Drug alert: 50 drug samples declared as NSQ in April 2024

Drug alert: Download the list of NSQ samples for April 2024, the link is given below the article

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NSQ Drugs Substandard drugs Fail samples NSQ Samples Substandard samples
NSQ Drugs

Last Updated on June 9, 2024 by The Health Master

Drug alert

Drug alert: Download the list of NSQ samples for April 2024the link is given below: 50 drug samples declared as not of standard quality (NSQ), nationwide.

NSQ Lists are given below the article

Out of these 50 samples, 33 were declared NSQ by CDSCO and 17 were declared NSQ by various STATES across India.

Laboratory Research Testing Flask Chemistry
Picture: Pixabay

Details of the NSQ samples declared by STATES is as under:

Sr.Name of STATESNumber of NSQ samples declared
 1Jammu & Kashmir2
 2Goa2
 3Kerala11
 4Madhya Pradesh2
 Total17

NOTE:

1. NSQ data was not received as per Format & in EXCEL SHEET from STATE Drugs Licensing Authorities of Karnataka & Uttar Pradesh for the Month of April, 2024 as per DCG(I) Circular dated 09.02.2024.

2. STATE Drugs Licensing Authorities of Mizoram, Tripura, Pondicherry have stated that the NSQ data as “NIL” for the Month of April, 2024.

3. STATE Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of April, 2024 as per DCG(I) Circular dated 09.02.2024.

Every month, the drug regulator comes up with a list of drugs, medical devices, and cosmetics that are declared not of standard quality, spurious, adulterated, or misbranded.

Drug alert: Previous months

During the month of March 2024, the authorities tested 931 samples, out of which 864 were of standard quality. The number of samples declared as not of standard quality was 66, with one being misbranded and none being spurious.

During the month of February 2024, the authorities tested 1167 samples, out of which 1018 were of standard quality. The number of samples declared as not of standard quality was 58, with none being misbranded and two being spurious.

During the month of January 2024, the authorities tested 932 samples, out of which 886 were of standard quality. The number of samples declared as not of standard quality was 46, with none being misbranded and none being spurious.

During the month of December 2023, the authorities tested 1008 samples, out of which 930 were of standard quality. The number of samples declared as not of standard quality was 78, with none being misbranded and none being spurious.

During the month of November 2023, the authorities tested 1197 samples, out of which 1133 were of standard quality. The number of samples declared as not of standard quality was 62, with one being misbranded and one being spurious.

During the month of October 2023, the authorities tested 1105 samples, out of which 1044 were of standard quality. The number of samples declared as not of standard quality was 61, with none being misbranded and none being spurious.

During the month of September 2023, the authorities tested 1188 samples, out of which 1126 were of standard quality. The number of samples declared as not of standard quality was 62, with none being misbranded and none being spurious.

During the month of August 2023, the authorities tested 1166 samples, out of which 1118 were of standard quality. The number of samples declared as not of standard quality was 48, with none being misbranded and none being spurious.

During the month of July 2023, the authorities tested 1306 samples, out of which 1252 were of standard quality. The number of samples declared as not of standard quality was 51, with none being misbranded and 3 being spurious.

During the month of June 2023, the authorities tested 1273 samples, out of which 1225 were of standard quality. The number of samples declared as not of standard quality was 48, with none being misbranded and one being spurious.

During the month of May 2023, the authorities tested 1302 samples, out of which 1274 were of standard quality. The number of samples declared as not of standard quality was 27, with none being misbranded and one being spurious.

During the month of April 2023, the authorities tested 895 samples, out of which 859 were of standard quality. The number of samples declared as not of standard quality was 35, with none being misbranded and one being spurious.

The test samples were drawn by the zonal and sub-zonal offices of CDSCO, and tested in the drug testing laboratories, i.e CDLs, CDTLs, and RDTLs, in Kolkata, Mumbai, Hyderabad, Chandigarh, Indore, and Guwahati.

List of Drugs declared as NSQ by CDSCO for the Month of April– 2024.

