Tag: NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has refuted claims that it approved the herbal product Lung Detox Tea or Lungitox (Smokers Pride), which falsely asserts that it makes smoking safe when used.  

NAFDAC condemned the misleading claim circulating in a video on social media, describing it as false and unfounded, emphasizing that such claims endanger public health while urging Nigerians to disregard them.  

In a statement on Sunday by its Resident Media Consultant, Sayo Akintola, NAFDAC clarified that the promoters of the product had applied for registration but the application was denied as the product’s scientific efficacy and safety could not be substantiated.  

The statement reads: “NAFDAC wishes to categorically state that this claim is false and completely unfounded.

“The product in question—Lung Detox Tea or Lungitox (Smokers Pride) or any similar product—is NOT registered by NAFDAC.

“The unscrupulous individual behind this product had submitted anti-smoke and lung detox tea for registration in 2023.

“It was queried at the Lagos Office Directorate LOD of NAFDAC and was not resubmitted for processing.

Read Also: JUST IN: NAFDAC recalls fake antibiotic medicine, investigates manufacturer, marketer 

“The application was outrightly queried due to the unsubstantiated and dangerous claim that smoking could be made “healthy” by consuming the product.

“It should be noted that we don’t allow pictorial of organs on product artwork.

“As a scientific and professional agency, NAFDAC will never permit the importation, exportation, manufacture, advertisement, distribution, sale, and use of products with claims that do not have any scientific basis.

“Herbal Products and any other related products are not allowed to make any therapeutic claims unless scientifically validated through proper clinical trial studies.

“NAFDAC remains steadfast in its mandate to protect public health and ensure that only safe, effective, and scientifically substantiated products are approved.

“We condemn any attempt to mislead or endanger the public with false claims.

“The public is advised to disregard this video and report any suspicious claims or products to the Agency through our official channels”.

The National Agency for Food and Drug Administration and Control (NAFDAC) has initiated an investigation into reports of serious adverse reactions linked to Deekins Amoxycillin 500mg capsules. 

The medication, allegedly produced by Ecomed Pharma Ltd and marketed by Divine Kings Pharmaceutical Ltd, is suspected to be substandard, particularly batch number 4C639001.  

The fake medicine, bearing a manufacturing date of March 2024 and an expiry date of February 2027, has since been recalled by the agency while warning caregivers and the public to be cautious and vigilant of the drug and alert the agency should they come across it while seeking care.

The Director General of NAFDAC, Prof. Mojisola Adeyeye disclosed in Abuja on Thursday at a press briefing, where she emphasized that the issue would be escalated to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) as the drug might have found its ways across the Nigerian borders.

This step, she said ensures that international stakeholders are informed of the risks posed by the counterfeit medication.  

Detailing how a hospital documented three cases of severe adverse reactions associated with the batch, which prompted the investigation and the eventual recall of their drug, she said, “In the statement obtained from Mr. Kingsley Ekeanyanwu, the Marketing Authorization Holder (MAH), capsule, Divine King Pharmaceutical Ltd, stated that all products were manufactured by Ecomed Pharma Ltd. 

“The manufacturer Ecomed Pharma Ltd in his statement claimed to have produced only twenty packets (20) of the affected batch number 4C639001 for the purposes of renewal of his registration. 

“He also claimed to have manufactured One Thousand, Nine Hundred and Sixty-One (1,961) packets, Batch No 4C639002. 

Read Also: NAFDAC destroys expired, fake, smuggled products worth over ₦10.9 Billion 

“However, Seven Hundred and Ninety (790) packs of Batch 4C639001 with manufacturing 03/2024 and Expiry Date 02/2027 were recalled, which he did not manufacture. 

“The products have been sampled for laboratory analysis against the suspects, Pharm Ekene Christopher, Ecomed Pharma Ltd and Mr. Kingsley Ekeanyanwu, of Devine Kings Pharmaceutical Ltd. 

“The analysis is currently pending determination while the investigation is ongoing.

“Meanwhile, the Quality Control and Production Managers have been invited for further investigation.

“The Pharmacy Council of Nigeria, the Agency that issues site licenses for the site and the Pharmacist in charge has been notified.  

While assuring that the agency has several Prevent, Detect and Respond mechanisms, including WHO-certified methods to prevent fake, falsified and substandard medicines from flooding the market, Adeyeye cautioned consumers to avoid using the suspected batch of Deekins Amoxycillin 500mg capsules. 

She said it was due to its vigilance that the agency operatives were able to detect a children’s medicine that contained zero content in Kano.

Describing the industry players that engage in falsified, fake and substandard drugs as murderers, the DG said the suspected perpetrators have been apprehended and are in court.

