AKI Tragedy Exposed: How Indian drugs claim lives of over 70 children in The Gambia
Concerns remain even after the release of the presidential task force report on the acute kidney injury outbreak that claimed the lives of more than 70 children. The report has seemingly been left to gather dust. Thousands of the banned and contaminated India drugs are still unaccounted for. More contaminated drugs have been discovered. The pharmaceutical industry, marked by entrenched conflict of interest, greed and systematic violation of healthcare laws, continues its tragic norm within the medicines regulatory system. To date, no one has been fully held accountable for the tragedy.
December 31. This time last year, when the night sky exploded with bursts of fireworks as jubilant crowds swelled the streets, welcoming the dawn of a new year, Lamin Darboe was lost in a reality so distant from the atmosphere that filled the air.
Overwhelmed with distress, he sat by his 4-year-old daughter, Isatou, whose small, frail body lay stretched on a hospital bed at the Edward Francis Small Teaching Hospital, in Banjul.
“I started crying when the doctor told me that she has a kidney problem. This kidney issue was already in the news. I had given up on her from there,” he told Malagen.
With a scary reputation of 85% death rate, the kind of acute kidney injury that has been afflicting children in The Gambia is no ordinary kidney disease. Autopsy reports and several other investigations indicate that not just the kidney gets affected. Multiple organs - lungs, liver, brain and chest - suffer damage, leading almost inevitably to death. On average, within nine days.
“You could see the panic on the faces of parents as soon as you tell them that this kid has a kidney problem,” said Abubacarr Dr Jagne, a kidney specialist and deputy chief medical director at the EFSTH.
Before little Isatou’s ordeal, 70 children died in six months, 83% aged two years or younger. Lamin could only wish for a miracle for his daughter. On the brink of midnight, he went out to pray. Unfortunately, no miracle was on the cards.
“When I came back from my prayers, I held her hands and continued to pray for her. She was not improving,” he said.
At 1:54 a.m, barely two hours into the New Year, Isatou passed.
“My wife can’t bear to even look at her clothes now. Once she came across one of her shirts and broke down,” he added.
Lamin himself collapsed into tears at this point. The pain in his eyes stemmed not solely from the death of his only daughter or her suffering in her final moments.
Like many other victims, he believes that the acute kidney injury outbreak, which struck The Gambia in the middle of last year, could have been prevented if those in charge had been a little less greedy and more truthful.
“When my son Ousman got sick in January, I cried because I did not know where to take him,” he said. “I took my Isatou to the hospital and she was killed by the drugs I bought to save her life.
"So, I used herbs to treat Ousman’s fever. I have lost faith in our health facilities. This is not just me. People are losing faith in our health system," he added
The AKI outbreak is blamed on four India-made contaminated cough and cold syrup medicines imported into the country. The circumstances of the importation did not apparently follow the legally established procedure.
The drugs - Promethazine Oral Solution BP, Kofexmalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and Magrip N Cold Syrup - were made by Maiden Pharmaceuticals, notorious for making substandard medicines.
The drugs - Promethazine Oral Solution BP, Kofexmalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and Magrip N Cold Syrup - were made by Maiden Pharmaceuticals, notorious for making substandard medicines.
The incident had once again put the country’s healthcare sector into sharp focus. The sector has in recent years been grappled with revelations of pervasive and systematic corruption. The AKI outbreak – and how it has been handled - seem to reinforce those concerns.
The first case of AKI could be traced to June last year. But while the ministry of health embraced false leads, made attempts at coverups, implemented half measures, and entertained misinformation campaigns by its officials, the death toll continued to rise.
"In the beginning, they did not believe us. They said it is not drugs. We had a lot of back and forth…," a senior doctor told Malagen.
Prof Muoneke Uzoamaka Vivian, the head of department of EFSTH paediatrics unit told the presidential task force investigators 'we had, as early as [July, 2022], suspected and associated [AKI with the intake of certain oral medicines…despite this declaration of E.coli being the cause.’
After more than eight months of investigations, Malagen has uncovered how a litany of systems failures, greed and conflicts of interest appear to have played a major role in the AKI tragedy.
At the centre of it are senior government officials, high-level pharmacists, and businesspeople who, even one year after the tragedy, have not only escaped accountability, largely, but have persisted in the practices that resulted in the tragic deaths of over 70 children.
How the floodgates opened for deadly drugs
The Medicines Control Agency (MCA) is a semi-autonomous body created by the government to regulate, among others, the importation of medical products.
