HOW THE WHO LEAVES POOR COUNTRIES EXPOSED TO DANGEROUS INDIAN DRUGS
Vidya Krishnan, Arshu John
Deadly Indian cough syrups in The Gambia and beyond point to shocking disparities in drug regulation for the world’s rich and poor, with the World Health Organisation failing to protect vulnerable countries.
This story is part of “Pills, Perils, Profits”, a Himal investigative series on Southasian pharmaceutical manufacturing and exports. Reporting for this story was supported by the Pulitzer Center.
EBRIMA SAGNIA had the patient look of a man who had spoken to a lot of journalists. At the age of 45, grief had transformed him, Sagnia said, since he inadvertently poisoned his son, Lamin.
“Just imagine, you give your child a syrup hoping he will get better,” Sagnia said. “Instead you realise you gave him poison from India. And you lose that child.” He adds softly, almost muttering to himself, “I am traumatised.”
Sagnia pulled up an image on his phone showing his son’s grave – a small bump of red earth, and above it a simple black board on a stick, stating the boy’s name and the short span of his life. Lamin Sagnia was born on 2 October 2018 and died on 13 September 2022, less than three weeks from his fourth birthday.
Lamin was one of at least 70 children in The Gambia – all younger than five – to die of acute kidney injuries (AKI) between July and October 2022 after consuming poisonous cough syrups made by an Indian company, Maiden Pharmaceuticals. His father had purchased a syrup from a local pharmacy in Banjul, the country’s capital, when he developed a fever. After consuming it, Lamin stopped urinating. His father rushed him to Edward Francis Small Teaching Hospital, the largest hospital in the country. Lamin died five days later.
“The day I took my boy to the hospital, he was sitting on my lap,” Sagnia recalled. “I told him he will be okay soon, and next week he will be at school, back with his friends. If I had known this…” His words trailed away. “You never recover from it. Not until you die and meet them after death. I will never stop fighting for justice.”
FOR SAGNIA, justice means holding to account those responsible for the deaths of his son and the other children. When the Gambian government, in an attempt to calm public fury over the deaths, announced compensation for the families of each lost child – roughly USD 285 for each life lost – most accepted the money; in one of the world’s poorest countries, few were in a position to decline. But 27 families, Sagnia told me, including his own, refused.
“Money doesn’t matter to us,” Sagnia said. “We want justice. We want to save others from this kind of bad medicine. How did this get into our country? Who tested them?”
The Gambia is the smallest country on mainland Africa, and among the most densely populated. According to 2023 figures from its health ministry, the country has just six major health centres and eight hospitals. It has no local pharmaceutical manufacturers, meaning all of its medicines are imported, and it has no local drug-testing laboratories to check the quality of imported drugs.
After the children started dying, samples of the cough syrups they had consumed had to be sent for testing first to Senegal and Ghana, then to France and Switzerland. Despite doctors immediately raising the alarm over the syrups, it took months for the Gambian government to confirm what they and the families had been saying all along: it was the Indian medicines that had killed them.
After these deaths in The Gambia, other toxic Indian-manufactured syrups resulted in the deaths of 20 children in Uzbekistan and 12 children in Cameroon. Poisonous cough syrups from India were also detected in Micronesia and the Marshall Islands, and numerous people in Sri Lanka reportedly suffered complications after using contaminated Indian-origin eye drops. Sri Lanka also reportedly had two patients die after being administered an Indian-made anaesthetic.
India has long prided itself as the “pharmacy of the poor”, supplying affordable pharmaceuticals to poor nations across the globe. It is the world’s third largest pharmaceutical producer by volume and the single largest producer of generic drugs, supplying over 20 percent of global generics exports. This reportedly includes half of the generic drugs in Africa, and 90 percent of pharmaceutical imports in The Gambia.
Many Southasian countries, too, rely heavily on Indian drugs to sustain their health systems. Nepal and Sri Lanka, the two largest regional buyers of Indian pharmaceuticals, each imported products worth more than USD 200 million in 2023. Even Pakistan, which has restricted trade with India, imported Indian drugs worth more than USD 100 million that year.
