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

    Meghna A SinghaniaWritten by Meghna A Singhania   |  

    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 Paracetamol tablets, Ciprofloxacin tablets, Gentamicin injections and Oxytocin Injections.


    The move comes following analysis and test conducted by the CDSCO on 1064 drug samples as a part of the random sampling. The test found that 31 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 four laboratories namely CDL, Kolkata, CDTL, Mumbai, RDTL, Guwahati and RDTL, Chandigarh.


    The set of these 31 drugs in various dosage forms failed the quality test over the presence of foreign matter, description, particulate matter, extractable volume & assay, sterility, disintegration, dissolution and others parameters. The manufacturers of the drugs are based in states like Rajasthan, Punjab, Chandigarh, Gujarat, Maharashtra, Himachal Pradesh, Uttarakhand and Goa.


    The medications included in the list are indicative of treating pain, cold or flu symptoms; antibacterial drug to treat and prevent several infections; induce labour, strengthen labour contractions childbirth, control bleeding after childbirth, or to induce an abortion.


    List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of April 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.IBUPROFEN TABLETS IP 200 MGB. No.: 5922,

    Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Vikram

    Laboratories (P) Ltd., Behind Tubewell Colony, Meerut Road,

    Muzaffarnagar-251002.    		Test for DissolutionCDSCO,

    South Zone, Chennai    		CDTL,

    Chennai
    2.PANCURE TABLETS (PANTOPRAZOLE TABLETS IP 40 MG)B. No.: SLP-18123,

    Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Sterlife

    Pharma Pvt Ltd., Plot No. 90 R.S No.3/P1,

    Vardhman Industrial Park, Nh-27, Bhojpara-360311, Rajkot, Gujarat.    		Test for DissolutionCDSCO,

    Zonal Office, Ahmedabad    		CDTL,

    Chennai
    3.Thyrocure - 100 (Thyroxine Tablets

    I.P. 100 mcg)    		B. No.: THDT605, Mfg dt: 07/2018, Exp dt: 12/2019,

    Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23,Sector- 3, Noida-201301, Distt.

    Gautam Budh Nagar (U.P.).    		AssayCDSCO, East Zone, KolkataCDL,

    Kolkata
    4.DIASET 2

    (Glimepiride Tablets

    I.P. 2 mg)    		B. No.: L35C15,

    Mfg dt: 06/2018, Exp dt: 05/2021,

    Mfd by: M/s. Stadmed Private Limited, C-18, Sarojini Nagar Industrial Estate, Lucknow – 226 008.    		DissolutionCDSCO, East Zone, KolkataCDL,

    Kolkata
    5.OCONA-CT Scalp Solution (Coal Tar & Ketoconazole Solution) – 50 mlB. No.: COAK89, Mfg dt: 12/2017, Exp dt: 11/2019,

    Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd. 47, 48, Sector - 6A, I.I.E.,

    SIDCUL, Haridwar – 249 403, Uttarakhand.    		Foreign MatterCDSCO, East Zone, KolkataCDL,

    Kolkata
    6.Tranexamic Acid Injection I.P. 500mg

    /5 ml    		B. No.: TA-024,

    Mfg dt: 01/2018, Exp dt: 12/2019, Mfd by: M/s. Redico

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

    Hyderabad    		CDL,

    Kolkata
    7.Gentamicin Injection

    I.P. 80 mg / 2ml    		B. No.: 1794,

    Mfg dt: 12/2017, Exp dt: 11/2020, Mfd by: M/s. Sai

    Parenterals Pvt. Ltd., D4, Phase V, IDA Jeedimetla, Hyderabad - 500 055.    		Description & Particulate MatterCDSCO,

    Hyderabad    		CDL,

    Kolkata
    8.Climox 1.2g (Amoxycillin & Potassium Clavulanate Injection I.P.),B. No.: I-16813,

    Mfg dt: 04/2018, Exp dt: 03/2020,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22- 24, Majitha Road, Bye

    Pass, Amritsar -143001 (India).    		Particulate Matter & Clarity of SolutionCDSCO, Sub

    Zone Goa    		CDL,

    Kolkata
    9.Oxytocin Injection I.P.B. No.: I-16999,

    Mfg dt: 05/2018, Exp dt: 04/2020,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22- 24, Majitha Road, Bye Pass, Amritsar 143001 (India)    		Description, Particulate Matter, Extractable Volume & AssayCDSCO, Sub

