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Tag: NAFDAC

  • NAFDAC insists report of under-dosed Paracetamol fake

    NAFDAC insists report of under-dosed Paracetamol fake

    The National Agency for Food and Drug Administration and Control (NAFDAC) says the recent publication claiming that paracetamol drugs in Nigeria are under-dosed is fake.

    Prof. Mojisola Adeyeye, Director-General of NAFDAC, stated this in an interview on Thursday in Abuja.

    Adeyeye said that the publication was a disservice to Nigeria, adding that academic publications need to be more responsive to issues of public health.

    A 2023 study with samples from five paracetamol brands claiming to contain 500mg paracetamol as its active ingredient, were said to have been tested and analysed using the spectrophotometric method.

    But the paracetamol concentrations were reportedly found to range from 185mg to 358mg, which is less than the recommended 500mg.

    The study’s researchers raised concerns about the possibility of treatment failure due to under-dosed paracetamol tablets.

    Adeyeye, however, said that findings have shown that the said publication has been retracted.

    Adeyeye, who cautioned against playing on the intelligence of the 250 million Nigerians, enjoined all Nigerians to use paracetamol.

    “There is nothing wrong with our paracetamol. The publication is fake and I’m speaking from the perspective of a professor.

    The NAFDAC boss said as a scientist she proved the publication wrong and immediately the agency instructed its staff to do sampling.

    “And when you are doing sampling, you don’t do sampling in one place. We used 36 made RS2 software of mathematical package to know where to go, to know how many samples to take.

    “So that statistically when the results come out it can be validated. So they went and took samples from Abuja and Lagos.

    “But as a scientists we did the test using international standard not a Nigerian university standard, not a Nigerian standard, not a West African standard.”

    She argued that there is no single lab in Nigeria that is better than that of NAFDAC, adding that the agency had been judicious in its financial management.

    “That lab were these products were tested this week is a WHO pre-qualified laboratory and we have been working on that for about six years.

    “We got that in September 2023, WHO pre-qualified laboratory, only few countries have such attainment or laboratory have such attainment in Africa.”

    The NAFDAC boss said that the agency was building quality culture in the industry and encouraging local production of food and drugs to allow for more jobs and save foreign exchange.

  • NAFDAC releases findings on paracetamol tablets in Nigeria

    NAFDAC releases findings on paracetamol tablets in Nigeria

    The National Agency for Food and Drug Administration and Control (NAFDAC), based on its scientific findings, has faulted claims that nearly all paracetamol drugs in the country are under the recommended doses.

    Prof. Mojisola Adeyeye, the Director-General of NAFDAC, made this known on Monday while briefing newsmen on findings carried out by the agency due to a publication’s claim of under dose paracetamol tablets in the country.

    Adeyeye said that based on a scientific response to recent reports suggesting widespread under-dosing of paracetamol tablets in Nigeria, NAFDAC conducted a comprehensive testing of tablets, sampled from different pharmacy outlets to investigate these claims.

    “As a Scientist and Professor of Pharmaceutical Manufacturing and Drug Evaluation for 30 years, the publication gave me a great concern on the lack of responsibility regarding the impact of the unscientific release on the Nigerian society.

    “The results of the laboratory testing are ready after paracetamol tablets from 13 different local manufacturers were sampled from Lagos and Abuja pharmacy outlets.

    “We assured the public that we will publish the result of our own investigation of the paracetamol tablets in Nigeria immediately after we conclude testing in the agency’s WHO pre-qualified laboratory.

    “A minimum of 20 tablets from each manufacturer were used for the assay analysis by regulatory officers with verifiable analytical skills and competencies using the British Pharmacopoeia monograph 2023 edition Volume 3.

    “The result of our test clearly showed that all the 20 tablets from each manufacturer met the stipulated dosage standards and specification.

    “This includes adherence to both national and international regulatory requirements”.

    She said: “This is a 100 per cent pass rate for the full compendia tests result for the 20 samples of paracetamol tablets tested.

    “While the assay was validated using British Pharmacopoeia testing methodologies for precise and reliable assessments of the dosage levels in the sampled paracetamol tablets.

    “The assay results clearly contradict the results of the published report circulated on social media and we fault this grim publication in totality,” she said.

