Category: Features

 

By Biola Lawal

Abuja: Prof. Mojisola Christianah Adeyeye, (FAS), the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians of the safety of children vaccines in the country.

In a statement she personally signed, a copy of which was made available to Flowerbudnews, Prof. Adeyeye declared that no vaccine with 40 per cent mercury was being administered on children in Nigeria.

The NAFDAC Boss also declared as untrue, some reported statement made that “children in Nigeria were being administered a vaccine that contains 40 percent mercury which was prescribed by foreign organisation.”

‘:This statement is not true,” Prof Adeyeye stated, explaining that ”Mercury is a metal, and it is not used as an element or as a component of vaccines
The NAFDAC DG explained further:

”The basic components of vaccines are Antigens, adjuvants to improve immune response, antibiotics to prevent contamination during manufacturing, preservatives, and stabilizers.

Thimerosal a mercuric compound which is a preservative used in multi dose vaccines contains a different form of mercury called ethyl mercury.

” As a vaccine preservative, thimerosal is used in concentrations of 0.003% to 0.01%, (for example, thimerosal content allowed in vaccine is between 30 parts to maximum of 10o parts out of million parts of the vaccine formula).

”Thimerosal is a mercury-based preservative that has been used for decades in the United States in multi-dose vials (vials containing more than one dose) of medicines and vaccines.

”There is no evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site.

”However, in July 1999, the Public Health Service agencies, the American Academy of Paediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.

”Nigeria still receives some multi dose vaccines which contains thimerosal but at accepted concentration.

”However, World health Organisation has not proscribed the use of thimerosal as an inactivating agent and preservative in vaccines as there is lack of evidence that thimerosal present risk to human health.

”The WHO has closely monitored the scientific evidence relating to the use thimerosal as a vaccine preservative for over 10 years especially through independent expert advisory group, the Global Advisory Committee on vaccines.

”The committee has constantly reached the same conclusion.

”There is no evidence to suggest that the amount of thimerosal used in vaccines poses a health risk
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”Other expert groups the U.S. Institute of Medicine, the American Academy of Paediatrics, the United Kingdom Committee on Safety of Medicines, and the European Agency for Evaluation of Medicinal Products have reached similar conclusions

”NAFDAC follows WHO approved protocol before issuing out lot release certificates before any human vaccines can be used in Nigeria, which is done after laboratory analysis and summary lot protocol review.

NAFDACSafeguarding the Health of the Nation (Flowerbudnews)

By Salisu Sani-Idris

The National Agency for Food and Drug Administration and Control (NAFDAC) has procured 40 detection devices to enable the agency track, trace, monitor and curb the influx of bad medicine in the country.

The Director-General of the agency, Prof. Mojisola Adeyeye, made the disclosure in an interview with the News Agency of Nigeria (NAN) on Thursday in Abuja.

Adeyeye said that the agency heightened enforcement and ensure stringent financial management because it need tools to go after the people that are bringing bad medicine into the country.

“Because of the money we are saving we need to purchase detection devices to put it on a tablet if it is a paracetamol it will show paracetamol but the new version of it will show paracetamol 85 per cent instead of 100 so it’s best qualitatively and quantitatively.

“Each of the devices is about 57,000 dollars and we bought 40 because we know our problems in Nigeria. NAFDAC was out of the port for almost seven years.

” And we became the haven of bad medicines everybody will say take to Nigeria there is nobody there and we have five countries surrounding us. People just work in and work out.

” So those are the peculiarities we faced while we needed the tools that we need to use like this small detection devices. We procured them and trained our staff to know how to use it.”

She revealed that this device allows for more accurate detection of drugs formulation.

“Before they could only say ok it is paracetamol they will not know whether it is 65, 10 or 100 per cent. Now the new version can do both, however, it is costlier.

”Before I came 70 to 80 per cent of our laboratory equipment were not working. Companies were sending vehicles for us to come and inspect them before I came.

” Who will not know that there will be compromise, if a company you want to inspect send you vehicles to come and inspect you know what it means.

” So things have to be put in place. Whatever we are able to do with the little we had, we did that almost breaking our backs but we needed to do a holistic reorganisations and refocusing which took us from the 2018 to like 2019.

” We started using the Quality Management System at the same time we went on the WHO global beach marking that give us Maturity Level Three after four years. But meanwhile the little money we are saving we started buying vehicles.”

