Dr. Abubakar Jimoh, NAFDAC Director of Public Affairs, a copy of which was made available to Flowerbudnews on Friday in Abuja.

    The Director-General’s reappointment came closely on the heels of her track record of monumental achievements and successes in the last five years especially the attainment of World Health Organisation (WHO) Maturity Level 3.

    Prof. Adeyeye who officially assumed duty today (Friday) was received by some staff at the Corporate Headquarters in Abuja. She will be unfolding her plans for the second tenure after the holidays. (Flowerbudnews)

  • Buhari reappoints Adeyeye as NAFDAC D-G

    Buhari reappoints Adeyeye as NAFDAC D-G

     

    President Muhammadu Buhari (GCFR) has reappointed the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Moji Adeyeye.
    A statement issued to the News Agency of Nigeria (NAN) by NAFDAC Director of Public Affairs, Dr Abubakar Jimoh, on Friday in Abuja stated that Adeyeye re-appointment was for a second tenure of five years.
    Jimoh said  that the re-appointment by the president was conveyed by the Secretary to the Government of the Federation, Mr Boss Mustapha.
    He said: “Adeyeye’s tenure renewal took effect from 1st December, 2022.
    “The DG’s reappointment came closely on the heels of her track record of monumental achievements and successes in the last five years especially in the attainment of World Health Organisation (WHO) Maturity Level 3.”
    Abubakar said that Adeyeye who assumed duty on Friday was received by some staffers at the corporate headquarters of the agency in Abuja.
    NAN
  • Prof Adeyeye Unfolds 2nd Term Agenda, Vows More Transformative Initiatives For NAFDAC

    Prof Adeyeye Unfolds 2nd Term Agenda, Vows More Transformative Initiatives For NAFDAC

     

    By Biola Lawal

    Abuja:.  The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye has  Unfolded her  second term Agenda, vowing more Transformative Initiatives For NAFDAC.

    In a speech titled – Second term resumption speech, continuation of transformative leadership of NAFDAC, Prof. Adeyeyel expressed appreciation to President Muhammadu Buhari for the opportunity given her to serve as DG NAFDAC.

    FULL SPEECH:

    SECOND TERM RESUMPTION SPEECH JANUARY 4, 2023

    CONTINUATION OF TRANSFORMATIVE LEADERSHIP of NAFDAC
    (An Agency Strictly Guided by International Standards)

    Doing the right things makes a nation great or, simply stated, Righteousness exalts a nation. On the contrary, not doing the right things brings setbacks.

    I would like to thank the President and Commander-in-Chief of the Nigerian Armed Forces, President Muhammadu Buhari (GCFR) for my reappointment for a second term as Director General of NAFDAC. I am immensely grateful for the Presidency and the efforts made to ensure that I got the second term.

    In the process of the renewal of the term, I have discovered senior Nigerians from different parts of the country that love the country with passion and who worked very hard to ensure that the transformative leadership that started in NAFDAC on November 30, 2017, is sustained.

    I am eternally grateful to my living mentor who has believed in me before I joined NAFDAC.

    He visited me in my university in the USA more than 15 years ago and saw what I was doing in building of quality into medicine development and training of students for such purpose could benefit Nigeria.

    I am indeed grateful to the National Assembly, The Leadership of the Federal Ministry of Health, NAFDAC Council, Sister Agencies with which we collaborate and other Stakeholders.

    My first tenure wouldnt have been successful without the dedicated NAFDAC staff who placed the Agency and the country first, above themselves, and worked hard for the international recognition that NAFDAC now enjoys in both food and drug administration, and control.

    I appreciate them very much.

    My appreciation also goes to African Medicines Regulatory Harmonization (AMRH) of African Union Development-Agency-New Partnership for Africa’s Development or AUDA-NEPAD (whose Steering Committee I chaired for almost five years) and WAHO/ECOWAS-MRH for their understanding during the wait for the second term.

    I am also grateful to the Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria that had been in the tunnel with me since 2017, and especially over the last few weeks in ensuring that the industry is strengthened and becomes competitive globally. NAFDAC (as Maturity Level 3 regulatory agency) is now guided by international standards to ensure that the regulated products are of quality, safe and efficacious, thus safeguarding the health of consumers.

    Our activities are global, and our regulated products are traded on an international platform, thus underscoring the need for use of international standards.

    That brings up our international partners who since 2017 have worked very closely with NAFDAC to ensure that the Agency is strengthened and becomes recognized as an international player in the global arena.

    I am very grateful for their support and waiting during the last six weeks before the announcement of my reappointment.

