Following the poisonous medication, at least 70 youngsters passed away. In a nation where authorities are used to facing legal challenges, their parents are suing the manufacturer and the Gambian government.
For Ebrima Sagnia, the most agonizing memories are of his small son playing about their capital city house in The Gambia. Sagnia, speechless with sadness, stops him midsentence as he attempts to speak.
Sagnia had seen Lamin writhing in agony on a hospital bed back in September of previous year. The four-year-old had experienced a typical rainy-season fever early in the month. Lamin’s parents had given him medication in the hopes that the fever would go down, but instead of that, he started to experience other symptoms, such fatigue and being unable to urinate for many days. Despite being transported to the hospital, his symptoms did not go away. Lamin was uncomfortable, but all he wanted was to go back to their Banjul house and play. He was an automobile and football fan. Lamin used to sit on his dad’s knee and act like he was the driver.
Lamin passed away by mid-September, around one week after his parents had brought him to the hospital. Sagnia’s doctors informed her that complications from acute kidney injury (AKI) were the cause. This illness, which is an abrupt start of renal failure, results in decreased urine output, swelling extremities, nausea, and disorientation.
Lamin was one of the 70 kids who died last year as a result of poor quality cough syrups that were imported from India and were found to have “unacceptable levels” of chemicals, according to the World Health Organization (WHO). A few of the kids belonged to the same family, and the majority were less than five. The case has highlighted the challenges low-income nations, such as The Gambia, have finding affordable drugs and putting in place local quality standards.
“Every day brings back memories of my kid and his constant requests for me to take him home, Daddy. I replied, “Take me home,” to him, Sagnia remarked.
Although Sagnia was unable to bring his kid home, the 44-year-old is now heading a group of 19 angry parents who have taken their government and private companies responsible for making and selling the medication in The Gambia to court. According to Sagnia, the parents are demanding compensation and justice for what they claim were fatalities brought on by “negligence and breach of statutory duty.” Defendants include the medicine producer and distributors, the Ministry of Health and Justice of The Gambia, and the Medicines Control Agency (MCA) of the nation.
The first court dates were July 21. Attorney Loubna Farage, who is defending the parents, stated that the court penalized them since none of the government’s officials appeared at the second hearing on October 24. Along with their family members who had come to provide support were about nine of the parents who had been selected to represent the group. With their extended features and solemn demeanor, the throng occupied the entire courtroom.
On November 7, government attorneys appeared in court again, but the distributor and manufacturer’s representatives were not present. It was necessary for the judge to postpone until late November.
There are four different types of cough syrup in issue that are imported by Atlantic Pharmaceuticals Co., a company located in The Gambia, and produced by Indian pharmaceutical Maiden Pharmaceuticals Ltd. The syrups had a WHO-certified emblem on their eye-catching packaging. Al Jazeera was informed by WHO officials that the report was untrue.
Officials from the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) verified that all four medications have significant concentrations of ethylene glycol (EG) and diethylene glycol (DEG). Both are lethal, sweet-tasting chemicals that are typically used to make windshield wipers and brake fluid.
Similar mass poisonings have lately been reported in Nigeria, India, and Panama. Manufacturers have been known to purposefully replace pharmaceutical-grade propylene glycol (PG), a somewhat sweet ingredient that helps make medications more soluble, with the far less expensive and lethal DEG and EG in a number of previous occurrences.
The World Health Organization (WHO) announced in January that it has documented 300 pediatric deaths in 2022 from tainted medicine in seven nations, including Uzbekistan and Indonesia. This year, Cameroon has also reported six deaths. Since 1996, this group of poisonings has been the deadliest on record.
In the instance of Indonesia, the syrups were created locally by Afi Farma, a company based there, whereas the syrups that were taken off the shelves in Cameroon were made by the Chinese company Fraken Group. Officials at Marion Biotech, another Indian firm, were put on trial in August by Uzbek authorities for allegedly distributing tainted cough syrups that are thought to have killed 65 children in the Central Asian nation.
Although medical professionals are unsure of the exact cause of the poisonings, they suspect that PG or other chemicals used to stabilize the drugs may be tainted. WHO representatives stated that they do not have any proof linking the incidents.
