Flowerbud News

Author: Ibrahim Abusadiq

  • 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

  • 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
  • NAFDAC DG Advocates Strong Regulatory System to Boost therapeutic medicines vaccines Devt in low income countries

    NAFDAC DG Advocates Strong Regulatory System to Boost therapeutic medicines vaccines Devt in low income countries

    By Aderogba George

    Prof.  Moji Adeyeye, Director-General,  National Agency for Food and Drug Administration and Control (NAFDAC), has sought  for a regulatory system for effective quality therapeutic medicines and vaccines in low and medium income countries.
    The D-G made the appeal in a statement signed by the agency’s  resident media consultant, Mr Olusayo Akintola on Wednesday in Abuja.
    The D-G made the assertion while speaking at the hybrid University of California San Francisco UCSF)-Stanford Centre of Excellence in Regulatory Science and Innovation, (UCSF-Stanford CERSI) summit in the United States.
     Adeyeye spoke at the summit as the only panelist selected from Africa on the theme: “Building a Global Vision for Product and Drug Development: Challenges and Opportunities”.
    Adeyeye said that only  a strong regulatory system would guarantee and accelerate the development, approval, and access of safe and effective quality therapeutic medicines and vaccines in low, medium income countries of the world.
    She admonished nations on the premise of strengthening regulatory system in compliance with the World Health Assembly Resolution 67.20 of 2014, to build the capacity of member states with the ultimate goal to have access to quality medicines to different low, medium income countries.
    According to her, the World Health Organisation (WHO) supports member states in reaching and sustaining effective regulatory oversight of medical products through the regulatory systems strengthening RSS programme.
    She explained to the global audience how NAFDAC under her leadership, used the WHO Global Benchmarking Tools to achieve the Maturity Level 3 WHO Certification Status in March 2022 and its significance to Nigeria.
    Using US Food and Drug Agency as reference which was categorised as Maturity Level four, Adeyeye said that ‘’you cannot get Maturity Level three without taking care of all the indicators under Levels one, and two. and indicators in MLone, MLtwo and MLthree.”
    Speaking on ‘’Global Benchmarking Tool and Access to Medicines’’ at the annual global event, she noted that there was no 95 or 99 per cent in terms of WHO Global Benchmarking.
    She disclosed that the GBT essentially facilitated NAFDAC to identify weaknesses and strength in licensing of products, in the manufacturers and distributors compliance, and how effective and how its post marketing surveillance were doing to contain market control in terms of illicit trade.
    She disclosed that NAFDAC was benchmarked on seven functions including licensing establishment which was under the Pharmacy Council of Nigeria (PCN) jurisdiction, adding that both agencies were benchmarked together.
    She said the agency met and satisfied 268 indicators and 860 recommendations, noting that 268 indicators were distributed under Maturity Levels one, two, three, and four and we were able to attain Maturity Level three after meeting all the requirements and were declared in March 2020.
    She, however, noted that attaining Maturity Level four would not be too difficult and that some of the standards or indicators had  already been met.
    She said that NAFDAC was  working round the clock as she had already set out targets for Maturity Level four and that the agency was  working for both in order to ensure that the system was well established and stable and well-functioning as a regulatory agency.
    The NAFDAC boss,  however,  emphasised the importance of reliance for different regulatory agencies in the world, adding that reliance represented a smarter way of regulating medical products through collaboration, shared knowledge, experience, and resources.
    “The reliance is among the different functions such as regulatory inspection, lab testing, clinical trials, market authorization, pharmacovigilance, market control and licensing establishment.
    She explained that there was a lot of reliance within different functions and there had to be a reliance between agencies, adding that agencies had to collaborate, identify weak links and leverage on the experience of others, mentor others.
    She stated that there could not be local manufacturing without a strong regulatory system, adding that NAFDAC was using a lot of tools to ensure that products from Nigeria were more affordable and were of high quality using different GMP inspection.
    She disclosed that the agency had employed detection devices to get rid of infiltrations in the supply chain,  adding that NAFDAC was  now  using traceability Track and Trace GS1 to monitor falsified medicines.
    NAN
  • NAFDAC shuts vegetable oil outlet in Kano State

    NAFDAC shuts vegetable oil outlet in Kano State

    By Aminu Garko

    The National Agency for Food and Drug Administration and Control (NAFDAC) says it has closed a vegetable oil-packaging outlet in Gidan Ruwa, Airport Road, Nassarawa Local Government of Kano State.

