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Tag: NAFDAC

  • Incoherence on Covid19 drug between NAFDAC and PaxHerbal – Chido Nwakanma

    Incoherence on Covid19 drug between NAFDAC and PaxHerbal – Chido Nwakanma

    By Chido Nwakanma

    Ineffective communication between two significant players in the health sector muddied the waters Saturday 11 July concerning the otherwise positive news of the development of a licensed Nigerian medication against aspects of Covid19. It showed what can go wrong in communication of sensitive matters such as those requiring the approval and consent of a third party. It also provides a teachable moment for professionals in healthcare, regulation, and communication.

    Pax Herbal Clinic and Research Laboratories, Ewu, Edo State announced that it had finally received the approval of NAFDAC for the marketing of its CUGZIN. It was all over the media on Saturday. The Pax Herbal news release stated, “After a series of screening, spanning eight weeks, NAFDAC has today approved our Paxherbal COVID-19 herbal drug, Paxherbal Cugzin, for public use.

    “It is the first to be so approved and presently the only one. The drug is specifically for treating the symptoms associated with the coronavirus.”

    Father Anslem Adodo, Director of Pax Herbal, stated further.

    Writing on their official Facebook page, Father Anslem Adodo, Director of Pax Herbal, expatiated on the announcement. He wrote under the headline Official Announcement from Pax Herbal. Father Adodo stated, “We at Pax Herbals are happy to confirm that our CVDPlus, which has been renamed CUZIN, has been issued a NAFDAC number as ‘an immune booster and an anti-infective.’

    We are aware that there is a lot of anxiety in the land, and people are hungry for any reliable immune booster as prevention. PAXHERBAL CUGZIN will help to boost body immunity, as there is yet no officially approved drug for the cure of COVID-19. We ask our followers to look out on our Facebook page for official statements and be weary of different claims or stories or images on social media about our products.

    The Guardian report on the matter amplified the statement. It reported Adodo as saying that NAFDAC had earlier given tacit approval for the drug to be used, even though the body was yet to make that approval official; hence the first packs of the herbal remedy bore the disclaimer, “these claims have not yet been verified by NAFDAC.”

    But with that hurdle crossed, Paxherbal Cugzin now has the NAFDAC number: A7-4358L.

    Pax Herbal Cugzin, which had earlier been produced under the brand name, ‘CVD PLUS,’ before it was rebranded to ‘Paxherbal Cugzin,’ is in capsules and packaged in a container of eighty 290mg capsules, each containing Garcinia Kola, Curcuma Longa and Zingiber officinale.”

    As the news hit the airwaves, print and social media, NAFDAC reacted as one stung. It issued a disclaimer. Prof Moji Adeyeye, Director General of the Agency, dismissed the Pax Herbal claim as wrong and inaccurate.

    Prof Adeyeye stated, “Pax Herbal applied for Listing of Pax Herbal Cugzin capsule 290mg which was approved by NAFDAC and Listed as “Safe to use”. The applicant claimed that it is an immune booster and an anti-infective.

    “However, as part of the labelling of the product, and in line with global practice, a Disclaimer is on the product label, which clearly states that the claims have not been evaluated by NAFDAC.

    Therefore, the statements circulating in the social media that NAFDAC has approved Paxherbal product “specifically for treating symptoms associated with Coronavirus” is WRONG and INACCURATE.

    Until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms.”

    It is difficult to understand the source of the disagreement. The NAFDAC statement confirmed everything that Pax Herbal stated. Everything.

    Check.

    ??? ??????: “We at Pax Herbals are happy to confirm that our CVDPlus, which has been renamed CUZIN, has been issued a NAFDAC number as ‘?? ?????? ??????? ??? ????-?????????’.

    ??????: Pax Herbal applied for Listing of Pax Herbal Cugzin capsule 290mg which was approved by NAFDAC and Listed as “Safe to use”. ??? ????????? ??????? ???? ?? ?? ?? ?????? ??????? ??? ?? ????-?????????.

    ??? ??????: PAXHERBAL CUGZIN will help to boost body immunity, ?? ????? ?? ??? ?? ?????????? ???????? ???? ??? ??? ???? ?? ?????-??.

