A judge in a Gambian court has adjourned until 7 November a trial involving the deaths of 70 children linked to cough syrup made by India’s Maiden Pharmaceuticals.
On Tuesday, Justice Ebrima Jaiteh of the High Court in Banjul adjourned the proceedings after finding that three state defendants who had failed to appear “lacked diligence”.
The children, all aged five and under, died in 2022 after taking over-the-counter medicines, leading to a national outcry in the West African nation, reports EWN.
Nineteen plaintiffs representing relatives who were victims in July filed the suit, according to Salieu Taal, president of The Gambia Bar Association and one of the lawyers representing the plaintiffs.
The families are suing five defendants: Maiden Pharmaceuticals, local distributor Atlantic Pharmaceuticals, the Medical Controls Agency (MCA), the Ministry of Health, and Attorney General Dawda A. Jallow, to demand they admit that the children were killed by consuming contaminated medicines.
They are also suing for an admission that the MCA failed in its statutory duty to regulate the quality and safety of medicines.
They are demanding 15m Dalasis (about $230 000) per child in damages.
None of the five defendants was present on Tuesday.
The Health Ministry, MCA and Attorney-General requested a delay to the start of the trial, a motion the judge dismissed. He ordered the three to pay 10 000 Dalasis to the plaintiffs.
The trial had already been delayed in July after the Attorney-General and Health Ministry claimed they had not been served subpoenas with adequate time to familiarise themselves with the lawsuit.
In September last year, The Gambia ordered a recall of several cough and cold medications, as well as all products manufactured by Maiden Pharmaceuticals, from which the adulterated syrups originated, after the deaths from kidney failure of at least 70 children.
It subsequently banned all products from the firm.
The World Health Organisation (WHO) reports that lab tests found “unacceptable amounts” of diethylene glycol (DG) and ethylene glycol (EG), commonly used as antifreeze, and which can be fatal when ingested.
The toxic impact from these substances includes “acute kidney injury which may lead to death”, the agency has said.
And in East Java, meanwhile, an Indonesian drugmaker whose cough syrup is among products linked to the deaths of more than 200 children last year, used ingredients with toxin concentrations of up to 99% in 70 batches of medicine, prosecutors said in a court filing.
The accusations against drugmaker Afi Farma were made in a court in Kediri, East Java, where the company is based, reports Medscape.
The criminal case comes as efforts grow worldwide to tighten oversight of drug supply chains after a wave of poisonings linked to contaminated cough syrups that killed dozens more children in countries.
Two batches of propylene glycol, a key base for syrupy medicines that Afi Farma received from October 2021 to February 2022 and used in its cough medicine, contained, instead, as much as 96% to 99% of ethylene glycol (EG), a charge sheet in the case showed.
When asked who had carried out the testing and how, prosecutor Ikhsan Nasrulloh told Reuters it was done by police last year.
A lawyer for Afi Farma said no accusation of intentional poisoning had been proved against the company, adding that Indonesia’s drug regulator, BPOM, did not require drugmakers to do a rigorous testing of ingredients.
He said a 2018 BPOM regulation allowed drugmakers to use tests done by raw material suppliers, requiring them only to run “identification tests” that do not stipulate toxicity testing.
BPOM did not immediately respond to a request for comment.
Afi Farma is one of four companies Indonesian police have charged in an investigation into the supply of tainted cough syrups, with a court case set to be heard this month.
The World Health Organisation (WHO) said the safe limit for the known toxins EG and diethylene glycol (DEG) was no more than 0.10%, based on global standards.
Indonesia’s Health Ministry also adopted that limit in its 2020 guidelines on drug standards.
Both EG and DEG can be substituted for propylene glycol by unscrupulous producers as they cost less than half the price, several drug experts said.
Afi Farma's licence to make drugs was revoked late last year and its products taken off the shelves for violating rules on manufacturing.
Four company officials, including the chief executive and the quality control manager, have been arrested and charged with negligence for “consciously” not testing the ingredients, despite having the means and responsibility to do so, the charge sheet shows.
Instead they relied on certificates provided by its supplier regarding product quality and safety.
Now prosecutors are seeking jail terms of up to nine years for the officials.
Afi Farma had denied the accusation.
Domestic drug regulator BPOM has previously said several parties in the drug supply chain had exploited a gap in the safety rules and drugmakers did not run sufficient checks on raw ingredients used.
EWN article – Gambia trial opens over cough children’s syrup deaths (Open access)
See more from MedicalBrief archives:
Gambian families sue Indian company for cough syrup deaths
Another Indian drugmaker linked to toxic cough syrups
Indian firm allegedly used industrial-grade ingredient in toxic cough syrups