She said that the agency enforcement became heightened and go to trade fairs where the enforcement team may carry 40 truck of medicine and cosmetics that were not registered.

” A lot of raid that they have done on trade fair is of goods worth billions of Naira. So we heighten it and we started destroying. They were destroyed before I came but the frequency may be not be high because it is money that we used.”

She said that the activities of the agency was being monitored by the WHO, adding that they came in 2019 to examine the NAFDAC level of self-audit.

“WHO came in 2019 and said we need to do better then and we said yes you are right we need to do better than in some areas. Bear in mind we started with 878 recommendations in 2018 and by 2019 June we have reduced it to 147.

” But the work has not finished even now the work has not finished. So we strengthen our pharmaco vigilance and post marketing surveillance.” (NAN)

By Salisu Sani-Idris

The National Agency for Food and Drug Administration and Control (NAFDAC) has emphasised the need for enactment of legislation that would ensure stiffer penalties for importers of bad medicine into the country.

The Director-General of the agency, Prof. Mojisola Adeyeye, made the disclosure in an interview with the News Agency of Nigeria (NAN) on Thursday in Abuja.

Adeyeye said that the agency would not spare any company and manufacturers that bring in bad medicine into the country.

She disclosed that the agency had scale up its Pre Shipment Testing, adding that more than 100 shipment of bad medicine was stopped.

The D-G explained that when you talk of 100 shipments it may be 10 or 100 containers per one, “but we have discovered that some of them don’t have anything.

” Some of them have very little. So these are things that we have been working on and despite that they still want to cut corners with us.

” So we started blacklisting them. Any company that made bad and substandard medicine, we blacklist them and we published some on national dailies.

” I was in India about six weeks ago and one of them said that his company had been blacklisted and I said so if your company is blacklisted you deserve it. As we speak we are going to blacklist some other companies.

” We will continue to blacklist companies, manufacturers and delist the product from our supply chain, delist the product from database. It is not just medicine coming from other countries it is also medicines within our own region.”

She stated that NAFDAC, with WHO collaboration, conducted a survey and discovered that few companies were trying to cut corners, adding that the agency shut the lines down for months which was going for billions of Naira for them.

” It has to hurt them in the pocket in order to have deterrent. Unfortunately you go to court they will fine them N250,000 or go to jail for five years.

” So I am urging and praying that the time will come when our judiciary will know that medicine kills, bad food kills.

”Right now as we speak we have what is call the C34 bill that the House of Representatives repeal the old one and they are actually enacting a new one which essentially contain a stiffer penalty.

” When we see countries that are stringent like the United States that I am familiar with, you break the rule you pay the time. You break the rules if your company is 200 million dollars, they will just fine you 215 million dollars and that is the end of the company.

“So, people’s feet are being put on the fire right from the beginning. I pray we will get to that point in Nigeria were the penalty will be stiffer so that people will think twice before they put medicine that will kill people.”

She vowed that NAFDAC would not spare anybody that intend to kill people with bad medicines, adding that the agency was adopting many strategies and intelligent to tackle the menace.

“Few months ago someone called me that the medicine that NAFDAC approved is making people to run mad.

” And I said how medicine that NAFDAC approved can make people mad and asked for the name. Immediately, we did a sweep operation on the company, we got samples from them, later we called Investigation and Enforcement Directorates to go and evacuate after we got the first lab results.

“It is what we call the bitters and they gave to rats in the lab and the rats die within five minutes. This was not the product we approved they have laced it with marijuana. So, people change formulation after we have approved.

“So part of what we do now is what is called Risk Based Sampling. If we know that your company is a violator your product will be on high risk if it is something that is going to be put in delicate parts like eyes or noise it will be on high risk.(NAN)

By Reporters

Bauchi:  Pharmarcists and other stakeholders in the North-East have called for more awareness campaign to combat circulation of counterfeit and falsified pharmaceuticals in the country.

The experts said the call was imperative to educate the people on the dangers of fake drugs and safeguard public health.

They spoke while responding to a survey by the News Agency of Nigeria (NAN) on circulation of fake drugs and chemicals in Bauchi, Damaturu, Dutse, Gombe, Maiduguri and Yola.

A pharmacist in Yobe, Mr Madu Ali said effective strategies were necessary to strengthen drug regulatory agencies to enable them to combat circulation of falsified drugs in the country.

