49 drugs samples including PAN 40, Calvam 625, Zerodol-SP Tablet fail to meet CDSCO quality test
New Delhi: In its latest drug alert, the Central Drug Standard Control Organization (CDSCO) has flagged forty-nine medicine batches for failing to qualify for a random drug sample test for September 2024.
The list declared not of standard quality includes Pantoprazole Gastro -resistant Tablets IP.. (PAN 40), Amoxicillin And Potassium Clavulanate Tablets I.P. (CLAVAM 625) manufactured by Alkem Health Science, Ciprofloxacin Tablets IP 500 mg (CIPRODAC 500) manufactured by Cadila Pharma, Paracetamol Paediatric Oral Suspension IP manufactured by Vivimed Labs, Aceclofenac 100 mg, Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets(ZEROD OL-SP TABLETS) manufactured by Ipca Labs.
Also Read: CDSCO declares 4 formulations as spurious including PAN D, SHELCAL 500
As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market.
A. CDSCO/Central Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Metronidazole Tablets I.P. 400 mg | HMAA04 | 07/2023 | 06/2025 | M/s. Hindustan Antibiotics Ltd., At: 11 W.E.A. Faridabad - 121001 (Haryana) R.O. Pimpri, Pune - 411 018, India | Dissolution | CDL, Kolkata |
2. | Domperidon Suspension (Vomitel) | U587F2401 | 06/2024 | 05/2026 | M/s. Rainbow Life Sciences Pvt. Ltd., C/o. Unijules Life Sciences Ltd., B-35, 36, MIDC Kalmeshwar, Nagpur 441 501. | Assay | CDL, Kolkata |
3. | Oxytocin Injection I.P. 5 IU/1 ml | OTC-382A | 04/2023 | 03/2025 | M/s. Pushkar Pharma, Kheri, Kala Amb - 173030 (H.P.). | Description, Particulate matter & Assay of Oxytocin | CDL, Kolkata |
4. | Metformin Hydrochloride 500 mg SR & Glimepiride 2 mg Tablets IP (SPAMET GM 2 Tablets) | TF147A | 02/2024 | 01/2026 | M/s. Swiss Biotech Parenterals , Kewat No. 1138, VPO - Kachhwa, Karnal- 132001, Haryana | Dissolution of Glimepiride | CDL, Kolkata |
5. | Diclofenac Sodium Tablets IP 50 mg | HDFA02 | 11/2023 | 10/2025 | M/s. Hindustan Antibiotics Ltd., At: 11 W.E.A. Faridabad - 121001 (Haryana) R.O. Pimpri, Pune - 411 018, India | Dissolution | CDL, Kolkata |
6. | Calcium Gluconate Injection I.P. 10 ml | MA24E55 | 05/2024 | 04/2026 | M/s. Martin & Brown Biosciences Pvt. Ltd., K. No. 918/419, Malkumajra, Nalagarth Road, Baddi, Dist. Solan (H.P.) 173205 | Description & Particulate matter | CDL, Kolkata |
7. | Oxytocin Injection I.P. 1 ml | 22X23002 | 07/2023 | 06/2027 | M/s. Radiant Parenterals Ltd., 242/4, 5 & 6, G.I.D.C. Estate at & Post Waghodia, Dist. Vadodara, Gujarat 391 760. | Assay | CDL, Kolkata |
8. | Ceftriiaxone Injection I.P. 1g | 324476 | 04/2024 | 03/2026 | M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025 | Particulate Matter & Clarity of Solution | CDL, Kolkata |
9. | Gentamycin Sulphate Injection I.P. 40 mg/ml | 324-564 | 05/2024 | 04/2026 | M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025 | Description & Particulate matter | CDL, Kolkata |
10. | Glycopyrrolate 0.5 mg / 5ml + Neostigmine methysulfate Injection 2.5 mg / 5ml) (Stimin) | GNI2406AC | 07/2024 | 06/2026 | M/s. Celon Laboratories Pvt. Ltd., Plot No. 2, ALEAP Industrial Estate, Gajularamaram, Medchal District - 500 090, Telangana State, India. | Description & Clarity of Solution | CDL, Kolkata |
11. | Ketoconazole Cream BP (Nozal Cream) | 4129 | 01/07/2024 | 30/06/20 26 | M/s. Olcare Laboratories 505/A, GIDC Estate, Wadhwan City - 363035, Dist. Surendranagar, Gujarat | Assay | CDL, Kolkata |
