Category: Health and Environment

  • NAFDAC DG reiterates commitment to safeguard public health

    NAFDAC DG reiterates commitment to safeguard public health

    Prof. Mojisola Adeyeye

    By Joshua Oladipo

    Oshogbo: Prof. Mojisola Adeyeye, the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC), has reiterated the agency’s commitment to protecting public health through effective and efficient regulatory system.

    Adeyeye made this assertions on the sidelines of the inauguration of the agency’s newly constructed office complex on Saturday in Oshogbo.

    She said the agency would not relent in its in ensuring that regulated products were of consistent quality and available at all times to the satisfaction of consumers.

    According to her, NAFDAC is commited to ensuring that processed foods, drugs, medical devices, cosmetics, chemicals and biological/vaccines are of thorough consistent quality for Nigerians.

    “To meet the mandate of the agency, the management under my supervision, has embarked on a journey of strengthening the processes of the agency through the establishment, implementation and continual improvement of the Quality Management System.

    “Quality Management System (QMS) in NAFDAC has transitioned over the years to a robust platform for institutionalising resourceful leadership, evidence-based decision-making and engagement of a trained and competent workforce for effective customer-focussed delivery of regulatory services,” she said.

    Adeyeye said the agency had commenced building of state offices across the country, out of which she said seven had been completed.

    “With the support of the Presidency, National Assembly and the NAFDAC Governing Council, we commenced the building of state offices across the country out of which seven had been completed.

    “We are now in the processes of commissioning the offices and Osogbo is the second in the role of the commissioning exercise to the Glory of God.

    “There is no doubt that this well-equipped office will enhance the activities and operations of the agency within the state, thereby contributing to the economic growth and well-being of our people,” she said.

    In his remarks, the Acting Chairman, NAFDAC Governing Board, Dr Mufatu Yahaya, assured stakeholders that the office would served its purpose by safeguarding public health in the state.

    Yahaya added that more offices would be inaugurated in the country.

    Also, the State Coordinator of the agency, Mr Anikoh Ibrahim, commended the NAFDAC Director-General for the great feat recorded under her leadership, which he described as rare.

    Ibrahim said that the befitting office complex was borne out of the commitment of NAFDAC management under the leadership of the director-general.

    He said the agency would continue to safeguard public health in the state through effective regulatory system.

    The News Agency of Nigeria (NAN) reports that the event witnessed the presence of traditional rulers, state security heads, health associations, government officials, health personnel and other key stakeholders.(NAN )(www. nannews.ng) / Flowerbudnews

     

  • NAFDAC aims at WHO’s maturity level 4, says D-G

    NAFDAC aims at WHO’s maturity level 4, says D-G

    By Aderogba George

    Abuja:  The National Agency for Food, Drug Administration and Control (NAFDAC), says it hopes to attain the World Health Organisation’s (WHO) Maturity Level 4 Certification, in drug and food regulations.

    In a statement on Sunday, NAFDAC”s Media Consultant, Mr Olusayo Akintola, said the agency’s Director-General (D-G), Prof. Mojisola Adeyeye, disclosed the plan at the inauguration of NAFDAC’s Ilorin office.

    Adeyeye said that the certification would place pharmaceutical products manufactured in Nigeria on a higher pedestal to compete favourably in the global market.

    She recalled that at the first quarter of this year, precisely in March, the agency attained Maturity Level 3, adding that, the agency would not rest on its oars until it attained level 4.

    She said that attainment of level 3 in the WHO Global Benchmarking Tools, had placed NAFDAC among the recognised regulatory agencies in the world.

    “It is pertinent to state that these huge achievements will not have been possible without a committed and dedicated workforce, and a very supportive Governing Council.

    “The agency is not resting on its oars, but is working assiduously towards the attainment of Maturity Level 4, and the sustenance of its developmental strides,” the D-G was quoted in the statement as saying.

    She listed sound infrastructure, standard equipment, conducive working environment for personnel, and accessible office locations for all stakeholders, as key to achieving this target.