He defined fake drug as any drug that do not contain active ingredients, but packaged to look like a genuine product.

The expert listed the effects of fake drugs to include disease progression, organ failure and prolong duration of treatment.

Ali, also the Head, Pharmaceutical Services, Specialists’ Hospital, Damaturu, said strengthening the agencies would enhance their operations to ensure that only genuine drugs were in circulation in the country.

“If you strengthen the drugs management agencies, you will improve their capabilities from mere physical inspection of drug colours to full-fledged laboratory investigation,” he said.

He said there was an urgent need to ban drug hawking and caution members of the public against patronising open drug markets.

Ali noted that although many suspected fake drugs were in circulation, the anomaly could only be confirmed by a formal research.

Recounting her ordeal; Mrs Josephine Audu, a victim of fake drugs in Gombe State, urged NAFDAC to intensify campaign to check circulation of counterfeit drugs and chemicals in the country.

Audu noted that fake drugs caused adverse side effects rather than providing remedy to diseases.
“I took a brand of Septrin tablet and developed skin rashes afterwards.
“I alongside six other females became ill and hospitalised after using the drug,” and urged relevant authorities to step up campaign to curb the menace.

To buttress the claim, the National Agency for Food and Drug Administration and Control (NAFDAC) in Borno has raised alarm over circulation of fake agricultural chemicals in the state.
NAFDAC’s State Coordinator, Jamil Audu said the Agency seized counterfeit agro chemicals in series of raids at markets in Maiduguri metropolis.
He said unsuspecting farmers used the chemicals for crop production and preservation in spite of associated health risks and environmental hazards.
“The discoveries are alarming as some people engaged in bad practices.
“The Agency is conducting awareness campaign as one of the veritable regulatory mechanisms to safeguard public health.
“We are sensitising marketers, herbal medicine practitioners, water and food processors to effectively regulate their activities,” he said.
He said the Agency had scaled up sensitisation activities through Consumer Safety Clubs in schools to educate them on how to detect unregistered products.

The campaign, he said, was part of strategies adopted by the Agency to protect the people against unwholesome food, falsified drugs and harmful cosmetics.
According to him, the siezed items will be destroy after laboratory analysis.
In the same vein; Mathias Buba, a Civil Society Organisation (CSO) activist, attributed high cases of treatment failure to consumption of fake drugs.
He said falsified drugs are deadly resulting to organs damage and worsen chronic diseases such as renal failure and liver cirrhosis.
Buba, therefore, advocated practical measures to regulate drugs import, and urged indigenous pharmaceuticals to adopt measures to make their products accessible.
In Adamawa; the Pharmaceutical Society of Nigeria (PSN), said it had seized and destroyed counterfeit drugs worth over N110 million.

Chaurman of the association in the state, Mr Ibrahim Talba said the exercise was part of comprehensive campaign to combat fake drugs.
“We usually conduct routine inspection to remove and destroy expired drugs.
“Most of the drugs expired or not certified by NAFDAC,” he said.
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However, Dr Kabir Ibrahim, Executive Secretary, Jigawa Primary Healthcare Development Agency (JSPHCDA), maintained that 100 per cent of drugs had been certified in public health facilities across the state.
“In Jigawa, 100 per cent of drugs in public health facilities are genuine.
“We have made it a policy that all public health facilities must procure drugs from the Jigawa Medical Supply Organisation (JIMSO),” Ibrahim said.
He said JIMSO procured drugs directly from manufacturers and supplied to healthcare facilities in the state.
The Agency, he said, subjected drug manufacturers to screening, including inspection of manufacturing plants, medicine manufacturing protocols and compliance with medical formulae.
According to him, the agency also engages manufacturing companies in quality improvement, talks and discussions and on-the-job supervision to ensure supply of genuine drugs. (NAN) (www.nannews.ng)/Flowerbudnews

 

Culled from Premium Times

Mrs Adeyeye, a professor, who was appointed in 2017, ended her renewable first term of office on 2 November.

By Nike Adebowale-Tambe

Following the expiration of her tenure as the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Moji Adeyeye has exited the office and an acting head has been appointed for the organisation.

In a leaked internal memo signed by the agency’s Director of Human Resources Management, Oboli A.U, and dated 17 November, directors of various units and departments were notified of the appointment of Monica Eimunjeze as the acting director-general..