A. CDSCO/Central Laboratories
S. N.Product/Drug NameBatch No.Manufa cturing DateExpiry DateManufactured ByNSQ ResultReported by CDSCO Laboratory
    1Pemolate                 Suspension (Paracetamol, Phenylephrine Hydrochloride                 & Chlorpheniramine Maleate Suspension)    407    10/2023    09/2025  M/s. Pulse Pharma MFG. Co., S. No. 553, Lala Estate, Idar Highway Road, Savgadh, Himatnagar, Gujarat, India  Assay              of Paracetamol                       & Phenylephrine Hydrochloride    CDL, Kolkata
  2Senocartine (Levocarnitine Injection USP 1g / 5ml)  RS23049  08/2023  01/2026M/s. Ratnatris Pharmaceuticals Pvt. Ltd., Survey No. 416, At Indrad, Tal- Kadi, Dist. Mehsana 382715 Gujarat, IndiaDescription       & Particulate Matter                       in Injections  CDL, Kolkata
  3  Frusemide Injection IP 10mg / ml (Senfuro)  RS23037  08/2023  07/2025M/s. Ratnatris Pharmaceuticals Pvt. Ltd., Survey No. 416, At Indrad, Tal- Kadi, Dist. Mehsana 382715 Gujarat, India  Particulate Matter  CDL, Kolkata
    4Dextromethorphan HBr,             Phenylephrine HCl               & Chlorpheniramine Maleate   Syrup               (DEX HS Syrup)    S24B045    02/2024    01/2026        M/s. Shri hari Pharmaceuticals, Vasdsar-Motibhoyan Road, Village: Vadsar – 382 721, Kalol District, Gandhinagar, Gujarat  Assay              of Dextromethorph an Hydrobromide    CDL, Kolkata
  5  Ofloxacin                             and Ornidazole Tablets IP  6001523  06/2023  05/2026M/s. Karnataka Antibiotics and Pharmaceuticals Limited, Plot No-14, Peenya-II, Phase, Bengalluru- 560058, Karnataka.  Description  CDL, Kolkata
  6Ambroxol, Guaiphenesin, Terbutaline                             and Menthol (Bromodex – T)  BDT-1257  12/2023  05/2025M/s. Aurio Pharma Laboratories Pvt. Ltd., Rabindra Sarani, Namita, Kolkata-700049  Assay of Menthol  CDL, Kolkata
    7  Human                        Growth Hormone                 Inj. (Norditropin Nordiflex 15mg / 1.5ml)    MC76638    05/2022    04/2024M/s. Novo Nordisk A/S Novo Alle, DK-2880 Bagsvaerd, Denmark, Imported by: Novo Nordisk India Prtivate Limited, Plot No. 32, 47-50, EPIP Area, Whitefield, Bangalore- 560066,    Description    CDL, Kolkata
  8Cilnidipine Tablets IP (Cinatab -10)  MT223472A  07/2022  06/2024M/s. Mascot Health Series Private Limited, Plot No. 79, 80, Sector-6A, IIE, SIDCUL, Haridwar 249 403.  DissolutionCDL, Kolkata
  9Atropine                     Sulphate Injection IP  23UJ85  10/2023  09/2025M/s. SVP Life Sciences, C/10/1, Sara Industrial Estate, Selaqui, Dehradun, UttarakhandpH,          Particulate Matter & AssayCDL, Kolkata
  10Metoclopramide Injection IP 10mg / 2ml  23DQE20  05/2023  04/2025M/s. SVP Life Sciences, C/10/1, Sara Industrial Estate, Selaqui, Dehradun, Uttarakhand  AssayCDL, Kolkata
    11Ambroxol Hydrochloride, Terbutaline                     Sulphate, Guaiphenesin Menthol Syrup (Luzicough-T)    JL-231248    12/2023    11/2025M/s. Jineka Healthcare Private Limited, Khasra No. 507-525, Bedpur Crossing Bhagwanpur Bypass, Roorkee, Distt. Haridwar (U.K.) 247 667Identification & Assay of Menthol and Assay of Terbutaline Sulphate  CDL, Kolkata