    She added that parameters including uniformity of mass, average weight, friability, hardness, identification and disintegration time that were not part of the subject in question were also tested.

    They were found to have met the BP specifications, she said.

    “Basic scientific facts such as the range of the concentrations of the standard curve solutions (0.01 to 0.05) being lower than the solution test samples (0.1) further invalidates all the analysis because the anticipated test solution concentration should fall within the calibration concentration range.

    “These are basic laboratory testing and scientific facts that those competent in pharmaceutical and regulatory science should know.

    “These are the simplest of many rigorous tests that earned the NAFDAC Central Drug Control Laboratory the coveted Pre-qualification by World Health Organisation (WHO),” she said.

    According to Adeyeye, the pharmaceutical manufacturing sector in the country strives to maintain and enhance the quality of pharmaceutical products to align with NAFDAC’s quality culture.

    “This publication that has now been retracted is a disservice to the pharmaceutical industry and the nation.

    “The mischief of placing the article in the social media on the background of World Health Organisation logo is highly distasteful and illegal.

    “NAFDAC emphasises the importance of evidence-based information to guide public discourse and urges stakeholders to rely on and check for accurate and comprehensive data”.

    The Director-General reassured Nigerians of the agency’s commitment to public health and safety.

  • NAFDAC speaks on circulation of substandard paracetamol

    NAFDAC speaks on circulation of substandard paracetamol

    Following the recent story being circulated on social media alleging that nearly all paracetamol tablets sold in Nigeria are under dosed, the National Agency for Food and Drug Administration and Control (NAFDAC) said its aware of the report.

    Prof Moji Adeyeye, Director General of NAFDAC in a statement said the agency received a copy of the publication of the research finding of the subject and wish to state categorically that the report is misleading, and the science is questionable.

    According to her, “as the quality culture of NAFDAC demands, as soon as the Agency became aware of the news, the Director General, had meetings with the respective Directors and gave a directive that a survey of the market should be done to sample and test.”

    “NAFDAC’s laboratories are ISO 17025-certified every year to ensure that the procedures used for testing are based on international standards and the equipment or instruments used are qualified similarly.

    “We do yearly post-marketing surveys of medicines to ensure that the quality and safety are maintained.

    “Where there is a deviation from this, i.e., whenever we find any regulated product to be substandard or falsified, NAFDAC regularly issues public alerts or do recalls.”

    She noted that in  last two years  the agency issued eighty-eight (88) public alerts and ordered thirty-two (32) recalls for medicines and foods.

    “We are using this medium to assure the public that NAFDAC is using international standards and scientific methods to survey the paracetamol product where samples are collected from different parts of the country in the right amount and will be tested using well calibrated, and qualified state-of-the-art equipment or instruments.

    “This is part of our routine regulatory post marketing surveillance among others throughout the life cycle of a medicine.

    “We want to reiterate that NAFDAC has five ISO-17025 Laboratories across the country, and a WHO Prequalified Laboratory at Yaba Lagos where medicines are tested for quality and safety.

    “The laboratories test medicines using official monographs of British Pharmacopeia, United States Pharmacopoeia, and International Pharmacopoeia.

    “As soon as we finish the laboratory testing, we will update the public.“

    NAFDAC reassure the public that the Agency is very vigilant in its responsibilities in safeguarding the health of the nation.

    “It is on this basis that NAFDAC has been recognized by WHO as a stable, well-functioning agency, and by other international partners as an organisation that places premium on the quality, safety and efficacy of medicines, food, and other regulated products.

     

  • NAFDAC releases list of adulterated drinks circulating in Nigeria

    NAFDAC releases list of adulterated drinks circulating in Nigeria

    The National Agency for Food and Drug Administration and Control (NAFDAC) has released a list of possible adulterated drinks circulating in the country.

    NAFDAC released the list on Monday in Abuja, saying it recently burst some producers of the counterfeit wine, soft drinks and other consumables in Eziukwu Market in Aba, Abia state.

    The Director-General (D-G) of the agency, Prof Mojisola Adeyeye, who disclosed this to newsmen at a press briefing, stated that the operation was carried out following a leaked information to the agency.

