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The health body said cough syrups made by Noida-based Marion Biotech Pvt. Ltd were ‘substandard medical products’ and “fail to meet quality standards or specifications and are therefore out of specification”.
The World Health Organization (WHO) has advised doctors against prescribing two cough syrups manufactured by an Indian pharma company following the death of 19 children in Uzbekistan due to their consumption.
The health body said cough syrups made by Noida-based Marion Biotech Pvt. Ltd were ‘substandard medical products’ and “fail to meet quality standards or specifications and are therefore out of specification”.
In a ‘medical product alert’ issued on Wednesday, the cough syrups were identified as ‘AMBRONOL’ and ‘DOK-1 Max’. “The stated manufacturer of both products is Marion Biotech Pvt Ltd. To date, the manufacturer has not provided guarantees to the WHO on safety and quality of these products,” the WHO said.
It further stated that the laboratory analysis of samples of both products, undertaken by national quality control laboratories of Uzbekistan’s ministry of health found unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. The toxic symptoms may include: abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death, stated the WHO.
Meanwhile, the production license of Marion Biotech was seized by the Uttar Pradesh Food Safety and Drug Administration on Tuesday.
The production of all medicines at the plant had already been stopped per a directive by Union Health minister Mansukh Mandaviya in December 2022.
Following inspection by @CDSCO_INDIA_INF team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday night, while further investigation is ongoing.
— Dr Mansukh Mandaviya (@mansukhmandviya) December 30, 2022
On Jan 6, Uzbekistan arrested four people after the deaths of 19 children who consumed a cough syrup made by the Noida-based pharma company. Two of the detainees of the Scientific Center for Standardization of Medicines were accused of violating testing procedures for the Doc-1 Max syrup. Two other detainees were senior employees of Quramax Medical LLC, which imported the syrup to the Central Asian country.
Uzbekistan said last month it has suspended the sale of all products by Marion Biotech and ordered all pharmacies in the country to remove the company’s products.
This is the second-such controversy surrounding India’s pharma exports after the first involving the deaths of 66 children in Gambia due to Indian-made cough syrup. The syrup was made by New Delhi-based Maiden Pharmaceuticals Ltd.