  12Gabapentin Tablets IP (Gabon-300)  MT225040  11/2022  10/2024M/s. Mascot Health Series Private Limited, Plot No. 79, 80, Sector-6A, IIE, SIDCUL, Haridwar 249 403.Related SubstancesCDL, Kolkata
  13Promethazine Hydrochloride Syrup IP (Phena Kid Syrup)  DEML- 304269  02/2023  01/2025M/s. Dr. Edwin Medilabs Pvt. Ltd., Plot No. B-29, Industrial Area, Focal Point Chanalon, Kurali, SAS Nagar – 140 103 (pb)  Assay  CDL, Kolkata
        14    ★Cefixime Trihydrate with Lactic Acid Bacillus Tablets I.P. (Presef-200                       LB Tablets)        BHCJ-009        11/2022        10/2024      M/s. Pragti Remedies, Plot No. 143, G. S. Road Link, Ulubari Guwahati, Assam-781008Identification                           & Assay                       of Cefixime               and Gram              Positive endospore bearing                       rod shaped bacterium. The sample deemed to be Spurious.  CDL, Kolkata   Refer Sr No 05            of spurious alert           April 2024
  15  Telmisartan Tables IP (Telwide 80 Tablets)  GT3F32  06/2023  05/2025M/s. Ritual Drugs Pvt. Ltd., Plot No. 271-272,                Phase-I,                HSIIDC,           Barhi Industrial Area, Sonepat (HR) – 131 101  Description                       & Dissolution  CDL, Kolkata
  16Quinine                     Sulphate Tablets IP 300 mg (REZ-Q* 300)  R22417106  09/2022  08/2024M/s. Shreya Life Sciences Pvt. Ltd., 13, 14, 15, Raipur, PO Bhagwanpur, Roorkee- 247 661, Uttarakhand.  Description  CDL, Kolkata
  17Cefixime Dispersible Tablets IP (Vixif-100 Tablets)  SBT136B  02/2023  01/2025M/s. Amster Labs, Unit-II Hilltop, Ind. Estate, Vill. Bhatauli Kalan, Baddi, Dist. Solan (H.P.)  DisintegrationCDL, Kolkata
    18Amoxycillin                               and Pottasium Clavulanate with Lactic Acid Bacillus             Tablets (Yamox-CL)    SEB-23122    09/2022    02/2025  M/s. Supermax Laboratories, Plot No. 40, Pharmacity, Selaqui Industrial Area, Dehradun – 248 011Assay / Content of Gram Positive endospore bearing                     rod shaped bacterium    CDL, Kolkata
  19Thyroxine Sodium Tablets I.P. (THYROX- 75)  MTC2338A  04/2023  03/2025M/s. Macleods Pharmaceuticals Ltd., Plot No. 2209, GIDC, Sarigam, Dist. Valsad 396 155  DissolutionCDL, Kolkata
  20Cyclosporine Capsules IP 25 mg (Cycloclean- 25)RDCPH230 02  10/2023  09/2025M/s. Johnlee Pharmaceuticals Pvt. Ltd., Plot No. 10, 11, Sector 6B, IIE, SIDCUL, Haridwar, 249403  WaterCDL, Kolkata
    21Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorphenamine Maleate    &                Menthol Syrup (Tuspress)    23CH0250    12/2023    11/2026M/s.   Enicar         Pharmaceuticals     Pvt. Ltd., Plot No. J-214, 215, 216, MIDC, Tarapur,    Boisar,    Dist.          Palghar- 401506    Assay of Menthol    CDL, Kolkata
    22  Tranexamic                          Acid Injection                                                    IP (GYNAEPIL Injection)    ANO43004 R    08/2023    07/2025  M/s. Psychotropics India Ltd., Plot No. 12, 12A, Industrial Park-2, Phase-1, Salempur, Mehdood-2, Haridwar-249403 (Uttarakhand)Description, Related Substances                       & Particulate Matter    CDL, Kolkata