The deaths in The Gambia and elsewhere revealed two grave crises in global health. The first is the state of India’s poorly regulated pharmaceutical industry, and how this Indian malaise imperils the health and the lives of people in much of the poor world. The second is the shocking inequality of standards in pharmaceutical manufacturing and trade for the world’s rich and poor countries, exposing profound racial fault-lines within the global health order.
Even now, more than two years later, the deaths of more than a hundred children from consuming toxic Indian-made cough syrups have failed to spur any comprehensive action by Indian or global health authorities. A court in Uzbekistan has sentenced 23 people, including an Indian national, to prison terms in response to the deaths there. In October 2024, a court in The Gambia allowed a group of parents whose children died from the toxic cough syrups, called the AKI Victims’ Association, to sue the country’s health ministry and Medicines Control Agency, rejecting the Gambian government’s efforts to evade liability. The families are also suing Maiden Pharmaceuticals and its local importer, Atlantic Pharmaceuticals.
Yet in India itself, beyond the suspension of Maiden Pharmaceutical’s production and export licences, there has still been no legal action against the company’s executives – including its founder, Naresh Kumar Goel – for producing the toxic syrups. (In February 2023, Goel and another Maiden executive were convicted in a decade-old case for exporting substandard drugs to Vietnam.) An official Indian inquiry into the cough-syrup deaths has yet to make its finding public more than two years after the scandal first broke. Goel has denied any wrongdoing in the cough-syrup deaths.
In the immediate aftermath of the deaths, despite a World Health Organisation (WHO) alert over four cough syrups from Maiden Pharmaceutical, the Indian government also denied responsibility instead of taking strong action. The head of India’s national drug regulator, the Central Drugs Standard Control Organisation (CDSCO), accused the WHO of jumping to conclusions, and wrote to the organisation complaining that the WHO’s “premature conclusion was unfortunately amplified by global media, building a wrong narrative against India’s pharmaceutical products.”
Mansukh Mandaviya, India’s health minister until last year, alleged that the scandal over the deaths was a conspiracy to malign the country’s pharmaceutical industry and also tried to deflect blame. “We tried to find out the cause of death and we found that the child had diarrhoea,” he said. “If a child had diarrhoea, who recommended cough syrup for that child?” Diarrhoea is a symptom of poisoning by diethylene glycol, a toxic solvent detected in the deadly syrups.
In the ensuing months, as scientific reports firmly established that Indian-made syrups had caused the deaths, the Indian government scrambled to respond. In March 2023, it cancelled the licences of 18 pharmaceutical companies and issued legal notices to 26 others. Pertinently, while the manufacturing licence of Marion Biotech, the manufacturer behind the deaths in Uzbekistan, was cancelled, Maiden’s licence remained only suspended. Three Marion employees were arrested. Riemann Labs, linked to the deaths in Cameroon, was also ordered to stop manufacturing following an inspection. In October 2023, the government of the state of Uttar Pradesh, where Marion Biotech located its manufacturing, gave the company permission to resume production of most of its products.
After the deaths, Indian authorities mandated additional quality tests for all cough syrups intended for export before they could be shipped abroad; within months, six percent of the samples supplied by 54 cough-syrup manufacturers had failed the tests. The government also banned certain anti-cold drug combinations for children below four years of age.
A CDSCO report on subsequent tests on more than 2000 cough syrups found that, as of October 2024, 128 products manufactured by 54 companies had been found to be of substandard quality. After the cough-syrup deaths, belatedly, it was revealed that at least four Indian states had raised flags over the quality of Maiden syrups in the preceding decade.
In October 2022, with the deaths in The Gambia still fresh, the drug controller for the Indian state of Haryana, Manmohan Taneja, collected samples of the suspect Maiden syrups for further testing. Eight months later, the Indian government launched an inquiry against Taneja for helping switch the test samples in exchange for a bribe from Maiden Pharmaceuticals. The inquiry remains ongoing; Taneja has denied the allegation and remains in his post. Goel, Maiden’s founder, has denied paying any bribe.
The CDSCO, India’s health ministry and Maiden Pharmaceuticals did not respond to questions for this story.