The Medicines and Related Products Act, 2014 mandates the Agency to subject every medicine intended for import to 'registration', a process where 'sufficient information about safety and efficacy of the medicines are provided'.
However, the regulatory agency is run by officials who either own pharmacies or are in business partnership with pharmacy owners. Steeped in this conflict of interest, the officials created a diluted system known as Listing.
The introduction of the Listing system, queried by many experts as illegal and ineffective, seems to have opened a floodgates for substandard and contaminated drugs.
For example, Maiden Pharmaceuticals, the manufacturer of the four drugs that ‘directly caused’ the outbreak of AKI has a history of producing contaminated drugs.
The facts that are a Google away.
But with the Listing system where the regulatory agency requires the importers to provide the most basic requirements - information about supplier and information medicines - neither the businesspeople, pharmacists nor the regulator seemed concerned about conducting any due diligence.
When Indian regulators raided the offices of the Maiden pharmaceuticals factory in early October, 2022, following the AKI outbreak in The Gambia, serious questions were raised regarding quality control issues and manufacturing practices.
The Indian regulatory body reported that Maiden has lied about manufacturing and expiry dates of their products.
“The firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question,” the Indian regulators said in their findings.
The company was ordered to shut down operations.
But this order came too late for The Gambia. The drugs arrived in the country on June 14, 2022, and left the port on June 21. Six days later, AKI claimed its first victim. In four months, the death toll surged to more than 70.
More than one year year on, AKI remains alive and threatening. Thousands of bottles of the banned and contaminated drugs still unaccounted for, posing risks to unsuspecting individuals.
In October last year, four months into the outbreak, the MCA sent letters to all importers of medical products, requesting registration of all medicines by the end of the year.
However, by this point, the damage had already been done. At that time, only 905 (later increased to 1,034 as of Oct.2023) out of over 5000 medicines in circulation had been registered.
And it was not until this month, when the MCA finally announced a ban on the use of medicines produced by Maiden
The dangerous conflict of interest
India’s Maiden Pharmaceuticals’ deadly cold and cough syrups were imported into the country by Atlantic Pharmaceuticals.
Registration details show the company was incorporated in 2019. It is owned by Ali Shuman who holds 60% shares and Haidar Chouman holds 40%.
To operate a pharmacy in The Gambia, per the law, one needs the backing of a certified pharmacist. This arrangement has a window for abuse. Pharmacy licence holders, many of whom hold senior positions in the government healthcare and regulatory offices, exploit the system for financial gain.
Several pharmacists told Malagen that a supervising pharmacist can earn between D60,000 and D100,000 monthly for lending their import licence, while the use of a retail licence can attract a monthly fee ranging from D30,000 to D35,000. Each pharmacist typically holds three licences: one for import and two for retail.
Atlantic Pharmacy imports using a licence owned by Sait Kebbeh, who works as a consultant for the National Aids Secretariat, a state-run office responsible for coordinating the national HIV/AIDS response. Sait gets an yearly payment of over D1m for the use of his licence, according to documents seen by Malagen.
As licence holder, by law, he is responsible for overseeing the pharmacy. But while many pharmacists are happy to pocket money from the use of their license, they do not fulfil the duties of supervision.
Sait wasn’t in town at the time of the outbreak. As he left for his master’s in Ghana, he wrote to the Pharmacy Council and MCA on January 18, 2022, informing them that Tijan Jallow would be supervising Atlantic Pharmacy.
Tijan though is employed full-time at the regulatory body, MCA, where he works as drug analyst. Besides, by Pharmacy Council regulations, each licence holder can supervise only one importer and two retail pharmacies. Tijan was already supervising one importer, and owns a pharmacy.
Even though Sait had told state investigators that he oversaw the importation of the contaminated drugs, the import documents bear Tijan’s signature.
Evidently torn between his employer, the MCA and Atlantic Pharmacy in the face of the outbreak, Tijan grappled with a crisis of loyalty, and he seemed to have picked the side of the company.
“Out of the 70 kids that died, some of them died without taking any medication,” he said in one of his many media appearances.
Before that, Malagen has learnt that he had shared a 5-page document with a Gambian social media influencer, which states that “about 40% of the kids who died from AKI took no medication, and another 20% died taking other branded medicines from Europe, Asia, and Africa.”
These claims were found to be unfounded.
