NEW DELHI: The World Health Organization has warned against using two Indian cough syrups linked to the deaths of 18 children in Uzbekistan.
Issuing a Medical Product Alert against the two substandard products, AMBRONOL syrup and DOK-1 Max syrup, manufactured by Noida-based Marion Biotech, WHO said that the firm had not provided guarantees on the safety and quality of these products.
It said that Ambronol syrup and Dok 1 Max “contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants as per laboratory analysis carried out by authorities in Uzbekistan."
Diethylene glycol and ethylene glycol are toxic to humans and could be fatal if consumed, it said in the alert on Wednesday.
The WHO alert comes weeks after Uzbekistan said that 18 children died after consuming a syrup made by the company.
This is the second medical product alert issued to an Indian company by the WHO for manufacturing adulterated drugs.
Last October, the world health body issued a medical alert for cough syrups manufactured by Haryana-based Maiden Pharma, which were linked to the alleged deaths of 66 children in The Gambia.
After Uzbekistan’s health ministry linked the deaths of 18 children to the cough syrups manufactured by Marion Biotech, the Union Health Ministry suspended production at the company. It carried out inspections and collected samples of the products. The results of the tests are yet to be announced by the authorities.
The Uttar Pradesh FSD also suspended the company’s production license this week.
Following the WHO alert against the Noida-based company, a joint team of the Central Drug Standard and Control Organisation (CDSCO) and the Uttar Pradesh Food Safety and Drug Administration Department (UPFSD) conducted fresh inspections in the company, official sources said.
WHO said the matter was reported to them on December 22.
It said substandard medical products fail to meet quality standards or specifications and are therefore "out of specification."
Both of these products - Ambronol syrup and DOK-1 Max syrup - may have marketing authorisations in other countries in the region. They may also have been distributed, through informal markets, to other countries or areas, WHO said.
It further said the “substandard products are unsafe and their use, especially in children, may result in serious injury or death.
“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death, added.
“It is important to detect and remove these substandard products from circulation to prevent patient harm. WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products, it said.