Manufacturer record

Kerala State Drugs and Pharmaceuticals Ltd: regulatory record

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories

19 batches manufactured by Kerala State Drugs and Pharmaceuticals Ltd (Kerala) were declared Not of Standard Quality between October 2024 and August 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.

Most recent flagged batch: TM5145, Telmisartan Tablets IP 40 mg (exp Aug 2027). DTL, Thrissur (state lab) found it not of standard quality: The sample does not conform to IP standards with respect to Description. Listed in the August 2026 alert.

Records by type

19 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
19Failed 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 Aug 2026

View original document

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 Always check the linked government document for the current position, and tell us if something is out of date.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.

19
NSQ batches since 2024
9
Products affected
Dissolution
Most common failure
Aug 2026
Latest alert

Flagged batches per year

2024 · 22025 · 62026 · 11

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Telmisartan Tablets IP 40 mg Batch TM5145Mfg Sep 2025 · Exp Aug 2027 The sample does not conform to IP standards with respect to Description.Description DTL, ThrissurState lab Aug 2026
Telmisartan Tablets IP 40 mg Batch TM 5139Mfg Sep 2025 · Exp Aug 2027 The sample does not conform to IP standards with respect to Description.Description DTL, ThrissurState lab Aug 2026
Diclofenac Sodium Tablets IP 50 mg Batch DG5027Mfg Feb 2025 · Exp Jan 2027 Sample does not conform to IP standards with respect to the test Dissolution and also shows category B defect of tablets (Capping) as described under DCC Guidelines on NSQ DrugsDissolution RDTL, EKMState lab Aug 2026
Telmisartan Tablets IP 40 mg Batch TM5143Mfg Sep 2025 · Exp Aug 2027 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 Batch DG5034Mfg Mar 2025 · Exp Feb 2027 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 Batch TM 5144Mfg Sep 2025 · Exp Aug 2027 DescriptionDescription DTL ThrissurState lab May 2026
Telmisartan Tablets IP 40 mg Batch TM5142Mfg Sep 2025 · Exp Aug 2027 DescriptionDescription DTL ThiruvananthapuramState lab May 2026
Diclofenac Sodium Tablets IP 50mg Batch DG 5031Mfg Feb 2025 · Exp Jan 2027 Dissolution.Dissolution DTL ThiruvananthapuramState lab May 2026
Folic Acid Tablets IP 5mg Batch F65092Mfg Aug 2025 · Exp Jul 2028 Sample fails the test Dissolution as per IPDissolution DTL, ThiruvananthapuramState lab Mar 2026
Diclofenac Sodium Tablets IP 50mg Batch DG5028Mfg Feb 2025 · Exp Jan 2027 Dissolution as per IPDissolution DTL, ThrissurState lab Mar 2026
Doxycycline Hyclate Tablets USP-100MG Batch DX 5042Mfg Jan 2025 · Exp Dec 2028 Sample fails the test Dissolution as per USP as specified in the Laboratory ProtocolDissolution DTL ThiruvananthapuramState lab Feb 2026
Glimepiride Tablets IP 2mg Batch GL 4142Mfg Nov 2024 · Exp Oct 2026 It fails the test "Dissolution". as per IP.Dissolution DTL ThrissurState lab Nov 2025
Glimepiride Tab IP 1 mg Batch GP4053Mfg Mar 2024 · Exp Feb 2026 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 Batch GP4039Mfg Mar 2024 · Exp Aug 2026 It fails the test ?Dissolution? Specified in the laboratory protocol as per IPDissolution Drugs Testing Laboratory ThiruvananthapuramState lab Mar 2025
Cetirizine Syrup IP Batch CE3010Mfg Sep 2023 · Exp Aug 2025 It fails the test ?Assay? as per IPAssay DTL ThiruvananthapuramState lab Jan 2025
Cetirizine Syrup IP Batch CE 3008Mfg Sep 2023 · Exp Aug 2025 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 Batch CE4019Mfg May 2024 · Exp Apr 2026 It fails the tests Microbial contamination in non- sterile products as per IPMicrobial limits DTL ThiruvananthapuramState lab Jan 2025
Chlorpromazine Tablets IP 50 mg Batch S73010Mfg Mar 2023 · Exp Feb 2025 The sample fails in the ?Descriptive Part? for Tablets as per IPOther DTL ThiruvananthapuramState lab Nov 2024
Theophylline & Etophylline Tablets Batch TE4029Mfg Apr 2024 · Exp Mar 2027 It fails the test ?Disintegration? Specified in the Laboratory Protocol as per IPDisintegration DTL ThiruvananthapuramState lab Oct 2024

Right of reply. Manufacturers may submit a response or a laboratory re-test result; it is published unedited alongside this record. Submit a response.