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    • Drug Alert: CDSCO...

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

    Farhat NasimWritten by Farhat Nasim Published On 2019-10-24T14:22:32+05:30  |  Updated On 16 Aug 2021 5:34 PM IST

    New Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared batches of 28 drugs made by certain manufacturers as sub-standard in quality, counterfeited and misbranded/ adulterated. These include Norfloxacin Tablets, Soframycin Skin Cream, Ciprofloxacin Tablets, Ranitidine Injection IP.


    The move came following analysis and test conducted by the CDSCO on 951 drug samples as a part of the random sampling. The test found that 28 out of the total drug samples did not meet quality and therefore they were affirmed as not of standard quality (NSQ), spurious and misbranded.


    The set of these 28 drugs in various dosage forms failed the quality test over the presence of description, Assay of Nortriptyline, particulate matter, Water Content and Assay, extractable volume, sterility, disintegration, dissolution and other parameters. The drug samples were drawn by the drug control department and CDSCO counterparts pan India.


    Among the manufacturers, prominent drug maker, Sanofi India's Framycetin Skin Cream (Soframycin Skin Cream) failed the quality test due to assay while a batch of Paracetamol Tablets manufactured by Zee Labs could not meet quality standards over dissolution. Notably, batch of Levocetirizine tablets manufactured by government-run Karnataka Antibiotics & Pharmaceuticals Limited was also found to be spurious.


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


    The medications included in the list are indicative in the treatment of bacterial infection, bacterial infections of the prostate or urinary tract, anxiety and panic disorder, diarrhoea, UTI, RTI, ulcer, constipation, unstable angina and others.




    List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of August 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.Cefixime Oral Suspension I.P.B. No.: MCS-17039,

    Mfg dt: 09/2017, Exp dt: 08/2019,

    Mfd by: M/s. Maxmed Lifesciences Pvt. Ltd. Plot No. 54, Sector IIDC SIDCUL Rudrapur,

    Uttarakhand.
    AssayDrug Control Department, Arunachal PradeshRDTL,

    Guwahati
    2.Norfloxacin Tablets

    I.P. 400 mg
    B. No.: NT606, Mfg dt: 02/2019, Exp dt: 01/2021,

    Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23, Sector-3, Noida, Gautam Budh Nagar, Uttar Pradesh-201301.
    DissolutionDrug Control Department, AssamRDTL,

    Guwahati
    3.Norfloxacin Tablets

    I.P. 400 mg (NORTEC-400)
    B. No.: NTK-18004,

    Mfg dt: 03/2019, Exp dt: 02/2022, Mfd by: M/s. Neutec Healthcare Pvt. Ltd. E- 698, DSIIDC Narela,

    Industrial Area Delhi- 110040.
    DissolutionDrug Control Department, MeghalayaRDTL,

    Guwahati
    4.PGAB-MB 75

    (Pregabalin and Mecobalamin Capsules 75 mg)
    B. No.: WGC1828, Mfg dt: 06/2018, Exp dt: 05/2021, Mfd by: M/s.

    West Coast Pharmaceuticals Works Limited, FP-17 & 16/5 Meldi Mata Temple Near Gota railway Station Crossing, Gota, Ahmedabad – 382481,

    Gujarat.
    Dissolution for PregabalinCDSCO,

    Ahmedabad
    CDTL,

    Mumbai
    5.Levocetirizine tablets I.P. 5mgB. No.: 9704418,

    Mfg dt: 12/2018, Exp dt: 11/2021,

    Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited

    )A Govt. of India Enterprise), Plot No. 14,

    II Phase, Peenya, Bengaluru – 560058.
    DissolutionCDSCO,

    West Zone, Mumbai
    CDTL,

    Mumbai
    6.Alprazolam tablets I.P.B. No.: TAZP-001, Mfg dt: 11/2018, Exp dt: 10/2020,

    Mfd by: M/s. Medipol Pharmaceuticals India Pvt. Limited, 1199/3,

    Bhud, Baddi, distt. Solan. Himachal Pradesh.
    DissolutionCDSCO,

    West Zone, Mumbai
    CDTL,

    Mumbai
    7.Eryfast-250 (Erythromycin Stearate Tablets

    B.P. 250 mg)
    B. No.: MD926, Mfg dt: 04/2019, Exp dt: 02/2022,

    Mfd by: M/s. Mihika Pharmaceuticals, 506,

    Parmeshwari Centre, 18, Dalmia estate, Mulund (W), Mumbai – 400 080.
    AssayCDSCO,

