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Gambia parents ‘fight for children’ in landmark trial on India syrup deaths | Health

Gambia parents ‘fight for children’ in landmark trial on India syrup deaths | Health

It’s the happy memories of his toddler son playing around their home in The Gambia’s capital that are most painful for Ebrima Sagnia to remember. When he tries to speak, Sagnia pauses mid-sentence, muted by grief.

In September last year, Sagnia watched Lamin writhe in pain on a hospital bed. The four-year-old had developed a fever early that month, which was common in the rainy season. His parents had given him prescribed medication, hoping the high temperature would go away, but Lamin developed new symptoms instead, becoming drowsy and unable to pass urine for days. He was rushed to the hospital, but his symptoms persisted. Despite his discomfort, Lamin just wanted to return to their home in Banjul and play. He loved football and motorcars. When his dad drove, Lamin would sit in his lap and pretend he was the driver.

By mid-September, about a week after his parents took him to the hospital, Lamin had died. Doctors told Sagnia the cause was complications from acute kidney injury (AKI). The condition, a sudden onset of kidney failure, causes swollen limbs, nausea, confusion and reduced urine flow.

Lamin was one of 70 children killed last year by substandard cough syrups imported from India that the World Health Organization (WHO) said contained “unacceptable levels” of toxins. Most of the children were under five, and some were from the same family. The case has underlined the difficulties low-income economies like The Gambia face in sourcing quality medication and implementing local quality controls.

“Every day reminds me of my son, how he kept saying to me, ‘Daddy, take me home. Take me home,’ and I told him I would,” Sagnia said.

Sagnia could not take his son home, but the 44-year-old is now leading a coalition of 19 aggrieved parents who’ve dragged their government and private entities involved in producing and distributing the medicine in The Gambia to court. The parents, Sagnia said, are seeking justice and restitution for what they say were deaths caused by “negligence and breach of statutory duty”. The Gambia’s Ministries of Health and Justice, the drug manufacturer and distributors, and the country’s Medicines Control Agency (MCA) are all listed as defendants.

Court hearings began on July 21. At the second sitting on October 24, none of the government’s representatives showed up, Loubna Farage, a lawyer representing the parents, said, and the court fined them. About nine of the parents chosen to represent the group were present along with their family members who had shown up for support. The group filled the courtroom, their faces long, their demeanor heavy.

At another court hearing on November 7, government lawyers showed up, but representatives of the manufacturer and distributor were missing. The judge was forced to adjourn until late in November.

Three-year-old Lamin Sagnia, who died of acute kidney injury in September 2022, is buried in Old Yundum, The Gambia [Edward McAllister/Reuters]

Deadly doses

The cough syrups in question are four brands, all manufactured by Maiden Pharmaceuticals Ltd, an Indian drugmaker, and imported by The Gambia-based Atlantic Pharmaceuticals Co. On their colourful packaging, the syrups carried a logo saying they were WHO-certified. Officials of the WHO told Al Jazeera the claim was a lie.

All four medicines contained high levels of diethylene glycol (DEG) and ethylene glycol (EG), officials at the WHO and the United States Centers for Disease Control and Prevention (CDC) confirmed. Both are sweet-tasting but deadly substances normally used to manufacture products like brake fluid and windshield wipers.

Mass poisonings like this have more recently been recorded in India, Panama and Nigeria. Several cases in the past document how manufacturers intentionally swap out pharmaceutical-grade propylene glycol (PG), a mildly sweet additive used to improve the solubility of medicines for the similar, much cheaper and fatal DEG and EG.

In a January alert, the WHO said it had recorded 300 child fatalities in 2022 across seven countries, including Indonesia and Uzbekistan, due to contaminated medication. Six deaths have also been recorded in Cameroon this year. It’s the deadliest set of poisonings recorded since 1996.

An Indonesian firm, Afi Farma, manufactured the syrups locally in that country’s case while China’s Fraken Group produced the syrups pulled off shelves in Cameroon. In August, Uzbek authorities began the trials of officials of Marion Biotech, another Indian manufacturer, for reportedly selling contaminated cough syrups believed to have killed 65 children in the Central Asian country.

Health experts are not sure how the poisonings are occurring but believe substances or additives like PG used to stabilise the medications are likely contaminated. WHO officials said they have no evidence the cases are linked.

