Lagatar24 Desk
New Delhi, Oct 6: The Central Drugs Standard Control Organization (CDSCO) has opened an investigation following a warning from the World Health Organization about four cold and cough medicines made in India that have been “potentially linked” to acute kidney injuries and 66 child fatalities in The Gambia, an African nation.
On the basis of the facts provided and shared by WHO, CDSCO has reportedly taken up the issue and ordered a thorough inquiry into the cough and cold syrups produced and exported to the Gambia by Maiden Pharmaceuticals Limited, which is situated in Haryana’s Sonepat.
The four syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
WHO Director-General Tedros Adhanom Ghebreyesus said, “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, adding that the loss of young lives due to the products is “beyond heart-breaking for their families”.
“To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the alert said, adding that laboratory analysis of samples of the products “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.”
Those substances are toxic to humans and can be fatal, it said, adding that the toxic effect “can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury.”
All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death, it added.
