NAFDAC Debunks Claim That 70 Per Cent Of Drugs In Nigeria Are Fake

The Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Professor Moji Adeyeye

 

The National Agency for Food and Drug Administration and Control (NAFDAC) has debunked claims by a report suggesting that 70 per cent of medicines in Nigeria are fake.

In a press statement on Friday, Prof. Moji Adeyeye, Director General of the agency said that the false report was published by Vanguard Newspaper.

Adeyeye described the report as “categorically untrue and grossly inaccurate,’’ arguing that a study jointly carried out by NAFDAC, the World Health Organisation (WHO) and the Department for International Development (DFID) in 2005 revealed that fake medicines in Nigeria stood at 16 per cent.

She further claimed that a survey conducted by NAFDAC in 2017 and 2018 on some widely used drugs showed that Nigerian medicines were 98 per cent wholesome.

Below is a full statement signed by the NAFDAC Director-General.

“The National Agency for Food and Drug Administration and Control (NAFDAC) wish to inform the members of the public, especially health care providers, policymakers, and development partners to disregard an online publication at https://www.vanguardngr.com that 70% of all drugs in Nigerian markets are fake.

“This is categorically untrue and grossly inaccurate. NAFDAC in collaboration with relevant stakeholders such as World Health Organization (WHO), Department for International Development (DFID) and United States Pharmacopeia conducted series of studies on quality of medicines in Nigeria and the report of these studies are outlined as follows:

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“A study of Counterfeit and Substandard Medicines in Nigeria conducted by NAFDAC in collaboration with World Health Organization (WHO) and Department for International Development (DFID) in 2005 revealed that counterfeit medicines stood at 16.7% in 2005 as against 40% in 2001.

“The National Survey on Quality of medicines using Truscan® device was conducted by NAFDAC across 29 States including FCT, Abuja from January 2010 to April 2012.

“The medicines involved in the survey included antibiotics, antimalarials, and antidiabetics. A total of 5,790 samples of medicines were tested.

“5,419 samples of medicines out of 5,790 (93.6%) tested during the survey passed quality tests while 371 samples (6.4%) failed.

“Another survey on the quality of medicines was conducted in Lagos State in May 2012 using the Truscan® device.

“A total of 235 samples of medicines comprising antimalarials, antibiotics, antidiabetics, and anti-inflammatory agents were tested.

“226 samples of 235 (96.2%) passed the quality test while 9 samples (3.8%) failed.

“The report of the survey on quality of antimalarial medicines conducted by NAFDAC in collaboration with National Malarial Elimination Program (NMEP), National Supply Chain Management Program (NSCMP) and the United States Pharmacopeia (USP) presented on 11th August 2015 revealed that:

“771 samples (96.4%) out of 800 samples of antimalarial medicines passed.
29 samples (3.6%) out of 800 samples of antimalarial medicines failed.
The samples of medicines for Round Two (2) survey on the quality of antimalarial medicines conducted by NAFDAC in collaboration with USP were procured between April and May 2016. The report of Round Two (2) survey was presented to stakeholders on the 11th April 2017.

“The report showed the level of substandard antimalarial medicines in circulation to be 4.33% (39 out of 900 samples) as against 3.6% in 2015.

“The samples of antimalarial medicines for Round Three (3) of the survey were procured between February and March 2017. The report of Round 3 survey presented to stakeholders on 12th December 2017 revealed that 883 out of 897 samples of antimalarial medicines (98.4%) passed quality tests while 14 samples (1.6%) failed.

“The samples of antimalarial medicines for Round Four (4) survey were procured in August 2017. The report of Round 4 Survey presented on 12th December 2018 revealed that 727 (98.1%) of samples passed laboratory analysis while 14 (1.9%) failed.

“The report of Round Five (5) Survey on quality of antimalarial medicines presented to stakeholders on 13th March 2019 revealed that 895 out of 907 samples of antimalarial medicines (98.7%) passed quality tests while 12 samples (1.3%) failed.