Yet, knowing Tijan’s involvement with Atlantic, and his misleading claims in defence of the company he supervises, the Ministry of Health chose to include him in the task force collecting evidence for the causality assessment, a scientific inquiry into the outbreak.
Tijan’s case - as a regulator, pharmacy owner, supervising pharmacist, and now, investigator of alleged crimes committed by one of the pharmacies he supervises - is not an isolated one.
The Gambia’s pharmaceutical industry, controlled by a small community of businesspeople in connivance with pharmacists who are on the payroll of taxpayers, is engrossed in such ‘dangerous conflict of interest’.
“We are supervising pharmacists. We work in partnership with [businesspeople]. You are the financiers. I am the one with a technical know-how. Then we partner,” Fatoumatta Jah-Sowe, the embattled former deputy executive director of MCA, had told a press conference in the wake of the outbreak.
As openly acknowledged by Mrs. Sowe, regulators and policy makers of the healthcare sector are actively involved in the market: importing and retailing of medicines and medical products.
The unmistaken result of the conflict of interest is that the rules that ‘provide safeguards on safety and efficacy of medicines’ are often bent or relaxed, and even then, they’re not effectively enforced.
For example, by Pharmacy Council regulations, supervising pharmacists are required to spend at least 10 hours of supervising per day, with two hours allocated to an importer and four hours with a retailer. Each pharmacist is allowed to supervise only one importer and two retailers.
However, Malagen’s investigation has uncovered widespread and systematic violations of the regulation. Not only do pharmacists exceed the stipulated limit, but many barely supervise at all.
At least half a dozen pharmacists interviewed by state investigators admitted that they do not spend the stipulated time at the pharmacies they supervise. Only few said they have time to visit the pharmacies weekends, while some claim they do their supervision remotely.
"The supervisors are involved in what you can call ticking the box,” a board member of MCA told Malagen. “The regulations and the law are not followed. We are playing with fire because unchecked conflict of interest is dangerous. It is practically impossible to supervise an import and 2 retail pharmacies and at the same time keep a full time job.”
The Ministry of Health was aware of the conflict of interest, and had been warned about the potential dangers to ‘public safety and well-being’ at least one year before the outbreak.
Precisely, in August 2021, the Gambia Competition and Consumer Protection Commission sent a policy notice and investigation report to the ministry of health, warning them to address the issue of conflict of interest in the pharmaceutical industry ‘first major step to rebuild trust’ in the MCA, and protect public health and safety.
It was not until September 2022, about 3 months into the AKI outbreak that the ministry of health wrote to the MCA, asking the agency to address the conflict of interest concerns raised by the consumer watchdog 14 months earlier.
More poisons on the shelves
With the relaxed and manipulated regulatory environment, the Indian drugs that claimed the lives of over 70 children are not the only contaminated medicines that have been circulating in the market.
Prompted by the AKI outbreak, the Medicine Control Agency had put in place a drug testing regime, between October and December of last year. This operation uncovered at least one batch of two syrups: Cambodia-made CARBOTOUX Adult Syrup and Pakistani-made KOF RELIEF Syrup, both contaminated with Ethylene and Diethylene Glycol.
It is not clear who imported it and in what quantity.
However, it took the Agency at least four months, until February 13, to inform importers about it.
Has the AKI outbreak affected public confidence in the heath system? Malagen goes out to find out
Has the AKI outbreak affected public confidence in the heath system? Malagen goes out to find out
“Although extensive efforts have been made to remove the above products from the market, it is likely that some quantities are still available on the market, including in private clinics, hospitals and other pharmaceutical premises,” the agency said in a letter to the importers.
This information has not been made public, and no recall notification was publicly issued, leaving the public at risk of consuming the medicines.
Continued tragedy and secrecy
The death toll has risen, but the health authorities are trying to bury recent cases under the rug
Remember Lamin Darboe at the hospital in Banjul. His little Isatou was given promethazine oral solution, one of Maiden’s deadly syrups, by a nurse at the Tanji Community Health Center.
This incident occurred on December 27 of last year, two months after the Ministry of Health had announced a ban and carried out a high-cost operation to recall the contaminated medicines.
“I don’t know how that syrup came to my facility because it is not part of my invoice for the past nine months,” the manager of the clinic, Isatou Suwareh, told Malagen.
The prescription given to Lamin's daughter, Isatou, at the Tanji community health centre
The prescription given to Lamin's daughter, Isatou, at the Tanji community health centre
Lamin paid D300 for the lab test on Isatou at the Tanji community centre, and this is the receipt given to him
Lamin paid D300 for the lab test on Isatou at the Tanji community centre, and this is the receipt given to him
But Isatou would not be the last victim of the Maiden drugs.