In The Gambia case, Indian health authorities said the WHO failed to show a direct link between Maiden’s cough syrups and the multiple deaths and accused the UN agency of trying to tarnish the country’s image. Tests by Indian health authorities, the Indian government said, did not reveal contaminants in Maiden’s products. Maiden has also said it did nothing wrong.

But Parsa Bastani, a CDC epidemiologist who led an expert team to assist The Gambia in its investigation, told Al Jazeera the tests conducted left no doubt as to what caused the clusters of AKI deaths.

“I don’t know what evidence the Indian government was reviewing,” Barstani said, “but the evidence we found highly suggested that there was a link.” His team had received a request to investigate from Banjul in late August last year and arrived in The Gambia just as the deaths peaked in mid-September.

“The drug testing showed there were levels of DEG in all the cases and that that led to the deaths,” Bastani said, clarifying that his team had not done a separate test but had analyzed tests done by WHO officials also on ground at the time. “That was a very difficult and sad process to be there and collect information from parents, some of whom had lost their kids within the past week.”

Industry malpractice?

Gambian authorities have flown into a flurry of activity since the tragedy.

In October last year, three months after they started investigating the unusual spike in AKI deaths among children, the country banned Maiden and Atlantic. In June, officials went further, tightening import controls from India. All drug exporters from that country must now present clearance certificates from a designated Indian testing laboratory.

Authorities also fired the head and deputy of the MCA, the entity in charge of certifying and monitoring imported pharmaceuticals, which should have stopped the drugs from going on the market. Children died in six of the country’s seven regions, underlining the spread of the contaminated medicine.

Banjul is also mulling legal action against Maiden and possibly the Indian government, the Reuters news agency reported.

Analysts have also pointed out “unacceptable” lapses in the Ministry of Health itself that might have contributed to the steepness of the death toll.

Although health workers at the Edwards Francis Small Teaching Hospital alerted the ministry about an unusual cluster of deaths in late July 2022, the first public warning to stop selling or using a list of suspected cough syrups did not materialise until September, more than 40 days later.

A review of the timeline of events as well as information from the CDC team and government reports show that the contaminated medicines were imported about June 21 and that AKI deaths peaked in mid-September before tapering off in October.

But there were already suspicions as early as August that the syrups were poisoned.

One parent whose child used the syrup in July and died on August 5 said doctors in Banjul asked him what type of drugs he used and that he had presented the syrup. “One of the doctors told me that they were having these cases and that my son was the fifth case,” Alieu Kijera, an eye nurse, said. Kijera said he was surprised when he continued to hear of many cases after his son, two-year-old Mohamed, died and was shocked to know the medication was still available on shelves in The Gambia at the end of August.

Some children, including Sagnia’s son, used the deadly drugs weeks after the authorities had been officially alerted.

“It’s unacceptable that after having some evidence, even if not confirmed, that the authorities there let it pass for another month,” said Prashant Yadav, a health supply chains scholar and Harvard Medical School lecturer, who has researched pharmaceuticals in Africa for more than a decade.

“Even if it was a wrong call, what would we have lost by preventively taking a product off the market? Safety comes so much higher than anything else,” Yadav said.

The Gambian Health Ministry and the MCA did not respond to Al Jazeera’s requests for comment. In a report by a government task force looking into the deaths, authorities said they “suspected that the AKI could be caused by drug toxicity” after the initial alert in July and that the Health Ministry “decided to ban these drugs even before receiving confirmation from the laboratory testing”.

Hiring people with vested interests in The Gambia’s pharmacy sector may have also contributed to the deadly medicines going on shelves across the country.

While fully employed elsewhere, Gambian pharmacists commonly double as supervisors in private dispensaries, local sources as well as the government task force report confirmed. The practice, referred to in local media as tantamount to “renting out licenses”, presents a potential case of conflict of interests, according to the government report.

While unusual, it is not illegal for pharmacists in the civil service to double as private workers. The law requires that dispensaries wanting to import drugs provide the certificate of a licensed pharmacist to be allowed to ship products in and the pharmacist must provide technical advice to the importer, spending two to four hours a day at the dispensary.

In several cases though, these supervising pharmacists are often full-time government staffers who don’t spend time at the dispensaries. Some even work for the MCA or the Gambian Pharmacy Council, both industry regulators. Some pharmacists also supervise several private dispensaries simultaneously.