    Adeyeye said that at the time she assumed office, most of the agency’s offices were sited within the states’ federal secretariats or in rented apartments, noting that this was not good for the corporate image of the agency.
    According to her, the situation is also responsible for Micro and Small Medium Enterprises (MSME) businesses, and other stakeholders’ inability to get access to NAFDAC offices.
    “NAFDAC was created in 1993 to regulate and control the
    importation, exportation, manufacture, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, bottled water, and chemicals.
    “To meet the mandate of the agency, the management under my supervision, has embarked on a journey of strengthening NAFDAC through the establishment, implementation, and continuous improvement of its Quality Management System.
    “Quality Management System (QMS) in NAFDAC, has transitioned over the years to a robust platform for institutionalising resourceful leadership, evidence-based decision-making, and engagement of a trained and competent workforce.
    “With the support of the Presidency, National Assembly, and the NAFDAC Governing Council, we commenced the building of state offices across the country, and seven have been completed.
    “We are now in the process of commissioning them beginning with the Kwara State Office, which we are witnessing today to the glory of God.”
    The NAFDAC boss also disclosed that the Osun State office of the agency had been commissioned, while Ogun, Ebonyi, Sokoto, Yobe and Kebbi, which had been completed, would soon be commissioned.
    She said that construction had also commenced in Kano, Edo and Delta states, and the projects were now at varying stages of completion.
    Adeyeye said that the Ilorin office of the agency now had a mini hall where it could conveniently relate with the sectoral groups, and also train personnel.
    She said that, there was also a warehouse and store where unwholesome regulated products could be kept pending further regulatory activities.
    “There is no doubt that the well-equipped office will enhance the activities and operations of the agency within the state, thereby contributing to the economic growth and well-being of the people,” she said.
    She expressed appreciation to Gov. AbdulRahman AbdulRazaq of Kwara, and the good people of the state for the support NAFDAC had so far received.

    ”We look forward to an enhanced co-operation and support, as NAFDAC will continue to do its best to safeguard the health of indigenes and residents of Kwara State,” Adeyeye said. (NAN) (www.nannews.ng)/ Flowerbudnews

  • NAFDAC targets WHO Maturity Level Four Certification,  builds seven new state offices

    NAFDAC targets WHO Maturity Level Four Certification,  builds seven new state offices

    The National Agency for Food and Drugs Administration and Control (NAFDAC) will not rest on its oars until it attains the World Health Organization (WHO) Maturity Level Four certification which will place pharmaceutical products manufactured in Nigeria in a better pedestal to compete favourably in the global market. (more…)

  • Our customers are number one priority – NAFDAC

     

    By Mujidat Oyewole

    Ilorin:  Prof. Mojisola Adeyeye, the Director-General, National Agency for Food, Drug Administration and Control (NAFDAC), says customers are the agency’s first priority and are always on its mind while making any decision.

    The director-general said this at inauguration of the new State Office in Ilorin on Friday.

    Adeyeye noted that there was need to take trade regulation to customers’ door step, as well as sensitisation, saying that all the work cannot be done from Abuja or Lagos.

    “In order to meet the mandate of the agency, we have embarked on a journey of strengthening the processes through establishment, implementation and continual improvement of the quality management system.

    “This is about thinking of customers first and the quality of management system had transitioned over years to a robust platform for institutionalising resourceful leadership,

    “Also evidence base decision making and engagement of a train and competent work force for effective customer focus delivery of regulatory activities,” she said.

    The director-general however said that out of seven state offices under construction, Kwara was the first to be completed and inaugurated, others would be Osun, Ogun, Ebonyi, Kebbi, Sokoto and Yobe.

    “The building was built to help achieve our mandate, apart from offices, there is a mini hall for staff training and sectorial groups interaction, enlightenment and sensitisation.

    “This will enhance the activities and operations of the agency with in the state, thereby contributing to economic growth and well being of the people in Kwara,” she said.

    Adeyeye thanked the state government and the good people of Kwara for their support and looked forward for more support.

    The Acting Chairman of NAFDAC, Dr Muftau Yahaya, said that the agency had attained maturity level three in the World Health Organisation global birth marking tools.

    Yahaya commended the director-general for her resource oriented and environmental strive, which he said had given NAFDAC a seat among the world recognised regulatory agencies.

    He explained that the level would help the pharmaceutical manufacturing companies in Nigeria and other food industry trade their products worldwide.

    The acting chairman said that the agency had started working tirelessly to attain level four and sustain the developmental strides.

    Yahaya disclosed that the governing board had decided to decentralised the agency’s laboratory unit and would have two laboratories in each of the six geopolitical zone, including other planned intervention.

    “Nigeria will get to maturity level four and our manufacturers will enjoy global distribution of their products with ease,” he said.

