Tag Archives: NAFDAC

Nigerian pharma companies import all other, except water – NAFDAC

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The only ingredient Nigerian pharmaceutical companies do not import is water, according to the National Agency for Food and Drug Administration and Control.

However this is changing as the Muhammadu Buhari administration steps up investment in the sector, Director-General of NAFDAC, Prof. Mojisola Adeyeye said on Saturday during her appearance on Sunrise Saturday.

“That is changing as we speak,” she said. “There are two or three companies now that are going to be making some active pharmaceutical ingredients.

“There is another talk about making lactose. Lactose is one of the nonactive ingredients – we cannot even make it because we think importation is the best thing, but it is the worst thing that could have happened to us.”

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COVID-19 Impact
Prof. Adeyeye said the coronavirus pandemic has transformed into a catalyst for investment into the nation’s health sector, after decades of neglect.

“I see a brighter future for Nigeria because COVID-19 woke up us from our comatose state as a country,” she said. “Before COVID-19, we had huge problems and COVID-19 kind of opened the Pandora box for us, because we were over-dependent.

NAFDAC Director-General, Professor Mojisola Adeyeye speaks on drug insecurity during an interview on Sunrise Daily on March 3, 2020.

“The health sector was neglected for decades. And what the Buhari administration is doing right now is phenomenal. Because it is something to know that neglect took place, it is another thing to start finding excuses.

“The current administration has now committed a lot of money to the health sector, from the primary health sector to the tertiary, to pharmaceutical companies, to researchers.”

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Improving NAFDAC
The NAFDAC DG said the country’s top regulatory agency for food and drugs is now being audited by the World Health Organisation as it moves to standardise its regulatory process.

“The regulatory system was weak. And I use ‘was’, because NAFDAC is no longer what NAFDAC was three years ago,” she said. “I knew a lot about regulatory science before I joined NAFDAC. And there were things that were done wrong, but we cannot live in the past.

“If a regulatory system is weak, the pharmaceutical industry will be weak. So what we are doing now is to build internal capacity. And that you cannot see on the air. We are making sure we use quality management systems, going through WHO audit, which is a very tasking and arduous process and the best thing that can happen to NAFDAC.

“We have about 200 pharma companies in the country. About 165 are active. We went there one by one to gauge their good manufacturing practice compliance.”


#Newsworthy…

We didn’t approve paxherbal products for COVID-19 treatment – NAFDAC denies

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The National Agency for Food and Drug Administration and Control (NAFDAC) on Saturday denied reports of approving Paxherbal product specifically for the treatment of Coronavirus symptoms

Prof. Mojisola Adeyeye, the Director-General of the agency in a statement on Saturday said the information making the rounds on social media is wrong and inaccurate.

“Until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms.

“PAXHERBAL, a pharmaceutical company applied for listing of Pax Herbal Cugzin Capsule 290mg, and was approved by the agency and listed as “Safe to use”

She disclosed that 21 herbal medicinal products are also being processed presently by the agency for “Safe use” or Listing status.

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The director-general stressed that no clinical study has been done yet on any of the products to prove their claim of efficacy.

According to her, manufacturers of these products who have applied to the agency claimed that their products are only immune boosters and useful for the relief of symptoms associated with Coronavirus.

Director-General of NAFDAC, Prof. Mojisola Adeyeye

“Once the product is able to meet all requirements, a listing status is granted with a clear disclaimer that states clearly that the claims have not been evaluated by NAFDAC.

“The applicant can arrange for clinical trials at this stage that will involve the use of human subjects in order to prove the efficacy of claim for treatment following laid down procedures and with the approval of NAFDAC,” Adeyeye added.


#Newsworthy…

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COVID-19: NAFDAC begin 4 remedy drug test.


National Agency for Food Drugs and Administration Control (NAFDAC) has started working on Coronavirus imminent remedy drugs submitted by Nigerians, its Director-General (DG) Prof. Mojisola Adeyeye said yesterday.

The DG explained that the submissions were made after the agency called for expression of interest for the COVID-19 related medicines from researchers and practitioners.

The NAFDAC DG, who spoke on a television programme, said the four applications submitted would undergo “due diligence”.

The DG also said instead of spending huge amount of money to get the COVID Organic from Madagascar, she would prefer such money to be spent on herbal remedies produced in Nigeria.

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NobleReporters learnt yesterday that the Federal Government is conducting a study on the efficacy of some drugs to treat patients who tested positive to Covid -19 in five centres in the country, Minister of Health Dr. Osagie Ehanire disclosed in Abuja.