“It is important to understand that the problem with the Indian drug regulatory framework is not limited to corruption,” the public-health activist Dinesh S Thakur and the lawyer Prashant Reddy T write in their 2022 book The Truth Pill: The Myth of Drug Regulation in India. “There is also the question of poor regulatory design.” Thakur, a former pharma executive, was earlier a key whistleblower in exposing egregious lapses at the Indian pharmaceutical manufacturer Ranbaxy. The problems “range from the lack of regulatory transparency to the absurdly complex distribution of regulatory powers in India,” with local regulatory authorities spread across the country’s many states and union territories plus the CDSCO at the national level.
(The second story in this series will examine the Indian regulatory system.)
It is no surprise, then, that international attention in the wake of the cough-syrup deaths has focused on the failure of India’s drug regulatory system. What has largely evaded public scrutiny is the absence of accountability on the part of global health authorities as well – in particular, the WHO. The organisation assumes the mandate of ensuring equitable global health systems, including access to quality drugs across the world; but, it says, it cannot solve the crisis of unsafe drugs in many of the world’s poorest and most vulnerable countries. As a result, Indian manufacturers are able to take advantage of a global health order in which poor countries are left at the mercy of global exporters.
“The Indian government said that it was on the importing country to ensure quality,” Loubna Farage, a lawyer representing the AKI Victims’ Association, said. “The importing country, Gambia, has said they are not responsible. The WHO is not responsible. Where does this leave the victims’ families?”
For Sagnia, the aftermath of Lamin’s death has revealed that the global health order, including the WHO, does not exist to serve Africa. “Imagine if these were American or European children dying instead of Gambians, there would be action straight away,” he said. “If mass poisoning were happening for decades, and the problem was impacting only developed nations, we’d be looking at a completely different regulatory landscape. But it is happening in Africa.”
DRUG SAFETY is one of global health’s most under-chronicled crises, as the cough-syrup deaths show.
Glycerine is a common ingredient in pharmaceutical syrups, used as a sweetener and to provide a liquid base for non-water-soluble drugs such as paracetamol. But manufacturers sometimes substitute glycerine for cheaper sweet-tasting solvents such as diethylene glycol (DEG) or ethylene glycol (EG) – as was the case with the toxic Indian syrups. This has caused at least a dozen mass poisoning incidents across the world.
The first of these occurred in the United States in 1937 and led to a new law that empowered the country’s Food and Drug Administration (FDA) to regulate drug safety. In South Africa, in 1969, seven people died from consuming a sedative syrup containing DEG. A DEG-laced paracetamol syrup led to the deaths of 47 children in Nigeria in 1990, and similar syrups took the lives of more than 200 children in Bangladesh between 1990 and 1992. Other such incidents occurred in Haiti, Panama and China between 1995 and 2006, and Nigeria saw another mass poisoning in 2008 and 2009.
In 2022, an EG-laced syrup was linked to the deaths of more than 200 children in Indonesia. A WHO probe into contaminated cough syrups identified 20 of them originating from India and Indonesia in 2023. Last year, Nigerian regulators recalled a batch of cough syrups manufactured by the American multinational Johnson and Johnson after discovering high levels of DEG during a routine test. The discovery prompted similar recalls in Kenya, South Africa, Tanzania, Rwanda and Zimbabwe. India itself has had five mass DEG poisoning events – the earliest in 1972, leading to the deaths of 15 children in the state of Tamil Nadu, and the latest in 2019, when 12 children died in Jammu.
When ingested and metabolised, DEG and EG cause damage to numerous organs, with notably severe effects on the kidneys. Victims of DEG and EG poisoning present with acute kidney infection, meaning an abrupt deterioration of kidney function and possible kidney failure. Children are especially vulnerable.
Dr Vivian Uzoamaka Muoneke, a paediatric nephrologist at the Edward Francis Small Teaching Hospital, identified an outbreak of AKI within weeks of the first case of cough-syrup poisoning in The Gambia. That case involved a 46-month-old boy admitted to the hospital on 7 July 2022 with fever and vomiting. As more patients with similar symptoms were rushed to the hospital that month, Dr Muoneke alerted the Gambian health ministry’s Epidemiology and Disease Control Unit about the number of children under the age of five showing symptoms of AKI.