    Alhaji Kasim Ibrahim, the coordinator of the agency in Kano State, announced this while addressing journalists in Kano on Monday.

    “We have arrested one Alwalu Abdulsamat and sealed the outlet in Gidan Ruwa, Airport Road, Nassarawa Local Government Area.

    “We have also intercepted a tanker at the premises discharging an unregistered vegetable oil into 25 litres plastic labelled with a trade mark not recognised by NAFDAC.

    The coordinator said “the refilling of the vegetable oil is taking place in an unregistered and unhygienic premises with poor packaging practices”.

    He said that the tanker was meant for the distribution of petrol chemical products.

    “We have sealed the premise and taken the tanker to our premises for further regulatory actions,” he said.

    NAN

  • NAFDAC arrests 8 suspects for allegedly producing unhealthy ice cream, yoghurt

    NAFDAC arrests 8 suspects for allegedly producing unhealthy ice cream, yoghurt

    By Obinna Unaeze

    The National Agency for Food and Drug Administration and Control (NAFDAC) in Niger State,  said it arrested eight suspects for allegedly producing unhealthy ice cream, yoghurt and bread.
    Mr  Shaba Mohammed, Director, North Central Zone of the agency, disclosed this to the News Agency of Nigeria (NAN) on Wednesday in Minna.
    She said this after a surveillance by the agency in Suleja area of the state.
     “During our surveillance in Suleja today, we discovered a cluster of 15 sites producing unhealthy ice cream, yoghurt and bread for school children in Suleja.
    “We immediately swung into action and eight suspects were arrested in connection with the unwholesome practices,” he said.
    Mohammed explained that the suspects produced the products and sold to unsuspecting school children in Suleja.
    He said that during the raid, one bakery that engaged in using potassium bromate to produce bread, was also discovered.
    The Director said that NAFDAC also discovered that the products were not registered and certified by the agency.
    “These products are unwholesome, we discovered the use of harmful chemicals in the products.
    “The products are being produced in an unhealthy environment.
    “Some of these products can cause cholera, cancer and other health issues,” he said.
    He admonished parents, guardians and school management to be conscious of what children consumed to ensure healthy living.
    “We want parents and school management to stop persons into such unwholesome activities from bringing their products into the school environment and report them to NAFDAC,” he said.
    Similarly, Mr Francis Ononiwu, Director of Enforcement in the gency, said the suspects, who were with the police, would be investigated and prosecuted accordingly.
     Mr Ahmed Yusuf, an Assistant Chief Regulatory Officer, said that the agency would intensify efforts with the police to apprehend the real owners of the production outlets.
    Earlier, Mr James Kigbu, the state Coordinator, said that the exercise was a continuous measure to protect and safeguard  public health.
    NAN
  • NAFDAC warns against use of unapproved cosmetics

    NAFDAC warns against use of unapproved cosmetics

    By Isaiah Eka/Nathan Nwakamma

    The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians not to use unapproved cosmetics because the dangers were largely irreversible.

    The Director-General NAFDAC, Prof. Mojisola Adeyeye, gave the warning during the media sensitisation workshop on dangers of bleaching creams and regulatory controls for South South Journalists in Port Harcourt on Tuesday.

    Adeyeye, who was represented by Dr. Leonard Omokpariola,  Director, Drug Evaluation and Research, said the menace of unapproved cosmetics such as bleaching creams in Nigeria had become a national health emergency that required multi-faced regulatory approach.

    According to the NAFDAC D-G, the unapproved cosmetics used banned and toxic chemicals to achieve skin lightening effects that leaves the user with undesirable effects.

    She listed some of the harmful effects of bleaching creams to include cancer, damage to vital organs of the body like kidney and liver.

    It also causes skin cancer, irritation and allergy, skin burn and rashes, wrinkles, premature skin ageing and prolonged healing of wounds.

    The DG said that  the World Health Organisation in a 2018 study, revealed that use of skin bleaching creams was prevalent among 77 per cent of Nigerian women which was highest in Africa, compared to 59 per cent in Togo, 35 per cent in South Africa and 27 per cent women in Senegal.