Malagen has learned that at least two more children are believed to have ingested the contaminated drugs. The latest case occurred as recently as five months ago - in June 2023, in Basse, where a 15-month-old girl was given one of Maiden’s drugs bought from a nurse at the Basse Health Center, Mamady Manneh, who runs an unregistered pharmacy from his home.
The case which occurred in Nuimi village of Aljamdu, is in dispute. The parents of 11-year-old Omar Daffeh have insisted their son has died of AKI, but the director of health services, Dr Bittaye, has dismissed it as unfounded.
What is clear though is that the Maiden drugs that are publicly known to be contaminated have not all been taken off the shelves. Maiden had over two dozen medical drugs circulating in the market by October last year.
In December last year, the Ministry of Health had announced that they had recovered over 42,000 bottles of the lethal syrups, leaving over 7000 bottles unaccounted for.
In Isatou’s case, as in the case of the 15-year-old girl, not only have the health authorities treated them with secrecy, but also no one has been held accountable.
The nurse in Tanji continues to report to work even though authorities had said that both were fired, and that the matters were ‘investigated and reported to the police for further action.’
Concerns remain after task force investigation
The outbreak of AKI has triggered an inquiry by a task force set up by President Adama Barrow. After a two-month investigation, the task force submitted its report in April of this year.
The presidential task force has affirmed that the death of the children ‘is a direct result of contaminated medicines found by the cough syrups imported by Atlantic Pharmacy from Maiden Pharmaceuticals in India.’
This conclusion has put to rest any debate about the cause of the outbreak, including the idea that AKI was caused by E-coli as insinuated by the officials of the ministry of health.
The inquiry said it was illegal on the part of the Medicines Control Agency to replace the legally-sanctioned registration system with listing. Registration, it says, ‘is a fundamental legal requirement for importation of medicines’.
“The executive director [Markieu Janneh Kaira] and deputy executive director [Fatoumatta Jah Sowe] should be held responsible,” the task force recommends, indicting them for neglecting and disobeying the law.
Mrs. Kaira has since been removed. Mrs. Sowe, who was due to retire, did not wait to be fired.
However, six months on, both have yet to face prosecution over the deaths of the children despite the recommendation of the presidential task force.
Moreover, concerns raised by the presidential task force regarding the ‘dangerous conflict of interest’ in the pharmaceutical industry which allowed tragedies like the AKI outbreak have persisted
Essa Marenah is among the senior-ranking MCA officials implicated in the AKI investigations. With Markieu removed, he has been promoted to head the MCA, and he continues to serve as a supervising pharmacist. He’s also the board chair of the Pharmacy Council.
Tijan Jallow, the MCA drug analyst under whose watch Atlantic Pharmacy imported the contaminated medicines, has also escaped any accountability.
As for Sait Kebbeh, the supervising pharmacist for Atlantic Pharmacy, the task force has recommended that his case be referred to the Pharmacy Council for ‘appropriate disciplinary action’.
Health Minister Dr Samateh had made a commitment that this would be done. As of October 4, the case has not been referred to the Pharmacy Council.
In fact, the situation with respect to registration has now taken an ironic turn of events.
The chairman of the health committee of the National Assembly, Mr Amadou Camara, last month introduced a private member’s bill to amend the Medicines and Related Products Act.
The amendment would allow medicines imported from countries with a ‘stringent regulatory authority’ to bypass the Gambia’s registration process.
"Stakeholders undergo insufferable measures to register products from certain countries because the manufacturers there prioritise registration in high population nations to ensure early return on investment...," the NAM for Nianija Constituency had told the Assembly when tabling the bill.
Talking to Malagen about his move, he said because the health ministry had failed to initiate amendments to the law as recommended by his committee’s AKI inquiry, he ‘deemed it very necessary to come up with this amendment in order to remedy the current situation of drug importation into the country.’
But multiple sources, including importers and regulatory officials, told Malagen that the amendment was influenced by pharmacy business operators.
The Bill has now been signed into law with the assent of President Adama Barrow on October 10.
“I am aware of the amendments. It was sponsored by the [medicines] importers association,” an importer and pharmacist told Malagen. “We had a series of meetings. We got some advice from lawyers on how to go about it.”
The amendment has raised eyebrows.