For two months, even as children were dying, the Gambian government did not flag the cough syrups in any public statements. “Initially they denied, then they blamed it on contaminated flood water,” Sagnia, who now chairs the AKI Victims’ Association, recalled. “The area I live in had no flood. It is red earth, all sand everywhere. All the victims live in similar surroundings. They were trying to escape responsibility.”
Eventually, the WHO, the US government’s Centers for Disease Control and Prevention and a Gambian national task force constituted to inquire into the deaths all confirmed that the Indian syrups were at fault. (In August 2023, the WHO also flagged DEG and EG contamination in another batch of Indian-made cough syrups, this time in Iraq.) Even then, the Indian government and sections of the Indian media continued to describe the cough-syrup deaths as “mysterious”.
When the WHO issued an alert regarding the Maiden Pharmaceuticals syrups exported to The Gambia, India’s health ministry effectively put the onus of quality assurance on the importing country. “It is a usual practice that the importing country tests these imported products on quality parameters,” it stated, “and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country.”
A large share of India’s drug exports – some 60 percent of them in 2022–2023 – go to rich, highly regulated markets such as the United States and Europe. To check the quality of medicines entering their jurisdictions, North American and European regulators can and do conduct their own on-site inspections of Indian manufacturing facilities. The FDA has offices in Delhi and Mumbai to ensure the quality of drugs destined for the United States, and also routinely flies in its inspectors. In 2019, the US agency noted that India had the lowest level of acceptable inspection outcomes among all the countries where it conducted checks; only 83 percent of inspected facilities in India passed muster, compared to 90 percent in China and 93 percent in the United States. Last year, the FDA announced that it will be increasing its inspections at Indian manufacturing units.
The poor countries that depend on affordable Indian pharmaceuticals the most, however, do not have the resources to send their own regulators into Indian facilities. They are left to rely on the CDSCO and other Indian authorities to guarantee the quality and safety of the drugs they consume – too often with disastrous consequences.
While the Indian government has introduced additional pre-export tests for cough syrups after the deaths in The Gambia and elsewhere, it does not mandate similar tests for other products. India has long maintained a system of licensing for pharmaceutical exports, with the requirements including a Certificate of Pharmaceutical Product – an international document meant to establish authenticity and quality, issued locally by the CDSCO. The CDSCO also issues certificates of compliance with the WHO’s Good Manufacturing Practices,
which set guidelines for quality and consistency in pharmaceutical production. But none of these serve as sufficient checks in the Indian context. The Gambian government’s investigative task force reported that Maiden Pharmaceuticals had produced a Good Manufacturing Practices certificate issued by the CDSCO – but not for the syrups in question.
INDIA’S CONTINUED FAILURE to bring to justice Maiden Pharmaceuticals and other companies tied to toxic cough syrups is a core part of the global problem, symptomatic of the kind of impunity allowed to drug manufacturers by authorities and regulators in the “pharmacy of the poor”. But the glaring risks for patients in the world’s poorest countries are not entirely a made-in-India problem.
In 2007, after mass poisonings in China and Panama the previous year that were traced back to Chinese manufacturers, the New York Times reported on how, “China’s safety regulations have lagged behind its growing role as low-cost supplier to the world.” The report also showed “how a poorly policed chain of traders in country after country allows counterfeit medicine to contaminate the global market.” Dr Henk Bekedam, then the WHO’s top representative in China – and later its top representative in India – was quoted as saying, “This is really a global problem, and it needs to be handled in a global way.”
Despite recurring cough-syrup poisonings, the WHO has done little to effectively address this global crisis. As Sagnia described it, the deaths in The Gambia were as much the result of the WHO’s failures as India’s.
The absence of a quality-assurance programme for all essential medicines across the world is one of global health’s weakest links. The WHO is aware of the problem: a 2024 WHO factsheet notes that at least one in ten medicines sold in low- and middle-income countries is substandard or falsified. Independent modelling studies estimate that this may mean as many as 285,000 otherwise preventable deaths among children every year from malaria and pneumonia. Moreover, the WHO estimates that low- and middle-income countries spend USD 30.5 billion on substandard and falsified drugs every year, which accounts for some ten percent of all drugs in these countries. A systemic review from 2018, after looking at studies covering over 400,000 drug samples, found the prevalence of substandard and falsified drugs in low- and middle-income countries to be even higher, at more than 13 percent, with an economic burden ranging between USD 10 billion and 200 billion.
