KENYA — Kenya’s Pharmacy and Poisons Board (PPB) has taken decisive action to safeguard the health of its citizens by recalling a widely used oral medicine designed to relieve pain and fever in children.
The paracetamol oral solution, known as Tamedol, has been banned as of Wednesday, marking a critical development in the ongoing effort to ensure medication safety in the country.
Dr. Fred Siyoi, the Chief Executive of the regulatory body, announced the ban, adding that Tamedol, manufactured by Kenyan pharmaceutical company Biopharma Limited, is now the ninth medication to be recalled by the PPB in this year alone.
The decision to initiate this recall was prompted by a series of complaints from concerned customers regarding the quality of several batches of Tamedol.
In an official statement released on Wednesday, September 20, 2023, the Pharmacy and Poisons Board (PPB) acknowledged the numerous complaints regarding the drug’s quality circulating in the market.
The statement reads, “The Pharmacy and Poisons Board (PPB) has received multiple market complaints on the quality of several batches of Tamedol oral solution (Paracetamol oral solution, 120mg/5m1, 60 mls) manufactured by Biopharma LTD, Kenya.”
In response to these alarming concerns, the PPB conducted thorough investigations, confirming that Tamedol failed to meet the prescribed market authorization requirements.
Consequently, the PPB invoked Section 3A(i) of the Pharmacy and Poisons Act (Cap. 244) to mandate the recall of the product by its manufacturer.
Dr. Siyoi emphasized the urgency of the situation, stating, “In response to these concerns, the PPB, upon investigations, indeed confirmed that the product failed to meet the prescribed market authorization requirements and has initiated a mandatory recall of the product.”
In light of this recall, the PPB has issued a clear directive to pharmaceutical outlets, healthcare facilities, healthcare professionals, and the general public to immediately cease all further distribution, sale, issuance, or use of Tamedol oral solution.
“Instructed to return the products to their respective suppliers, we encourage the public to remain vigilant at all times and promptly report any suspected cases of sub-standard medicines or adverse drug reactions to the nearest healthcare facility or the Pharmacy and Poisons Board,” the PPB added.
This recall comes after the PPB’s previous action earlier this year when they withdrew Betamethasone Dipropionate, a cream used to treat certain skin conditions, from the market due to potential corrosion issues with a component used during manufacturing.
Furthermore, last year, the PPB recalled 11 different products for various reasons, including discolouration, signs of moulding, fragmented tablets, and crumbled capsules.
The recall of pharmaceutical products underscores the critical importance of safety and quality control in the healthcare sector.
Medications may be recalled for a multitude of reasons, including concerns related to safety, mislabelling, contamination, and variations in strength or potency.
In parallel news, medical professionals in Kenya have once again raised alarms about the state of the country’s healthcare system.
In a peaceful demonstration held in Nairobi on Tuesday, September 12, the Kenya Medical Practitioners Pharmacists Dentists Union (KMPDU) voiced their collective concerns, demanding immediate action to address pressing issues that continue to plague the healthcare sector.
Led by the union’s Secretary-General, Davji Bhimji Atellah, the doctors highlighted challenges such as severe shortages of human resources, inadequate availability of essential drugs, and chronic shortages of medical supplies in both public hospitals.
“We are particularly concerned about the severe shortage of human resources, inadequate availability of essential drugs, and a chronic shortage of medical supplies in public hospitals.
“These challenges have significantly compromised the ability of our overburdened and demotivated healthcare professionals to deliver effective and timely medical services to the citizens of our nation,” Atellah said.
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