  23Carvedilol                  Tablets                IP 6.25    mg          (Carviv-6.5 TABLETS)  VDT-23931  Oct- 2023  Sep- 2025M/s. Vidhyasha Pharmaceuticals, 28, Industrial Area, Johron Trilokpur Road, Kala Amb, Distt. Sirmour, H.P.- 173030  Dissolution  RDTL, Chandigarh
    24Terbutaline                     Sulphate, Ambroxol, Guaiphenesin                     and Menthol Syrup (Cufrish EXPECTORANT)    S-2245  Nov- 2023  Oct- 2025  M/s. Northern India Chemical Works Pvt.Ltd., V.Dantal, MRT-250001    pH  RDTL, Chandigarh
    25  Clindamycin                          and Adapalene Gel (CLON- A Gel)    YEX-463  Jan- 2024  Dec- 2025  M/s. Yaxon Biocare Pvt.Ltd., Plot No. 6, HSIIDC, Industrial Area Rai, Sonipat-131029 (HR).Assay              of Clindamycin Phosphate calculated                      as Clindamycin  RDTL, Chandigarh
  26Neostigmine Mehtysulphate Injection   IP   (N-MINE Injection)  HINM23002 B  Feb- 2023  Jan- 2025M/s. Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt.Solan (H.P.) India-173205  Identification (A)  RDTL, Chandigarh
  27Diphenhydramine Hydrochloride Capsules IP (XL Dryl-D Capsules)  CPD240100 6  Jan- 2024  Dec- 2025M/s. Caspian Pharmaceuticals, Mauza Ogli, Suketi Road, Kala-Amb, Sirmaur-173030Dissolution                    and Assay                             of Diphenhydramin e Hydrochloride  RDTL, Chandigarh
    28  Cloxacillin Sodium Oral Suspension                          USP 125mg/5ml    RD220020    Jul-2022  Jun- 2024  M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC Indl.Complex, Narela, Delhi-110040Assay              of Cloxacillin Sodium calculated                      as Cloxacillin  RDTL, Chandigarh
    29Enteric                            Coated Rabeprazole                  Sodium and               Domperidone (Sustained               Release) Capsules (STOMCOOL       DSR CAPSULES)    SCDSR240 01    Feb- 2024    Jan- 2026    M/s. VIP Pharmaceuticals Pvt. Ltd., Village, Manpura, Tehsil Nalagarh, Distt. Solan-174101 (H.P.)Dissolution                       of Domperidone (8th hours) and Dissolution                       of Domperidone (12th hours)    RDTL, Chandigarh
  30AMOXYCILLIN TRIHYDRATE                                I.P. (MARKMOX                               ORAL SUSPENSION I.P.)  OD-598  Apr-2023  Mar- 2025M/s.                      J.R.S.                          ORYX PHARMACEUTICALS (P) LTD., 217- 218, Sector-3, H.S.I.I.D.C., KARNAL- 132001 (India)  Assay  RDTL, Guwahati
  31Amoxycillin                                Oral Suspension IP  RD220034  Oct-2022Sep- 2024M/s. Ridley Life Science Pvt. Ltd., D- 1651, DSIDC, Indl. Complex, Narela, Delhi- 110040Assay/Content of AmoxycillinRDTL, Guwahati
  32  Telmisartan Tablets IP 40 mg. (Tzil 40)  189TTF002  Jan-2023  Dec- 2024M/s. Swiss Garniers Biotech Pvt. Ltd., 21, Industrial Area, Mehatpur, District- Una, Himachal Pradesh-174 315, INDIA.  Dissolution  RDTL, Guwahati
  33  Amlodipine                      Besylate Tablets IP 5 mg  1125  Nov- 2023  Oct- 2026M/s.Brilliant Lifesciences Pvt Ltd., At Chuval Dangarwa, Ta : Detroj Dist: Ahmedabad (Guj) India  Dissolution  CDTL, Indore