    The News Agency of Nigeria (NAN) also reports that the NAFDAC Coordinator for South West Zone, Mrs Rose Ajayi, explained that she started the project during her tenure as the Kwara Coordinator.

    Ajayi noted that the director-general’s first visit to the state in 2018 helped towards achieving their goal in 2020 when they started construction, until her handing over in 2021.

    The new state office was inaugurated by the acting chairman and director-general of the agency in the presence of the State Coordinator, Mr Kenneth Azikwe, members of staff, other sister agencies and stakeholders. (NAN) (www.nannews.ng)/ Flowerbudnews

  • NAFDAC trains 564 health workers on med safety tool for E-reporting

    By Stella Kabruk

    The National Agency for Food and Drug Administration and Control (NAFDAC) said that it had trained 564 health workers on med safety tool for E- reporting of Adverse Event Following Immunisation (AEFI).

    The state Coordinator, Nasiru Mato, stated this in an interview with the News Agency of Nigeria (NAN) on Friday in Kaduna.

    He said that as vaccine-preventable infectious diseases continue to decline, people had become increasingly concerned about the risks associated with vaccines.

    He said that the trained health officials were drawn from both primary and secondary health facilities.

    Mato described AEFI as an untoward medical occurrence which follows immunisation but does not necessarily have a causal relationship with the usage of the vaccine.

    He said that vaccine-associated adverse events might affect healthy individuals and should be promptly identified to allow additional research and appropriate action.

    He said that  the World Health Organisation (WHO) had established a Global Advisory Committee on vaccine safety in order to respond promptly, efficiently, and with scientific rigour to vaccine safety issues.

    The coordinator said that NAFDAC plays a vital role in ensuring that all medicines available to the consumer are safe, qualitative and efficacious adding that the safety of medicines is critical in any healthcare system

    “Continuous monitoring has been identified as a centre point and critical toward the attainment of this goal.

    “Core stakeholders and healthcare providers at all levels have an important role to play in this regard, hence, the need to remain abreast with the skill on the use of the globally accepted electronic-based *MED SAFETY* tool for reporting of adverse event following immunisation.

    “It is in view of this that NAFDAC in conjunction with the African Field Epidemiology Network (AFENET), and the Kaduna State Primary Care Board (KSPHCDB) conducted refresher hands-on practical training sessions for some of their personnel.

    Mato said that the training was for Disease Surveillance Notification Officers (DSNOs), Monitoring Evaluation Officers (MEOs), Local Government Cold Chain Officers (LCCOs) and Local Government Immunisation Officers (LIOs) in the 23 local government areas (LGAs) of Kaduna State.

    NAN

  • NAFDAC Boss, Prof Moji Adeyeye assures Nigerians of safety of children vaccines in the Country

     

    By Biola Lawal

    Abuja: Prof. Mojisola Christianah Adeyeye, (FAS), the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians of the safety of children vaccines in the country.

    In a statement she personally signed, a copy of which was made available to Flowerbudnews, Prof. Adeyeye declared that no vaccine with 40 per cent mercury was being administered on children in Nigeria.

    The NAFDAC Boss also declared as untrue, some reported statement made that “children in Nigeria were being administered a vaccine that contains 40 percent mercury which was prescribed by foreign organisation.”

    ‘:This statement is not true,” Prof Adeyeye stated, explaining that ”Mercury is a metal, and it is not used as an element or as a component of vaccines
    The NAFDAC DG explained further:

    ”The basic components of vaccines are Antigens, adjuvants to improve immune response, antibiotics to prevent contamination during manufacturing, preservatives, and stabilizers.

    Thimerosal a mercuric compound which is a preservative used in multi dose vaccines contains a different form of mercury called ethyl mercury.

    ” As a vaccine preservative, thimerosal is used in concentrations of 0.003% to 0.01%, (for example, thimerosal content allowed in vaccine is between 30 parts to maximum of 10o parts out of million parts of the vaccine formula).

    ”Thimerosal is a mercury-based preservative that has been used for decades in the United States in multi-dose vials (vials containing more than one dose) of medicines and vaccines.

    ”There is no evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site.

    ”However, in July 1999, the Public Health Service agencies, the American Academy of Paediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.

    ”Nigeria still receives some multi dose vaccines which contains thimerosal but at accepted concentration.

    ”However, World health Organisation has not proscribed the use of thimerosal as an inactivating agent and preservative in vaccines as there is lack of evidence that thimerosal present risk to human health.

