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WHO warning on Maiden Pharma cough syrups — How can low quality ingredient become a killer

healthcare | Oct 6, 2022 11:08 AM IST

WHO warning on Maiden Pharma cough syrups — How can low-quality ingredient become a killer

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Four cough syrups from Maiden Pharma have been linked with acute kidney injuries and 66 deaths among children in The Gambia. Authorities, including CDSCO, have sprung into action. In 2020, too, nine children died of renal failure in Jammu and Kashmir due to Digital Vision's Coldbest PC Cough Syrup, which contained the same ingredient found in Maiden Pharma products.

The WHO has identified four paediatric cough syrups made by Maiden Pharma in India — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — as substandard and linked to the 66 deaths among children in The Gambia, West Africa.

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The Central Drugs Standard Control Organisation (CDSCO) has swung into action and is probing the World Health Organizations' warning against the use of the four cough syrups.
But such contaminations have been found the world over. In 2020, 17 children were hospitalised with renal failure in Jammu and Kashmir due to Coldbest PC Cough Syrup that contained the same ingredient found in Haryana-based Maiden Pharma products. Himachal Pradesh-based pharmaceutical company Digital Vision's Coldbest product was banned, but by then, nine children had lost their lives.
What's the matter about
These cough syrups have been linked with acute kidney injuries among children in The Gambia, leading to deaths. WHO has warned that though the tested samples were from The Gambia, the product might have been travelled or distributed, through informal markets, to other countries or regions.
WHO has recommended all countries remove these products.
As per the tentative results received by the WHO, four out of 23 samples tested have been found to contain diethylene or ethylene glycol (DEG). The WHO said DEG is toxic to humans when consumed and can prove fatal. Their toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury.
What is diethylene glycol?
Diethylene glycol is a solvent present in numerous formulations like brake fluids, paints and chemical preparations. These solvents can cause renal failure and can even cause death when ingested.
DEG is not used to manufacture cough syrups, but the contamination arises mostly if the company manufacturing the drugs uses low-quality industrial grade propylene glycol for the cough syrups where DEG is one of the impurities.
Hence, pharma companies need to ensure that they are using propylene glycol, which is safe as per pharma standards.
Industrial propylene glycol contains high levels of DEG, and if substituted in pharma products, it can be toxic. While there could be other contamination factors, such as an overall faulty supply chain, this is probably the most common one, especially when it comes to cough syrups.
DEG contamination is not new
DEG contamination is not new, as many cases have been recorded since the late 1930s globally. Below are some cases reported in India earlier:
YearCases
1973Linked to deaths of 14 children in Chennai
1986Linked to 21 fatalities in Mumbai
1998Linked to 36 children with renal failure in Gurugram
2020 17 children hospitalised with renal failure in Jammu and Kashmir due to Coldbest PC Cough Syrup
Cough syrups under scanner
This is not the first time cough syrups have been under scrutiny by the government. Earlier in July, a News 18 report had said that the government is reviewing a policy to ban the manufacturing and sale of codeine-based cough syrups. This came after several MPs raised concerns that these syrups are being used as narcotics rather than medicine.
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