    ??????: “As part of the labelling of the product, and in line with global practice, a Disclaimer is on the product label which clearly states that the claims have not been evaluated by NAFDAC.

    Therefore, the statements circulating in the social media that NAFDAC has approved Paxherbal product “specifically for treating symptoms associated with Coronavirus” is WRONG and INACCURATE.”

    NAFDAC evaluated the product of Pax Herbal, which clearly stated that it is an immune booster and declared it as SAFE TO USE. It then gave it a NAFDAC number. All across West and Central Africa, everyone regards a registration number from NAFDAC as a seal of approval. It is what it is.

    NAFDAC admits to approving the drug as “safe to use” but only requires a disclaimer that it has not done clinical trials. Why did they then pass it? They licensed it and gave it a number. Why the prevarication in the statement?

    Pax Herbal is no pushover in research. The research laboratory is better equipped than most institutions in Nigeria. They subject their products to rigorous testing in line with the highest scientific protocols.

    The contradictory statement of NAFDAC sees an agency in conflict with itself on the matter of regulation of traditional medicine. There is no western protocol to follow. The call is on NAFDAC to develop and implement protocols for the regulation of medication developed using indigenous herbs. It struggles with sounding scientific according to the Western canons and doing the right by our society and systems.

    NAFDAC seeks to comply with the dictates of Good Regulatory Practices (GRP). It should. The World Health Organisation states that “Good regulatory practices (GRP) provide a means for establishing sound, affordable and effective regulation of medical products as an important part of health system strengthening.”

    The WHO stipulations for GRP include legality, impartiality, consistency, proportionality, and flexibility. Others are effectiveness, efficiency, clarity, and transparency. NAFDAC should look at the dictates on proportionality, flexibility and clarity again.

    The NAFDAC statement has thrown eggs in both their faces. It was unfortunate and unnecessary. The announcement cast needless doubts on the efficacy of NAFDAC as the regulator and the desirability of using the CUGZEN. In which case, it threatens the investment of a Nigerian firm in these difficult times.

    The kerfuffle between NAFDAC and Pax Herbal stems from inadequate consultation and procedure. Best practice in managing communication on matters involving two bodies is an agreement on the tenor of public statements and the text. NAFDAC and Pax Herbal should have issued a joint statement or at least vet the statement that Pax Herbal issued.

    NAFDAC may want to look at incorporating Communication Procedure for Regulated Products in its GRP for Nigeria.

  • Reps urge Fed Govt to return SON, NAFDAC to ports

    Reps urge Fed Govt to return SON, NAFDAC to ports

    Members of the House of Representatives have called on the Federal Government to reconsider its earlier decision barring the Standards Organisation of Nigeria (SON) and the National Agency for Food, Drugs Administration and Control (NAFDAC) from operating at the nation’s seaports.

     

    The lower chamber maintained that the two key agencies are needed at the seaports and borders to fight the influx of sub-standard and life-endangering goods into the country, especially amid the COVID-19 pandemic.

     

     

     

    The lawmakers said the call has become important as Federal Government strategies to kick-start the nation’s economy post-COVID-19 pandemic

     

    Adopting a motion under “Matters of urgent public importance”, raised at the plenary session, the House stated that allowing SON and NAFDAC back to the ports will represent part of the strategies to effectively check the influx of sub-standard goods into the country.

     

    The House has mandated its committee on finance to meet and liaise with the Minister of Finance on the urgent need for SON and NAFDAC to return to the ports and borders.

     

    The motion was moved by the Minority Leader, Ndudi Elumelu, representing Anaocha South/Anaocha North/Oshimili South federal constituency of Delta State.

     

    The House categorically stated that no other agency can carry out the statutory functions of SON and NAFDAC, maintaining that the functions of quality assurance cannot be inter-changed with any other sister agency.

     

     

     

    There have been several appeals from the various sectors, operators and stakeholders on the need for the Federal Government to return SON in particular at the nation’s ports as a major move against the menace of sub-standard and counterfeited products across the country.

