The National Agency for Food and Drug Administration and Control (NAFDAC) has deployed its officials to all ports and select markets to check for some drugs imported from China which are suspected to have been made from the flesh of babies or foetuses.
The Director-General of NAFDAC, Prof. Moji Adeyeye, said this in a statement on Friday.
Adeyeye said, “NAFDAC was informed by the Federal Ministry of Health on Thursday of some Chinese drugs that contain human remains. I immediately alerted the agency’s Ports Inspection Directorate to be on the lookout (for these) at our ports and borders since the drugs may be brought into the country as small packages.
“The Pharmacovigilance and Post-Marketing Directorate has also been alerted to conduct surveillance in our markets. The Registration and Regulatory Affairs Directorate is also on the lookout.”
Adeyeye said she had contacted her counterpart in South Korea since the news was disseminated by Nigerian and Korean intelligence agencies.
In a memo which leaked online on Thursday, the National Intelligence Agency had asked NAFDAC and other agencies such as the Standards Organisation of Nigeria and the National Drug Law Enforcement Agency to be on the lookout for drugs imported from China suspected to have been made from human flesh.
The memo read in part, “The South Korean Customs Service, on September 30, 2018, revealed that it had seized 2,751 Chinese drugs/capsules, containing human remains from foetuses, infants and flesh imported into the country by some Chinese nationals.
“The manufacturers claim that the drugs/capsules can boost stamina, cure cancer, diabetes and some other terminal diseases. The capsules were smuggled in suitcases and through international mail.”
The agency revealed that South Korean Ministry of Food and Drug Safety indicated that 18.7 billion viruses, including hepatitis B virus were found in the capsules.
It described producing the drugs and consuming them as crimes against humanity, which could also lead to serious health challenges.
Tag: NAFDAC
-
NAFDAC intensifies search for drugs made from human flesh
-
NAFDAC bans Malco vitamin B complex injection in Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) has banned the importation, sale and distribution of Malco Vitamin B Complex injection in Nigeria due to contamination.
The drug is produced by Shreechem Pharmaceuticals PVT Ltd, India.
The Director-General of the agency, Prof. Mojisola Adeyeye, announced the ban in a statement in Abuja on Wednesday.
Adeyeye said laboratory analysis by WHO indicates that the product is unfit for human consumption.
She said that use of the product could cause serious health hazard, urging healthcare providers and members of the public to stop the administration and use of the affected product to avoid negative health complications.
The director-general therefore directed all importers, wholesalers and retailers to immediately stop the importation, distribution and sale of Malco vitamin B complex injection.
She urged anyone in possession of the affected product to submit it to the nearest NAFDAC office.
Adeyeye also advised consumers to report any adverse events related to the use of the product to the nearest NAFDAC office or NAFDAC PRASCOR 20543 toll free.
“NAFDAC has been informed that the Zambia Medicines Regulatory Authority (ZARMA) has directed International Drug Company (IDC) Limited, Lusaka, Zambia, to recall all batches of Malco vitamin B complex injection manufactured by Shreechem Pharmaceuticals PVT Limited, India.
“The recall is a precautionary measure due to observed particulate materials possibly microbial growth in the bottles of the product.
“Preliminary observation from World Health Organisation (WHO) facilitated laboratory analysis indicates that the sample is unfit for human consumption.
“The body needs Vitamin B complex for various functions such as supporting cellular metabolism, maintaining healthy nerve cells and proper neurological function; aiding the bone marrow to produce healthy red blood cells and helps to control blood levels of homocysteine,’’ the statement read in part.
The director-general also noted that although Malco vitamin B complex injection was registered with NAFDAC, but its marketing authorisation license expired in 2016.
NAN -
NAFDAC urges Gombe State Govt. to establish drug abuse control committee
The National Agency for Food and Drug Administration and Control (NAFDAC) has appealed to Gombe State Government to establish drug abuse control committee comprising of NAFDAC and other relevant agencies to fight substandard drugs.
