Author: Lara Olaniyi

The National Agency for Food and Drugs Administration and Control (NAFDAC) has been
notified by World Health Organization (WHO) on the circulation of falsified Chloroquine
Phosphate 250mg tablets in Cameroon.
The falsified Chloroquine Phosphate 250mg tablets are manufactured by Jiangsu
Pharmaceutical Inc, Longchil Road, Ylxing, Jiangsu, China and Astral Pharmaceuticals,
New Bhupalpura, Regd No: 0587612.
The falsified Chloroquine Phosphate 250mg Tablets manufactured by the above two
companies have no Active Pharmaceutical Ingredient (API) and are in packs of 1000
tablets.
The use of falsified Chloroquine Phosphate 250mg tablets may result in treatment failure
and even death.
The labelling information on falsified Chloroquine Phosphate 250mg tablets manufactured
by Jiangsu Pharmaceutical Inc, Longchil Road, Ylxing, Jiangsu, China are:
• Product Name: Chloroquine Phosphate 250mg Tablets
• Batch No: 660
• Mfg Dt: 09/2018
• Exp Dt: 09/2022
• Code: MH/DRUGS/KD-271
• Labelled fake NAFDAC No: 028060
The pictorial presentation of the falsified Chloroquine Phosphate 250mg tablets
manufactured by Jiangsu Pharmaceutical Inc, Longchil Road, Ylxing, Jiangsu, China is asThe labelling information on falsified Chloroquine Phosphate 250mg tablets manufactured
by Astral Pharmaceuticals, New Bhupalpura, Regd No: 0587612 are:
• Product Name: Chloroquine Phosphate 250mg Tablets
• N’Lot: EBT 2542
• Date de fab: 01/2019
• Date de Pe’rl: 10/2022
• Regd No: 0587612
The pictorial presentation of the falsified Chloroquine Phosphate 250mg tablets
manufactured by Astral Pharmaceuticals, New Bhupalpura, Regd No: 0587612 is as

Genuine Chloroquine Phosphate 250mg tablets registered by NAFDAC is used for
treatment of rheumatoid arthritis and extraintestinal amebiasis.
All importers, wholesalers and retailers are implored to desist from illegal importation,
distribution and sale of the falsified Chloroquine Phosphate 250mg tablets.
Surveillance has been strengthened by NAFDAC at all ports of entry to prevent illegal
importation of the falsified Chloroquine Phosphate 250mg tablets.
The Agency has heightened surveillance in the thirty-six States and the Federal Capital
Territory, Abuja to prevent distribution and sale of falsified Chloroquine Phosphate
250mg tablets.
Health care providers and other members of the public are advised to be vigilant and
contact the nearest NAFDAC office with any information on the falsified Chloroquine
Phosphate 250mg tablets.
Anybody in possession of the falsified Chloroquine Phosphate 250mg tablets should
submit it to the nearest NAFDAC office.
Consumers are advised to report adverse events related to use of medicines to the nearest
NAFDAC office, 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks or pharmacovigilance@nafdac.gov.ng

The National Agency for Food and Drug Administration and Control, pursuant to the powers conferred on it by section 5 of the NAFDAC Act, to regulate and control the manufacture, importation, exportation distribution sale, use and advertisement of Medical Devices, has taken some regulatory steps in the fight against COVID-19.
The current COVID-19 pandemic has necessitated that NAFDAC put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes. These include, but are not limited to, diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.
The antibody test kits (IgG/IgM) can be used in COVID-19 confirmed individuals, who can then be tested at the designated centers using the antibody kits, to confirm that they have antibodies and as such may not be infected again. The antigen tests kits on the other hand, can detect the COVID-19 antigen in patients with or without symptoms. The results are only qualitative (positive or negative)

There has been a global effort by innovative diagnostic companies to develop test kits to aid in detection of the virus in patients to guide the management of the disease. The Agency has recently received many requests for Emergency Use Authorization for some of such diagnostic test kits to support the national response and ensure expanded testing capabilities.

NAFDAC has put in place regulatory measures to ensure quality, safety and efficacy criteria are assessed.
These measures are supported by documentation which include the following:
1. Prior registration and approval by reference regulatory authorities such as those of Japan, USA, Germany, Canada, European Medicine Agency, etc.
2. Registration by the Regulatory Authority in the Country of Manufacture
3. Declaration of Conformity
4.Validation/performance evaluation /Clinical Evaluation Report

NAFDAC is part of the African Medical Devices Forum (AMDF), a Technical Working Group of African Medical Products Regulatory Harmonization (AMRH) that has a joint secretariat with WHO. Deliberations of the Forum that will be shared with the AMRH Steering Committee for approval and implementation, will further guide NAFDAC. Some of the technical issues that will come out of the deliberations include updates on the list of COVID-19 in vitro diagnostics and medical devices, substandard and falsified commodities and handling of donations.

NAFDAC will continue to stay abreast of current best global practices in this area and monitor updates to the WHO collated list of medical devices being used by different countries.