  • NAFDAC, WHO raise alarm over fake COVID-19 drugs in circulation

    NAFDAC, WHO raise alarm over fake COVID-19 drugs in circulation

    As the world anxiously await a cure for COVID-19 (Coronavirus), the World Health Organisation (WHO) and the National Agency for Food and Drug Administration and Control (NAFDAC) on Wednesday raised the alarm over the rising number of adulterated medical products in the markets.

    They specifically mentioned Chloroquine as one of such products that have been faked and bandied by unscrupulous manufacturers as Coronavirus drug.

    Director-General of NAFDAC, Prof. Moji Adeyeye and WHO Resident Representative in Nigeria, Dr. Tayo Hamzat, spoke of the adulterated products during a webinar organised by Bloom Public Health in Lagos on Wednesday.

    They ventilators, sanitisers and face masks as products that unscrupulous people produced and started fake ones.

    Adeyeye explained that NAFDAC has however stepped up post-marketing surveillance of COVID-19 medical products as some companies change formulations.

    She said, “Post-marketing surveillance is part and parcel of NAFDAC. We stepped it up because we knew that companies were changing formula and formulations for us.

    “We see falsified Chloroquine without any active ingredients in it. Of course, we also have had fake sanitizers and masks, which we have to deal with regulatory-wise.

    “Chloroquine and Hydroxychloroquine are some of the therapeutics that Nigeria is using for clinical trial treatment only. We started with Chloroquine and then Hydroxychloroquine came in. However, WHO said that Hydroxychloroquine should be removed from the solidarity trial.

    “Nigeria accepted that, however, there are clinical trials that started before solidarity trials began. Many of us did not know anything about COVID-19 until six months ago.

    “The disease has at least three stages: early stage, mild, and the severe stage. It is not all the therapeutics that can work in all the stages.

    “But thus far in Nigeria, Chloroquine and Hydroxychloroquine are being used in most hospitalised settings or clinical trial treatment and isolation centres.

    “In fact, there have been a lot of social media videos of people saying they went in COVID-19 positive and came back COVID-19 negative but all they gave them is anti-malaria. So, we can figure that out.

    “At the beginning of the pandemic, I envisaged that there will be a need for Chloroquine after clinical data started coming from China, France and US where it was stated that Chloroquine may be effective.

    “I asked a company that used to make Chloroquine to make an emergency batch before the first Index Case came into the country. That did not sit well in some quarters but this is what a regulatory agency is supposed to do in times of emergency.”

    On alcohol-based hand sanitizers, she said: We had about 21 hand sanitiser companies in Nigeria before COVID-19. Now, we have over 110 hand sanitiser companies.”

    Adeyeye said no herbal preparation has been granted emergency use approval as efforts are being made to collate evidence of their safety .

    The WHO Representative, Dr. Hamzat, said: “For COVID-19 response, WHO has been sending out alerts about substandard and falsified medical products related to COVID-19. We have specific alert about Chloroquine products circulating in Africa and some other parts of the world.

    “For example, there are scam websites which exhibit ventilators that are actually fake. WHO is trying to monitor all these and give guidance to countries.”

  • NAFDAC stops firms from using COVID-19 to promote brands

    NAFDAC stops firms from using COVID-19 to promote brands

    The National Agency for Food and Drug Administration and Control has warned infant foods producing companies from using the coronavirus pandemic as a means to promote their brands.

    It gave this order in a statement on, “COVID-19 pandemic lockdown and guidance note to companies that donate or market breastmilk substitutes for infants.”

    NAFDAC stated that pursuant to provisions of the NAFDAC Act, CAP N1 LFN 2004 and the Marketing (Breast-Milk Substitutes) ACT CAP M.5 LFN 2004 and the BMS regulations, in keeping with the WHO International Code of BMS, wished to provide clarifications regarding donations of BMS in the context of lockdown and financial barriers occasioned by the national response to the COVID-19 pandemic.

    It stated, “Companies that market foods for infants and young children (breastmilk substitutes) should not provide free products, samples or reduced-price foods for infants (below six months old) to families through health workers or health facilities, except as supplies distributed through government or officially sanctioned health programmes.

    “The WHO International Code of Marketing of Breastmilk Substitutes requires that products distributed in such programmes should not display company brands.

