TheNewsGuru

Tag: NAFDAC

  • How NAFDAC return to ports helped in curbing fake drugs importation

    How NAFDAC return to ports helped in curbing fake drugs importation

    The return of National Agency for Food and Drug Administration and Control (NAFDAC) personnel to the ports in 2018 has helped in reducing importation of fake and substandard products into the country.

    Prof. Mojisola Adeyeye, NAFDAC Director-General, said this on Wednesday in Lagos.

    Recall that NAFDAC was excluded from security checks at the ports in 2011 and was reinstated on May 16, 2018.

    Adeyeye noted that the presence of NAFDAC officials at the ports had assisted to curb importation of bad products and identified the nefarious importers and cabals behind such transactions.

    According to her, the ports are safer now compared to when NAFDAC officials were absent at the ports.

    The director-general said that NAFDAC’s presence at the ports would continue to ensure that dangerous drugs or substances of abuse – many times falsely shipped as building materials, electrical appliances, computer accessories – are intercepted at the point of entry.

    Adeyeye noted that the agency would continue to work with relevant government agencies to ensure that foods, drugs, chemicals and other NAFDAC regulated products that pose danger to the population are controlled at the point of entry.

    She said that the agency would continue to upscale its laboratories with functional equipment to enable it to test products effectively.

    According to her, the laboratories investigate and pronounce on the quality, safety, efficacy and wholesomeness of regulated products, both imported and locally manufactured.

    Adeyeye noted that NAFDAC had seven laboratories across the country, with various equipment, saying that the least amount of equipment in the lab cost N300 million.

    She noted that the agency had leveraged ICT to drive its operational efficiency, saying its website had been revamped to increase transparency and access to vital information.

    The director-general said that the agency would continue to strive to build a more robust ICT platform.

    Adeyeye added that NAFDAC was committed to strengthening its regulatory framework to enhance its efficiency and improve on service delivery to the public.

    According to her, in the last four years NAFDAC has improved from an indebted agency to a solvent agency, imbibed international best practices and aligned with global regulatory standards to strengthen its oversight functions.

    “You cannot have an agency that’s not accountable financially, that’s not accountable in terms of what happens to a customer and you want to say that’s a strong regulatory system.

    “Because you have already put holes there; holes of corruption, holes of lack of responsiveness to customers.

    “We reduced debt from N3.2 billion to zero, have a budget system that’s directorate focused, started using standard operating procedure which is part of quality management system,” she said.

    Adeyeye stressed that the agency would continue its regulatory controls in all sectors to safeguard the health of the nation.

  • Why you must stop using man power to impress your partner

    Why you must stop using man power to impress your partner

    The National Agency for Food and Drug Administration and Control (NAFDAC) has urged Nigerian men to desist from using performance-enhancing substances known as “aphrodisiac” in order to impress their female partners.

    This is contained in a statement for the Christmas and New year goodwill message to Nigerians released on Sunday by the Director General of NAFDAC, Prof. Moji Adeyeye.

    Adeyeye decried the preponderance of performance-enhancing drugs, otherwise known as ‘’Manpower’’ in the local parlance, in the Nigeria market.

    According to Adeyeye, most of the performance-enhancing drugs are not registered with NAFDAC, and that some of them were smuggled into the country.

    “If they were registered, the producers and peddlers would not get it to the supermarkets, social media platforms and on the streets.

    “Many men have died using such drugs and their relatives would blame their death on some imaginary witches in the village. Some of the producers of these drugs will claim they have no side effects.

    “Majority of these products did not go through the approval process of the agency, the agency will not relent in running after the peddlers of such dangerous drugs until they are brought to book for violating the regulations,” Adeyeye said.

    She said that most human beings have the need for intimacy and for a healthy sexual life and this determines their overall wellbeing.

    She said that If there are physical or psychological problems with a person’s sexuality, it can hamper their self-confidence.

    According to her, many people today have been caught in the web of such circumstances, leading them to seek a way out of the woods and that in recent times, the use of aphrodisiacs has become the range.

    She said that many people are ignorant of the possible damage the misuse of aphrodisiacs or use of unregistered drugs could cause.

    She noted that there are manufacturing quality guidelines and mandated regulations that control the production.

    According to her, unbridled use of aphrodisiacs has a lot of implications in the entire body system and that the use of the products could potentially affect the blood pressure of the body.

    “When you have a disproportionate flow of blood to a particular part of the body and lasting longer than normal, they tend to disrupt the normal flow of the circulatory system,” she said.

    Adeyeye further said that aphrodisiacs could also interact with other drugs in the system and cause problems for the liver which could be responsible for breakdown of drugs while the byproduct of all waste goes down through the kidneys.

    She said that when these things are used especially with some herbal medicines that don’t have dosage and professional prescription, it could lead to internal organ damage, as well as hurt the liver and the kidneys and this could cause untimely death.

    She said that the way the body system works, everything should function the way God designed it.

    She said: “when we begin to disrupt the functions of the body organs over time, it affects the balance and the ecosystem of how the body physiology works and can lead to unintended consequences.