12. | Heparin Sodium Injection IP 5000 IU / 5ml (Hepathin 5000 Injection 5 ml / vial) | L1192317G | 08/2023 | 07/2025 | M/s. Protech Telelinks, Mauza Ogli, Suketi Road, Kala Amb, Dist- Sirmour (H.P.) 173030 | Description & Particulate matter | CDL, Kolkata |
13. | Heparin Sodium Injection IP 5000 IU / 5ml (Hepathin 5000 Injection 5 ml / vial) | L1192317C | 08/2023 | 07/2025 | M/s. Protech Telelinks, Mauza Ogli, Suketi Road, Kala Amb, Dist- Sirmour (H.P.) 173030 | Description, Particulate matter and Assay of Heparin (Anti- factor IIa activity) | CDL, Kolkata |
14. | Gentamicin Injection I.P. (Gentagain ) | IGMJ330 | 10/2023 | 09/2025 | M/s. Regain Laboratories 134/5, HTM Road, Raipur Lane, Hisar-125001 | Description & Particulate matter | CDL, Kolkata |
15. | Glipizide Tablets I.P. 5 mg | Z24-187 | 02/2024 | 01/2026 | M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173205 | Dissolution | CDL, Kolkata |
16. | Omeprazole & Domperidone Capsules IP (Omerin-D Capsules) | RC-331223 | 12/2023 | 11/2025 | M/s. Renowed Life Sciences, Plot No-12, Sector-6B, SIDCUL,, Haridwar, Uttarakhand (India) 249403 | Dissolution of Omeprazole | CDL, Kolkata |
17. | Dried Aluminium Hydroxide, Magnesium Hydroxide & Activated Dimethicone Suspension (Chill Acid MPS) | DNS- 2210001 | 10/2022 | 09/2024 | M/s. Devout Nord (I) Ltd., Plot No. 28B, Sector-8B, IIE, Sidcul, Haridwar-249 403 (U.K). | Description, Microbial Limit Test, Identification and Assay of Activated Dimethicone | CDL, Kolkata |
18. | Nimesulide & Paracetamol Tablets (Nimuvent-P Tablets) | GD332005 | 04/2022 | 03/2025 | M/s. Innova Captab Limited, 1281/1, Hilltop Industrial Estate, Near EPIP, Phase-I, Jharmajri, Baddi, Dist. Solan (H.P.) | Description | CDL, Kolkata |
19. | Cipronir 500 (Ciprofloxacin Tablets IP 500 mg) | CCF212003 | 12/2022 | 11/2025 | M/s. Celebrity Biopharma Ltd., Vill. Panga, Via - Jharmajri, Hill Top Estate, Barotiwala, Distt. Solan, H.P. 174103 | Dissolution | CDL, Kolkata |
20. | Ofloxacin & Ornidazole Tablets I.P. (SMB OZ TABLETS) | B22-114 | 08/2022 | 07/2025 | M/s. Saint Michael Biotech, No. 130, Village Kurdi, Manglore, Jharbrera Road, Roorkee- 247656 (Haridwar) (U.K.) | Dissolution of Ofloxacin & Ornidazole | RDTL, Guwahati |
21. | Calcium 500 mg and Vitamin D3 250 IU Tablets IP | LMT240025 | 01/2024 | 12/2025 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector 6A, IIE, SIDCUL, Haridwar249403 (U.K) | Assay of Calcium and Vitamin D3 and Dissolution of Calcium | RDTL, Guwahati |
22. | Loperamide Hydrochloride Tablets I.P. 2 mg (LOMJAN) | L-2401 | 01/2024 | 12/2025 | M/s.Arya Pharmaceuticals, 111- c, Industrial Estate, Indore-15. | Dissolution and Assay/ Content of Loperamide Hydrochloride and Description | RDTL, Guwahati |
23. | Glimepiride Tablets IP 1 mg | LMT240339 | 03/2024 | 02/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Dissolution | RDTL, Guwahati |
24. | Fexofenadine Hydrochloride Tablets I.P. | 658-021 | 11/2023 | 10/2025 | M/s. Signature Phytochemical Industries, 122, MI, Selaqui Industrial Area, Dehradun - 248 011. | Dissolution | RDTL, Guwahati |
25. | Glimepiride Tablets I.P. 2 mg | LMT240157 | 02/2024 | 01/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Dissolution | RDTL, Guwahati |
