Ban on Cough Syrup by Maiden Pharmaceuticals: Soon after the World Health Organization (WHO) banned four Indian-made cough and cold syrups, the Central Drugs Standard Control Organization (CDSCO) launched an investigation into the drugs linked to the deaths of 66 children in The Gambia. Manufactured by Haryana-based Maiden Pharmaceuticals Ltd, there are four cough and cold syrups banned by the WHO —Promethazine Oral Solution, Cofexmaline Baby Cough Syrup, Macoff Baby Cough Syrup and Magrip N Cold Syrup.Also Read – WHO issues warning, investigates Indian cough syrup after 66 children die in Gambia
“The four medicines are cough and cold syrups manufactured by Maiden Pharmaceuticals Limited in India. They failed the test because they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”, the global health agency said. According to provisional results received by the WHO, four of the 23 samples tested were found to contain diethylene glycol/ethylene glycol.
What is diethylene glycol, why is it dangerous?
- Diethylene glycol or ethylene glycol is considered toxic to the human body. When ingested, it can result in kidney and neurological toxicity. DEG has been associated with many cases of mass poisoning when ingested through drugs.
- It is a colorless, practically odorless and hygroscopic liquid with a sweet taste. It is miscible in water, alcohol, ether, acetone and ethylene glycol.
- Toxic effects of diethylene glycol include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status, and acute kidney injury.
- According to a paper from the National Library of Medicine, 10 DEGs of mass poisoning have occurred in the last 70 years. This mass poisoning was caused by DEG-contaminated liquid or ointment drugs. DEG contamination occurs when it is used in medicinal products instead of safer—but more expensive—dilutants such as pharmaceutical grade glycerin.
CDSCO investigation is underway
Meanwhile, sources close to the matter said the CDSCO has taken up the matter and ordered a detailed investigation against the cough and cold syrup manufactured and exported to The Gambia by Maiden Pharmaceuticals Limited.
A preliminary inquiry revealed that Maiden Pharmaceutical Limited is a manufacturer licensed by the State Drug Controller for the products under reference and holds a manufacturing permit for these products.