    These partners include AUDA-NEPAD, WHO, World Bank, Global Fund, USAID, UNICEF, FAO, and Codex Alimentarius; IAEA, GAIN, Alive & Thrive, International Coalition of Medicine Regulatory Authorities (ICMRA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and Organisation For The Prohibition Of Chemical Weapons (OPCW).

    LOOKING BACK 2017-2022

    Upon my assumption of duty on November 30, 2017, I listed the following cardinal points as the goals to be achieved:

    Maintaining a well disciplined and motivated workforce
    Working towards eliminating substandard and falsified medicines (SFs), unsafe or illicit drugs, unwholesome foods, chemicals and other products

    Aligning NAFDAC with international standards in food, drugs and other regulated products regulation
    Reconstruction of NAFDAC web presence and streamlining the submission and approval of dossiers for registration of drugs, food, and water.
    Working towards eliminating overlaps among sister agencies, such as FCCPC, SON, NESREA, NAQS and PCN
    Engagement of Micro, Small and Medium Enterprises (MSMEs)
    Providing much needed Transportation and logistics to inspection sites as part of concerted efforts to strengthen our enforcement activities.
    I thank God that all these and much more have been achieved as stated below.

    For these, I wish to thank again His Excellency, President Muhammadu Buhari (GCFR) and his Advisers for the wisdom in appointing me as the Director General of NAFDAC in the first instance.

    You may please recall; I met an Agency with glaring symptoms of sundry administrative and procedural lapses such as shown below.
    A huge debt of 3.2 billion naira,
    Dismally low Internally Generated Revenues (IGR) of 700 million naira and a collection of 7 billion naira as user fees. Furthermore, adherence to Budget was most irregular or absent altogether.
    Essential physical facilities and laboratory infrastructures had fallen into terrible states of disrepair. Indeed, some NAFDAC laboratories were almost non-functional
    No Scheme or Condition of Service, and payment of staff allowances was very irregular.
    The skewness of nominal roll revealed a disregard for the requirements for Federal Character.
    No Post-marketing Good Distribution Practice (GDP) Surveillance

    It is with gratitude to God, and for the immeasurable support of President Muhammadu Buhari that I report that most of these problems were assiduously confronted and solved as listed below.:

    Governance (WHO GLOBAL BENCHMARKING TOOL (GBT) REGULATORY SYSTEM)

    Capitalized on competence-based HUMAN CAPITAL
    3.02 billion naira inherited debt was paid off within my first year in office. The sum of about 180 million naira were discovered to be fictitious
    Better financial management. The IGR have tripled to 2.5 billion naira. User fees have more than doubled to 15 billion naira.
    2019-Date: International Partners funding (Cash and Technical Support) received – amounted to $3,927,186.00. These funds are currently being utilized for specified purposes.
    NAFDAC was reorganized and more directorates created (from 13 to 27) for effective management
    Established a continuous training culture in customer-centric Quality Management System (QMS) for all NAFDAC mandates
    Accreditation on QMS (ISO 8001-2015) in 2019 and yearly re-accreditation since that time
    More motivated staff through trainings and better emoluments
    The better financial management enabled improvement of infrastructures and building of State offices and laboratories:
    Sokoto, Kebbi, Yobe, Ogun, Kwara, Osun and Ebonyi; plus, Ports Inspection Directorate Airport NAHCO Office and Yaba Drug Laboratory are completed or near completion respectively to meet WHO specifications.
    Over 140 New Utility Vehicles were procured for Inspection and other activities.
    Over 5 billion naira worth of laboratory equipment.
    Scheme and Condition of Service were instituted for the first time in the history of the Agency – currently awaiting approval by The Head of Service.
    Lopsidedness in hiring of new staff was remedied FCC Compliance Certificate on File.
    Established palpable and sustained collaborations with sister agencies (e.g., PCN, NHREC, NCDC, NPHCDA, FCCPC, SON, etc.), with some supported with Memorandum of Understanding
    Aligning NAFDAC with international standards in food, drugs and other regulated products regulation
    Re-accreditation (ISO 17025-2017) of four laboratories since 2018, and accreditation and continual re-accreditation (ISO 17025-2017) of Biologics/Vaccines laboratories in 2019
    All the above are part of WHO Requirements for Maturity Level 3 that were met

    Public Communications
    Transparency
    Basis for Global Benchmarking (Information shared with WHO via SharePoint)
    Most information can be obtained from the website
    Open communication with staff and Union
    Digitalization of regulatory processes
    Procurement and Finance/Account/Human Resources becoming more transparent through SAP platform
    Open communication with international partners
    Continuous improvement

     

