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    • CDSCO declares 21 drug...

    CDSCO declares 21 drug samples Not of Standard Quality

    Farhat NasimWritten by Farhat Nasim Published On 2019-10-29T16:07:17+05:30  |  Updated On 16 Aug 2021 4:13 PM IST

    New Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared batches of 21 drugs made by certain manufacturers including Cadila Pharma's Chloramphenicol Capsules, as sub-standard in quality, counterfeited and misbranded, spurious/ adulterated in a random drug sample test.


    This came following analysis and test conducted by the CDSCO on 1134 drug samples. Out of this 21 were declared as Not of Standard Quality (NSQ). The drug samples did not meet quality and therefore they were affirmed as not of standard quality (NSQ), spurious, adulterated and misbranded.


    The drug samples tested failed due to the presence of Dissolution, Assay, Fineness of Dispersion, Uniformity of Content, Dissolution and Assay, Particulate Matter, Related Substances, Clarity of Solution & Particulate Matter, Identification of Mycophenolate Sodium, Assay of Sucralfate.


    The drugs samples collected were manufactured by various drug makers including Cadila Pharma, Unicure India Ltd., Nestor Pharma, Syncom Healthcare Limited, Ultra Life Sciences and others.


    The drug samples were tested at four laboratories namely CDL Kolkata, CDTL Mumbai, RDTL Guwahati and CDTL Mumbai.


    The drug samples mentioned in the list include Chloramphenicol Capsules manufactured by Cadila Pharma, Ciprofloxacin Tablets, Dispersible Paracetamol Tablets, Primaquine Tablets, Ranitidine Injection, Atorvastatin Tablets, Calcium Carbonate Tablets and so on.


    The medications are indicative of treating Bacterial infection, headache, including migraine, toothache, sore throat, dysmenorrhoea, rheumatic pains, malaria, bad cholesterol and so on.


    List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of September 2019 reads;






















































































































































































    S. N.Name of

    Drugs/medical device/cosmetics
    Batch No./Date of

    Manufacture/Date of Expiry/Manufactured By
    Reason for failureDrawn ByFrom
    1.Ciprofloxacin Tablets IP 500 MgB. No.: 05028-BTN21,

    Mfg dt: 02/2018 Exp dt: 01/2020,

    Mfd by: M/s. Biogenetic Drugs Pvt. Ltd., Vill.- Jharmazri, Baddi-174103, Dist. Solan, Himachal

    Pradesh.
    DissolutionCDSCO,

    South Zone, Chennai
    CDTL,

    Chennai
    2.Pantoprazole Sodium Tablets IP 40 mgB. No.: GSM-18557,

    Mfg dt: 04/2018, Exp dt: 03/2020, Mfd by: M/s. Chem Pharmaceuticals Pvt. Ltd., plot No. 22, Sector- 3, SIDCUL-IIE, Kudrapur, Dist. US Nagar (Uttarakhand) 263153.
    AssayCDSCO,

    South Zone, Chennai
    CDTL,

    Chennai
    3.Norfloxacin Tablet

    I.P. 400 mg.
    B. No.: NT603, Mfg dt: 02/2019, Exp dt: 01/2021,

    Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23 Sector-3, Noida-201301 Dist-Gautam Budh Nagar (UttarPradesh).
    DissolutionDrugs Control Department, AssamRDTL,

    Guwahati
    4.Chloramphenicol Capsules I.P. 250 mg. (Starphenicol 250)B. No.: JK18002,

    Mfg dt: 03/2019, Exp dt: 02/2020, Mfd by: M/s. Cadila Pharmaceuticals Ltd. Indst. Growth Centre, Samba (Jammu & Kashmir)-184121.
    DissolutionDrugs Control Department, MizoramRDTL,

    Guwahati
    5.Thyrocure-50 (Thyroxine Tablets

    I.P. 50 mcg)
    B. No.: THAT616, Mfg dt: 12/2018, Exp dt: 05/2020, Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida – 201 301, Distt. Gautam Budh Nagar (Uttar Pradesh).AssayCDSCO,

    East Zone,
    CDL,

    Kolkata
    6.Dispersible Paracetamol Tablets B.P. 250 mgB. No.: T-17517,

    Mfg dt: 07/2018, Exp dt: 06/2020,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amristar – 143001 (Punjab).
    Fineness of DispersionCDSCO,

    East Zone,
    CDL,

    Kolkata
    7.Primaquine Tablets IP 2.5mgB. No.: PJVT-01, Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western, Extension Area, Faridabad-121001 (Haryana)Uniformity of Content, Dissolution and AssayCDSCO,

    East Zone,
    CDL,

    Kolkata
    8.Primaquine Tablets I.P.,B. No.: PRD1801, Mfg dt: 03/2018, Exp dt: 02/2020,

    Mfd by: M/s. La-Chemico Private Limited, Taki Road, Kadambagachi, Barasat, North 24- Parganas,

    Kolkata- 700125.
    Uniformity of Content and AssayCDSCO,

    East Zone, Kolkata
    CDL,

    Kolkata
    9.Ranitidine Injection I.P.B. No.: I-17347,

    Mfg dt: 07/2018, Exp dt: 06/2020,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143 001 (Punjab).
    Particulate MatterCDSCO,

    Sub Zone Jammu
    CDL,

    Kolkata
    10.Amiject 500 (Amikacin Sulphate Injection I.P.)B. No.: L079018,

    Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Abaris Healthcare Pvt. Ltd., Survey No.1407-11, Village-Rajpur, Taluka- Kadi, Distt. Mehsana

    (Gujarat).
    Description & Particulate MatterCDSCO,

    Ahmedabad Zone
    CDL,

    Kolkata
    11.PQ-7.5

    (Primaquine Phosphate Tablets I.P.)
    B. No.: PRM-1001B, Mfg dt: 01/2017, Exp dt: 12/2019,

    Mfd by: M/s. Ridley Life Sciences Pvt. Ltd., D- 1651, DSIDC Indl.