In the instance of The Gambia, Indian health officials said the WHO was attempting to damage the country’s reputation as it was unable to provide evidence linking Maiden’s cough syrups to the numerous deaths. According to the Indian government, tests conducted by health officials in India did not find any pollutants in Maiden’s goods. Maiden added that it done nothing improper.
However, Parsa Bastani, a CDC epidemiologist who oversaw a knowledgeable team that helped The Gambia with its inquiry, told Al Jazeera that the results of the testing were unambiguous on the source of the AKI mortality clusters.
Barstani stated, “The evidence we found strongly suggested that there was a link, but I’m not sure what evidence the Indian government was reviewing.” His team traveled to The Gambia in mid-September, right before the death toll surged, having been asked by Banjul to look into the matter in late August of last year.
“The drug testing revealed levels of DEG in all the cases and that that caused the deaths,” Bastani stated, emphasizing that his team had examined tests carried out by WHO personnel who were also present at the time rather than conducting a separate test. Being there and getting information from parents—some of whom had lost their children within the previous week—was a really trying and depressing procedure.
Malpractice in the industry?
Following the catastrophe, Gambian officials have been extremely busy.
The nation outlawed Maiden and Atlantic in October of last year, three months after authorities began looking into the strange rise in AKI mortality among youngsters. Officials tightened import restrictions from India in June, going one step further. It is now mandatory for all pharma exporters from that nation to provide clearance certificates from an approved Indian testing facility.
The MCA, which is in charge of approving and overseeing imported medications, was also sacked by the authorities, along with its deputy. This action should have prevented the pills from entering the market. Six of the seven areas of the nation had child deaths, highlighting the spread of the tainted medication.
According to the Reuters news agency, Banjul is also considering suing Maiden and maybe the Indian government.
Analysts have also identified “unacceptable” shortcomings in the Ministry of Health, which may have played a role in the death toll’s steepness.
The government was notified by medical staff at the Edwards Francis Small Teaching Hospital about an odd cluster of deaths in late July 2022, but it wasn’t until September—more than 40 days later—that the public was given the first warning to cease using or selling a list of suspected cough syrups.
The tainted medications were imported around June 21, according to information from the CDC team and official records, and the number of AKI deaths peaked in mid-September before declining in October, according to an analysis of the timing of events.
However, there were already rumors in August that the syrups were tainted.
According to a father whose child used the syrup in July and passed away on August 5, medical professionals in Banjul inquired about the kind of medications the youngster used and the syrup he had provided. The eye nurse Alieu Kijera stated, “One of the doctors told me that they were having these cases and that my son was the fifth case.” After his son Mohamed, then two years old, passed away, Kijera claimed he was stunned to learn that the drug was still on the shelves in The Gambia at the end of August. He was also surprised to hear of other cases after Mohamed’s death.
The lethal medications were taken by a few kids, including Sagnia’s son, weeks after the authorities were formally informed.
“It’s unacceptable that the authorities there let it pass for another month after having some evidence, even if it’s not confirmed,” stated Prashant Yadav, a lecturer at Harvard Medical School and a health supply chains expert with over ten years of experience studying medicines in Africa.
“What would we have lost by proactively removing a product from the market, even if it was the incorrect decision? Everything else is so much less important than safety, according to Yadav.
Responses to requests for comment from Al Jazeera were not received by the MCA or the Gambian Health Ministry. Following the initial warning in July, officials “suspected that the AKI could be caused by drug toxicity,” according to a report by a government task group investigating the fatalities. The Health Ministry “decided to ban these drugs even before receiving confirmation from the laboratory testing,” the report stated.
It’s also possible that the lethal medications on the shelves in The Gambia are a result of hiring individuals with strong ties to the country’s pharmaceutical industry.
Local sources and the government task force report indicated that Gambian pharmacists sometimes work double shifts as supervisors in private dispensaries while being fully employed elsewhere. The government assessment states that the practice, which is described as equivalent to “renting out licenses” in the local media, may give rise to a conflict of interest.
Pharmacists in the federal service are permitted to work as private contractors, despite the fact that this is uncommon. In order to import medications, dispensaries are required by law to present the certificate of a certified pharmacist. The pharmacist must also spend two to four hours a day at the dispensary in order to offer technical guidance to the importer.
