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Uzbekistan Says 18 Deaths Linked To India-Made Syrup, Centre Responds

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  • Uzbekistan Says 18 Deaths Linked To India-Made Syrup, Centre Responds


    Reported by Vedanta Agarwal, Vishnu Som, Edited by Aditi Gautam Updated: December 29, 2022 2:09 pm IST

    Uzbekistan Says 18 Deaths Linked To India-Made Syrup, Centre Responds

    Uzbekistan Cough Syrup Deaths' Claim: The health ministry of Uzbekistan, in a statement, said that the 18 children who died had consumed cough syrup Doc-1 Max - manufactured by Noida-based Marion Biotech.

    New Delhi:

    Uzbekistan has claimed that at least 18 children in the country have died after allegedly taking an India-manufactured cough syrup.

    The health ministry of Uzbekistan, in a statement, said that the children who died had consumed cough syrup Doc-1 Max - manufactured by Noida-based Marion Biotech.

    India has launched a probe into the matter and the manufacturing of the cough syrup has been halted until the samples are tested.

    Health Minister Mansukh Mandaviya said the samples have been sent to Regional Drugs Testing Laboratory in Chandigarh for testing and that the government would "initiate further action based on the inspection report."

    Mr Mandaviya said the Centre is in touch with Uzbekistan since December 27.

    According to the Uzbekistan's health ministry, the laboratory tests of a batch of syrups found "the presence of ethylene glycol", a toxic substance.

    It also said the syrup was given to children at home without a doctor's prescription, either by their parents or on the advice of pharmacists, with doses that exceeded the standard dose for children...

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  • #2
    Medical Product Alert N°1/2023: Substandard (contaminated) liquid dosage medicines

    Substandard (contaminated) liquid dosage medicines identified in WHO European Region

    11 January 2023
    Medical product alert

    Geneva

    Reading time: 2 min (511 words)

    Alert Summary


    This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical products are products that fail to meet quality standards or specifications and are therefore "out of specification"[1].

    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.

    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.

    Both of these products may have marketing authorizations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions. Please see the Annex for further product information.

    WHO has previously published two Alerts on other contaminated liquid dosage medicines. Please see Medical Product Alert N°6/2022 and Medical Product Alert N°7/2022.
    [1] WHO definitions: https://www.who.int/teams/regulation...nd/definitions

    Risks


    Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal

    The substandard products referenced in this Alert are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.
    Advice to regulatory authorities and the public


    It is important to detect and remove these substandard products from circulation to prevent harm to patients.


    WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised. National regulatory authorities/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.


    Manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, are urged to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.


    All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt.


    If you have these substandard products, please DO NOT use them. If you, or someone you know, have used them or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre. If you have any information concerning the manufacture or supply of these products, please contact WHO via rapidalert@who.int.

    Please see Annex for details of the substandard products referenced in Alert N°1/2023.

    This Alert (including photographs) will be updated if further relevant information becomes available.



    WHO Global Surveillance and Monitoring System

    for Substandard and Falsified Medical Products

    For more information, please visit our website

    Email: rapidalert@who.int

     Alert SummaryThis WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022, and identified in Cambodia, and reported to WHO on 3 April 2023. Substandard medical products are products that fail to meet quality standards or specifications and are therefore "out of specification"[1]. 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.Laboratory analysis of samples of both products found unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.Both of these products may have marketing authorizations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions. Please see the Annex for further product information.WHO has previously published two Alerts on other contaminated liquid dosage medicines. Please see Medical Product Alert N°6/2022 and Medical Product Alert N°7/2022.[1] WHO definitions: https://www.who.int/teams/regulation-prequalification/incidents-and-SF/background/definitionsRisksDiethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal The substandard products referenced in this Alert are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.Advice to regulatory authorities and the publicIt is important to detect and remove these substandard products from circulation to prevent harm to patients. WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised. National regulatory authorities/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.Manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, are urged to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt. If you have these substandard products, please DO NOT use them. If you, or someone you know, have used them or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre. If you have any information concerning the manufacture or supply of these products, please contact WHO via  rapidalert@who.int.  Please see Annex for details of the substandard products referenced in Alert N°1/2023.This Alert (including photographs) will be updated if further relevant information becomes available. WHO Global Surveillance and Monitoring System   for Substandard and Falsified Medical ProductsFor more information, please visit our websiteEmail: rapidalert@who.int    
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