    West Zone, Mumbai
    CDTL,

    Mumbai
    8.Thyrocure-100 (Thyroxine Tablets

    I.P. 100 mcg)
    B. No.: THDT611, 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, KolkataCDL, Kolkata
    9.Eufox-O (Ofloxacin and Ornidazole Tablets)B. No.: CJM711031,

    Mfg dt: 11/2017, Exp dt: 10/2020,

    Mfd by: M/s. Celebrity Biopharma Ltd.,

    Vill: Panga Hill Top Estate, Via-Jharmajri, Barotiwala, Distt. Solan, Himachal Pradesh.
    DisintegrationCDSCO, East Zone, KolkataCDL, Kolkata
    10Ornizole (Ornidazole Tablets I.P. 500 mg)B. No.: T-1710151,

    Mfg dt: 10/2017, Exp dt: 09/2019, Mfd by: M/s. Aagya Biotech Pvt. Ltd.,

    1.5 KM, Manglour- Saharanpur Road, Manglour-247656, Roorkee, Distt. Haridwar,

    (Uttarakhand).
    DescriptionCDSCO, East Zone, KolkataCDL, Kolkata
    11ZEPARA –XT 650

    mg (Paracetamol Tablets 650mg)
    B. No.: 418-955,

    Mfg dt: 10/2018,

    Exp dt: 09/2020, Mfd by: M/s. Zee Laboratories, Industrial Area, Paonta Sahib-

    173025. (Himachal Pradesh)
    DissolutionCDSCO, East Zone KolkataCDL, Kolkata
    12Ticomox CV (Amoxycillin & Potassium Clavulanate Tablets I.P.)B. No.: EBT-18L1588,

    Mfg dt: 12/2018, Exp dt: 02/2020, Mfd by: M/s. Edwin Biotech, Plot No. 184, Indl. Area, Phase IX, SAS, 160059 (Punjab).
    Assay & DissolutionCDSCO,

    Baddi
    CDL, Kolkata
    13MOXCON-CV 625

    (Amoxycillin & Potassium Clavulanate Tablets I.P.)
    B. No.: SRDTB-1233, Mfg dt: 06/2019,

    Exp dt: 11/2020, Mfd by: M/s. Spas Remedise, Vill. Bersan,

    P.O. - Lodhi Majra, Teh. Baddi, Distt. Solan – 173 205 (Himachal Pradesh).
    Dissolution, Water & Assay of Potassium ClavulanateCDSCO,

    Baddi
    CDL, Kolkata
    14Framycetin Skin Cream (Soframycin Skin Cream)B. No.: N8080,

    Mfg dt: 04/2018, Exp dt: 09/2020, Mfd by: M/s. Sanofi India Limited, Plot No. C-1, Madkaim Ind. Estate,

    Ponda, Goa – 403 404.
    AssayCDSCO,

    Baddi
    CDL, Kolkata
    15Monozin 50 (Cefpodoxime Proxetil Oral Suspension I.P.)B. No.: SRDS-1031 , Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Spas Remedies, Vill. Bersan,

    P.O. Lodhi Majra, Teh. Baddi, Distt. Solan – 173

    205. (Himachal Pradesh).
    Assay & "Stability of Cefpodoxime"CDSCO,

    Baddi
    CDL, Kolkata
    16Clopidogrel & Aspirin TabletsB. No.: T8202,

    Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Bharat Parenterals Ltd., Vill. Haripura, Ta. Savli, Dist. Vadodara -391 520,Gujrat.
    Free Salicylic Acid TestCDSCO,

    Ahmedabad
    CDL, Kolkata
    17Frusemide Injection I.P. 2 mlB. No.: AI18064,

    Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Alves Healthcare Pvt. Ltd., Nangal Uperia, Swarghat Road, Nalagarh, Dist.