26. | Pantoprazole Gastro-resistant Tablets IP.. (PAN 40) | 22442076 | 07/2022 | 12/2024 | M/s. Alkem Health Science, A Unit Of Alkem Laboratories Limited, Unit-2, Samardung, Karek Block, P.O.: Namthang, South Sikkim - 737 137. | Assay and Dissolution in acid stage | RDTL, Guwahati |
27. | Cefpodoxime Tablets IP 200 mg (Monocef-O 200) | BPH232520 | 08/2023 | 07/2025 | M/s. Aristo Pharmaceuticals Pvt. Ltd., Village: Makhnumajra. P.O.- Bhud, Baddi, Dist: Solan (H.P.)- 173205 | Identification and Assay/ Content of Cefpodoxime | RDTL, Guwahati |
28. | Cefpodoxime Tablets IP 200 mg (Monocef-O 200) | BPD231045 | 04/2023 | 03/2025 | M/s. Aristo Pharmaceuticals Pvt. Ltd., Village: Makhnumajra. P.O.- Bhud, Baddi, Dist: Solan (H.P.)- 173205 | Identification and Assay/ Content of Cefpodoxime | RDTL, Guwahati |
29. | Amoxicillin And Potassium Clavulanate Tablets I.P. (CLAVAM 625) | 23443940 | 11/2023 | 04/2025 | M/s.Alkem Health Science, A Unit of Alkem Laboratories Limited, Unit-2, Samardung, Karek Block, P.O. Namthang, South Sikkim - 737 137 | Identification, Dissolution and Assay of Amoxicillin and Clavulanic Acid | RDTL, Guwahati |
30. | Fexofenadine Hydrochloride Tablets IP | T-2403971 | 03/2024 | 02/2026 | M/s. Oscar Remedies Pvt. Ltd., Oscar House, Badi Majra, Yamuna Nagar - 135 001 (HR) | Uniformity of Weight and Dissolution | RDTL, Guwahati |
31. | Ciprofloxacin Tablets IP 500 mg (CIPRODAC 500) | JKBD24009 | 01/2024 | 12/2026 | M/s.Cadila Pharmaceuticals Limited,, Industrial Growth Center, Samba -184 121, State of J & K | Dissolution of Ciprofloxacin | RDTL, Guwahati |
32. | Ramipril Tablets I.P. 2.5 mg | RT-231084 | 10/2023 | 09/2025 | M/s.Relief Biotech Pvt. Ltd., Khasra No. 72, Makhyali Dundi, Peerpura Road, Roorkee Bypass, Delhi Road, Manglour, Roorkee - 247656, Haridwar (U.K.). | Assay of Ramipril | RDTL, Guwahati |
33. | COMPOUND SODIUM LACTATE INJECTION I.P. (RL) | 03BF2475 | 04/2024 | 03/2027 | M/s.Paschim Banga Pharmaceuticals, NH- 31, TIN MILE HAT, SONAPUR HAT, P. S. CHOPRA, DISTRICT- UTTAR DINAJPORE, PIN-733214 (W.B.) | Bacterial Endotoxins Test | RDTL, Guwahati |
34. | Promethazine Hydrochloride Injection I.P. (PHENERGAN) | AHH0367 | 12/2022 | 11/2025 | M/s.Nitin Lifesciences Ltd., Rampur Road, Paonta Sahib, Dist. Sirmour - 173025 (H.P.), India | Assay of Promethazine Hydrochloride | RDTL, Guwahati |
35. | Paracetamol Paediatric Oral Suspension IP | V0244001 | 02/2024 | 01/2026 | M/s.Vivimed Labs Limited., Plot No. 25, Kundeshwari Village, Kashipur 244713, Uttarakhand | Related Substances | CDTL-Mumbai |
36. | Aluminum Hydroxide, Simethicone & Magnesium Hydroxide Suspension (Spisam Gel) | L22455 | 12/2022 | 11/2024 | M/s.Aan Pharma Pvt. Ltd., 816/1, Rakanpur, Tal. Kalol, Dist. Gandhinagar, 380060, Gujarat, (India) | Assay / Content of Magnesium Hydroxide, Simethicone and Aluminium Hydroxide gel | CDTL-Mumbai |
37. | Gentamicin Sulphate Injection IP (P- Genta Injection) | PA022415 | 02/2024 | 01/2026 | M/s.Primus Pharmaceuticals, Sadhoura Road, Mouza ogli Khari Vill Asgarpur Majra, Kala Amb. Distt. Sirmour- (H. P.) 173030 | pH | CDTL-Mumbai |
38. | Fluconazole Tablets IP 150 mg (Flucse - 150) | CHT23621 | 02/2024 | 01/2026 | M/s.Cureza Healthcare Pvt. Ltd., A.B. Road, Girwai- 474001 | Uniformity of weight | CDTL-Mumbai |