    “In this specific instance, the unbranded packaging is to focus on the need to support the response to the COVID-19 pandemic, where necessary in terms of infant and young child feeding, rather than use the pandemic as a platform for brand promotion.”

    The agency directed all infant food manufacturers/distributors and non-governmental organisations wishing to make foods for infants and young children (BMS) available for distribution, through officially sanctioned health programmes, to adhere to the clarification provided and approach NAFDAC for the necessary guidance.

    It noted that the importance of infant and young child feeding and the continued protection, promotion, and support of breastfeeding during the COVID-19 pandemic could not be over-emphasised.

    NAFDAC stated, “Breastmilk is the best food for the newborn child as it protects them from sicknesses, it also helps to protect infants and young children.

    “Breastfeeding is especially effective against infectious diseases as it boosts the child’s immunity by directly transferring antibodies from the mother to the child.”

     

  • BREAKTHROUGH! NCDC awaits NAFDAC to make COVID-19 treatment available for Nigerians

    BREAKTHROUGH! NCDC awaits NAFDAC to make COVID-19 treatment available for Nigerians

    …NCDC DG says objectives of COVID-19 lockdown were achieved

    …Talks more on community transmission, says there are different outbreaks of COVID-19 in Nigeria

    Director General (DG) of the Nigeria Centre for Disease Control (NCDC), Dr Chikwe Ihekweazu has said conversations to enable Nigerians to gain access to Coronavirus disease (COVID-19) treatment have started.

    TheNewsGuru.com (TNG) reports Dr Ihekweazu, who made this known on Sunday as guest on the Sunday Politics television programme, said the COVID-19 treatment is a drug that failed clinical trial for the Ebola virus but passed for the new Coronavirus.

    He said the COVID-19 treatment is a drug called Remdesivir, and that it is a victory for science, but that the National Agency for Food and Drug Administration and Control (NAFDAC) would be needed to speed up the regulatory process for it before it is made accessible and available to Nigerians.

    “It is kind of a victory for science because you know over the last few days, we’ve gotten emerging evidence for the first drug that has shown evidence of efficacy.

    “It is a drug called Remdesivir that came out to prominence over trials to use it for the Ebola virus. Well, it did not really work. So, those trials did not show that it worked for Ebola.

    “But these drugs remained in our arsenal. We now tried it in a clinical trial and we have seen that it does produce benefit to people.

    “In the beginning of this outbreak, there was a lot of pressure, not just on NCDC, on State governments across the country to buy and invest in medications, I won’t name them by name, but many types of pills both conventional, medical and everything else.

    “I stood firm and said, listen, we have to wait for the science to come through for us, for the clinical trials to evolve because what we don’t want to do is give people something, not only are we not sure it will work, it could actually cause harm.

    “Many of these drugs that we take have side effects. If we don’t know that the benefit outweighs the side effects, then, as a doctor, I am causing more harm to my patient and the one vow, as a doctor that we take, as most sacrosanct, is to cause no harm.

    “So, I am actually happy that finally some clinical trial evidence has emerged about a new drug.

    “What we now need to do is gain access to this drug. It is a difficult process at the moment but we’ve started those conversations to enable access to Nigerians.

    “We will speak with NAFDAC to hasten, speed up the regulatory process so we can make this drug accessible and available to Nigerians.

    “So, it is the first step. That is how science works. Sometimes, it is slower than we want it and would like it to be, but that is really what we have to do,” Dr Ihekweazu said.

    NCDC DG says objectives of COVID-19 lockdown were achieved

    Meanwhile, the NCDC DG also said that the objectives of the COVID-19 lockdown were achieved, stressing that there were three primary purposes in mind when President Muhammadu Buhari instituted the restriction of movement across Nigeria four weeks ago.

    “Four weeks ago when Mr President instituted this restrictions of movement across Nigeria, focusing particularly on three States of the FCT, Lagos and Ogun States, there were three primary purposes.

    “The one everyone remembers is of course we wanted to reduce the risk of transmission from one individual to another, and we achieved that to some extent. Our modeling shows that we had at least 50% reduction of where the numbers would have been if had not instituted the lockdown versus where they are today. So, there was some successes there.

