Explained: How cough syrups can lead to deaths
Explained: How cough syrups can lead to deaths
The death of 66 children in The Gambia linked to cough syrups manufactured by an Indian firm has spurred authorities to begin a probe in the matter.
The government on Thursday said samples of the cough syrups manufactured by the Sonepat-based firm allegedly linked to the deaths of children have been sent for testing by drug regulator Drugs Controller General of India (DCGI) and its results will guide further course of action.
Reports also stated that The Gambia has launched a door-to-door campaign to collect the cough and cold syrups blamed for the deaths in the tiny West African country.
The “contaminated” cough syrups
The World Health Organization (WHO) sounded off an alert against four cough syrups produced by Maiden Pharmaceuticals Limited based in Haryana’s Sonepat, saying that they could be the reason for the deaths in the West African nation.
The four cough syrups allegedly linked to the deaths are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
WHO Director-General Tedros Adhanom Ghebreyesus said that the loss of young lives due to the products is “beyond heart-breaking for their families”, adding that laboratory analysis revealed that each of the four cough syrups contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
“WHO has today issued a medical product alert for four contaminated medicines identified in #Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children. The loss of these young lives is beyond heartbreaking for their families”-@DrTedros
— World Health Organization (WHO) (@WHO) October 5, 2022
Ghebreyesus further added that as while the contaminated products had only been detected in The Gambia so far, they may have been distributed to other countries.
He added that the global health body will ask all countries to detect and remove these products from circulation to prevent further harm to patients.
The WHO also added that the Indian company had not yet provided guarantees on the safety and quality of these products.
Dangers of diethylene glycol and ethylene glycol
As per the WHO, the cough syrups linked to the deaths of the children in the African nation contained “unacceptable” amounts of diethylene glycol and ethylene glycol.
Diethylene glycol is a colourless, practically odourless, and hygroscopic liquid with a sweetish taste. Diethylene glycol is a derivative of ethylene glycol, which also has similar effects on the human body when ingested.
The chemical is toxic to humans when consumed and can prove fatal. A high amount of diethylene glycol could cause gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and diarrhoea. Some patients may develop early neurological symptoms like altered mental status, central nervous system depression, coma and mild hypotension.
According to a paper in the National Library of Medicine under the National Center for Biotechnology Information, the chemical is used in antifreeze, brake fluids, cosmetics, and lubricants and causes renal insufficiency and failure and could even lead to coma and death.
In fact, this isn’t the first time that deaths have been linked to the presence of diethylene glycol in cough syrups.
In Bangladesh between 1990 and 1992, 339 children developed kidney failure, and most of them died, after being given paracetamol (acetaminophen) syrup contaminated with diethylene glycol.
Also read: Explained: Why the Centre is planning to ban some Codeine-based syrups
The Centre for Disease Control and Prevention (CDC) had said in 2009 that the Nigerian Federal Ministry of Health had received reports of “13 cases of unexplained acute renal failure among children from a hospital in Lagos state”. These patients had been exposed to a teething medication which, the Nigerian authorities discovered, had been contaminated by diethylene glycol.
In Panama, over a hundred people died from diethylene glycol poisoning in 2006.
In 2020, nine children had died in Jammu owing to the presence of a “poisonous compound” in a cough syrup manufactured by Digital Vision. That “poisonous compound” was later found to diethylene glycol.
How India has reacted
As news came in of the WHO putting a halt on the cough syrups, India stepped in with the DCGI already initiating a probe in the matter.
Haryana’s Health Minister Anil Vij on Thursday said samples of four cough syrups manufactured by the firm have been sent to the Central Drugs Laboratory in Kolkata for examination.
Vij said the cough syrups manufactured by the pharma company were approved for export. “It is not available for sale or marketing in the country.”
“Whatever action has to be taken will be taken once the CDL report comes. Only after the report is in, we can arrive at any conclusion,” Vij added.
The Union Health Ministry also said the exact “one-to-one causal relation of death” has neither been provided by the UN health agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
➡️Press Note on @WHO Medical Product Alert regarding Maiden Pharmaceuticals Ltd.
https://t.co/VaqtPdV5sT pic.twitter.com/FWMInIneQF— Ministry of Health (@MoHFW_INDIA) October 6, 2022
The health ministry in a detailed statement said that Maiden Pharmaceutical Limited, Sonepat, Haryana had manufactured and exported these products only to The Gambia.
The controversial drug maker
The tragedy has put the spotlight on Maiden Pharmaceuticals, which started operations on 22 November 1990.
The company, which claims to be a WHO-GMP & ISO 9001-2015 certified pharmaceutical company, has two manufacturing units in Haryana — one at Kundli and another at Panipat.
The pharma company has a global presence with a strong concentration in Africa, in countries such as Algeria, Senegal, Nigeria, Cameroon, Kenya and Tanzania.
It manufactures a range of products such as capsules, injectables, syrups, ointments and tables across various therapeutic areas. The company has an annual production capacity of 60 crore capsules, 1.8 crore injections, 3 lakh tubes of ointments, 22 lakh syrups and 120 crore tablets, according to its website.
With inputs from agencies
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