New Delhi: A task force formed by the Gambian president Adama Barrow has recommended that the country sue the Indian government in the case where contaminated syrups caused acute kidney injury among children and led to the death of 70 of them in the country last year. Most of them were younger than two years old.
The task force had started an inquiry in November last year and submitted its report in March this year. The Gambian government released it on July 21 and issued a statement regarding its response to the committee’s recommendations. The Wire has a copy of both the task force report and the government statement.
The task force has said, “The Government of The Gambia through the Ministry of Justice should forthwith explore the possibility of instituting legal action against Atlantic Pharmaceuticals [importer], Maiden Pharmaceuticals [Indian manufacturer], and the Government of India to seek redress on behalf of the families of the victims of AKI [acute kidney injury] outbreak.””
The Gambian government has accepted the recommendation as far as initiating a legal action against Maiden Pharmaceuticals, the Indian-based drug manufacturer, and Atlantic Pharmaceuticals, the US-based importer which procured the drugs from the Indian manufacturer for Gambia. It has said it has engaged a “top tier international law firm” for legal advice. The statement did not say anything, though, about taking legal action against the Indian government. It said the Gambian government would “engage” with its Indian counterpart.
But what that engagement will yield remains to be seen.
This is the fifth scientific report to come to a conclusion that the India-based firm’s products were contaminated with highly toxic chemicals – diethylene glycol (DEG) and ethylene glycol (EG). However, the Indian government has plainly refused to acknowledge any role of the Indian firm, if its reaction to the previous four reports are anything to go by.
These reports were made by the Gambian parliamentary committee, US Centers for Disease Control and Prevention (CDC), and a team of international experts that published a causality assessment report. The earliest proof of drugs being contaminated in very high amounts came in the form of results from a Switzerland-based lab where the World Health Organisation (WHO) had sent samples for testing in September 2022.
In fact, participating in a podcast hosted by ANI editor Smita Prakash earlier this month, India’s health minister Mansukh Mandaviya had said there was no evidence to suggest contamination led to deaths. “You will be surprised to know that the children suffered from diarrhoea and they were given cough syrups,” he said.
Mandaviya made this statement despite two reports – one by the US CDC and another by the Gambia parliamentary committee – last year saying that diarrhoea had no role to play in the deaths of the children.
This new task force report has offered by far the most detailed explanation about why diarrhoea was not the reason for the deaths of the children. It was in November last year that a media report published the first plausible statements emerging from Gambia linking E. coli, a bacterial infection causing diarrhoea, with the deaths. The Indian government also alluded to this ‘media report’ in a letter written to the WHO last December in this case wherein it had said nothing was wrong with the drugs exported to Gambia.
It is important to note here as to who made that statement on the purported behalf of Gambia and was quoted in the media. It was Tijan Jallow, a staff member of the Gambia’s drug regulator, Medicines Control Agency (MCA). Jallow’s statement was quoted as that of the MCA in the said media report, though he is just a staff member (and not a senior official). In fact, he also repeated his stance before the task force in his interview and said that “diseases associated with flooding” could have contributed to the deaths.
Now, this current report hints at a potential conflict of interest on the part of Jallow as he is currently the supervising pharmacist of Atlantic Pharmaceuticals – the company which purchased drugs from Maiden pharmaceuticals and sent them to Gambia.
As a supervising pharmacist working with importers, one is supposed to provide professional advice to the importer “during the process of importation and distribution of medicines and related products.” Under the Gambian law it is legit for an MCA member to, simultaneously, take up a job at a private supervising pharmacist provided there is a formal declaration to that effect.
To be clear here, Jallow was not the supervising pharmacist for the Atlantic Pharmaceuticals when the import took place. At that time, it was one Sait Kebbeh.
Kebbeh, like Jallow, also doubled as a staff member of Gambia’s drug regulator. And just like Jallow, Kebbeh also told the task force that he didn’t think the drugs were responsible. Instead some other infection could have also caused the deaths, he had said.
In his role as supervising pharmacist for Atlantic Pharmaceuticals, Kebbeh cleared the decks for it and through it, for exporting Maiden-made syrups to Gambia. He accepted before the task force that he provided technical support and the go-ahead to Atlantic pharma for import without making background checks on the Maiden Pharmaceuticals.
As such, the task force recommended disciplinary action against him which the Gambian government has accepted. It has referred his case to the Pharmacy Council for necessary action. It also recommended that the Gambian government make rules to prevent any such future conflict of interest.
Experts’ opinion on causes
The task force interviewed clinical and pharmaceutical experts to, just like the previous committee did, to go into the causes of deaths. Based on their interviews and previous reports the task force concluded:
“The Task Force finds it safe to conclude, without any qualms, that the death of the seventy children below the age of five, between July and October 2022 related to Acute Kidney Injury, is as a direct result of contaminated medicines found in four cough and cold syrups imported by Atlantic Pharmacy from Maiden Pharmaceuticals Company Limited in India.”
