By Biola Lawal

Lagos:. NAFDAC Director-General, Prof. Mojisola Adeyeye has successfully facilitated Contract Manufacturing partnership in the drug  production sector to further enhance growth and expansion.

Flowerbudnews reports that the contract manufacturing partnership signing  ceremony was well attended by dignitaries including Mr.  Fidelis Ayebae, Managing Director,  Fidson Healthcare Plc;.

Others include Mr Kunle Oyelana, Managing Director, GlaxoSmithKline Nigeria Plc.

L-R: Mr Fidelis Ayebae, Managing Director,  Fidson Healthcare Plc; Prof Mojisola Adeyeye,  Director General, National Agency for Food and Drug Administration and Control NAFDAC; and Mr Kunle Oyelana, Managing Director, GlaxoSmithKline Nigeria Plc, at the NAFDAC facilitated contract manufacturing partnership signing and production commencement ceremony in Lagos…on Thursday.

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By Biola Lawal

Abuja:  Professor Mojisola Adeyeye, the Director-General of the National Agency for Food and Drug Administration and Control, (NAFDAC) has cautioned Nigerians against using ‘’manpower’’ enhancing drugs, warning that their consumption can lead to stroke or sudden death.

Prof. Adeyeye, who gave the warning in her Christmas and New Year goodwill message to Nigerians, decried the preponderance of performance enhancing drugs in the Nigeria market, noting that many men used the dangerous substances in order to impress their female partner.

The NAFDAC Boss disclosed that most of the performance enhancing drugs are not registered with NAFDAC., saying, ‘’They are smuggled into the country. If they were registered, the producers and peddlers alike would not be doing what they are doing in the supermarkets, social media platforms and on the streets’’.

In a statement by Sayo Akintola, NAFDAC’s Resident Media Consultant made available to Flowerbudnews in Abuja on Saturday quoted Prof. Adeyeye as lamenting that many men had died using performance enhancing drugs, while their relatives would blame their death on some imaginary witches in the village.

She described as false, the claim by the producers of the products that they have no side effects, insisting that majority of the products did not go through the approval process of the Agency.

Prof. Adeyey however, warned that the Agency would not relent in running after the peddlers of such dangerous drugs until they are brought to book for violating the regulations.

‘’Just like the need to have food and water, intimacy is also a primary requirement in life. Most human beings have the need for intimacy for a healthy sexual life which determines their overall wellbeing. If there are physical or psychological problems to a person’s sexuality it can hamper their self-confidence,’’ she noted.

‘’Many people today have been caught in the web of such circumstances leading them to seek a way out of the wood. In recent times, the use of aphrodisiacs has become the range.

‘’Many people are ignorant of the possible damage that misuse of aphrodisiacs or use of unregistered drugs could cause’’, said Prof Adeyeye, adding that there are manufacturing and quality guidelines, and mandated regulations that control the production, importation, exportation, advertisement, and the use of such products.’’.Prof. Adeyeye said.

According to her, unbridled use of aphrodisiacs has a lot of implications in the entire body system, noting that the use of the products could potentially affect the blood pressure of the body.

She stressed that ‘’when you have a disproportionate flow of blood to a particular part of the body and lasting longer than normal, they tend to disrupt the normal flow of the circulatory system’’.

Prof Adeyeye further warned that aphrodisiacs could also interact with other drugs in the system, explaining that the liver is responsible for breakdown of drugs while the byproduct of all waste goes down through the kidneys.

‘’When these things are used especially with some herbal medicines that don’t have dosage and professional prescription, it can lead to internal organ damage, it can hurt the liver and the kidneys, leading to untimely death’’ she warned.

The way the body system works, she explained: ‘’everything should function the way God designed it. When they begin to disrupt those functions overtime it affects the imbalance and the ecosystem of how the body physiology works and can lead to unintended consequences.’’.

‘’For those who have certain health risks, like people that are hypertensive, or people that have heart disease, there is more of anxiety that the drug could stimulate into the system, and with anxiety, that can lead to changes in the physiology of the body and can lead to stroke or sudden stoppage of the heart.

‘’These happen in cases when men suddenly slump during sexual intercourse as reported in Rivers and Cross Rivers States recently’’, she said in a tone laden with grief.

‘’There are a lot of side effects. Every drug is a potential poison. Every drug has one side effect or the other. These are chemical products with side effects. In some cases there are associated Adverse Drug Reactions, which means it could lead to death or more serious organ damage depending on usage’’, she said.

