THE Medicines Control Authority of Zimbabwe (MCAZ) warns the public not to acquire yet consume a fake and substandard version of Flumed found being sold in some Harare and Chivhu pharmacies.
By Kuda Pembere
This is part of its efforts of safeguarding the safety and efficacy of medicinal products for public and animal health.
“This Medicinal Product Alert relates to one falsified version of Flumed ® (Paracetamol/ Phenylephrine Hydrochloride/ Dextromethorphan Hydrobromide/ Chlorpheniramine Maleate) Syrup circulating in Harare and Chivhu, presented under the name Flumed ® Syrup manufactured by Varichem Pharmaceuticals,” said MCAZ Head of Licensing & Enforcement Division Mr Richard Rukwata. “Varichem Pharmaceuticals has confirmed that they did not manufacture this falsified version. The variable details on the product label do not correspond to the genuine manufacturing records. There are labelling and packaging inconsistencies. A certificate of analysis for the falsified product showed that the active ingredients are at sub-therapeutic levels.”
The Authority’s spokesperson said. regarding this Flumed, investigations are still underway to determine full acts but felt it wise to issue this preliminary statement after a complaint.
“The MCAZ was informed through the police as part of an ongoing investigation that falsified Flumed ® Syrup was sold in a pharmacy in Harare. At this stage, several investigations have been done, and it is strongly suspected that the falsified Flumed ® syrup is substandard, Mr Rukwata said. “We however think the distribution was limited to a few pharmacies.”
Mr Rukwata urged the public to take note of these features to distinguish authenticity.
“The bottle is smaller than the original Varichem Pharmaceuticals for Flumed ® Syrup. The original product and the falsified product have the same batch number but different expiry dates. The falsified product was allocated a batch number similar to original products which expired in 2018, he said.
Mr Rukwata added that falsified products are reported to the MCAZ through as regulatory complaints from customers, or as a product problem/defect.
“MCAZ requests increased vigilance within the supply chains of cities likely to be affected by these falsified medical products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products,” he said.
He urged the public not to take this product.
“If you are in possession of the above mentioned falsified product, please do not consume this product. If you have taken these falsified medical products, or if you suffer an adverse event or an unexpected lack of efficacy, please seek immediate advice from a qualified health professional, and ensure they report the incident to the MCAZ.
“All medical products must be obtained from authentic and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.
“If you have any information concerning the manufacture, distribution, or supply of this medical product please contact email@example.com,” Mr Rukwata said.
As It Intercepts Medical Contraband
Meanwhile, MCAZ in collaboration with the Zimbabwe Republic Police (ZRP) & Zimbabwe Revenue Authority (ZIMRA) intercepted a haulage truck smuggling unregistered medicines and other contraband through the Mukumbura Border Post in Kanyemba.
“Driver & accomplices have since been arrested, investigations are ongoing.
Sale of unapproved medicines is illegal.
“Members of the public are urged to buy approved medicines from approved sources.
“MCAZ, Protecting your right to good quality medicines and medical devices,” said the Authority.
A World Health Organisation report shows Africa alone accounts for 42% of globally detected cases of substandard and fake medical products. The UN Office on Drugs and Crime suggests the penetration of counterfeit pharmaceuticals is much higher in the developing world, reaching 30%, as opposed to less than 1% in the developed world. It is widely accepted that perpetrators of the phenomenon see Africa as a soft target because the continent has weak technical capacity and tools when compared with the West.