In addition to these requirements, the full approval of any diagnostic/test kit by NAFDAC for COVID-19 will be subject to in-country validation to assess the sensitivity or rate of failure (i.e., indication of false positives), and specificity.

Failure to comply could lead to revocation of any approval granted for importation of the products and forfeiture of same to the agency for destruction.

NAFDAC has reduced the “registration to approval” time from 120 working days to 10 working days due to the COVID-19 pandemic. Thus far, the Agency has processed seventeen (17) applications using the expedited review process but has only granted Emergency approval to seven (7) companies using the criteria listed above.

The availability of Personal Protective Equipment (PPE) for health care providers is a critical component of the effort to stem the COVID 19 pandemic. These PPEs include gloves, protective goggles, face shields, protective gowns and masks in the form of particulate respirators and surgical masks. These must meet certain technical requirements and specifications in order to achieve the objective and offer some measure of protection to health care providers and limit their exposure to infection .

Please note, no vaccines have been approved for any clinical trial. That may not happen before one year to eighteen months, after clinical trials must have been conducted in different countries. This will be followed by rigorous in-country assessment in line with laid down protocols to further ensure safety and efficacy.

The National Agency for Food and Drug Administration and Control (NAFDAC) hereby alerts the public on illegal distribution and sale of unregistered Hand Sanitizers. The unregistered Hand Sanitizers are illegally distributed and sold under various names including:

• Mighti Shield Instant Hand Sanitizer.
• Assured Instant Hand Sanitizer.
• One Step Hand Sanitizer.
• Shield Germ Hand Sanitizer.
• Lima Hand Sanitizer.
• Senarita Hand Sanitizer.
• AUS-B Hand Sanitizer.
• Bakson Hand Sanitizer.
• Peru Hand Sanitizer.

The package labels of affected unregistered Hand Sanitizers have no NAFDAC Registration Numbers, no batch numbers, no manufacturing and expiry dates; no names and full location addresses of manufacturers.

The quality and safety of the unregistered Hand Sanitizers are not guaranteed because they are not evaluated and registered by NAFDAC.

The members of the public are advised to use genuine NAFDAC registered Hand Sanitizers. Due to the COVID-19 pandemic, the Agency had recently given expedited review to many businesses that are capable of producing sanitizers.

For sanitizers approved by NAFDAC, we appealed to the public not to hike prices suggested by manufacturers to the point that the public cannot afford. Sanitizer is needed to prevent spreading of COVID-19 infection and if sold at exorbitant price, somebody who could not afford to purchase may be exposed to the risk of infection.

NAFDAC has heightened surveillance in the thirty-six (36) States and the Federal Capital Territory, Abuja to prevent distribution and sale of unregistered Hand Sanitizers.

The members of the public are implored to contact the nearest NAFDAC Office with any information on illegal distribution and sale of unregistered Hand Sanitizers.

Anybody or organization discovered to be involved in illegal distribution and sale of unregistered Hand Sanitizers will be severely sanctioned

The National Agency for Food and Drug Administration and Control (NAFDAC) has the mandate to enlighten the public regarding the medical products needed for the nation’s response to the COVID-19 pandemic.  As a result, the Agency has put in place an expedited registration pathway to allow the granting of Emergency Use Authorization (EUA) for the masks and Personal Protection Equipment. 

Personal Protective Equipment (PPE): These are used in different settings to provide some level of personal protection. They serve to protect the wearer as they carry out various activities.  Any setting that entails some level of risk in a work environment, has a requirement for the use of PPE.

 

Face masks and Protective clothing are some of the examples of PPEs worn by persons to create a barrier and offer different levels of protection.  This barrier reduces the spread of infectious material in the hospital and or in the community. 

 

There are different types of face masks and protective clothing available for use, depending on the degree of risk of exposure to infectious material.  The risk of exposure may range from minimal/low to very high risk.  The higher the risk, the higher the level of protection needed. There are different types of face masks and protective clothing depending on the levels of exposure.  Health care professionals by virtue of their jobs, are at highest risk.

 

TYPES OF MASKS

There are basically two types of masks: 

Non-Medical 

Medical masks and Respirators

 

 

NON-MEDICAL OR BARRIER FACE MASKS

Non-medical face masks include self-made or commercial masks or face covers made of cloth, other textiles or other materials such as paper. They are not standardized and are not intended for use in healthcare settings or 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. 

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

 

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.

 

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.

 

Barrier masks are not intended for use in healthcare settings or by healthcare professionals

 

MEDICAL MASK

 

• SURGICAL/ MEDICAL MASK

 

These are fairly loose-fitting disposable masks used by medical/health personnel in health facilities. The surgical masks  are made of non-woven fabric (polypropylene) consisting of multiple layers. 

These masks help prevent large droplets of bodily fluids that may contain germs, including viruses, from coming in direct contact with the patient or the healthcare personnel. They also help to prevent hand-to-face contact.

 

 

 

• RESPIRATORS

 

Respirators which are also called N95, N98 or KN95 respirator masks, are designed to protect the wearer from small (0.3 micron) particles in the air, such as  viruses, which the regular surgical masks do not protect against.