    ‘’For those who have certain health risks, like people that are hypertensive or people that have heart disease, there is more of anxiety that the drug could stimulate into the system and can lead to changes in the physiology of the body, stroke or sudden stoppage of the heart.

    “These happen in cases when men suddenly slump during sexual intercourse as reported in Rivers and Cross River States recently.

    “There are a lot of side effects. Every drug is a potential poison. Every drug has one side effect or the other.

    “These are chemical products with side effects. In some cases, there are associated Adverse Drug Reactions which could lead to death.

    “It is not all cases of sudden death that are caused by witches and wizards in the village; but in most cases they are caused by what we eat or drink carelessly,” she said.

    Adeyeye, however, urged Nigerians to eat right and drink right, especially in this festive season, to avoid health complications after the annual events.

    The NAFDAC boss recalled that over N3 billion worth of falsified and banned drugs and unwholesome food products were seized by the agency recently at the Lagos trade fair complex.

    She added that no fewer than 20 trailer loads of such banned and unwholesome products were carted away by officers of the agency’s Investigation and enforcement directorate, led by Barrister Kingsley Ejiofor.

    According to her, some of the drugs impounded at the trade fair complex were performance-enhancing drugs and that most of them are counterfeit.

    The director general said that manufacturers don’t care about quality, they add what they are not supposed to add or add more than what they are supposed to add, and in the end, the user is the loser.

    Adeyeye disclosed that the agency has ordered 40 units of a detecting device, TRU SCAN, worth US$70,000 each for use on the field to spot fake medicines.

    According to her, the device will show you whether a drug is 5mg or 50mg and that the device is both qualitative and quantitative.

    The NAFDAC Director General said that the agency is the first agency in the world to use the Tru Scan which does quantitative spot check on the chemical content of medicines and chemical level of the drug.

    According to her, this is part of the multifaceted approach the agency is adopting in fighting the preponderance of banned and falsified drugs in the country.

    She blamed people that want to make quick money at the expense of the health and lives of undiscerning consumers.

    She added that the agency would ensure minimized falsification of drugs to give confidence to consumers.

  • FG confesses: Why we accept donation of expiring COVID-19 vaccines

    FG confesses: Why we accept donation of expiring COVID-19 vaccines

    The federal government of Nigeria has explained why the nation accepted Coronavirus disease (COVID-19) vaccines with expiring shelf lives from donor countries.

    TheNewsGuru.com (TNG) reports the explanation is contained in a statement released by the Minister of Health, Dr Osagie Ehanire on Wednesday.

    According to the statement, Nigeria has utilized most of the short-shelf-life doses of Covid-19 vaccines so far donated, stressing that the donations saved the country N16.4 billion.

    Dr Ehanire also stated that the vaccines that expired before usage had been withdrawn, and that they will be destroyed accordingly by the National Agency for Food and Drug Administration and Control (NAFDAC).

    The Minister of Health, however, noted in the statement that the nation now politely declines all vaccine donations with short shelf life or those that cannot be delivered in time.

    The statement reads: “The attention of the Federal Ministry of Health has been drawn to reports circulating in the media to the effect that some Covid-19 vaccines had expired in Nigeria.

    “This Press statement is to properly brief the public and set records right.

    “Nigeria has, of late enjoyed the generosity of several, mainly European countries, who have offered us doses of Covid-19 vaccines out of their stock piles, free of charge, through COVAX or AVAT facility. These donations are always acknowledged and thankfully received: however, some of them had residual shelf lives of only few months that left us very short time, some just weeks, to use them, after deduction of time to transport, clear, distribute and deliver to users. If such vaccines arrive back-to-back or are many, logistic bottlenecks occasionally arise.

    “We appreciate the kind gesture of donors, but also communicated the chal lenge of short shelf lives, whereupon some manufacturers offered to extend the vaccine shelf life after the fact, by 3 months, a practice that, though accept ed by experts, is declined by the Federal Ministry of Health, because it is not accommodated in our standards. Nigeria does not dispense vaccines with a validity extended beyond labelled expiry date. We continue to adhere to our rigorous standards.

    “Donation of surplus Covid-19 vaccines with expiring shelf lives to Developing Countries has been a matter of international discussion.

    “Developing countries like Nigeria accept them because they close our critical vaccine supply gaps and, being free, save us scarce foreign exchange procure ment cost. This dilemma is not typical to Nigeria, but a situation in which many Low- and medium-income countries find themselves.

    “Donors also recognize a need to give away unused vaccines, before they expire in their own stock, but they need to begin the process early enough and create a well-oiled pathway for prompt shipment and distribution through the COVAX and AVAT facilities, to reduce risk of expiration. With better coordination, vaccines need not expire in the stock of Donors or Recipients.

    “Nigeria has utilized most of the over 10m short-shelf-life doses of Covid-19 vaccines so far supplied to us, in good time, and saved N16.4B or more than $40m in foreign exchange. The vaccines that expired had been withdrawn before then, and will be destroyed accordingly, by NAFDAC

    “The Ministry of Health shares its experience with partners regularly and now politely declines all vaccine donations with short shelf life or those that cannot be delivered in time.