She insisted that ‘’it’s not all cases of sudden death that are caused by witches and wizards in the village; but in most cases they are caused by what we eat or drink carelessly’’

In the spirit of Christmas and New Year festivities, she urged Nigerians to eat right and drink right to avoid health complications after the annual events.

Prof Adeyeye recalled that over N3b worth of falsified and banned drugs and unwholesome food products were seized by the Agency recently at the Lagos Trade fair complex where no fewer than 20 trailer loads of such banned and unwholesome products were carted away by officers of the Agency’s Investigation and enforcement directorate led by Barrister Kingsley Ejiofor.

She disclosed that some of the drugs impounded at the trade fair complex were performance enhancing drugs. ‘’Worse still they are counterfeited. When something is counterfeited, the manufacturers don’t care about quality.

‘’They add what they are not supposed to add or add more than what they are supposed to add. Invariably, the user is the loser’’, she said.

Prof Adeyeye however, disclosed that the Agency has ordered 40 units of a detecting device, TRU SCAN, worth 70,000 dollar each for use on the field to spot check the medicines.

She explained that ‘’the device will show you whether a drug is 5mg or 50mg. Before, it would only show you that it’s X-drug, it will not show you the level. This device is both qualitative and quantitative!

Prof. Adeyeye disclosed that NAFDAC is the first Regulatory Agency in the world to use the Tru Scan which does quantitative spot check on the chemical content in the medicines. It will show the chemical level of the drug.

‘’This is part of the multifaceted approach we are adopting in fighting the preponderance of banned and falsified drugs in the country’’, she said, blaming the menace on people that want to make quick money at the expense of the health and lives of undiscerning consumers.

‘’We will ensure we minimize falsification of drugs to the level that will give a lot of confidence to the consumers.” The Director-General assured.  (Flowerbudnews)

 

By Flowerbud News

Dec. 26, 2021

The National Agency for Food and Drug Administration and Control, (NAFDAC) has urged Nigerian men to desist from using performance-enhancing substances, known as “aphrodisiac”, in order to impress their female partners.

The is contained in a statement for the Christmas and New year goodwill message to Nigerians by the the Director General of NAFDAC, Prof. Moji Adeyeye.

The statement was released to the News Agency of Nigeria (NAN) on Sunday by the agency’s resident media consultant, Mr Olusayo Akintola.

Adeyeye decried the preponderance of performance-enhancing drugs, otherwise known as ‘’Manpower’’ in the local parlance, in the Nigeria market.

According to Adeyeye, most of the performance-enhancing drugs are not registered with NAFDAC, and that some of them were smuggled into the country.

“If they were registered, the producers and peddlers would not get it to the supermarkets, social media platforms and on the streets.

“Many men have died using such drugs and their relatives would blame their death on some imaginary witches in the village. Some of the producers of these drugs will claim they have no side effect.

“Majority of these products did not go through the approval process of the agency, the agency will not relent in running after the peddlers of such dangerous drugs until they are brought to book for violating the regulations,” Adeyeye said.

She said that most human beings have the need for intimacy and for a healthy sexual life and this determines their overall wellbeing.

She said that If there are physical or psychological problems to a person’s sexuality, it can hamper their self-confidence.

According to her, many people today have been caught in the web of such circumstances, leading them to seek a way out of the wood and that in recent times, the use of aphrodisiacs has become the range.

She said that many people are ignorant of the possible damage the misuse of aphrodisiacs or use of unregistered drugs could cause.

She noted that there are manufacturing quality guidelines and mandated regulations that control the production.

According to her, unbridled use of aphrodisiacs has a lot of implications in the entire body system and that the use of the products could potentially affect the blood pressure of the body.

“When you have a disproportionate flow of blood to a particular part of the body and lasting longer than normal, they tend to disrupt the normal flow of the circulatory system,” she said.

Adeyeye further said that aphrodisiacs could also interact with other drugs in the system and cause problem for the liver which could be responsible for breakdown of drugs while the byproduct of all waste goes down through the kidneys.

She said that when these things are used especially with some herbal medicines that don’t have dosage and professional prescription, it could lead to internal organ damage, as well as hurt the liver and the kidneys and this could cause untimely death.

She said that the way the body system works, everything should function the way God designed it.

She said “when we begin to disrupt the functions of the body organs overtime it affects the imbalance and the ecosystem of how the body physiology works and can lead to unintended consequences.

