LATEST NEWS & EVENTS

LATEST NEWS & EVENTS (25)

The National Agency for Food and Drug Administration and Control (NAFDAC) has scheduled a Stakeholders sensitization workshop on NAFDAC Integration with Nigeria  Trade Portal for the purpose of product importation into Nigeria.

The Stakeholder’s workshop will be held on:

Date:  19th April, 2018

Time:  9:00am prompt.

Venue:  Nigeria Employers’ Consultative Association (NECA) House,

             Plot A2, Hakeem Balogun Street, CBD, Alausa, Ikeja, Lagos

The National Agency for Food and Drug Administration and Control have been informed that the Qatar Ministry of Public Health (MOPH), on 19th of February, 2018 warned against the purchase and consumption of Wales Golden Honey and Macum Eqimedyumly Honey. The products contain harmful chemical substances such as Vardenafil, Homosildenafil and Sildenafil.

The Ministry stated that the harmful substances were not declared on the products’ labels thus posing risk to the life and health of those who have medical conditions against the use of the undeclared substances. Wales Golden Honey is produced by Jordans’ Al-Kaaba Company and Eqimedyumly Macum is produced by the Turkish company Therma.

Sildenafil is the active ingredient in Viagra, a prescription drug for the treatment of erectile dysfunction which could trigger a sharp drop in blood pressure when used in combination with prescription drugs containing nitroglycerine, commonly found in medications for diabetes, high cholesterol, heart disease and hypertension.

Vardenafil is another selective PDE-5 inhibitor that is approved for the treatment of erectile dysfunction. It is effective in a broad spectrum of underlying conditions of patients.

Homosildenafil (also known as methyl-sildenafil) is a synthetic drug which acts as a phosphodiesterase inhibitor. It is an analog of sildenafil and vardenafil. Homosildenafil is identified as an adulterant in sex enhancement products and was more recently detected in dietary supplements.

Importers, Distributors, and Retailers in possession of these products are to submit to the nearest NAFDAC office.

Report adverse events relating to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC...........Safeguarding the health of the Nation!!!

The National Agency for Food and Drug Administration and Control (NAFDAC) has been notified of the circulation of a falsified version of Augmentin (Amoxycillin + Clavulanate potassium) in Cameroun.

Amoxycillin + Clavulanic acid is used to treat a range of bacterial infections and is listed as a WHO Essential Medicine.

The existence of the falsified product was reported to WHO in early 2018 by an NGO. The NGO reported that this product was available at patient level in a street market of Douala, Litorral Region, Cameroun. Samples were sent for quality-assurance laboratory testing and the result shared with WHO. The result of analysis did not identify any of the expected active ingredient.

The packaging of the falsified product appears to be a close imitation of the genuine product manufactured by GSK (GlaxoSmithKline), although there are some mistakes on the packaging inscription. The source(s) of the falsified product has not yet been identified.

The stated manufacturer (GSK) has confirmed they did not manufacture this falsified version. No known adverse reactions to this product have been reported.

The details of the falsified product are;

Product Name Augmentin (Amoxycillin+ Clavulanate potassium)
Batch Number 562626
Expiry Date MAY 2019
Manufacturing Date MAY 2016
Declared active ingredient

500mg Amoxycillin Trihydrate E.P

125mg Clavulanate Potassium B.P

Stated Manufacturer GSK GlaxoSmithKline

NAFDAC advices wholesalers, distributors and pharmacies that products should be obtained from authentic and reliable sources. Increased vigilance is hereby encouraged within the supply chain to avoid infiltration of the falsified product.

NAFDAC implores healthcare providers to ensure vigilance to prevent the administration of the falsified product to unsuspecting patients.

Healthcare providers and the general public should notify the nearest NAFDAC office of any information concerning the distribution, sale and use of the falsified Augmentin product.

SIGNED MANAGEMENT

NAFDAC...........Safeguarding the health of the Nation!!!

           

The attention of the Agency has been drawn to a publication by the Pharmaceutical Society of Nigeria (PSN) in the Daily Trust Newspaper of 17th February 2018 on the recommendation by the reform panel of the ruling party led by Governor Nasir El-Rufai that proposes to move drug matters which are presently on the Exclusive List (item 21 of part I of the second schedule of the 1999 constitution) to the concurrent list. NAFDAC as an Agency of Government and a major stakeholder in drug regulation in the country, thought it important to lend its voice to this emerging concern as such recommendation portends great danger for the nation.