“The report of series of studies conducted by NAFDAC in collaboration with relevant stakeholders outlined above established that the online publication in Vanguard has no scientific basis, untrue and grossly misleading and as such it should be disregarded.

“One of the focus and priority areas of my administration is reducing substandard and falsified drugs through an emphasis on local manufacturing. Promotion of local manufacturing has been on my priority list. This is to reverse the trend of 30% locally manufactured drug products toward 70%. It has been documented that ordinarily, most of the SFs are imported due to the fact that access and fastness to inspect local companies are quite spontaneous and therefore locally produced registered pharmaceuticals are of good quality.

“Local manufacturing ensures drug security, reduces unemployment and increases contribution of the pharmaceutical industry to the nation’s GDP

“A disclaimer statement is written below distancing NAFDAC from Christabel International Organisation who organized the said meeting and the untrue statements.

“DISCLAIMER

“The attention of the Agency has been drawn to a publication dated 19th April, 2019 by the Vanguard newspaper titled “70% of drugs in Nigerian markets are fake”.

“The National Agency for food and drug Administration and Control (NAFDAC) hereby states that the Agency was never a party to any sensitization workshop organised by Christabel International Organisation at Onitsha for the National Association of Patent and Proprietary Medicine Dealers (NAPMED), wherein it was claimed that 70% of Drugs in Nigeria are fake. For avoidance of doubt, NAFDAC is hereby unequivocally refuting her participation/Involvement in the said workshop.

“The agency hereby wishes to inform the general public that the fight against the menace of fake drugs and other unwholesome NAFDAC regulated products is something that the Agency considers as an utmost and daily routine activity.

“All NAFDAC’s Directorates are on their toes to ensure that our country Nigeria is free of fake drugs and other unwholesome NAFDAC regulated products.

“The public is hereby implored to disregard the publication in Vanguard Newspaper of 19th April 2019.”

I Was Shocked When Lawmakers Demanded Bribe, Threatened Me – NAFDAC DG

 

The Director-General of the National Agency for Food and Drugs Administration and Control (NAFDAC), Mojisola Adeyeye, has revealed some ‘abnormalities’ she has experienced during her time on the job.

According to her when she assumed her role as NAFDAC DG, some House of Representatives members demanded bribes from her and even threatened her upon refusing to concede to their demand.

“When I came to NAFDAC, there were a lot of things that were wrong. Take oversight function or whatever that is done, I was shocked when I was told to give money, I said money for what? … money to the committee that visited us. The Health Care Services Committee of the House of Representatives,” she said on Friday during an interview on Channels TV’s Sunrise Daily.

Adeyeye further stated that the request from the federal lawmakers came at a time the agency was ‘bleeding profusely’ from a paucity of funds.

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Beyond shocking, she described the day as the worst day of her life as ‘a chief regulator.’

“I said I cannot. For just the visit? I couldn’t believe my ears because it saddens me. Yes, it can be referred to as them asking for a bribe. It saddens me. This is an organisation that was bleeding profusely.

“It wasn’t taken well at all. I was threatened and I couldn’t believe that too, you are threatening me?” she stated.

Speaking further, the NAFDAC boss explained that since assuming office in 2017, the agency has cleared debts of about 3 billion Naira.

Asked how funds are generated, she stated that officials rake in money from user fees and the Internally Generated Revenue.

According to her, user fees comprise charges on companies for the evaluation and subsequent approval of their products.

NAFDAC Raids Warehouse Stacked With Tramadol, Other Drugs

 

The National Agency for Food and Drug, Administration and Control (NAFDAC), raided a warehouse in Lagos State, where banned and controlled pharmaceutical products were being stored.

In a statement issued on Thursday, NAFDAC’s Director General said the raid was carried out after the agency received information about nefarious activities going on in the area as well as a cartel involved in the illegal importation of drugs.