In 2012 and 2013, the WHO set up two bodies meant to address this issue: the Member State Mechanism, and the Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. Both systems have so far proven inadequate.
The Global Surveillance and Monitoring System is responsible for receiving reports from WHO member states about substandard or fake drugs, comparing these against other reports to identify any matches, and issuing product alerts. The Member State Mechanism, similarly, calls upon WHO members to report detected occurrences of substandard or falsified drugs, which are then compared against other reports. All matches are passed on to the reporting state and to the Member State Mechanism, which prompts all countries to take appropriate action against substandard or fake products – as happened in the case of the toxic Indian cough syrups.
Effectively, the WHO has created dual processes for the identification of dangerous drugs across the world – but it has done little to hold countries accountable for upholding safe production and distribution standards, or to protect the countries most vulnerable to substandard medical products. The WHO’s 2022 report on the Member State Mechanism does no more than recommend that member states “develop their own implementation plans for the prevention, detection and response to substandard and falsified medical products using the outputs of the Member State Mechanism.” This is a reactive approach to help member states identify and recall substandard drugs already out in the world, rather than a proactive approach to prevent the manufacture and distribution of such drugs in the first place.
Moreover, the team behind the WHO’s global surveillance efforts is small and stretched beyond capacity, according to a global health expert who works closely with this team. “They are trying to do their best,” the expert said, speaking on condition of anonymity. “It is the hierarchy above” – the WHO and its top decision-making body, the World Health Assembly – “who do not campaign for more resources.”
A WHO spokesperson wrote that the Member State Mechanism is supported by a secretariat and a WHO budget. “The Mechanism ensures that no country has to face the problem of substandard and falsified medicines alone,” the spokesperson added, “and promotes global best practices that benefit all.” The global surveillance and monitoring team comprises a permanent staff of five technical and two administrative personnel, plus a contractual technical position and “several consultants who contribute to various related projects. Moreover, the Global Surveillance and Monitoring System (GSMS) operates as a collaborative network uniting governments, regulatory agencies, international organizations, the pharmaceutical industry, healthcare professionals, and civil society. Through information sharing, coordinated enforcement, and regulatory capacity-building, GSMS enhances the global response to SF threats” – that is, threats from substandard and falsified drugs.
Asked about the Gambian families’ questions as to whether the WHO is doing enough to protect The Gambia and Africa, the spokesperson replied, “The deaths of children, linked to contaminated medicines, is a tragedy beyond words, and our deepest sympathies are with the families. The quality of medical products is non-negotiable.” A write-up on the WHO’s website, titled “WHO’s swift response saves lives, halting acute kidney injury outbreak in The Gambia”, states that the organisation’s actions included coordinating “a systematic approach to investigating and responding to the outbreak” of AKI, activating emergency procedures and deploying an emergency medical team to The Gambia, and releasing USD 470,000 in contingency funds “which enabled an immediate response from WHO.”
The WHO continues to work to address the issue of substandard and falsified drugs, the spokesperson added, “and urge country action through a number of activities.” The organisation “also continues to urge all countries and National Regulatory Authorities to promptly report incidents of substandard /contaminated medicines, and adverse events, as well as monitoring for potential signals of DEG/EG poisoning.”
The WHO’s present approach does not address the concern that low-income countries such as The Gambia do not have the necessary resources or medical infrastructure to prevent or expediently mitigate problems arising from substandard drugs. The WHO report on the Member State Mechanism effectively absolves the organisation of responsibility, stating that while “the problem of substandard and falsified medical products is a global concern, solutions often lie at the national level.”
But the solutions do not have to lie at the national level alone. There is an existing WHO initiative, the Prequalification of Medicines Programme (PQP), meant to ensure that pharmaceutical products purchased through certain international procurement channels meet acceptable standards of quality, safety and efficacy. The WHO’s website claims the PQP’s central purpose is to establish a global standard for medicines, vaccines and diagnostics.