She, however, urged distributors and healthcare providers to check the authenticity of all medical products and ensure they are sourced from licensed suppliers.  

While emphasizing the importance of vigilance within the supply chain to prevent the distribution and administration of counterfeit drugs, the DG called on anyone in possession of the affected batch to cease its use immediately and submit any remaining stock to the nearest NAFDAC office.  

She also advised patients who have used the product and experienced adverse effects to seek medical attention promptly. 

The DG reiterated NAFDAC’s commitment to safeguarding public health while urging all stakeholders to remain vigilant in reporting and addressing incidents of substandard and falsified medicine. 

…urges Nigerians to support fight against counterfeiting

The National Agency for Food and Drug Administration and Control (NAFDAC) on Wednesday, December 11, 2024, destroyed expired, unregistered, counterfeit, and smuggled products valued at ₦10,991,458,374.60. 

The destroyed items, collected from five states in the Southwest Zone (excluding Lagos) and Kwara State in the North Central Zone due to its proximity, were incinerated in Ibadan. 

Speaking at the event, NAFDAC Director General, Prof. Mojisola Adeyeye, represented by the South West Zone Director, Mrs. Roseline Ajayi, stated that the exercise aims to reassure the public that confiscated products are not diverted for personal use but destroyed under strict supervision.

She added that the disposal was conducted at an approved dumpsite provided by the Oyo State government to minimize environmental pollution. 

The destruction exercise was witnessed by key stakeholders, including the Chairman of the Oyo State Hospital Management Board, Dr. Akin Fagbemi, officials from the Nigerian Security and Civil Defense Corps (NSCDC), the Nigerian Drug Law Enforcement Agency (NDLEA), and other agencies. 

Read Also: NAFDAC seizes alcoholic beverages in sachet, pet bottles in Asaba

The DG said: ‘’The destruction exercise taking place today in Ibadan is a key component of the functions of the Investigation and Enforcement Directorate, charged with the responsibility for investigation of unwholesome, substandard, fake and counterfeit regulated products and to mop them from circulation so as safeguard the health of the citizens.

‘’The effort of ridding the system of unwholesome and substandard regulated products from circulation is being supported by sister agencies represented here among whom are; the Nigerian Customs Service (NCS), the Nigerian Police (NP), the Department of State Service (DSS), Nigerian Security and Civil Defense Corps (NSCDC), the Nigerian Drug Law Enforcement Agency (NDLEA).

‘’The items for destruction here today are collected from the five states of the South West Zone (excluding Lagos) of the Agency and Kwara state of the North Central Zone (because of proximity) to the Southwest zone.

‘’These items include expired products that were voluntarily forfeited by those in the drug distribution channel, unregistered and unwholesome products that were raided from different outlets and warehouses, fake and counterfeit as well as unregistered imported products smuggled into the country. The worth of what is being destroyed today is estimated to ₦10, 991, 458, 374.60”.

The DG however called on Nigerians to join hands to keep Nigeria safe and free from unwholesome, substandard, fake, and counterfeit medicinal and other Regulated products.

‘’As a matter of fact, every Nigerian is expected to be an ambassador of NAFDAC, joining hands with the Agency in the bid to sanitize the Food and Drug sector in Nigeria.”

The Danish Embassy and Danish Veterinary and Food Agency (DVFA) have announced their commitment to support the National Agency for Food and Drug Administration and Control (NAFDAC) to fight the growing threat of Antimicrobial Resistance (AMR) in Nigeria, it emerged on Sunday.

Described as a ‘Silent Pandemic’ to the human race because infections once easily treated with antimicrobials are now becoming increasingly difficult and sometimes impossible to manage, due to the scourge of AMR, the Director General of NAFDAC, Prof. Mojisola Adeyeye described the collaboration between the two as timely.

The collaboration emerged in Lagos during a stakeholders’ workshop themed ‘Educate. Advocate. Act Now’, in Lagos to mark the 2024 World Antimicrobial Awareness Week, where the NAFDAC DG highlighted that antimicrobial resistance is reversing decades of medical progress, making infections once treatable with antibiotics increasingly difficult to manage. 

The workshop also reflected on global commitments made at the 79th United Nations General Assembly High-Level Meeting on AMR which include reducing the annual 4.95 million AMR-related deaths by 10% by 2030, improving infection prevention and control, and significantly reducing antimicrobial use in agriculture.  

Adeyeye noted that the growing antimicrobial resistance endangers decades of medical progress, potentially reversing successes in treating common infections, performing surgeries, and conducting medical procedures, adding that the most pressing danger is the antimicrobial resistance found at birth in newborn babies in a teaching hospital in Nigeria. 