The statement said, “The Agency’s Operatives at about 1:00hrs on September 14, 2018, raided a transit warehouse at Ijora Ororo, Lagos State and discovered 187 cartons of assorted Tramadol (120mg, 200mg and 225mg respectively) and more than 49 cartons of Diazepam (a controlled drug) concealed amongst household items including but not limited to bicycle, used tyres and printers”.

According to the agency, the seized products were worth about N105,650,000 million.

The drugs have, however, been evacuated from the warehouse for further investigation.

NAFDAC advised the public to remain vigilant and not hesitate to report any suspicious activities within their environment.

NAFDAC Destroys Harmful Drugs, Items Worth N464m In Gombe

PCN Seals 397 Drug Stores In Abia

 

The National Agency for Food and Drug Administration and Control (NAFDAC), has destroyed fake and unwholesome products with a value of about N464 million.

According to a statement from the agency on Saturday, the goods were destroyed at a dump along Bajoga Road in the capital city of Gombe State.

The drugs include antibiotics, anti-hypertensive, antiretroviral, cancer drugs, anti-malaria, and herbal remedies.

Other items destroyed are controlled drugs such as codeine-containing cough syrup and tramadol, as well as tomato paste, non-alcoholic beverages, maize flour, and insecticides.

The statement read, “The counterfeit, fake and unwholesome products destroyed were seized from companies that engaged in sharp practices by gallant and committed NAFDAC officers during surveillance and enforcement activities.

“Other products were voluntarily handed over to the NAFDAC by compliant companies, sister agencies, and associations.”

The agency assured Nigerians that it 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.

NAFDAC appealed to political, traditional and religious leaders to sensitise their members, subjects, and congregation on the dangers of drugs and substance abuse.

The agency warned smugglers of codeine-containing cough syrups, tramadol, substances of abuse and fake products to desist henceforth or face the wrath of the law, saying it has intensified surveillance and enforcement activities at all ports of entry.

It called for the establishment of Drug Abuse Control Committee comprising of NAFDAC officials and that of other relevant agencies by various state governments.

NAFDAC also urged the Gombe State government to provide office accommodation and vehicles for its use at each of the three senatorial districts for effective coverage.

The State Governor Ibrahim Dankwambo, who was represented at the site by the Commissioner of Animal Husbandry, Barka Sammy, assured the agency of continued support to ensure that the people consume only good quality and safe drugs.

He also directed the state media corporation to cover NAFDAC regulatory activities, towards sensitising the public on substandard products.

NAFDAC Seeks FG’s Support To Fight Drug Abuse

NAFDAC Seeks FG's Support To Fight Drug Abuse
File photo

 

The National Agency for Food and Drug Administration and Control (NAFDAC) is seeking the support of the Federal Government to tackle the menace of drug abuse in the country.

NAFDAC Director General, Professor Mojisola Adeyeye, revealed this in a statement personally signed by her on Wednesday.

She disclosed that stakeholders are working with the Minister of Health, as well as the Office of National Security Adviser and the Presidency to develop strategies to mitigate the trend.

Professor Adeyeye decried the rate of abuse of prescription medicines and other psychoactive substances not under international control.

According to her, the fundamental objective of the drug control conventions is to achieve a balance between ensuring availability for medical and scientific purposes and preventing diversion to illicit use and abuse.

In this regard, NAFDAC vowed to continually raise awareness of the public health consequences of drug abuse.

They also promised to promote healthy lifestyles through effective and comprehensive demand reduction initiatives, in accordance with the three international drug control conventions and national legislation.

The statement read, “The most commonly abused drugs in the country are tramadol and codeine. tramadol is a synthetic opioid analgesic used to treat moderate to severe pain and is the most abused effective medicine among addicts. It has no effects on the respiratory system, but overdose causes arrhythmias, cramps, coma and death.

