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    • CDSCO flags 34 drugs...

    CDSCO flags 34 drugs for failing quality test; Details

    Farhat NasimWritten by Farhat Nasim Published On 2020-02-15T11:40:19+05:30  |  Updated On 15 Feb 2020 11:40 AM IST
    CDSCO flags 34 drugs for failing quality test; Details

    New Delhi: The apex drug regulator, Central Drugs Standard Control Organization (CDSCO) has flagged 34 batches of medicines for failing quality tests in January, including Sun Pharmaceutical Ltd's Valaciclovir Hydrochloride, Hydrated Ph. Eur; Zydus Healthcare Ltd's Depotex 16 mg (Methylprednisolone Tablets IP) and others.

    The CDSCO recently issued an alert, stating that the regulator tested 1177 drug samples in January. Out of this, 1143 samples were declared as of Standard Quality while 34 drug samples failed to clear the test. The drug samples failed the quality test due to lack of assay content, dissolution, uniformity of volume and presence of particulate matter in the injection.

    The samples were tested in various laboratories in Kolkata, Chandigarh, Guwahati and Mumbai. The samples were drawn by CDSCO in Mumbai, Kerala, Assam, Indore, Arunanchal Pradesh, Ghaziabad, Ahmedabad, Bangalore, Mizoram and Jammu.

    The formulations mentioned in the list include drugs indicated for treating obesity, mental illness, bacterial infection, arthritis and others. The details read;

    S.No.

    Name of Drugs/medical device/cosmetics

    Batch No./Date of Manufacture/Date of Expiry/Manufactured

    By

    Reason for failure

    Drawn By

    From

    1.

    Absorbent Cotton Wool I.P.,

    B. No.: A/1812,

    Mfg dt: 12/2018, Exp dt: 11/2021, Mfd by: M/s. Altus

    Surgical Pvt. Ltd., 21/D, Mahagujarat Ind. Estate, Sarkhej-Bavla Road, Moraiya, Ahmedabad.

    Water Soluble Substances and Sulphated Ash Content

    CDSCO,

    Ahmedabad

    CDL,

    Kolkata

    2.

    Ranitidine Injection I.P.

    B. No.: RI-138,

    Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Rathi Laboratories (Hindustan) Pvt. Ltd.

    Industrial Area, Patna- 800013.

    Particulate matter

    CDSCO,

    North Zone, Ghaziabad

    CDL,

    Kolkata

    3.

    REGUNAC – 50

    (Diclofenac Gastro- Resistant Tablets I.P. 50 mg)

    B. No.: FZ57F801,

    Mfg dt: 06/2018, Exp dt: 05/2021, Mfd by: M/s. Zim

    Laboratories Limited, B- 21/22, MIDC Area,

    Kalmeshwar -441 501, Dist. Nagpur, Maharashtra.

    Description

    CDSCO,

    East Zone, Kolkata

    CDL,

    Kolkata

    4.

    Diclofenac Sodium Tablets I.P.

    B. No.: DF-R008, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Bengal Chemicals &

    Pharmaceuticals Ltd., 115-C, Industrial Estate, Pologround, Indore – 452 015.

    Disintegration

    CDSCO,

    East Zone, Kolkata

    CDL,

    Kolkata

    5.

    Fluconazole Tablets

    B. No.: TOH-02, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Om

    Biomedic Pvt. Ltd., Plot No. 68,69, 82 & 83,

    Sector -6A, Sidcul, Haridwar – 249403 (Uttarakhand).

    Uniformity of Dispersion

    CDSCO,

    East Zone, Kolkata

    CDL,

    Kolkata

    6.

    THEOIMMUNE

    (Pro-Biotic Capsules)

    B. No.: GC190060,

    Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Theon

    Pharmaceuticals Ltd., Vill: Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh -174

    101.

    Assay of Streptococus faecalis, Clostridium butyricum, Bacillus mesentericus, and Lactic Acid bacillus

    CDSCO,

    East Zone, Kolkata

    CDL,

    Kolkata

    7.

    Pantoprazole Gastro- resistant Tablets I.P.

    B. No.: T-6988,

    Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Kwality

    Pharmaceuticals Ltd.,

    Nagkalan, Majitha Road, Amritsar Punjab.

    Description

    CDSCO,

    Sub-Zone, Guwahati

    CDL,

    Kolkata

    8.

    Amloclav 625 (Amoxycillin & Potassium Clavulanate Tablets I.P.)

    B. No.: BT136026,

    Mfg dt: 04/2018, Exp dt: 03/2020, Mfd by: M/s. Shashi

    Pharma, S.N. 77/P, At Vill. Dhanot, Chhatral - 382729, Ta. Kalol. Dist. Gandhinagar (Guj.)

    Water, Dissolution and Assay

    CDSCO,

    Bangalore

    CDL,

    Kolkata

    9.

    Gabapentin Tablets IP 300 Mg

    B. No.: STN-181861,

    Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Terrace Pharmaceuticals (P)

    Description and Related substances

    Drug Control Office District-

    Bilaspur

    RDTL,

    Chandigarh


    Ltd. 3-B (a), Phase-III, Industrial Area Sansarpur Terrace,

    Distt. Kangra ( H.P)-176501

    (H.P.)