    She said that the essence of the sensitisation workshop was to train Journalists and stakeholders, who will inform the public on the dangers of those cosmetics.

    Adeyeye added that the sensitisation workshop was a Train the Trainers’ programme with the great expectation that participants would assume role of champions in the campaign against use of bleaching creams in the country.

    She added that after the sensitisation campaign, the agency would take stringent regulatory actions to stem the dangerous tide of rampant and pervasive cases of Nigerians using bleaching creams.

    The director general thanked journalists and stakeholders for their collaboration and support for NAFDAC to rid the country of the menace of substandard and falsified medicines, unwholesome foods, corrosive cosmetics and other substandard regulated products.

    Representatives of Pharmaceutical Society of Nigeria, cosmetics manufacturers, supermarket operators, Nigerian Customs Health officials, amongst other stakeholders attended the workshop.

    Earlier, Dr Abubakar Jimoh, NAFDAC Director of Public Affairs, said the war against menace of bleaching cream across the country was sequel to a resolution of the 2022 Senate, promoted by Sen Oluremi Tinubu.

    According to Jimoh, the Senate resolution crystallised to a memorandum from the  Secretary to Government of the Federation directing NAFDAC to strengthen its regulatory functions to curb the menace.

    NAN

  • NAFDAC approves R21 malaria vaccine

    NAFDAC approves R21 malaria vaccine

    By Aderogba George

    The National Agency for Food and Drug Administration and Control
    (NAFDAC) said it has granted approval to Serum Institute Pvt. Ltd. (SIIPL) R21 malaria vaccine for the treatment of malaria in Nigeria.

    The Director-General, Prof. Mojisola Adeyeye, said this at a news conference on Monday in Abuja.

    She said that the granting of registration/approval was in line with the agency’s mandate as stipulated
    by its enabling law — NAFDAC Act CapN1, Law of the Federation of Nigeria (LFN) 2004.

    Adeyeye said that it became necessary to grant approval for the vaccine following the 2021 World Malaria Report that Nigeria had the highest number of global malaria cases of 27 per cent.

    She said the highest number of deaths stood at 32 per cent of global malaria deaths in 2020, adding that Nigeria
    accounted for an estimated 55.2 per cent of malaria cases in West Africa in 2020.

    “Malaria is one of the most important public health concerns in the world, the latest World Health Organisation (WHO)
    Malaria Report shows there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020.’’

    She explained that the estimated number of malaria deaths stood at 619000 in 2021 compared to 625000 in 2020.

    “Over the two peak years of the pandemic (2020–2021), COVID-related disruptions led to about 13 million more malaria
    cases and 63000 more malaria deaths.

    “The WHO African Region continues to carry a disproportionately high share of the global malaria burden. In 2021 the
    region was home to about 95 per cent of all malaria cases and 96 per cent of deaths.

    “Children under five years of age accounted for about 80 per cent of all malaria deaths in the region. Four African countries
    accounted for just over half of all malaria deaths worldwide, with Nigeria; 31.3 per cent, the Democratic Republic of the Congo;
    12.6 per cent, United Republic of Tanzania; 4.1 per cent and Niger; 3.9 per cent respectively.

    “Malaria is transmitted throughout Nigeria, with 97 per cent of the population at risk. The duration of the transmission
    season ranges from year-round transmission in the south to three months or less in the north,’’ she stressed.

    She said that the Marketing Authorisation Holder’s (MAHs) for the vaccine is Fidson Healthcare Ltd,
    which had the agency’s Drug and Related Products Registration Regulation 2021.

    According to Adeyeye, the R21 malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution.

    She explained that “a dose, which is 0.5ml, is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an
    adjuvant filled in a vial as ready to use liquid formulation for intramuscular injection.’’

    She said that the vaccine is indicated for prevention of clinical malaria in children from five months to 36 months
    of age, adding that the storage temperature of the vaccine is 2-8 °C.

    The NAFDAC boss said the agency had several pathways for registration of vaccines, in line with the agency’s guideline for registration of Imported Drugs, Vaccines and IVDs under Collaborative Registration Procedure.

    Adeyeye said the agency received the dossier of the R21 Malaria manufactured by SIIPL and subjected it to independent review at two different levels.

    She added that as a matured regulatory agency, it is expected as part of global benchmarking that external advisory
    committee was put in place to give advise upon invitation on certain functions of the agency.