“In Nigeria, it is regulated as the 50 and 100mg dosage strengths but very high dosage forms of 200 and 225mg have infiltrated the market. There is also a noticeable increase in smuggling of tramadol capsules. tramadol use disorder is associated with physical withdrawal symptoms and compulsive behaviour.”

“Codeine can be obtained in a compound form in Over-The-Counter painkillers and cough medicines, but consumers often became addicted. The risk of addiction is great and, in many countries, including Nigeria consumers require a prescription for all opioid-based medication.

“The misuse of codeine products contributes to severe health outcomes including liver damage, stomach ulceration, respiratory depression, coma and death. In Nigeria, all codeine-containing products are locally manufactured and are prescription-only-medicines since 2012, but the reclassification did not stem the trend of abuse partly due to non-adherence to the provisions of prescription,” it added.

NAFDAC identified the lack of due diligence to ensure the integrity of the distribution chain as the cause of unauthorised persons distributing the products to illicit channels.

In a bid to address the social problems and other threats resulting from drug use, the agency stressed the need for extra-territorial enforcement to identify, disrupt and dismantle organised criminal groups operating across the borders.

They also decried over-prescription by health professionals and overconsumption by the public, as well as the lack of collaborative and inter-professional research among stakeholders that could generate the needed data and justify control at the nation’s borders.

NAFDAC also pointed out the common phenomenon of users by-passing the health facilities and turning directly to pharmacies and medicine stores.

They, however, stated their commitment to implementing the recommendations of the United Nations General Assembly (UNGASS) 2016 outcome document on the safe use of controlled medicines for pain and palliative care and others.

The agency emphasised the need to develop early warning systems that look at the emergence and consequences of the non-medical use of narcotics and psychotropic substances.

NAFDAC Back At Borders To Monitor Imports

 

 

The National Agency for Food and Drug Administration and Control (NAFDAC), in collaboration with relevant Ministries, Departments and Agencies (MDA’s) and with the active support of the Office of the National Security Adviser (ONSA), Presidential Enabling Business Environment Council (PEBEC), Ministry of Transport has been returned to the seaports and borders.

According to the agency, this is to effectively control importation of unregulated products, falsified and substandard drugs, unwholesome foods, narcotic drugs and hazardous chemical substances and foods into the country.

NAFDAC said it received the notice on Wednesday, May 16, 2018 in a letter dated 29th March, 2018 from the office of the Vice-President, Professor Yemi Osinbajo as part of the PEBEC reforms.

In a statement signed on Thursday, the Director General of NAFDAC, Professor Christianah Mojisola Adeyeye, said thousands of Nigerians have died because of falsified and substandard medicines.

He also noted that the development became even more necessary following a recently released documentary on codeine abuse.

He said: “Many are currently ill, most likely due to unwholesome foods, drugs and abuse of narcotics and controlled substances, such as codeine, tramadol,
pentazocine, etc. These are partly due to exclusion of NAFDAC from our ports since 2011. The recent documentary on codeine abuse brought more attention to the issue”.

He further stated that apart from the dangers posed to public health, drug abuse weakens and slows down economic and national development, as well as “increases the threats to national security”.

“The need for return of NAFDAC officials to the Ports and borders has been emphasized in different fora by the new NAFDAC’s DG but received a boost in the Communique issued by the Office of the National Security Adviser at the end of the National Chemical Security Training Conference in Abuja on 16th March, 2018.

The theme of the conference was “Towards a Secured Importation, Distribution, Storage and Use of Chemicals in Nigeria,” the statement noted.

The agency expressed gratitude to the Office of the NSA, the Chemical Society of Nigeria, The Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMGMAN), among other key stakeholders for recognizing it as a key player in the national security architecture,

It therefore, promised that with the help of Nigerian Customs Service, the Shippers Council and other sister agencies, it will “ensure that products that pose danger to the population are controlled at the point of entry.