    She said that NAFDAC carried out several weeks of intelligence gathering and collation of data on the activities of these ‘merchants of death’ in collaboration with other security agencies.

    The NAFDAC boss said that the agency carried out the sting operation in the market to burst the criminal operation taking place there.

    According to her, “it is worthy of note that this dastard activity has been going on for a long time and that they operate like a cartel threatening anyone who dares to challenge them.”

    She said that some of the nefarious activities of the counterfeiters included the manufacture of all kinds of adulterated products, especially different kinds of wine from a wide variety of brands, ranging from Seaman, Schnapps, Henessy, Four cousins, and Carlo Rossi.

    Others are Jenney, Chelsea London dry gin, Schnapp dry gin, McDowells, Black labels, Gordons, Martell, Campari, Smirnoff ice, Eva Non-Alcoholic drink, Evra non-alcoholic drink, Cartel and others.

    The D-G said that there is also date revalidation for expired products like Peak milk, powdered milk, Ketchups, Yoghurt, Coca-Cola products, packaging of fake and substandard products, which are later sold to unsuspecting members of the public for consumption.

    Adeyeye said because of the extensive operation, the agency raided over 240 shops-turned factories where the harmful products were being produced and marketed.

    “The shops-turned factories are very filthy, using water from very unhygienic sources, harmful chemicals, saccharin, colouring, dirty recycled bottles, and cloned packaging materials of other brands.

    “The adulteration of alcoholic beverages by criminal elements in the country is done by mixing of cheaper sources of sugar and starch besides grapes or fruits, among other harmful chemicals unsuitable for human consumption.

    “Over 1,500 cartons of fake and substandard products were destroyed during the operation while 300 cartons were evacuated to NAFDAC warehouse. The street value of the confiscated and destroyed fake products is estimated at over N750 million.

    “Ten people were arrested on arrival at the scene of the crime and will be charged to court after a thorough investigation.

    “Due to the sheer magnitude of illegality going on in that section of the market, NAFDAC had to shut the entire market for thorough regulatory activity until an agreement was reached with all stakeholders who signed that the market will never be used for nefarious activities.

    “Drinking adulterated alcohol can cause nausea and vomiting, abdominal pain, drowsiness, and dizziness, blue tinged or pale skin, irregular or slow breathing, low body temperature, unconsciousness or even death.

    “It can also lead to kidney and liver failure. Methanol, a substance which can be used in fake vodka, may cause permanent blindness,’’ she stressed.

    The NAFDAC boss said that the World Health Organisation (WHO), in its Global Status Report on Alcohol and Health, estimated that more than three million people died all over the world as a result of alcohol poisoning.

    She also stated that the International Agency for Research on Cancer (IARC) had also ascertained that one of every 10 cancer cases in Nigeria can be traced to Alcohol and 4.7 per cent of overall cancer cases in Nigeria in 2019 could also be attributed to consumption of adulterated alcohol.

    Adeyeye urged Nigerians to remain vigilant, saying that the agency was also tasking consumers to always scrutinize branded drinks to distinguish them from counterfeits before consumption.

    The D-G advised members of the public to be careful during this yuletide season and think about the “4 Ps”, which are Place, Price, Packaging and Product before purchasing alcohol.

    She advised consumers of alcohol to always inspect the seal on the bottle, look for the contact information and address of the manufacturer, adding that if it is missing, then then drink is fake.

    According to her, “if you have an app on your mobile phone that scans bar codes, scan it and see if it’s listed as the correct product.

    “People should be wary of bad smells that smells like paint stripper or nail polish remover. These are added to these fake drinks.”

    She said that NAFDAC would continue to ensure that the level of counterfeit products nationwide is brought to the barest minimum, saying that its aim was for people to continue to consume only healthy and safe products.

    The NAFDAC boss pledged to be on the trail of these evil counterfeiters, and bring them to book, while enjoining the public to report any suspicious activity of illegal producers of adulterated products or similar activities to the nearest NAFDAC office nationwide.

  • NAFDAC warns Nigerians against fake injection in circulation

    NAFDAC warns Nigerians against fake injection in circulation

    The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians, particularly healthcare providers, to one batch of counterfeit Meronem 1g injection being purchased in Nigeria.