    10.

    (Amoxycillin Dispersible Tablets IP 250 mg )

    B. No.: LBT-1578,

    Mfg dt: 03/2019, Exp dt: 09/2020, Mfd by: M/s. Legen

    Healthcare, Plot No.20, Sector -5, Parwanoo,

    Distt.Solan.(H.P.) 173

    220

    Uniformity of Dispersion

    Drug Control Office District - Mandi (H.P.)

    RDTL,

    Chandigarh

    11.

    Albendazole Tablets IP 400MG

    B. No.: 8600219,

    Mfg dt: 01/2019, Exp dt: 12/2021,

    Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot no.14, II Phase, Peenya, Bangalore- 560058.

    Dissolution

    Drug Control Office Ghaziabad (UP)

    RDTL,

    Chandigarh

    12.

    Albendazole Tablets IP 400 MG

    B. No.: ABTW-05, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Nestor

    Pharmaceuticals Limited 11, Western Extension Area, Faridabad-121001 (Haryana).

    Dissolution

    Drug Control Office Ghaziabad (UP)

    RDTL,

    Chandigarh

    13.

    Albendazole Tablets IP 400 MG

    B. No.: 8600119,

    Mfg dt: 01/2019, Exp dt: 12/2021,

    Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot No.14, II Phase, Peenya, Bangalore- 560058.

    Dissolution

    CDSCO,

    Sub-Zone, Jammu

    RDTL,

    Chandigarh

    14.

    Dom-H (Domperidone Suspension)

    B. No.: 1801,

    Mfg dt: 03/2018, Exp dt: 02/2020, Mfd by: M/s. Harsh Healthcare 100-101, Industrial Area Rau- 453331 Madhya Pradesh.

    Assay

    Drugs Control Department, Arunachal Pradesh

    RDTL,

    Guwahati

    15.

    Albendazole Tablets I.P.

    B. No.: 8491015,

    Dissolution

    Drugs

    RDTL,

    400mg

    Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Bengal Chemicals &

    Pharmaceuticlas Ltd. 164, Maniktala Main Road, Kolkata-700054.

    Control Department, Arunachal Pradesh

    Guwahati

    16.

    Albendazole Tablets I.P. 400mg

    B. No.: 9622,

    Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Orissa

    Drugs & Chemicals Ltd. 1, Mancheswar Industrial Estate,

    Bhubaneswar Odisha.

    Dissolution

    Drugs Control Department, Arunachal Pradesh

    RDTL,

    Guwahati

    17.

    Frusemide Tablets I.P. 40 mg. (Rasix)

    B. No.: 7127,

    Mfg dt: 06/2017, Exp dt: 05/2020, Mfd by: M/s.Ramson Remedies 186-187,

    Insustrial Focal Point, Amritsar, A.O. 2G Floor, Baktawar, Malabar Hill,

    Mumbai-6.

    Dissolution

    Drugs Control Department, Arunachal Pradesh

    RDTL,

    Guwahati

    18.

    Nimesulide Tablets 100mg

    B. No.: NP17016,

    Mfg dt: 09/2017, Exp dt: 08/2020,

    Mfd by: M/s. Navketan Pharma Pvt. Ltd., F-106, MIDC, Waluj, Aurangabad-431136 Maharashtra.

    Dissolution

    Drugs Control Department, Arunachal Pradesh

    RDTL,

    Guwahati

    19.

    Telmisartan Tablets I.P. 40mg

    B. No.: TMA1001, Mfg dt: 02/2019, Exp dt: 01/2021,

    Mfd by: M/s. Sai Mirra Innopharm Pvt. Ltd. 288 & 299, SIDCUL Estate, Ambattur, Chennai- 600098 Tamilnadu.

    Dissolution

    Drugs Control Department, Arunachal Pradesh

    RDTL,

    Guwahati

    20.

    Ferrous Sulphate and Folic Acid Tablets I.P.

    B. No.: IFTJ18028, Mfg dt: 09/2018, Exp dt: 08/2020, Mfd by: M/s. Vivek Pharmachem (India) Ltd. EPIP, Bari Brahmana, Jammu- 181133.

    Disintegration

    Drugs Control Department, Assam

    RDTL,

    Guwahati

    21.

    Preginate (Doxylamine

    B. No.: ZD18715,

    Adulterated

    Drugs

    RDTL,

    Succinate and Pyridoxine Hydrochloride Tablets)

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

    Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd. B-3, Dev Bhoomi Industrial Estate Puhana, Iqbalpur Road,

    Roorkee- 247667Uttarakhand.

    Control Department, Nagaland

    Guwahati

    22.

    Radin Syrup (Ranitidine Oral Solution I.P.)

    B. No.: S18J025,

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

    Mfd by: M/s. Shri Hari Pharmaceuticals Plot No. 767/1, Vadsar- Motibhoyan Road, Vill- Vadsar- 382721,

    Taluka, Kalol, Dist- Gandhinagar, Gujarat.