    Zone, Baddi    		CDL,

    Kolkata
    10.Hemosponge (Absorbable Gelatin Sponge U.S.P.)B. No.: 20180601,

    Mfg dt: 06/2018, Exp dt: 05/2022,

    Mfd by: M/s. Goodwill Lifesciences, 157-158, RJD Integrated Textile Park, Paal-Hazira Road, Ichhapore, Surat - 394510    		SterilityCDSCO,

    Ahmedabad    		CDL,

    Kolkata
    11.Vomiros-4MD (Ondansetron Orally Disintegrating Tablets IP)B. No.: ST-457,

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

    Mfd by: M/s. Sridhara Life Science Pvt. Ltd., Khasra No.285, 290, Village- Sisona, Bhagwanpur, Roorkee, Haridwar (Uttarakhand) 247661.    		DisintegrationCDSCO,

    West Zone, Mumbai    		CDTL,

    Mumbai
    12.Carbamazepine Tablets I.P. 200 mgB. No.: CRB801, Mfg dt: 02/2018, Exp dt: 01/2021, Mfd by: M/s. Medico

    Remedies Limited, (A WHO GMP & ISO 9001-

    2015 Certified Company)

    50, Juhu Supreme Shopping Center, Gulmohar Cross Road No.9, Juhu, Mumbai-400

    049. Factory at 8 & 9 Dewan & Sons Udyog

    Nagar, Palghar 401 404 Maharashtra.    		DisintegrationCDSCO,

    West Zone, Mumbai    		CDTL,

    Mumbai
    13.Fusigen Ointment (Sodium Fusidate Ointment BP)B. No.: GF568003,

    Mfg dt: 11/2018, Exp dt: 04/2021, Mfd by: M/s. Geno

    Pharmaceuticals Private Limited., situated at Thivim Industrial Estate, Karaswada, Mapusa, Goa- 403526.    		AssayCDSCO, Sub

    Zone/ Port Office, Goa    		CDTL,

    Mumbai
    14.Ciprofloxacin Tablets I.P. 500mgB. No.: CT70140,

    Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega    		DissolutionDrugs Control Department AssamRDTL,

    Guwahati
    Biotech Ltd. 7th Mile Stone,
    Dehradun Road, Roorkee,
    Uttarakhand- 247667.
    15.Cefpodoxime Proxetil Dispersible Tablets (Eziprod 200)B. No.: MHV-100, Mfg dt: 12/2017, Exp dt: 11/2019, Mfd by: M/s. Vee

    Laboratories Village Kaller,    		Assay &

    Disintegration    		Drugs Control Department MizoramRDTL,

    Guwahati
    Subathu Road, Saproon
    (Post) Solan- 173211
    (H.P.).
    16.Paracetamol Tablets I.P 650 mg (Pelmol-650)B. No.: MST-17528,

    Mfg dt: 07/2017, Exp dt: 06/2019, Mfd by: M/s. M Sea

    Pharmaceuticals Pvt. Ltd. Surajpur, Paonta Sahib, Dist- Sirmour (H.P.)-

    173025.    		DissolutionDrugs Control Department AssamRDTL,

    Guwahati
    17.Paracetamol Tablets I.P 500 mgB. No.: CT70153,

    Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile

    Stone, Dehradun Road, Roorkee, Uttarakhand- 247667.    		DissolutionDrugs Control Department AssamRDTL,

    Guwahati
    18.Paracetamol Tablets I.P 500 mgB. No.: BT70106,

    Mfg dt: 05/2017, Exp dt: 04/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile

    Stone, Dehradun Road, Roorkee, Uttarakhand-

    247667.    		DissolutionDrugs Control Department AssamRDTL,

    Guwahati
    19.Paracetamol Tablets I.P 500 mgB. No. : CT70154,

    Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile

    Stone, Dehradun Road, Roorkee, Uttarakhand-

    247667.    		DissolutionDrugs Control Department AssamRDTL,

    Guwahati
    20.Ciprofloxacin HCL Tablets I.P 500mgB. No.: CT70140,

    Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile

    Stone, Dehradun Road, Roorkee, Uttarakhand-

    247667.    		DissolutionDrugs Control Department AssamRDTL,

    Guwahati
    21.PANTOPRAZOLE GASTRO- RESISTANT TABLETS IP 40 MGB. No.: TJPE802, Mfg dt: 03/2018, Exp dt: 02/2020,

    Mfd by: M/s. Unicure (India) Ltd. (Unit - II) 46(B)/49/B, Village Raipur, Bhagwanpur, Roorkee - 247661 (U.K.).    		DissolutionCDSCO,