    TheNewsGuru.com, (TNG) reports this was contained in a public alert No. 036/2023, signed by the agency’s Director-General, Prof. Mojisola Adeyeye on Tuesday.

    Adeyeye said the Marketing Authorization Holder (MAH), Pfizer, reported the incident, as received through a patient notification platform, concerning a suspicious Meronem 1g injection purchase.

    She reported Pfizer as saying that the vial content did not dissolve when reconstituted for use and that further visual inspection of the pack was observed.

    It was also reported that the crimp code did not match the code reported on the production documentation batch of 2A21F11, the semi-finished batch used for 4A21I17.

    The D-G said that the production process did not meet Pfizer’s specifications.

    “The vial label compares favourably to the purported artwork version.

    “Meronem (Meropenem trihydrate injection) is an antibiotic used to treat skin and abdominal (stomach area) infections caused by bacteria and meningitis (infection of the membranes that surround the brain and spinal cord) in adults and children 3 months of age and older.

    “The administration of the counterfeit product will pose a high risk to patients as the quality and safety are not guaranteed,” Adeyeye said.

    The NAFDAC boss, however, said that healthcare providers and patients were advised to obtain all medical products from authorized or licensed suppliers.

    According to her, products’ authenticity and physical condition should be carefully checked before purchase and administration.

    She also implored importers, wholesalers, and retailers to maintain vigilance within the supply chain and desist from the illegal importation, distribution, and sale of counterfeit Meronem 1g injection and other substandard medicinal products.

    Adeyeye said that anybody in possession of the counterfeit product should stop using it and submit it to the nearest NAFDAC office.

    She also called on those in possession of the counterfeit product to seek immediate medical advice from a qualified healthcare professional if they had already used the product or suffered from any adverse reactions after using it.

  • NAFDAC notifies public on energy drink with high level of caffeine

    NAFDAC notifies public on energy drink with high level of caffeine

    The National Agency for Food and Drugs Administration and Control (NAFDAC), has notified the public that the recalled G Fuel brand Energy Drinks by T&E Imports and GPAE Trading Corp, contains high levels of caffeine.
    The notification of this product is contained in a public alert with No. 034/2023, issued to newsmen in Abuja on Thursday by NAFDAC Director-General (D-G), Prof Mojisola Adeyeye.
    Adeyeye said that the agency was equally notified about the recall of the product by the Netherlands Food and Consumer Product Safety Authority (NVWA) and the Canadian Food Inspection Agency (CFIA).
    The NAFDAC boss said that the consumption of product containing high level of caffeine could cause headaches, insomnia, irritability, and nervousness.
    She said that people sensitive to caffeine can experience these effects at very low consumption levels.
    Adeyeye also cautioned pregnant women not to take these products, adding that the possible health effects of consuming too much caffeine include the risk of miscarriage and a chance of low birth weight.
    The D-G also stated that the affected products has no cautionary statement to limit the number of servings per day, adding that these products are sold online.
    “The product is not registered by NAFDAC, which implored consumers and retailers to refrain from using, selling, serving, or distributing the implicated product.
    “Members of the public are encouraged to report any suspicion distribution and sale of unwholesome packaged food products to the nearest NAFDAC office.
    “NAFDAC could also be reached on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
    “Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of any substandard NAFDAC-regulated product to the nearest NAFDAC office.
    “NAFDAC could also be reached through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores.
    “The public could also reach NAFDAC via e-mail on pharmacovigilance@nafdac.gov.ng,” she added
  • NAFDAC destroys goods worth N500m in Abuja

    NAFDAC destroys goods worth N500m in Abuja

    The National Agency for Food and Drug Administration and Control (NAFDAC) on Wednesday destroyed fake and expired goods worth over N500 million in Abuja.

    Speaking during the exercise, the Director-General of NAFDAC, Prof Mojisola Adeyeye, stated that some of the goods were voluntarily submitted to the agency.

    Represented by Mr Francis Ononiwu, NAFDAC Director of Investigation and Enforcement, the D-G stated that the exercise is carried out routinely all over the country.

    The NAFDAC boss said that the destruction of the products were done to prevent their re-introduction to the supply chain.

    Adeyeye listed some of the products destroyed as drugs made up of psychoactive and controlled substance like antibiotics, antihypertensive, antimalarials, herbal snuff and herbal remedies, and drugs confiscated from drug hawkers.