    “But, there are two other critical objectives. One is to prepare the work that we were doing in collaboration with all the State governments across the country to enable the public health system respond in that very difficult case finding, identification, contact-tracing all the contacts and following them up, enabling the development and maturity of that process. That is the second objective.

    “The third objective was to enable the health system, altogether, to prepare for a completely new disease that has emerged in our landscape. That, too, has happened. So, in terms of the primary objectives of the lockdown, they have been achieved

    “The objective was never, and to be clear, aiming at stopping transmission altogether before we restart our activities. We knew from the onset that, that was not going to be possible in our context.

    “So, we needed so time to prepare ourselves for the easing of these measures from tomorrow, and this is not a complete easing. It is very carefully calibrated easing of the measure, and we work collectively, and not just the federal government of the State government, we need to now collectively make sure that we manage these measures as articulated by the presidential task force in order to keep ourselves safe, and to begin a new normal in Nigeria.

    “Living with COVID-19, that is our reality, and we cannot get out of that reality until we get a vaccine and everyone in the global space is working towards that goal. So, until we get to that goal, we have to learn to live with this new normal, new reality.

    “Whether we do it today or push it off one week or two weeks or three weeks, we will still have to come to that inflection point. So, Mr President made a very difficult decision last weekend. We literally weighed the pros and cons of all the data in front of him and he challenged us to start this process from tomorrow.

    NCDC DG talks more on community transmission, says there are different outbreaks of COVID-19 in Nigeria

    Meanwhile, the NCDC DG said even though epicurve of COVID-19 in the country shows just one outbreak, there are have different outbreak in Nigeria, and that the government was trying throw resources properly for that reasons.

    “We have established that there is community transmission in three major cities: in FCT, Lagos and Kano. 75 per cent of all the cases in Nigeria still come from these three cities and that is why one of the measures that have been kept in place by Mr President is the restriction on inter-State travel. That is such an important restriction. It is important for every Nigerian to understand why this is important.

    “We have different outbreak in Nigeria. Even though we show it on one curve, it is really not one outbreak. We are seeing three significantly large cities outbreak in Lagos, in Abuja, and Kano, that have instituted community transmission in almost all the States. Now, we beginning to see something like that happen in Borno, but less in almost all the other States we have found introductions. And you know many of them have been managed to a few number of cases.

    “So, what we are trying to do is to throw our resources into these States that have established community transmission, trying to limit spread in these States, while preventing this virus from going to other States. The virus does not fly on its own to other States. It is carried by people, carried by individuals that are travelling. We have analyzed our own data to see that most of the cases in other States have emerged out of travelers from these high burden States.

    “So, what we are trying to do is keep some of the most important restrictions such as inter-State travel, international travel and large congregations. Those will remain almost completely banned until subsequent weeks when Mr President will evaluate the situation.

    “While we start easing the restrictions on work places, some of the economic activities can start because the economic activities are linked to livelihood, which are linked to lives. So, these are the decisions we have made.

    “I really think every new directive to do things is always difficult in the beginning. I will really forgive a lot of Nigerians who have struggled with this in the early days. But what I always urge people is to keep at it. We will get better. People often jump to into judgment on how well people perform in the first days of the advice to wear masks or the early days of hand washing, but what I know is that people have been getting better at this.

    “Communities have found ways to implement these, to put out hand washing basins in front of their offices, to use sanitizers. I see an increasing number of people wearing masks when I go out, so, Nigerians know what to do and I am confident that we will get to where we want to be by carrying everyone along, not by government saying you must do this, but by Nigerians themselves saying this is what we need to do as a people to stay alive. This is what I need to do for my business to stay in business. This is what I need to do as a family to keep my family safe. This is the only way we can achieve anything out of the new measures we are requesting.

    “To be honest, I categorize these measures into two. There are some of the things like hand washing, sanitizers, that I hope that we will continue to do well after this outbreak. I hope never to be in a situation where I am advising Nigerians to wash their hands regularly. This must become a way of life for us.

    “The use of sanitizer where water is not available must become a way of life. So, there are many of these restrictions that I hope will become contingent on how we wake up everyday and live our lives.