    She said that as a new biological molecule being given consideration for full registration, the independent review
    by an external body became imperative to further safeguard public health.

    The external advisory body known as NAFDAC’s Vaccine Advisory Committee (NEVAC) is made up of four highly
    recognised, well-published experts from Nigeria’s tertiary institutions, she said.

    She listed the institutions where the advisory body members were selected as Nnamdi Azikwe University, Awka,
    Anambra State; University of Lagos, Lagos State, University of Ibadan, Oyo State and Usman Dan Fodio University, Sokoto, Sokoto State.

    Adeyeye said that the agency also had in-house Vaccine Review Committee (NEVAC) extracted from different directorates of NAFDAC to oversee, evaluate, as well as carry out clinical trials on vaccine before approval was made.

    She said that the dossier was reviewed using WHO standard across relevant domains, in addition to the European Medicines Agency guidelines (where appropriate), scientific rigor on the vaccine.

    According to her, the review of NAFDAC’s committee has always been guided by the same international standards and best practices with the same modality of independent review by members.

    “This is followed by long hours of plenary where rigorous assessment of each review took place.’’

    She said that the committee also independently scored the assessment as satisfactory, which was then
    forwarded to the director-general and that upon submission of the reviews of both committees, the NAFDAC boss
    called for a joint review session on April 14.

    Adeyeye said that the joint review process provided the opportunity to harmonise the assessments, the outcomes of the reviews were discussed, and the recommendations and queries/clarifications were consolidated to be referred to the
    manufacturers.

    She said that the R21 Malaria Vaccine dossier complied substantially with best international standards with which
    the dossier was benched-marked.

    She added that the Joint Review Committee concluded that the data on the R21 malaria vaccine were robust
    and met criteria for efficacy, safety and quality.

    NAN

  • NAFDAC solicits stakeholders, public cooperations to rid country of hazardous pesticides

    NAFDAC solicits stakeholders, public cooperations to rid country of hazardous pesticides

    By Aderogba George

    The National Agency for Food and Drug Administration and Control (NAFDAC) is soliciting the cooperation of stakeholders and the general public to rid the country of hazardous pesticides.
    The agency’s Director-General, Prof. Mojisola Adeyeye, said this in a Statement issued to newsmen by its resident media consultant, Mr Olusayo Akintola, on Sunday in Abuja.
    According to her, pesticides are applied both indoors and outdoors for the management of pests, vector-borne diseases, and for crop protection.
    Adeyeye said that pesticides are sometimes impregnated in textiles, paints, carpets, and treated wood to control pests and fungi.
    She said what was worrisome was the toxicity associated with the misuse and abuse of pesticides as it affected food safety and food security.
    According to her, the toxicity of pesticides is managed through stringent regulatory activities to reduce severe health implications on humans, crops, and the environment.
    She disclosed that this could be achieved through awareness and continual sensitisation of stakeholders on the dangers posed by these pesticides.
    Adeyeye said that the dangers posed by pesticides were of immense concern to the agency and that there had been recent concerns from stakeholders about this dangers
    “The report of the study conducted by Heinrich Boll Foundation; a Non-Governmental Organization, that claimed that 40 per cent of pesticides used in Nigeria had been banned in the EU.
    “There was also an alert received from the Federal Ministry of Agriculture and Rural Development (FMARD), cautioning on the possibility that the European Union and United Kingdom were exporting banned Neonicotinoid Pesticides to Nigeria and other poorer countries.
    “Emphasis was placed on Chlorpyrifos and its variants due to their harmful effects on humans, animals, beneficial insects, and the environment.
    “The mandate of NAFDAC as established by Act Cap N1 Laws of the Federation of Nigeria 2004 is to regulate and control the manufacture, importation, exportation, advertisement, distribution, sale, and use of food, drugs, cosmetics, detergent and others.
    “This necessitated the review and analysis of the list of registered pesticide and agrochemical active ingredients in the NAFDAC Registered Product Automated Database (NARPAD) vis-à-vis actives banned, non-approved.
    “The outcome of the review was shared with stakeholders at a three-day virtual stakeholders’ engagement held on the 22nd, 24th, and 29th of November 2022,” she stressed.
    Adeyeye said that the core function of the agency of safeguarding the health of the nation was so paramount to the agency.
    She disclosed that the reviewed meeting focused much on the proposed phase-out/ban of these active ingredients and it had in attendance, proponent holders of marketing authorizations and NGOs.
    Others, she mentioned in the statement, were All Farmers Association of Nigeria, CropLife Nigeria, Nigeria Agro-Input Dealers Association, Ministries, Departments and Agencies (MDAs) as well as research institutes.
    According to her, at the end of the meeting, it was agreed that Pesticide and agrochemical importers and manufacturers would be advised to institute stewardship plans such as Post Marketing Surveillance and research in their companies.
    Adeyeye stated that NAFDAC would  collaborate with research institutes in the conduct of research and scientific data generation on pesticides to enable the agency make evidence-based decisions and policies.
    She said that NAFDAC would also intensify Post-Marketing Surveillance