    “The long term measure to prevent such incident is for Nigeria to produce its own vaccines, so that vaccines produced have at least 12 months to expiration. This is why the Federal Ministry of Health is collaborating with stakeholders to fast-track establishment of indigenous vaccine manufacturing capacity. This is a goal we are pursuing with dedication”.

  • NAFDAC to Reps: We can’t match drug cabals without manpower, vehicles

    NAFDAC to Reps: We can’t match drug cabals without manpower, vehicles

    By Emman Ovuakporie

     

    Apparently showing helplessness, the Director General of National Agency for Food, Drug Administration and Control, (NAFDAC), Prof Mojisola Adeyeye raised alarm that the agency cannot fight the drug war in Nigeria without adequate operational vehicles.

    TheNewsGuru.com, (TNG) reports the DG declaring that the war against drug counterfeiting and the dangers it poses to the health of the citizenry if adequate manpower and operational vehicles are not made available to the regulatory authority can’t be won.

    The Director General of the National Agency for Food, Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, made this known on Thursday at a budget defence session with the House of Representatives Committee on Health Services.

    This was as the House Committee has queried what it referred to as an “overbloated figures” in the 2022 budget of the Agency for the many capital projects earmarked to be executed by it in the 2022 fiscal year.

    In her submission, the DG explained that its utilization of what was released in the preceding year, the nation’s Food and Drugs regulatory boss told lawmakers that the agency had to in the past rely on companies for their operational mobility before their could go for inspection.

    “In the past, NAFDAC was asking companies to send them vehicles to come and inspect them. Who does not know that you will have to do a favour for those who provided us vehicles? What I am saying is that there were no vehicles and we use vehicles for good manufacturing practice, we use it for clinical sites and other inspections. About 80 percent of our work is field work and without vehicles, we cannot work and that is what you will use to pursue those who wants to kill our people.

    “In 2020, we had a survey which was done in collaboration with WHO. But it was limited in scope. Some of the products were local products and others imported and we found some compromises and we shut down production lines and companies involved lost hundreds of millions of naira because we wanted to send a message to them that our people are more important and the health of our people are more important.

    “We have black listed companies and we published them for trying to take us for granted. These are companies from South East Asia and we also black listed products of companies they are associating with in Nigeria. Our enforcement team work round the clock.

    “About ten days ago, they went on a raid based on a tip off and they recovered eight trucks load of falsified medicines.
    Another way we are approaching it is to use a detection device which FEC (Federal Executive Council) approved for us in December 2020. Each one of them cost about 57000 dollars after it has been discounted for us. We are able to buy 40 which they are manufacturing right now. It is called Truscan. NAFDAC is the first agency in the world to use it about 10 years ago and we bought about 6 then and we are no buying 40 more. It can tell you whether the drug is falsified or substandard”, the DG told lawmakers.

    Chairman of the House Committee Hon. Tanko Sununu and other committee members had raised issues with the figures proposed in the 2022 budget of the agency for its capital projects.

    The DG had presented an estimate of N25.2 billion for the 2022 fiscal year as expenditure and revenue projections of the agency including capital projects earmarked for execution.

    In summary of the capital projects, the agency had earmarked, N2.9 billion is for building of state offices, N1.7bn for generators, N1.4 billion for laboratory equipments, N1.42 billion for motor vehicles, N666 million for information and communications technology and N78 million for furniture, totalling N6.01 billion

    Moreover, in 2022 budget, the agency had earmarked N6.78 billion for staff emoluments, N262 million for equipments and N157.8 million for purchase of laptop computers and N40.1 million for the building of its Ebonyi state office.

    But the Committee helmsman and other lawmakers expressed displeasure with the huge budget proposal items for each of the budget heads saying that it is worrisome to see such huge figures in the budget items despite the previous years approved budgets.

    Sununu while querying these line items presented by the agency called on the DG to ensure effective collaboration of NAFDAC with other relevant healthcare agencies, such as Nigeria Institute of Pharmaceutical Research and Development NIPRD and Nigeria Institute of Medical Research NIMR.

    Meanwhile the lawmaker and another committee member, Hon. Omowumni Ogunlola (Osun, APC) had earlier raised issues with the lopsidedness of the recent recruitment carried out by the NIMR during the agency’s budget defence session by the Committee.

    Other lawmakers in the Committee notably Hon. Isiaka Ibrahim (Ogun, APC), Hon. Aminu Suleiman (Kano, APC) as well as Hon Muhammad Wudil (Kano, APC) also kicked against the award of contracts above the approved threshold of these agencies by the chief executive officers.

  • Why you should not take herbal concoctions after 14 days of preparation – NAFDAC

    Why you should not take herbal concoctions after 14 days of preparation – NAFDAC

    Liquid herbal concoctions should not be consumed more than two weeks after preparation, NAFDAC warned in Lagos on Monday.

    This, it said was for safety reasons.

    Prof. Mojisola Adeyeye, its Director General, gave the advice in a statement issued to commemorate the World Herbal Medicine Day which holds annually on Aug. 31.