List of Drugs declared as NSQ by STATES for the Month of April– 2024.

B. STATE LABORATORIES
S.N oProduct    /                 Drug NameBatch No.Mfg DtExp DtManufactured ByNSQ ResultsReported By CDSCO    / State Lab
1Ceftriaxone Injection IP 250 mg (JKMSCL                 Hospital Supply)HD1607FJune, 2023May-25M/s. Himalaya Meditek Pvt Ltd Plot No. 35 & 36 Pharmacity Selaqui Ind. Area Dehradun – 248197The sample                      fails in Uniformaity                           of weights                       & Assay/Contents                       are found less than the label claimState            Drugs Testing Laboratory Srinagar (Jammu            & Kashmir)
2Exudase DP03023118Sep-23Aug-25M/s. Ravenbhel Healthcare Pvt Ltd . 16-17, EPIP, SIDCO Kartholi Bari Brahmana Jammu -1881133 Mrk. By: Ravenbhel Pharmaceuticals (P) Ltd 7-A, Baba Budha Avenue G.T Road Amritsar- 143001The sample fails in the test, “Description of tablets”.State            Drugs Testing Laboratory Srinagar (Jammu            & Kashmir)
3Rabeprazole Sodium Tablets IP 20mg (RAB 20mg)UTGRBB3 04Aug-23Jul-26M/s.                          Khandelwal Laboratories Pvt. Ltd., Plot No. 20, Sector-6, IIE, Sidcul, Pantnagar, U. S. Nagar- Uttarakhand, 263153does not comply to IP Standards                      with respect to dissolution testState Food & Drugs Laboratory, Bambolim, Goa
4Rabeprazole Sodium Tablets IP (CYRA)CA21880Aug-23Jul-25M/s. Mepro Pharmaceuticals Pvt. Ltd.; (Unit II), Q Road, Phase IV, GIDC, hwan- 363035, Dist. Surendranagar, Gujarat.does not conform to IP Standards with respect to the test for dissolutionState Food & Drugs Laboratory, Bambolim, Goa
5Metronidazole Tablets IP 200 mg2869A07/2306/25M/s. Arco Pharma Pvt Ltd, 1,2,3, Akshay Industrial Estate, Vasai, Palghar (M.S)It     fails     the       test ‘Dissolution’ as per IPState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
6Ciprofloxacin Tablets IP 500 mgCPT 2302209/2308/26M/s. Vivek Pharmachem (India)          Ltd,                   NH-8, Chimanpura, Amer, Jaipur- 303102It     fails     the       test ‘Dissolution’ as per IPState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
7Bimatoprost      Eye Drops 3 mlCHE-303604/2303/25M/s. Cotec Healthcare Pvt.Ltd, K.H.No. 593/1 Roorkee , Dehradun , High way, Kishanpur, Roorkee- 247667 UttarakhandIt     fails     the       test ‘Sterility’ as per IPState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
8Frusemide Injection IP 20 mgFRIA-1111/2310/25M/s. Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad -121001It     fails     the       test ‘Sterility’ as per IPState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
9Salbutamol Nebuliser                 Solution BPD 2259/23- 2406/2305/25Supplied by M/s. Kerala Medical services Corporation Limited, Thycaud P.O, ThiruvananthapuramIt fails the test Acidity pH as per BPState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
10Warfarin                   sodium Tablet IP 5 mgTW25000407/2306/26M/s. Centurion Remedies pvt.Ltd, G/5, G/6, Idl.Estate, Gorwa, Vadodara 390016It          fails            the ‘Description’.State            Drugs Testing Laboratory Thiruvananth apuram, Kerala
11Amloheart-AT [Amlodipine Besylate                     and Atenolol Tablets]LE 22303003/2302/25M/s.                                 Lividus Pharmaceuticals pvt.Ltd, ikeva level 2, Agnito Tech Park, 141, Kandanchavadi, Near      Perungudi,     OMR, Chennai- 600096It fails the test ‘Assay’ as per IPState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
12Bupivacaine Hydrochloride                     in Dextrose Inj. USP 0.50% 4 ml AmpD2258/23- 2409/2308/25Supplied by M/s. Kerala Medical services Corporation Limited, Thycaud P.O, ThiruvananthapuramIt fails the test Sterility as per USPState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
13Mucoid-A                   [Acetyl Cysteine                          & Ambroxol                     HCL Tablets ]MTT-685612/2311/25M/s. MDC Pharmaceuticals Ltd, Unit-II, sai Road, Baddi- 173 205The content of active ingredients is not within the limits of Schedule V of Drugs and cosmetic act and rules there underState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
14Sallaki TabletsAB 2305511/2310/26M/s. Gufic Biosciences Limited, 703, Udayambag, Belgaum, KarnatakaThe sample fails the test Disintegration as per APIState            Drugs Testing Laboratory Thiruvananth apuram, Kerala
15Panion Tablets796404/2303/27M/s.            Win                  Trust Pharmaceuticals Ltd. Dugri, Dhandra Road, LudhianaThe   sample          is an Ayurvedic preparation It gives positive result for the presence                    of Diclofenac            Sodium (Allopathic drug) and hence           declared         as Not   of         Standard Quality. The sample is a spurious drug.State            Drugs Testing Laboratory Thiruvananth apuram, Kerala
16Paracetamo Paediatric Oral Suspension IP 125 mg/mlL-0475Oct-22Sep-24Quest laboratories Pvt. Ltd., Plot No. 45, Sector III, Pithampur, Dist. Dhar- 454 775The Sample failed in descriptionMP State lab reported on 19.04.2024
17Paracetamo Paediatric Oral Suspension IP 250 mg/ml21350Sep-22Aug-24Zenith Drugs Pvt. Ltd., 75/5, Muradpura(Orangepura), Dhar Road , Near Kalaria, Indore 453 001The Sample failed in descriptionMP State lab reported on 19.04.2024

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