Drug alert: CDSCO flags 60 formulations as not of standard quality
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has flagged sixty drug batches for failing to qualify for a random drug sample test for April 2025.
The medicines include Ciprofloxacin Tablets IP 250 mg (Ciprodac 250) manufactured by Cadila Pharma, Oxcarbazepine Tablets IP 300 mg (OXCARBAJAJ 300) manufactured by Bajaj Healthcare and Bupivacaine Hydrochloride Injection IP (Bupicain-0.5%) manufactured by Themis Medicare Limited.
The samples were collected and tested in five laboratories, namely CDL, Kolkata, RDTL, Guwahati, CDTL-Mumbai, RDTL,Chandigarh and CDTL, Indore.
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.
NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF APRIL-2025- (CDSCO/Central Laboratories)
| S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
| 1. | Carboxymethyl Cellulose Sodium Eye Drops IP | MO24H27 | 08/2024 | 07/2026 | M/s. Martin & Brown Bio- sciences Pvt. Ltd. K.no. 918/419 Malkumajra Nalagarh Road Baddi, Dist. Solan (H.P.)-173205 | pH, Sterility and Assay | CDL, Kolkata |
| 2. | Carboxymethyl Cellulose Sodium Eye Drops IP | MO24H21 | 08/2024 | 07/2026 | M/s. Martin & Brown Bio- sciences Pvt. Ltd. K.no. 918/419 Malkumajra Nalagarh Road Baddi, Dist. Solan (H.P.)-173205 | pH, Sterility and Assay | CDL, Kolkata |
| 3. | Carboxymethyl Cellulose Sodium Eye Drops IP | MO24H22 | 08/2024 | 07/2026 | M/s. Martin & Brown Bio- sciences Pvt. Ltd. K.no. 918/419 Malkumajra Nalagarh Road Baddi, Dist. Solan (H.P.)-173205 | pH, Sterility and Assay | CDL, Kolkata |
| 4. | Bupivacaine Hydrochloride Injection IP (Bupicain-0.5%) | BPC24007 | 12/2024 | 10/2026 | M/s. Themis Medicare Limited, Sector 6A, Plot No.16,17,&18, IIE, SIDCUL Haridwar - 249403, Uttarakhand | Particulate matter and Description | CDL, Kolkata |
| 5. | Ceftriaxone and Sulbactam for Injection IP (CEFRITZ S 1.5) | 24DH13V | 08/2024 | 07/2026 | M/s. MMG Healthcare, Trilokpur Road, Kala Amb, Distt. Sirmour- 173030 (H.P.) | Bacterial endotoxins for Sterile water for Injection. | CDL, Kolkata |
| 6. | Pantoprazole Gastro- Resistant Tablets IP 40 mg. | MT240578 | 08/2024 | 07/2026 | M/s. Mancare Laboratories Pvt. Ltd., Plot No-11, Pharmacity, Selaqui, Dehradun, Uttarkhand-248011 | Dissolution in Buffer Stage | CDL, Kolkata |
| 7. | Oxcarbazepine Tablets IP 300 mg (OXCARBAJAJ 300) | OXB02I24 | 09/2024 | 08/2026 | M/s. Bajaj Healthcare Ltd. R.S. No. 1818, Manjusar-Savli Road, At & Post Manjusar, Tal Savli, Dist. Vadodara-391775, Gujarat, India | Dissolution | CDL, Kolkata |
| 8. | Calcium & Vitamin D3 Tablets IP | QT23136 | 11/2024 | 10/2026 | M/s. Quest Laboratories Limited, Plot No.-45, Sector-III, Pithampur, Dist-Dhar-454775 (M. P.) | Dissolution (for Calcium) and Assay of Elemental Calcium | CDL, Kolkata |
| 9. | Calcium Carbonate 500 mg + VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1289 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 10. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1292 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 11. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1286 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 12. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1298 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 13. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1301 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 14. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1302 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 15. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1303 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 16. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1304 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 17. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1305 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 18. | Calcium Carbonate 500 mg +VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1306 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 19. | Amikacin Sulphate Injection I.P. 500 mg | 24AM18 | 10/2024 | 09/2026 | M/s. SAI Parenterals Limited, D1 &D4, Survey No.280, Phase-V, IDA, Jeedimetla, Hyderabad- 500055.Telangana, India | Particulate matter and Description | CDL, Kolkata |
| 20. | Sucralfate & Oxetacaine Suspension (Rabeflux Suspension) | RBLS-02501 | 01/2025 | 12/2026 | M/s. Tidal Laboratories Pvt. Ltd., Patch-5, Phase-II, Gowalthai, Distt. Bilaspur- 174201 (H.P.), INDIA | Identification, Assay of Sucralfate and Assay of Oxetacaine | CDL, Kolkata |
| 21. | Iron Sucrose Injection USP 100mg/5ml | 24RS15 | 12/2024 | 11/2026 | M/s. SAI Parenterals Limited, D1 &D4, Survey No.280, Phase-V, IDA, Jeedimetla, Hyderabad-500055, TS | pH and Alkalinity | CDL, Kolkata |
| 22. | Iron Sucrose Injection USP 100mg/5ml | 24RS03 | 01/2024 | 12/2025 | M/s. SAI Parenterals Limited, D1 &D4, Survey No.280, Phase-V, IDA, Jeedimetla, Hyderabad-500055, TS | pH | CDL, Kolkata |
| 23. | Iron Sucrose Injection USP 100 mg/5ml | 24RS06 | 02/2024 | 01/2026 | M/s. SAI Parenterals Limited, D1 &D4, Survey No. 280, Phase-V, IDA, Jeedimetla, Hyderabad-500055, TS | pH and Alkalinity | CDL, Kolkata |
| 24. | Compound Sodium Lactate Injection IP (RINGER-LACTATE SOLUTION FOR INJECTION ) (RL) | 1I245476 | 09/2024 | 08/2027 | M/s. Aculife Healthcare Pvt. Ltd., Sachana, Gujarat- 382150, India | Sterility | CDL, Kolkata |
| 25. | Rifampicin, Isoniazid and Ethmbutol Hydrochloride Tablets IP | TR-820008 | 07/2024 | 06/2026 | M/s. Centurion Remedies Pvt. Ltd., G/5,6, B.I.D.C. Gorwa, Vadodara -390016 | Assay of Rifampicin | CDL, Kolkata |
| 26. | Calcium Carbonate 500 mg + VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1294 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod-389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 27. | Calcium Carbonate 500 mg + VIT. D3 250 IU Tablets IP (CALXIA 500 ) | GTL1299 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod-389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 28. | Calcium Carbonate 500 mg + VIT. D3 250 IU Tablets IP (CALXIA 500) | GTL1300 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod-389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
| 29. | Ondansetron Oral Solution I.P. 2mg/5ml | ONES-1004 | 09/2024 | 08/2026 | M/s. Wings Biotech, 43 and 44, HPSIDC, Industrial Area, Baddi-173 205 (H.P.) | Related Susbtances | CDL, Kolkata |
| 30. | Gentamicin Injection IP (Gentatore Injection 80 mg/2ml) | IGMG418 | 07/2024 | 06/2026 | M/s. Regain Laboratories, 134/5, HTM Road, Rajpur Lane, Hisar-125001, Haryana | Particulate matter and Description | CDL, Kolkata |
