Of the 53 drugs flagged by Karnataka, injectables were among the most concerning, with at least 16 failing sterility tests. Several brands of paracetamol tablets also did not meet standards for appearance, dissolution, and active content.
Published Jul 20, 2025 | 5:19 PM ⚊ Updated Jul 20, 2025 | 5:19 PM
Spurious drugs
Synopsis: Karnataka flagged 53 out of 189 drug samples as Not of Standard Quality (NSQ), the highest among all states, according to the Central Drugs Standard Control Organisation’s monthly alert for June 2025. The failed drugs spanned a wide range, including antibiotics, paracetamol, psychiatric medicines, and injectables, with many found to be contaminated, improperly formulated, or incorrectly labelled.
Karnataka’s state drug testing laboratories flagged 53 pharmaceutical products as Not of Standard Quality (NSQ) in June 2025, accounting for 30 percent of the 189 drug samples – 130 state NSQs, 55 flagged by central labs, and 4 deemed spurious – listed in the latest national alert from India’s apex drug regulator.
The monthly alert, compiled by the Central Drugs Standard Control Organisation (CDSCO), includes reports from 15 state and central laboratories across the country.
Karnataka led in identifying quality failures across a wide range of medicines, including antibiotics, antihypertensives, psychiatric drugs, and intravenous fluids such as normal saline and dextrose.
Under the Drugs and Cosmetics Act, 1940, a drug is deemed Not of Standard Quality if it fails to meet Indian Pharmacopoeia specifications – whether due to contamination, incorrect potency, poor appearance, or faulty labelling.
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Injectable failures raise alarm
Of the 53 drugs flagged by Karnataka, injectables were among the most concerning, with at least 16 failing sterility tests – posing serious risks of infection.
Puniska Injectables Pvt Ltd had six batches of sodium chloride injections fail, while iron sucrose, methotrexate, dexamethasone, frusemide, atropine, and vitamin B12 injections were also found unsafe.
Essential oral medicines also failed testing. Several brands of paracetamol tablets did not meet standards for appearance, dissolution, and active content. Rodal 650 failed on all three counts.
Drugs used for hypertension – particularly telmisartan-based combinations – were repeatedly flagged for issues such as non-uniform tablet weight, poor dissolution, and assay failures. These included Telapp MT 25 and multiple products from Wings Biotech LLP.
Among psychiatric medications, lorazepam tablets (1 mg and 2 mg) and Nexikam-Plus (escitalopram + clonazepam) were found to have failed assay and content uniformity tests.
Paediatric and respiratory formulations, including ambroxol-based syrups such as Salbrox-XL and DKOF-LA, were flagged for assay and labelling issues. A multivitamin softgel capsule from Asoj Soft Caps was found unusable due to leakage and sticking.
Even topical formulations such as Mupirocin ointment and povidone iodine solution failed identification and assay tests, while ofloxacin and dexamethasone eye/ear drops failed sterility checks.
Several veterinary drugs – such as enrofloxacin tablets, cephalexin bolus, and oxytetracycline injections – were also deemed substandard.
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Repeat offenders and labelling violations
The repeated appearance of certain manufacturers stood out. Martin & Brown Bio-Sciences, based in Baddi, Himachal Pradesh, had more than a dozen batches of calcium and vitamin D3 tablets flagged in different states, including Karnataka. These were found with description failures – often a sign of poor formulation or degradation.
Other repeat offenders across multiple product lines and dosage forms included Wings Biotech, Oscar Remedies, and Puniska Injectables.
The CDSCO alert also flagged violations of labelling norms. While often dismissed as administrative lapses, such errors can mislead doctors and patients. Several products lacked the suffix “IP” (Indian Pharmacopoeia) despite being listed drugs.
Others had undeclared colours, missing manufacturer information, or ambiguous formulation names – all of which violate Schedule D of the Drugs Rules.
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Four medicine batches found to be spurious
The CDSCO has identified four batches of commonly used medicines as spurious during its regulatory surveillance in June 2025. These include widely prescribed drugs used to treat infections, blood clots, and cholesterol disorders.
Taxim-O 200 (cefixime), batch 24460967, flagged in Bihar, failed identification and assay tests. This antibiotic is commonly used for respiratory and urinary tract infections, typhoid, and gonorrhoea.
Thrombophob ointment, batch I404138, flagged in Delhi, failed tests for heparin sodium. The topical medication is commonly used for blood clots, bruises, varicose veins, and is often prescribed to relieve pain and swelling.
Rosuvas F 10 and Rosuvas F 20 – two batches (SIF2676A and SIF2736A), flagged in Telangana – failed fenofibrate assay tests. These tablets are prescribed to manage mixed dyslipidaemia, helping regulate cholesterol and reduce the risk of heart attacks or strokes.
In all four cases, the companies named on the labels have categorically denied manufacturing the batches in question.
However, the CDSCO noted that while the products are “purported to be spurious,” a final determination is “subject to outcome of investigation.” The manufacturing origins of all four batches remain “under investigation.”
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55 NSQ drugs flagged by central laboratories
In addition to the four spurious drugs and the 130 products flagged at the state level, the CDSCO also listed 55 medicine batches that failed to meet quality standards.
Many of these were injectables, including critical medications such as dextrose, dexamethasone, methylcobalamin, tranexamic acid, oxytocin, and adrenaline. Common quality issues included presence of particulate matter, failure of sterility tests, assay inconsistencies, and abnormal pH levels.
Several oral medications were also found to be substandard. These included batches of telmisartan tablets (used for blood pressure), rabeprazole capsules (for acid reflux), and sitagliptin-metformin combinations (used in diabetes management), which failed dissolution and assay tests.
The alert showed a concentration of quality failures among manufacturers based in Himachal Pradesh, Haryana, and Maharashtra. Multiple batches from the same companies appeared on the NSQ list, pointing to systemic lapses in quality control.