    “The more difficult things for us that we will have to endure over the next few weeks, such as wearing masks, keeping at least two meters apart from each other, the restriction on mass gathering; these are new and very difficult for us because we are a social people. Even our work places are social environment. So, we will all have to learn”.

  • NAFDAC clears air on discovery, approval of COVID-19 drugs, vaccines in Nigeria

    NAFDAC clears air on discovery, approval of COVID-19 drugs, vaccines in Nigeria

    The National Agency for Food and Drug Administration and Control (NAFDAC) says it has not approved any drug or vaccine for the treatment of COVID-19.

    The Director General of the agency, Prof. Mojisola Adeyeye, said in a statement on Saturday that NAFDAC had not granted approval for any vaccine for the treatment and cure of COVID-19.

    “To put the record straight, no drugs or vaccines have been given approval in the country for cure of COVID-19.

    “While the medical researchers globally, the Federal Government of Nigeria and the World Health Organisation (WHO), are working tirelessly on the discovery of vaccines and drugs to cure COVID-19, the agency urges the public to desist from making unsubstantial claims.

    “NAFDAC is the only authority in the country to grant approval to such drugs and vaccines,” Adeyeye said.

    She said that NAFDAC would continue to work with all relevant stakeholders to safeguard the health of Nigerians and that in the event of any approved drug or vaccine for the cure of COVID-19, the agency would not hesitate to inform the public.

    Adeyeye, however, advised Nigerians to comply strictly with measures issued by NCDC to prevent the spread of COVID-19, adding that these include the use of face covering masks, social distancing, washing of hands and use of alcohol based sanitisers.

  • NAFDAC issues regulatory control to curtail COVID-19 spread

    NAFDAC issues regulatory control to curtail COVID-19 spread

    The National Agency for Food and Drug Administration and Control (NAFDAC) says it has put up control measures for its operations to curb the spread of the Coronavirus.

    The was contained in a statement by the Director-General of the agency, Prof. Mojisola Adeyeye, on Tuesday in Abuja.

    According to Adeyeye, the measures are aimed at ensuring adequate protection of staff and clients of the agency as a regulatory organisation.

    She said that the agency had now moved to ensure emergency approvals for product necessary and critical to support response to the pandemic.

    The DG noted that there would be limited Good Manufacturing Practice (GMP) inspections for local facilities at this period.

    She added that the conduct of GMP of foreign facilities cannot be undertaken due to the pandemic and the current travel restriction on international travel for public officers.

    According to her, application for registration of products deemed to have urgent public health impact will be processed and given conditional approvals.

    Adeyeye said that all regulatory processes would continue, adding that the agency remains operational with restricted access in place.

    She said that stakeholders should engage relevant directorate via emails and other functional electronic platforms.

    “The situation is fast evolving and we will continue to monitor and adjust our responses accordingly. For further information, visit our website: nafdac.gov.ng.

    “The agency wishes to assure the public that it remains committed to safeguarding public health and executing its mandate by ensuring that regulated products meet set standards,” it said.

  • COVID-19: Chloroquine may cause more harm than good, says Lagos Govt.

    COVID-19: Chloroquine may cause more harm than good, says Lagos Govt.

    The Lagos State Government has said popular malaria drug, chloroquine, approved by the U.S. for treatment of Coronavirus disease (COVID-19) has significant side effects and should not be used without medical supervision, stressing it may cause more harm than good.

    TheNewsGuru.com (TNG) reports the U.S. on Thursday approved chloroquine, for the treatment of Coronavirus (COVID-19), with President Donald Trump saying at a Coronavirus Task Force news conference that the drug could help with symptoms of COVID-19.

    “It is known as a malaria drug and it’s been around for a long time and it’s very powerful. The nice part is, it’s being around for a long time, and so we know that if things don’t go as planned it’s not going to kill anybody.”

    “Normally the FDA would take a long time to approve something like that and it was approved very, very quickly. We’re going to be able to make that drug available almost immediately,” Trump said.

    However, according to the Lagos State Ministry of Health, there is no hard evidence that chloroquine is effective in preventing or managing COVID-19.