| 31. | Teneligliptin & Metformin Hydrochloride (Sustained Release) Tablets IP (Teglisure-M 500) | AOT244-00B | 03/2024 | 02/2026 | M/s. Astonea Labs Pvt. Ltd., Vill- Haripur, Teh. Raipur Rani, Dist. Panchkula, Haryana, INDIA-134204 | Assay/content of Teneligliptin | CDL, Kolkata |
| 32. | Cefpodoxime Proxetil Tablets I.P. 200 mg (BREPOD-200) | ST-25456 | 10/2024 | 09/2026 | M/s. Sunvij Drugs Private Limited, 511, GIDC, Waghodia, Baroda-391760, Gujarat | Dissolution | CDL, Kolkata |
| 33. | Rabeprazole Sodium Injection IP | MD23H19 | 08/2023 | 07/2025 | M/s. Martin & Brown Bio Sciences, K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)- 173205 | pH, Particulate matter, Clarity of Solution, Assay of Rabeprazole Sodium and Description | CDL, Kolkata |
| 34. | Nimesulide & Paracetamol Tablets (Somu Gold) | TTX0093 | 01/2024 | 12/2026 | M/s.Pro-pharma Care Pvt. Ltd., Khasara No. : 68, 69, 71, Village : Sikandarpur, Bhaiswal, Near Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand-247661 | Dissolution | RDTL, Guwahati |
| 35. | Fluconazole Tablets I.P. 150 mg (Megmazole- 150 Tablets) | TSF-C0116 | 01/2024 | 12/2025 | M/s.Spen Formulations Pvt. Ltd., Plot No-123, Industrial Area, Mehatpur, Distt. UNA174315 (H.P.) | Assay/Content of Fluconazole | RDTL, Guwahati |
| 36. | Ampicillin Sodium Injection I.P. (AMPIVEE- 500 Injection) | TGDI082319 04 | 8/2023 | 07/2025 | M/s.T & G Medicare, Village Kunjahal, PO Baddi, Distt:. Solan (H.P.) | Sterillity | RDTL, Guwahati |
| 37. | Sulbactam Sodium Sterile I.P./USP. | 23051901 | 5/2023 | 04/2026 | M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas Bhiwandi,MH-421302, India. | "Identification and Assay/Content of Sulbactam Sodium | RDTL, Guwahati |
| 38. | Sulbactam Sodium Sterile I.P./USP. | 23051806 | 5/2023 | 04/2026 | M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas Bhiwandi,MH-421302, India | Identification and Assay/Content of Sulbactam Sodium | RDTL, Guwahati |
| 39. | Sulbactam Sodium Sterile I.P./USP. | 23051903 | 5/2023 | 04/2026 | M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas Bhiwandi,MH-421302, India. | Identification and Assay/Content of Sulbactam Sodium | RDTL, Guwahati |
| 40. | Ciprofloxacin Tablets IP 250 mg (Ciprodac 250) | CT24001 | 2/2024 | 01/2027 | M/s.CADILA PHARMACEUTICALS LIMITED, 1389, Dholka- 382225, Dist. Ahmedabad | Dissolution" of Ciprofloxacin | RDTL, Guwahati |
| 41. | Ciprofloxacin Tablets IP 250 mg | CITB-02 | 7/2024 | 06/2026 | M/s. NESTOR PHARMACEUTICALS LIMITED, 11, Western Extension Area, Faridabad - 121 001, INDIA | Dissolution | RDTL, Guwahati |
| 42. | Sulbactam Sodium Sterile I.P./USP | 23051904 | 5/2023 | 04/2026 | M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas Bhiwandi,MH-421302, India. | Identification and Assay/Content of Sulbactam Sodium | RDTL, Guwahati |
| 43. | Sulbactam Sodium Sterile I.P./USP. | 23051902 | 5/2023 | 04/2026 | M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas Bhiwandi,MH-421302, India. | Identification and Assay/Content of Sulbactam Sodium | RDTL, Guwahati |
| 44. | Albendazole Tablets IP 400 mg | LMT241100 | 9/2024 | 08/2026 | M/s.Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Dissolution | RDTL, Guwahati |
| 45. | Telmisartan I.P. 40 mg, Amlodipine Besylate I.P. 5 mg Tablets | ST 211 | 4/2024 | 03/2026 | M/s.Soham Healhcare INC, Soham Healthcare Inc A-49, Sector-25, Gandhinagar, Gujarat | "Dissolution" (Telmisartan and Amlodipine) and "Assay/ content of Telmisartan and Amlodipine" | CDTL-Mumbai |