These respirators provide an air tight seal, when fitted correctly, and filter out very small particles, including viruses such as the COVID 19. The respirators are made of fine mesh synthetic polymer fiber.

 

 

• N95 Masks

 

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.

The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks. 

 

 

•  N98 Masks   

 

An N98 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.

The ‘N98’ designation means that when subjected to careful testing, the respirator blocks at least 98 percent of very small (0.25 micron) test particles. If properly fitted, the filtration capabilities of N98 respirators exceed those of face masks. 

 

 

• KN95   

 

The KN95 respirator mask is a Chinese version of the American N95 respirator with significant difference in design and face fit.

 

 

 

 

 

 

 

 

 

 

 

 

PROTECTIVE CLOTHING

These are clothing designed and made of suitable material to protect either the wearer’s body or other items of clothing from contact with disease causing agents.

These include:

1. Protective Coveralls (with attached hood):These   are one-piece, loose-fitting protective suits that offer protection against outside contaminants over a large area of the body.  They are used by all workers (such as emergency workers) who due to the nature of their job, are exposed to disease causing agent.
2. Medical Gowns:  These are Protective clothing used in healthcare setting:

There are basically two types:

1. Surgical gowns:  These are used by medical personnel during surgical procedure and should confer protection from cross contamination.
2. Non-surgical gowns:  These should cover as much of the body as is appropriate for the intended use.

1. Apron:  This is a garment usually of cloth, plastic, or leather usually tied around the waist and used to protect clothing.
2. Head and Shoe Covers: provide a barrier to the feet and head against possible exposure to disease causing organisms.
3. Goggles: These are safety glasses that fit tightly to the eye, and protect the eye from contact. 
4. Face Shields:  These are used to protect the entire face from potentially infectious material.  

 Important points to note on protective clothing:

• Simply wearing protective clothing will not guarantee protection. The protective effect of the clothing  can only be ensured if the clothing is put on and taken off in the correct way and, if correct working procedures are followed.
•  Protective clothing is disposable in most cases though, some can be reused after sterilization.

• Standard protective clothing should be chosen.
• Protective clothing should fit the wearer and should not hamper movement.
• Protective clothing should be checked before use and replaced if damaged.
• Contaminated protective clothing should be disposed of in specially designed rubbish bag.

Artificially ripened fruits where Calcium carbide is used is inimical not only to sound and good health, but also dangerous to the consumer by rendering the fruits poisonous due to the hazardous nature of acetylene gas, phosphorus and arsenic that forms when calcium carbide reacts with water.

Sequel to the ripening of fruits and vegetables saga, NAFDAC Borno State, like all other States immediately swung into action by intensifying surveillances, roundtable discussions, enlightenment campaigns with focus on sensitizing all relevant stakeholders on the dangers and ill-effect of possible use of calcium carbide to ripen banana and other fruits and vegetables.

According to the State Coordinator, Mr. Nasiru Mato, this move becomes necessary amidst public speculations and rumors; thus, the need for a well-coordinated and collaborative effort to deal with the situation.

In a move to revert and stop the negative trend of unacceptable destructive artificial possible method of ripening fruits, exclusive intelligence gathering per excellence has boosted the efforts of NAFDAC Borno State Office to unravel a warehouse facility meant for artificial ripening of banana.

NAFDAC alongside personnel from the Department of State Services (DSS) conducted the exercise recently in Maiduguri as part of collaborative efforts to address health concerns. Meanwhile, samples have been drawn for investigative analysis.

According to Mr. Mato, so far concurrently, NAFDAC Borno State Office is relentlessly looking at the issue with greater emphasis on evidence-based and multifaceted approaches and intelligence gathering to get to the root, hence the involvement of all critical stakeholders to mitigate the problem and in assisting to take further necessary regulatory actions.

To ensure the availability of all right quality and safe products in the state, the agency seizes unregistered and fake products worth One million six hundred and twenty eight thousand, nine hundred Naira (N 1,628, 900.00). These products include several food products and different kind of cosmetics found in City store, Arabian Supermarket, F&S Supermarket and MRS mini mart all in Bauchi metropolis.

The need to ascertain the quality and safety of the regulated products sold in the state led to the  unscheduled surveillance visit to supermarkets, markets and corner shops in the metropolis  where the four supermarkets were found selling unregistered and expired products;

The violating products were mopped up and the owner sanctioned for selling unwholesome products.

The general public is therefore advised to look out for adequately labeled products e.g. Company’s name and address, Batch coding, Production and Expiry/ Best before dates, NAFDAC Reg. No before making their purchases from super markets to avoid consumption of any fake/ counterfeit, unwholesome and expired product, they should report to NAFDAC office any products that have any form of lapses as mentioned above.

The owners of departmental stores, corner shops and other selling points are therefore warned to desist from selling unwholesome products or face the wrath of the law.

NAFDAC will not relent in its effort to monitor all regulated products produced, consumed or sold in the state to ensure that they meet up with required standard.