    Complex, Nbarela, Delhi- 110 040.
    Uniformity of Content, Dissolution & AssayCDSCO,

    Subzone Bangalore
    CDL,

    Kolkata
    12.Cetfast (Cetirizine Hydrochloride Tablets I.P.)B. No.: MT-17533,

    Mfg dt: 03/2018, Exp dt: 02/2020,

    Mfd by: M/s. Medimark Drugs &Pharmaceuticals, Plot No. 39, Sector - 6A, IIE, Sidcul Haridwar - 249403 (Uttarakhand).
    AssayCDSCO,

    North Zone
    CDL,

    Kolkata
    13.Okacet-L (Levocetirizine Tablets I.P. 5 mg)B. No.: AFB8D36, Mfg dt: 09/2018, Exp dt: 08/2020,

    Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A-30, Sector-8A,

    I.I.E. SIDCUL, Haridwar- 249403 (Uttarakhand).
    Related SubstancesCDSCO,

    North Zone
    CDL,

    Kolkata
    14.Zylocef-S 375 (Ceftriaxone & Sulbactam for Injection)B. No.: 14718/A,

    Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Osper

    Formulations Pvt. Ltd., Plot No. 134-B, Export Promotion Industrial Park, Phase- 1, Jharmajri Baddi, Dist. Solan

    (Himachal Pradesh).
    Clarity of Solution & Particulate MatterCDSCO,

    Baddi
    CDL,

    Kolkata
    15.Atorvastatin Tablets IP 20mgB. No.: 968-01,

    Mfg dt: 01/2019, Exp dt: 12/2020, Mfd by: M/s. Hab Pharmaceuticals & Research Limited., 10, Pharmacity, SIDCUL, Selaqui, Dehradun –

    248011 (Uttarakhand).
    AssayCDSCO,

    West Zone Mumbai
    CDTL,

    Mumbai
    16.Calcium Carbonate Tablets I.P.B. No.: T190324,

    Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Micron Pharmaceuticals, 2117, A-2, Phase-III, G.I.D.C.,

    Vapi – 396195 (Gujarat).
    Uniformity of WeightCDSCO,

    SubZone Indore
    CDTL,

    Mumbai
    17.Cetirizine Hydrochloride Tablets IP 10mgB. No.: SHT9114, Mfg dt: 01/2019, Exp dt: 12/2021,

    Mfd by: M/s. Syncom Healthcare Limited., D- 42, IIE SIDCUL., Selaqui,

    Dehradun – 248197 (Uttarakhand).
    Related SubstancesCDSCO,

    SubZone Indore
    CDTL,

    Mumbai
    18.Mycophenolate Sodium Tablets USP 720 mg

    (Mycophaz-720 Tablets )
    B. No.: AT/7822,

    Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Apple Biotech Vill.Deep Nagar, Tehsil Payal, Ludhiana (Punjab )-141421.
    Identification of Mycophenola te SodiumCDSCO,

    Sub-Zone, Baddi,
    RDTL,

    Chandigarh
    19.Ofloxacin Tablets 400 mg (Ofloz-400 Tablets)B. No.: AHT-1133,

    Mfg dt: 01/2019, Exp dt: 12/2020, Mfd by: M/s. Algen Healthcare Limited 134/2. Vill. Khara Khari, Sadhaura Road, Kala Amb, Distt. Sirmour

    (Himachal Pradesh).
    Uniformity of weight and AssayCDSCO,

    Sub-Zone- Baddi, H.P.
    RDTL,

    Chandigarh
    20.Sucralfate with Oxetacaine Oral Suspension (Sucrazed-O Suspension )B. No.: SL-416,

    Mfg dt: 06/2019, Exp dt: 05/2021,

    Mfd by: M/s. Sridhara Lifesciences Pvt. Ltd. Khasra No. 28, Sisona, Bhagwanpur, Roorkee, Distt. Haridwar

    (Uttrakhand).
    Assay of SucralfateCDSCO,

    Sub-Zone- Baddi, H.P.
    RDTL,

    Chandigarh
    21.Sucralfate with Oxetacaine Oral Suspension (Sucrazed-O Suspension )B. No.: ULL-1855,

    Mfg dt: 09/2018, Exp dt: 08/2020,

    Mfd by: M/s. Ultramed Life Sciences Khasra No. 26, Shiv Ganga Indi. Estate, Lakeshwari

    Bhagwanpur, Roorkee- 247667 (Uttrakhand).
    Assay of SucralfateDrugs Controller Kupwara (HQ), J&KRDTL,

    Chandigarh

    Also Read: Drug Alert: CDSCO declares 28 samples including Soframycin, Ranitidine as sub-standard in quality; Details

    AtorvastatinCadila PharmaCalcium Carbonate tabletsCDSCOCeftriaxoneCentral Drugs Standard Control OrganizationChloramphenicol CapsulesDispersible Paracetamoldrug samplesdrug testiprofloxacinMycophazNestor PharmaOflozPrimaquineRanitidine injectionStarphenicolSucrazedSyncom Healthcare LimitedThyroxineUltra LifeUnicure India

    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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