The Director-General of NAFDAC, Prof. Moji Adeyeye, made the appeal in a statement in Abuja on Saturday.
Adeyeye said that such committee should also provide office accommodation and vehicles for NAFDAC use at each of the three senatorial districts like Kumo and Billiri for effective coverage.
She assured Nigerians that NAFDAC would continue to support to ensure that Gombe people consumed only good quality and safe drugs and other consumables.
The News Agency of Nigeria (NAN) reports that NAFDAC had, on Thursday, destroyed N464.7 million worth of counterfeit, fake, expired and unwholesome products from six states of North-East in Gombe.
The products destroyed at the Bajoga road Dump Site in Gombe, included antibiotics, anti hypertensive, antiretroviral, cancer drugs, anti malaria, herbal remedies and controlled drugs such as codeine containing cough syrup, Tramadol.
Others include tomato paste, non alcoholic beverages, maize flour and insecticides.
The director-general said that the products destroyed were seized by gallant and committed NAFDAC officers during surveillance and enforcement activities at companies that engaged in sharp practice.
She said other products were voluntarily handed over to the NAFDAC by compliant companies, sister agencies and associations.
Adeyeye assured Nigerians that NAFDAC would continue to do everything possible to ensure that only safe and right quality medicines, wholesome foods and other regulated products were distributed and consumed in the country.
-
FG recalls alarming number of cough syrup containing codeine
The Federal Ministry of Health has recalled 2.4 million bottles of cough syrup containing codeine after a recent audit of the substance carried out by National Agency for Food and Drug Administration and Control (NAFDAC).
According to a statement by Mrs Boade Akinola, Director Media and Public Relations of the ministry on Sunday in Abuja, the recall demonstrated the Federal Government’s resolve to stem the abuse of codeine and other substances in Nigeria.
Akinola said the minister had recently received the final report of the 22-man Stakeholders Committee set up by the Ministry to address the worrisome menace of codeine abuse in Nigeria.
She quoted the Minister of Health Prof Isaac Adewole as saying that the audit trail and subsequent recall of the substance was part of recommendations of Stakeholders Committee set by the ministry to address codeine abuse in Nigeria.
The minister said the committee members were drafted from a broad spectrum of the health sector in collaboration with relevant agencies as part of Pharmacovigilance and renewed effort to monitor drug distribution channels and sanitise the system.
The Minister recalled that the committee was an offshoot of the Press release issued by the Ministry on the temporary ban of Codeine production and distribution.
He said the committee has Director-General of NAFDAC, Prof. Christianah Adeyeye as the chairman. Other members include Muhammad Abdullahi, Chairman of National Drug Law Enforcement Agency (NDLEA), Elijah Mohamed, the Registrar of Pharmacists Council of Nigeria; Mr Moshood Lawal, Director, Food and Drugs Services, Federal Ministry of Health; Ahmed Yakasai, President, Pharmaceutical Society of Nigeria (PSN) among others.
News Agency of Nigeria (NAN) reports that on May 1, Federal Government banned the production and importation of codeine as active pharmaceutical ingredient for cough syrup preparations to check substance abuse among Nigerians.
The minister directed NAFDAC to ban the issuance of permits for the importation of codeine as active pharmaceutical ingredient for cough preparations.
He also directed the Pharmaceutical Council of Nigeria, (PCN) and NAFDAC to supervise the recall for labelling and audit trailing of all codeine containing cough syrups nationwide.
The federal government had also banned the sale of cough syrup containing codeine without prescription.
In this regard, the minister said PCN had been directed to continue enforcement activities on pharmacies, patent and proprietary medicine vendors’ shops and outlets throughout the country.He also directed NAFDAC to carry out its functions in compliance with the new directives.
The minister said cough syrups containing codeine should be replaced with dextromethorphan which is less addictive.
Dextromethorphan is a cough suppressant used to treat coughing. It is also a drug of the morphinan class with sedative, dissociative, and stimulant properties.