He said: “As I said before, there is a study being done on the efficacy of some drugs by about five centres in our country and hydraulic chloroquine is one of them. When the result comes out, I will share with you.


#Newsworthy

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FG’s Rice sent to States not ‘Expired’ – NAFDAC counters. [Nigeria]


Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof. Mojisola Adeyeye, says the agency does not know the status of the controversial 1,800 bags of rice sent to Oyo State.

The consignment was delivered to the State by the Nigeria Customs Service (NCS) on the orders of the Federal Government.

However, the Oyo government returned the rice after discovering that it was weevils-infested.

Minister of Humanitarian Affairs, Sadiya Umar Farouq, had claimed that the rice distributed to States was inspected and certified fit for human consumption by NAFDAC.

But Adeyeye stated that NAFDAC was not invited to take samples and conduct consumption fitness test.

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She made the clarification in a TVC programme, Journalists’ Hangout.

In her explanation, Adeyeye explained that only the consignments to Lagos and Ogun States were tested by NAFDAC and certified fit for consumption.

“The one for Oyo State, I cannot say anything because NAFDAC was not called by the Ibadan or South-West Command of the (Nigeria) Customs, to test samples in Ibadan. I cannot speak about the Ibadan command rice that went to Oyo and possibly to Osun.

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“I don’t know why NAFDAC was not called to take samples from the Oyo State Command to test. We were not invited to come and take samples and we cannot do that.

“The ones that we tested (in Lagos and Ogun) were good enough and the rest of the samples are still in the lab in Oshodi”, she said.


#Newsworthy….

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COVID-19: NAFDAC speak on using face mask from clothing materials. [Nigeria]

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The National Agency for Food and Drug Administration and Control (NAFDAC) has stated that face masks made from clothing materials can be effective in preventing the spread of coronavirus.

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The agency, however, advised Nigerians to carry out a test to ensure that such face masks are effective in protecting against the virus before using them.

The agency said, “Simple test: If wearer can put off a flame from a cigarette lighter that is placed in front of the wearer, the mask is protective enough.”

NAFDAC added: “Barrier face masks do not prevent you from contracting disease but, they have been found to contribute to reduce spread of infections when used widely in conjunction with other measures. Such measures include social distancing, not touching the face, eyes or mouth, washing of hands with soap for 20 secs or use of alcohol based hand sanitizers.”

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NAFDAC further revealed that face masks from clothing materials are not allowed in healthcare settings or to be used by healthcare professionals.

“They serve to limit spread of droplets and offer some measure of protection to those around you.

“The material of construction is usually cloth(textile fabric), non-woven wadding, or paper-like materials. For these Barrier Masks, 100% cotton is preferred though, polyester, linen or knit fabric can be used.

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“These face masks are recommended to be washed daily and preferably should be a double layer of fabric to increase the absorbency and effectiveness.

“It must be noted that several washes, drying and stretching of the mask over time reduce the effectiveness of the mask,” the statement read in part.


#Newsworthy…

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COVID-19: NAFDAC orders production of chloroquine


The National Agency for Food and Drug Administration and Control (NAFDAC) says it has ordered the manufacturing of Chloroquine for emergency stock for possible clinical treatment of Coronavirus.

The agency’s Director-General, Prof. Mojisola Adeyeye, in a statement made available to Channels Television on Monday said the old antimalarial is now being repurposed for the clinical trial treatment of Coronavirus.


Adeyeye said the decision follows the use of chloroquine in other countries to treat Coronavirus.

“Other researchers in France, US have used the drug for the clinical trial treatment of COVID-19 and they reported effectiveness of the drug.


“Lagos State will be starting a clinical trial on chloroquine to evaluate the effectiveness,” she said.

She also explained how Chloroquine was demonstrated in China to be effective in treating COVID-19.


“In a very recent publication, chloroquine was reported in a press briefing by the State Council of China, indicating that chloroquine phosphate had demonstrated marked efficacy and acceptable safety in treating COVID-19 associated pneumonia in a multi-center clinical trials conducted in China.

“The study involved 10 hospitals in Wuhan, Jingzhou, Guangzhou, Beijing, Shanghai, Chongqing and Ningbo, and 100 patients.


“The investigators reported that Chloroquine phosphate is superior to the control in inhibiting the pneumonia associated with COVID-19, and shortening the course of the disease. ”

Adeyeye explained further that Chloroquine was discontinued in Nigeria many years ago for use as antimalarial because of the resistance that the parasite developed against the drug but now she has approached a manufacturing to make a batch of the drug for emergency stock.