‘’For those who have certain health risks, like people that are hypertensive or people that have heart disease, there is more of anxiety that the drug could stimulate into the system and can lead to changes in the physiology of the body, stroke or sudden stoppage of the heart.

“These happen in cases when men suddenly slump during sexual intercourse as reported in Rivers and Cross River States recently.

‘’There are a lot of side effects. Every drug is a potential poison. Every drug has one side effect or the other.

“These are chemical products with side effects. In some cases, there are associated Adverse Drug Reactions which could lead to death.

“It is not all cases of sudden death that are caused by witches and wizards in the village; but in most cases they are caused by what we eat or drink carelessly,” she said.

Adeyeye, however, urged Nigerians to eat right and drink right, especially in this festive season, to avoid health complications after the annual events.

The NAFDAC boss recalled that over N3 billion worth of falsified and banned drugs and unwholesome food products were seized by the agency recently at the Lagos trade fair complex.

She added that no fewer than 20 trailer loads of such banned and unwholesome products were carted away by officers of the agency’s Investigation and enforcement directorate, led by Barrister Kingsley Ejiofor.

According to her, some of the drugs impounded at the trade fair complex were performance-enhancing drugs and that most of them are counterfeit.

The director general said that manufacturers don’t care about quality, they add what they are not supposed to add or add more than what they are supposed to add, and in the end, the user is the loser.

Adeyeye disclosed that the agency has ordered 40 units of a detecting device, TRU SCAN, worth US$70,000 each for use on the field to spot fake medicines.

According to her, the device will show you whether a drug is 5mg or 50mg and that the device is both qualitative and quantitative.

The NAFDAC Director General said that the agency is the first agency in the world to use the Tru Scan which does quantitative spot check on the chemical content of medicines and chemical level of the drug.

According to her, this is part of the multifaceted approach the agency is adopting in fighting the preponderance of banned and falsified drugs in the country.

She blamed people that want to make quick money at the expense of the health and lives of undescerning consumers.

She added that the agency would ensure minimized falsification of drugs to give confidence to consumers.

NAN

By Flowerbud News

Jan. 3, 2022

Nigeria will not be a dumping ground for chemicals banned in other countries.

Prof. Moji Adeyeye, the agency’s Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC) has said.

This is contained in a statement issued by Mr Olusayo Akintola, The resident media consultant of NAFDAC.

Adeyeye also explained that it was not true that 40 per cent of the registered brands of pesticide products in Nigeria were banned or restricted for use by European Union.

“The agency has put in place procedures to enable it take regulatory decisions and determine whether an active ingredient should be banned or restricted.

“NAFDAC is a signatory to the international convention that banned chemicals and pesticides such as the Rotterdam Convention, an international treaty designed to facilitate informed decision-making by countries with regard to trade in hazardous chemicals and pesticides.

“NAFDAC is ISO: 900: 2015 Quality Management System (QMS) and a certified organisation that has put in place procedures that enable the agency take regulatory decisions to determine whether an active ingredient should be banned or restricted.

“Chemicals banned by international convention have been phased out and never entertained for registration or given import permits as raw materials for production as a sovereign state,” she said.

She said NAFDAC has stringent requirement of ensuring that any pesticide to be imported into Nigeria is on the Market in the exporting country, the current Free Sale Certificate is authenticated by the Nigerian Embassy in the exporting country.

The NAFDAC boss also stated that in order to ensure that only active ingredients approved by the agency are allowed into the country, appointed testing agents (CRIA) and laboratories to conduct tests and forward results to the agency before any pesticide is shipped in.

Adeyeye stated that the World Health Organization (WHO) names four toxicity classes of pesticides:Class I – a: extremely hazardous, Class I – b: highly hazardous, Class II: moderately hazardous, Class III: slightly hazardous, Class U: Unlikely to present acute hazard.

She said these classifications are for guidance purposes to enable users to take necessary precautionary measures and to ensure the safety of food for humans, animals, and the environment.

Adequate quality control tests, she said,  are carried out by the agency before granting certifications for all products that are either imported or manufactured within the country.

The NAFDAC boss disclosed that the field trial evaluation is conducted in collaboration with research institutes in Nigeria to determine the safety, quality and efficacy of new molecules as well as inspection of manufacturing facilities.

She said that all was in the aim to establish that a Good Manufacturing Practice (GMP) was in place to ensure that product manufactured meets the quality standard specification for the intended use.