At the time of the deaths last year, an MCA official was supervising Atlantic Pharmacy, the entity that imported the contaminated syrups, investigations by Gambian officials showed. The same official, speaking for the agency in the early days of the crisis, had claimed that floodwaters, not the contaminated medicines, caused the mass deaths. The man, who told authorities that another supervising pharmacist with Atlantic had signed off on the drug imports, did not respond to a request for comment.

“It’s not normal,” Yadav, the supply chain scholar, said of the industry practice. But the multiple issues with the response to the deaths underscores a deep-seated issue in The Gambia and other low-income countries like it, he pointed out.

“It’s a country that has a very limited budget and the regulation is very weak,” Yadav said. “In theory, there’s what authorities should be doing, but the practicality is different. Saying that they could have removed those syrups earlier, for example, that’s a matter of financial luxury. So in a way, I also empathise with the ministry because it’s not straightforward.”

From left, twins Adama and Hawa. Their father, Ebrima Saidy, says he has not found a way to tell Hawa that her sister is not coming back home [Courtesy: Ebrima Sandy]

Dependence on imports

The Gambia, which has four public hospitals and 170 registered drug stores for a population of 2.6 million people, has no local drug manufacturers, meaning all of its medicines are imported. The country has no drug testing laboratories to authenticate imports either. To test the syrups, officials sent samples to Senegal, Ghana, France and Switzerland.

Enter India. With about 10,500 drug manufacturers in the country, India is by far the world’s biggest generic medicine maker, cornering a 20 percent share of global production. The country is often referred to as the “pharmacy of the world”.

India provides half of Africa’s generic drugs. Their comparatively low cost makes the country all the more attractive to middle- and low-income countries. As of 2019, at least 90 percent of The Gambia’s pharmaceutical imports came from India.

While it has recorded major successes, India’s pharmaceutical scene is riddled with problems, including substandard production and a chaotic regulation process that often make it unclear who is in charge of what between its many state control agencies and the federal drug control body.

The country itself has recorded five DEG mass poisonings. Experts linked the latest deaths in 2019 in Jammu and Kashmir to a failure of manufacturers to test raw materials as required by law. Twelve children died after their kidneys and other organs stopped functioning.

Researchers have found that some Indian manufacturers produce substandard drugs specifically for export to African markets and to other low-income countries because of lax regulation. The Pharmacy Export Council of India (Pharmexcil), in one document, said Africa is particularly attractive because “market access to these countries is simpler in nature as compared to stringent regulatory authorities of other developed nations.”

The string of recent DEG cases implicating at least two Indian manufacturers spurred authorities to crack down on drug producers with spot checks.

After news of the Gambian deaths emerged, the Indian government confirmed that Maiden was not licensed to sell the syrups in India but was licensed to sell them to the African country. The company is also on a government list of “WHO-GMP-certified” manufacturers, a certification implying it met the WHO’s “good medical practices” standard for exports.

But Maiden had been prosecuted by multiple Indian states in the years leading up to its fatal Gambia exports, mainly for providing substandard products. Top officials in the company were also handed jail sentences in an Indian court in February for exporting substandard drugs to Vietnam almost a decade ago.

India suspended Maiden’s production last year after the deaths in The Gambia. Allegations that a state regulator helped switch the samples Indian health authorities tested in The Gambia case emerged in June. India’s anticorruption agency told reporters those claims are being investigated.

WHO officials told Al Jazeera they’ve ordered Maiden to cease using “WHO-certified” labels, as it did on the syrup bottles. However, Maiden still remains on the Indian government’s WHO-GMP-certified list, meaning it still meets WHO production standards, according to the Indian government.

Hopeful for justice

After the second court hearing in the Gambian parents’ case, Sagnia felt hopeful, he said, even if the fight ahead looked daunting.

He and other parents felt hurt by the no-show from government representatives at that hearing. It made them feel like the case was not important to them, he said, adding, however, that the authorities’ attitude did not surprise him.

“None of the government officials has ever visited us in our homes since this whole thing happened,” Sagnia told Al Jazeera after the court session.“They only called us to meet them in their offices while we lost our children due to their negligence. It might be that the judge rules in our favour if they continue like that.”