    She also listed the food products such as Spaghetti, vegetable oil, non-alcoholic beverages, including 1 by 40ft container of unregistered Faurecia instant powered milk that was handed over to the agency by the Nigeria Customs Services (NCS).

    Others were cosmetics such as creams, lotion, pomade, including skin lightening creams seized from SPAS and beauty centres, chemicals such as fake insecticides and medical devices.

    Also destroyed were expired and unwholesome products voluntarily handed over for destruction by complaint companies, Non-Governmental Organisations (NGOs) and Association of Community Pharmacy of Nigeria (ACPN).

    According to the NAFDAC boss, the estimated street value of the products being destroyed is N535, 000, 657.00.

    “I have said it on several platforms that drug counterfeiting is an act of economic sabotage, and it also represents a serious threat to public health, and NAFDAC under my watch has been repositioned to fight this menace.

    ”The agency has adapted proactive approach by engaging political, traditional, faith leaders, journalists and other Nigerians to sensitise their wards on the dangers of dealing on substandard and falsified medicine.

    “I wish to use this medium to urge all and sundry to be on the look-out for spurious and counterfeit medicines, unwholesome foods and other regulated products and reports same to NAFDAC,” she said.

    Mr Isiaku Gamajira, FCT Coordinator, Standard Organisation of Nigeria (SON), stated that NAFDAC is a sister agency when it comes to regulation of products, hence the reason why SON was at the event.

    He noted that many people lack education on how to get certification for their products, stressing that it is the reason why most goods from Nigeria are rejected abroad.

    “We are aware of government policy on zero rejection of Nigeria products, we have a policy called product certification in which a certificate is issued on products made in Nigeria that are to be exported.

    “In doing all these, we ensure that we key in to the principle set up in line with the government of the exporting country, and issue a certificate of performance to avoid Nigeria product rejection when they get to the point of entry.

    “We have offices all over the country where information about product certification can be gotten, our addresses are also available online for you to reach out to us.

    “We provide people with proper guidance when they approach us, SON has been carrying out its compliance activities among which is the seizure of substandard products. We have just destroyed tyres

    “Tyre is a product which lives depend on and SON has a serious interest when it comes to compliance action, seizure in that regards, on Sep. 29,  SON destroyed a lot of tyres and these are some of the things we do.

    “Most of these tyres are imported, it is our own common wealth, If you see the quantum of what we have destroyed in the last few months, you will be surprised,” Gamajira said.

    Mr Enejoh Amade, Chairman, Association of Community Pharmacist of Nigeria (ACPN), FCT Chapter, said his association would continue to support  NAFDAC to rid the country of substandard drugs.

    He said that his association had partnered with NAFDAC on the exercise by bringing some expired drugs collected from members of ACPN.

  • NAFDAC warns against four popular daily-use products

    NAFDAC warns against four popular daily-use products

    The National Agency for Food and Drugs Administration and Control (NAFDAC) has warned Nigerians against the use of four products found to contain potent medicinal ingredients, steroids and other banned substances.

    The warning is contained in a public alert signed by the Director-General of the agency, Prof. Mojisola Adeyeye,  in Abuja on Sunday.

    Adeyeye said that the agency was notified of the product in a statement by the Health Sciences Authority (HSA) of Singapore.

    She said that the implicated potent medicinal ingredients are not allowed in the affected products and may cause severe side effects on consumers.

    According to her, the HSA confirmed that four consumers experienced adverse effects after taking three of the products.

    The NAFDAC boss said that laboratory analysis conducted by HSA on the products revealed that they contain potent medicinal ingredients, including steroids.

    She said that the products also contain sibutramine (a banned weight loss medicine) and tadalafil (an erectile dysfunction medicine).

    The products are Fercy Dietary Supplement Product’, ‘TANDUK RUSA KUAT LELAKI’ and ‘mentalk candy’.

    NAFDAC disclosed the source of the products as: ‘ENRU PLUS+’Sibutramine, Local e-commerce and social media platforms ‘HKT HERBA KURUS TRADISI’

    According to her, possible adverse effects of potent ingredients found in the products are: Dexamethasone and Prednisolone.

