The World Health Organisation (WHO) issued a Medical Product Alert for two substandard (contaminated) products made by Noida-based Marion Biotech. A cough syrup from the company was linked to the death of 18 children in Uzbekistan.
The two products now under the WHO glare are Ambronol syrus and DOK-1 Max syrup. These products were reported to WHO on December 22. The WHO said substandard medical products are those that fail to meet quality standards or specifications and are therefore "out of specification".
This is the second medical product alert issued to an Indian company by the WHO for manufacturing adulterated drug.
The global body issued a medical alert for cough syrups manufactured by Haryana-based Maiden Pharma last October.
The WHO has said that Marion Biotech has not provided guarantees to them on the safety and quality of these products.
Also read: Exclusive | Uzbek Cough Syrup row: Drug regulators inspect Marion Biotech's manufacturing site
According to the WHO, the laboratory analysis of samples of both products, undertaken by national quality control laboratories under the Ministry of Health of the Republic of Uzbekistan found that both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.
“Both these products may have marketing authorisations in other countries in the region. They may also have been distributed through informal markets to other countries or regions,” the global health body said.
Also read: Cough syrup report awaited; regulator suspends license of Marion
The Drug Controller General of India didn't respond to Moneycontrol's queries related to Marion Biotech's product being red flagged by the WHO.
The development comes after Uttar Pradesh Food Safety and Drug Administration Department suspended the production licence of Marion Biotech Pvt Ltd.
“We have suspended the drug manufacturing licence of Marion Biotech. The company hasn’t responded to the show-cause notice issued by us on the reason for manufacturing violations at the production plant in Noida,” an official at the department told Moneycontrol.
Also read: Pharmexcil suspends membership of Marion Biotech
Asked if these products were sold in India, an official from UP FSDA said, DOK-1 Max syrup was not being sold in India. "We are checking if the company supplied Ambronol syrup in the Indian market," the official said.
According to the official, Marion Biotech founders had two licenses - Form 25 and Form 28 - for manufacturing different types of drugs at the Noida factory.
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