    Adeyeye advised Nigerians to use herbal medicines with caution to prevent avoidable deaths and complications.

    According to her, for safety reasons, no liquid herbal formulation should be ingested after days of preparation and such medicines should always be kept refrigerated.

    “After 14 days, if it is liquid, it may start to develop bacteria that can make people sick.

    “The general public should use herbal medicines with care because you don’t know the quantity that you are supposed to take.

    “The fact that it is natural doesn’t mean it is not toxic,’’ she stressed.

    She explained that toxicity was not about the volume consumed, but that something could be in micro quantity and could kill.

    “Just because you prepared the concoction in your house doesn’t mean you can drink it like water. It may be dangerous,’’ she cautioned.

    Adeyeye noted that the problem associated with herbal medicines was that many people did not understand that it should be scientifically driven.

    “If you prepare herbal medicine in liquid form you don’t know how stable the medicine will be in water. If it is not stable and it is degrading to another thing, it may hurt.

    “Those who engage in hawking herbal preparations on the streets under the scorching sun, the heat generated by the sun may have a way of causing decomposition of the active ingredients in the medicines being sold.

    “This may pose significant health risks to those buying and consuming these preparations.

    “That’s why herbal medicines in Nigeria have to be handled with care. Some people take herbal medicines like vaccines.

    “Herbal medicines are derived from plants mostly, sometimes from animals in few cases while vaccines are from human or animal cells that have been programmed to elicit immunologic effects in the body.’’ She added

    Adeyeye also advised against simultaneous use of both herbal and conventional medicines by members of the public.

    “If someone is using herbal medicine and a conventional medicine simultaneously, there may be a problem.

    “Let’s say that a medicine is supposed to lower blood pressure or lower sugar level for diabetes and a person takes conventional medicine and the sugar level is lowered and he then takes herbal remedy, that person may go into a shock.

    “This means that the level of sugar in the blood is too low because the two are now working synergistically.

    “Sometimes herbal medicines may actually reduce the effectiveness of the conventional medicine. That’s why studies need to be done because there is drug-herbal medicine interaction that may cause a lot of harm.

    “Whoever is taking herbal medicine should talk to his or her pharmacist and medical doctor for professional advice,’’ she stated.

    Adeyeye, however, called for collaboration between herbal medicine practitioners and medical researchers to achieve rapid development of the herbal medicine industry in the country.

    The D-G noted that NAFDAC in March 2019 set up herbal medicine product committee before the COVID-19 pandemic broke out to advance research in herbal medicines.

    According to her, the goal of setting up the committee is to make sure that the herbalist and the researcher are collaborating.

    “So, whatever the herbalist knows from ancestral history that does not have research to back it up, collaboration with researchers will enable that herbal medicine to be advanced to be listed by NAFDAC if it’s deemed safe.

    “Right now, there is no single herbal medicine that has gone through full clinical trial the way clinical trial is supposed to be done.

    “There could be herbal medicines that have been used to treat a symptom of COVID-19 or whatever, but it has not been published in which case, it is not an official clinical trial,’’ she said.

  • NAFDAC makes move against aggressive marketing of breast-milk substitutes

    NAFDAC makes move against aggressive marketing of breast-milk substitutes

    The National Agency for Food and Drug Administration and Control (NAFDAC) on Wednesday unveiled documents to support compliance to breastfeeding code implementation and Breast Milk Substitutes (BMS) regulations in the country.

    The unveiling ceremony was done in Abuja at the 40th Anniversary of the International Code of marketing of the BMS in Nigeria with the theme “Implementing the BMS Code in Nigeria: Progress, Challenges and Opportunities”.

    The Director General of NAFDAC, Prof. Mojisola Adeyeye, said that the BMS Code was an international health policy framework for breastfeeding protection and promotion adopted by the 3rd and 4th of the World Health Assembly (WHA) in 1981.

    Represented by her Special Assistant, Mr Gbenga Fajemirokun, the director general said that the Code was developed as a public health strategy.

    She added that it was aimed at contributing to the provision of safe and adequate nutrition for infants by protecting and promoting breastfeeding and to ensure proper use of breast-milk substitutes only when they were necessary.

    Adeyeye said that the code was to protect mothers from aggressive marketing of breast-milk substitutes.

    She further said that the code was also to ensure safe feeding and better nutrition for infants and young children as the provision of the code recommended restrictions on marketing of BMS.

    She added that “Nigeria, a member of the World Health Organisation (WHO) voted for code adoption in 1981 and is expected to implement all its provisions in the entirety as a minimum requirement and to translate it into national legislation, regulations and other suitable measures.

    “As a country, Nigeria takes her international and national obligations very serious which is why the provisions of CAP M5 Marketing BMS Act, Laws of the Federation of Nigeria 2004 as amended by Decree 22 of 1999.

    “This Act designated NAFDAC as the regulatory agency to implement, monitor and enforce the code in Nigeria.

    “It is our collective desire as NAFDAC, the agency designated to implement and enforce this code compliance in Nigeria, to work collaboratively with all stakeholders and partners.