The memo, with reference number NAFDAC/ADM/SM/075, has as its subject: “Appointment of Acting Director General NAFDAC.”

It reads in part: “The management is in receipt of a letter appointing Dr Monica Eimunjeze as the Acting Director General NAFDAC with effect from 12th November, 2022.

“I am therefore directed to bring this development to you for information and guidance.”

Mrs Adeyeye, a professor, who was appointed in 2017, ended her renewable first term of office on 2 November. It is, however, not clear why the announcement of her replacement was delayed and whether her tenure will be renewed.

Monica Eimunjeze, acting Director General of NAFDAC
About NAFDAC’s new boss
According to NAFDAC, the new acting director general’s profile indicates that she studied Pharmacy at Ahmadu Bello University (ABU) Zaria, and graduated in 1986.

She later bagged her Doctor of Pharmacy (Pharm D) from Mercer University, Atlanta Georgia and a Master of Science (MSc) in Biotechnology, Innovation and Regulatory Science from Purdue University.

She is said to have a varied experience in the pharmaceutical sector spanning different areas of practice, having had her industrial exposure with GlaxoSmithKline from 1989 to 1996.

She served the company in various capacities and held different positions including as medical representative, quality control manager, and as regulatory affairs manager.

Until her appointment as the acting director general, Ms Eimunjeze was NAFDAC’s Director of Registration and Regulatory Affairs.

She was said to have previously served as the Technical Assistant to the Director General of NAFDAC and as the Director, Drug Evaluation and Research.

 

 

 

By Aderogba George

Abuja: The acting Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Dr Monica Eimunjeze, will on Tuesday convene a meeting with directors of the agency.

The Director of Public Affairs of the agency, Dr Jimoh Abubakar, told the News Agency of Nigeria (NAN) in an interview on Saturday that the meeting is for the D-G to disclose her areas of focus.

He said that the NAFDAC D-G would also seek the support of the directors to excel in her new task of piloting the agency’s affairs.

Abubakar said “the new D-G wants to hit the ground running, this is why she has decided to convene a meeting with directors of the agency on Tuesday, Nov. 22.

“She wants to touch on what will be the focus of her administration, using the SWOT analysis and move in quick succession.

“What I mean by SWOT analysis is for her to look at the Strength, Weaknesses, Opportunities and Threats for the agency.

“The meeting will also be looking at gap analysis, this is the process companies use to compare their current performance with their desired, expected performance and look whether we are meeting our expectations.

“All these will be geared toward improving the system.”

The appointment of Eimunjeze followed the expiry of the tenure of Prof. Mojisola Adeyeye on Nov. 2.(NAN(www.nannews.ng) / Flowerbudnews

 

By Obinna Unaeze

Minna:  The National Agency for Food and Drug Administration and Control (NAFDAC) in Niger, says it has arrested a suspect, Kabiru Idris, who produces adulterated agro-chemicals in the state.

Mr James Kigbu, the state Coordinator, NAFDAC, disclosed this on Saturday when the suspect was brought to the agency’s office in Minna with some of the adulterated products.

“Recently we embarked on surveillance on agro-chemicals within Niger state and arrested one Alhaji Kabiru Idris in Makira, Mashegu Local Government Area, where he produces fake agro-chemicals.

“Our investigations so far reveal that he is the producer and distributor of agro-chemical known as Dudual 45 per cent used for pest control,” he said.

Kigbu said that Idris has confessed to the crime and is helping the agency in its investigation into the illicit trade.

He explained that after investigations, the suspect would be charged to Court and made to pay the necessary fines with written undertaking from the court not to engage in such unwholesome activity again.

The NAFDAC Coordinator said that before the arrest of Idris, the agency noticed that hawkers with no fixed addresses were selling many agro-chemicals to unsuspecting farmers in the state, especially in the rural areas.

He said that when the agency arrested some of the hawkers, they revealed that many of them came from Kano state to engage in the unwholesome trade.

Kigbu said that it was discovered that the agro-chemicals they were selling were fake and expired.

“The hawkers told us that after each farming season they stored the chemicals and continue with them again in the next farming season,” he said.

The NAFDAC Coordinator said that many of the hawkers do other jobs but turn to selling fake agro-chemicals because it is lucrative.

“Some of the hawkers are shoe shiners and water vendors,” he said.

