Drug Alert: CDSCO Flags 52 Formulations As Not Of Standard Quality
New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 52 medicine batches for failing to qualify for a random drug sample test for January 2025.
These include Monopropylene Glycol manufactured by Shell Eastern Chemicals, Ticagrelor Tablets manufactured by Monique Pharmaceuticals, Calcium Aspartate, Calcium Orotate, Calcitriol, Minerals And Vitamins Tablets manufactured by Overseas Healthcare, Diclofenac Sodium manufactured by Srinija Parenterals and others.
The alert stated that, as part of the continuous regulatory surveillance, drug samples are picked from sales/distribution points, analyzed, and lists of Not of Standard Quality (NSQ) drugs are displayed on the CDSCO portal on a monthly basis.
The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs.
Furthermore, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs and 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.
The alert further mentioned that as part of the continuous regulatory surveillance, drug samples are picked from sales/distribution points, analyzed, and lists of Not of Standard Quality (NSQ) drugs are displayed on the CDSCO portal on a monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware of the NSQ batches identified in the market.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of pH, particulate matter, and description.
The samples collected were tested in five laboratories CDL, Kolkata, RDTL, Guwahati, CDTL-Mumbai, CDTL - Indore, CDTL Hyderabad and RDTL Chandigarh.
NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF JANUARY 2025
A. CDSCO/Central Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Monopropylene Glycol USP | 9971702044 | 04/2024 | 04/2026 | M/s. Shell Eastern Chemicals, the Metropolis Tower 1, 9, North Buona Vista Drive#0701, Singapore-138588 | Water | CDL, Kolkata |
2. | Ticagrelor Tablets IP 90 mg (Tigamon 90) | MT230087 | 11/2023 | 10/2026 | M/s. MONIQUE PHARMACEUTICAL S PVT. LTD., Plot No-676, Sector-69, IMT, Faridabad, Haryana-121004 | Dissolution | CDL, Kolkata |
3. | Calcium Aspartate, Calcium Orotate, Calcitriol, Minerals And Vitamins Tablets | EZF-1989 | 07/2024 | 12/2026 | M/s. Overseas Healthcare Pvt. Ltd., 335 Km Milestone, National Highway No.1, P.O. Box-25, Phillaur-144410 (Pb) | Assay/content of 'Calcitriol' and 'Zinc' | CDL, Kolkata |
4. | Diclofenac Sodium Injection I.P (DEPAIN-75) | SNDA23801 | 08/2023 | 07/2025 | M/s. Srinija Parenterals, D.No. 283, Doctors Estate, Perecherla 522 009 | pH | CDL, Kolkata |
5. | Iron Sucrose Injection USP 100mg/5ml | 24RS04 | 01/2024 | 12/2025 | M/s. SAI Parenterals Limited, D1 & D4, Survey No.280, Phase-V, IDA, Jeedimetla, Hyderabad- 500055.TS | pH | CDL, Kolkata |
6. | Iron Sucrose Injection USP 100mg/5ml | 24RS08 | 02/2024 | 01/2026 | M/s. SAI Parenterals Limited, D1 &D4, Survey No.280, Phase-V, IDA, Jeedimetla, Hyderabad- 500055.TS | pH | CDL, Kolkata |
7. | Tramadol Hydrochloride Injection 50 mg/ml (Tramacop ) | RP-04 | 07/2023 | 06/2025 | M/s. Bio Medica Laboratories Pvt. Ltd., 254, Sector-F, Sanwer Road, Industrial Area, Indore-452015 | 'Acidity or Alkalinity' and 'Assay of Tramadol' | CDL, Kolkata |
8. | Metformin Hydrochloride Sustained Release Tablets I.P. 500mg (Conmet SR- 500) | C21D93400 3 | 06/2024 | 05/2027 | M/s. Concept Pharmaceuticals Ltd., A-28/3, MIDC, Chikalthana, Aurangabad-431006 | Dissolution | CDL, Kolkata |
9. | Cefuroxime Axetil Tablets IP 500 mg | 4617001 | 05/2024 | 04/2026 | M/s. Bengal Chemicals and Pharmaceuticals Ltd., 164, Maniktala Main Road, Kolkata-700 054 | Dissolution | CDL, Kolkata |
