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    • CDSCO warns against...

    CDSCO warns against Cancer Causing Impurities in anti-acidity drug Ranitidine, writes to state drug controllers

    Farhat NasimWritten by Farhat Nasim Published On 2019-09-25T13:19:14+05:30  |  Updated On 16 Aug 2021 12:08 PM IST

    New Delhi: To ensure patient safety, the country's apex drug regulatory body, Central Drugs Standard Control Organisation (CDSCO) has ordered an investigation into the popular anti-acidity drug Ranitidine, for a probable presence of carcinogen impurity. In its directive, the regulator has further asked to ensure that the drug is sold only under prescription.


    In this regard, CDSCO has written to all the state regulators asking them to "communicate to the manufacturers of ranitidine API (active pharmaceutical ingredient) and formulations under your jurisdiction to verify their products and take appropriate measures to ensure patient safety."


    It has been reported from other countries that some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.


    Medical Dialogues had earlier reported that Dr Reddy's Labs suspended the supply of its drug Ranitidine worldwide as a precautionary measure, following the ongoing probe by the US Food and Drug Administration into the reported impurity N-nitrosodimethylamine in it at low levels.






    Also Read: Dr Reddys suspends worldwide supply of Ranitidine over cancer fears until USFDA probe over




    The regulator flagged the concern, ordering to check the presence of N-nitrosodimethylamine in Ranitidine. N-nitrosodimethylamine has been classified by the Internal Agency for Research on Cancer (IARC) as probably carcinogenic to humans.



    As per the letter issued by CDSCO, "The drug Ranitidine is approved for multiple indications in the country and is available in various formulations including tablets, injections, etc. It is a prescription drug included in Schedule H and, therefore, it should be sold by retail only under a prescription of a registered medical practitioner."


    Ranitidine is a commonly prescribed medicine for countering acidity and is on the World Health Organisation's 'Model List of Essential Medicines'. In India, a host of companies including the GalxoSmith Kline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy's, Sun Pharmaceuticals sell over 180 versions of the drug. The market size for Ranitidine brand in India is Rs 688.6 crore, as per data shared by AIOCD PharmaTrac.


    Also Read: Drug Alert: CDSCO declares 31 samples as sub-standard in quality in random sampling; Details

    antacidCadila PharmacarcerCDSCOcdsco alertcdsco letterDCGIDr Reddy'sDr Reddy's LabsGSKHeartburn drugIARCJB Chemicalsndma impuritypharmapharma newspharma news indiaranitidineSun Pharmav g somaniZydus Cadila

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
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