39. | BISACODYL TABLETS I.P. (Bisalax Tablets) | T-14996 | 12/2022 | 05/2025 | M/s. Karnani Pharmaceutical Pvt. Ltd., Fact. 38, Pharma City, Selaqui Dehradun- 248011 (Uttarakhand) | Dissolution (Buffer stage), Related substances and Assay of Bisacodyl | CDTL-Mumbai |
40. | Cetirizine Dihydrochloride Syrup (Citrize- P) | 275 | 06/2024 | 05/2026 | M/s. Arrow Pharma, Palia road, Hatod- 453111 | pH | CDTL, Hyderabad |
41. | Ifosfamide for Injection IP with Mesna Injection (Celofos 1000 Injection) | OL0492(for Ifosfamide), GN2064(for Mesna) | 08/2023 (for Ifosfamide) 08/2023 (for Mesna) | 07/2025 (for Ifosfamid e) 07/2026(f or Mesna) | M/s. Kwality Pharmaceuticals Limited,1-A,Industrial Area,Raja Ka Bagh, Tehsil Nurpur, Kangra- 176201(India) | Water and Assay of Ifosfamide | RDTL,Chandigarh |
42. | Aceclofenac 100 mg, Serratiopeptidas e 15 mg & Paracetamol 325 mg Tablets(ZEROD OL-SP TABLETS) | FND033076 AS | 08/2023 | 01/2026 | M/s. Ipca Laboratories Ltd. .,393/394, Melli Jorethang Road, Gom Block, Bharikhola, South District, Sikkim- 737 121 | Identification and Assay of Aceclofenac Serratiopeptidas e and Paracetamol | RDTL,Chandigarh |
43. | Ofloxacin and Ornidazole Intra Uterine Solution (Vet.) (UTROCLEAR- OZ SOLUTION) | V-2727 | 01/2024 | 12/2025 | M/s. Ramson Remedies,186-187, Industrial Focal Point, Amritsar. | Assay of Ofloxacin and Ornidazole | RDTL,Chandigarh |
44. | Bupropion Hydrochloride Extended Release Tablets USP (Nopion 150 Tablets) | GTD0768 | 11/2023 | 10/2025 | M/s. Digital Vision, 176, Mauza Ogli, Nahan road, Kala- Amb, Distt. Sirmour (H.P.)-17030 | Description and Assay of Bupropion Hydrochloride | RDTL,Chandigarh |
45. | Dextromethorph an Hydrobromide, Chlorpheniramin e Maleate and Phenylephrine Hydrochloride Syrup (COUGH- DM Cough Syrup) | SHL3037 | 11/2023 | 10/2025 | M/s.Sunfine Healthcare,Plot No. 63, Ind. Area Lodhimajra, Tehsil Baddi, Distt. Solan (H.P.) 173205 | Assay of Phenylphrine Hydrochloride | RDTL,Chandigarh |
46. | Cefoperazone and Sulbactam for Injection (KEFZONE-S INJECTION) | AB234007C | 06/2024 | 05/2026 | M/s.ANG Lifesciences India Ltd.,Village: Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt.: Solan, HP- 174101 | Particulate Matter | RDTL,Chandigarh |
47. | Piperacillin and Tazobactam Injection IP (CASIDTAZ P Injection) | AB154006B | 06/2024 | 05/2026 | M/s.ANG Lifesciences India Ltd.,Village: Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt.: Solan, HP- 174101 | Particulate Matter | RDTL,Chandigarh |
48. | Methylcobalami n Injection 2500 mcg (NUROFENS- 2500 Injection) | SRID24010 1 | 04/2024 | 09/2025 | M/s.Systole Remedies Pvt. Ltd.,Vill. Ogli, Kala Amb, Teh. Nahan, Distt. Sirmour (H.P.) - 173 030 | Particulate matter and Assay of Methylcobalami n | RDTL,Chandigarh |
49. | Torsemide Tablets IP 10 mg (Torverge- 10 Tablets) | GT7137A | 03/2023 | 02/2025 | M/s. J.M.LABORATORIES., Village- Bhanat, PO - Ghatti, Subathu Road, Solan (HP) 173211Himachal Pradesh - 173 205 | Assay of Torsemide | RDTL,Chandigarh |
The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality mean that the drug complies with the standards set out in the Second Schedule of the said Act.
For more details, check out the full story on the link below:
https://medicaldialogues.in/pdf_upload/nsq-alert-for-the-month-of-sept-2024-258519.pdf
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