Other regulatory activities she said include but not limited to the issuance of authority to clear, continual sensitization and awareness exercises for relevant stakeholders on safe and responsible use of pesticides, post-marketing surveillance to mop-up fake and unregistered products.

She added that the agency also does other regulatory activities such as destruction of destruction and seized of products.

According to her, the EU uses much lower Maximum Residual Limits (MRLs) than most other CODEX member countries, hence the EU raised observations for the codex secretariat and subsequently for World Trade Organisation (WTO) to take note.

She explained that products with active ingredients that are accepted by other codex member countries including Nigeria are not allowed into the EU.

Adeyeye pointed out that lack of scientific data in Nigeria has been identified as a gap why the country participants refrain from raising observations during codex meetings, and have no choice but to go by the general codex alimentarius resolutions.

The NAFDAC boss called on all relevant research institutions to generate enough data and make available such data for the Nigerian team that attends Codex Committee meeting on Pesticides Residues (CCPR) to advance the country’s interest.

She said that all the pesticides approved for use by NAFDAC are also in use in other parts of the world, and called on investors to feel free and be confident to invest in Agricultural production in Nigeria.

She reiterated the agency determination and assurance to Nigerians that no stone would be left unturned to ensure that food products available to Nigerians are safe and wholesome.

She said that NAFDAC in the last four years of her administration has been repositioned to effectively regulate all agricultural inputs such as pesticides, and agrochemicals amidst other regulated products.

“The quality and safety of the inputs have a direct impact on the food from the farms and the health of humans, animals, and plants in line with the federal government agenda and investment in agriculture.

“The agency wishes to encourage investors to consider investing in agricultural production so that creation of jobs and ability to feed ourselves as a nation without depending too much on foreign exchange can be achieved.

‘’It is noteworthy that a lot of regulatory activities have been carried out to ensure that all inputs regulated by NAFDAC required in the production of safe food are safe, efficacious and of the right quality.

“Local production of food is highly encouraged, in the last four years, has reviewed her regulations, guidelines and strengthen collaboration with Ministry, Department and Agencies (MDA) and stakeholders to ensure effective regulations.

“Such collaborative efforts have  been recorded in agrochemicals regulation, NAFDAC has reviewed the safety of all registered agrochemicals in Nigeria in consultation with relevant stakeholders,” she stressed.

Adeyeye said a four year initiation plan was rolled out to phase-out plan for obsolete and some hazardous agrochemicals adding that such phase-out plan is currently running for Paraquat, which would be phase-out in 2024 and Atrazine in 2025.

According to her 100ml pack size of Dichlorvosis already banned due to inappropriate use and that about 30 pesticides have been banned in Nigeria.

She therefore advised the general public to visit the NAFDAC website (www.nafdac.gov.ng) for detail of banned pesticides.l, adding that, a prudent and responsible use of pesticides and agrochemicals was the paramount caution to use the priducts in Nigeria.

NAN

By Aderogba George
Abuja:  The National Agency for Food and Drug Administration and Control (NAFDAC), has warned importers, distributors, and consumers to discontinue the sale and use of Lefin Pediatric Suspension drug with immediate effect.
The agency, on Sunday in a public alert with No. 0047/2021, also asked consumers to hand over the remaining stock of the drug to the nearest NAFDAC office.
According to the alert, NAFDAC has been informed by Drug Regulatory Authority of Pakistan (DRAP) about a recent recall of Lefin Pediatric Suspension manufactured by M/S Leama Chemi Pharma (PVT) Limited for being substandard.
The alert disclosed that Lefin Pediatric suspension is a brand of Paracetamol used for the relief of mild to moderate pain such as headache, muscle aches, toothache as well as pain caused by cold, flu, and sprains.
“NAFDAC implores importers, distributors, and consumers in possession of the recalled lots of Lefin Pediatric Suspension to discontinue sale or use and hand over the remaining stock to the nearest NAFDAC office.
“Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of these medicines to the nearest NAFDAC office.

“The public could also make use of NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) or its TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng.

“The public is also required to make use of the e-Reporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety application available for download on Android and IOS stores. (NAN) (www.nannews.ng/ Flowerbudnews

Jan. 20, 2022

By Stella Kabruk

The National Agency for Food and Drug Administration and Control (NAFDAC) says it registered about 400 regulated products
in 2021.