He cautioned farmers in the rural areas to always purchase their agro-chemicals from a government approved retail outlet to avoid damaging their crops with adulterated agro-chemicals.

Kigbu noted that the persons who engage in the unwholesome practices use the empty containers of the original products to adulterate the agro-chemicals to defraud unsuspecting farmers.

Idris, 42, who hails from Mashegu area of the state, told NAN that he had been in the business for nine years now. (NAN) (www.nannews.ng) / Flowerbudnews

By Yetunde Fatungase

Abeokuta:  The National Agency for Food and Drug Administration and Control (NAFDAC) has warned stakeholders to avoid practices capable of undermining the functions of the agency.

The Director, Southwest Zone, Mrs Roseline Ajayi, gave the warning at a recent stakeholders’ engagement in Abeokuta.

She said the engagement had become imperative to keep stakeholders abreast of evolving technological advancements.

According to her, the agency recognises that continuous engagement and collaborations would foster better understanding of regulatory requirements between “the regulated and the regulator’’.

She said that any manufacturer or business owner who flouted any compliance directive would be sanctioned.

“There’s no doubt that with advancement in technology, increase in knowledge, research outcomes, climate change effect and the AfCFTA agreement, the regulatory space has been evolving.

“This is why the requirements have also been changing to match with the trend in the regulatory space.

“Those in the drug manufacturing sector have witnessed a lot of changes recently and all efforts are aimed at repositioning the facilities for global competition,’’ she said.

She urged stakeholders to use their smart phones for registration and documentation on the agency’s website, to avoid third party influence of being extorted or duped.

Ajayi said that all stakeholders should see themselves as whistleblowers as the agency could not be everywhere at once.

She said the agency had strengthened all its processes by providing monitoring tools for more routine and surveillance activities.

In his remarks, the Coordinator of NAFDAC in Ogun, Mr Daniel Danjuma, thanked the stakeholders for deeming it fit to attend the workshop.

He noted that the workshop was not to witch-hunt them, rather to help them advance in their businesses with global best practices.

In their separate responses, the stakeholders urged the agency to create more offices in the state.

NAN reports that some of the stakeholders include water producers, patent medicine store operators, master bakers, supermarket owners and Micro, Small and Medium Enterprise (MSME) groups. (NAN)/ Flowerbudnews

 

by Biola Lawal

Abuja: (Flowerbudnews): The National Agency for Food and Drugs Administration and Control (NAFDAC) has successfully integrated its Automated Products Administration and Monitoring System (NAPAMS) into the tax database of the Federal Inland Revenue Service. (FIRS).

A NAFDAC statement made available to Flowerbudnews on Friday in Abuja disclosed that NAPAMS was now integrated with FIRS Tax Identification Number Database”.

NAFDAC said that the integration ”is to ensure validation and authentication of Tax Identification Numbers (TIN) submitted by clients on the NAPAMS portal”.

The Agency advised its clients to visit NAPAMS portal to confirm the status of their TIN, adding. ”where it is not validated, clients are required to ensure registration of their TIN with the FIRS before 1st January 2023”.

NAFDAC warned that clients without validated TIN would not be granted login access into NAPAMS from 1st January 2023: (Flowerbudnews)

The Full NAFDAC statement below:

NOTICE TO NAFDAC CLIENTS ON IMPLEMENTATION OF TAX IDENTIFICATION NUMBER (TIN) VALIDATION ISSUED BY THE FEDERAL INLAND REVENUE SERVICE ON THE NAFDAC AUTOMATED PRODUCTS ADMINISTRATION AND MONITORING SYSTEM (NAPAMS) FOR REGULATED PRODUCTS REGISTRATION

Dear Esteemed Client,

This is to inform you that NAFDAC has integrated her NAFDAC Automated Products Administration and Monitoring System (NAPAMS) the Federal Inland Revenue Service (FIRS) Tax Identification Number Database.

This is to ensure validation and authentication of Tax Identification Numbers (TIN) submitted by clients on the NAPAMS portal.

As a result, all clients are advised to visit the NAPAMS portal to confirm the status of their TIN. Where it is not validated, clients are required to ensure registration of their TIN with the FIRS before 1st January 2023.

Please note that clients without validated TIN would not be granted login access into NAPAMS from 1st January 2023.

Please take note for compliance.

Thank you
Signed Management
NAFDAC…Customer focused; Agency minded