Rudolf Gaiseb
Pharmaceutical giant Fabupharm, which had been manufacturing medicines without a valid licence for over a year, has come out guns blazing, denouncing allegations that its children’s paracetamol syrup is of inferior quality and life-threatening.
The Namibia Medicines Regulatory Council (NMRC) Registrar of Medicines Fransina Nambahu recently issued a statement.
“Fabupharm Namibia (Pty) Ltd, a pharmaceutical manufacturing company, has been in breach of Regulation 35 of the Medicines and Related Substances Control Act 13 of 2003. Fabupharm Namibia (Pty) Ltd has been manufacturing medicines without a valid licence since January 2024,” said Nambahu.
“To this effect, Fabupharm has to immediately stop production and manufacturing of pharmaceuticals and all products that require a manufacturing licence(s),” she stated.
The instruction remains valid until Fabupharm puts its house in order.
However, Fabupharm last week wrote that a verification and review of the syrup by two independent, duly certified laboratories unsubstantiated the claims.
It declared that the products meet all applicable safety, quality and regulatory standards.
“Recent media coverage in Namibia has raised concerns about the quality and safety of Fabupharm’s children’s paracetamol syrup. Fabupharm wishes to clarify that these allegations were made without supporting evidence or scientific evaluation,” the company said. This publication last month reported that the NMRC ordered Fabupharm to recall all oral liquid products and suspend manufacturing on the affected production line.
This is until the company fully complies with pharmaceutical safety standards.
The directive followed a routine Good Manufacturing Practices (GMP) inspection, during which serious deficiencies were identified in the company’s oral liquid dosage facility. “The inspection uncovered violations requiring urgent corrective and preventative measures to address lapses in quality and safety protocols,” Nambahu had said.
Fabupharm last week stated that after the media reports, it immediately commenced a comprehensive, independent verification and review of the paracetamol syrup by two independent, duly certified laboratories to test the unsubstantiated claims.
“Fabupharm is pleased to report that the first of the laboratory reviews has now become available, confirming that the products meet all applicable safety, quality and regulatory standards,” it said.
The pharmaceutical company said it awaits the review by the second independent third-party laboratory and expects these results to be no different.
“Both internal and [Quality Surveillance Laboratory] QSL testing confirm the children’s paracetamol syrup to be perfectly within international standards and specifications, results supported by the independent testing results,” the statement read.