    “To contribute to achieving safe and adequate nutrition for our infants through protection and promotion of breastfeeding.”

    The Minister of Health, Dr Osagie Ehanire, said that the ministry remained committed to improve survival of children, especially the ones under the age of five-year and maternal child care through various policies that would promote healthy living.

    Represented by Dr Anas Kolo, the Director of Family Health in the ministry, said that the ministry had gone ahead to promote baby friendly hospital initiative.

    Ehanire maintained that the ministry would continue to promote exclusive breastfeeding and other initiatives in the same direction.

    The minister, therefore, encouraged mothers to continue to breastfeed their babies in spite of the COVID-19 pandemic, adding that support mechanisms were on the way to encourage mothers.

    In his goodwill message, the Chairman, Senate Committee on Health, Sen. Ibrahim Oloriegbe, said that discussions were on at the National Assembly to permit mothers to embark on six months maternity leave after delivery.

    He added that this would also support exclusive breastfeeding.

    Oloriegbe noted that Nigeria had not achieved its target as far as exclusive breastfeeding was concerned, adding that the environment had not been friendly to achieve that.

    “We must promote friendly environment for this initiative, a lot must be done to encourage this to meet our target,” he said.

    Mr Sheriff Olagunju, the NAFDAC Director of Food Safety and Applied Nutrition, said the implementation of BMS Code had earned the country improved rating in the 2020 International Code Status Report.

    He added that NAFDAC would not rest on its oars to continue to enforce the code.

    “The BMS Code spelt out roles and responsibilities of various stakeholders in ensuring that breastfeeding is promoted, supported, and protected by implementing the provisions of the BMS Code and subsequent relevant WHA resolutions in its entirety.

    “These stakeholders include but not limited to the government, policy makers, healthcare workers, healthcare system, the media, mothers and their families, development partners, Non-Governmental Organisations and Civil Society Organisations.

    “The importance of breastfeeding is also evident in its significantly positive impact on our planet.

    “This is because breast-milk is a natural and renewable food which requires no preparation, no packaging, no storage and no transportation.

    “The earth benefits when women are encouraged to breastfeed their infants and young children, therefore, the enabling environment must be created by the society at large for this to happen,” Olagunju said.

  • COVID-19: FG sets date for phase 2 vaccination

    COVID-19: FG sets date for phase 2 vaccination

    The Federal Government has announced a new date of Aug. 16 to begin administering the second batch of COVID-19 Moderna vaccines doses donated by the U.S.

    The Minister of Information and Culture, Alhaji Lai Mohammed made the announcement on Monday when he featured on “Good Morning Nigeria’’ a live programme of the Nigerian Television Authority.

    Speaking on televised programme monitored in Abuja, the minister said the postponement of the vaccination exercise from Aug. 10 to Aug. 16 was “purely administrative’’.

    “We have received 4,80,000 doses of the Moderna vaccine and we will commence administering the doses on Monday Aug. 16.

    “The exercise was supposed to commence tomorrow Aug. 10, but we suspended it till Monday, and the reason is purely administrative.

    “You see, when vaccines arrive the country, they are taken to National Agency for Food and Drug Administration and Control (NAFDAC).

    “The agency which will analyse them and thereafter give us a green light for the use,’’ he said.

    The minister debunked reports in certain publications that the exercise was postponed indefinitely over concerned raised by some experts on the propriety of using Moderna vaccines.

    He said, like the first batch of the Astrazeneca Vaccine which had been fully administered without hitch, the doses of Moderna vaccine donated to the country by the US were “safe and meant to save lives’’

    “I want to thank Nigerians for the way they responded to the first batch of Astrazeneca Vaccine.

    “I can say authoritatively that we succeeded administering the four million doses of the vaccine and we do not have a single expired vaccine.

    “They were all administered to the targeted population.

    “I want to encourage Nigerians to come out also to take the Moderna vaccine.

    The minister also disclosed that the second phase of the vaccination exercise would target people from 18 years and above.

    He explained that the 18 years and above were targeted because the younger ones, even in the US, were now becoming more vulnerable to COVID-19infection and attack

    Mohammed underscored the need for people to come out to take the vaccine stressing that “Nigeria has entered the third wave of COVID-19’’.

    He explained that the Delta variant of COVID-19 pandemic which is more virulent and deadly had been recorded in some states since July.

    “If you have our two doses, it is clear that even if you are infected with COVID-19, it will be very mild.

    “You will not be hospitalised, talk less of death as opposed to the fellow that has not taken the vaccine.

    “So, we must encourage people to go out and take the vaccine,’’ he said.

    Mohammed said following the pandemic, a major challenge faced was “infodemic’’ caused by fake news around the vaccine.

    “For instance, they first came up with the fake news that it has magnetic effect if you take the vaccine.

    “After that, they said it was meant to depopulate certain part of the country.

    “ All this is not true because every vaccine you use today has been proven to be safe and to safe life.

    “ If the vaccines are not safe, they will not be administered,’’ he said.

