Four cough syrups manufactured by a Haryana-based pharmaceutical firm have come under an investigation after the World Health Organization (WHO) cautioned about their linkage to the deaths of 66 children in The Gambia.
On September 29, WHO cautioned the Drugs Controller General of India (DCGI) about the cough syrups, said the media reports. Afterwards, the Central Drugs Standard Control Organisation immediately began working on the matter with the Haryana regulatory authority and launched a detailed investigation, it added.
The media reports said that cough syrups were manufactured by M/s Maiden Pharmaceutical Limited in Haryana's Sonepat, as seemingly the firm exported these products only to The Gambia. The company is yet to respond to the allegations, reports added.
The WHO has also cautioned about the possibility of syrup's distribution outside the West African country leading to global exposure.
Yesterday, Tedros Adhanom Ghebreyesus, the WHO chief, told reporters that the four cold and cough syrups have a potential link with acute kidney injuries and 66 deaths among children.
Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup are the four products mentioned in the WHO alert.
The alert further added that, so far, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products. The alert also mentioned 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 effects can be in the form of abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury, which may lead to death.
According to media reports, WHO is yet to provide a precise one-to-one causal relationship of death. Along with this, the WHO has not yet shared details and photos of labels confirming the manufacturer of the products.
The WHO is yet to provide details on when these deaths occurred.