“With this Private Member’s bill which removed registration, you are saying Markieu [who has been fired for similar move] is right for listing,” a board member of MCA told Malagen. “There is already a review of the Act which should be ready in the next eight months. The registration part is premised on very sound safety measures.
“With registration, the exporting country would have vouched for the efficacy of the medicine. It is not the cost of registration they are running away from, it is the dossier they are to provide to vouch for the safety and efficacy of the medicine they want to avoid. This includes the batch numbers, the active ingredients and certificate of analysis. They claim the quantities they ordered from these countries are too small for manufacturers to provide certificates of analysis, among others, but this is untrue.”
Meanwhile, after successfully lobbying President Adama Barrow, who allegedly told them, ‘let the status quo remain’, the pharmacy licence holders - many of whom are the regulators - will continue to rent out their licence to businesspeople, a decision which contradicts the position of the presidential task force.
Will the gov't provide justice for the victims?
The Gambia government had been urged to lead the quest for justice for victims of the AKI tragedy, but has so far failed to take any tangible actions, and the victims have apparently run out of patient.
"The Government of The Gambia through the Ministry of Justice should forthwith explore the possibility of instituting legal action against Atlantic Pharmaceuticals, Maiden Pharmaceuticals, and the Government of India to seek redress on behalf of the families of the victims of the AKI outbreak.”
This is one of the 18 recommendations contained in the report of the AKI task force, established by President Adama Barrow, to investigate the outbreak of acute kidney injury.
It wasn’t the first time such a recommendation had been put forward to the government.
In December last year, the Gambia government, through the Gambian High Commission in India, had sought legal advice from an Indian law firm over the damage caused by the India-made syrups.
In a legal opinion seen by Malagen, the firm’s managing partner, Shashank Dewan, has argued that while the Indian manufacturer should be held responsible for ‘breach of duty of care’, the government of India should also be held equally responsible as the certification authority.
“In such cases, adequate compensation is paramount and therefore, a case of criminal nature as well as civil nature must be thoroughly pursued,” he said.
In the view of the Indian law firm, each of the victims should receive compensation accordingly
In the view of the Indian law firm, each of the victims should receive compensation accordingly
However, the Gambia government seems to have a different idea. In November last year, the ministry of health issued a D14,285 cheque as compensation to each of the victims. The offer was declined by a good number of the affected families.
However, the Gambia government seems to have a different idea. In November last year, the ministry of health issued a D14,285 cheque as compensation to each of the victims. The offer was declined by a good number of the affected families.
In July this year, the Health Minister Dr Ahmadou Samateh disclosed at a press conference that the government was ‘benefiting from legal advice from a top-tier international law’ firm to explore potential legal action against Maiden Pharmaceuticals, and their Gambian counterparts, Atlantic, and a redress from the Indian government.
However, he fell short of mentioning the name of the law firm. He also did not clarify whether the legal options being explored include compensation for victims.
Six months on, no announcement about the progress made, if any.
Already dissatisfied with the government’s handling of their plight, the families of the victims had taken matters into their own hands.
Out of 70 affected families, at least 19 have joined the lawsuit filed at the High Court in Banjul in July this year, seeking D15m in compensation for each child who has tragically lost their life to AKI.
“When we read the reports [of the presidential task force], we came to learn that the medicines were imported into the country illegally,” Ebrima Saidy, who lost his 3-year-old daughter, told Malagen.
“All the people involved in the importation process should face the full force of the law,” he added.
At the last hearing in court two weeks ago, on Dec. 18, both the state and defence counsels have confirmed that negotiations are in progress to settle the matter out of courts.
“We have not reached any agreement yet," the lawyer for the victims of the AKI tragedy told the court.
"My lord, just for the record, this settlement outside the court should not bar the court to proceed with the matter,” she however added.
But will that agreement include the government taking legal action against India, Atlantic and Maiden?
That remains to be seen.
Malagen has however confirmed that in November last year - barely four months into the AKI tragedy - the government had started negotiation for at least six loan deals, totalling $357m, with the Indian government.
And in December last year, a few days before the release of the parliamentary inquiry into the AKI, the National Assembly ratified a visa exemption agreement for diplomatic passport holders of the two countries.
Authors: Mustapha K Darboe and Awa Makalo
Editing: Editor
Artwork: T. Keita
This story is part of the OMC Investigative Reporting Fellowship, jointly funded by U.S Embassy in Banjul and Freedom House-The Gambia. None of our funders have any influence over our editorial decisions.
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