    Assay

    Drugs Control Department, Mizoram

    RDTL,

    Guwahati

    23.

    Paracetamol Tablets

    I.P. 650 (Cule 650)

    B. No.: TPT-190266,

    Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Talwar

    Pharma Jhabrera Road, Kurdi, Manglour-

    247656, Roorkee, Dist- Haridwar Uttarakhand.

    Dissolution

    Drugs Control Department, Assam

    RDTL,

    Guwahati

    24.

    Dressipad (1 Surgical Dressing 10cm. X 10cm.)

    B. No.: KSCD-29, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s.K.S.

    Surgical Pvt. Ltd. Vill- Begmabad, Budhana, Unchi Sadak, Modi

    Nagar, U.P.

    Sterility test

    Drugs Control Department, Kerala

    RDTL,

    Guwahati

    25.

    Dressipad (1 Surgical Dressing 10cm. X 10cm.)

    B. No.: KSCD-12, Mfg dt: 11/2017, Exp dt: 10/2020, Mfd by: M/s. K.S.

    Surgical Pvt. Ltd. Vill- Begmabad, Budhana, Unchi Sadak, Modi Nagar, U.P.

    Sterility test

    Drugs Control Department, Kerala

    RDTL,

    Guwahati

    26.

    Vitamin B-complex Tablet (Prophylactic) NFI (III)

    B. No.: T8605,

    Mfg dt: 12/2018, Exp dt: 05/2020, Mfd by: M/s. Zest

    Pharma, Plot No.275, Sector F, Sanwer Road,

    Assay of Vitamin B1

    Drugs Inspector, CDSCO,

    Sub Zone, Indore

    CDTL,

    Mumbai



    Indore (M.P.) 452015.

    27.

    Depotex 16 mg (Methylprednisolone Tablets IP)

    B. No.: AFV1010, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Zydus Healthcare Ltd., Manufatured at : Vill.

    Saini Majra, Nalagarh- Ropar Road, Nalagarh, Distt.: Solan-HP.

    Dissolution

    CDSCO,

    West Zone, Mumbai

    CDTL,

    Mumbai

    28.

    Olmemark-40 (Olmesartan Medoxomil Tablet IP 40 mg)

    B. No.: TPT8689, Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Trugen

    Pharmaceuticals Pvt. Ltd., Village-Tejjupur, Near Chodiala Rly.

    Station Roorkey, Dist- Haridwar (UK)- 247661.

    Dissolution

    CDSCO,

    Sub Zone, Indore.

    CDTL,

    Mumbai

    29.

    Decodil Expectorant

    B. No.: LF19008,

    Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Ortin

    Laboratories Ltd., 275 & 278 (part) I.D.A.

    Pashamilaram 502307, Sanga Reddy Dist.

    Telangana.

    pH

    CDSCO,

    West Zone, Mumbai

    CDTL,

    Mumbai

    30.

    Ampicillin Capsules I.P. 250 mg

    B. No.: CB181217,

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

    Pharmaceuticals, 2117, A-2, Phase III, G.I.D.C,

    Vapi-396195, Gujarat.

    Assay

    CDSCO,

    West Zone, Mumbai

    CDTL,

    Mumbai

    31.

    Valaciclovir Hydrochloride, Hydrated Ph. Eur.

    B. No.: AA41927,

    Mfg dt: 05/2019, Exp dt: 04/2022, Mfd by: M/s. Sun Pharmaceutical Industries Limited, Industrial Area No.3,

    Dewas 455001 Madhya Pradesh.

    Related Substances

    CDSCO,

    Sub Zone, Indore.

    CDTL,

    Mumbai

    32.

    Valaciclovir Hydrochloride, Hydrated Ph. Eur.

    B. No.: AA41926,

    Mfg dt: 04/2019, Exp dt: 03/2022, Mfd by: M/s. Sun Pharmaceutical

    Related Substances

    CDSCO,

    Sub Zone, Indore.

    CDTL,

    Mumbai


    Industries Limited, Industrial Area No.3, Dewas 455001 M.P.

    33.

    Oral Rehydration Salts IP

    B. No.: GP19127,

    Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Globela

    Pharma Pvt. Ltd., 357,

    358 GIDC, Sachin, Surat-394230, Gujarat.

    Assay for Potassium

    CDSCO,

    West Zone, Mumbai

    CDTL,

    Mumbai

    34.

    Oral Rehydration Salts IP

    B. No.: GP19128,

    Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Globela

    Pharma Pvt. Ltd., 357, 358 GIDC, Sachin, Surat-394230, Gujarat.

    Assay for Potassium

    CDSCO,

    West Zone, Mumbai

    CDTL,

    Mumbai

    Also Read: Drug Alert: CDSCO Declares 49 Drug Samples As Not Of Standard Quality; Details

    For more details click on the below:

    https://business.medicaldialogues.in/pdf_upload/pdf_upload-124157.pdf

    cdscodrug testZydus Healthcaresun pharma

    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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