-
Codeine abuse: FG orders NAFDAC to return to ports
The National Agency for Food and Drug Administration and Control (NAFDAC) says Vice-President Yemi Osinbajo has ordered the agency to return to the ports immediately.
The order came less than three weeks after the NAFDAC Director-General, Prof. Mojisola Adeyeye, partly ascribed the drug abuse among youths to the unlawful importation of certain banned substances.
The agency said in a statement on Thursday that the directive to return to the ports was to effectively control the importation of unregulated products, falsified and substandard drugs, unwholesome foods, narcotic drugs and hazardous chemical substances and foods.
The statement read in part, “NAFDAC in collaboration with relevant Ministries, Departments and Agencies and with the active support of the Office of the National Security Adviser, the Presidential Enabling Business Environment Council, and the Ministry of Transport, has been returned to the seaports and borders to effectively control importation of unregulated products, falsified and substandard drugs, unwholesome foods, narcotic drugs and hazardous chemical substances and foods.
“NAFDAC received the notice on May 16, 2018, in a letter dated March 29, 2018, from the office of the Vice-President, as part of the PEBEC reforms.”
Adeyeye had said recently that thousands of Nigerians had died as a result of falsified and substandard medicines.
She had further stated that many were ill, most likely due to unwholesome foods, drugs and abuse of narcotics and controlled substances, such as codeine, tramadol and pentazocine.
“These are partly due to the exclusion of NAFDAC from our ports since 2011. The recent documentary on codeine abuse brought more attention to the issue,” she had said.
The NAFDAC boss promised to work with the Nigeria Customs Service, the Nigerian Shippers’ Council and other sister agencies in ensuring that foods, drugs, chemicals and other NAFDAC regulated products that pose danger to Nigerians were controlled at the point of entry.
Adeyeye said NAFDAC at the ports would ensure that dangerous drugs or substances of abuse, many times falsely shipped as building materials, electrical appliances and computer accessories would be intercepted at the point of entry.
-
CPC laud NAFDAC actions on abuse of codeine
Consumer Protection Council (CPC) has commended the National Agency for Food and Drug Administration and Control (NAFDAC) for its decisive regulations, actions on production and distribution of Codeine.
Director-General of the council, Mr Babatunde Irukera, made the commendation in a statement on Thursday in Abuja.
Irukera said that the council welcomed all meaningful efforts to address the rising cases of “abusive consumption of controlled substances’’.
He revealed the council on April 10, issued an “Advisory’’ that publicly called for a ban and prohibition on the prescription of cough medication containing Codeine.
However, Irukera said the outright ban of the product by NAFDAC was commendable.
“Protecting citizens’ addiction and the harm done by abuse of controlled substances must remain a priority always, to the exclusion and sometimes, at the expense of commercial considerations.
“The council will deploy its entire apparatus and resources to support NAFDAC, Ministry of Health, the National Drug Law Enforcement Agency and other relevant agencies to enforce this ban.
“It will deploy resources to also prevent access to codeine and similar addictive substances.
“The council advocates and encourages a strong and zero tolerance approach to access distribution or proliferation of these substances or any combination of chemical properties that have similar effect.
“We will also ensure that production and availability of legitimate medication remain inviolate and uncompromised,” Irukera said.
NAN
-
Codeine saga: NAFDAC lifts shutdown on Emzor, two other companies
The National Agency for Food, Drug, Administration and Control (NAFDAC) on Saturday lifted the shutdown order on three companies who were closed on May 7, for production of codeine cough syrups have been lifted and the normal company operations could resume.
The companies include the Emzor Pharmaceuticals Ind. Ltd, Lagos, Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara.
According to a statement from the agency, the Director-General, NAFDAC, Prof. Mojisola Adeyeye gave the directive following meetings held with the companies and its directorates of Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS).
According to NAFDAC, the production of codeine syrup is to be stopped immediately until further notice while investigations continue.
“Therefore, the hold placed on the active pharmaceutical ingredient and the already made codeine syrups stands. NAFDAC will monitor the compliance.
