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The Indonesian government orders a temporary ban on cough syrup following the Gambian tragedy
Following a WHO warning about possible toxic ingredients in four Indian-origin cough syrups, the Indonesian government has ordered a temporary ban on all liquid medicines in the country as a spike in child deaths linked to medicinal syrups has been reported. Indonesia's October 19 ban came two weeks after the WHO issued a global warning on medical products in response to the deaths of 69 children in Gambia, a country in West Africa, from acute kidney failure. In a series of tweets, the Indonesian Ministry of Health said that as of October 18, 206 children in 20 provinces had acute kidney failure...
The Indonesian government orders a temporary ban on cough syrup following the Gambian tragedy
Following a WHO warning about possible toxic ingredients in four Indian-origin cough syrups, the Indonesian government has ordered a temporary ban on all liquid medicines in the country as a spike in child deaths linked to medicinal syrups has been reported.
Indonesia's October 19 ban came two weeks after the WHO issued a global warning on medical products in response to the deaths of 69 children in Gambia, a country in West Africa, from acute kidney failure.
In a series of tweets, Indonesia's Ministry of Health said that as of October 18, 206 children in 20 provinces had suffered from acute kidney failure and that 99 of them had died. That number rose to 133 this week and is expected to rise as the Health Ministry continues its investigation into unregistered medicinal syrups being sold in the country.
SciDev.Net reached out to the Indonesian Ministry of Health and the head of the Indonesian Pediatrician Association, but neither of them responded to questions about the connection to the Indian drugs, which are reportedly not sold locally.
A WHO official said the global health organization had "issued an alert about substandard/contaminated children's medicines - mainly cough syrup - being manufactured by a company in India and sold in The Gambia."
According to the WHO, as of October 6, 81 cases of acute kidney injury had been reported, including 69 fatal outcomes. The WHO named the products Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup manufactured by Maiden Pharmaceuticals Limited, Haryana State, India. The contaminated products contained “unacceptable amounts” of ethylene glycol and diethylene glycol.
SciDev.Net attempted to reach Maiden Pharmaceuticals officials to comment on the controversy surrounding their products, but all calls made were repeatedly ignored.
On Wednesday, the Philippine Food and Drug Administration issued its own advisory against the four drugs, although it clarified that they are not registered locally.
The WHO said in an email to SciDev.Net that the quality of medical products is non-negotiable and said it is working with the Gambian government as well as Indian regulators who are conducting investigations to ensure that unsafe products are removed from circulation. “The deaths of children possibly linked to contaminated medicines are an unspeakable tragedy,” the WHO statement said.
Dinesh S. Thakur, a public health activist and co-author of a book on the shortcomings of India's drug regulation, said the deaths of children in Gambia were a glaring example of the inadequate functioning of India's drug regulators. “This has happened time and again because India has a dysfunctional drug regulatory system... and there is no accountability of drug regulators to the people,” Thakur told ScidDev.Net.
Every batch of medication shipped from a factory carries a certificate of analysis, a legal document that tells the buyer that the pharmaceutical company has tested the shipped batch. If the pharmaceutical company makes false statements on this document, it must be held liable.”
Dinesh S. Thakur, public health activist
Queries sent to the Drug Controller General of India's office on October 20 were acknowledged but not responded to. An official told SciDev.Net: “An investigation has been launched and I cannot speak until the investigation is completed.”
On September 29, the Indian Ministry of Health issued a statement saying that preliminary investigations had shown that the products mentioned by the WHO were actually manufactured by Maiden Pharmaceutical Limited, a company based in the state of Haryana, which had exported these products exclusively to Gambia.
“It is standard practice for the importing country to test such imported products on quality parameters and satisfy itself about the quality of the products before the importing country decides to release such products for use in the country,” the statement said.
"According to the preliminary results received by the WHO, out of the 23 samples of the reference products tested, 4 samples were found to contain diethylene glycol/ethylene glycol. It was also informed by the WHO that the certificate of analysis will be made available to the WHO in the near future and the WHO will share it with the Indian regulatory authority on what remains to be done," it said Government statement. “The exact one-to-one causal relationship of death has not yet been communicated by the WHO to the CDSCO (Central Drugs Standard Control Organization).”
According to an article published by the U.S. government's National Library of Medicine, diethylene glycol is a toxic alcohol used in brake fluid, paint and household cleaning products that has been used illegally as a cheap substitute solvent in drug manufacturing.
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