    “We are watching the global research space to clearly define its efficiency in COVID-19. Lagos State Ministry of Health will be conducting its own clinical trial on the effectiveness of chloroquine in the prevention or management of COVID-19 infection.

    “Chloroquine has significant side effects and should not be used without medical supervision, as it may cause more harm than good. In summary, await our directives for the use of chloroquine and do not use it without medical supervision,” the Ministry stated.

    COVID-19: NCDC warns Nigerians against use of Chloroquine

    Similarly, the Nigeria Centre for Disease Control (NCDC) has warned Nigerians against the use of Chloroquine, saying it was not approved for treatment or prevention of COVID-19.

    NCDC, in a tweet on Friday, noted that the World Health Organisation (WHO) has not approved the use of Chloroquine for COVID-19 management.

    The agency said that scientists were working hard to confirm the safety of several drugs for the disease, thus warned citizens against engaging in self-medication.

    “This will cause harm and can lead to death,” it said.

    Also, Gboyega Akosile, the Chief Press Secretary to the Lagos State Governor, through his Twitter handle, @Gboyegaakosile, disclosed that hospitals were receiving patients suffering from Chloroquine poisoning.

    Akosile attributed the information to Dr OreOluwa Finnih, the Senior Special Assistant to the Lagos State Governor on Health.

    He urged the citizens against massive consumption of Chloroquine as a measure to fight.

    The News Agency of Nigeria reports that some Nigerians had started purchasing Chloroquine as a preventive measure against COVID-19, since news broke that China allegedly used Chloroquine as part of treatment for its COVID-19 patients.

    Coronavirus: Virologist warns against use of chloroquine

    Also, a Clinical Virologist, Dr Adeola Fowotade, has cautioned Nigerians against the use of Chloroquine, an anti-malaria drug, for the treatment of Coronavirus, also known as COVID-19.

    Fowotade, a staff of the University College Hospital Ibadan, gave the warning on Friday in an interview with the News Agency of Nigeria in Ibadan.

    The virologist said the Nigeria Centre for Disease Control (NCDC) has not included the drug as a treatment option for COVID-19 in its treatment guidelines.

    She said while early reports from China showed the potency of Chloroquine in treating patients with COVID-19, there was no formal and in-depth study to get information on its efficacy and safety.

    “Currently, the studies we have on using chloroquine to treat COVID-19 are mainly from China and they are still evolving research.

    “They found that chloroquine has a way of inhibiting COVID-19 by reducing the multiplication of the virus introduced to the cell lines.

    “The studies also reveal that chloroquine helped to improve recovery in some patients and also helped to reduce the number of deaths from COVID-19,” she said.

    Fowotade said that although chloroquine has shown potency in treating corona virus, NCDC was hesitant to approve it for COVID-19 treatment until adequate clinical trials were conducted.

    According to her, there is no enough evidence to also ascertain a safe and effective dosage to use in treating the virus.

    “Clinical trials take time but are necessary. Clinical trial is something that is meant to go through a number of phases starting from what they do in cells and they also need to do the same things in animals and they also want to look at the safety of the drugs.

    “For instance, if chloroquine is going to be used to treat COVID-19 there is probability that you will be using it at a much higher dose than what you use for malaria and check its safety at that higher dose.

    ”All these need to be checked even before you get to human clinical trial.

    “However, because of the urgency of the situation, the studies done in China simply moved from cells to humans and so the result that they have generated from there is not sufficient enough for us as a country and the NCDC is not adopting chloroquine at the moment.

    “In any case, the thing about viral infections ultimately is that most viral infections are self-limiting in immuno competent persons, the immune system is sufficient to clear the virus.

    “Ideally, for persons that have good immune response by themselves, if you give them good supportive care, the immune system is able to take care of the viral infection by itself,” she said.

    The virologist also cautioned Nigerians against using the antimalarial chloroquine as a prophylactic or preventive drug for COVID-19.

    She warned against panicking to avoid falling prey to misinformation and unfounded claims about coronavirus with regard to its prevention and treatment.

    “If the virus is not there, then there is no use or basis whatsoever for taking chloroquine as prophylaxis.

