By Edward McAllister

DAKAR Families of 20 Gambian children who died after consuming cough syrups made in India will take their government to court this month for allegedly mishandling drug imports – a rare step in one of Africa's poorest countries, where few have the means to challenge authorities.

The parents' allegations and testimony, detailed in court documents shared exclusively with Reuters, paint the most comprehensive picture yet of the panic, confusion and heartbreak caused by the drugs in an already stretched medical system.

From one mother who unwittingly continued to give her child toxic medicine for two days after he started vomiting, to a family forced to repair a leaking intravenous drip that the hospital had attached to their child, the affidavits show parents in desperation as children with originally minor ailments succumbed.

At least 70 children died from acute kidney injury in Gambia last year, cases the World Health Organization (WHO) linked to medicines made by Indian drugmaker Maiden Pharmaceuticals that were contaminated with diethylene glycol (DEG) and ethylene glycol (EG), toxins normally used as industrial solvents and antifreeze agents.

Unscrupulous actors sometimes substitute a key ingredient with DEG and EG because they are cheaper, pharmaceutical experts say. Last year, medicines laced with DEG and EG also allegedly killed about 200 children in Indonesia and Uzbekistan.

India's government has said its own tests showed the syrups were safe, and Maiden, which did not respond to requests for comment for this story, has denied wrongdoing.

Now, as Reuters previously reported, parents of 20 of the children are taking legal steps, seeking about $250,000 in compensation for each child.

Three Gambian lawyers said this is the highest profile case of its kind against the nation's health ministry and the drug regulator, as well as against Maiden itself.

The case shows the risks of importing drugs into countries which – like Gambia – have no means of testing them before consumption. It highlights how, in a globalised economy, tainted medicines can poison people across the world with no clear path to redress for victims.

The first hearing is scheduled for July 17. Then the case will be adjourned for 30 days to allow the defendants to file their response, a court spokesperson said.

The lawsuit, prepared by lawyers working for no fees, argues that authorities failed to uphold their own laws requiring they ensure that all drugs imported into Gambia are safe.

The regulator "did not take...any measures to inspect or test the cough syrups for the adulteration and thereby was in breach of statutory obligations," according to the suit. It adds that the regulator and the health ministry failed to ensure that drugs were prescribed "with the expected standard of care."

Gambia's health ministry did not respond to requests for comment. In a June letter to the parents' lawyers, seen by Reuters, it said it had "initiated a number of steps", including a probe into the incident, which is currently under review.

After the deaths, the World Bank approved funding for Gambia to build a medicines testing lab. An environmental assessment is underway, after which construction will begin, a spokesperson said last month.

FEW OPTIONS

Gambia's health spending is the third lowest of any country measured by the World Bank, at $18.58 per person in 2020, Bank data show.

The parents' testimonies paint a picture of a system powerless to help once the syrups were on the shelves of Gambian pharmacies. Reuters was unable to verify all the details in the statements.

In nearly half the affidavits, parents said they experienced delays in receiving urgent medical attention from a doctor or in getting a diagnosis as their children vomited, stopped urinating, and lost appetite after taking the medicines, according to a Reuters review of the testimony.

One family said a lack of portable oxygen meant their child's treatment was delayed. Another said they had to mend a leaking intravenous drip. A third said their child was discharged from hospital despite not urinating properly for days.

Five took their children to neighbouring Senegal because they thought they had better chances there. But all 20 children died within days of taking the medicine.

One parent, Amie Jammeh, took her 2-year-old son Mafugi Jassey to a pharmacy in mid-August when he developed a fever, she said in her affidavit. A pharmacist prescribed some medicines.

By this stage, the Gambian health ministry had sent samples of the Maiden syrups abroad for testing. But confirmation that they contained deadly toxins did not come until September.

Two hours after taking the first dose, Mafugi began vomiting. His mother continued to give him the drugs for two more days.

When Mafugi did not improve, Jammeh took him to hospital, where she noticed he had stopped urinating. After a brief consultation, she waited three days for a doctor to visit, she said.

By the time the doctor did come, Mafugi was breathing fast and his stomach and limbs were swollen. The doctor said Mafugi would need surgery but a blood test was required to determine the boy's blood type.

As they waited for the tests, Mafugi died strapped to his mother's back.

CONFLICTS OF INTEREST

"Gambians, especially poor ones, do not believe they can run up against the government and win. And since most incidents occur in government-run hospitals and clinics, malpractice claims are never pursued," said Loubna Farage, the lead counsel for the parents.

This time is different, because of the scale of the tragedy and the fact that lawyers are working for free, but also because families have told Reuters they are angered by the lack of accountability. Almost one year on, no one in Gambia or India has been penalised for the deaths.

"Many countries in Africa lack a strong regulatory authority," said Jude Nwokike, vice president of the Promoting the Quality of Medicines Program at U.S. Pharmacopeia (USP), a non-profit that helps set drug-making standards globally. "These countries don't have the ability to appropriately assess and approve medicines or monitor the quality of medicines in the market."

The World Health Organization said it was an obvious concern that recent cases of contaminated syrups have been in low and lower-middle income countries with less capacity to test, but said ultimately drug makers are responsible.

"Regardless of a country’s regulatory capacity, it is the producer's responsibility to ensure that medical products they release on to any market are safe," a spokesperson said.

The suit also alleges that Maiden fraudulently said its products were WHO-certified; Maiden did not respond to Reuters on that point.

The suit says there are potential conflicts of interests in Gambia's pharmaceutical trade, because some regulators also hold supervisory roles in the pharmacies they regulate.

The drugs regulator, the Medicines Control Agency, which is part of the health ministry, did not respond to a request for comment for this story. But its executive director, Markieu Janneh Kaira, told Reuters in March that any potential conflict of interest in pharmacy regulation did not affect the Agency's oversight of the industry.

"Conflicts are declared and managed so no conflicted staff conducts any of the regulatory process of the premise being supervised," Kaira said.

(Reporting by Edward McAllister; Additional reporting by Jennifer Rigby in London; Edited by Michele Gershberg and Sara Ledwith)