“In addition, the presence of NAFDAC at the ports and borders will reduce significantly the evasion of payments of statutory fees for importation of regulated products, thus increasing the Agency’s internally generated revenue and that of the Federal Government,” the agency stated.

Codeine Syrup: NAFDAC Lifts Shutdown Of Emzor, Two Others

FILE PHOTO: NAFDAC Office, Abuja.

 

The National Agency for Food and Drug Administration and Control (NAFDAC) has lifted the shutdown its earlier ordered on three pharmaceutical companies over the codeine syrup scandal.

The companies include Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited and Emzor Pharmaceuticals Industry Limited.

NAFDAC in a statement signed on Saturday by the Director General, Professor Mojisola Adeyeye, said this decision was reached after meeting of high-powered executives of the companies that were implicated in the codeine syrup distribution.

“The three companies cooperated with NAFDAC during the meeting, provided the needed documents, some of which are being verified. The shutdown of the three companies has been lifted and the normal company operations can resume. However, the companies have been given the following sanctions,” the statement read in part.

Adeyeye gave the directive for the meetings to be held with the companies following NAFDAC directorates – Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS) who led the meeting.

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NAFDAC had separate meetings with the companies – Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State, and Emzor Pharmaceuticals Industrial Limited, Lagos.

The sanctions given to the companies ordered that all production of codeine syrup should be stopped immediately until further notice. It also instructed that an hold should be placed on the active pharmaceutical ingredient and the already made codeine syrups stands.

Also, all codeine products are to be recalled and the process verified through audit trail verified by NAFDAC.

“An 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 read further.

NAFDAC said a stakeholders meeting on the codeine crisis will also be held to develop a road map for the supply chain distribution and the future of codeine syrup manufacturing, in line with the Minister of Health, Issac Adewole’s pronouncements in his press release on the codeine crisis.

Codeine Syrup: NAFDAC Shuts Down Emzor, Two Other Pharmaceutical Companies

 

FILE PHOTO: NAFDAC Office, Abuja.

 

The National Agency for Food and Drug Administration and Control (NAFDAC) has shut down three pharmaceutical companies over the codeine syrup scandal.

The companies include Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited and Emzor Pharmaceuticals Industry Limited.

Director-General of the Agency, Professor Mojisola Adeyeye in a statement on Monday said the companies will remain shut to allow for a full and comprehensive investigation.

Among the allegations levelled against the closed companies include refusal to abide by regulations on the distribution of certain medications.

“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 product lines of the three companies – Peace Standard Pharmaceutical Limited. Plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State; Bioraj Pharmaceutical Limited. No 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 statement read in part.

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The reopening of the manufacturing companies according to Adeyeye will depend on the level of cooperation that is shown during the comprehensive investigation.

The statement added further that Adeyeye had earlier called for an emergency meeting with the PMG-MAN Executive to discuss critical issues relating to Codeine-containing cough syrup together with other controlled substances.

Also, a Task Force to be made up of NAFDAC Directors- Registration and Regulatory Affairs; Narcotics and Controlled Substances; and Drug Evaluation and Research. Members of PMG-MAN in the Committee included the Executive Secretary of PMG-MAN, Fidson Healthcare; May & Baker PLC; and Emzor Pharmaceutical Industries was constituted by the DG.

“A team of nine NAFDAC officers (two from Drug and Evaluation Research – DER and seven from Investigation & Enforcement – I&E) and ten mobile police officers were sent to Ilorin, Kwara state 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 statement added.

A documentary by BBC recently exposed the addiction of some Nigerians, mostly youths, to codeine and reported the complicity of some pharmaceutical companies.

NAFDAC Is Denied Access At Ports Unless Invited By Customs – Adeyeye

The Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Professor Moji Adeyeye

 

The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Professor Moji Adeyeye, has lamented that officials of the agency are often denied access at the nation’s ports unless invited by men of the Customs.