The nation has over the years put in place several policies and measures to ensure drug security and improved healthcare delivery in the country. Some of these measures include a national Drug policy which is targeted amongst other objectives to make available at all times to the Nigerian populace adequate supplies of drugs that are effective, affordable, safe and of good quality.

The country is also putting a lot of effort to strengthen administrative, legislative, and regulatory controls of the importation, exportation, manufacture, procurement, storage, distribution, supply, advertisement, sale and use of drugs in tandem with global best practice as obtained all over the world.

The reasons for placing drugs and poisons on the exclusive legislative list by countries are not far-fetched. These include but not limited to the following:

  1. Firm control on drugs and drug-related matters by the federal government.
  2. Prescription and enforcement of grades and minimum standards of quality for drugs and drug products.
  3. Prevention of drug misuse and abuse by central regulatory control on substances of abuse.
  4. Protection of patent rights for innovators of medicines to prevent infringement and promote data exclusivity.
  5. Entrenchment of a rational and properly structured drug distribution system
  6. Enhancement of compliance with Trade-Related aspects of Intellectual Property Rights (TRIPS) agreement
  7. Strengthening of regulatory mechanisms in line with globalization and medicines regulatory harmonization.

No nation ever compromises the well-being of its citizens by way of liberalizing and decentralizing medicine legislation.

A thorough analysis of global best practices showed that where regulatory controls are placed on the exclusive legislative list, the prevalence of counterfeiting and other drug-related vices are at the lowest ebb.

The burden of counterfeit drugs is a global phenomenon that has plagued even the most technologically endowed nations. On account of the enormity of this public health menace, regulation and control of medicines as well as related activities in all countries are centrally coordinated to enhance effective and adequate governmental control and assert adequate regulatory oversight on account of retaining control of medicines in the exclusivelist.

Removal of drugs and poisons from the exclusive legislative list will lead to multiplicity of drug legislations having innumerable dire consequences that include the following:

  1. Lack of uniformity of standards of drug products across the country
  2. Chaotic drug legislation that will discourage foreign investment and disruption of existing collaboration with international support partners and donor agencies.
  3. Defeat of the purpose of the Federal Government’s drive on ease of doing business in the country as different jurisdictions will have different requirements.
  4. Proliferation of organized crime and money laundering offences.
  5. Loss of recognition of the country as a preferred destination for clinical research due to haphazard legislative requirements.
  6. Lowered product quality standards will further worsen Nigeria’s health indices
  7. Aggravation of the current menace of misuse and abuse of controlled drugs
  8. Infringement on patent and intellectual property rights which will have untoward consequences on the nation being a signatory to the Trade-Related aspects of Intellectual Property Rights (TRIPS) agreement.
  9. Proliferation of Counterfeiting, falsification of medicines, spuriously labeled pharmaceuticals and allied products, pronounced adverse drug reactions, entropic Pharmacovigilance reporting system, unwholesome and sharp practices to mention a few.

Issues ranging from poorly packaged medicines, expansion of open drug markets, sharp practices centered on pecuniary interest, compromise in the drug registration process and unprofessional licensing procedures will be the outcome of movement of drugs and poisons from the exclusive to the concurrent legislative list.

Our dear country cannot afford to go that route. Rather, the various drug regulatory agencies and bodies should be strengthened and given more support through the federal might. NAFDAC for instance has over the years been at the forefront of seeking more punitive measures for drug offenders and counterfeiters through the legislative arm of government but this bill is yet to see the light of day.Governmental support to stimulate more collaboration with international agencies to fight the civic threat called fake drugs can only make meaning where drug and pharmacy related issues are retained on the exclusivelist.

