SWITZERLAND — The World Health Organization (WHO) has issued an alert for batches of two contaminated cough syrups blamed for the deaths of at least 20 children in Uzbekistan.
The contaminated products, Ambronol syrup, and DOK-1 Max syrup were identified in Uzbekistan and reported to the WHO on Dec. 22 of last year.
WHO said the products, manufactured by India’s Marion Biotech, were “substandard” and that the firm had failed to provide guarantees about their “safety and quality.”
India’s health ministry subsequently suspended production at the company and Uzbekistan banned the import and sale of DOK-1 Max.
The WHO alert said an analysis of the syrup samples by the quality control laboratories of Uzbekistan found “unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.”
Diethylene glycol and ethylene are toxic to humans when consumed and can prove fatal. The WHO warned that consumption of the chemicals can result in serious injury or death, including abdominal pain, headache, altered mental state, or acute kidney injury, among other ailments.
The WHO has requested that areas likely to be affected by the contaminations ramp up their surveillance within supply chains, and report back if they discover anything.
It also urged manufacturers of syrups that contain glycerin to test for the presence of contaminants.
The WHO lists Marion Biotech, based in Uttar Pradesh, India, as the manufacturer and it is the second Indian drugmaker to face a probe by regulators since October.
At that time, the WHO linked New Delhi-based Maiden Pharmaceuticals Ltd’s cough syrups to a spate of child deaths in Gambia. The victims, mostly between five months and four years old, died of acute renal failure.
India launched a probe into Maiden Pharmaceuticals but later said the investigation had found the suspect drugs were of “standard quality” and has since denied the allegations.
India is known as the ‘pharmacy of the world,’ and has doubled its pharmaceutical exports over the last decade, touching US$24.5 billion in the last fiscal year.
The alerts over Indian medicines are a blow to the reputation of one of the country’s top industries. India is one of the world’s leading pharmaceutical players supplying key drugs to many countries, particularly in the developing world, including 60 percent of the world’s vaccines.