“All codeine products are to be recalled and the process verified through audit trail verified by NAFDAC.
“Embargo has been placed on new applications for permit or renewals for the importation of codeine as an active pharmaceutical ingredient for cough preparations, i.e., NAFDAC will not issue any permit until further notice
“The companies have been charged with administrative fees that are commensurate with the respective violations,” the statement said.
NAFDAC said that it would hold a stakeholders meeting on the codeine crisis in a few days to develop a roadmap for the supply chain distribution and the future of codeine syrup manufacturing.
The agency also noted that the stakeholders meeting was in line with the Minister of Health pronouncements in his press release on the codeine crisis.
Recall that NAFDAC clamped down on the three companies due to their inability to provide required documents for NAFDAC officials during an inspection of the facilities on May 2 and 3 at Ilorin and Lagos.
Earlier, the Federal Ministry of Health had announced a ban on the production and import of cough syrup containing codeine.
-
Codeine saga: Senator Sani kicks against Emzor closure
Kaduna Central District Senator Shehu Sani has kicked against the closure of Emzor pharmaceutical company by the National Agency for Food and Drug Administration and Control (NAFDAC).
TheNewsGuru reports Emzor and two other pharmaceutical companies were shutdown by NAFDAC after being implicated in a BBC investigation on illegal manufacturing and distribution of codeine-containing syrup.
In a statement by NAFDAC, Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited and Emzor were shut for apparent resistance to provide needed documents during the organisation’s inspection in Ilorin and Lagos on May 2.
“Earlier on April 30, 2018, a day before the BBC documentary was aired, having seen the preview, Mojisola Adeyeye, the director general, had a meeting with technical directors of NAFDAC. She outlined the steps to be taken to strengthen the weakness in the control of the manufacturing and distribution of codeine-containing medicines as demonstrated in the documentary.
“One of the recommendations of the meeting was that NAFDAC should immediately deploy officers from its inspection and enforcement directorate (I&E) to inspect the alleged companies.
“A team of nine NAFDAC officers and ten mobile police officers were sent to Ilorin on May 2, 2018 to carry out investigational inspection at the companies of the two different pharmaceutical companies that are licensed to manufacture codeine-containing syrup, and which were implicated in the BBC documentary.
“The same investigational inspection by a different NAFDAC team took place on the same day and time as the Ilorin companies at the manufacturing facility of Emzor Pharmaceuticals Industry Limited, Ajao Estate, Lagos.
“The focus of the assignment was to access and monitor from records the utilization, sales and effective distribution of the codeine containing cough syrups to the end users,” that statement read.
“The shutdown of Emzor and the two other pharmaceutical companies by NAFDAC is an overkill,” Sani said, stressing that “Issues of violations if actually true, can be penalized with proportionate sanctions”.
According to Sani, “Such reputable companies doing legitimate business and employing thousands of Nigerians must not be ruined”.
Meanwhile, Emzor, on Tuesday insisted that only one production site of its firm was shut, contrary to claims that the entire company was shut.
In a series of tweets on its Twitter handle, Emzor said NAFDAC only sealed its liquid line. It said the rest of its manufacturing operation was going on normally.
The firm said NAFDAC sealed the line five days after carrying out an inspection on the site. It added that the regulator raised no issues at the time of the inspection, only for it to return later to close the line without explanation.
The tweet was in reaction to a press statement from NAFDAC that it has sealed off all the production lines of three pharmaceutical companies which were implicated in a BBC documentary on illegal codeine sale in Nigeria.
“Due to insufficient evidence gathered and apparent resistance to provide needed documents during our inspection on May 2, 2018, at the respective companies in Ilorin and Lagos, respectively, it has become necessary to shut down all the product lines of the three companies – Peace Standard Pharmaceutical Limited, plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State; Bioraj Pharmaceutical Limited, 405 Kaima Road, Ilorin, Kwara State and Emzor Pharmaceuticals Ind. Ltd., Ajao Estate, Lagos. This is to allow for a full and comprehensive investigation. The three companies, therefore, remain closed,” the regulator said.
