A day after the World Health Organization issued a formal alert against India-made substandard medicines exported to Uzbekistan, a team of drug inspectors has once again raided the manufacturing unit of Uttar Pradesh-based Marion Biotech.
The WHO on Wednesday announced that the laboratory analyses of samples of Ambronol and DOK-1 Max syrups – both manufactured by Marion Biotech – have found unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants.
The tests have been undertaken by national quality control laboratories of the ministry of health of the Republic of Uzbekistan.
“To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the alert said.
“While the Indian authorities were earlier informed about contamination issue in DOK-1 Max syrup, the alert also named Ambronol syrup. Today, the inspection is going on at Marion’s premises again to collect Ambronol samples as well,” a government official privy to the development told News18.com.
Drug inspectors both from state and central teams have visited the premises.
When asked about the results of the previous samples picked up, the officer said that “the report will be submitted first to the drug controller general of India (DCGI). We are expecting the results soon.”
He also said that DOK-1 Max syrup in the alert was manufactured only for export. “We are checking about the other one (Ambronol syrup).”
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal, the WHO said.
It also said that the substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.
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