The parents, who are spread across the country, have turned inward to find solace. They formed a WhatsApp group, so they can stay in touch about the case, and it has become a therapy platform of sorts with members pitching in when one person needs help, even outside the case. At the moment, Sagnia is trying to get a good doctor to see one member who has suffered a hand injury. “As the group leader, I feel like it is my duty,” he said. “We have all become just like a family.”

Many of the parents are confident of a win. “I believe there is hope for us, inshallah,” Alassan Kamaso said, using a phrase meaning “as God wills”, which is popular in Muslim-majority Gambia. Kamaso’s son, Musa, was 18 months old when he died in September last year.

An unprecedented trial

The mass AKI deaths are on a scale never-before experienced in The Gambia, but the trial too is just as historic, Farage, the lawyer representing the parents, said.

Never before have parents bonded together to go after the authorities in such a manner – an unusually brave stand in a country where the courts have traditionally had little autonomy.

For two decades, The Gambia was under the iron-fisted rule of Yahya Jammeh, who cracked down on dissidents and controlled the judiciary. It was Jammeh’s electoral defeat in 2017 by President Adama Barrow that halted the dictator’s plans to withdraw The Gambia from the International Criminal Court. The ongoing legal case to bring Jammeh to justice, involving dozens of witnesses, is one of the few that legally compare to the syrup deaths case.

“I believe this is why the government does not know how to deal with this matter since there is no precedent,” the lawyer said.

A lack of financial resources, Farage added, also often discourages many Gambians from seeking justice in a country where half the population lives in poverty. The average salary in The Gambia is $68 a month, so paying for legal fees costing about $250 an hour is almost impossible although there are legal aid programmes.

“One needs to understand that poor people have no hope and often feel neglected by the system,” said Farage, whose firm is providing assistance to the 19 parents free of charge. “They do not understand their rights. They do not understand that the government is here to serve the people. They will often be heard to say that God has a reason for their suffering. They are taught to be patient and leave everything in God’s hands.”

Some of the parents of the children killed by the cough syrups are neither influential nor wealthy. Kamaso is unemployed and spent all he had on his son’s treatment, he said. When Sagnia is not working at the bank where he is a chauffeur, he drives a taxi to supplement his income.

Farage said these parents are bent on pushing for regulatory changes to ensure such a tragedy never happens again. They want accountability for the government agencies involved, and they want proper compensation, he said.

Some of them are still angry that last year, when their grief was still fresh, authorities pressed them to take monetary compensation of about $200 even before investigations were concluded.

Ebrima Saidy is one of them. His five-year-old daughter Adama died on September 19. The 23-year-old is currently in Italy, where he is studying the language to prepare for a computer science course, but he has been glued to his phone for updates on the case. His partner remains in The Gambia.

“We want them to dismiss anyone who needs to be dismissed,” he said in a recent call, his papery voice rising over the phone line. Saidy also acts as a spokesperson for the group and said that for many parents, the firing of the MCA head and deputy is not enough. And the money they were offered? It was offensive, he said.

“What is the life of my daughter to 14,200 dalasi?” Saidy asked. The $200 sum, around the same price as 10 bags of rice in The Gambia, seemed the equivalent of hush money, he told Al Jazeera. “We are not here for the money. We want them to tighten their protocols and, if possible, to stop importing from India altogether,” Saidy said.

In addition to Saidy’s grief and loss, there’s the fear that grips him every time he calls home to speak to Adama’s sister, Hawa, who won’t stop asking for a twin she thinks is still coming home.

“She will ask, ‘Is she still at the hospital? Is she still with grandma?” Saidy said. He has not yet found the courage to tell Hawa the truth. “I’ll say, ‘Yes, she is still at the hospital. She is coming,’” he said.

Although at least 70 children were killed, only 19 parents are involved in the lawsuit, Saidy said, because government officials would not release all the names of the affected families so he could contact them. Eight other parents have recently signalled that they want to join the case too, but some parents, he added, have already accepted the compensation money while others have simply given up on getting any justice in a system where malpractice is common.

Not Saidy.

“Some of them said, ‘I leave them to God’ and they left,” Saidy said. “But we said, ‘No, we will fight for our children.’”

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Gambia parents ‘fight for children’ in landmark trial on India syrup deaths | Health

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