Emzor, however, denied the claim. The company’s statement reads:
“NAFDAC have only temporarily sealed one of Emzor’s production sites, the liquid line. The rest of Emzor is still operating as normal. On Wednesday the 2nd of May NAFDAC inspected one of our production sites where Emzolyn with Codeine was made. There were given full access and our complete cooperation, with no issues raised at the time.
“On Monday the 7th of May, NAFDAC sealed the inspected site without giving us a reason nor an explanation of what the violation of the Good Manufacturing Practice (GMP) Code was and it will be wrong for us to speculate as to the reason why.
“Emzor continues to make good quality affordable medicines for the Nigerian public and the products are still available to buy. We believe in Emzor Wellocracy, unlimited wellness available to all and affordable by all.”
-
Codeine saga: Emzor refutes NAFDAC’s closure, says ‘We are still manufacturing’
Embattled pharmaceutical company, Emzor, on Tuesday insists that only one production site of its firm was shut contrary to claims that the entire company was shut by officials of National Agency for Food and Drug Administration and Control (NAFDAC).
In a series of tweets on its Twitter handle, Emzor said NAFDAC only sealed its liquid line. It said the rest of its manufacturing operation was going on normally.
The firm said NAFDAC sealed the line five days after carrying out an inspection on the site. It added that the regulator raised no issues at the time of the inspection, only for it to return later to close the line without explanation.
The tweet was in reaction to a press statement from NAFDAC that it has sealed off all the production lines of three pharmaceutical companies which were implicated in a BBC documentary on illegal codeine sale in Nigeria.
“Due to insufficient evidence gathered and apparent resistance to provide needed documents during our inspection on May 2, 2018, at the respective companies in Ilorin and Lagos, respectively, it has become necessary to shut down all the product lines of the three companies – Peace Standard Pharmaceutical Limited, plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State; Bioraj Pharmaceutical Limited, 405 Kaima Road, Ilorin, Kwara State and Emzor Pharmaceuticals Ind. Ltd., Ajao Estate, Lagos. This is to allow for a full and comprehensive investigation. The three companies, therefore, remain closed,” the regulator said.
Emzor, however, denies the claim.
The company’s statement reads:
“NAFDAC have only temporarily sealed one of Emzor’s production sites, the liquid line. The rest of Emzor is still operating as normal. On Wednesday the 2nd of May NAFDAC inspected one of our production sites where Emzolyn with Codeine was made. There were given full access and our complete cooperation, with no issues raised at the time.
“On Monday the 7th of May, NAFDAC sealed the inspected site without giving us a reason nor an explanation of what the violation of the Good Manufacturing Practice (GMP) Code was and it will be wrong for us to speculate as to the reason why.
“Emzor continues to make good quality affordable medicines for the Nigerian public and the products are still available to buy. We believe in Emzor Wellocracy, unlimited wellness available to all and affordable by all.”
-
NAFDAC speaks on availability of plastic fish in Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) says there is no plastic fish in circulation in Nigeria.
NAFDAC Management said in a statement in Abuja on Thursday that its finding followed “a thorough investigation and analysis of some unsuspected plastic fish samples’’ in its laboratory.
The agency said that “the investigation was triggered by a report from a consumer in Abuja who claimed that he bought a fish which refused to cook when set on fire for several minutes.
“The suspected sample of the fish, after thorough investigation, was confirmed to contain protein and fat which is normal to fish.
“The fish was, however, found to be unwholesome due to serious bacterial contamination.”
“While encouraging Nigerians to watch carefully the kind of fish they buy, it is however important to stress that there is no plastic fish in Nigeria.’’
The management noted that few weeks ago, there had been the circulation of suspected plastic fish in some parts of the world on the social media but stressed that no single case had been found in Nigeria, so far.
The agency urged Nigerians to “report any suspected unwholesome product, including fish to the nearest NAFDAC office for further investigation.”