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    • Drug Alert: CDSCO...

    Drug Alert: CDSCO declares 26 drug samples as sub-standard in quality in random sampling; Details

    Farhat NasimWritten by Farhat Nasim Published On 2019-07-08T16:16:41+05:30  |  Updated On 17 Aug 2021 10:14 AM IST

    New Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared more than a dozen drugs as sub-standard in quality, counterfeited and misbranded/ adulterated. These include Aspirin Gastroresistant tablets IP, Ofloxacin Tablets I.P. 400 mg, Ciprofloxacin Tablets IP (P-CIP 500 TABLETS), Glimepiride Tablets IP 3mg and others.


    The move comes following analysis and test conducted by the CDSCO on a total of 843 drug samples as a part of the random sampling. The test found that 26 out of the total drug samples did not meet quality and therefore they were affirmed as not of standard quality (NSQ), spurious and misbranded under Form-13, Form-34 and Form- MD-32.


    The drug samples were tested at CDSCO, South Zone, Chennai; Drug Control Department at Meghalaya, Mizoram and Assam. CDSCO, Sub Zone/Port Office, Goa; CDSCO, North Zone, Ghaziabad; Office of Drugs Inspector, Sirmour (H.P) and Drugs Control Department Delhi and Jhajjar also named from where the drug samples were drawn.


    The set of these 26 drugs in various dosage forms failed the quality test over Particulate Contamination, pH, Test for Salicylic Acid and assay of Aspirin, Test for Dissolution, Identification & Assay, Identification, Uniformity of weight & Assay, Description & Particulate Matter.


    The medications included in the list are indicative of preventing blood clots forming following a heart attack or stroke; drug to treat a variety of bacterial infections; medication for the treatment of severe bacterial infections; drug to control high blood sugar in people with type 2 diabetes and others.


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






















































































































































































































    S.

    N.
    Name of Drugs/Medical

    device/cosmetics
    Batch No./Date of Manufacture/Date of

    Expiry/Manufactured By.
    Reason for failureDrawn ByFrom
    1.TELMISARTAN TABLETS IP 40 MG (TELMIRAL 40)B. No.:78TML18002,

    Mfg dt: 11/2018, Exp dt: 06/2020,

    Mfd by: M/s. Crescent Therapeutics Limited Khasra No. 587/588, Beside Jharmajri, Village: Kunjhal, Baddi, Tehsil: Nalagarh, Dist. Solan(H.P)

    173205.
    Test for DissolutionCDSCO,

    South Zone, Chennai.
    CDTL,

    Chennai
    2.Compound Sodium Lactate Injections I.P.B. No.: R-1/18/145,

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

    Mfd by: M/s. Sanctus Drugs & Pharmaceutical Pvt. Ltd, Plot No. 251, Sector-1, Pithampur, Dist. Dhar (M.P.).
    BETDrug Control Department, MeghalayaRDTL,

    Guwahati
    3.Compound Sodium Lactate Injections I.P.B. No.: R-1/18/140,

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

    Mfd by: M/s. Sanctus Drugs & Pharmaceutical Pvt. Ltd, Plot No. 251, Sector-1,

    Pithampur, Dist. Dhar, Madhya Pardesh.
    BETDrug Control Department, MeghalayaRDTL,

    Guwahati
    4.Amoxycillin And Potassium Clavulanate Tablets

    I.P. (Clavage-1000)
    B. No.: SBPT- 4321, Mfg dt: 02/2018, Exp dt: 07/2019, Mfd by: M/s. Saitech

    Medicare Pvt. Ltd. Trilokpur Road, Kala Amb (H.P.)- 173030.
    Test for DissolutionDrug Control Department, MizoramRDTL,

    Guwahati
    5.Pantoprazole For Injection (Panzel)B. No.: 318-7,

    Mfg dt: 01/2018, Exp dt: 06/2019, Mfd by: M/s. Zee

    Laboratories, 47, Industrial Areas, Paonta Sahib- 173025.
    Particulate ContaminationDrug Control Department, AssamRDTL,

