Drug Alert: 47 Drug Samples Fail To Clear CDSCO Test, 1 Declared spurious
New Delhi: With an aim to make stakeholders aware of the not-of-standard-quality (NSQ) batches identified in the market, in its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 47 medicine batches for failing to qualify for a random drug sample test and declared Telma H (Telmisartan 40mg & Hydrochlorothiazide 12.5mg) batch no. 05240198 as spurious for the month of February 2025.
This came as part of the continuous regulatory surveillance, where drug samples are picked from sales/distribution points, analyzed, and a list of spurious drugs is displayed on the CDSCO portal on a monthly basis. The purpose of displaying the spurious drugs list is to make stakeholders aware of the spurious drug batches identified in the market.
These include compound sodium lactate injection IP (Ringer Lactate Solution for Injection) manufactured by Eurolife Healthcare, Rabeprazole Tablets IP 20 mg manufactured by Martin and Brown BioSciences, Adrenaline Bitartrate Injection I.P. 1ml manufactured by Health Biotech, compound sodim lactate injection IP 500 ml. (Ringers Lactate I.P. ) (RL) manufactured by Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd), Co-trimoxazole Tablets I.P. manufactured by OMEGA PHARMA, Glimepiride Tablets I.P. 1mg manufactured by Karnataka Antibiotic and Pharmaceuticals, Nitrofurantoin Tablets IP 100mg manufactured by Jackson Laboratories, Amoxycillin and Clavulanate Potassium for Oral Suspension I.P. 3.6gm/30ml manufactured by Zee Laboratories and others.
In addition, the apex drug regulatory body has released the list of spurious drugs for the month of February, 2025, mentioning that Telma H (Telmisartan 40mg & Hydrochlorothiazide 12.5mg) with batch no. 05240198 failed critical quality tests and was declared as spurious. Manufactured in February 2024 with an expiry date of January 2027, this product does not conform to Indian Pharmacopoeia (IP).
As per the alert, the actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.
Furthermore, in accordance with the alert, a drug shall be deemed to be spurious;
a. If it is manufactured under a name which belongs to another drug; orb. if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; orc. If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; ord. If it has been substituted wholly or in part by another drug or substance; ore. If it purports to be the product of a manufacturer of whom it is not truly a product.The term “Spurious Drug” has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940.
List of Drugs, Medical Devices, Vaccines, and Cosmetics declared as Spurious for the Month of February-2025
S.No. | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufact ure | Date of Expiry | Manufactured By | Reason for failure | Drawn By | Firm’s reply | Remarks |
1. | Telma H (Telmisartan 40mg & Hydrochlorothiazide 12.5mg) | 05240198 | Feb-2024 | Jan-2027 | Under Investigation | Does not Conform to I.P. | - | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. | The product is purported to be spurious, however, the same is subject to outcome of investigation. |
Meanwhile, drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. The term ‘standards of quality’ is defined under Section 16 (1) (a) of the Drugs and Cosmetics Act, 1940, as ‘standards of quality’ meaning 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, description, etc.
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 FEBRURARY-2025
A. CDSCO/Central Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufactur ing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) | DCSL3021 | 11/2023 | 10/2026 | M/s. Eurolife Healthcare Pvt. Ltd., K.No-520, Bhagwanpur, Roorkee-247667, Uttarakhand | Particulate Contamination, Bacterial endotoxin test, Sterility and Description | CDL, Kolkata |
