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NAFDAC alerts Nigerians on substandard, contaminated syrup

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The National Agency for Food and Drug Administration and Control (NAFDAC)
has notified the public about five contaminated syrups allegedly going around in World Health Organisation (WHO) regions.

 

 

The notification is contained in a public alert No. 037/2023, signed by the Director-General of the agency, Prof. Mojisola Adeyeye, a copy of which was obtained by thecolumn.ng Abuja on Monday (today).

 

 

The agency listed the WHO regions to include: America, Eastern Mediterranean, South-East Asia and Western Pacific.

 

It stated that the five oral liquid dosage forms (syrup and suspension) were also detected in the Maldives and Pakistan and that some of the affected products have also been detected in Belize, Fiji and Lao People’s Democratic Republic.

 

 

The agency listed the sysrups as: ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension and ZINCELL Syrup, adding that “a total of 23 batches of the products are affected and the stated manufacturer is
PHARMIX LABORATORIES (PVT.) LTD (Pakistan).

 

 

“In November 2023, samples of five different batches of ALERGO syrup were screened for non-compliance by the quality control laboratory of the Maldives Food and Drug Authority (MFDA).

 

 

“This is in accordance with the Thin Layer Chromatography (TLC) test for Diethylene Glycol and Ethylene Glycol for inclusion in the International Pharmacopoeia.

 

 

 

“The routine screening detected potentially unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

 

“Laboratory testing conducted by the Therapeutic Goods Administration of Australia (TGA) confirmed that all five batches were contaminated with ethylene glycol at levels ranging from 0.62 to 0.82 per cent w/w relative to the accepted limit of not more than 0.10% w/w.

 

 

“A follow-on inspection of PHARMIX LABORATORIES (PVT.) LTD was conducted by the Drug Regulatory Authority of Pakistan (DRAP).

 

 

“The DRAP review of the manufacturing facility and manufacturing records suggested that diethylene glycol/ethylene glycol as contaminants may be present in other products and batches manufactured by PHARMIX LABORATORIES (PVT.) LTD.

 

 

 

The NAFDAC boss said that as a precautionary measure, DRAP had instructed PHARMIX LABORATORIES to stop production of all oral liquid dosage medicines and issued

a Recall Alert for the five different oral dosages manufactured by the company.

 

She disclosed that Diethylene Glycol and Ethylene Glycol are toxic to humans when consumed and can prove fatal.

 

According to her, toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

 

 

The NAFDAC boss stated that manufacturers of liquid dosage forms, especially syrups that contain excipients, are at risk of contamination with EG/DEG such as glycol, sorbitol, and/or glycerin/glycerol.

 

 

 

Adeyeye added that the substandard products referenced in the alert are unsafe and that their use, especially in children, may result to serious injury or death.

 

She stated that although the products are not registered by NAFDAC, they may have been distributed through formal and informal markets to other countries or regions, including Nigeria.

 

 

 

She implored importers, distributors, retailers and consumers to exercise caution and increase vigilance within the supply chain to avoid the importation, distribution, sale and use of substandard cough syrups.

 

She said all medical products must be obtained from authorised/licensed suppliers, adding that products’ authenticity and physical condition should be carefully checked when buying.

 

The director-general advised the public, who have the listed products not to sell or use the products, but submit stock to the nearest NAFDAC office.

She urged those who may have used the products to seek immediate medical advice from qualified healthcare professionals.

 

 

She also advised healthcare professionals and consumers to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office on 0800-162-3322 or via email: [email protected].

 

 

She encouraged healthcare professionals and patients to report adverse or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download and IOS stores or via e-mail on

[email protected]

Health & Wellness

Doctors Reject Bill Proposing Jail Term Over Emergency Delays, Says Bill Will Increase Brain Drain

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The Nigerian Association of Resident Doctors (NARD) has rejected proposed legislation seeking a six-month jail term or ₦300,000 fine for healthcare professionals over delays in emergency medical treatment.

 

This is contained in a statement issued by the NARD President, Dr Ogar Idoko, in Calabar on Friday.

Idoko described the proposed amendment to the National Health Act as punitive, arguing that doctors should not be criminalised for failures arising from inadequate healthcare infrastructure.

He said the association recognised the importance of prompt emergency care and protecting patients but insisted that systemic challenges must be addressed before imposing criminal sanctions.

According to him, doctors nationwide work under difficult conditions, including obsolete equipment, inadequate staffing, unreliable electricity and insufficient emergency medical supplies.

“The challenges are consequences of longstanding institutional neglect rather than professional negligence, so I urge lawmakers to prioritise healthcare funding and infrastructure.

“We also challenge the National Assembly to demonstrate similar legislative urgency in providing functional emergency departments, modern diagnostic equipment, reliable ambulance services and adequate personnel,” he said.

He asserted that lawmakers should consider legislation compelling public office holders to use Nigerian government hospitals, with sanctions for misuse of public resources on avoidable overseas medical treatment.