    “This is just like what happened during the outbreak of Ebola virus when people were told to take salt, the same is happening with chloroquine, this is wrong and should be discouraged.

    “When people get misinformed, they take wrong actions and refuse to observe the necessary and the correct actions.

    “Ultimately, this puts the lives of people at risk, increase the spread and makes nonsense of the entire control effort,” she said.

    NAN reports that chloroquine, which is a medication used to prevent and treat malaria was a widely prescribed treatment for malaria in Nigeria.

    The Food and Drug Administration (FDA) in the United States on Thursday said it was looking at a widespread and pragmatic clinical trials of the antimalaria drug for COVID-19.

    It has yet to approve chloroquine for the treatment of the coronavirus.

    NAN also reports that COVID-19 has infected over 200,000 persons world-wide, including 21 confirmed cases in Nigeria.

    NAFDAC approves chloroquine for clinical trials

    Meanwhile, the National Agency for Food and Drug Administration and Control (NAFDAC) has approved chloroquine for clinical trials in tackling COVID-19.

    Director-General of the agency, Mojisola Adeyeye, made the disclosure at NAFDAC headquarters in Lagos on Friday, stressing that the Agency was not approving the drug for the treatment of COVID-19 but for clinical trials to find treatment for the virus.

    “In the case of Chloroquine, it has been demonstrated in the literature and with clinical research which is still ongoing, that Chloroquine is superior to the Placebo.

    “NAFDAC is not approving Chloroquine as a product that has can be used for Coronavirus because there is no submission to us for registration but because it is under clinical trials, NAFDAC approves medicines meant for clinical trials.

    “Therefore the medicine is being approved just for the clinical trials. Right now, we have asked one company to make a batch of Chloroquine for the purpose of clinical trials.

    “Nobody should use chloroquine as anti-malaria because of the resistance that has been proven to develop in the past after the use of chloroquine in the population,” Adeyeye said.

  • Coronavirus: NAFDAC approves Chloroquine production for clinical trial

    Coronavirus: NAFDAC approves Chloroquine production for clinical trial

    The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the production of Chloroquine for clinical trials in tackling the deadly Coronavirus.

    Prof. Mojisola Adeyeye, agency’s Director-General, who spoke in Lagos on Friday, stated that NAFDAC was not approving Chloroquine for the treatment of COVID-19 but for clinical trials to find treatment for the virus.

    She said in the case of Chloroquine, it had been demonstrated in the literature and with clinical research which is still ongoing, that Chloroquine is superior to the Placebo.

    “NAFDAC is not approving Chloroquine as a product that can be used for Coronavirus because there is no submission to us for registration but because it is under clinical trials, NAFDAC approves medicines meant for clinical trials.

    “Therefore the medicine is being approved just for the clinical trials,” Adeyeye said.

    She, therefore, called on experts and researchers that were interested in doing a clinical trial on Chloroquine to approach approved outlets, adding that a drug company had been given an approval to produce chloroquine in batches.

    “Right now, we have asked one company to make a batch of Chloroquine for the purpose of clinical trial,” Adeyeye added.

  • Four years unaudited accounts of NAFDAC, Reps summon Orhi, Adeyeye

    The House of Representatives Committee on Public Accounts has summoned summoned former and current director general of National Agency for Food, Drug Administration and Control (NAFDAC), Paul Orhi and Mojisola Adeyeye respectively to appear before it Tuesday next week.

    Chairman of the committee, Hon Oluwole Oke gave the directive on Wednesday in Abuja following NAFDAC’s inability to render 2009 to 2013 Accounts.

    Mr. Orhii had informed the committee that he did not come prepared adding that he only got to know about the meeting through the current director general of the agency and due to the respect he has for the committee, he has to attend the meeting.

    In order to ensure a fair hearing, the committee chairman asked Mr. Orhii to liaise with the accounting department of the agency to enable him have access to account document having left the agency for years.

    The committee to this regard charged NAFDAC to render detailed 2009 – 2013 audit reports and provide all relevant documents to it when appearing next week Tuesday.

    According to Mr. Oke, it is unheard of for an agency not to render accounts for four years.