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    UP Drug Controller finds lapses in Marion Biotech's plant, halts production

    Synopsis

    The UP Drug Controller who is probing the Marion Biotech's facilities that manufactured the alleged contaminated cough syrup linked to death of 18 children in Uzbekistan, said it has found certain lapses in the compliance to current good manufacturing practices (cGMP) and asked the company to halt manufacturing immediately, a top official of the UP Food Safety and Drug Administration told ET.

    cough syrupIANS
    cough syrup
    The UP Drug Controller who is probing the Marion Biotech's facilities that manufactured the alleged contaminated cough syrup linked to death of 18 children in Uzbekistan, said it has found certain lapses in the compliance to current good manufacturing practices (cGMP) and asked the company to halt manufacturing immediately, a top official of the UP Food Safety and Drug Administration told ET.

    "There were certain discrepancies noted, we are also testing the raw materials used to manufacture the cough syrup," a top official of UP Food Safety and Drug Administration told ET.

    "We are coordinating with the CDSCO team, which was also part of the probe, the matter is under investigation," the official added.

    The UP Drug Controller and CDSCO team have launched a joint probe of the Noida-based Marion Biotech facilities that manufactured the Dok-1-Max syrup cough syrup, following Uzbekistan’s health ministry flagging the issue on Wednesday.

    Marion holds an export licence from the Drugs Controller, Uttar Pradesh, to manufacture the Dok-1-Max syrup and tablets.


    The Uzbekistan health ministry has allegedly linked the deaths of 18 children to the Dok-1-Max cough syrup manufactured by the Noida-based Marion Biotech. Uzbekistan had said that a chemical - ethylene glycol - was found in a batch of the cough syrup during laboratory tests.

    Samples of the cough syrup have been taken from the manufacturing unit and sent to the Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing.

    Hasan Harris, a legal representative of Marion Biotech, told ET earlier that there is no problem from the company end and they found no issue in testing.

    "We have been there for the past 10 years. Once the government report comes, we will look into it. For now, the manufacturing has stopped,” Harris said.


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