10. | Cefixime & Ofloxacin Tablets | CT5853A | 03/2024 | 02/2026 | M/s. J.M.LABORATORIES Village-Bhanat, P.O.- Ghatti, Subathu | Assay of Cefixime | CDL, Kolkata |
(CEPHAFLU- 400) | Road, Solan (HP)- 173211 | ||||||
11. | Ambroxol HCL, Levosalbutamol sulphate and Guaiphenesin Drops (Breath- LS Drops ) | HBD 2403 | 04/2024 | 03/2026 | M/s. HIPPO LABS PVT. LTD, Plot No- 17, R. G. Nagar, IDA, Prashanthi Nagar, Kukatpally, Hyderabad-72 | Description | CDL, Kolkata |
12. | Ofloxacin Ophthanmic Solution IP (Ocuex Eye Drops) | ED4648 | 11/2024 | 10/2026 | M/s. Captab Biotec, Unit-II, Plot No. 125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Dist. Solan (H.P.)- 173205 | Assay of Ofloxacin | CDL, Kolkata |
13. | Gentamicin Injection I.P. 30 ml | GM-19 | 04/2024 | 03/2026 | M/s. New Lab Industry, Ramnagar, Kurthoul, Patna | SPURIOUS Particulate Matter, Extractable Volume, Composition of Gentamicin Sulphate, Identification and Assay of Gentamicin Sulphate and Description | CDL, Kolkata |
14. | Non-Sterile Not for Intravenous Administration Concentrated Acidic Solution | BT229 | 07/2024 | 06/2025 | M/s. Bio Tech Formulation, Block A- 10, Plot No-136, D.No. 17-65, Penamaluru Mandal, New Autonagar, Kanuru, Vijayawada- 520007 | Appearance of solution, assay of sodium, potassium, calcium, magnesium and total chloride. Particulate contamination and description | CDL, Kolkata |
15. | Clobazam Tablets IP 5 mg | TPT-012058 | 01/2024 | 12/2026 | M/s. Tanpal Pharmaceuticals, D- 12-13, Focal Point, Nabha-147 201 | Dissolution | CDL, Kolkata |
16. | Vitamin B- Complex with Vitamin C and Zinc Capsules (Nutribest-Plus ) | 1724-226 | 05/2024 | 10/2025 | M/s. ZEE LABORATORIES LTD., Behind 47, Industrial Area, Paonta Sahib-173025 | Assay of 'Cyanocobalami n' and 'Calcium Pantothenate' | CDL, Kolkata |
17. | Metoclopramide Injection BP | 4EC038092 | 08/2024 | 07/2027 | M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., N-118/119, M.I.D.C., Tarapur, Boisar, Dist-Palghar- 401506 | Description and Particulate Contamination | CDL, Kolkata |
18. | Sodium Chloride and Glycerine Sterile Diluent for fowl pox vaccine and its combinations for wing web application | ACF24159 | 11/2024 | 10/2026 | M/s. Safe Parenterals Pvt. Ltd. Gollapadu 522408, Palnadu Dist, Andhra Pradesh, India | Description, Appearance of solution and Particulate matter | CDL, Kolkata |
19. | Rabeprazole Sodium Injection I.P. | MD23H13 | 08/2023 | 07/2025 | M/s. Martin & Brown Bio-Sciences Pvt. Ltd., K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist- Solan (H.P.)-173205 | pH, Water, Clarity of Solution, Particulate matter and Assay of Rabeprazole Sodium | CDL, Kolkata |
20. | Ofloxacin & Ornidazole Tablets IP (Zeof-O) | SCZAG230 07 | 06/2023 | 11/2025 | M/s. Sano-Cito Therapeutics Inc., Vill. Loharan, P.O. Ghatti, Solan-173211 (H.P.) | Dissolution | CDL, Kolkata |
21. | Calcium Gluconate Injection I.P. 10% w/v (REOCAL) | CG-386 | 03/2024 | 02/2026 | M/s. Rathi Laboratories(Hindust an) Pvt. Ltd., Industrial Area, Patna-800013 | pH, Particulate matter, Sterility and Description | CDL, Kolkata |
22. | Dexamethasone Sodium Phosphate Injection (Dexamethason e 30ml) | DX-18 | 04/2024 | 03/2026 | M/s. New Lab Industry, Ramnagar, Kurthoul, Patna | SPURIOUS pH, Extractable volume, Particulate matter, Sterility, Identification and Assay of Dexamethasone Sodium Phosphate and Description | CDL, Kolkata |
