In total, 13 of the 216 substandard medicines in October were liquid formulations for children, approximately six percent of all substandard drugs identified that month.
Published Nov 24, 2025 | 9:07 AM ⚊ Updated Nov 24, 2025 | 9:07 AM
Cough Syrup. Representational image. (iStock)
Synopsis: The October 2025 drug testing reports, released a few days back by the CDSCO, confirmed quality testing failure of several medicines, including Coldrif cough syrup, which killed at least 20 children starting in September. Beyond the 211 substandard medicines, five products in the October reports were found to be spurious drugs.
The October 2025 drug testing reports, released a few days back by the Central Drugs Standard Control Organisation (CDSCO), confirm what parents across Madhya Pradesh and Rajasthan learned too late: Coldrif cough syrup, which killed at least 20 children starting in September, had failed quality tests. The Chennai Drugs Testing Laboratory marked it “adulterated” in its monthly report.
However, the same reports revealed something authorities did not announce during the Coldrif crisis: Two more children’s liquid medicines failed quality tests in Tamil Nadu in the same month.
Azini-100 suspension containing the antibiotic Azithromycin, manufactured by Dexter Formulation Private Limited in Keelathukudi, failed content tests at the Madurai drug testing laboratory. LOWFE-250, a paracetamol paediatric suspension made by Casid Pharmaceuticals in Trichy, failed assay requirements at Puducherry’s testing facility.
The October lists from the CDSCO and state laboratories document 216 medicines that failed quality standards. This includes 211 non-standard quality (NSQ) drugs and five completely spurious products that manufacturers said they never produced. Among them were also 13 liquid formulations given to children — nine specifically marketed as cough and cold syrups.
While the quality test failure of Coldrif at Chennai’s drug testing laboratory was publicised, the other two children’s medicines that were substandard were not public knowledge till the report was released.
Dexter Formulation Private Limited, located in Keelathukudi in Tamil Nadu’s Nagapattinam district, manufactures Azini-100 suspension — an Azithromycin antibiotic formulation for children. Batch DL0028, manufactured in July 2025 with expiry in June 2027, failed content requirements when tested at the Drugs Testing Laboratory in Madurai. The October report lists the result simply as: “Content”.
Casid Pharmaceuticals Private Limited in Trichy manufactures LOWFE-250, a paracetamol paediatric oral suspension. Batch CL-24098, manufactured in February 2025 with expiry in January 2027, failed assay tests at the Drug Testing Laboratory in Puducherry. The report states: “Failed in Assay”.
An assay test is a procedure used to determine the presence, amount, and/or functional activity of a drug’s active ingredient.
Unlike Coldrif, these two products did not contain the lethal diethylene glycol that destroyed children’s kidneys in Madhya Pradesh. However, assay and content failures mean the active pharmaceutical ingredients measured either too high, too low, or were distributed unevenly across batches. Children prescribed these medicines may have received incorrect doses — sometimes receiving too little to treat their infections or fevers, sometimes getting concentrations that could cause side effects.
Tamil Nadu reported a total of 17 substandard medicines in the October lists. Besides the three children’s liquid formulations, the state’s manufacturers had products fail for issues ranging from dissolution problems in tablets to content errors in topical gels.
The Drugs Testing Laboratory in Chennai flagged seven products. The laboratory in Madurai caught nine. Puducherry’s testing facility identified one.
Across India, nine cough and cold syrups appear in the October NSQ lists, manufactured in five states.
In Himachal Pradesh, five syrups failed: NUREX-AP from Apple Formulations, Roorkee, showed assay failures with Ambroxol at only 81.53 percent and Terbutaline at 74.40 percent of claimed content. Kufnas-Am Syrup from Star Filteration Systems in Kala-Amb failed content tests. Maticold Suspension from Haustus Biotech in Tahliwal failed assay requirements. KLEANKOF-PLUS Syrup from Go-Ish Remedies in Nalagarh failed assay tests. Khasigo-LS Syrup from Sotac Pharmaceuticals, though registered in Gujarat, also appears in testing reports with content failures.