According to the DG in a statement by the agency’s Resident Media Consultant, Sayo Akintola, the implication of one of the most urgent global health challenges of our time, AMR, often referred to as the ‘Silent Pandemic’ to the human race is unquantifiable because it poses a threat to man, animals and plants.

Read Also: Nigeria spent N5.14tn on mineral fuels import in Q3, says NBS

She, however, disclosed that NAFDAC has implemented measures to address AMR, including limiting antibiotics formulations to two active ingredients to curb overuse, discouraging antibiotics as growth promoters in livestock, and raising awareness about the risks of using colistin in animal feed. 

Colistin, classified by the World Health Organization (WHO) as a last-resort antibiotic for humans, has been misused in poultry and swine production, she noted.  

According to the DG, the agency has also been educating farmers on alternatives, such as organic acids and probiotics, and has established a dedicated in-house AMR-One Health committee to collaborate with national and international partners like the Nigeria Centre for Disease Control (NCDC), Federal Ministry of Agriculture, WHO, and the European Union.  

“AMR is not a distant threat; it is already impacting lives,” she stated, emphasizing the urgent need for coordinated action to combat the silent pandemic.

The Danish Ambassador to Nigeria, Jens Ole Bach Hansen, reiterated his country’s commitment to supporting NAFDAC’s efforts against AMR while noting with concern that it is one of the major causes of death around the world and therefore recognized as one of the global public health challenges which requires global solutions.

According to him, the collaboration is supported by a learning program facilitated by the Danish Fellowship Centre, which trains NAFDAC regulatory officers in food safety, disease control, and the One Health approach. 

“The Danish partnership is particularly focused on transferring knowledge and experience to help combat the spread of AMR in Nigeria,” he added.

The National Agency for Food and Drug Administration and Control (NAFDAC) has notified the general public of the sale of counterfeit Combiart (Artemether Lumefantrine 20/120mg) Dispersible Tablet in Nigeria.

The notification is in a public alert marked: No. 043/2024, issued on NAFDAC website, disclosing the date of manufacturing of the drug to be February 2023 and June 2023.

It equally gave the expiry date of the drug as May 2026 and June 2026, as well as Batch No: 7225119 with NAFDAC Reg No: A11-0299.

The agency also gave the manufacturer name and address as Strides Arcolab Limited, 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore- 562 106, India.

NAFDAC, in the alert, said that all its zonal directors and state coordinators had been directed to carry out surveillance and mop up the counterfeit products within the zones and states.

It advised importers, distributors, retailers, healthcare professionals and caregivers to exercise caution and vigilance within the supply chain and avoid importation, distribution, sale and usage of the counterfeit product.

It said that all medical products must be obtained from authorised/licenced suppliers and that products’ authenticity and physical condition must be carefully checked.

The alert also advised healthcare professionals and consumers to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office.

Read Also: NAFDAC destroys N2b counterfeit alcohol in Lagos

It urged Nigerians to call NAFDAC on 0800-162-3322 or report any suspicious event via email: sf.alert@nafdac.gov.ng.

“Healthcare professionals and patients are similarly encouraged to report adverse or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng.,” it said.

It advised Nigerians to report any adverse effects via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng.

NAFDAC promised that the notice would be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).

The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned frozen food dealers to stop the sale and distribution of unregistered and prohibited products.

The agency made this announcement on Friday during a one-day sensitisation programme at Kado Fish Market in Abuja.

The Director-General of NAFDAC, Prof. Mojisola Adeyeye, emphasised that the importation and distribution of banned products must stop to support local farmers and producers of frozen food.

Adeyeye was represented by Mr Kenneth Azikiwe, the Director in charge of the FCT Directorate.

She reiterated NAFDAC’s commitment to eliminating the illegal production, distribution, and sale of unregistered packaged food, water, and other regulated products.

Read Also: NAFDAC warns of counterfeit malaria drug circulating in Nigeria

She noted that the initiative aims to safeguard public health, particularly during the festive season.

“This sensitisation programme is designed to ensure good storage and distribution practices in the market because properly stored food products maintain quality before consumption.

“We are here at Kado Fish Market, the largest fish market in North-Central Nigeria, to ensure that frozen chicken, fish, and meat products are appropriately stored and safe for public consumption”.

She urged market association members to prioritise purchasing locally manufactured and NAFDAC-registered frozen products to ensure quality and safety for consumers.

Adeyeye warned that violators of the Federal Government’s ban on the importation of frozen chicken, turkey, and catfish would face strict enforcement measures.

The Chairman of the Frozen Food Sellers Association at Kado Fish Market, Alhaji Ibrahim Mohammed, welcomed the sensitisation programme and pledged the association’s support for NAFDAC’s regulations.

He assured the agency that members would comply with the policies to promote the well-being of Nigerians.

