Drug Alert: CDSCO Flags 51 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 41 medicine batches for failing to qualify for a random drug sample test for December 2024.
These include Cefotaxime Sodium Injection IP 1 g manufactured by Bengal Chemicals and Pharmaceuticals, Aspirin Gastro resistant Tablets IP 75mg manufactured by Unicure India, Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) manufactured by Zenith Drugs, and Calcium with Vitamin D3 Tablets (CITCAL TABLETS) manufactured by Uniplus Biotech and others.
Furthermore, the list includes Thyroxine Sodium tablets IP (THYROX -25) manufactured by Macleods Pharmaceuticals and Pantoprazole gastro-resistant tablets IP 40 mg (PANTIN) manufactured by Hetero Healthcare.
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.
Not of Standard Quality (NSQ) drugs are 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 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.)
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: RDTL Chandigarh, CDL Kolkata, CDTL Mumbai, CDTL Chennai, and RDTL-Guwahati.
NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF DECEMBER – 2024
A. CDSCO/Central Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Cefotaxime Sodium Injection IP 1 g | DP24029 | 04/2024 | 03/2026 | M/s. Bengal Chemicals & Pharmaceuticals Ltd., At-620, Diamond Harbour Road, Behala Indl. Estate, Kolkata- 700034. | Test of Clarity of solution, Particulate matter | Central Drugs Laboratory, Kolkata |
2. | Meropenem Injection IP 500 mg (Merohuge 500 ) | A4ITX004 | 08/2024 | 07/2026 | M/s. Shamshree Lifesciences Limited, Plot No. 11, Industrial Area, Katha- Bhatolikalan, Baddi- 173205, H.P. | Test of Clarity of solution, Particulate matter | Central Drugs Laboratory, Kolkata |
3. | AMIKACIN SULPHATE INJECTION IP 250 mg (AMIKACIN SULPHATE INJECTION IP 250 mg/ 2 ml for IM/IV Injection) | 17800124 | 01/2024 | 12/2025 | M/s. Karnataka Antibiotics And Pharmaceuticals Limited, Plot No-14, Peenya II Phase, Bengaluru-560058, Karnataka. | Particulate mattter and Description | Central Drugs Laboratory, Kolkata |
4. | Rabeprazole Injection IP | AGI-23216 | 06/2023 | 05/2025 | M/s. Alliaance Biotech, 440/3, Vill-Katha, Badddi, Solan (H.P.) - 173205 | Sterility, Clarity of Solution, Particulate matter, Identification, | Central Drugs Laboratory, Kolkata |
Assay of Rabeprazole Sodium and Description”. The sample is deemed to be spurious as per section 17B of Drugs and Cosmetics Act | |||||||
5. | Rabeprazole Injection IP | AGI-23217 | 06/2023 | 05/2025 | M/s. Alliaance Biotech, 440/3, Vill-Katha, Badddi, Solan (H.P.) - 173205 | pH, Clarity of Solution, Particulate matter, Assay of Rabeprazole Sodium and Description | Central Drugs Laboratory, Kolkata |
6. | Tranexamic Acid Tablets IP 500 mg (Clip 500 ) | 054A003 | 01/2024 | 12/2025 | M/s. FDC Limited L-56 & L-57, Phase-II-D Verna Industrial Estate, Verna-403722, Salcete, Goa | Related Substances | Central Drugs Laboratory, Kolkata |
7. | Fexofenadine Hydrochloride Tablets IP (MANOFEX-180 ) | CT24250327 A | 05/2024 | 04/2026 | M/s.CMG BIOTECH PVT.LTD, (Unit-II)Plot No-58, Phase-III, Industrial Area, Sasarpur Terrace, HP- 176501 | Dissolution | Central Drugs Laboratory, Kolkata |
8. | Rabeprazole Sodium Injection IP | MD23H20 | 08/2023 | 07/2025 | M/s. Martin & Brown Bio Sciences, K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)- 173205 | pH, Water, Clarity of Solution, Particulate matter, Assay of Rabeprazole Sodium and Description | Central Drugs Laboratory, Kolkata |
