Last Updated on June 9, 2024 by The Health Master
Drug alert
Drug alert: Download the list of NSQ samples for April 2024, the 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.
Details of the NSQ samples declared by STATES is as under:
Sr. | Name of STATES | Number of NSQ samples declared |
1 | Jammu & Kashmir | 2 |
2 | Goa | 2 |
3 | Kerala | 11 |
4 | Madhya Pradesh | 2 |
Total | 17 |
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.
Drug alert: 66 out of 931 samples declared as NSQ in March 2024
Drug alert: 58 out of 1167 samples declared as NSQ in February 2024
Drug alert: 46 out of 932 samples declared as NSQ in January 2024
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List of Drugs declared as NSQ by CDSCO for the Month of April– 2024.
A. CDSCO/Central Laboratories | |||||||
S. N. | Product/Drug Name | Batch No. | Manufa cturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1 | Pemolate 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 |
2 | Senocartine (Levocarnitine Injection USP 1g / 5ml) | RS23049 | 08/2023 | 01/2026 | M/s. Ratnatris Pharmaceuticals Pvt. Ltd., Survey No. 416, At Indrad, Tal- Kadi, Dist. Mehsana 382715 Gujarat, India | Description & Particulate Matter in Injections | CDL, Kolkata |
3 | Frusemide Injection IP 10mg / ml (Senfuro) | RS23037 | 08/2023 | 07/2025 | M/s. Ratnatris Pharmaceuticals Pvt. Ltd., Survey No. 416, At Indrad, Tal- Kadi, Dist. Mehsana 382715 Gujarat, India | Particulate Matter | CDL, Kolkata |
4 | Dextromethorphan 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 | 05/2026 | M/s. Karnataka Antibiotics and Pharmaceuticals Limited, Plot No-14, Peenya-II, Phase, Bengalluru- 560058, Karnataka. | Description | CDL, Kolkata |
6 | Ambroxol, Guaiphenesin, Terbutaline and Menthol (Bromodex – T) | BDT-1257 | 12/2023 | 05/2025 | M/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 | 04/2024 | M/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 |
8 | Cilnidipine Tablets IP (Cinatab -10) | MT223472A | 07/2022 | 06/2024 | M/s. Mascot Health Series Private Limited, Plot No. 79, 80, Sector-6A, IIE, SIDCUL, Haridwar 249 403. | Dissolution | CDL, Kolkata |
9 | Atropine Sulphate Injection IP | 23UJ85 | 10/2023 | 09/2025 | M/s. SVP Life Sciences, C/10/1, Sara Industrial Estate, Selaqui, Dehradun, Uttarakhand | pH, Particulate Matter & Assay | CDL, Kolkata |
10 | Metoclopramide Injection IP 10mg / 2ml | 23DQE20 | 05/2023 | 04/2025 | M/s. SVP Life Sciences, C/10/1, Sara Industrial Estate, Selaqui, Dehradun, Uttarakhand | Assay | CDL, Kolkata |
11 | Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin Menthol Syrup (Luzicough-T) | JL-231248 | 12/2023 | 11/2025 | M/s. Jineka Healthcare Private Limited, Khasra No. 507-525, Bedpur Crossing Bhagwanpur Bypass, Roorkee, Distt. Haridwar (U.K.) 247 667 | Identification & Assay of Menthol and Assay of Terbutaline Sulphate | CDL, Kolkata |
12 | Gabapentin Tablets IP (Gabon-300) | MT225040 | 11/2022 | 10/2024 | M/s. Mascot Health Series Private Limited, Plot No. 79, 80, Sector-6A, IIE, SIDCUL, Haridwar 249 403. | Related Substances | CDL, Kolkata |
13 | Promethazine Hydrochloride Syrup IP (Phena Kid Syrup) | DEML- 304269 | 02/2023 | 01/2025 | M/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-781008 | Identification & 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 | 05/2025 | M/s. Ritual Drugs Pvt. Ltd., Plot No. 271-272, Phase-I, HSIIDC, Barhi Industrial Area, Sonepat (HR) – 131 101 | Description & Dissolution | CDL, Kolkata |
16 | Quinine Sulphate Tablets IP 300 mg (REZ-Q* 300) | R22417106 | 09/2022 | 08/2024 | M/s. Shreya Life Sciences Pvt. Ltd., 13, 14, 15, Raipur, PO Bhagwanpur, Roorkee- 247 661, Uttarakhand. | Description | CDL, Kolkata |
