Over the past month, 20 children in India have died after consuming cough syrup contaminated with a toxic substance that causes ‘multi-organ failure’
The World Health Organization has shared “deep concern” over India’s drug safety regulations after news broke that at least 20 children have died from contaminated cough syrups.
The deaths in the Madhya Pradesh and Rajasthan areas over the last month, have been connected to three cough syrups. Samples of the products found a toxic substance found in industrial solvents called diethylene glycol (DEG).
India’s drug regulator named the three contaminated syrups as Coldrif (Sresan Pharmaceuticals), Respifresh (Rednex Pharmaceuticals), and ReLife (Shape Pharma). Production of the medication has been stopped and an investigation has been launched.
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However, the WHO has also warned that the cough syrups could reach other countries through unregulated distribution channels, the BBC reported. DEG is a toxic substance “that can be fatal even taken in small amounts, especially for children”, the WHO explained.
It also stated: “Diethylene glycol (DEG) and ethylene glycol (EG) are commonly used in the manufacture of industrial products such as antifreeze and glues and are never to be ingested by humans.”
On Thursday, the 73-year-old owner of Sresan Pharmaceuticals, G Ranganathan, was arrested. The firm’s manufacturing licence would be “permanently cancelled”, Tamil Nadu Health Minister Ma Subramaniam said.
A drug department inspection found that Sresan Pharmaceuticals violated 364 manufacturing rules. The report, which mentioned poorly qualified staff and lack of pest control, stated, per the BBC: “Manufactured products are stored in a very unhygienic manner…Sewage was discharged without purification. Water for drug production was stored in an unhygienic manner.”
The report also found that there were missing production monitoring procedures, substandard water and equipment, and no data collection department.
This is not the first time concerns over Indian-made cough syrups have been raised. In 2022, more than 70 children died in Gambia from acute kidney failure after consuming imported cough syrup. Later on, between 2022 and 2023, 68 children died in Uzbekistan after consuming another contaminated syrup from India.
India is the third-largest drug producer by volume after the United States and China. Pharmaceutical products are usually tested for DEG by gas chromatography. However, many laboratories in “remote and less-resourced countries do not have access to the technique”, the WHO said.
Earlier this year, the organisation put out a call for public consultation over screening devices to detect medication contaminated with DEG. It explained that the substance had found its way into pediatric syrups with outbreaks of deaths affecting a number of countries.
The WHO added: “DEG & EG cause multiorgan failure, especially acute renal failure and neurological dysfunction, and have resulted in hundreds of deaths, especially of children.”