“About four weeks ago, I approached a local manufacturing company (May and Baker), a member of Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria (PMGMAN), whose flagship product in the past was chloroquine to make a batch of the drug for emergency stock.

“The company had NAFDAC approval for the production of the drug as antimalarial many years ago before the discontinuation.


“The Managing Director expressed possible difficulty in getting the API due to the fact that the drug has been discontinued. He called shortly after that he was able to get the API and was asked to manufacture a batch for emergency stock just in case more people become exposed and infected with the virus.

“The batch has been manufactured and the company plans to make more batches if needed.”


NAFDAC, however, advised the public to desist from the use of Chloroquine without the guidance of a medical doctor or clinician for treatment of COVID-19.

NAFDAC boss noted that the drug has side effects such as gastrointestinal upset, blurred vision, headache and pruritis (itching).

She added that through her regulatory activities of NAFDAC, it will ensure that the clinical trial protocol protocol guidelines are followed and wishes the clinical research teams great success in stopping the raging pandemic.


#Newsworthy…

COVID-19: NAFDAC approve chloroquine for clinical test.


The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the production of Chloroquine for clinical trials in tackling COVID-19.

Director-General of the agency, Mojisola Adeyeye, made the announcement on Friday at the NAFDAC headquarters in Lagos.


She, however, pointed out that NAFDAC is not approving Chloroquine for the treatment of COVID-19 but for clinical trials to find treatment for the virus.

“In the case of Chloroquine, it has been demonstrated in the literature and with clinical research which is still ongoing, that Chloroquine is superior to the Placebo.


“NAFDAC is not approving Chloroquine as a product that has can be used for Coronavirus because there is no submission to us for registration but because it is under clinical trials, NAFDAC approves medicines meant for clinical trials.

“Therefore the medicine is being approved just for the clinical trials,” Adeyeye said.


She, therefore, called on experts and researchers that are interested in doing a clinical trial on Chloroquine to approach approved outlets, adding that a drug company has been given an approval to produce chloroquine in batches

“Right now, we have asked one company to make a batch of Chloroquine for the purpose of clinical trial,” Adeyeye added.

The NAFDAC DG also urged Nigerians not to use Chloroquine as anti-malaria.

“Nobody should use chloroquine as anti-malaria because of the resistance that has been proven to develop in the past after the use of chloroquine in the population.”


#Newsworthy…

Mashayi Tea: See NAFDAC’s Warning To Nigerians


The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians to be cautious when taking cup of tea popularly known as `Maishayi’ from vendors.

Prof. Mojisola Adeyeye, NAFDAC Director-General gave the warning in an interview.


Adeyeye said that the warning became necessary following information the agency received that Maishayi now mix intoxicating drugs in the tea prepared for customers.

She mentioned intoxicating drugs such as tramadol, Vieteling, Marijuana and others, adding that people could lose their lives after taking tea mixed with such drugs.


“In the US, lots of people are dying because of these medicines. How can such medicines mix with palm wine in the name of getting high in Nigeria?

“There are some medicines you cannot take if you have cardiovascular problem,’’ she said.


The director-general said that the agency was working toward collaborating with the National Institute for Pharmaceutical Research and Development (NIPRD) to check for quality medicine in orthodox and herbal.

According to her, the idea is necessary since NIPRD specialises on research, and the purpose is to safeguard health of the nation.


She however, called on the people to desist from harmful medicine in the name of power enhancement in whatever area they think of.

Adeyeye added that the agency’s five laboratories had been accredited many times and has quality with high standard.

“We are going further, we want a central drug lab to be World Health Organisation (WHO) pre-qualify; we are raising our bar higher,’’ she said.

Adeyeye said that it would continue to sensitise people against the drugs and believe that within the year, the agency would get the WHO pre-qualified central drug lab


#Newsworthy…

NAFDAC: Why kidney, liver disease is in rise (Must Read)


Director-General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has stated that illicit cooking practices, poverty and ignorance are fuelling the rise of kidney and liver diseases in the country.

According to her, many people due to ignorance use paracetamol as tenderiser in cooking meat and also use dye to make red oil, an act she described as shocking.

Adeyeye, who spoke while addressing newsmen yesterday in Lagos, said that the agency had engaged in a lot of public enlightenment to reduce the menace.She said that using paracetamol to cook is like digging one’s grave because when subjected to heat, the drug loses the pain-killing property and becomes highly acidic and dangerous for human consumption.

