Tainted cough syrups pulled from the shelves after they were linked to dozens of deaths.
The recent deaths of dozens of children from acute kidney problems in The Gambia and Indonesia have caused alarm worldwide. They were possibly caused by harmful substances in medicinal syrups.
The first fatalities were reported in The Gambia last month, prompting authorities to launch an investigation. Separately, Indonesia this month announced a ban on all syrup and liquid medicines after the reported deaths there of dozens of children, also from acute kidney injuries.
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There is no confirmed link between the cases in the two countries, but investigations are ongoing.
Here is what to know about what has happened.
In September, the government of The Gambia launched an inquiry into the deaths of 28 children from acute kidney problems after they took a paracetamol syrup to treat fever.
In early October, the World Health Organization (WHO) said the deaths in The Gambia may be linked to four contaminated cough and cold syrups made by Maiden Pharmaceuticals, an Indian drug manufacturer. It said an investigation was under way, together with Indian regulators and the New Delhi-based company.
The WHO said in a medical product alert on October 5 that excessive levels of diethylene glycol and ethylene glycol had been found in the four products produced by Maiden Pharmaceuticals and sold in The Gambia: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The agency warned that their use may result in serious injury or death, especially in children,
Diethylene glycol and ethylene glycol are alcoholic toxic chemicals used in industrial applications such as the making of paints, ink or brake fluids. Their effects reportedly include altered mental states, stomach cramps, nausea, vomiting and diarrhoea. They might cause damage to the kidney, liver and central nervous system.
Gambian authorities on Friday ordered all cough and cold syrups in circulation in the country to be recovered, extending the scope of a previous recall for medicines containing paracetamol or promethazine syrup.
Last week, police in The Gambia said in a preliminary investigative report that the number of child deaths had increased to at least 69.
The report also said the deaths from acute kidney injury were linked to four India-made cough syrups mentioned in the WHO’s alert, according to news agencies. It did not name Maiden Pharmaceuticals directly but included the company’s four liquid products in question.
Indian health authorities, who also conducted their own internal probe, halted all production at Maiden Pharmaceuticals in mid-October after discovering violations at its production facilities in Haryana state.
The state drug regulator said the tainted products sold in The Gambia had been made at the factory in Harayana in December, according to Indian media reports.
“In view of the seriousness of the contraventions observed during the investigation and its potential risk to the quality, safety and efficacy of the drug being produced, all the manufacturing activities of the firm is being stopped with immediate effect,” said an order by federal and state drug authorities.
Al Jazeera reached out to Maiden Pharmaceuticals but did not a receive a response by the time of publication.
Maiden Pharmaceuticals director Naresh Goyal told India’s Economic Times newspaper that “the deaths have been due to paracetamol syrup and not due to our cough syrups”.
Prashant Reddy, a lawyer and writer who researches drug regulations in India, said the country’s drug regulatory laws are inadequate and outdated.
“In total India has 38 regulators with limited jurisdiction, limited to their own states and a lot of bad actors slip through the cracks,” he told Al Jazeera.
Reddy added that longtime government efforts to consolidate the system to create a more unified regulator have not been successful.
“It is important to understand that the Indian pharmaceutical industry is a very powerful entity in the country,” he said. “A lot of them are completely against a more unified system because they know that this will increase the quality and efficiency of regulations and perhaps the cost of manufacturing drugs.”
Indonesian health authorities first announced an investigation into the death of about 20 children from acute kidney injury in early October.
Alongside WHO officials, the authorities formed a team of experts to investigate the fatalities.
Health Minister Budi Gunadi Sadikin said on Thursday that the deaths were among a total of 241 cases of kidney failure in 22 provinces, adding that most patients were children under the age of five.
Budi added that some of the medicinal syrups containing paracetamol in Indonesia also included ethylene glycol and diethylene glycol, the same ingredients that have been linked to the deaths of children in The Gambia.
Indonesia’s food and drug agency announced on Thursday that five locally produced medicines, out of 26 tested, contained excessive levels of ethylene glycol. It said it had ordered the manufacturers to pull them out of circulation and destroy them.
According to the agency, Maiden Pharmaceuticals’ products are not available locally.
In its alert, the WHO said the four products identified in The Gambia “may have been distributed, through informal markets, to other countries or regions”.
In the winter of 2019 and 2020, at least 14 children died after taking an adulterated cough syrup prescribed to them by local doctors in India-administered Kashmir and the Jammu region. Twelve of the deaths happened in Jammu.
The Coldbest PC cough syrup manufactured by Himachal Pradesh-based Digital Vision contained diethylene glycol, according to media reports that cited authorities.
The Jammu and Kashmir police have still not indicted the company, and a court case against it is still pending.
In Nigeria, 84 children died in various parts of the country between late 2008 and early 2009 after taking a teething syrup tainted with diethylene glycol.
The government at the time said there had been 111 reported cases of children who had fallen ill after taking the syrup called My Pikin.
SOURCE: AL JAZEERA