    Mohammed reiterated the call on religious and community leaders, media and other influential people to join the Presidential Committee on COVID-19 in fighting fake news and disinformation around the vaccines.

    The News Agency of Nigeria (NAN) reports that on Aug.2, Nigeria received four million doses of Moderna’s COVID-19 vaccines donated by the United States government.

    Health Minister Osagie Ehanire said the vaccines, which arrived are undergoing validation by the country’s drug regulator.

    He said the doses will be distributed to the local states once they are certified fit for use.

    The U.S. government last week shipped nearly 10 million doses to two of the most populous African countries – Nigeria and South Africa.

  • NAFDAC accuses U.S., EU of ‘persistently rejecting Made in Nigeria food’

    NAFDAC accuses U.S., EU of ‘persistently rejecting Made in Nigeria food’

    The National Agency for Food and Drug Administration and Control (NAFDAC) has called for synergy amongst government agencies to end the rejection of made in Nigeria food products by the U.S and European Union.
    The call was made in a statement signed by the agency’s resident media consultant, Mr Olusayo Akintola, and issued to newsmen in Abuja, on Sunday.
    The statement quoted NAFDAC’s Director General, Prof. Mojisola Adeyeye, as decrying the persistent rejection of food and agricultural commodities from Nigeria by the two entities on account of poor quality.
    She urged all the regulatory agencies at the port to find a lasting solution, by ensuring Rapid Alert System for Food and Feed (RASFF) of border rejection by the EU of products originating from Nigeria.
    Adeyeye was speaking on quality and safety of export food trade at a virtual technical roundtable with government agencies like Ministry of Agriculture, Foreign Portfolio Investments (FPIS) and the Standard Organization of Nigeria (SON), among others.
    She lamented the resulting bad image the repeated rejection of commodities from Nigeria by the EU had caused the country, noting that the stakeholders meeting was, therefore, apt.
    The NAFDAC chief executive said that the meeting was apt in view of the volume of food and agricultural commodities from Nigeria that were currently facing challenges at entry points in some European countries and the U.S.
    ‘’ NAFDAC has a statutory responsibility to safeguard public health, through the execution of its mandate, we are charged with the responsibility to regulate and control the manufacture, importation, exportation, distribution and advertisement.
    “We are also charged with the responsibility of monitoring sale, use of food, drugs, cosmetics, medical devices, bottled and packaged water, chemicals, that were generally referred to as NAFDAC regulated products.’’
    “NAFDAC is designated as World Trade Organization/sanitary and phytosanitary enquiry point in Nigeria on food safety to facilitate international trade, and respond to enquiries on safety standards, regulations, and guidelines on food trade in Nigeria,” she said.
    Nigeria’s products meant for the export market are faced with the presence of contaminants, such as pesticide residues, notoriously dichlorvos and other impurities, exceeding the maximum permitted level, she also stated.
    Some of the products, she noted, also faced the challenges of inadequate packaging and labeling which had caused a lot of product rejections in the global market.
    Adeyeye explained that the international market was competitive in nature and only accepted products of high quality with relevant certifications and quality packaging that was environmentally friendly, to trade globally.
    She stressed the need to address the issue of rejection because the problem of quality, standard, certification, and appropriate packaging for made-in-Nigeria products destined for export had been a recurring issue in the international market.
    NAFDAC had over the years intervened to assist Nigerian exporters meet with international regulations, thereby creating employment and earning foreign exchange for Nigeria, she said.
    Through this intervention by NAFDAC, Adeyeye added, it was agreed that the products be subjected to 100 per cent pre-export testing and issuance of health certificate to products with satisfactory limits before further EU verification at their border control points.
    She also disclosed that NAFDAC had analysed the RASFF alert from the EU and observed that most rejected products by the EU were smuggled out and we’re not certified by the agency nor the Nigeria Agricultural Quarantine Services at the ports.
    Adeyeye stated that the issue really called for proper collaboration and synergy amongst all agencies of government, to curb the inappropriate behaviors of some exporters and ensure that only quality and certified products were exported.
    ‘’We need to close the gaps and work together to prevent regulatory gaps being exploited by the unscrupulous traders and their collaborators. There must be a convergence for all regulatory activities.
    “We have to do this, especially at the Ports of Exit, before we begin cleaning up and capacitating the honest operators and traders in the country’’.
    “Based on the RASFF alert received from the EU, she said, NAFDAC had sensitized food processors, handlers and exporters through training programmes, workshops and seminars on the current food safety management requirements.
    “Hazard Analysis and Critical Control Point (HACCP), Good Manufacturing Practices (GMP), Good Hygiene Practices (GHP) and Risk Analysis are crucial to ensure that products are safe and of good quality.
    “To gain consumers’ confidence and acceptability from Nigeria, effective assessments of export products are very key, basic information that may be needed to be considered in the accompanying shipping documents include Certificate of Radiation,” Adeyeye said.
    She called on the participants at the roundtable, especially the MDAs, to be awake to their responsibilities as the nation’s gatekeepers by ensuring the availability of quality-assured, safe, wholesome and efficacious products, stressing that they must always strive hard to meet up with quality, to stop further rejection.
    The NAFDAC director general said that they must converse together, understand one another, agree to work together, and come up with a workplan for whatever we agreed to do and must turn a new leaf for the sake of the country.
    She said that there was need for coordination, cognition, and collaboration between regulatory agencies of the government in order to effectively address the problem faced in the international market.
  • Why we didn’t approve herbal medicine for COVID-19 treatment- NAFDAC

    Why we didn’t approve herbal medicine for COVID-19 treatment- NAFDAC

    The National Agency for Food and Drug Administration and Control (NAFDAC) has given reasons why it has yet to approve any herbal medicine for the treatment of COVID-19.