He warned that additional criminal penalties against overstretched healthcare professionals could worsen the country’s brain drain, popularly known as the “Jar-pa syndrome.”

He stated that the association acknowledged that the proposed bill reportedly contained safeguards for circumstances beyond practitioners’ control but insisted that such provisions must be explicit and enforceable.

He called for the withdrawal and reconsideration of the proposed punitive provisions, alongside consultations involving healthcare associations, hospital administrators, patient representatives and other stakeholders.

He urged the National Assembly to prioritise legislation guaranteeing adequate health funding, minimum emergency-care standards, appropriate staffing, constant electricity and functional referral systems.

“We will consider all lawful options, including nationwide industrial action, if lawmakers proceeded with legislation unjustly criminalising doctors for institutional failures.

“We however, pledged to make necessary arrangements to protect emergency and critically ill patients during any industrial action, while we reaffirm our commitment to patient safety and quality healthcare.,” he said.

The Senate is considering a bill that seeks to punish hospitals and healthcare workers who refuse or delay emergency medical treatment.

The bill which passed its second reading on Wednesday, was sponsored by Sen. Abdulaziz Yar’Adua, representing Katsina Central Senatorial District.

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Health & Wellness

NCDC Defends ₦100,000 Weekly Pay To Ebola Contacts

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The Nigeria Centre for Disease Control and Prevention (NCDC) has disclosed that its decision to pay ₦100,000 weekly to people quarantined following an imported Ebola case was an emergency intervention that had not been included in its budget.

 

The agency’s Director-General, Dr Jide Idris, said the financial support was introduced on compassionate grounds to ease the burden on individuals whose daily lives had been disrupted by quarantine measures.

Idris spoke during an interview, explaining that the affected individuals had been separated from their usual routines to protect public health.

“That was not budgeted for. Those people who were in the quarantine area were people who never planned to be there. We took them out of their comfort zones; we put them there for public health reasons, so we are responsible for their feeding, accommodation,” he said.

According to him, some of those under quarantine expressed concerns about being away from their families and the financial losses they could suffer by remaining at the facility.

“Some of them said they had families at home they need to take care of. But one or two said they had businesses. By staying here again, you’re going to lose a lot of money again,” Idris added.

He said the possibility of some individuals leaving the facility prompted further concern, as their health status had yet to be conclusively established.

“If you allow them to leave the place, it’s a public health issue because you don’t know whether they will turn positive or who is ill,” the NCDC chief said.

Idris explained that the agency opted to provide financial assistance to discourage the individuals from leaving quarantine and to address their immediate needs.

“On compassionate grounds, we said, okay, let’s see how best we can support them. It’s a temporary thing because it’s not something we’ve done,” he said.

He also clarified that state governments were ordinarily responsible for providing quarantine facilities and the associated support, adding that the NCDC intervened because the expected arrangements had not materialised.

“In this kind of thing, the quarantine facility, there are the responsibilities of each state government, not any NCDC. But because this is not forthcoming, to avoid this one, just to temper this thing, we decided to step in,” he said.

The NCDC had earlier announced an emergency payment of ₦100,000 per person weekly for individuals placed in isolation or quarantine following the confirmation of an imported Ebola case in the Federal Capital Territory.

The intervention followed complaints from contacts about the cost of food, accommodation and maintaining their families while complying with public health monitoring requirements.

At a press briefing on Sunday, Idris said the agency was covering the basic expenses of those affected.

“We are paying for their accommodation; we are paying for their feeding. Some of them are asking for a stipend to maintain their families,” he said.

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Health & Wellness

Nigeria’s Lone Ebola Patient Evacuated To Switzerland

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Nigeria’s index case of the imported Ebola virus disease has been evacuated to Switzerland for further care, Minister of Health, Ali Pate, has said.

 

Pate disclosed that the patient departed Abuja earlier Monday with his approval, adding that her spouse, who has remained asymptomatic, accompanied her.

In a statement, the minister said the patient’s clinical condition had improved significantly before the evacuation.

He said she was stable, conscious and able to communicate, while her laboratory test results were approaching baseline levels.

However, Pate cautioned that the improvement did not necessarily mean the patient was no longer infectious, stressing that strict public health protocols remained in place.

“The index patient was clinically much improved, stable, conscious, communicating, and her clinical laboratory test results closing towards baseline. This does not mean she is not still infectious, hence the strict protocols in place,” he said.

The minister commended the clinical personnel who treated the patient, as well as public health officials who coordinated the evacuation in accordance with established public health measures.

He said the government would provide further updates later Monday after the patient and her spouse had arrived safely at their destination.

Pate assured Nigerians that public health measures were ongoing to contain the imported virus, urging citizens to remain vigilant and obtain information from credible sources.

“All public health measures are continuing to ensure successful containment of the imported virus. I urge Nigerians to remain vigilant and rely on information from credible sources,” he said.

The minister did not provide further details about the circumstances of the evacuation or the treatment arrangements in Switzerland.

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