The April alert also lists several injectable drugs critical to emergency and surgical care as substandard, along with spurious drugs masquerading as genuine products.
Published May 25, 2025 | 7:52 PM ⚊ Updated May 25, 2025 | 7:52 PM
Representative image of drugs (iStock)
Synopsis: The CDSCO has flagged 60 medicines – including eye drops and IV fluids linked to blindness in the US and maternal deaths in Karnataka – as substandard in its April 2025 alert. The drugs failed quality tests for sterility, contamination, and incorrect dosage, affecting treatments for surgery, chronic conditions, and infections. The alert also highlights an alarming circulation of spurious and counterfeit medicines.
Eye drops and intravenous fluids previously linked to cases of blindness in the United States and maternal deaths in Karnataka have been officially classified as “Not of Standard Quality” by India’s apex drug regulator.
The Central Drugs Standard Control Organisation (CDSCO), in its April 2025 alert, flagged 60 drug samples as substandard based on tests conducted at official drug control laboratories across the country.
Among them are Carboxymethylcellulose Sodium Eye Drops, used to treat dry eyes.
In 2023, the US Food and Drug Administration (FDA) recalled over 1.8 million cartons of similar formulations made by multiple Indian manufacturers, citing sterility issues that led to infections and cases of vision loss and blindness.
In the April alert, three batches of the same composition – manufactured by Martin & Brown Biosciences Pvt Ltd, based in Himachal Pradesh – failed CDSCO quality checks for pH, sterility, and assay levels.
Similarly, Compound Sodium Lactate Injection (Ringer’s Lactate) – administered to women who later died after caesarean sections in Ballari, Karnataka between 9 and 11 November 2024 – was flagged once again.
This time, the flagged batch was manufactured by Aculife Healthcare Pvt Ltd, and failed CDSCO testing for sterility.
The earlier batch linked to the maternal deaths had been produced by Paschim Banga Pharmaceuticals in West Bengal.
In January 2025, Mamoni Ruidas, a 22-year-old woman in West Bengal, died two days after childbirth at Midnapore Medical College.
She had received a sodium chloride IV fluid labelled as substandard or expired. Afterwards, 47 other patients fell ill, six were moved to ICU, and two required life support.
The CDSCO has since flagged multiple batches of this IV fluid – manufactured by Captab Biotec in Himachal Pradesh – for the presence of bacterial endotoxins, a contaminant that can trigger fatal septic shock.
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Life-saving drugs fail quality tests
The April alert also lists several injectable drugs critical to emergency and surgical care as substandard.
Bupivacaine Hydrochloride Injection, a local anaesthetic widely used during surgeries, was found to contain particulate matter, which poses serious risks if administered into the bloodstream.
Iron Sucrose Injection, commonly used for treating anaemia, failed tests for pH and alkalinity, which can result in tissue necrosis, vein inflammation, or iron toxicity.
Meanwhile, Ceftriaxone and Sulbactam Injection, a broad-spectrum antibiotic combination, was found contaminated with bacterial endotoxins, raising the risk of severe allergic reactions and treatment failure.
Other antibiotics, including Amikacin Sulphate and Gentamicin Injections, failed due to particulate contamination, which can lead to embolism and reduced effectiveness in treating serious infections, respectively.
Chronic disease medicines also affected
Drugs prescribed for chronic conditions also featured prominently among the failed samples.
Several antiepileptic drugs, including Phenytoin Sodium and Levetiracetam Tablets, did not meet dissolution or content specifications, potentially exposing patients to breakthrough seizures due to inadequate dosing.
Antidiabetic combinations, such as Teneligliptin-Metformin and Glimepiride Tablets, showed assay failures, increasing the risk of uncontrolled blood sugar levels.
Likewise, Telmisartan Tablets, an antihypertensive, failed quality tests, a lapse that could lead to elevated blood pressure, stroke, or cardiac arrests.
A fixed-dose anti-tuberculosis formulation – Rifampicin-Isoniazid-Pyrazinamide Tablets – also failed assay standards, potentially contributing to drug resistance and treatment failure – an alarming possibility in the fight against TB.
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Spurious drugs in circulation
The CDSCO also identified spurious drugs masquerading as genuine products.
A batch of Nandrolone Decanoate Injection, sold under the brand name Deca-Durabolin 50, and typically prescribed for treatment of osteoporosis in postmenopausal women, failed identification and assay tests.
The purported manufacturer denied producing the batch, prompting CDSCO to classify it as spurious, pending further investigation.
Similarly, a batch of D’mex Colecalciferol (Vitamin D3) Tablets, meant to aid in vitamin D supplementation, flagged for failing assay tests for cholecalciferol content, was deemed potentially counterfeit.
The manufacturer listed on the label again denied producing the flagged batch, reinforcing fears about the spread of counterfeit drugs in the Indian pharmaceutical supply chain.
(Edited by Dese Gowda)