    This is contained in a statement signed by the agency resident Media Consultant, Mr Olusayo Akintola, and issued to newsmen on Sunday, in Abuja.

    The statement quoted Prof Moji Adeyeye, NAFDAC Director- General, as saying that “no single drug has been found yet to cure COVID -19”.

    Adeyeye also warned Nigerians against excessive consumption of onions and garlic with a view to curing COVID-19, saying, ‘’If you eat too much your breath will be smelling and nobody will want to stay by you.”

    She said that medicinal products available now could only help ease symptoms and up the odds of survival.

    She warned Nigerian researchers and other herbal medicine practitioners to desist from parading unverified medicine for the virus.

    She said that any product without NAFDAC approval for the cure of COVID-19 is null and void, adding that such an act was a violation of the national regulatory authorities and breach of protocols.

    She admitted that onions or garlic or any of the natural fruits that we take have antioxidant and nutrients that can help us feel better, adding that people might have been using it and they get better.

    “If it is not documented, it cannot be recognised by NAFDAC for COVID – 19. They work on our cells to keep people healthier, but not to cure COVID – 19. They help our body to function better. There is no cure for COVID -19 yet.

    She added that they may boost the immunity and the person may not be easily susceptible to infection, adding that ‘’even with that, you still have to protect yourself.

    “If you eat garlic and onion and you don’t use face mask you will get COVID -19. If you are in a bad environment; If you don’t wash your hands, you will get COVID -19.

    “Everything has to be put together. University of Jos said that there was an herbal medicine, whether it is tea or whatever, that can cure COVID-19, they linked it with treatment of COVID -19, they did the packaging.

    ‘’We did a letter to warn them that they cannot claim something unless it has gone through our listing process. They were trying to sell it to their staff. That is violation of our own regulatory policies.

    “Nobody should say that this one can cure this or that without going through NAFDAC listing process, the research into herbal medicine by the academia is normal.

    ‘’It is now for the academia to also recognise the national regulatory authority established to safeguard the safety of the Nigerian populace, by ensuring that the product that they are working on has to go through NAFDAC,” Adeyeye said.

    According to her, there have been one or two cases where the University of Jos product was being encouraged to be used by people without going through NAFDAC.

    She said that the university was supposed to go through the national regulatory authority and pave the way for NAFDAC to declare it safe for consumption.

    The DG insisted that her agency must approve the clinical trial protocol, stressing that ‘’If they don’t do that and go ahead to market and sell their product, such act would be a violation of regulatory procedures.

    According to her, some people might have been using it and they got better, but without being approved scientifically and documented, we may not be able to guarantee its safety for human consumption.

    She recalled that NAFDAC set up an herbal medicine product committee in March 2019 before the pandemic broke out, to advance research in herbal medicine.

    Adeyeye said that the goal for such idea was to make sure that the herbalist and the researcher were collaborating, so that whatever the herbalist knows from ancestral history that the research will back it up.

    She explained further that collaboration with researcher would enable such herbal medicine to be advanced and to be listed by NAFDAC, if found safe for consumption.

    According to her, during the pandemic there were lots of assertions that there were herbal medicines, that could be used to treat symptoms of COVID -19, pointing out that there was no single medicine that has been identified yet.

    “But there are herbal medicines that could alleviate symptoms of COVID -19. However, NAFDAC has not granted registration of approval for any medicine for that.

    “NAFDAC approves such medicines for listing, it means that it’s been tested and was deemed safe to use. NAFDAC cannot say herbal medicine can treat COVID -19, until clinical trial is done.

    “Right now, there is no single herbal medicine that has gone through full clinical trial the way clinical trial is supposed to be done,” she said.

    According to her, to do official clinical trial, you must write a protocol, you must pass it through the National Health Research Ethical Committee (NHREC), and you must pass it through NAFDAC.”

    She said that the agency has not given any pass mark as regards COVID-19 herbal medicine, but that the agency has approved some herbal medicines that they claim can alleviate some of the symptoms of COVID -19.

    She said that some of the approved herbal medicine which they claim can alleviate COVID-19 symptoms only work as immune boosters.

    Adeyeye pointed out that such herbal medicine may prevent one from getting the disease, adding that, as far as NAFDAC was concerned, it has not approved any medicine to treat COVID -19.

    “We have approved medicines that they said can alleviate symptoms and relieve people of some symptoms of COVID – 19, when the product is listed then clinical trial may start.