    ”The WHO has closely monitored the scientific evidence relating to the use thimerosal as a vaccine preservative for over 10 years especially through independent expert advisory group, the Global Advisory Committee on vaccines.

    ”The committee has constantly reached the same conclusion.

    ”There is no evidence to suggest that the amount of thimerosal used in vaccines poses a health risk
    .
    ”Other expert groups the U.S. Institute of Medicine, the American Academy of Paediatrics, the United Kingdom Committee on Safety of Medicines, and the European Agency for Evaluation of Medicinal Products have reached similar conclusions

    nafdacc

    ”NAFDAC follows WHO approved protocol before issuing out lot release certificates before any human vaccines can be used in Nigeria, which is done after laboratory analysis and summary lot protocol review.

    NAFDACSafeguarding the Health of the Nation (Flowerbudnews)

  • NAFDAC procures 40 detection devices to curb influx of bad medicine, says D-G

    By Salisu Sani-Idris

    The National Agency for Food and Drug Administration and Control (NAFDAC) has procured 40 detection devices to enable the agency track, trace, monitor and curb the influx of bad medicine in the country.

    The Director-General of the agency, Prof. Mojisola Adeyeye, made the disclosure in an interview with the News Agency of Nigeria (NAN) on Thursday in Abuja.

    Adeyeye said that the agency heightened enforcement and ensure stringent financial management because it need tools to go after the people that are bringing bad medicine into the country.

    “Because of the money we are saving we need to purchase detection devices to put it on a tablet if it is a paracetamol it will show paracetamol but the new version of it will show paracetamol 85 per cent instead of 100 so it’s best qualitatively and quantitatively.

    “Each of the devices is about 57,000 dollars and we bought 40 because we know our problems in Nigeria. NAFDAC was out of the port for almost seven years.

    ” And we became the haven of bad medicines everybody will say take to Nigeria there is nobody there and we have five countries surrounding us. People just work in and work out.

    ” So those are the peculiarities we faced while we needed the tools that we need to use like this small detection devices. We procured them and trained our staff to know how to use it.”

    She revealed that this device allows for more accurate detection of drugs formulation.

    “Before they could only say ok it is paracetamol they will not know whether it is 65, 10 or 100 per cent. Now the new version can do both, however, it is costlier.

    ”Before I came 70 to 80 per cent of our laboratory equipment were not working. Companies were sending vehicles for us to come and inspect them before I came.

    ” Who will not know that there will be compromise, if a company you want to inspect send you vehicles to come and inspect you know what it means.

    ” So things have to be put in place. Whatever we are able to do with the little we had, we did that almost breaking our backs but we needed to do a holistic reorganisations and refocusing which took us from the 2018 to like 2019.

    ” We started using the Quality Management System at the same time we went on the WHO global beach marking that give us Maturity Level Three after four years. But meanwhile the little money we are saving we started buying vehicles.”

    She said that the agency enforcement became heightened and go to trade fairs where the enforcement team may carry 40 truck of medicine and cosmetics that were not registered.

    ” A lot of raid that they have done on trade fair is of goods worth billions of Naira. So we heighten it and we started destroying. They were destroyed before I came but the frequency may be not be high because it is money that we used.”

    She said that the activities of the agency was being monitored by the WHO, adding that they came in 2019 to examine the NAFDAC level of self-audit.

    “WHO came in 2019 and said we need to do better then and we said yes you are right we need to do better than in some areas. Bear in mind we started with 878 recommendations in 2018 and by 2019 June we have reduced it to 147.

    ” But the work has not finished even now the work has not finished. So we strengthen our pharmaco vigilance and post marketing surveillance.” (NAN)

  • NAFDAC advocates stiffer penalty for substandard medicine importation

    By Salisu Sani-Idris

    The National Agency for Food and Drug Administration and Control (NAFDAC) has emphasised the need for enactment of legislation that would ensure stiffer penalties for importers of bad medicine into the country.

    The Director-General of the agency, Prof. Mojisola Adeyeye, made the disclosure in an interview with the News Agency of Nigeria (NAN) on Thursday in Abuja.

    Adeyeye said that the agency would not spare any company and manufacturers that bring in bad medicine into the country.

    She disclosed that the agency had scale up its Pre Shipment Testing, adding that more than 100 shipment of bad medicine was stopped.

    The D-G explained that when you talk of 100 shipments it may be 10 or 100 containers per one, “but we have discovered that some of them don’t have anything.