    nationwide, adding that there would be continual sensitization and education of relevant stakeholders on the safe and responsible use of pesticides.
    The D-G disclosed that NAFDAC would  engage with other sister agencies like the Federal Ministry of Agriculture and Rural Development, Standards Organization of Nigeria (SON).
    Other organisations the agency would engage with are the National Environmental Standards and Regulation Enforcement Agency (NESREA), Nigeria Agricultural Quarantine Service.
    She said that the engagement was to ensure synergy in the regulation of pesticide and agrochemical products.
    The NAFDAC boss said that this is in addition to the Ban of Paraquat, Chlorpyrifos, and Atrazine with effective dates from 1st January 2024, 1st November 2024, and 1st January 2025 respectively.
    She said that the agency had also initiated the action plan for the ban/phase-out of 12 active ingredients and the reclassification of four others.
    The D-G said that the availability of alternatives in the country were put into consideration to ensure that stakeholders, most especially farmers, will not be affected by the decisions taken.
    NAN

     

  • Institute lauds NAFDAC for prompt action on indomie ‘special chicken flavour’ noodles

    Institute lauds NAFDAC for prompt action on indomie ‘special chicken flavour’ noodles

    By Abujah Racheal

    The National Institute for Cancer Research and Treatment (NICRAT), has commended the National Agency for Food and Drug Administration and Control (NAFDAC) on the prompt intervention on the imported Indomie ‘special chicken flavour’ noodles

    This is contained in a statement issued by the Director-General/Chief Executive Officer, NICRAT, Prof. Usman Aliyu in Abuja.

    Aliyu’s statement followed ongoing investigations and analysis by NAFDAC in respect of Indomie Instant Noodles in Nigeria.

    This followed the news of the recall of Indomie instant noodles (special chicken flavour) by Taiwan and Malaysia authorities on the alleged presence of ”ethylene oxide”, a compound associated with increased cancer risk.

    Aliyu said that the institute  will be collaborating with NAFDAC to ensure safety of Nigerians.

    “NICRAT is deeply worried that, if found that some brands of Indomie noodles contain ethylyne oxide, then, Nigerians should expect an escalation of various forms of cancers in the months or years ahead, depending on how long people have consumed that brand.

    “More worrisome, is that Nigerians should also expect an increase in cancer cases among children because Indomie noddles is a popular food among most Nigerian children.

    “Our in-depth review of ethylyne oxide indicates that it is a highly reactive chemical that is used as a raw material to make other compounds such as glycol ethers and polyglycol ethers, as well as a range of emulsifiers, detergents, and solvents.

    “Ethylene oxide is also widely used as a fumigant for cleaning culinary goods, including spices,” he stated.

    He noted with concern the fact that cancer has claimed a lot of lives in Nigeria.

    In 2020 alone, he said, 78,000 Nigerians died as a result of cancer-related complications (34,200 males and  44,699 females).

    He, therefore, advised Nigerians to obey NAFDAC’s instructions on the ban and consumption of Indomie Instant Noodles ‘Special Chicken Flavour’.

    NAN reports that NAFDAC reaffirmed the ban on importation of Indomie noodles into the country.

    NAN reports that NAFDAC began random sample tests of the noodles and other brands on Tuesdat.

    NAFDAC’s food safety and applied nutrition directorate is to randomly sample Indomie noodles (including the seasoning) from the production facilities while post-marketing surveillance directorate (will) samples from the market.

    NAN reports that NAFDAC said ethylene oxide   is on the prohibition list of the federal government

    NAN