Mohammed, however appealed to NAFDAC to enforce its policies with fairness and compassion.

In a related development, NAFDAC has conducted inspections of water production factories in the FCT.

The inspection is to ensure compliance with hygienic standards and good manufacturing practices among sachet and table water producers.

(NAN)

The National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm over the distribution of counterfeit Combiart Dispersible Tablet 20/120mg in Nigeria, warning of significant public health risks.

The fake medication, falsely labeled as a product of Strides Arcolab Limited in India, was uncovered during surveillance operations by NAFDAC’s Post-Marketing Surveillance Directorate in the Federal Capital Territory (FCT) and Rivers State.

To ensure global surveillance and coordinated action against the counterfeit medicine, and as part of its global responsibility, NAFDAC confirmed that the issue would be uploaded to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) to strengthen international efforts against counterfeit medicines. 

The move, it said, underscores the potential cross-border implications of the counterfeit Combiart tablet and the urgent need for a coordinated response.

NAFDAC gave the details of the medicine as Brand Name: Combiart Dispersible Tablet 20/120mg.

Generic Name: Artemether + Lumefantrine 20/120mg Dispersible Tablet.

Batch No: 7225119.

NAFDAC Reg No: A11-0299.

Manufacturing Date: June 2023 and Feb 2023.

Expiry Date: May 2026 and June 2026.

Manufacturer’s Name and Address: Strides Arcolab Limited, 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore- 562 106, India.

This was disclosed by the agency on its X microblogging platform on Thursday, where it revealed that laboratory analysis of the product revealed it contained no active pharmaceutical ingredients (APIs), rendering it ineffective against malaria, the condition it is designed to treat. 

Further investigations by NAFDAC uncovered significant discrepancies in the product’s labelling, including two different manufacturing and expiry dates and an invalid NAFDAC registration number. 

The agency also confirmed that the product license had expired, further disqualifying it from legitimate distribution.  

It noted that Combiart, a combination of Artemether and Lumefantrine, is a well-known antimalarial medicine used to treat uncomplicated malaria. 

However, according to the agency, the counterfeit version circulating in Nigeria not only fails to treat malaria but poses grave health risks, the agency noted, warning that counterfeit medicines can lead to treatment failure, worsening of medical conditions, and, in severe cases, death.  

To address the situation, NAFDAC said it has directed all zonal directors and State coordinators to intensify surveillance and remove the counterfeit products from circulation. 

Read Also: NAFDAC destroys N2b counterfeit alcohol in Lagos

Importers, distributors, and retailers have been urged to verify the authenticity of their medical supplies and ensure they source products only from authorized suppliers. 

Healthcare professionals, caregivers, and the general public are also advised to remain vigilant and report any suspicious products to NAFDAC immediately.  

Urging the public to exercise caution and prioritize safety by obtaining medical products only from verified sources, the agency said reports of substandard or falsified medicines can be submitted via NAFDAC’s hotline at 0800-162-3322 or by email at sf.alert@nafdac.gov.ng. 

Additionally, it said healthcare professionals and consumers can report adverse drug reactions or side effects through NAFDAC’s Med-Safety app or the e-reporting platform available on the agency’s website.

Officials of the National Agency for Food and Drug Administration and Control (NAFDAC) have dismantled counterfeit alcohol worth N2 billion in Lagos State.

The illegal facilities where the fake alcohol was being produced were located in the Abule-Osun area.

“NAFDAC has dismantled illegal alcohol packaging operations at Article Market in Abule-Osun, Lagos State,” the agency announced yesterday in a statement shared on its X handle.

It disclosed that during the operation, over 50,000 counterfeit branded labels and packaging materials for fake alcoholic beverages, valued at approximately N2 billion, were confiscated.

These items, NAFDAC added, were being used to produce unapproved and hazardous alcoholic products

The agency highlighted the dangers of consuming counterfeit alcohol and to caution consumers.

Read Also: NAFDAC workers vow to continue strike

“NAFDAC warns about the severe health risks of counterfeit alcohol, including poisoning and organ damage. Consumers are advised to purchase alcoholic beverages only from trusted vendors and report any suspicious activities to the nearest NAFDAC office,” the statement said.

The Lagos raid comes on the heels of another major operation in Nasarawa State, where NAFDAC seized counterfeit wines and spirits worth over N41.2 million.

The raid targeted shops in Mararaba Market, New Nyanya, and Masaka areas, with the agency’s Investigation and Enforcement team now working to identify the importers or manufacturers responsible.

“NAFDAC has conducted a major raid on wine shops in Mararaba Market and the New Nyanya and Masaka areas of Nasarawa State. The operation targeted counterfeit and adulterated wines and spirits, resulting in the seizure of products valued at over N41.2 million,” the agency revealed.