    Guwahati
    6.Finzest (Terbinafine Hydrochloride Cream 1% w/w)B. No.: FZ0417,

    Mfg dt: 11/2017, Exp dt: 10/2019,

    Mfd by: M/s. Medizest Pharmaceuticals Pvt. Ltd., Plot No. L-40, Verna

    Industrial Estate, Verna, Goa-403722.
    pHCDSCO, Sub

    Zone/Port Office, Goa
    CDTL,

    Mumbai
    7.LEVOCETIRIZINE HYDROCHLORIDE TABLETS IP 5 MGB. No.: SHT8957, Mfg dt: 09/2018, Exp dt: 08/2021,

    Mfd by: M/s. SYNCOM Health care Limited,D- 42,IIE SIDCUL,

    Selaqui, (Dehradun) 248197 Uttarakhand.
    Test of DissolutionCDSCO,

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    8.ASPIRIN GASTRO- RESISTANT TABLETS IPB. No.: HAGT18004, Mfg dt: 09/2018, Exp dt: 08/2020,

    Mfd by: M/s. RAVIAN LIFE SCIENCE PVT.LTD

    Plot No 34 Sector -8 A IIE SIDCUL

    Haridwar-249403, Uttarakhand India.
    Test for Salicylic Acid and assay of AspirinCDSCO,

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    9.Cefixime Tablets IP (MICRA-200

    Tablets)
    B. No.: R-132,

    Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Escape

    Lifesciences Pvt. Ltd. Chudiala Station Road, Village Khelpur Bhagwanpur, Roorkee, UK.
    Identification & AssayOffice of Drugs Inspector, Sirmour (H.P)RDTL,

    Chandigarh
    10.Ciprofloxacin Tablets IP (P-CIP 500 TABLETS )B. No.: R-124,

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

    Mfd by: M/s. Pansun, Pharmaceuticals,Plot No. 183, Sector 6A, IIE,Sidhgual, Haridwar

    (U.K).
    Identification, Uniformity of weight & AssayOffice of Drugs Inspector, Sirmour (H.P)RDTL,

    Chandigarh
    11.Amoxycillin and Potassium Clavulanate Tablets IP 625 mg

    (ANAXIM-CV 625 TABLETS)
    B. No.: R-20219,

    Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. AnA

    Pharmaceuticals Plot No.183, Sector 6A, IIE, Sidhgual Haridwar (U.K).
    Identification & AssayOffice of Drugs Inspector, Sirmour (H.P)RDTL,

    Chandigarh
    12.Cefixime Tablets IP (GECEFF-200

    Tablets)
    B. No.: R-129,

    Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. GEFEX

    PHARMA Pvt. Ltd. IGC,

    Phase-I, Samba- 184121(J&K).
    Identification & AssayOffice of Drugs Inspector, Sirmour (H.P)RDTL,

    Chandigarh
    13.Neomycin Sulphate, Polymixin-B Sulphate and Bacitracin Zinc PowderB. No.: GLEP-181020,

    Mfg dt: 10/2018, Exp dt: 09/2020,

    Mfd by: M/s. Grampus Laboratories Vill. Johron,

    Industrial Area,Kala Amb, Distt. Sirmour (H.P).
    IdentificationCDSCO,

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    14.Neomycin Sulphate, Polymixin-B Sulphate and Bacitracin Zinc PowderB. No.: GLEP-181006,

    Mfg dt: 10/2018, Exp dt: 09/2020,

    Mfd by: M/s. Grampus Laboratories Vill. Johron, Industrial Area,Kala Amb, Distt. Sirmour (H.P).
    IdentificationCDSCO,

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    15.Cefixime and Ofloxacin Tablets (P-XIME-O TABLETS )B. No.: R-110,

    Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Pansun

    Pharmaceuticals, Plot No. 22&23, Station Road,Bala Industrial Area, Sikkim.
    Identification, & AssayOffice of Drugs Inspector, Sirmour (H.P)RDTL,

    Chandigarh
    16.Ciprofloxacin HCl Tablets IP (PENCIP- 500 TABLETS)B. No.: R-21719,

