WHO recommends not using two Indian cough syrups in Uzbekistan

So far, the manufacturer has not provided guarantees to WHO on the safety and quality of these products, the agency said

Two weeks after Uzbekistan reported deaths of children following consumption of two made-in-India cough and cold syrups, the World Health Organisation has issued an alert against the substandard medicines manufactured by a Noida-based company.

“Laboratory analysis of samples of both products - Ambronol syrup and DOK-1 Max syrup by Marion Biotech - undertaken by national quality control laboratories of the Uzbekistan Ministry of Health found both products contained unacceptable amounts of diethylene glycol and or ethylene glycol as contaminants,” the UN health body said in an alert issued on Wednesday.

"To date, the stated manufacturer has not provided guarantees to the WHO on the safety and quality of these products," the WHO said, identifying the two medicines as "substandard medical products" that fail to meet quality standards or specifications.

The Union Health Ministry, till the time of filing this report, has not responded to queries to clarify whether the two syrups or their equivalent are being sold to other countries or in the Indian market.

The Uttar Pradesh Food Safety and Drug Administration on Wednesday suspended the production license of Marion Biotech, following reports of deaths in Uzbekistan and the company’s inability to provide necessary documents that the drug inspectors sought. On December 30, Union Health Minister Mansukh Mandaviya said all manufacturing activities at the company had stopped.

Within the last six months, the Uzbekistan incident is the second case of DEG/EG contamination in medicines exported from India after the Gambian tragedy in which nearly 70 children died.

The WHO in October flagged the presence of ethylene glycol and diethylene glycol as toxic contaminants in four cough syrup samples (made by Maiden Pharmaceuticals, Haryana) that are reportedly linked to deaths of 70 children in The Gambia. But this was not the first time EG and DEG were found in cough syrups made in India as there have been many similar cases in the past with fatal consequences.

A press statement from the Uzbekistan Health Ministry identified two factors behind the tragedy – excess doses of the medicine in kids who don’t require the drug and contamination of ethylene glycol – one of the two toxic chemicals found in the Gambian case.

The DEG and EG, according to the WHO, are toxic to humans when consumed and can prove fatal. 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.