2. | Rabeprazole Tablets IP 20 mg | MT-24E30 | 05/2024 | 10/2025 | M/s. Martin & Brown Bio- Sciences Pvt. Ltd. K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan (H.P.) 173205 | Related Substances, Dissolution (Buffer Stage) and Assay of Rabeprazole Sodium | CDL, Kolkata |
3. | Haloperidol Injection IP (Radipace) | L2403/2 | 03/2024 | 02/2026 | M/s. SBS Biotech, Mouza Rampur Jattan, Nahan Road, Kala Amb, District Sirmour (H.P.) | Particulate matter and Description | CDL, Kolkata |
4. | Rabeprazole Sodium Injection IP | MD23H10 | 08/2023 | 07/2025 | M/s. Martin & Brown Bio- Sciences K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist- Solan (H.P) 173205 | pH, Clarity of Solution, Particulate matter, Related Substances and Assay of Rabeprazole sodium | CDL, Kolkata |
5. | Disinfectant Fluid Phenolic Type (Konark Super Phenyle) | KSP-355 | 12/2024 | 05/2026 | M/s. Teedeecol (India), Hari Om Complex, Behind Sri Krishna Goshala, Bangali Para, Jharsuguda -768201 Odisha | Grade and Germicidal Value | CDL, Kolkata |
6. | Levosalbutamol Sulphate, Ambroxol Hydrochloride & Guaiphenesin Syrup, (Blurex-LS Syrup) | TBHX0448 | 05/2024 | 04/2026 | M/s. Three B Healthcare Ltd., Opp. Dental college, Rampur Road, Paonta Sahib, Distt- Sirmour (HP)-173025 | Assay of Ambroxol Hydrochloride | CDL, Kolkata |
7. | Adrenaline Bitartrate Injection I.P. 1ml | HIAN24005A | 09/2024 | 08/2025 | M/s. Health Biotech Ltd. Village Sandoli, Nalagarh Road, Baddi, Distt. Solan (HP) 173205, India | Appearance of solution, Particulate matter and Description | CDL, Kolkata |
8. | Aminophylline Injection I.P .10 ml | MA23L108 | 12/2023 | 11/2025 | M/s. Martin and Brown Biosciences K.No-918/419, Malkumajra, Nalagarh Road, Baddi, Dist-Solan (H.P.)- 173205 | Particulate matter, Assay of Ethylenediamine and Theophylline and Description | CDL, Kolkata |
9. | Bupivaaine Hydrochloride in Dextrose Injection USP | HIBU23010 | 09/2023 | 08/2025 | M/s Health Biotech Ltd., Vill- Sandoli, Nalagarh Road, Baddi, Dist- Solan, HP-173205 | Particulate Matter in Injection and Description | CDL, Kolkata |
10. | Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection ) (Hi- Ring-RL) | F41746 | 11/2024 | 10/2027 | M/s. HIGGS HEALTHCARE , Khasra No-480/1, Bhatolikalan Baddi, H.P. | Bacterial endotoxins | CDL, Kolkata |
11. | Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection ) (Hi-Ring-RL ) | F41799 | 11/2024 | 10/2027 | M/s. HIGGS HEALTHCARE , Khasra No-480/1, Bhatolikalan Baddi, H.P. | Bacterial endotoxins | CDL, Kolkata |
12. | COMPOUND SODIUM LACTATE INJECTION IP 500 ml. (Ringers Lactate I.P. ) (RL) | 03BF2442 | 03/2024 | 02/2027 | M/s.Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, Tin Mile Hat, Sonapur Hat, PS-Chopra, Dist-Uttar Dinajpur-733214 (W.B.) | Bacterial endotoxins | CDL, Kolkata |
13. | Ciprofloxacin Injection IP (0.2%w/v) | 09AF0075 | 05/2023 | 04/2026 | M/s.Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, Tin Mile Hat, Sonapur Hat, P.S.-Chopra, Dist-Uttar Dinajpur-733214 (WB) | Particulate contamination | CDL, Kolkata |
14. | Carboxymethylcellulose Sodium Eye Drops IP 10 ml | MO24H19 | 08/2024 | 07/2026 | M/s. Martin & Brown Bio- Sciences Pvt. Ltd. K. No. 918/419 Malkumajra, Nalagarh Road, Baddi, Distt. Solan (HP) 173205 | pH and Sterility | CDL, Kolkata |
15. | Drotaverine Hydrochloride Tablets 40 mg. (Dratovis-40 ) | 12680 | 01/2024 | 12/2026 | M/s. Syncom Formulations (India) Ltd., Factory-256-257, Sector-1, Pithampur (Dhar )- 454775 , Madhya Pradesh India | Assay of Drotaverine Hydrochloride | CDL, Kolkata |
16. | Azithromycin Oral Suspension I.P. (Azysafe Liquid-100 ) | AZ1-206 | 10/2023 | 03/2025 | M/s. Overseas Healthcare Pvt. Ltd., 335KM Milestone, National Highway No.1, P.O. Box No.-25, Phillaur-144410 (Pb) | Uniformity of Volume | CDL, Kolkata |
17. | Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup), | BOB-2423 | 06/2024 | 11/2025 | M/s. Apple Formulations Pvt. Ltd., Plot no. 208, Kishanpur, Roorkee-247667 (U.K.) | Assay of Calcium D-Pantothenate | CDL, Kolkata |
18. | Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup) | BOB-2424 | 06/2024 | 11/2025 | M/s. Apple formulations Pvt. Ltd. Plot no. 208, Kishanpur, Roorkee-247667 (U.K.) | Assay of Calcium D-Pantothenate | CDL, Kolkata |
19. | Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup) | BOB-2438 | 06/2024 | 11/2025 | M/s. Apple formulations Pvt. Ltd. Plot no. 208, Kishanpur, Roorkee-247667 (U.K.) | Assay of Vitamin B12 | CDL, Kolkata |
20. | Phenytoin Sodium Injection USP | PTS-225A | 05/2024 | 04/2026 | M/s. Pushkar Pharma, Kheri, Kala-Amb-173030 (H.P.) | Alcohol Content and Propylene Glycol content | CDL, Kolkata |
21. | Rabeprazole Sodium Injection IP | MD24E30 | 05/2024 | 04/2026 | M/s. MARTIN & BROWN BIO- SCIENCES PVT. LTD., K.No- 918/419, Malkumajra, Nalagarh Road, Baddi, Dist- Solan (H.P.)-173205 | pH, Clarity of Solution, Particulate matter and Description | CDL, Kolkata |
22. | Polywin Vitamin B Complex Injection (Polywin) | MA24H16 | 08/2024 | 01/2026 | M/s. MARTIN & BROWN BIO- SCIENCES PVT. LTD., K.No- 918/419, Malkumajra, Nalagarh Road, Baddi, Dist- Solan (H.P.)-173205 | Extractable volume, Particulate matter, Assay of Riboflavin Sodium Phosphate and Description | CDL, Kolkata |
23. | Sitagliptin Phoshpate Tablets I.P. (50 mg) | MT243714 | 11/2024 | 10/2026 | M/s. Mascot Health Series Pvt. Ltd., Plot No. 79,80, Sec-6A, IIE, Sidcul, Haridwar 249403 | Assay of Sitagliptin Phosphate | CDL, Kolkata |
24. | Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- | BOB-2452 | 06/2024 | 11/2025 | M/s. Apple formulation Pvt. Ltd., Plot no. 208, Kishanpur, Roorkee-247667 (U.K.) | Assay of Vitamin B12 | CDL, Kolkata |
Pantothenate Syrup (B- Complex Syrup) | |||||||
25. | Sucralfate USP | LSU2409105 | 09/2024 | 08/2029 | M/s. LEGEND INDUSTRIES, Unit-II, Plot No. C1/200-201/4, Phase-II, Opp. Encore Ltd., Naroda, G.I.D.C., Ahmedabad- 382 330 | Spurious Identification and Assay of Sucralfate | CDL, Kolkata |
26. | Wholeshield Refire Premium Herbal Blend Capsule | EAHC24021 | 09/2024 | 08/2027 | M/s. Aeron Lifescience Pvt. Ltd.D 152 & 153 Zaveri Com. Co.Op, Road Number 11, Kathwada GIDC, Ahmedabad, Gujarat 382430, | Assay | CDL, Kolkata |
27. | Wholeshield Refire Premium Herbal Blend Capsule | EAHC24020 | 09/2024 | 08/2027 | M/s. Aeron Lifescience Pvt. Ltd.,D 152 & 153 Zaveri Com. Co.Op, Road Number 11, Kathwada GIDC, Ahmedabad, Gujarat 382430 | Assay | CDL, Kolkata |
28. | Co-trimoxazole Tablets I.P. (D.S.= Double Strength) | PT30119 | 05/2023 | 04/2025 | OMEGA PHARMA,, Khasra No.482, Village Saliyar, Roorkee-247667, Distt. Haridwar. (Uttarakhand) | Dissolution (Sulphamethoxazol e and Trimethoprim) | RDTL, Guwahati |
29. | Albendazole Tablets IP 400 mg | LMT241138 | 10/2024 | 09/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | "Dissolution" of Albendazole | RDTL, Guwahati |
30. | Glimepiride Tablets I.P. 1mg | GLI10823 | 05/2023 | 04/2025 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED, Arka The Business Centre, Plot No. 37, Site No. 34/4, NTTF Main Road, Peenya Industrial Area, 2nd Phase, Bengaluru-560058, INDIA. | Dissolution | RDTL, Guwahati |
31. | Linezolid Tablets I.P. 600 mg. (ALINO-600 Tablets) | VLB-GT-2500 | 12/2023 | 11/2025 | Vee Laboratories,, Village Kalier, Subathu, RoadSaproon (Post Office) Solan173211, Himachal Pradesh | Dissolution | RDTL, Guwahati |
