Hours after the World Health Organisation (WHO) gave an alert over four cough syrups made in India, the Central Drugs Standard Control Organisation (CDSCO) launched a probe over the drugs that have been linked to acute kidney injuries and 66 deaths among children in The Gambia.<\/p>\n
The four cough syrups, Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, manufactured by Maiden Pharmaceuticals Limited, Haryana, failed the tests after they were found to have unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.<\/p>\n
“To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products. These four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions,” WHO said in its alert.<\/p>\n
WHO said that Diethylene Glycol (DEG) or ethylene glycol is poisonous to humans when consumed and can prove fatal. It can cause kidney and neurological toxicity and has been associated with several cases of mass poisoning when consumed via drugs.<\/p>\n
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.<\/p>\n
The chemical tastes sweet and is water-insoluble. The toxic effects of the chemical include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury. The NIH paper pointed to at least 10 mass poisoning events that have taken place due to the toxic chemical in the past.<\/p>\n
“DEG contamination occurs when it is used in medicinal products instead of a safer\u2014but more expensive\u2014diluent such as pharmaceutical grade glycerin,” the NIH said.<\/p>\n
WHO in its alert ordered that all batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities and immediately notify WHO if these substandard products are discovered in their respective countries.<\/p>\n
India’s CDSCO has taken up the matter and ordered a detailed investigation against the cough and cold syrups produced and exported to The Gambia by Maiden Pharmaceuticals Limited.<\/p>\n
“The CDSCO, while responding to WHO, within an hour-and-a-half, took up the matter immediately thereafter with the concerned State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located. Further, a detailed investigation was launched to ascertain the facts or details in the matter in collaboration with State Drugs Controller, Haryana (the concerned State Drug Control Authority),” the government said in its statement.<\/p>\n