Muoneke Uzoamaka Vivian, a paediatric nephrologist at Gambia’s Edward Francis Small Teaching Hospital (EFSTH), told the committee that on the basis of autopsies that she conducted and which revealed multi-organ failure, the same set of symptoms in children who died, observations made by her colleagues at US, UK, Nigeria and South Africa, and the initial lab results of medicines that she received and which had confirmed contamination, she was convinced that the drugs were responsible for the deaths.
Later, WHO lab reports also confirmed Vivian’s findings as far as the contamination was concerned.
It was at the EFSTH, the hospital based in the country’s capital, Banjul, where the first cases of AKI outbreak landed in July 2022.
But the most important fact that made her conclude this was the fact that the point after which the four medicines were withdrawn from the market following her recommendation, AKI cases drastically dropped in October 2022.
Regarding diarrhoea, she said, in some children an infection of E. Coli bacteria was established. However, these were not the children who had landed at her hospital. They were children from the northern part of the country. The Gambian parliamentary committee report had also said exactly the same thing.
The task force also interviewed Gabriel Ogun, a pathologist for 22 years and currently serving as head of lab at EFSTH. He told the committee that the probability of DEG and EG causing multiple organ failure in the children – which was revealed through autopsies – was “extremely high” due to the nature of the organ damage.
He had said that no bacterial or viral infection could have manifested in that way, and thus ruled out an E. coli bacterial infection leading to diarrhoea – just like other committees did in the future.
The task force committee also noted in the report that the expert opinions of Professor Vivian, Professor Ogun and Dr. Leigh of the EFSTH had been “strongly corroborated” by the report of the US-CDC and the causality assessment report made by a team of international experts.
Ever since the controversy erupted in October last year, Maiden Pharmaceuticals has consistently denied any wrongdoings, claiming its products were not tainted.
The Indian government had also formed an expert committee of its own last year which cleared the name of the firm – though it did not come to any conclusion about diarrhoea causing deaths. The Indian government also never made its own report public. The WHO did not accept the Indian report.
The health minister also claimed in the podcast that the Indian government had made some correspondence with the Gambian government in this case to enquire about the details after the news of deaths of children surfaced. He did not clarify what the correspondence resulted in, and if and when it was done.
The minister went on to add in the podcast that out of 23 samples tested, India was told, only four failed. “If in one [same] batch of a drug, a few units fail the test, then all should and not just four,” he said, casting doubts over lab reports.
However, the fact remains that all the drugs tested were not from the same batch. Not only were they from the different batches, but in fact there were 23 different drugs altogether which were tested. Four of them failed the tests. They were Makoff Baby Cough Syrup, MaGrip N Cold syrup, Kofexmalin Baby Cough Syrup and Promethazine Oral solution. They could not have been from the same batch since they were different formulations.
The minister’s claims went unchecked in the podcast.
Role of the importer: Atlantic Pharma
Atlantic Pharmaceuticals confessed to the task force that it did not run a detailed check into Maiden Pharmaceuticals beyond its officials visiting its site once in India before initiating the import. The US-based importer said it relied on the good manufacturing practices certificate that the Indian drug regulator had issued to Maiden Pharmaceuticals.
The Atlantic Pharmaceuticals did not find it necessary to look whether Maiden Pharmaceuticals had any past record – which, indeed, Maiden had. The Gujarat government had flagged substandard products of the company in 2015 – as did the Kerala government. Their warnings were available in the public domain.
Add to this the fact that Atlantic Pharmaceuticals also got another leeway from Gambia’s drug regulator. Usually a company has to be ‘registered’ with Gambia’s drug regulator before importing medicines. The task force report has revealed that Atlantic pharma was merely ‘listed’ and not ‘registered’.
The process of listing, as explained to the inquiry committee by the executive director of the Gambia’s regulator, involved recording only the basic information of the product and supplier, to be utilised in the event of necessary recall. On the other hand, ‘registration’ involves submission of a number of documents prior to initiating the trade. Most importantly, the importer has to submit safety and efficacy of drugs being received in the country. The ‘listing’ does not mandate this bit either.
The task force found that the executive director and deputy executive director of Gambia’s regulatory authority contradicted the Medicines and Related Products Act 2014 and Regulation 2020 laws of the country by allowing the ‘listing’ process. And thus, it recommended their immediate removal and prosecution for “neglecting and abdicating their responsibilities”.
The Gambian government said in its statement on July 21 that the executive director has been dismissed with immediate effect and that the services of deputy director too have been terminated. For further legal action, the task force report has been sent to the Gambia police force.
The Gambian government has also permanently revoked the licence of Atlantic Pharmaceuticals as well as has launched a legal suit against it.
article was first published by The Wire and written by Banjot Kaur