9. | Lignocaine Hydrochloride Gel IP 5% w/v (30 g) | G406 | 09/2024 | 08/2026 | M/s. Gnosis Pharmaceuticals Pvt. Ltd., Nahan Road, Village Moginand, Kala- Amb, Distt.Sirmour, | pH | Central Drugs Laboratory, Kolkata |
H.P.-173030 | |||||||
10. | Cold Plus Syrup (Cold Plus Syrup) | 4EL02283 | 09/2024 | 08/2027 | M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., N- 118,119,113,119/1, 119/2 & 118/1, M.I.D.C., Tarapur, Boisar, Dist-Palghar- 401506, Maharashtra | Assay of Phenylephrine Hydrochloride | Central Drugs Laboratory, Kolkata |
11. | Omeprazole Lyophilized Powder for Injection (I.V) (OMERA 40mg Lyophilized Powder for Injection ) | 0ZI2415AC | 06/2024 | 05/2026 | M/s. CELON LABORATORIES PVT. LTD., Plot No-2, ALEAP Industrial Estate, Gajularamaram, Medchal District-500 090, Telangana State, India | Test of Water by KF | Central Drugs Laboratory, Kolkata |
12. | BUPIVACAINE HYDROCHLORI DE INJECTION IP 0.5% | BCV22315 | 12/2023 | 11/2025 | M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore | Particulate mattter and Description | Central Drugs Laboratory, Kolkata |
13. | AXBEX Suspension (Multivitamin Mulltimineral & Antioxidant Suspension) | A21410 | 05/2024 | 10/2025 | M/s. Ozone Pharmaceuticals Ltd., Katha, Baddi-173205, Himachal Pradesh | Identification & Assay of Cholecalciferol | Central Drugs Laboratory, Kolkata |
14. | AXBEX Suspension (Multivitamin Mulltimineral & Antioxidant Suspension) | A21411 | 05/2024 | 10/2025 | M/s. Ozone Pharmaceuticals Ltd., Katha, Baddi-173205, Himachal Pradesh | Identification & Assay of Cholecalciferol | Central Drugs Laboratory, Kolkata |
15. | Thyroxine Sodium tablets IP (THYROX-25) | 16240148D | 05/2024 | 04/2026 | M/s. Macleods Pharmaceuticals Ltd., Plot No-2209, GIDC, Sarigam, Dist-Valsad- 396155, Gujarat | Dissolution | Central Drugs Laboratory, Kolkata |
16. | Dexamethasone Sodium | 119 | 06/2024 | 05/2026 | M/s. Hindustan Medicines Pvt. Ltd., | Free Dexamethasone, | Central Drugs Laboratory, Kolkata |
Phosphate Injection I.P. | BARAUNI-851112. | Particulate matter, Sterility, Extractable volume and Description | |||||
17. | Amikacin Sulphate Injection I.P. (AmikaVen- 500 Injection) | L-24A-23I | 01/2024 | 12/2025 | M/s. Inmac Laboratories, Bangsipura-142033 (Pb) | Particulate mattter, Assay/content of Amikacin and Description | Central Drugs Laboratory, Kolkata |
18. | Aspirin Gastro- resistant Tablets IP 75mg | ANET1121 | 08/2023 | 07/2025 | M/s. Unicure India Ltd., C-21, 22 & 23, Sector- 3, Noida- 201301, Distt. Gautam Budh Nagar (U.P.) | Test of Dissolution Buffer Stage | Central Drugs Laboratory, Kolkata |
19. | Absorbent Cotton Wool IP | 331 | 07/2024 | 06/2026 | M/s. Vandana Surgi Pharma (P) Ltd., GA- 26, RIICO Industrial Area, Bijaynagar- 305624, (Raj) | Acidity or alkalinity, Absorbency Sinking Time, Absorbency Water-holding Capacity, Foreign Fibres, Fluorescence, Water soluble substances, Neps and Sulphated ash | Central Drugs Laboratory, Kolkata |
20. | Noscapine, Chlorpheniramine Maleate, Guaiphenesin & Sodium Citrate Syrup | NGC-091 | 12/2023 | 11/2025 | M/s.Medipol Pharmaceuticals India Pvt. Ltd., 1199/3, Bhud, Baddi, Dist-Solan, H.P., India | Description | Central Drugs Laboratory, Kolkata |
21. | Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl | 40183 | 02/2024 | 01/2026 | M/s. Zenith Drugs Limited 72/5 & 72/3, 72/4, 74/1/1, 75/1/1, Muradpura (Orangpura) Dhar Road, Near Kalaria Indore 453001 | Assay of Menthol and Description | Central Drugs Laboratory, Kolkata |
Plus) | (MP), India | ||||||
22. | Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml | 17B24005 | 09/2024 | 08/2026 | M/s. Radiant Parenterals Ltd., 242/4, 5 &6, G.I.D.C., Estate at & Post Waghodia, Dist-Vadodara , Gujarat-391760 | pH and Bacterial Endotoxins | Central Drugs Laboratory, Kolkata |
23. | Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml | 17B24004 | 06/2024 | 05/2026 | M/s. Radiant Parenterals Ltd., 242/4, 5 &6, G.I.D.C., Estate at & Post Waghodia, Dist-Vadodara , Gujarat-391760 | pH, Bacterial Endotoxins and Sterility | Central Drugs Laboratory, Kolkata |
24. | Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) | 40186 | 02/2024 | 01/2026 | M/s. Zenith Drugs Limited 72/5 & 72/3, 72/4, 74/1/1, 75/1/1, Muradpura (Orangpura) Dhar Road, Near Kalaria Indore 453001 (MP), India | Assay of Menthol and Description | Central Drugs Laboratory, Kolkata |
25. | Telmisartan Tablets I.P.. (TELMOPI-40) | 23I-T2003 | 12/2023 | 11/2025 | M/s. Orison Pharma International, Vill. Khari, Mauza Ogli, Kala Amb, Distt. Sirmour - 173030 (H.P.) | Dissolution | RDTL, Guwahati |
26. | Acyclovir Dispersible Tablets IP (Zovibact 800 mg) | SRTH230874 B | 08/2023 | 07/2025 | M/s. SYSTOLE REMEDIES PVT. LTD., Vill. Ogli, Kala Amb, Teh. Nahan, Distt. Sirmour (H.P.) - 173 030 | Uniformity of dispersion & Disintegration | RDTL, Guwahati |
27. | GLIMEPIRIDE TABLETS IP (GLIMP-1) | SPT240261 | 02/2024 | 01/2026 | M/s. SALUS PHARMACEUTICALS, 480/211, Harraipur, PO Gurumajra, Teh. Baddi, Distt. Solan (H.P.) 173205 | Dissolution | RDTL, Guwahati |
28. | Zinc Sulphate Dispersible Tablets IP 20 mg | LMT240811 | 07/2024 | 06/2026 | M/s.Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, | Uniformity of dispersion & Disintegration | RDTL, Guwahati |
IIE, SIDCUL, Haridwar249403 (U.K) | |||||||
29. | Glimepiride Tablets I.P. 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 of Glimepiride | RDTL, Guwahati |
30. | INFUSION SET- NV (INFUSION SET - NV) | KT-033 | 03/2024 | 02/2027 | M/s.MEDIVISION HEALTHCARE, 84/4 Span Industrial complex. Second Floor, Phase-1, "F" Road, Opp. Kotak Mahindra Bank, G.I. D.C. Vatva, Ahmedabad- 382445, Gujarat | Sterility | RDTL, Guwahati |
31. | Compound Sodium Lactate Injection I.P. (RL) | 03BF2472 | 04/2024 | 03/2027 | M/s.Paschim Banga Pharmaceutical,, NH- 31,TIN Mile Hat, Sonapur Hat, PSChopra, Dist. Uttar Dinajpur, PIN- 733214 (WB) | Sterility and Particulate Contamination | RDTL, Guwahati |
32. | Compound Sodium Lactate Injection I.P. 500 ml (Ringers Lactate I.P.) (RL) | 03BF2474 | 04/2024 | 03/2027 | M/s.PASCHIM BANGA PHARMACEUTICAL (A Unit Of FARISTA VANIJYA PVT. LTD.), NH-31, TIN MILE HAT, SONAPUR HAT, P.S. CHOPRA, DIST: UTTAR DINAJPUR, PIN 733 214 (W.B.) | Sterility | RDTL, Guwahati |
33. | Calcium with Vitamin D3 Tablets (CITCAL TABLETS) | 470823 | 08/2023 | 07/2025 | M/s.Uniplus Biotech (P) Ltd., 4 km. Meerut Road, Assoda 245101 | Dissolution (calcium) and Assay of Vitamin D3 | RDTL, Guwahati |
34. | Calcium 500 mg with Vitamin D3 250 IU Tablets IP | LMT240346 | 03/2024 | 02/2026 | M/s.Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar- | Assay of Vitamin D3 and Dissolution for calcium | RDTL, Guwahati |
249403 (U.K) | |||||||
35. | Co- trimoxazole Tablets I.P. (D.S.=Double Strength) | PT30119 | 05/2023 | 04/2025 | M/s.Omega Pharma., Khasra No. 482, Village - Saliyar, Roorkee - 247667. Distt-Haridwar (Uttarakhand) | Dissolution (Trimethoprim and Sulphamethoxazo le) | RDTL, Guwahati |
36. | PRIMAQUINE PHOSPHATE TABLETS IP 2.5 mg | T-1338 | 07/2023 | 06/2025 | M/s.Jackson Laboratories Pvt.Ltd, 22-24, Majitha Road, Bye Pass, Amritsar-143 001(India) | Dissolution and Assay | RDTL, Guwahati |
37. | PANTOPRAZOL E GASTRO- RESISTANT TABLETS IP 40mg (PANTIN) | GT24502A | 06/2024 | 05/2027 | M/s. Hetero Healthcare limited, AIIDC Industrial Growth Centre, Changsari, Niz Sindurighopa (Village), Sila Sindurighopa (Mouza), Kamrup (Dist) Assam-781101 | Dissolution of Buffer Stage | RDTL, Guwahati |