The PQP was first established in 1996 to cover vaccines, then gradually expanded to also cover certain medicines – ones to treat HIV, tuberculosis and malaria, for instance – as well as diagnostics tools, vector-control products, immunisation devices and cold-chain equipment. It was an elegant solution to a complicated problem, establishing quality standards for medicines that were made and regulated under complicated domestic laws in individual countries. Any manufacturer may submit its product for PQP assessment, after which the WHO checks and certifies the product for quality. This then makes the product eligible for supply to international organisations active in global health, including the United Nations. Individual countries may also rely on the PQP’s lists of vetted products to select drugs for their own procurement.
As of December 2023, the programme had prequalified 657 finished pharmaceutical medicines and 168 active pharmaceutical ingredients – the key molecules in medicines, responsible for their pharmacological effects. (The PQP also prequalifies diagnostic and medical devices, vaccines, vector-control products and quality-control laboratories.)
In April 2024, the WHO announced the expansion of the PQP to include in-vitro diagnostics for diabetes. But the syrups that caused the deaths in The Gambia and elsewhere did not come under the PQP’s purview – because they were not sourced via international procurement agencies, and because cough syrups have remained excluded from the PQP.
The latest annual report for the WHO’s department of regulation and prequalification notes that five out of the eight medical alerts reported in 2023 concerned DEG/EG contamination in cough syrups. It indicates that over half of the world’s population – four billion people – live in countries with well-functioning national regulators. But that still leaves billions of the world’s poorest and most vulnerable people exposed.
“There is a lot of pressure on the WHO but they say it will cost a lot of money to expand the PQP,” the global health expert said. “It is an excuse and not a reason. The PQP simply needs to be expanded.”
“Not every medicine is eligible for prequalification,” the WHO spokesperson said. “Cough mixtures are not among the medicines to be evaluated by the prequalification process. The contaminated syrups result from poor-quality raw materials, not the active pharmaceutical ingredient.”
“Since the 1970s, the WHO has had a certification scheme on the quality of pharmaceutical products moving in international commerce,” K M Gopakumar, a legal advisor for the Third World Network, which advocates for access to affordable medicines across the globe, explained. “It should be expanded to supply essential medicines for resource-strapped and vulnerable countries such as The Gambia. The problem is mainly a lack of global will, backed by the necessary resources, to do so.”
The PQP also remains chronically underfunded, although the programme is not prohibitively expensive. An assessment by PricewaterhouseCoopers put the cost of implementing the PQP strategic plan for 2019–2023 at USD 228 million – a minute fraction of the WHO’s budget, which presently stands at over USD 7 billion per year. The annual report for the WHO’s department of regulation and prequalification puts its 2023 budget at USD 42 million.
The problem extends to the underfunding of the WHO itself, recently exacerbated by US president Donald Trump’s decision to withdraw his country from the organisation. The WHO’s members pay what are called “assessed contributions”, a set percentage of a country’s GDP agreed upon every two years. (The United States provided the largest contribution of any member state until its withdrawal.) Of late, these sums have covered less than 20 percent of the WHO’s total budget, leaving the organisation massively reliant on contributions from philanthropic organisations such as the Gates Foundation.
As part of the PQP, national regulatory authorities in countries that wish to manufacture prequalified products are required to comply with the WHO’s Global Benchmarking Tools (GBT). These are the means through which the WHO evaluates regulatory systems and sets standards for a variety of medical products, including drugs, vaccines and medical devices. One of the most alarming gaps in the PQP is that India has chosen to not participate in the WHO’s benchmarking standards for medicines.
“Participation in the WHO Global Benchmarking Tool for evaluation of national regulatory systems is a voluntary process,” the WHO spokesperson said. “The CDSCO has been benchmarked for vaccine regulation” – this happened in 2017, when the WHO certified India’s vaccine regulatory system under the GBT – but “India has not applied for a similar exercise for the regulation of medicines.” This means India’s drug manufacturers are governed by local regulations that have not been checked against GBT standards. The result, again, is that poor countries are typically left at the mercy of the CDSCO, which has become a de-facto drug regulator for much of the world.