    Scheduled stakeholders awareness meeting for different sectors (Examples)
    NAFDAC-MAN (Manufacturers Association of Nigeria) Quarterly Interactive Dialogue
    Pharmaceutical Manufacturers Group of MAN engendered better understanding
    Association of Food, Beverage & Tobacco Employers (AFBTE) for control of consumption of alcohol among children
    National Association of Supermarket Operators of Nigeria (NASON) for tariff reduction and other pending issues
    Small and Medium Enterprises Development (SMEDAN) encouraging small businesses in registration facilitation using the online NAPAMS platform
    Association of Table Water Association. Master Bakers Association, Patent & Proprietary Medicine Vendors Association for self-regulation aside from NAFDAC regulation, and for market collaboration
    Chemical Stakeholders proper handling, storage and moving of certain chemicals
    Food Manufacturers Association on hygienic and safe handling of foods in restaurant or other facilities
    Agro-Allied Sectors on Use of Pesticides
    Herbal Medicines Product Committee of Practitioners and Researchers
    Micro Small Medium Size Enterprises (MSMEs)
    TV Media weekly show on NAFDAC and Your Health (NTA&TVC)
    NAFDAC and Your Health (NTA&TVC) Radio weekly program on FRCN in English, Yoruba, Igbo, and Hausa
    Inter-Agency Meetings to Foster Quality of Product-driven Exportation of NAFDAC Regulated Products
    Social Media coverage of NAFDAC Activities (Moved Desk to DGs Office in October 2022 for better management)
    Quarterly Media Parley
    News from the Zones and States

     

     

     

    NAFDAC Regulations
    Gazetted twenty-eight regulations for food, drug, and Cosmetics (Part of WHO GBT ML3 Regulatory System)
    More regulations on Foods, Drugs, Vaccines, and Traceability in the pipeline for gazetting
    National Assembly Member-Sponsored Amendment of NAFDAC CAP N1 and C34 Bill
    Developed Traceability of the Supply Chain Regulation in process for gazetting
    Developed Vaccine Lot Release Regulation in process for gazetting

    Information and Communication Technology (IMPACTED ALL WHO GBT FUNCTIONS)

    Reconstruction of NAFDAC web presence and digitalization of many regulatory activities such as:
    E-Registration using NAFDAC Automated Product Administration and Monitoring System (NAPAMS) -WHO Global Benchmarking Tool (GBT) – MARKET AUTHORIZATION
    Single Portal Window for Ports Inspection, E-Clinical Trial Application WHO GBT Clinical Trials
    Ports Inspection Data Capture and Risk Management System (PIDCARMS). (WHO GBT MARKET CONTROL)
    E-database for registered drug products Green Book
    E-portal for dossier submission and review App to be launched in Q1 2023

    Training of Staff (Continuous and Agency-wide) WHO GBT Regulatory System Function

    Dedicated budget for staff training
    Technical areas such as Common Technical Document Formatting, Good Manufacturing Practices (Food, Chemical and Drugs), Good Clinical Practice, Good Distribution Practice,
    Leadership and Anti-corruption
    Emotional Intelligence
    Knowledge Management

    Substandard and Falsified (SFs), Counterfeit Medicines, Narcotics & Unwholesome Foods through different means and continual regulatory efforts such as listed below. WHO GBT VIGILANCE, (VT) MARKET CONTROL (MC)

    Restoration of NAFDACs presence at the ports was restored in 2018 after absence since 2011
    Tighter pre-shipment testing and control through Clean Report and Inspection Analysis (CRIA) in India & China since 2019
    Instituted Good Distribution Practices Inspection for the first time since the 1993 as part of supply chain monitoring and mitigating SFs
    Good Manufacturing Practices Road Map that involved 165 companies and resulted in risk-based categorization and monitoring of GMP Compliance
    Instituted in 2021 for the first time in the Agency history, Good Distribution Practice Post-Market Inspection
    Inspected over 550 distribution sites to ensure quality of that medical products
    Blacklisting of erring companies
    Public enlightenments
    Provision for on-the-spot detection of SFs using detection devices
    increased enforcement activities.
    Creation of the Traceability (Track and Trace) system that has been successfully used for the distribution and tracking of COVID-19 vaccines during the pandemic.