In Haryana, Montecas-L Syrup manufactured by Casca Remedies in Ambala Cantt failed assay tests for Montelukast. From Faridabad, GESIDRYL DMR Cough Syrup made by Alpha Pharmaceuticals failed assay requirements for Phenylephrine Hydrochloride.
In Uttarakhand, Azithromycin Oral Suspension AZAM-200 by Jainsons Healthcare in Pantnagar failed assay tests.
In Tamil Nadu, as reported earlier, Coldrif failed the tests. Beyond cough syrups, four other paediatric liquid formulations failed tests, including the Azini-100 and LOWFE-250 in Tamil Nadu, as well as Albendazole oral suspension from Telangana which was marked “misbranded” with pH failures.
In total, 13 of the 216 substandard medicines in October were liquid formulations for children, approximately six percent of all substandard drugs identified that month.
Among South Indian states, Karnataka’s Drug Testing Laboratory in Bengaluru reported the highest number of substandard products: 27 medicines failed quality tests in October, representing 12.8 percent of all NSQ drugs detected nationwide.
The Karnataka laboratory tested a wide range of products and found failures in everything from dissolution issues in common pain medications to sterility problems in injectable drugs, as well as assay errors in vitamin supplements.
Tamil Nadu followed with 17 failed products. Kerala reported 12 through laboratories in Thiruvananthapuram, Ernakulam and Thrissur. Andhra Pradesh and Telangana together identified seven problematic medicines. Puducherry’s testing laboratory flagged six products.
Collectively, South Indian states accounted for 69 of the 211 substandard medicines in the October reports — nearly one-third of all quality failures detected across India.
Bihar’s drug testing laboratory in Patna reported 17 substandard products, most of which were common pain medications like Paracetamol that failed dissolution tests — tablets that do not break down properly in the digestive system and may pass through without releasing their active ingredients.
Punjab’s laboratory reported 15 products, most of them Buprenorphine and Naloxone tablets used for opioid addiction treatment, that failed content uniformity tests.
While toxic cough syrup deaths generate immediate attention because children die within days, the October data revealed a broader quality crisis affecting a different population: People taking Calcium Carbonate and Vitamin D3 tablets.
Twenty-seven separate batches from multiple manufacturers failed quality tests — the highest failure count for any single medicine composition. These tablets, consumed daily by pregnant women to prevent pre-eclampsia, by elderly citizens to avoid bone fractures, and by children for growth, either contained incorrect amounts of vitamins or failed dissolution tests.
Six batches from Vzoic Healthcare Private Limited in Punjab, all branded as Aemcal-D3 with different batch numbers manufactured in December 2024, failed both dissolution and assay tests at the Central Drugs Laboratory in Kolkata.
Six batches from Mercury Pharmaceuticals in Himachal Pradesh, branded as TISE-CAL and manufactured between September and November 2024, failed assay requirements. Six batches from Gidsha Pharmaceuticals in Gujarat, branded as CALXIA 500 and manufactured in January 2025, failed dissolution tests.
Additional batches from Helax Health Care, Cureza Healthcare, and other manufacturers showed similar patterns — tablets that either did not dissolve properly or contained vitamin D3 amounts that did not match label claims.
A dissolution failure means the tablet could travel through the intestine without breaking down, delivering no nutrition despite patients believing they are addressing a calcium deficiency. For pregnant women who depend on these supplements to support fetal bone development, or elderly people trying to prevent osteoporosis, failures accumulate over months without obvious symptoms until complications emerge.
Injectable medications that failed the October quality tests represent immediate threats because contaminated products injected directly into the bloodstream can trigger septic shock within hours.
Compound Sodium Lactate Injection, commonly called Ringer Lactate and used in every emergency room for fluid resuscitation during shock or severe dehydration, failed sterility tests. The batch from Vision Parental Private Limited in Uttar Pradesh, tested at the Central Drugs Laboratory in Kolkata, showed bacterial contamination.