38. | Albendazole Tablets I.P. | MT-24G01 | 07/2024 | 06/2026 | M/s.MARTIN & BROWN BIOSCIENCES PVT. LTD., K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)-173205 | Dissolution | RDTL, Guwahati |
39. | Calcium & Vitamin D3 Tablets IP (CALCI-D) | CDD23089 | 11/2023 | 10/2025 | M/s. Danish Healthcare (P) Ltd, 76/27-28, Industrial Estate, Maxi Road, Ujjain-456 010 INDIA | Assay of Vitamin D3 | RDTL, Guwahati |
40. | Alprazolam Tablets IP 0.5 mg | BT1224 | 01/2024 | 12/2025 | M/s.Brilliant Life Sciences Pvt.Ltd. , At Chuval Tagarwa, Teh Detroj Dist. Ahmedabad(Gujarat) | The Sample does not conform to IP Standards with respect to Test for Dissolution only | CDTL, Chennai |
41. | Valsartan Tablets IP 80mg(Valsalar- 80 Tablets) | VSR1-05 | 04/2024 | 03/2026 | M/s. Lark Laboratories (I) Ltd., At, SP-1192 E, RIICO Indl Area, Phase | The Sample does not conform to IP Standards with | CDTL, Chennai |
IV, Bhiwadi-Rajasthan | respect to Test for Dissolution only | ||||||
42. | Nutrisacc Bolus | MVNUR2403 | 02/2024 | 02/2026 | M/s. Maven iLab Pvt.Ltd., No.19 Byraveshwara Industrial Area, Andrahalli Main Road Hegganahalli, Bangalore-560091 | Disintegration test and Assay of Iron, Magnesium, Calcium, Vitamin B3,Zinc and Vitamin A | RDTL, Chandigarh |
43. | Duloxetine Gastro-resistant Tablets IP 20 mg | T26904 | 01/2024 | 12/2025 | M/s Quest Laboratories Limited, Plot No. 45, Sector-III, Pithampur, Dist.Dhar-454775 (M.P.) | Description and Dissolution | RDTL, Chandigarh |
44. | Bortezomib Injection IP (BORTEWIN 2 mg Injection) | L24BZ08A7 | 08/2024 | 07/2026 | M/s. MEDION BIOTECH PVT.LTD., Village-Kaundi, Baddi, Solan, Himachal Pradesh, 173205 | Assay of Bortezomib | RDTL, Chandigarh |
45. | Rabeprazole Gastro-resistant Tablets IP 20 mg (Robijick - 20) | T- 1047 | 06/2023 | 05/2025 | M/s.Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar - 143 001 (India). | "Dissolution (Acid stage) & (Buffer stage) and Description" | CDTL, Mumbai |
46. | Ramipril & Metoprolol Succinate Tablets (Ramigan -MT 2.5/ 25 Tablets) | AOT23322 | 06/2023 | 05/2025 | M/s.ASTONEA LABS PVT. LTD., Vill. Haripur Teh. Ranipur Rani, Distt. Panchkula, Haryana, India - 134204 | "Assay of Ramipril" | CDTL, Mumbai |
47. | Sertraline Hydrochloride (USP/ EP) | SER240002B FP | 05/2024 | 04/2025 | M/s.Exemep Pharmaceuticals., Block No. 628 (A & B), ECP Canal Road, Village : Luna, Tal : Padra, Vadodara 391440, INDIA | "Related substances" | CDTL, Mumbai |
48. | Pantoprazole Gastro-resistant | UC-23001C | 07/2023 | 06/2025 | M/s.Ultra Drugs Pvt. Ltd., (Unit- II) HS No. | "Dissolution of Domperidone" | CDTL, Mumbai |
and Domperidone Prolonged- release Capsules IP (Unipraz - DSR) | 211, K. No. 77/1, 78/1 Vill. Katha, Baddi, Distt. Solan (H.P.) | ||||||
49. | Paracetamol Paediatric Oral Suspension IP (MYPAR) | S404115 | 04/2024 | 03/2026 | M/s.ION Healthcare Pvt. Ltd., Baddi- Barotiwala Road, Baddi, Distt. Solan (H.P.)- 173 205. | "Related substances" | CDTL, Mumbai |
50. | Hydroxychloroqui ne Sulphate Tableta IP 200 mg (QUEENJAJ 200) | HCQ19K23 | 11/2023 | 10/2026 | M/s. Bajaj Healthcare Ltd., R.S. No. 1818, Manjusar - Savli Road, At & Post - Manjusar, Tal. Savli, Dist. Vadodra - 391775, Gujarat, India. | "Related substances" | CDTL, Mumbai |
51. | DOXYCYCLINE CAPSULES IP 100 mg | HDXA08 | 06/2023 | 05/2025 | M/s.Hindustan Antibiotics Ltd., At 11 W.E.A., Faridabad- 121001. | "Uniformity of weight" | CDTL, Mumbai |
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