23. | Dmex Colecalciferol (Vitamin D3) Tablets B.P. | 4D077301 | 09/2023 | 08/2026 | M/s. 4Care Lifescience Pvt. Ltd. Survey No. 23/3P & 24, Opp. Jeans Factory, Daduram Vistar, Village- Bagdol, Tal. Kathlal, Dist. Kheda-387630, Gujarat, India | Assay of Cholecalciferol | CDL, Kolkata |
24. | Rabeprazole Sodium 20mg (EC) & Domperidone 10mg (IR), Domperidone 20mg (SR) Capsules (Rebast-ARD) | LC-6943 | 01/2024 | 12/2025 | Lifevision Healthcare, Plot No. 140-141, E.P.I.P., Phase-1, Jharmajri, Baddi, Distt. Solan (H.P.) 174 103 | Dissolution | RDTL, Guwahati |
25. | Montelukast & Levocetirizine Hydrochloride | VLB-GT- 2219 | 09/2023 | 08/2025 | Vee Laboratories,, Village-Kalier, Subathu, Road- | Dissolution | RDTL, Guwahati |
Tablets IP (SOLIKAST-L) | Saproon (Post Office) Solan-173211, Himachal Pradesh | ||||||
26. | Zinc Sulphate Dispersible Tablets IP 20 mg | LMT240811 | 07/2024 | 06/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Uniformity of dispersion & Disintegration | RDTL, Guwahati |
27. | Nimesulide & Paracetamol Tablets (SOMOO) | T-24004 | 04/2024 | 03/2026 | Kshipra Drugs Pvt. Ltd., 40- 41/22-B, Industrial Area, No. 1, Dewas (M.P.)- 455001 | Disintegration | RDTL, Guwahati |
28. | Fexofenadine Hydrochloride Tablets I.P. 120 mg. | UGT231163 | 08/2023 | 07/2025 | Unimarck Healthcare Ltd., Plot No.: 24, 25 & 37 Sector 6A, SIDCUL, Haridwar - 249403 (Uttarakhand) | Dissolution | RDTL, Guwahati |
29. | HYPODERMIC SYRINGE WITH NEEDLE (Nusafe 2ml) | 2407154 | 07/2024 | 06/2029 | NUBENO HEALTHCARE PRIVATE LIMITED, Plot No. 10A, Sector23, Mihan Nagpur- 441108 | Sterility | RDTL, Guwahati |
30. | Rabeprazole Sodium (as enteric coated) & Domperidone (As Sustained Release) Capsules (Rabito-DSR) | RTD.23010 5 | 08/2023 | 07/2025 | M/s Cartel Laboratories, 10/A, 11/A, Chengicherla, Medchal-Malkajgiri (Dist.), Hyderabad-92 | Assay of Rabeprazole Sodium | RDTL, Guwahati |
31. | Losartan Tablets IP 50 mg | LMT240826 | 07/2024 | 06/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector | Dissolution | RDTL, Guwahati |
6A, IIE, SIDCUL, Haridwar249403 (U.K) | |||||||
32. | Albendazole Tablets IP 400 mg (Albendazole 400) | T-3159 | 01/2024 | 12/2025 | Jackson Laboratories Pvt.Ltd, 22-24, Majitha Road, Bye Pass, Amritsar-143 001(India) | Dissolution | RDTL, Guwahati |
33. | Itraconazole Capsules IP 100 mg | CTA-01 | 02/2024 | 01/2026 | Agron Remedies Pvt. Ltd., Sarverkhera, Moradabad Road, Kashipur-244713 (Uttarakhand) | Dissolution | RDTL, Guwahati |
34. | Diclofenac Sodium Injection IP (AL- DICLO) | A-1694 | 02/2024 | 01/2026 | ALCHEMIST REMEDIES PVT. LTD., 133-139, Industrial Estate, At13, Road, Dewas | pH , Sterility, Particulate Matter, and Assay | RDTL, Guwahati |
35. | Calcium 500 mg with Vitamin D3 250 IU Tablets IP | LMT240431 | 04/2024 | 03/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Identification and Assay of Vitamin D3 and Dissolution of Calcium | RDTL, Guwahati |
36. | Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP (Montura-L) | ZT23547C | 11/2024 | 10/2025 | M/s Zenon Lifesciences Pvt. Ltd., Survey-no. 343/P, Bavla Sanand Highway, Modasar, Ahmedabad, Gujarat, INDIA 382220 | Dissolution of Montelukast | RDTL, Guwahati |
37. | Paracetamol Oral Suspension BP (100 ml) 120 mg/ 5 ml | ZA23019 | 07/2023 | 06/2026 | Brussels Laboratories Pvt. Ltd., 33, Changodar Ind. Estate, Sarkhej Bavla Road, Changodar | Assay of Paracetamol | CDTL-Mumbai |
Ahmedabad - 382 210, (Gujarat) | |||||||
38. | Amlodipine Tablets IP 5 mg (Systogan-5) | CT062 | 08/2024 | 07/2026 | Ryzer Pharmaceutical Pvt. Ltd., Plot No. 901, Dholakuva, Mansa, Gandhinagar, Gujarat- 382845. | Related substances | CDTL-Mumbai |