    S.Z., Jammu.    		RDTL,

    Chandigarh
    22.B-COMPLEX TABLETS NFIB. No.: T-17313,

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

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22- 24, Majitha Road, Bye Pass, Amritsar- 143001(India).    		Identification B and the Assay of Calcium PantothenateH.Q. State JammuRDTL,

    Chandigarh
    23.B-COMPLEX TABLETS NFIB. No.: T-17377,

    Mfg dt: 07./2018, Exp dt: 06./2020, Mfd by: M/s. Jackson

    Laboratories Pvt. Ltd. 22- 24, Majitha Road, Bye Pass, Amritsar- 143001(India).    		Identification B and the Assay of Calcium Pantothenate.H.Q. State JammuRDTL,

    Chandigarh
    24.Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets ( AMOXRAG-625 TABLETS )B. No.: SLB-759, Mfg dt: 08/2018, Exp dt: 01/2020,

    Mfd by: M/s. SKOHIND LABS 20, Ext HPSIDC,

    Ind. Area, Baddi (H.P.) 173205.    		Identification B and the Assay of Potassium Clavulanate Diluted calculated as Clavulanic Acid, Lactic Acid

    Bacillus.    		H.P StateRDTL,

    Chandigarh
    25.Hydroxy Propyl Methyl Cellulose Ophthalmic Solution ( HYPROMELLOSE OPHTHALMIC SOLUTION USP )B. No.: 8B05170,

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

    Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt Ltd.

    N-118, 119, 113, 119/1, 119/2, & 118/1, M.I.D.C.,

    Tarapur, Boisar, Dist.Palghar - 401506.    		SterilityFDA,

    Haryana    		RDTL,

    Chandigarh
    26.Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP along with sterile Pricon Angular Cannula 23G. ( APPAVISC PFS SOLUTION )B. No.: PFB-701, OPCP-195,

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

    Mfd by: M/s. Appasamy Ocular Devices (P) Ltd., Plot No. 74-D, Katha Baddi, Distt.Solan (H.P.)- 173205 Mfd. By: Iscon Surgicals Limited 22/4 Heavy Industrial Area

    Jodhpur-342003, Rajasthan, India.    		Sterility B.Drug Controller officer, Haryana KarnalRDTL,

    Chandigarh
    27.(DEXAMETHASON E SODIUM PHOSPHATE INJECTION IP)B. No.: 317-936,

    Mfg dt: 09/2017, Exp dt: 08/2019, Mfd by: M/s. Zee

    Laboratories Ltd Behind 47, Industrial Area, Paonta Sahib -173025. INDIA.    		Assay of Dexamethasone Sodium Phosphate Calculated as Dexamethasone PhosphateDrugs Controller officer, JhajjarRDTL,

    Chandigarh
    28.Amoxycillin Trihydrate, Clavulanate Potassium Tablets (AMOXCV-625 TABLETS)B. No.: VRBT-1863, Mfg dt: 09/2018, Exp dt: 02/2020,

    Mfd by: M/s. Vaishnav Remedies Khasra No. 524, Village - Sailyar Shalapur, Madhopur Road, Roorkee, Distt- Haridwar Uttrakhand

    - 247667.    		Identification and the Assay of Amoxycillin Trihydrate calculated as Amoxycillin, Clavulanate Potassium calculated as

    Clavulanic Acid.    		Drugs Controller officer, Haryana KarnalRDTL,

    Chandigarh
    29.Heparin Injection IP 25000 units (AZZIRIN INJECTION )B. No.: MCP19388,

    Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Health Biotech Ltd. Unit-II, Sandholl-173205.    		Assay of Heparin SodiumDrugs Controller officer, PanchkulaRDTL,

    Chandigarh

    Also Read: Red Flag: CDSCO warns against Medtronic pacemaker for battery-related malfunction
    analysisCarbamazepine TabletsCDSCOCefpodoxime Proxetil Dispersible TabletsCentral Drugs Standard Control OrganisationclimoxDCGIdrug samplesDrugs Controller General of IndiaEziprodFusigen OintmentGentamicin injectionGlimepiride TabletsHemospongeIbuprofen tabletsLaghu Udyog BharatiNot of Standard QualityNSQoxytocin injectionpancure tabletsParacetamolParacetamol TabletsSpuriousSQstandard qualityThyrocureTranexamic Acid Injection

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    Meghna A Singhania
    Meghna A Singhania

      Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

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