    ” Some of them have very little. So these are things that we have been working on and despite that they still want to cut corners with us.

    ” So we started blacklisting them. Any company that made bad and substandard medicine, we blacklist them and we published some on national dailies.

    ” I was in India about six weeks ago and one of them said that his company had been blacklisted and I said so if your company is blacklisted you deserve it. As we speak we are going to blacklist some other companies.

    ” We will continue to blacklist companies, manufacturers and delist the product from our supply chain, delist the product from database. It is not just medicine coming from other countries it is also medicines within our own region.”

    She stated that NAFDAC, with WHO collaboration, conducted a survey and discovered that few companies were trying to cut corners, adding that the agency shut the lines down for months which was going for billions of Naira for them.

    ” It has to hurt them in the pocket in order to have deterrent. Unfortunately you go to court they will fine them N250,000 or go to jail for five years.

    ” So I am urging and praying that the time will come when our judiciary will know that medicine kills, bad food kills.

    ”Right now as we speak we have what is call the C34 bill that the House of Representatives repeal the old one and they are actually enacting a new one which essentially contain a stiffer penalty.

    ” When we see countries that are stringent like the United States that I am familiar with, you break the rule you pay the time. You break the rules if your company is 200 million dollars, they will just fine you 215 million dollars and that is the end of the company.

    “So, people’s feet are being put on the fire right from the beginning. I pray we will get to that point in Nigeria were the penalty will be stiffer so that people will think twice before they put medicine that will kill people.”

    She vowed that NAFDAC would not spare anybody that intend to kill people with bad medicines, adding that the agency was adopting many strategies and intelligent to tackle the menace.

    “Few months ago someone called me that the medicine that NAFDAC approved is making people to run mad.

    ” And I said how medicine that NAFDAC approved can make people mad and asked for the name. Immediately, we did a sweep operation on the company, we got samples from them, later we called Investigation and Enforcement Directorates to go and evacuate after we got the first lab results.

    “It is what we call the bitters and they gave to rats in the lab and the rats die within five minutes. This was not the product we approved they have laced it with marijuana. So, people change formulation after we have approved.

    “So part of what we do now is what is called Risk Based Sampling. If we know that your company is a violator your product will be on high risk if it is something that is going to be put in delicate parts like eyes or noise it will be on high risk.(NAN)

  • Adeyeye exits NAFDAC as acting DG takes over

     

    Culled from Premium Times

    Mrs Adeyeye, a professor, who was appointed in 2017, ended her renewable first term of office on 2 November.

    By Nike Adebowale-Tambe

    Following the expiration of her tenure as the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Moji Adeyeye has exited the office and an acting head has been appointed for the organisation.

    In a leaked internal memo signed by the agency’s Director of Human Resources Management, Oboli A.U, and dated 17 November, directors of various units and departments were notified of the appointment of Monica Eimunjeze as the acting director-general..

    The memo, with reference number NAFDAC/ADM/SM/075, has as its subject: “Appointment of Acting Director General NAFDAC.”

    It reads in part: “The management is in receipt of a letter appointing Dr Monica Eimunjeze as the Acting Director General NAFDAC with effect from 12th November, 2022.

    “I am therefore directed to bring this development to you for information and guidance.”

    Mrs Adeyeye, a professor, who was appointed in 2017, ended her renewable first term of office on 2 November. It is, however, not clear why the announcement of her replacement was delayed and whether her tenure will be renewed.

    Monica Eimunjeze, acting Director General of NAFDAC
    About NAFDAC’s new boss
    According to NAFDAC, the new acting director general’s profile indicates that she studied Pharmacy at Ahmadu Bello University (ABU) Zaria, and graduated in 1986.

    She later bagged her Doctor of Pharmacy (Pharm D) from Mercer University, Atlanta Georgia and a Master of Science (MSc) in Biotechnology, Innovation and Regulatory Science from Purdue University.

    She is said to have a varied experience in the pharmaceutical sector spanning different areas of practice, having had her industrial exposure with GlaxoSmithKline from 1989 to 1996.

    She served the company in various capacities and held different positions including as medical representative, quality control manager, and as regulatory affairs manager.

    Until her appointment as the acting director general, Ms Eimunjeze was NAFDAC’s Director of Registration and Regulatory Affairs.

    She was said to have previously served as the Technical Assistant to the Director General of NAFDAC and as the Director, Drug Evaluation and Research.