However, in a few of instances, these supervising pharmacists are not present at the pharmacies; instead, they are full-time employees of the government. Some even work for the industry regulators, the Gambian Pharmacy Council and the MCA. A few pharmacists manage many private dispensaries at the same time.
According to investigations conducted by Gambian officials, Atlantic Pharmacy, the company that imported the tainted syrups, was being overseen by an MCA officer at the time of the fatalities last year. Speaking on behalf of the organization in the early stages of the disaster, the same official had asserted that the mass fatalities were caused by flooding rather than tainted medications. The individual did not answer a request for comment. He informed investigators that the medicine imports had been approved by another supervisory pharmacist with Atlantic.
Yadav, the supply chain expert, described the industry standard as “not normal.” However, he noted that there are other problems with the way the fatalities were handled, which highlights a long-standing problem in The Gambia and other low-income nations.
“It’s a nation with extremely tight budgets and lax regulations,” Yadav said. Theoretically, authority ought to accomplish certain things, but in practice, things work differently. Claiming that, for instance, they might have eliminated such syrups sooner is an issue of luxury spending. As a result, I can somewhat relate to the ministry because it’s not easy.
reliance on imported goods
With 2.6 million residents, four public hospitals, and 170 licensed pharmacies, The Gambia lacks domestic pharmaceutical producers, hence all of its medications are imported. Additionally, the nation lacks drug testing facilities for verifying imports. Officials sent samples of the syrups to Senegal, Ghana, France, and Switzerland for testing.
Go to India. With 10,500 pharmaceutical companies operating there, India dominates the worldwide market for generic medications, accounting for 20% of total manufacturing. The nation is frequently referred to as the “world pharmacy.”
Half of Africa’s generic medicine supply comes from India. For middle-class and lower-class nations, the country’s relative affordability makes it even more alluring. At least 90% of the pharmaceuticals imported into The Gambia as of 2019 originated in India.
Despite its significant achievements, India’s pharmaceutical industry has several challenges, such as poor manufacturing quality and a disorganized regulatory framework that sometimes makes it difficult to determine who is in charge of what among the country’s numerous state control agencies and the federal drug control agency.
There have been five DEG mass poisonings in the nation. Experts connected manufacturers’ statutory failure to verify raw materials to the most recent killings in Jammu and Kashmir in 2019. After their kidneys and other organs failed, twelve youngsters passed away.
Because of weak regulations, researchers have discovered that certain Indian producers make inferior medications expressly for export to low-income markets in Africa. Africa is particularly appealing, according to a paper from the Pharmacy Export Council of India (Pharmexcil), since “market access to these countries is simpler in nature as compared to stringent regulatory authorities of other developed nations.”
The latest wave of DEG cases that involved at least two Indian manufacturers prompted law enforcement to target drug makers with targeted spot checks.
The Indian authorities verified that Maiden had a permission to sell the syrups to the African nation but not to sell them in India following the announcement of the Gambian deaths. The business is also listed by the government as a manufacturer who has undergone “WHO-GMP certification,” which indicates that it complies with the WHO’s “good medical practices” requirement for exports.
However, Maiden had faced legal action from many Indian states in the years preceding its disastrous shipments to Gambia, primarily for supplying inferior goods. In February, an Indian court sentenced top corporate leaders to prison terms for supplying Vietnam with inferior medications over 10 years prior.
In response to the killings in The Gambia last year, India halted Maiden’s manufacture. In June, there were allegations that a state regulator had assisted in changing the samples that Indian health officials had analyzed in the Gambia case. Reporters were informed by India’s anti-corruption body that the allegations are being looked at.
WHO representatives informed Al Jazeera that Maiden is no longer permitted to use “WHO-certified” labels, such as those found on the syrup bottles. Nonetheless, Maiden is still listed by the Indian government as a WHO-GMP-certified product, indicating that it continues to satisfy WHO manufacturing requirements.
wishing for justice
Sagnia expressed hope during the second court hearing in the Gambian parents’ case, despite the fact that the battle ahead appeared difficult.
The government officials’ absence from the hearing wounded him and other parents. He said that this gave them the impression that the matter was unimportant to them, but he did not find the attitude of the authorities surprising.
Following the court hearing, Sagnia told Al Jazeera, “No government official has ever visited us in our homes since this whole thing happened.””We lost our children as a result of their carelessness, and all they did was summon us to meet at their offices. If they go on like that, the court could decide in our favor.