32. | Norfloxacin Tablets I.P. 400mg. | NFXT-1002 | 06/2023 | 05/2026 | WINGS BIOTECH LLP, 43 & 44, HPSIDC, Industrial Area, Baddi - 173205 (H.P.) | Dissolution | RDTL, Guwahati |
33. | Nitrofurantoin Tablets IP 100mg | T-2485 | 11/2023 | 10/2025 | Jackson Laboratories Pvt.Ltd, 22-24, Majitha Road, Bye Pass, Amritsar-143 001(India) | Dissolution | RDTL, Guwahati |
34. | Amoxycillin & Clavulanate Potassium for Oral Suspension I.P. 3.6gm/30ml | 724-37 | 02/2024 | 01/2026 | M/s. ZEE LABORATORIES LTD, Behind 47, Industrial Area, Paonta Sahib-173025 | Identification and Assay/Content of Clavulanic Acid | RDTL, Guwahati |
35. | Telmisartan Tablets IP 40mg (Savtel 40 Tablets) | PT-40584 | 02/2024 | 01/2026 | Pharmaroots Healthcare, Khasra No. 411, Village Tipra, P.O. Barotiwala, Tehsil Baddi, Distt. Solan, H.P. | Dissolution | RDTL, Guwahati |
36. | Telmisartan Tablets IP (TELMOPI-40 Tablets) | 23I-T2013 | 12/2023 | 11/2025 | M/s. Orison Pharma International, Vill. Khari, Mauza Ogli, Kala Amb, Distt. Sirmour - 173030 (H.P.) | Dissolution | RDTL, Guwahati |
37. | Paracetamol & Diclofenac Sodium Tablets I.P. (IG Pyrin) | IGN-2602 | 05/2023 | 04/2026 | I.G. PHARMA LTD., 12.4KM, MEERUT ROAD, ROORKEE, DIST. HARIDWAR (UK) | Dissolution of Paracetamol & Diclofenac Sodium | RDTL, Guwahati |
38. | Iron Sucrose Injection USP 100 mg/ 5 ml | 23IS10 | 12/2023 | 11/2025 | Sai Parenterals Limited, D1 & D4, Survey No. 280, Phase-V, Ida, Jeedimetla, Hyderabad- 500055, Telangana, India. | "pH", "Alkalinity" and "Particulate Matter In Injection" | CDTL-Mumbai |
39. | Linezolid IV Injection 600 mg/ 300 ml (ABAZOLID) | A4544004 | 04/2024 | 03/2026 | Abaris Healthcare Pvt. Ltd., Survey No. 1407-11, Villate : Rajpur, Taluka : Kadi, Dist : Mehsana- 382740.Gujarat | "Related substances" | CDTL-Mumbai |
40. | Bacillus clausii Spores Suspension (Bactogermina Oral Suspension 2 Billion/ 5 ml) | AFL241415 | 10/2024 | 09/2026 | AARMED FORMULATIONS PVT. LTD., Survey No.431/2, Plot No.1, Steel Town, Moraiya, Tal. Sanand, Dist. Ahmedabad, (Gujarat) | Assay as "Viability" (Total viable count) | CDTL-Mumbai |
41. | Lignocaine Hydrochloride Gel IP 5 % w/v (30 g) | G407 | 09/2024 | 08/2026 | Gnosis Pharmaceuticals Pvt. Ltd., Nahan Road, Village Moginand, Kala- Amb Distt. Sirmour, H.P. - 173030. | "pH" | CDTL-Mumbai |
42. | Ferric Carboxymaltose Injection 500 mg/ 10 ml (For IV Injection / Infusion) | SVI-24171A | 08/2024 | 07/2026 | Sunvet Healthcare, Village Shambhuwala, Paonta Road, Distt. Sirmour (H.P.) 173001, | "Bacterial Endotoxins", "Sterility" and "Assay" | CDTL-Mumbai |
43. | Ferric Carboxymaltose Injection 1 g,/ 20 ml (For IV Injection / Infusion) | SVI-24168B | 08/2024 | 07/2026 | Sunvet Healthcare, Village Shambhuwala, Paonta Road, Distt. Sirmour (H.P.) 173001, | "Bacterial Endotoxins", "Sterility" and "Assay" | CDTL-Mumbai |
44. | Levocetirizine Dihydrochloride Tablets IP 5 mg (Alercet-5) | 2411110 | 11/2024 | 10/2026 | M/s. Brij Healthcare Pvt. Ltd, 51/10, G.I.D.C Esatae, Motipura, Himatnagar - 383001, Gujarat | Dissolution | CDTL, Indore |
45. | Clonazepam Tablets IP 0.5 mg (NOZIM-0.5) | DT40078 | 12/2024 | 11/2027 | M/s. Elikem Healthcare Private Limited, Plot/Survey No. 146, Near Sarbhara Beverages, Village - Borisana, Tal. - Kadi, Dist. - Mehsana - 382 715, Gujarat, India | Dissolution | CDTL, Indore |
46. | Aceclofenac, Paracetamol & Serratiopeptidase Tablets (Acemarc-SP Tablets) | MT-306 | 12/2024 | 11/2026 | M/s Maha Avtar, Health Care Pvt. Ltd., D-22, Sector-17, Kavi Nagar Indl.Area, GZB-201002 | Uniformity of weight | RDTL, Chandigarh |
47. | Sodium Bicarbonate Tablets U.S.P. 1000 mg (NABOSIS 1000 mg | T-2307270 | 07/2023 | 06/2025 | M/s. Rivpra Formulation Pvt. Ltd., Plot No. 8, Sector-6A, IIE SIDCUL, Haridwar-249 403 (U.K. | Description | CDTL, Hyderabad |
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