    Strict testing of Covid-19 vaccines and Issuance of over 120 Lot Release Certificates
    First African Regulatory Agency to develop Guidance on Regulatory Preparedness for Licensing and Accessing COVID-19 Vaccines
    Developed Guidance to Sponsors of Clinical Trials in Nigeria Including COVID-19 Related Trials
    Testing and issuance of over 140 quality/safety-based Lot Release certificates for ALL COVID-19 vaccines used in Nigeria during the pandemic
    Track and Trace monitoring of all COVID-19 vaccines
    Science-driven rejection of a vaccine consignment that did not meet international standards
    Staff training on Testing and Bio-manufacturing
    Strengthening Local Pharmaceutical Industry through regulatory policies or mediation with the government (WHO GBT MARKET CONTROL AND REGULATORY INSPECTION)

    Good Manufacturing Practice (GMP) Inspection Road Map Inspected over 165 companies GMP compliance that resulted in risk-based categorization
    Instituted Five Plus Five Policy
    NAFDAC Ceiling for medicines with large in-country manufacturing capacity
    Partnership of multi-nationals with local manufacturers are being formed based on good manufacturing practices compliance: Examples – GSK-Fidson Healthcare Plc and Sanofi-May & Baker Nigeria Plc
    Choice of Nigeria as a country that can manufacture vaccines facilitated by Director General and enhanced by attainment of ML3

    Herbal Medicine and Medical Devices Regulation

    New Guidance and Guidelines
    New Technical Information Submission Template
    Inaugurated Herbal Medicine Product Committee
    Organized many stakeholders/practitioners/researchers meetings
    Paired and mediated practitioners/researchers collaboration
    Registered more than forty (40) COVID-19 related herbal medicinal products during the pandemic
    Registered the first Nigerian-made medical mask during the pandemic, and was exported/sold in the USA

    International Collaboration and Reliance

    NAFDAC received support from the following international partners – World Bank, World Health Organization (WHO), United States Pharmacopeia (USP), Bill and Melinda Gates Foundation (BMGF), Global Fund (GF), United States Agency for International Development (USAID), United Nations Industrial Development Organization (UNIDO). These various supports contributed to respective global benchmarking functions and attainment of ML3.
    Training on Food Safety: The Agency has been amply supported in various aspects of Food Safety by the Danish Government through the Royal Danish Consulate General in Nigeria
    Support from Organization for Prohibition of Chemical Weapons (OPCW) in Lab Analysis/Validation and Chemical Management
    Partnership with Global Alliance for Improving Nutrition (GAIN)
    Technical support from USP on Vaccines and Biologics in some aspects of laboratory analysis and Lot Release
    Support from Family Health International (FHI) 360-Alive & Thrive for Breastmilk Substitute (BMS) Code Compliance
    Support from FAO on Total Diet Study that focuses on contaminants including mycotoxins in food as eaten and assessing the risks to the consumers.

    TRANSFORMATIONS IN SECTIONS A-J LISTED ABOVE RESULTED IN ATTAINMENT OF WHO MATURITY LEVEL 3. NAFDAC BECAME ONE OF THE 30% OF ALL REGULATORY AGENCIES GLOBALLY TO ATTAIN ML3
    THE ATTAINMENT MADE NIGERIA TO BE RECOGNIZED AS ONE OF THE SIX AFRICAN COUNTRIES THAT CAN MANUFACTURE VACCINES

    Food Safety Assurance

    Stricter regulatory Inspection or regulated foods and bottled water
    Shutting down of many food companies and water companies
    Baseline inspection of food handling facilities eateries/restaurants
    Faster time for approval (90 working days)
    Re-equipment of Food Laboratories for analysis of food components trace nutrients
    Monitoring of micronutrients in specific food items such as Fats/Oils, Sugar, Milk, etc.
    Training of staff in food safety and certification in ISO 22000
    Improvement on National Total Diet Study Activities to reduce contaminants such as mycotoxins or aflatoxins in foods that are consumed daily or slated for exports
    Risk-based regulatory inspection of food industry
    Better attention paid to products under global listing
    Continuous training in various aspects of food safety

    Proactive interaction and delivery of services to Micro, Small and Medium Enterprises (MSMEs) – Herbal Medicines and Cosmetics – WHO GBT Market Authorization (MA) and Market Control (MC)

    Effective management of MSMEs through decentralization of Food Registration to Zones plus FCT and Lagos Offices headed by Directors (six +2 Directors) for effective management
    NAFDAC was Recognized as most-improved MDA by MSME in 2020
    Continuous improvement in surveillance of food, herbal medicines, and cosmetics

    Chemical Safety

    Continuous engagement of stakeholders in the chemical industry
    Strict guidance on Chemical Good Manufacturing and Distribution Practices
    Close collaboration with Office of National Security Adviser on Distribution of Certain Chemicals
    Training of staff

    Establishment of Organization for Prohibition of Chemical Weapons (OPCW) Laboratory