Dispersed around the nation, the parents have retreated inside in search of comfort. To remain in contact regarding the case, they created a WhatsApp group, and since then, members have been lending a hand when someone needs it—even when it has nothing to do with the case. Sagnia is now attempting to schedule a visit with a reputable physician for a member who has had a hand injury. “I feel like it’s my duty as the group leader,” he stated. “Everyone here has bonded like a family.”
A large number of the parents are sure they will win. Alassan Kamaso stated, “I think there is hope for us, inshallah,” referring to a widely used expression in the Gambia, a country with a majority of Muslims that means “as God wills.” Musa, Kamaso’s kid, passed away in September of last year at the age of eighteen months.
A first-ever trial
Farage, the parents’ attorney, stated that while the mass AKI fatalities are unprecedented in The Gambia, the trial is as historic.
In a nation where courts have historically had limited power, parents have never previously united to take such a daring stance against the government.
Yahya Jammeh ruled The Gambia with an iron grip for twenty years, suppressing opposition and maintaining control over the courts. President Adama Barrow’s electoral victory against Jammeh in 2017 put an end to the dictator’s intentions to remove The Gambia from the International Criminal Court. One of the rare cases that bears legal comparison to the syrup killings case is the continuing court battle involving several witnesses to bring Jammeh to justice.
The attorney remarked, “I think this is why the government does not know how to deal with this matter since there is no precedent.”
In a nation where half of the people live in poverty, Farage said, a lack of financial means frequently deters many Gambians from pursuing justice. Even if there are legal assistance programs, it is nearly impossible to pay for legal costs, which are around $250 per hour, given the average monthly wage of $68 in The Gambia.
“It is important to recognize that impoverished individuals lack hope and frequently experience abandonment by the system,” said Farage, whose company is offering the 19 parents free support. “They’re unaware of their legal rights. They are unaware that the purpose of the government is to serve the people. They frequently claim that there is a purpose for God’s pain in their lives. They are instructed to have patience and to entrust everything to God.
Some of the parents of the kids who died from the cough syrups are not well-off or powerful. According to Kamaso, who is unemployed, he gave his son’s medical care his whole fortune. Sagnia drives a cab to augment his income when he isn’t working as a chauffeur at the bank.
According to Farage, these parents would stop at nothing to guarantee that a catastrophe like this never occurs again. According to him, they demand fair recompense as well as responsibility from the government organizations engaged.
Some of them are still upset that officials forced them to accept monetary compensation of roughly $200 even before investigations were finished last year, when their sorrow was still raw.
Saidy Ebrima is one of them. On September 19, Adama, his five-year-old daughter, passed away. The 23-year-old has been hooked to his phone for case updates even though he is learning Italian to get ready for a computer technology degree. His companion is still in the Gambia.
His papery voice rose across the phone line in a recent conversation, “We want them to dismiss anyone who needs to be dismissed.” Saidy, who serves as the group’s spokeswoman, stated that removing the MCA’s head and deputy is insufficient for many parents. The cash that was extended to them? He said it was insulting.
“How is my daughter doing at 14,200 dalasi?” Sayy enquired. He told Al Jazeera that the $200 amount appeared like hush money, around the same cost as ten sacks of food in The Gambia. “Money is not our motivation. Saidy stated, “We want them to strengthen their regulations and, if feasible, completely cease importing from India.
Apart from his sorrow and loss, Saidy also experiences terror each time he makes a phone call to Adama’s sister, Hawa, who persistently begs for a twin that she believes is still coming home.
“Is she still at the hospital?” she will inquire. Is she and Grandma still together? Says Saidy. He still lacks the guts to be honest with Hawa. “Yes, she is still at the hospital,” I will respond. “She’s coming,” he announced.
Only 19 parents are named in the complaint, despite the fact that at least 70 children were killed, according to Saidy, since government representatives would not provide him access to all the names of the impacted families. In a system where malpractice is rampant, some parents have already taken the compensation money, while others have given up on obtaining any justice. He said that eight more parents have lately indicated that they wish to join the lawsuit as well.
Saidy claimed, “Some of them said, ‘I leave them to God,’ and they went.” “No, we will fight for our children,” we responded.