    “It takes a lot of money to do clinical trial. University of Jos has been given approval to commence clinical trial of their products which is yet to commence.

    The DG further disclosed that many herbal products have been submitted for federal government grants, because most of the herbal practitioners lack the required wherewithal to do clinical trial.

    She said that many of these herbal products were being subjected to review by different agencies of government in the country.

    “In terms of going through clinical trial and official protocols, none has come through yet.”

    According to her, such herbal products can be used during the clinical trial to investigate whether it could be effective for COVID -19.

  • NAFDAC approves more vaccines for COVID-19

    NAFDAC approves more vaccines for COVID-19

    The National Agency for Food and Drug Administration and Control (NAFDAC) has approved more vaccines for the treatment of the Coronavirus (COVID-19) pandemic.

    The Director General of the agency, Prof. Mojisola Adeyeye, disclosed this at a news conference in Abuja on Thursday.

    She said approval had been given to Moderna, a vaccine from the Rovi Pharma Madrid, Spain.

    Other vaccines also approved are: AstraZeneca AZD1222 produced by SK Bioscience Company Limited from Korea and Sputnik V, produced by Gamaleya National Centre of Epidemiology and Microbiology, Russia.

    Adeyeye said that the NAFDAC Vaccine Committee had been carefully assessing the vaccines and several others in spite of
    the approval by stringent regulatory countries and the World Health Organisation (WHO) Emergency Use Listing (EUL).

    She added that all the COVID-19 vaccines that had gone through the process of approval had been certified for quality, safety and efficacy evaluation, a prerequisite for acceptance by COVAX facility.

    According to her, most regulatory agencies across the world use this mechanism to expedite their own regulatory approval to import and administer the vaccines.

    She noted that NAFDAC spent 15 days to thoroughly examine the dossier or submission package of the vaccines to ensure that the benefits outweighed the risks and any other side effect for proper monitoring.

    She said “the EUL will allow Nigeria to receive supplies of the vaccines from the COVAX facility. COVAX is the pillar of the Access to COVID-19 Tools (ACT) accelerator’s jointly led by the Global Alliance for Vaccines and Immunisation (GAVI) and the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO.

    “Its aim is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access to low-middle income countries (LMIC) of which Nigeria is one.

    “NAFDAC also gives full review for vaccines that have not gone through EUL route. This mechanism is explained in our guidance developed by the COVID-19 Vaccine Committee.”

    On Moderna and AstraZeneca AZD1222 vaccines, the director general said that the vaccines had received WHO EUL and were given accelerated approval, while Sputnik V was yet to receive the EUL approval, subjected to six months review by NAFDAC.

    She said that NAFDAC was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca AZD1222 from the WHO website at different times over the past two months.

    According to her, the Moderna vaccine is presented as a white to off-white, ready-to-use dispersion for intramuscular injection in a
    multi-dose vial containing 6.3ml (10 doses in a 10-vial pack, adding that, each dose have (0.5ml) contains 100 micrograms of messenger RNA, and is given as two dose vaccine.

    She said that unopened vaccine vials could be stored or transported frozen at -25 degree centigrade to -15 degree centigrade for up to seven months and 30 days when stored at 2 to 8 degree centigrade, protected from light.

    She added that the AstraZeneca AZD1222 is a recombinant ChAdOx adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2.

    Adeyeye said that the AstraZeneca AZD1222 vaccine solution is colourless to slightly brown, clear to slightly opaque packed as a 5ml solution that contains 5 x 10 virus particles for injection in a 5ml clear glass multidose vial that could be stored at 2 to 8 degree centigrade, and is given as two dose injection.

    On Sputnik V vaccine which is also known as Gam-COVID-Vac COVID-19 vaccine, NAFDAC DG said “it is supplied as a two-component product, both of which are 3ml (5 doses) solution for intramuscular injection in glass vial.

    “It is a two-dose injection. Each 0.5 ml dose of the component I is formulated to contain virus particles (1.0+0.5) x 10 of Ad26 vector encoding the S glycoprotein of SARS-CoV-2,” adding that the product has a shelf life of six months when stored at -18 degree centigrade or three months when stored at 2-8 zero degree centigrade.

    Adeyeye said the agency did a thorough assessment of each vaccine and were found to have the quality, safety and efficacy attributes, with the benefits far outweighing the risks.

    She said that the pharmacovigilance unit would conduct safety and monitoring studies on the vaccines to record the side and adverse effects following immunization.

    She further said that other studies like immunological responses, incidences of reactogenicity and possible dose optimisation would be done in a cohort of vaccines.

    The director general added that the agency would be using its recently launched Med Safety App for active pharmacovigilance of the vaccines in collaboration with respective sister agencies, and urged healthcare workers to download same App to monitor Adverse Drug Reaction (ADR) and report.

    She said NAFDAC had begun in-country training on the use of the App for healthcare workers.

    She noted that the agency planned to also use the traceability with GS1 technology to monitor vaccines distribution using Global Trade Item (GTIN), adding that “all these were to prevent fake vaccines from infiltrating the supply chain and to ensure there was no diversion.”