    Solan, Himachal Pradesh

    – 174 101.
    Extractable VolumeCDSCO,

    Ahmedabad
    CDL, Kolkata
    18Dermacur Cream

    20g (Clobetasol Propionate Cream)
    B. No.: E19009,

    Mfg dt: 01/2019,

    Exp dt: 36 months from date of mfg, Mfd by: M/s. Curis Lifesciences Pvt. Ltd., PF-23, Sanand GIDC - II,

    Sanand, Ahmedabad – 382110.
    AssayCDSCO,

    Ahmedabad
    CDL, Kolkata
    19FLI Drops Eye Drops 5 ml (Fluorometholone Acetate Ophthalmic Suspension 0.1% w/v)B. No.: FLD904021,

    Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Senses Phamaceuticals Ltd., No. 77, 3rd Road, Bommasandra Industrial Area, Bommasandra 4th Phase, Bangalore –

    560 099.
    AssayCDSCO,

    Bangalore
    CDL, Kolkata
    20Dulcoflex (Biscodyl Tablets I.P. 5 mg)B. No.: DLA18146,

    Mfg dt: 12/2018, Exp dt: 11/2021,

    Mfd by: M/s. Recipharm Pharmaservices Pvt. Ltd., Khatha No. 845/713 & 1108/970/1, 34th KM,

    Tumkur Road, T- Begur, Nelamangala, Bangalore, Rural – 562123.
    DisintegrationCDSCO,

    Bangalore
    CDL, Kolkata
    21Ciprofloxcin Tablets I.P. 500mgB. No.: RCTW-06, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Westrn Extension Area

    Faridabad – 121001, India.
    DissolutionCDSCO,

    North Zone, Ghaziabad
    CDL, Kolkata
    22Climox 1.2g (Amoxycillin & Potassium Clavulanate Injection I.P.)B. No.: I-17225,

    Mfg dt: 06/2018, Exp dt: 05/2020,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd.,

    22-24, Majitha Road, Bye Pass, Amritsar 143001 (India) Punjab.
    Assay of Potassium ClavulanateCDSCO,

    Sub-Zone, Goa
    CDL, Kolkata
    23Abiraterone AcetateB. No.: 20180303,

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

    Mfd by: M/s. Shijiazhuang Dingmin Pharmaceuticals Sciences Co. Ltd., No. 41 Zhaiyng South Street, Shijiazhuang, Hebei, China
    Water Content & AssayCDSCO,

    Zone
    CDTL,

    Chennai
    24Calcium-Vitamins Tonic (CALCINOL SYRUP)B. No.: T18016,

    Mfg dt: 07/2018, Exp dt: 12/2019,

    Mfd by: M/s. Raptakos, Brett & Co. Ltd. 1st Pokhran Road, Thane- 400606.
    Assay of CyanocobalaminCDSCO,

    North-Zone Ghaziabad, (UP).
    RDTL,

    Chandigarh
    25(RANITIDINE INJECTION IP)B. No.: HLI849K, Mfg dt: 10/2018, Exp dt: 09/2020,

    Mfd by: M/s. Himalaya Meditek Pvt. Ltd. Plot No. 35 & 36 Pharmacity Selaqui, Industrial Area Dehradun-248197

    (Uttarakhand).
    Particulate MatterCDSCO,

    Ghaziabad (UP).
    RDTL,

    Chandigarh
    26Allopurinol Tablets IP 300 mg (AURINOL-300 TABLETS)B. No.: AT/5515,

    Mfg dt: 11/2018, Exp dt: 10/2020, Mfd by: M/s. Apple Biotech Vill.Deep Nagar, Teh Payal, Ludhiana- 141421 (Punjab) India.
    Assay and DissolutionCDSCO,

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

    Chandigarh
    27Lactic Acid Bacillus Capsules (VIZYLAC CAPSULES)B. No.: G2AD219010,

    Mfg dt: 02/2019, Exp dt: 07/2020, Mfd by: M/s. Uni Medicolabs Plot No. 25 & 26, Pharma City, Selaqui, Dehradun (Uttrakhand).
    Uniformity of filled weightCDSCO,

    North-Zone, Ghaziabad, UP.
    RDTL,

    Chandigarh
    28Gabapentin 400 mg and Nortriptyline 10 mg Tablets (DOLENEURON NT TABLETS )B. No.: DNT1099D, Mfg dt: 04/2019, Exp dt: 01/2021, Mfd by: M/s. Pulse Pharmaceuticals Pvt. Ltd. Khasra No:- 400,407 and 409, Karondi, Roorkee, Uttarakhand-247667.Assay of NortriptylineCDSCO,

    North-Zone, Ghaziabad, UP.
    RDTL,

    Chandigarh

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



    AsprinaurinolCDSCOCentral Drug Standard Control Organisationdermacure creamDrug alertdrug control deptDulcoflexlow quality medicinesnsq drugranitidinesoframycinsub standard drugsVizylaccalcinol syrup

    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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