The state Coordinator, Mr Nasiru Mato, disclosed this in an interview with the News Agency of Nigeria (NAN) in Kaduna on Thursday.

Mato said the products comprised of foods, cosmetics and packaged water.

He added that “it was indeed a success story as NAFDAC in Kaduna State witnessed huge increase in product registration,
with about 400 new foods, cosmetics and packaged water secured in 2021.’’

He said that the deployment of e-registration via Automated Product Administration and Monitoring System (NAPAMS)
had tremendously turned around the registration processes for regulated products.

He added that “the process is seamless, real-time enabled, hassle-free and transparent, and eliminates possible registration bottlenecks.

“With NAPAMS, clients can go online to submit their applications for product registration and renewal of licences.”

The coordinator added that Kaduna State intending manufacturers of NAFDAC regulated products had embraced the technology,
resulting in increase in the number of registered products in the state in recent time.

He stressed that “with NAPAMS, product registration is just a *’click’* away, as vetting of submitted documents can feasibly
and easily be done online”.

He explained that the decentralisation of the registration process for Micro, Small and Medium Enterprise (MSME) product categories
with minimal risk had effectively reduced the possible delay in registration timeline as licenses were now obtained with ease.

“The remarkable accomplishment demonstrates the resilience and determination, as well as the continued support of the Director-General
of NAFDAC, Prof. Mojisola Adeyeye,” he noted.

He also said that the agency’s focus would be intensified with regards to critical stakeholders and grassroots engagement to ensure greater results and healthy citizenry.

NAN

By Biola Lawal

Lagos: Prof. Mojisola Adeyeye, Director-General, National Agency for Food and Drug Administration and Control (NAFDAC) has called for increased funding for research and development of herbal medicines to support universal health coverage in the country.

Adeyeye made the call at the Inaugural Symposium and Launching of the Africa Centre of Excellence for Drug Research, Herbal Medicine Development and Regulatory Science (ACEDHARS), University of Lagos.

The theme of the event is Drug Development from African Medicinal Plants: Opportunities, Challenges and Regulatory Approach.

The DG, who delivered the keynote speech at the event. said that investment in herbal medicine research and development would positively impact the economy of the pharmaceutical traditional medicine industry.

She said: Herbal medicines are very important to healthcare delivery and can contribute significantly to universal health coverage in our country.

Despite the widespread use, traditional medicines have not yet been integrated into the national healthcare system of many developing countries including Nigeria.

The increasing use of herbal medicine despite general lack of research on some of this product is a call for concern.

Investment in herbal medicine research and development is needed from all stakeholders including the government , so we can benefit from whatever God has given to us freely.

According to her, ACEDHARS is very important to Nigeria because of the focus which is the development of herbal medicine for the use of the people.

This centre will function to ensure that adequate research is conducted and clinical trials are done on herbal products before usage.

As it were, some herbal medicine get to the market without adequate research and clinical trials to confirm their safety and efficacy.

Adeyeye advised herbal practitioners to take advantage of the centre to increase their knowledge in the practice.

Herbal practitioners must have continued education, even if they have before and for those that dont have, this centre will be of immense benefit to them expand their horizon.

They can take short courses and if they are not well schooled, they can have somebody in their organisation that can attend, she said.

Speaking earlier, Prof. Oluwatoyin Ogundipe, Vice Chancellor, University of Lagos, represented by Prof. Obinna Chukwu, Deputy Vice Chancellor, Management Services, said that there was need to tap into the indigenous knowledge of herbal practitioners.

Ogundipe described the symposium as timely in examining the challenges, opportunities as well as the regulatory approach for drug development for Africa medicinal plants.

We must appreciate the fact that the herbal medicine we have are quite efficacious and there is the need for us to tap into the indigenous knowledge.

Some herbal medicine are quite useful in addressing a number of ailments but the problem is that some of these medicine had been seen as a cure for all ailments which the Yoruba call gbogbo nise.

The issue of quality control, proper identification of medicinal plants, standardisation of active ingredients and chemical compound in herbal medicine will be addressed.

We are also looking forward to a period where modern technology will be applied in herbal medicine research, he said.

Speaking also, Omobolanle Ade-Ademilua, Director/Centre Leader, said ACEDHARS, which is a World Bank approved centre of excellence, is established to train skilled manpower.

Ade-Ademilua said the training includes quality assurance, standardisation of dosages, reproducibility of herbal preparations and safety monitoring of drugs in West and Central African region. / Flowerbudnews