17 | Cefixime Dispersible Tablets IP (Vixif-100 Tablets) | SBT136B | 02/2023 | 01/2025 | M/s. Amster Labs, Unit-II Hilltop, Ind. Estate, Vill. Bhatauli Kalan, Baddi, Dist. Solan (H.P.) | Disintegration | CDL, Kolkata |
18 | Amoxycillin 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 – 248 011 | Assay / Content of Gram Positive endospore bearing rod shaped bacterium | CDL, Kolkata |
19 | Thyroxine Sodium Tablets I.P. (THYROX- 75) | MTC2338A | 04/2023 | 03/2025 | M/s. Macleods Pharmaceuticals Ltd., Plot No. 2209, GIDC, Sarigam, Dist. Valsad 396 155 | Dissolution | CDL, Kolkata |
20 | Cyclosporine Capsules IP 25 mg (Cycloclean- 25) | RDCPH230 02 | 10/2023 | 09/2025 | M/s. Johnlee Pharmaceuticals Pvt. Ltd., Plot No. 10, 11, Sector 6B, IIE, SIDCUL, Haridwar, 249403 | Water | CDL, Kolkata |
21 | Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorphenamine Maleate & Menthol Syrup (Tuspress) | 23CH0250 | 12/2023 | 11/2026 | M/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 |
23 | Carvedilol Tablets IP 6.25 mg (Carviv-6.5 TABLETS) | VDT-23931 | Oct- 2023 | Sep- 2025 | M/s. Vidhyasha Pharmaceuticals, 28, Industrial Area, Johron Trilokpur Road, Kala Amb, Distt. Sirmour, H.P.- 173030 | Dissolution | RDTL, Chandigarh |
24 | Terbutaline 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 |
26 | Neostigmine Mehtysulphate Injection IP (N-MINE Injection) | HINM23002 B | Feb- 2023 | Jan- 2025 | M/s. Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt.Solan (H.P.) India-173205 | Identification (A) | RDTL, Chandigarh |
27 | Diphenhydramine Hydrochloride Capsules IP (XL Dryl-D Capsules) | CPD240100 6 | Jan- 2024 | Dec- 2025 | M/s. Caspian Pharmaceuticals, Mauza Ogli, Suketi Road, Kala-Amb, Sirmaur-173030 | Dissolution 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-110040 | Assay of Cloxacillin Sodium calculated as Cloxacillin | RDTL, Chandigarh |
29 | Enteric 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 |
30 | AMOXYCILLIN TRIHYDRATE I.P. (MARKMOX ORAL SUSPENSION I.P.) | OD-598 | Apr-2023 | Mar- 2025 | M/s. J.R.S. ORYX PHARMACEUTICALS (P) LTD., 217- 218, Sector-3, H.S.I.I.D.C., KARNAL- 132001 (India) | Assay | RDTL, Guwahati |
31 | Amoxycillin Oral Suspension IP | RD220034 | Oct-2022 | Sep- 2024 | M/s. Ridley Life Science Pvt. Ltd., D- 1651, DSIDC, Indl. Complex, Narela, Delhi- 110040 | Assay/Content of Amoxycillin | RDTL, Guwahati |
32 | Telmisartan Tablets IP 40 mg. (Tzil 40) | 189TTF002 | Jan-2023 | Dec- 2024 | M/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- 2026 | M/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 o | Product / Drug Name | Batch No. | Mfg Dt | Exp Dt | Manufactured By | NSQ Results | Reported By CDSCO / State Lab |
1 | Ceftriaxone Injection IP 250 mg (JKMSCL Hospital Supply) | HD1607F | June, 2023 | May-25 | M/s. Himalaya Meditek Pvt Ltd Plot No. 35 & 36 Pharmacity Selaqui Ind. Area Dehradun – 248197 | The sample fails in Uniformaity of weights & Assay/Contents are found less than the label claim | State Drugs Testing Laboratory Srinagar (Jammu & Kashmir) |
2 | Exudase DP | 03023118 | Sep-23 | Aug-25 | M/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- 143001 | The sample fails in the test, “Description of tablets”. | State Drugs Testing Laboratory Srinagar (Jammu & Kashmir) |
3 | Rabeprazole Sodium Tablets IP 20mg (RAB 20mg) | UTGRBB3 04 | Aug-23 | Jul-26 | M/s. Khandelwal Laboratories Pvt. Ltd., Plot No. 20, Sector-6, IIE, Sidcul, Pantnagar, U. S. Nagar- Uttarakhand, 263153 | does not comply to IP Standards with respect to dissolution test | State Food & Drugs Laboratory, Bambolim, Goa |
