The World Health Organisation (WHO) issued an alert saying four “substandard” cough syrups manufactured by India-based Maiden Pharmaceuticals Ltd. are likely responsible for the deaths of 66 children from acute kidney issues in the Gambia.
The WHO said that four Indian products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – “fail to meet either quality standards or specification and are, therefore, out of specification,” noting that the children died between three and five days after consuming the products.
Indian pharma company #MaidenPharma's 4 cough and cold syrups tied to 66 deaths in #Gambia: @WHO
— Moneycontrol (@moneycontrolcom) October 6, 2022
It is conducting further probes with the company and Indian regulatory authorities.
CDSCO has now launched an ‘urgent investigation’ into the matter.
Listen in! 👂#CoughSyrup pic.twitter.com/xjOG75jXyo
All four products are manufactured by Haryana’s Maiden Pharmaceuticals Limited, which has not provided the WHO with any guarantees on the safety or quality of the medicines.
Laboratory analysis of the samples showed that the medicines contain “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.” The chemicals have several “toxic effects” that can cause acute kidney injury and even death in certain instances.
Keeping this in mind, the WHO determined the four products to be “unsafe,” particularly for children, and warned against the use of the medicines until they are approved by the relevant National Regulatory Authorities.
The Organisation called on countries to increase “surveillance and diligence within the supply chains of countries and regions” that could be using these products. Furthermore, it urged countries to report the presence of the substandard medicines within their borders.
#MaidenPharmaceuticals has remained incommunicado on concerns raised by WHO on cough & cold syrup.
— Ayushmann Kumar (@Iam_Ayushmann) October 6, 2022
Company's office in Delhi is locked, the Director is silent on allegations. @CDSCO_INDIA_INF is conducting an investigation in the Sonipat factory. pic.twitter.com/Ro6rCdSOQR
While there has been no proven link between the 66 child deaths and the medicines, WHO Director-General Tedros Adhanom Ghebreyesus said that the contents of the cough syrups are “potentially linked with acute kidney injuries and 66 deaths among children.”
He added that the organisation is investigating the incident in collaboration with the pharmaceutical company and Indian regulatory authorities.
According to sources cited by Indian Express, India’s Central Drugs Standard Control Organisation was informed about the issue on 29 September and has already initiated an investigation into the matter. In addition, the Haryana regulatory body confirmed that Maiden Pharmaceutical produced the medicines. It further clarified that the drugs had only been exported to the Gambia.
The government of The Gambia is launching a probe into the recent deaths of dozens of young children from kidney failure and possible links to a paracetamol syrup, the country’s health director said.
— IG:IRIEFM_JA (@IRIE_FM) September 9, 2022
Dozens of children [under the age of five] have died in the last three months. pic.twitter.com/Sd71IDkKh8
However, Indian official sources cited by BBC raised concern that WHO has not established a “causal relation to death with the medical products in question.”
In addition, the WHO has not yet provided the Indian authorities with details of the product or photos confirming the manufacturer of the medicines.
India has been previously lauded as the “pharmacy of the world,” as it is responsible for one-third of the world’s medicines, a majority of which are generic drugs. The low-cost medicines have provided relief to mutiple poor countries. In fact, Maiden Pharmaceuticals exports medicines to Asia, Africa, and Latin America.
Concerningly, this is not the first time India-made cough syrups have attracted concern in the market. In 2020, 17 children in Jammu and Kashmir died after consuming another brand of cough syrup that also contained diethylene glycol. Similarly, three other children died in New Delhi in 2021 after consuming a cough syrup with dextromethorphan.