AFRICA IS THE REGION worst affected by substandard medicines. A WHO analysis from 2017 found that 42 percent of all reports of substandard or falsified medicines over the preceding four years came from Africa; other studies suggest as much as 70 percent of the drugs in some African countries are fake. With Indian drug regulation badly in need of reform and the WHO only offering ad-hoc, piecemeal solutions, African countries that rely heavily on Indian pharmaceutical imports are on their own.
The Gambia’s struggles, including its reckoning with its own role in the cough-syrup deaths, illustrate just how dire the situation is.
The country’s limitations of health infrastructure, including testing facilities, and its lack of trained medical personnel, are compounded by poor enforcement and conflicts of interest in its existing regulatory procedures. The national pharmaceutical regulator, the Medicines Control Agency (MCA), is supposed to ensure the quality of imported drugs via a registration process that requires information about their safety and efficacy. In practice, however, the agency adopted a makeshift practice that it identified as “listing”, which involved only recording the details of imported products and their suppliers in case a recall proved necessary.
The Gambian task force to inquire into the cough-syrup deaths, constituted by the country’s president in November 2022, was told to ascertain the “circumstances that allowed the importation and distribution of the four contaminated medicines into the country.” In an interview with the task force, the MCA’s director of registration and inspection, Essa Marenah, stated that the practice of listing rather than registering imported drugs was the result of a lack of capacity and acknowledged that the Maiden cough syrups had not been registered. Marenah added that “the only way to verify documents is to conduct quality control tests,” but, as the task force reported, there were no drug-testing labs in the country to do so. In its final report, the task force noted that the regulator never carried out its full responsibilities under the law to ensure drug safety even when it came to registered drugs.
The task force also found another glaring issue in the regulatory system. Any pharmacist that wishes to operate a pharmacy in The Gambia must obtain a licence from the MCA. Since the country does not have any domestic medical manufacturing, it is also necessary for pharmacies to associate with individuals holding separate drug-import licences, termed “supervising pharmacists”. Many officials who were also members of the staff or the board of the MCA served in a private capacity as supervising pharmacists for pharmaceutical companies without independent drug-import licences of their own. These pharmaceutical companies paid these supervising pharmacists to allow them to import drugs without any actual supervision. At least five MCA staff members were supervising pharmacists for various companies, with clear conflicts of interest in their two roles.
The government accepted the task force’s recommendation to dismiss the MCA’s top two officials. The task force also recommended other measures: recruiting new staff for the MCA and establishing a school of pharmacy; creating a National Medicines Quality Control Laboratory and a fully functional Pharmacovigilance Department; reforming laws and regulations to address concerns over drug imports and conflicts of interest.
In July 2023, The Gambia mandated pre-shipping quality tests on all pharmaceutical products coming from India. It continues to rely heavily on the Indian pharmaceutical industry. As of November 2024, the MCA website noted that 1139 of the 1803 products registered by the regulatory body had been manufactured in India. This included 18 cough syrups.
Drug regulatory agencies in many, if not most, African countries are unable to effectively perform the functions expected of them. In 2019, the African Union adopted a treaty to establish an African Medicines Agency, modelled on the European Medicines Agency (EMA) of the European Union. This body, with support from the EMA, is meant to harmonise the regulatory systems of the African Union’s 55 member states. Only 25 African states have so far ratified the treaty. The Gambia is not among them.
“We, the victims, are saying this will not happen again,” Sagnia said. “Whether you are Gambian or non-Gambian, it doesn’t matter. This cannot happen again.” Among the demands of the dead children’s families is an expansion of the WHO’s PQP to cover cough syrups. “We cannot have this hypocrisy with regards to different quality medicines for poor and rich. People are dying. It needs to be stopped.”
Sagnia, along with some other parents from the AKI Victims’ Association, sometimes goes to hospitals to tell other parents not to use Indian medicines. “Anytime you see an Indian product, I tell parents, be careful,” he said. “I inform government authorities. I tell parents to check the names of medicines they buy. If they cannot read, give it to someone who can read it for you.”
He continues to go to the courthouse in Banjul where the association’s cases are being heard. “When I go to the courthouse, I do not go alone. I go with the spirit of our babies. When I see other parents, I can also see each one of those babies standing right next to them.”