Raising serious public health concerns, several pediatric cough syrups failed quality tests, with NSQ data showing content deficiencies that could compromise treatment and endanger medication safety for vulnerable children
Published Jun 26, 2025 | 7:32 PM ⚊ Updated Jun 26, 2025 | 7:32 PM
Synopsis: The CDSCO’s May 2025 report flags 186 drugs nationwide as Not of Standard Quality (NSQ), with Karnataka reporting the most critical failures in South India. Alarming among them are five injectable fluid batches that failed sterility tests—the same type implicated in the 2024 maternal deaths at Ballari and Sindanur hospitals. Investigations had attributed those deaths solely to contaminated Ringer’s Lactate injections
Just months after a series of maternal deaths in Karnataka hospitals were linked to contaminated intravenous fluids, the latest government drug quality report has revealed new failures in injectable medications across the state.
The Central Drugs Standard Control Organisation (CDSCO) May 2025 report identifies 186 Not of Standard Quality (NSQ) drugs nationwide, with Karnataka accounting for the highest number of critical failures among southern states.
Most concerning are five separate batches of injectable fluids that failed sterility tests – the same type of medication that caused maternal deaths in government hospitals between October and December 2024.
The earlier tragedy saw at least nine mothers die following C-section surgeries at Ballari District Hospital and Sindanur Taluk Hospital in Raichur after receiving contaminated Ringer’s Lactate injections from Paschim Banga Pharmaceuticals. Expert investigations ruled out medical negligence, pointing to the IV fluid as the sole cause of deaths.
The new NSQ data reveals that contamination issues in injectable medications persist across multiple manufacturers. Five batches of critical IV fluids failed sterility tests in Karnataka alone:
Karnataka’s Health Minister issued an urgent advisory: “The Karnataka Drug Testing Laboratory has opined that the following medicines/cosmetics are ‘not of standard quality.’ All drug retailers, doctors, hospitals, and nursing homes are requested to immediately stop storing/selling/using these products,” said karnataka Health Minister Dinesh Gundu rao on X.
He added if any stock is found in hospitals or drug stores, please inform your local Drug Inspector or Assistant Drug Controller immediately. “Your safety is our priority. Please do not use the medicines/cosmetics from the batches listed below. Strict action will be taken against those who violate this regulation,” he said.
Drugs Testing Laboratory, Karnataka, has opined that the following drugs/cosmetics as “Not of Standard Quality”.
I urge all chemists, doctors, hospitals & nursing homes to IMMEDIATELY stop stocking/selling/using these products. If you have any stock, inform your local Drugs… pic.twitter.com/WDdwpv1QGf
— Dinesh Gundu Rao/ದಿನೇಶ್ ಗುಂಡೂರಾವ್ (@dineshgrao) June 25, 2025
“These sterility failures represent an immediate threat to patient safety,” said, a senior pharmacologist who declined to be named. “Injectable medications that fail sterility tests can cause sepsis, organ failure, and death – exactly what we witnessed in Karnataka’s maternal death cases.”
Adding to public health concerns, several cough syrups intended for children failed quality tests, raising fears about medication safety for India’s most vulnerable population. The NSQ data reveals multiple pediatric formulations with content failures that could compromise treatment effectiveness.
In Tamil Nadu, Manoril-BR Syrup containing Terbutaline Sulphate, Bromhexine HCL, Guaiphenesin and Menthol from AASSK Pharmaceuticals failed to meet label claims for Bromhexine Hydrochloride content. Similarly, Entcof Syrup with Ambroxol Hydrochloride, Guaiphenesin, and Terbutaline Sulphate from Mediguard Remedies showed content failures for Terbutalline Sulphate.
These failures are particularly concerning given India’s recent history with contaminated pediatric medications. In 2022, the World Health Organization linked Indian-made cough syrups to the deaths of over 70 children in Gambia, while similar products were associated with 20 child deaths in Uzbekistan. The contaminated syrups contained dangerous levels of diethylene glycol and ethylene glycol, toxic compounds that can cause kidney failure and death.
The analysis of NSQ data from the southern states reveals quality failures extending far beyond injectable medications, affecting critical drug categories that millions of Indians depend on daily.
Cardiovascular medications – essential for preventing heart attacks and strokes – showed widespread dissolution and assay failures across Tamil Nadu and Puducherry. Atorvastatin tablets from Candour Pharmaceuticals failed dissolution tests, while Telmisartan & Amlodipine tablets from Revantis Healthcare showed assay failures that could leave patients with uncontrolled blood pressure.
Anti-diabetic medications critical for managing diabetes showed alarming patterns of failure. Glibenclamide and Glimepiride tablets from multiple manufacturers failed dissolution tests, potentially leaving diabetic patients with poor blood sugar control and risk of complications.
Antibiotic medications failed across multiple states, with Norfloxacin tablets in Telangana and Amoxicillin combinations in Tamil Nadu showing dissolution and content failures that could lead to treatment failure and antibiotic resistance.
The geographic distribution of failures reveals troubling patterns:
Karnataka reported 16 NSQ drugs, dominated by sterility failures in injectable medications and dissolution problems in critical oral medications.
Tamil Nadu reported 15 NSQ drugs, with particular concerns around injectable medications showing pH compliance failures and cardiovascular drugs with dissolution issues.
Telangana identified 9 NSQ drugs, including multiple batches of the same drug from repeat offender manufacturers, suggesting systemic quality problems.
Puducherry found 6 NSQ drugs, with notable physical defects including leaking soft gelatin capsules and assay failures in critical medications.
The data reveals concerning patterns of repeat violations by certain manufacturers. Himalaya Meditek appears twice for pH failures in injectable medications, while Samkem had multiple batches of the same drug failing dissolution tests. Prosafe Biologicals had two probiotic products with insufficient viable bacterial counts.
The report also highlights widespread regulatory compliance violations, with manufacturers frequently omitting required “IP” (Indian Pharmacopoeia) designations on labels, using incorrect font sizes for drug names, and failing to properly disclose colour additives.
(Edited by Ananya Rao)