Prof Mojisola Christianah Adeyeye

Director General, NAFDAC

The Minister of Health, Prof. Isaac Adewole has inaugurated the Governing Council of the National Agency Food and Drug Administration and Control (NAFDAC) along with other agencies and parastatals under the supervision of the ministry.
Prof. Adewole while inaugurating the board members recently appointed by President Muhammadu Buhari, charged them to live above board and work in concert with the change agenda of the current administration by providing robust and purposeful transformation of the health sector.
He cautioned against unnecessary rivalry and indulgence in sharp practices that may result to acrimony and stall progress of the institutions in delivering on their mandate.
In his maiden visit to the Agency's headquarters in Abuja shortly after the inauguration, Chairman of NAFDAC Governing Council, Hon. Inuwa Abdulkadir pledged the desire of members to discharge their duties with trust and accountability.
He promised greater synergy and collaborative effort by all stakeholders which according to him will make the work of regulation and enforcement easier.
Also speaking, the Director-General of NAFDAC, Prof. Moji Adeyeye appealed to the council to intervene in the issue of the suspension of the Agency from the Ports as such action is counter-productive while observing that the rising epidemic of the use and abuse of narcotic substances by the youth, could be traced to this gap.
She listed other challenges that needs prompt intervention of the council members to include provision of vehicles to police the vast territory of the country including border ports, improved ICT, staff welfare among others.

In her relentless fight against the menace of drug abuse and counterfeit regulated products, National Agency for Food and Drug Administration and Control (NAFDAC), has impounded more than 40 container loads of drug substances and other regulated products from January to date.

The controlled drugs which are mostly Tramadol of various strength were confiscated at different sea ports across the country in addition to other unregistered products such as Viagra, Colds time, Diclofenac among others.

Director General NAFDAC, Prof Moji Adeyeye who disclosed this in kebbi state while addressing an awareness programme on drug abuse organized by the wife of Kebbi state Governor, Dr. Zainab Bagudu said drug abuse has become a growing epidemic in the country resulting to devastating consequences such terrorism, armed robbery, kidnapping and even death.

Speaking on the theme: “The Role NAFDAC Plays To Help Create Our Ultimate Goal Of Drug Free Nigeria”, Prof. Adeyeye identified such barriers as the absence of NAFDAC at sea ports to properly police the influx of controlled drugs, porous land borders, evasion of regulations and control among others as mitigating factors against a Drug free Nigeria.

To reverse the trend, “the law that create NAFDAC`s mandate must be kept, challenges associated with the control of drugs must be addressed and a state of emergency should be declared and all three arms of the government must recognize that children are dying, our youth are being enticed to criminality and terrorism through proceeds of drug and drug abuse”, she asserted.

Also speaking, wife of kebbi state Governor, Dr. Zainab Bagudu decried the emerging trend of abuse of legal pharmaceuticals like codeine containing syrup in which most victims are increasingly women saying the regulations governing pharmacies are treated with levity and no longer work as ‘prescription only’ drugs are sometimes sold without valid prescription.

She implored NAFDAC to undertake a holistic review of control and regulations guiding the procurement, distribution and access to prescriptive drugs that are regularly abused and prosecute offenders.

In his brief remarks, Kebbi state Governor, Alhaji Atiku Bagudu praised the initiative of the awareness campaign as laudable and promised to support interventions that will see to the end of the incidence of substance abuse in the state.

In his concerted efforts to combat the rising incidence of drug abuse and support the fight against counterfeit drugs and other substandard regulated products, Yobe State governor, Alhaji Ibrahim Gaidam has donated two office complexes and a large parcel of land to the National Agency for Food and Drug Administration and Control, NAFDAC to help tackle the twin menace.

The governor while making the donation in his office in Damaturu, said the gesture was to assist the Agency to eliminate counterfeit and illicit drugs as the state is regarded as frontline area by smugglers leading to drug abuse and accompanying criminal activities.

Speaking further, he said his government will in addition to her earlier gesture provide two operational vehicles to enable NAFDAC police the vast territory of the state in order to check the proliferation of fake drugs, drug hawking and the increasing cases of drug abuse in the hinterlands where the offices are located.

Receiving the keys and papers to the offices, the highly elated Director-General of NAFDAC, Prof. Moji Adeyeye described the donation as unprecedented saying it will go a long way in assisting the Agency in combating drug abuse/misuse and unwholesome regulated products in the State by ensuring safety and security of her citizens.