Adeyeye stated this on Wednesday while speaking on a breakfast show, Sunrise Daily, aired on Channels Television.

“I found out NAFDAC is not allowed to be at the ports unless we are invited by the Customs,” she said. “To me that is very wrong. Over the last three months, we have intercepted about 33 containers of Tramadol.”

The NAFDAC boss was speaking on the prevailing cases of drug abuse in the country, especially the consumption of Codeine among youths that make them wrestless.

She, however, reiterated the commitment of her agency in addressing the situation described by many as worrisome.

To Adeyeye, “Some were packaged as building materials but those containers were the ones we were able to intercept.

“They were intercepted at the ports – Tincan Island, Apapa and the Onne in Port Harcourt, the Rivers State capital.”

Adeyeye, who is also a Professor of Pharmaceutics, regretted the addiction of hard drugs by most Nigerians, shortly after the Federal Government decided to clamp down on Codeine.

Minister of Health, Professor Isaac Adewole, announced the ban in Abuja on Tuesday, as contained in a press statement by his Assistant Director of Information, Mr Olajide Oshundun.

In line with the decision, the Ministry of Health directed the National Agency for Food and Drug Administration and Control (NAFDAC) to stop further issuance of permits for the importation of codeine as an active pharmaceutical ingredient for cough preparations with immediate effect.

The minister said the directive became necessary due to the gross abuse codeine usage has been subjected to in the country.

Earlier, the National Drug Law Enforcement Agency (NDLEA) announced that Kano State was leading among states notable for abusing drugs with over two million users.

Codeine, a prescription pain medication used to treat mild or moderate pain is a drug which is abused by some youths in the state. It comes in tablet and syrup form and as the main ingredient in the prescription for cough suppressants.

Statistics by NDLEA said despite its efforts to stem the trend in the bud, two million bottles of codeine syrup and thousands of kilograms of narcotics are reportedly being consumed daily in Kano State.

NAFDAC Destroys Illegal Drugs Worth N80m

PCN Seals 397 Drug Stores In Abia

Counterfeit drugs worth over 80 million naira have been destroyed by officials of the National Agency for Food and Drug Administration and Control, (NAFDAC).

The Director General of NAFDAC, Prof Mojisola Adeyeye, who was speaking in Abuja, says the agency is working relentlessly to rid the Nigerian market of unsafe and unwholesome products.

Although the circulation of counterfeit drugs is said to have dropped from 19.6 percent in 2012 to 3.6 percent in 2015, officials of the agency are promising not to rest on their oars until drug counterfeiters are totally defeated.

The NAFDAC boss further noted that the support will be in the areas of surveillance and enforcement.

And after the speeches, the agencies boss and other officials started setting the goods ablaze.

This gesture according to some Nigerians will serve as a deterrent to those who are bent on carrying out the illicit trade of drug counterfeiting.

NAFDAC Reduces Registration Fee For Locally Made Items

The National Agency for Food, Drug Administration and Control (NAFDAC) says it has cut down registration fee for locally made items by 50 per cent.

The move which is in line with Federal Government’s ease of doing business agenda aims to promote small and medium scale enterprises and grow the economy.

NAFDAC’s latest policy also looks to terminate agreements with fees collection agencies following the discovery of illegal charges under the deal.

The agency has also re-affirmed that waivers on its young-graduates business registration scheme remains intact.

Fire Razes NAFDAC Facility In Lagos

nafdacThe premises of the National Agency For Food, Drug Administration and Control (NAFDAC) located in Oshodi, Lagos state, was on Saturday gutted by fire.

The fire was said to have started from a generator and spread to a store.

The extent of damage done to the building however could not be immediately ascertained as Channels Television’s crew was not allowed access to the affected scene.

Men of the fire service from the Lagos State Response Unit were seen battling to put out the inferno.

A spokesperson of the agency however confirmed that the fire was prevented from spreading beyond the store.