Manufacturer record

Kerala State Drugs and Pharmaceuticals Ltd: regulatory record

Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories

16 batches manufactured by Kerala State Drugs and Pharmaceuticals Ltd (Kerala) were declared Not of Standard Quality between October 2024 and June 2026. Records are batch-specific findings by government laboratories as published in CDSCO's monthly alerts; where a company has stated that a flagged batch was counterfeit, that statement is noted when reported.

Records by type

16 records linked to Kerala State Drugs and Pharmaceuticals Ltd in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.

0Banned or prohibited
0Recalled or suspended
16Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, Oct 2024 to Jun 2026

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Scope. A company appearing here is not a finding that its products are unsafe. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

16
NSQ batches since 2024
9
Products affected
Dissolution
Most common failure
Jun 2026
Latest alert

Flagged batches per year

2024 · 22025 · 62026 · 8

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Telmisartan Tablets IP 40 mg TM5143Mfg 2025-09 · Exp 2027-08 It fails the Descriptive part for tablets as per IP, as specified in the laboratory protocol. As per IP, tablets should have sufficient hardness to withstand handling without crumbling or breaking. These tablets are soft and in powdered condition and cannot be removed from the strips in intact formOther DTL, TVPMState lab Jun 2026
Diclofenac Sodium Tabelts IP 50 mg DG5034Mfg 2025-03 · Exp 2027-02 The sample does not conform to IP standards. If fails the Descriptive part as per IP,as specified in the Laboratory Protocol.Other DTL TVPMState lab Jun 2026
Telmisartan Tablets IP 40 mg TM 5144Mfg 2025-09 · Exp 2027-08 DescriptionDescription DTL ThrissurState lab May 2026
Telmisartan Tablets IP 40 mg TM5142Mfg 2025-09 · Exp 2027-08 DescriptionDescription DTL ThiruvananthapuramState lab May 2026
Diclofenac Sodium Tablets IP 50mg DG 5031Mfg 2025-02 · Exp 2027-01 Dissolution.Dissolution DTL ThiruvananthapuramState lab May 2026
Folic Acid Tablets IP 5mg F65092Mfg 2025-08 · Exp 2028-07 Sample fails the test Dissolution as per IPDissolution DTL, ThiruvananthapuramState lab Mar 2026
Diclofenac Sodium Tablets IP 50mg DG5028Mfg 2025-02 · Exp 2027-01 Dissolution as per IPDissolution DTL, ThrissurState lab Mar 2026
Doxycycline Hyclate Tablets USP-100MG DX 5042Mfg 2025-01 · Exp 2028-12 Sample fails the test Dissolution as per USP as specified in the Laboratory ProtocolDissolution DTL ThiruvananthapuramState lab Feb 2026
Glimepiride Tablets IP 2mg GL 4142Mfg 2024-11 · Exp 2026-10 It fails the test "Dissolution". as per IP.Dissolution DTL ThrissurState lab Nov 2025
Glimepiride Tab IP 1 mg GP4053Mfg 2024-03 · Exp 2026-02 It fails the Descriptive part for tablets as specified in the Laboratory Protocol as per IPOther Drugs Testing Laboratory ThiruvananthapuramState lab Mar 2025
Glimepiride Tab IP GP4039Mfg 2024-03 · Exp 2026-08 It fails the test ?Dissolution? Specified in the laboratory protocol as per IPDissolution Drugs Testing Laboratory ThiruvananthapuramState lab Mar 2025
Cetirizine Syrup IP CE3010Mfg 2023-09 · Exp 2025-08 It fails the test ?Assay? as per IPAssay DTL ThiruvananthapuramState lab Jan 2025
Cetirizine Syrup IP CE 3008Mfg 2023-09 · Exp 2025-08 It fails the test Assay and content of packaged dosage forms specified in the laboratory protocol as per IPAssay DTL ThiruvananthapuramState lab Jan 2025
Cetirizine Syrup IP CE4019Mfg 2024-05 · Exp 2026-04 It fails the tests Microbial contamination in non- sterile products as per IPMicrobial limits DTL ThiruvananthapuramState lab Jan 2025
Chlorpromazine Tablets IP 50 mg S73010Mfg 2023-03 · Exp 2025-02 The sample fails in the ?Descriptive Part? for Tablets as per IPOther DTL ThiruvananthapuramState lab Nov 2024
Theophylline & Etophylline Tablets TE4029Mfg 2024-04 · Exp 2027-03 It fails the test ?Disintegration? Specified in the Laboratory Protocol as per IPDisintegration DTL ThiruvananthapuramState lab Oct 2024

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