    Mfg dt: 12/2018, Exp dt: 11/2020,

    Mfd by: M/s. Pansun, Pharmaceuticals,Plot No. 183, Sector 6A, IIE,

    Sidhgual, Haridwar (U.K).
    Identification, & AssayOffice of Drugs Inspector, Sirmour (H.P)RDTL,

    Chandigarh
    17.Glimepiride Tablets IP 3mgB. No.: GPDT18005, Mfg dt: 10/2018, Exp dt: 09/2020,

    Mfd by: M/s. RAVIAN LIFESCIENCE PVT. LTD.,

    Plot No. 34, Sector- 8A, IIE, SIDCUL, Haridwar-249403,

    (Uttarakhand).
    Test for DissolutionDrugs Control Department, DelhiRDTL,

    Chandigarh
    18.Lignocaine and Adrenaline Injection IPB. No.: V-7079,

    Mfg dt: 11/2017, Exp dt: 10/2019, Mfd by: M/s. ALPA

    LABORATORIES LTD, 33/2, A.B.Road,

    Pigdamber-453446, Indore (M.P.).
    Test for AssayDrugs Control Officer, JhajjarRDTL,

    Chandigarh
    19.PRE AND PROBIOTIC CAPSULES-DSB. No.: UPPC-1801 Mfg dt: 08/2018, Exp dt: 01/2020,

    Mfd by: M/s. Heal (India) Laboratories Pvt. Ltd.,No. 197/1,Periyapalayam Road, Manjankaranai- 601102,Tamilnadu.
    Identification & AssayCDSCO,

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    20.METRONIDAZOLE BENZOATE ORAL SUSPENSIONB. No.: MNSG18-255,

    Mfg dt: 11/2018, Exp dt: 10/2020,

    Mfd by: M/s. ORNATE LABS PVT. LTD. Bela

    Industrial Estate, Muzaffarpur-842005, Bihar
    Test for MetronidazoleCDSCO,

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    21.Drotaverine Hydrochloride InjectionB. No.: DTB-003, Mfg dt: 10/2017, Exp dt: 09/2019, Mfd by: M/s. Radico

    Remedies, 123, Mandhala, Barotiwala, Distt. Solan (H.P.) 174103.
    Description & Particulate MatterCDSCO,

    Hyderabad Zone
    CDL,

    Kolkata
    22.Ofloxacin Tablets

    I.P. 400 mg
    B. No.: BT8291,

    Mfg dt: 10/2018 Exp dt: 09/2020,

    Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee-247667, Uttarakhand.
    Uniformity of weightCDSCO,

    North Zone, Ghaziabad
    CDL,

    Kolkata
    23.Alprazolam Tablets I.P.B. No.: TAZP-002, Mfg dt: 11/2018, Exp dt: 10/2020, Mfd by: M/s. Medipol

    Pharmaceuticals India Pvt.

    Ltd., 1199/3, Bhud, Baddi, Distt. Solan, H.P., India.
    Test for DissolutionCDSCO,

    North Zone, Ghaziabad
    CDL,

    Kolkata
    24.M-BETASONE

    (Betamethasone Tablets I.P. 0.5 mg)
    B. No.: OPT7531, Mfg dt: 01/2018, Exp dt: 06/2020, Mfd by: M/s. Omega

    Pharma, Khasra No. 482, Village Saliyar, Roorkee, Dist. Haridwar, Uttarakhand
    Assay & Related substancesCDSCO,

    Ahmedabad Zone.
    CDL,

    Kolkata
    25.Domperidone Tablets I.P. 10 mgB. No.: DMP-18, Mfg dt: 02/2017, Exp dt: 01/2020,

    Mfd by: M/s. Bewell Labs Pvt. Ltd., Rabindranagar,

    P.O. Laskarpur,

    Dist. 24 Parganas (S) West Bengal 700 153.
    Assay & DissolutionCDSCO,

    East Zone, Kolkata
    CDL,

    Kolkata

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

    adulterated drugsAspirinbacterial infectionCDSCOCiprofloxacinDelhidiabetesDrug alertDrug Control DepartmentDrug Control officerGlimepirideheart attackOfloxacinpharmapharma newspharma news indiaSubstandard drugs

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    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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