39. | Lorazepam Tablets IP 1 mg (PROLINE - 1) | 06P23T03 | 08/2023 | 04/2027 | Shine Pharmaceuticals Limited., Plot No. 132, Karjan-Vermardi Road, Juni Jitherdi, Ta. Karjan- 391240, Dist : Vadodara, (Gujarat) | Assay | CDTL-Mumbai |
40. | Itraconazole Capsules (Trax - 200) | AFC - 102 | 05/2024 | 04/2026 | APEX FORMULATIONS PVT. LTD., 1276, Rajpur Ahmedabad- Mehsana Highway, Dist. Mehsana, Gujarat. | Dissolution | CDTL-Mumbai |
41. | Enteric Coated Rabeprazole Sodium And Domperidone Sustained Release Capsules (Dorab SR Capsules) | AFC - 111 | 08/2024 | 07/2026 | APEX FORMULATIONS PVT. LTD., 1276, Rajpur Ahmedabad- Mehsana Highway, Dist. Mehsana, Gujarat. | Dissolution for Domperidone | CDTL-Mumbai |
42. | Aceclofenac Tablets IP 100 mg | T042304 | 11/2023 | 04/2025 | Bengal Chemicals & Pharmaceuticals Ltd., (A Govt. of India Enterprise) at 11, | Related substances and Assay of Aceclofenac | CDTL-Mumbai |
W.E.A. Faridabad - 121001 (Haryana) | |||||||
43. | Montelukast Sodium and Levocetirizine Hydrochloride Dispersible Tablets (ROMILAST® L 4) | 18RT2401 | 04/2024 | 09/2026 | Adnova Healthcare Pvt. Ltd. 156, 157 A, Siddhi Industrial Infrastructure Park, Waghodia, Vadodara - 391760, Gujarat | Description and Uniformity of dispersion | CDTL - Indore |
44. | Metoprolol Succinate Prolonged Release Tablets IP 25 mg | DT 2403 | 10/2026 | 09/2027 | M/s. Triveni Formulations Limited, Plot No.52, 53, 54 ALEAP Industrial Estate, Surampalli- 521212 | Dissolution | CDTL, Hyderabad |
45. | Ciprofloxacin Injection IP | LV4210 | 03/2024 | 02/2026 | Captab Biotec, Unit- II, Plot No. 125, E.P.I.P.Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)- 1732025 | In test of Lactic Acid per mg of Ciprofloxacin | RDTL, Chandigarh |
46. | Ceftriaxone Injection IP (Cefiglad-1 Injection) | SRIJ240041 | 10/2024 | 09/2026 | SYSTOLE REMEDIES PVT. LTD., Vill. Ogli, Kala Amb. Teh. Nahan, Distt. Sirmour (H.P.)- 173030 | Particulate matter | RDTL, Chandigarh |
47. | Cefixime and Lactic Acid Bacillus Tablets (CEFIZOC-200 LB TABLETS) | BT-240511 | 05/2024 | 04/2026 | A.N.D. HEALTHCARE LTD, Plot No. C-24, Focal Point, Kurali, Mohali- 140103 | Assay of Lactic Acid Bacillus | RDTL, Chandigarh |
48. | Hyoscine Butylbromide Tablets IP | PT-102441 | 10/2024 | 09/2026 | Primus Pharmaceuticals, Sadhoura Road, Mouza Ogli Khari Vill | Assay of Hyoscine Butylbromide | RDTL, Chandigarh |
(BUSCOPRIME -10 TABLETS) | Asgarpur Majra, Kala Amb, Dist. Sirmour- (H.P.) 173030 | ||||||
49. | Ambroxol HCl, Guaiphenesin, Terbutaline Sulphate and Menthol Syrup (BRONKOREX AM Syrup) | BALS-2005 | 11/2023 | 10/2025 | Wings Novitas Healthcare LLP,, 43 & 44, HPSIDC, Industrial Area, Baddi-173205 (H.P.) | Assay of Ambroxol Hydrochloride and Terbutaline Sulphate | RDTL, Chandigarh |
50. | Ramipril Tablets IP 5 mg | TPT- 0102040 | 10-2024 | 09-2026 | Tanpal Pharmaceuticals, D- 12-13, Focal Point, Nabha-147201 | Assay of Ramipril | RDTL, Chandigarh |
51. | Pyridoxine Tablets IP 10 mg (Pyrotan-10) | TPT- 0102064 | 10-2024 | 09-2026 | Tanpal Pharmaceuticals, D- 12-13, Focal Point, Nabha-147201 | Assay of Pyridoxine | RDTL, Chandigarh |
52. | Aceclofenac, Paracetamol and Serratiopeptidas e Tablets (ST- SP Tablets) | NBT- 240624 | 11/2024 | 10/2026 | Soft Touch Pharmaceuticals India Lt., Plot No. 8, Industrial Area, Waknaghat, Distt. Solan (H.P.)-173234 | Assay of Aceclofenac and Paracetamol | RDTL, Chandigarh |
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