"These offices will go a long way in eradicating drug abuse/misuse and unwholesome food and other regulated products within the state. Potiskum which serves as a transit point for unscrupulous people for transporting drugs and illicit goods especially to Kano and Maiduguri. Gashua office will serve in checkmating the activities of smugglers from neighbouring Niger Republic", Prof. Adeyeye added.

While commending the cordial relationship between Yobe State government and NAFDAC, she promised that the Agency will work relentlessly in carrying out her mandate of safeguarding public health.

The offices are located in two Local Government Areas representing two senatorial districts, namely Potiskum in Zone A and Gashua Bade in Zone C respectively.

The National Agency for Food and Drug Administration and Control (NAFDAC) is sharing an alert that was sent out by the United States Food and Drug Administration (USFDA) that Clarithromycin (Biaxin) is risky in patients with heart disease. Heart disease patients who take the drug, sold under the brand name Biaxin, can die years later. The FDA said it does not know how Clarithromycin might cause heart problems or death, but it’s been warning about the problem since 2005. Review of data ten (10) years later shows heart patients still have a higher risk of dying if they took the antibiotic for two weeks. NAFDAC urges Healthcare Providers to exercise caution when prescribing the macrolide antibiotic Clarithromycin (Biaxin) to patients with coronary heart disease because of a potential increased risk for heart problems or death that can occur. Healthcare Professionals should be aware of these significant risks and weigh the benefits and risks of Clarithromycin before prescribing it to any patient, particularly patients with heart disease. Patients with heart disease should make sure they inform Healthcare Professionals handling their condition. Clarithromycin is used to treat a variety of infections affecting the skin, ears, sinuses, lungs, and other parts of the body, including Mycobacterium avium complex (MAC) infection, a lung infection that often affects people with HIV. NAFDAC encourages Healthcare Providers to report adverse drug reactions or side effects related to Clarithromycin to the nearest NAFDAC Office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it. NAFDAC............Safeguarding the Health of the Nation!!!
Wednesday, 14 February 2018 16:02

Disclaimer on NAFDAC Recruitment!

NAFDAC hereby alerts the General public particularly the prospective applicants about the false and misleading post of a recruitment exercise by the Agency on a faceless and fake website.

Please Note:

The public is advised to note that information on any future recruitment exercise by NAFDAC would be posted on the official website of the agency; www.nafdac.gov.ng and other social media platforms of the agency and National dailies.

NAFDAC will not use any third party individuals, websites or other platforms to advertise positions or source for applicants.

Management

The National Agency for Food and Drug Administration and Control (NAFDAC) has been alerted by the World Health Organization (WHO) on the circulation of two versions of falsified Cefixime products in the eastern part of the Democratic Republic of Congo (South Kivu).

The two versions of falsified Cefixime products were identified and reported to the World Health Organization in late 2017. Both products are presented in standard white plastic containers of 100 tablets. The label of both products display spelling mistakes.

The tablets of both products are round, small and without any embossing.

Cefixime is an antibiotic used to treat a range of bacterial infections. Treatment with ineffective falsified Cefixime tablets can lead to emergence of resistant organisms. In extreme cases, the use of falsified Cefixime tablets may result in death.

The details of the two versions of falsified Cefixime product are listed below:

Information on: Version 1 Version 2
Product Name Cefixime Cefixime trihydrate
Batch Number 4734 Et078776
Expiry Date 01/2016 Nov 2014
Declared active ingredient Cefixime Cifixime trihydrate
Stated manufacturer Merck & Co Inc Holden Medical The Netherlands
Assay testing results 2.5% of Cefixime No Cefixime detected

It should be noted that the manufacturers stated on the label have confirmed that they did not manufacture these products.

NAFDAC implores wholesalers, distributors, pharmacies, healthcare providers, proprietors of healthcare facilities, program managers and other members of the public to be vigilant and report anybody or organization distributing falsified Cefixime tablets to the nearest NAFDAC office.

If you are in possession of falsified Cefixime products, do not use or sell. Submit the falsified products to the nearest NAFDAC office.

Adverse events resulting from use of the falsified versions of Cefixime tablets should be reported to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it. .

NAFDAC............Safeguarding the Health of the Nation!!!

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