The NAFDAC director-general, who said that it was weird to learn that Nigerians use paracetamol to cook and warned of its ability to cause severe organ damage due to a chemical compound that undergoes change and becomes toxic to humans when exposed to extreme heat, said the agency had been working with the government to increase its capacity to serve the Nigerian people better, adding that in the midst of disease outbreaks in the country, basic hygiene practices should be adhered to.

She said that part of the plans was to engage corps members to educate the locals because illiteracy level has increased tremendously, adding that the fight against illicit food and drugs practices needs collaborative efforts from different stakeholders.

“We want to make NAFDAC very strong. We cannot have goals without having internal capacity. We have already started training. Our goal is to reach that level that will help NAFDAC manufacture vaccine,” she said.


#Newsworthy…

N307.5Mn: FEC approves sum for vehicle operations by NAFDAC.

…meant to improve mobility.

The Federal Executive Council (FEC) has approved N307.5 million for the purchase of operational vehicles for the National Agency for Food and Drug Administration and Control (NAFDAC).

Minister of State for Health, Adeleke Mamora, briefed State House correspondents after FEC meeting, presided by Vice President Yemi Osinbajo on Wednesday at the Presidential Villa, Abuja.

He said that the vehicles were needed for effective execution of the agency’s mandate.

“These 15 vehicles are meant to improve mobility.

“You recall that NAFDAC is a regulatory agency and has a lot to do in terms of field work.

“ In order to improve mobility and enhance operational efficiency; regulation—checking so many things; claims in terms of products, drugs, food items, water production; they need to move around and confirm claims and certify.

“So, that is the need for these operational vehicles and these are Hilux vehicles, 15 in number,’’ he said.

Mamora said that the 15 Hilux vehicles would cost N307.562 million.

He said that Hilux vehicles had stood the test of time in terms of durability and ability to perform on Nigerian roads.

#Newsworthy…

1,600 cartons of expired dubic malt beverage seized by NAFDAC..

Nigeria

About 1,600 cartons of Dubic Malt beverage packed in 330ml bottles have been confiscated by the National Agency for Food and Drug Administration and Control in the Gombe commercial area, Gombe State.

The state Coordinator of NAFDAC, Bedima Gonzuk, disclosed this in an interview with Northern City News in Gombe on Tuesday.

She said the incident occurred on Friday and warned consumers of carbonated and similar beverages to be vigilant.

Gonzuk said the store owner, Saleh Maina, and his employees were caught tampering with the expiry date before they were apprehended by NAFDAC operatives.

She stated, “Our officers went out for normal routine checks and from experience towards the end of the year and because of the rush between December and January, there is always an upsurge in the sale of beverages.

“People usually sell products that are already expired and most of the times move them from towns to the suburbs. It was not that we had a tip-off.

“We got to Saleh Maina’s warehouse and ran into some youths, who were using methylated spirit to clean the date marking on the PET bottles of the Dubic Malt drink. We seized about 1,600 in total packed in 12 bottles of 330ml each; some expired in July and others in October, but they were busy cleaning the expiry dates, perhaps ready to move them to the suburbs.

“Right now, we have evacuated the whole thing to the NAFDAC store to ensure that they are not circulated.

“We will commence regulatory actions on the owner of the warehouse as I await the outcome of my report to the headquarters.”

#Newsworthy…

Unregistered Cocoa Factory Handed By The Nigerian Navy To NAFDAC…

The Nigerian Navy in Lagos on Wednesday handed over a suspect and an unregistered cocoa beverage factory to the National Agency for Food and Drugs Administration and Control.

The Flag Officer Commanding, Western Naval Command, Rear Admiral Oladele Daji, handed over the suspect alongside the items to NAFDAC at Nigerian Navy Ship WEY in Lagos.

Daji, who was represented by the Commander NNS WEY, Commodore Uduak Ibanga, said the suspect was caught producing unregistered cocoa beverage named Belling Chokovita.

“The suspect was caught by NNS WEY security patrol team at 01:30hrs on Sunday November 17 in his factory at Mammy market, Navy Town, Ojo.

“The following items recovered from the suspect’s illegal factory are 10 cartons x 12 pieces of finished products, 152 pieces of unpacked products.

“Others are 23 bags of grounded cocoa powder and seven bags of Calcium Carbonate Power,” he said.

Commodore Ibanga advised Nigerians to purchase only NAFDAC registered products and to always check the manufacturing or production and expiry dates of products before consumption.

“The navy will not rest on her oars in carrying out this task and the cooperation of the general public is solicited,” he said.

(NAN)

#Newsworthy…