Spurious drugs: Gambian report blames Maiden syrups for deaths

Tribune News Service

Bhartesh Singh Thakur

Chandigarh, December 24

On July 7, a 46-month-old child was brought to the Emergency Paediatric Unit (EPU) of Edward Francis Small Teaching Hospital, Banjul (Gambia), with fever and vomiting for four days, and was on oral medications, including ampicillin, metronidazole and paracetamol. Two days post-ingestion, her mother noticed that the child was no longer able to pass urine as the diaper was dry. By the end of July, the number swelled to 21 at the EPU with similar symptoms. Overall, acute kidney injury (AKI) killed 70 kids in Gambia.

The Select Committee on Health of the National Assembly of Gambia, tasked with looking into the causes and impact of the AKI, in its report, dated December 20, has concluded that “all cases of the AKI were linked to the consumption of the contaminated medical products imported by Atlantic Pharmaceuticals and manufactured by Maiden Pharmaceutical Ltd, India”.

Maiden Pharmaceuticals is based in Sonepat, Haryana.

The committee recommended the Medicines Control Agency (MCA), Gambia, “to blacklist Maiden Pharmaceuticals products and ban all their products in the Gambian market”. It added that the government should pursue “legal action against Maiden Pharmaceuticals for exporting contaminated drugs to Gambia”.

Atlantic told the committee that contaminated products had come with a certificate of analysis (COA) and added that efforts were made to contact Maiden Pharmaceuticals, “but they have not been answering their emails and calls”. Of the 10 syrups collected by the Gambian health ministry, six came out to be perfect and only four manufactured by Maiden Pharma were contaminated.

Prof Mahama Duwiejua and Prof Noel Wannang from the West African Postgraduate College of Pharmacy (WAPCP), who met all stakeholders, told the committee, “It is a quality assurance failure on the part of the manufacturer. All raw material for production on arrival in a factory is quarantined and released only when quality control certifies the material as having met the required standards. Sampling is carried out at every stage of the production process for quality control till the final product. The final product is certified again with a label indicating contents and quantities. It is obvious this was not done for the contaminated products. The manufacturer did not follow good manufacturing practice (GMP).”

Prof Muoneke Vivian Uzoamaka, Professor of Paediatrics and Postgraduate Medical Trainer, told the committee the same pattern of not being able to pass urine was observed in all admitted 66 cases of the AKI.

Dr Abubacarr Jagne, consultant nephrologist, told the committee that the lab results of the organ functions of children showed very high levels of creatinine, liver enzymes and uric acid that was unusual for children mostly under two years. He said the autopsy results of two of them showed multi-organ failure and fatty necrosis explaining that there was a toxin that was causing multi-organ failure.

Gambia’s National Public Health Laboratories Sciences and Epidemiology and Disease Control Unit of the Ministry of Health told the committee that clinical samples of patients revealed the presence of E. coli.

Compelling reasons

• Of 10 syrups collected by Gambian health ministry, six were okay but four made by Maiden Pharma were contaminated
• Quality assurance failure on the part of the manufacturer, who did not follow good practices
• High levels of creatinine, liver enzymes & uric acid mentioned in laboratory reports
• Fatty necrosis and organ failure in the autopsy results of two children clearly indicated the presence of a toxin

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