    She said that dexamethasone and prednisolone are potent steroids that are usually prescribed for inflammatory conditions and could only be used under strict medical supervision.

    Adeyeye said that long-term unsupervised use of steroids can cause increased blood glucose levels, which she said my lead to diabetes, high blood pressure, cataracts, muscular and bone disorders.

    She said that steroids could also cause an increased risk of infections and cushing’s syndrome (a round or ‘moon face’ appearance and upper body obesity with thin limbs).

    The NAFDAC boss added that discontinuation of steroids without proper medical supervision can cause serious withdrawal symptoms such as fatigue, confusion and low blood pressure.

    She also described Diclofenac in the products as a potent painkiller that may potentially cause serious gastric bleeding, as well as cardiovascular events such as heart attacks and stroke when used for a prolonged period.

    According to her, Diclofenac should be used under close medical supervision, especially in consumers with underlying heart conditions.

    The D-G said that Sibutramine is a medicine prescribed for weight loss, and has been banned in Singapore since 2010 because of an increased risk of heart attacks and strokes.

    Other serious adverse effects including fast heart rate, hallucinations or hearing voices which she said it had also been reported by consumers who took slimming products adulterated with sibutramine.

    She stated that Tadalafil is a prescription medicine used to treat erectile dysfunction that should only be given under medical supervision.

    According to her, inappropriate use of tadalafil is dangerous and can increase the risk of serious adverse effects, including heart attack, stroke, headache, migraine, irregular heart rate and priapism (painful and exceedingly long erections).

    “Tadalafil can also pose serious risks to certain individuals, including those with heart-related problems. It can cause potentially life-threatening low blood pressure in those who are on heart medications, especially those containing nitrates,” she said.

    Adeyeye further warned the public to be cautious with all these substances, adding that they are all dangerous to health.

  • NAFDAC addresses increase in prices of drugs over GSK exit

    NAFDAC addresses increase in prices of drugs over GSK exit

    Prof. Mojisola Adeyeye, Director-General, National Agency for Food and Drug Administration and Control (NAFDAC) says exit of GlaxoSmithKline (GSK) pharmaceutical company is not responsible for increase in prices of drugs in the country.

    Adeyeye spoke against the backdrop of speculations that the exit of GSK had affected the prices of drugs in the country on Friday in Lagos.

    Recall GSK, a British multinational pharmaceutical and biotechnology company, in August announced plans to shut down its operations in the country.

    The company had operated for 51 years in Nigeria, haven been incorporated in June 1971, and commenced business the following year.

    Adeyeye said:  “The first reason for the increment in the prices of drug is that the value of naira has depreciated.

    “Before the planned exit of GSK from the country, prices of commodities general has gone up and some of the products GSK produced has decreased.

    “From the regulatory perspective, we encourage local manufacturing and GSK have collaborated with local manufacturers. So it is not like they import everything.

    “The issue of foreign exchange is huge for some of the multinational companies.

    “They generate funds and it becomes difficult to repatriate the money back to their parent company where other developments will take place.”

  • NAFDAC releases top 10 rejected Nigerian food abroad

    NAFDAC releases top 10 rejected Nigerian food abroad

    The National Agency for Food and Drug Administration and Control (NAFDAC) has released a list of 10 rejected  Nigerian food items abroad, blaming the rejection on non-adherence to standardized clearance procedures by stakeholders.

    The Deputy Director, Export Division, Ports Inspection Directorate, NAFDAC, Sanwo-Olu O.A. stated this in an address she delivered at the 3rd CHINET Aviacargo conference in Lagos, with the title, “Unlocking the Logistics Barrier to Improving Agro Exports Products.”

    According to her, the top commonly rejected export food commodities from Nigeria are, sesame, beans, melon seeds, peanut and smoked fish/fish meal, ginger, spices paper, hibiscus flower, palm oil and ogbono.

    She blamed the rejection on non-adherence to set standard by freight forwarders, cargo handlers, airlines/carriers, regulatory agencies, as well as poor inter-agency collaboration, amongst others.

    Sanwo-Olu called for collaboration among stakeholders to ensure that export trade meets the requirements of the country’s trading partner, in terms of quality, standards and quantity as trade increases.