The cough syrups came under scanner following the death of 66 kids in The Gambia
On Wednesday, the World Health Organisation (WHO) issued an alert over four cough syrups which are manufactured in India. The Indian manufactured cough syrups came under scanner following the death of 66 kids in The Gambia.
"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," WHO Chief Dr Tedros Adhanom Ghebreyesus said in a series of tweets.
"The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India. WHO is conducting further investigation with the company and regulatory authorities in India," he said in another tweet.
Here are key points on this issue:
The four cough syrups are...
The four cough syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
These medicines have been manufactured by Maiden Pharmaceuticals Limited (Haryana, India).
"Linked to acute kidney injuries"
The WHO has said that the contaminants found in the syrups are linked to cute kidney injuries in kids which has subsequently led to the death of those children.
"The loss of these young lives is beyond heartbreaking for their families," the WHO Chief has said.
"Unacceptable amounts of contaminants"
The syrups contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants, the global health agency has said in the alert issued on Wednesday.
The medicines contain diethylene glycol and ethylene glycol. The US has a strict limitation on the use of these compounds. As per reports, the US government allows only 0.2% of diethylene glycol in polyethylene glycol when polyethylene glycol is used as a food additive.
Human consumption of these contaminants is fatal
Diethylene glycol and ethylene glycol are toxic and when humans consume these compounds it leads to abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury and even death.
These compounds are highly toxic
Several research studies have found the toxic nature of these compounds and the hazards they can put on a human body.
While diarrhea, altered mental status are the initial symptoms, "Acute kidney injury is usually the main cause of death, appearing between 8 and 24 hours after exposure to lethal doses of diethylene glycol," says a study.
Diethylene glycol poisoning can also result in hepatic disease, pancreatitis, and neurologic abnormalities, which appear up to a few days after exposure, it adds.
The lethal dose of ethylene glycol is approximately 1400 mg per kg. Mass outbreaks from this contaminated compound were seen in Haiti in 1995-1996, Bangladesh in 1990 and Panama in 2006.
Diethylene glycol is a sweet-tasting, colorless, non odoriferous, hygroscopic liquid commonly used in the commercial preparation of antifreeze, brake fluid, cigarettes, and some dyes.
Indian government says medicine not sold in India
Amid huge concerns over the presence of contaminants in the medicine, the Indian government has said that the four cough syrups under investigation are not sold in India.
“The State Drug Controller had given licenses to the said Company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Further all these 04 drugs manufactured only for exports by M/s. Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s. Maiden Pharmaceuticals is sold domestically in India,” a press release from the Union health ministry said.
Pharma company website unavailable
While ETimes-TOI could not ascertain since when the website of the company has been unavailable from, information retrieved from search engines says the company's website was indexed ten years ago.
A snapshot of the cached version of the website says, "Maiden Pharmaceuticals Limited is a WHO-GMP & ISO 9001-2015 certified pharmaceutical company, started on 22nd November, 1990."
It also says that the company has two manufacturing plants based in Kundli-Haryana and Panipat-Haryana, and has its corporate office at Netaji Subhash Place, Pitampura, Delhi.
WHO denies claims over authorisation
In the alert, the WHO has said that to date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.
"All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities," it has warned countries.
"Maybe in circulation in other countries"
Urging nations to restrict the consumption of these medicines, the global health leader has said that to date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.