4 | Rabeprazole Sodium Tablets IP (CYRA) | CA21880 | Aug-23 | Jul-25 | M/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 dissolution | State Food & Drugs Laboratory, Bambolim, Goa |
5 | Metronidazole Tablets IP 200 mg | 2869A | 07/23 | 06/25 | M/s. Arco Pharma Pvt Ltd, 1,2,3, Akshay Industrial Estate, Vasai, Palghar (M.S) | It fails the test ‘Dissolution’ as per IP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
6 | Ciprofloxacin Tablets IP 500 mg | CPT 23022 | 09/23 | 08/26 | M/s. Vivek Pharmachem (India) Ltd, NH-8, Chimanpura, Amer, Jaipur- 303102 | It fails the test ‘Dissolution’ as per IP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
7 | Bimatoprost Eye Drops 3 ml | CHE-3036 | 04/23 | 03/25 | M/s. Cotec Healthcare Pvt.Ltd, K.H.No. 593/1 Roorkee , Dehradun , High way, Kishanpur, Roorkee- 247667 Uttarakhand | It fails the test ‘Sterility’ as per IP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
8 | Frusemide Injection IP 20 mg | FRIA-11 | 11/23 | 10/25 | M/s. Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad -121001 | It fails the test ‘Sterility’ as per IP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
9 | Salbutamol Nebuliser Solution BP | D 2259/23- 24 | 06/23 | 05/25 | Supplied by M/s. Kerala Medical services Corporation Limited, Thycaud P.O, Thiruvananthapuram | It fails the test Acidity pH as per BP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
10 | Warfarin sodium Tablet IP 5 mg | TW250004 | 07/23 | 06/26 | M/s. Centurion Remedies pvt.Ltd, G/5, G/6, Idl.Estate, Gorwa, Vadodara 390016 | It fails the ‘Description’. | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
11 | Amloheart-AT [Amlodipine Besylate and Atenolol Tablets] | LE 223030 | 03/23 | 02/25 | M/s. Lividus Pharmaceuticals pvt.Ltd, ikeva level 2, Agnito Tech Park, 141, Kandanchavadi, Near Perungudi, OMR, Chennai- 600096 | It fails the test ‘Assay’ as per IP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
12 | Bupivacaine Hydrochloride in Dextrose Inj. USP 0.50% 4 ml Amp | D2258/23- 24 | 09/23 | 08/25 | Supplied by M/s. Kerala Medical services Corporation Limited, Thycaud P.O, Thiruvananthapuram | It fails the test Sterility as per USP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
13 | Mucoid-A [Acetyl Cysteine & Ambroxol HCL Tablets ] | MTT-6856 | 12/23 | 11/25 | M/s. MDC Pharmaceuticals Ltd, Unit-II, sai Road, Baddi- 173 205 | The content of active ingredients is not within the limits of Schedule V of Drugs and cosmetic act and rules there under | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
14 | Sallaki Tablets | AB 23055 | 11/23 | 10/26 | M/s. Gufic Biosciences Limited, 703, Udayambag, Belgaum, Karnataka | The sample fails the test Disintegration as per API | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
15 | Panion Tablets | 7964 | 04/23 | 03/27 | M/s. Win Trust Pharmaceuticals Ltd. Dugri, Dhandra Road, Ludhiana | The 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 |
16 | Paracetamo Paediatric Oral Suspension IP 125 mg/ml | L-0475 | Oct-22 | Sep-24 | Quest laboratories Pvt. Ltd., Plot No. 45, Sector III, Pithampur, Dist. Dhar- 454 775 | The Sample failed in description | MP State lab reported on 19.04.2024 |
17 | Paracetamo Paediatric Oral Suspension IP 250 mg/ml | 21350 | Sep-22 | Aug-24 | Zenith Drugs Pvt. Ltd., 75/5, Muradpura(Orangepura), Dhar Road , Near Kalaria, Indore 453 001 | The Sample failed in description | MP State lab reported on 19.04.2024 |
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