    President Buhari Intervention Fund in 2018/2019 jump-started the OPCW Lab
    Training and Capacity Building of Kaduna and Oshodi Laboratory Staff
    Continuous proficiency Testing for qualification

     

    Veterinary Medicine and Allied Products

    Capacity building of staff
    Awareness and sensitization Programs for Stakeholders
    Banning of Dichlorvos (100 ml)
    Phase-out banning of Paraquat and other unsafe agrochemicals
    Enhancement in GMP Inspection of veterinary medicine and agrochemical facilities
    Post-marketing monitoring of regulated products

    STRATEGIC GOALS FOR 2023-2028

    Governance, Financial Management and Publicity
    Governance
    Continuation of meaningful deployment use of human capital
    Sustain Strong Governance Expansion of Directorates for greater and impactful management
    Obtain approval of Hazard and Regulatory Allowance (To be funded from NAFDAC Generated User Fees)
    Secure approval of Scheme and Condition of Service
    Sustain Strong Financial Management Continuity and Consolidation
    Ensure well-trained staff on SAP Account Software
    Increase IGR and User Fees by 20% from the current levels based on availability of more infrastructure and tools stated
    More accountability
    Publicity
    Use additional media outlets to disseminate noteworthy NAFDACs activities
    Initiated in October 2022 by deploying Social Media Staff to DGs Office
    Use of Twitter, Facebook, Linkedin, etc.
    Use of drama and comedy artists to convey importance of quality, safe, efficacious, and wholesome regulated products
    Make the Media parley more structured

     

    New Initiatives
    Attain WHO ML4 and World Listed Authority (WLA) Status – Attainment will enable:
    Global trade of Nigerian-made pharmaceuticals through collaborative registration with other regulatory agencies
    Local Pharma manufacturers to be more competitive in AFCTA
    Attain Vaccine Lot Release ML4 to position Nigeria strategically for vaccine manufacturing
    Ensures Good Manufacturing Practice of Nigeria Vaccine Company
    Assures quality, safety and efficacy of vaccines manufactured in Nigeria or imported
    Establishes Vaccine Clinical Trial Research and Service Pipeline for the Local Manufacturer
    Create Office of Womens Health Office
    Understudy drug, cosmetics, and food products that affect women, the unborn and the child
    Emphasize misuse or abuse of drug among women and impact on the child
    More focus on maternal and child mortality and morbidity rate

    Newer Initiatives
    Supply Chain Monitoring
    Continual sanitization of the Supply Chain Units to mitigate counterfeits and SFs
    Scale up Track and Trace of Imported and locally Manufactured Pharmaceuticals
    Establish Structured and Active Tracking and Tracing through Solution Providers
    Initiate Track and Trace of Foods
    Continual vigilance to Reduce SFs, Counterfeit Medicines, and Narcotics
    Enhancing Local Manufacturing (including Vaccines) Quality and Trade
    Training on Active Pharmaceutical Ingredients (API) Regulation
    Develop NAFDAC-Industry API Manufacturing Regulation
    Enhance Research and Development Training Platforms with the Pharmaceutical Industry

    Expand Post Marketing Surveillance (PMS)
    Recruit more staff and provide more tools
    Provide capacity building
    Make Enforcement nimbler for sustained response

    Increase collaboration with Academia
    Regulatory science training
    Drug, food, and herbal medicines regulation-oriented research

    Continuous Strengthening Regulatory Activities
    Creative Engagement of Micro, Small and Medium Enterprises (MSMEs)
    More proactive interaction with different sectors of MSMEs at the State Level
    Better Engagement on Exportation of Regulated Products
    Establish evidenced-based facilitation of export of quality NAFDAC regulated products
    Expand the role of the NAFDAC Office of Trade and International Relations
    Investigation and Enforcement and work collaboratively with NDLEA in mitigating substances or drugs of abuse
    Increase vigilance on cosmetic products
    Maintain Food Safety
    Ensure Chemicals and Agrochemicals Safety
    Establish well-structured Pharmacovigilance Inspection
    Continuation of improvement in ICT Functions
    Enhance Digitalization of More Regulatory Processes for better management and transparency
    Improve the website for better navigation

    Continuation of Infrastructural Development
    Build NAFDAC Headquarters in Abuja
    Continuation of Nation-wide Improvement of working environment Adding more Laboratories, Zonal and State Office Infrastructures

     

    CONCLUDING REMARKS:
    To the glory of God Almighty, and through the relentless efforts of a hard-working staff, the Agency has achieved much success under my leadership in the last five years. We look forward to building on these achievements while working even harder to record more achievements and successes in the coming years. Thank you and God bless.(Flowerbudnews)