Marion Biotech’s production licence suspended
The World Health Organisation (WHO) has also issued a medical product alert on Ambronol and Dok-1 Max syrups, both manufactured by Marion Biotech in Noida, Uttar Pradesh
The production licence of Noida-based pharmaceutical firm Marion Biotech, allegedly linked to the deaths of 18 children in Uzbekistan, has been suspended while the results of its controversial cough syrup are awaited, an Uttar Pradesh drug official said on Thursday.
The World Health Organisation (WHO) has also issued a medical product alert on Ambronol and Dok-1 Max syrups, both manufactured by Marion Biotech in Noida, Uttar Pradesh. A team of central agencies and the Uttar Pradesh drug department had carried out an inspection at the firm’s office here on December 29 and taken six more samples for testing.During the inspection, the company representatives could not produce documents related to the production of ‘Dok-1 max’ cough syrup, prompting the government to order halting of its production immediately, Gautam Buddh Nagar Drug Inspector Vaibhav Babbar said. “The production licence of the firm remains suspended, as was ordered on December 29. Now the suspension order has been issued in writing to the firm on January 10 and has been acknowledged by the firm,” Babbar said.On the status of the test results, the officer said the samples were taken by the central agencies and their results are yet to arrive. Marion Biotech did not sell ‘Dok-1 Max’ and Ambronol in India and its only export has been to Uzbekistan, Babbar said on Thursday and estimated that the company exported around 1 lakh Dok-1 Max syrups in 45 days. On Wednesday, the WHO also issued a ‘medical product alert’, referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022.
According to WHO, substandard medical products are those that fail to meet quality standards or specifications and are therefore “out of specification.”“The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the WHO stated. “Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants,” it said. The global health body said that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.