| 46. | Pioglitazone Hydrochloride Tablets (GLITO 15) | D40292 | 5/2024 | 04/2027 | M/s.Medley Pharmaceuticals Ltd., Plot No. 18 & 19, Survey No.378/7 & 8, 379/2 & 3, Zari Causeway Road, Kachigam Daman- 396210 (U.T), INDIA | "Dissolution" | CDTL-Mumbai |
| 47. | Glimepiride Tablets I.P. 1 mg | 12801124 | 8/2024 | 07/2026 | M/s.Karnataka Antibiotics & Pharmaceuticals Limited (A Govt of India Enterprise), Plot No.14, II Phase, Peenya, Bengaluru - 560 058. | "Related substances" | CDTL-Mumbai |
| 48. | Telmisartan & Hydrochlorothiazide Tablets IP (Telmijack-H) | T-20560 | 3/2024 | 02/2026 | M/s.Jackson Laboratories Pvt. Ltd., Plot No. 56 & 61, Industrial Area, Phase III, Sansarpur Terrace, Distt. Kangra (H.P.)- 176501. | "Related substances and Assay of Hydrochlorothiazi de" | CDTL-Mumbai |
| 49. | Sulphamethoxazole and Trimethoprim Tablets IP | MT386 | 10/2023 | 09/2026 | M/s.Mayasha Lifesciences, H.B. 86, Village-Bhatian Nalagarh, Distt.-Solan (H.P.) 174101 | Dissolution of Sulphamethoxazol e | RDTL, Chandigarh |
| 50. | Levamisole & Oxyclozanide Bolus Vet. (Wormizole Bolus) | EMVB-24162 | 10/2024 | 09/2026 | M/s.Events Corporation, UNIT- II, Kala Amb, Tehsil Nahan, District Sirmour (H.P.)-173030 | Disintegration test | RDTL, Chandigarh |
| 51. | Sodium Chloride Injection IP 0.9 %w/v | LV4979 | 11/2024 | 10/2026 | M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Bacterial endotoxins and Sterility | RDTL, Chandigarh |
| 52. | Sodium Chloride Injection IP 0.9 %w/v | LV4987 | 11/2024 | 10/2026 | M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Bacterial endotoxins and Sterility | RDTL, Chandigarh |
| 53. | Sodium Chloride Injection IP 0.9 %w/v | LV4983 | 11/2024 | 10/2026 | M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Bacterial endotoxins and Sterility | RDTL, Chandigarh |
| 54. | Sodium Chloride Injection IP 0.9 %w/v | LV4984 | 11/2024 | 10/2026 | M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Bacterial endotoxins and Sterility | RDTL, Chandigarh |
| 55. | Sodium Chloride Injection IP 0.9 %w/v | LV4985 | 11/2024 | 10/2026 | M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Bacterial endotoxins and Sterility | RDTL, Chandigarh |
| 56. | Sodium Chloride Injection IP 0.9 %w/v | LV4982 | 11/2024 | 10/2026 | M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Bacterial endotoxins and Sterility | RDTL, Chandigarh |
| 57. | Sodium Chloride Injection IP 0.9 %w/v | LV4978 | 11/2024 | 10/2026 | M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Bacterial endotoxins and Sterility | RDTL, Chandigarh |
| 58. | Sodium Chloride Injection IP 0.9 %w/v | LV4988 | 11/2024 | 10/2026 | M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Particulate matter, Bacterial endotoxins and Sterility | RDTL, Chandigarh |
| 59. | Doxycycline Capsules IP 100 mg | B240705 | 05/2024 | 04/2026 | M/s.Bochem Healthcare Pvt. Ltd., 83-84, Industrial Area, Dewas Road, Nagziri, Ujjain 45601-(M.P.) India | Dissolution of Doxycycline | RDTL, Chandigarh |
| 60. | Levetiracetam Tablets IP 500 mg | LMT241488 | 12/2024 | 11/2026 | M/s.Life Max Cancer Laboratories Plot No. 106 & 106A, Sector-6A, IIE, SIDCUL, Haridwar-249403 (U.K) | Dissolution | CDTL, Indore |
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/cdsco-nsq-alert-for-the-month-of-april-2025-1-287801.pdf