Calcium Gluconate Injection, used during cardiac arrest and in the emergency treatment of severe calcium deficiency, failed multiple safety tests, including sterility, bacterial endotoxin testing, and particulate contamination. The batch from Farbe Firma Private Limited in Gujarat failed testing at the Central Drugs Testing Laboratory in Mumbai.
Amikacin Sulphate Injection, a life-saving antibiotic for severe bacterial infections, showed sterility failures and particulate matter contamination in two separate batches from two different manufacturers: Konis Pharmaceuticals in Andhra Pradesh and Oscar Remedies in Haryana.
Paracetamol Injection used in intensive care units failed sterility tests. The batch from Bio Medica Laboratories in Indore, tested in Bengaluru, failed to meet Indian Pharmacopoeia standards for sterile injectable products.
Other failed injectables included Bupivacaine injection used for anaesthesia, Vecuronium Bromide injection used as a muscle relaxant during surgery, Dexamethasone injection used for severe allergic reactions, Docetaxel injection used for cancer chemotherapy, and Labetalol injection used for emergency blood pressure control.
When injectable medicines fail sterility tests, the consequences can manifest within hours as patients develop fever, dropping blood pressure, and organ failure. Hospital records may attribute these deaths to “sepsis of unknown origin” or “hospital-acquired infection” rather than contaminated medicines, making it difficult to trace the true scope of harm.
Beyond the 211 substandard medicines, five products in the October reports fall into a more disturbing category: Spurious drugs. These are not poorly manufactured medicines. These are completely counterfeit products, as the companies named on the packaging say they never produced those batches.
Azithromycin 500mg tablets branded as “Azithral-500,” batch 2408000201, manufactured supposedly in March 2024, were found in Bihar. The Bihar Drug Control Laboratory in Patna tested the product and confirmed quality failures. The authorities later released a statement after contacting the manufacturer listed on the packaging: “The actual manufacturer has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.”
Telmisartan 40mg and Amlodipine 5mg tablets, branded as “Telma-AM,” batch 05241217A, supposedly manufactured in August 2024, were found in Delhi. The National Capital Territory drug testing laboratory confirmed the product was spurious after the listed manufacturer denied production.
Buprenorphine Injection 2ml, branded as “NOOPHIN,” batch LM 18907, supposedly manufactured in July 2023 with expiry date in June 2029, was found in Kolkata. The Central Drugs Laboratory testing confirmed it was counterfeit. This injectable medication is used for treating opioid addiction — a controlled substance that requires careful dosing to prevent withdrawal symptoms or overdose.
Two separate batches of Trypsin-Chymotrypsin tablets, branded as “Chymoral Forte”, were confirmed to be spurious. Batch 2KU6L057, supposedly manufactured in December 2024, and batch 2KU6L030, which showed a manufacturing date of July 2027, impossibly preceding its expiry date of June 2027, were both found in Kolkata. The manufacturer listed on the packaging denied producing either batch.
The presence of these counterfeit medicines indicates organised pharmaceutical fraud networks operating across state lines. Someone is printing fake packaging, filling bottles or blister packs with unknown substances, and distributing them through channels that reach licensed pharmacies, where patients buy them trusting the brand names.
Approximately 20 Paracetamol products in various strengths — 500mg and 650mg tablets — failed quality tests in October, primarily due to dissolution issues. These failures span multiple manufacturers across several states.
Bihar’s drug testing laboratory caught the highest concentration: Ornate Labs in Muzaffarpur had two batches of 500mg tablets fail dissolution tests. Laborate Pharmaceuticals in Paonta Sahib had 500mg tablets fail. Arcon Labs in Baddi had 650mg tablets fail. Vrindavan Global in Baddi had 650mg tablets fail.
Karnataka’s laboratory in Bengaluru detected Paracetamol failures from Aban Pharmaceuticals in Gujarat and Vivek Pharmachem in Rajasthan. Other state laboratories identified additional batches from Leeford Healthcare, Unicure India, and other manufacturers.
Parents give the medicine to feverish children and wait for temperatures to drop. When nothing happens after the expected time, they assume the illness is more severe and give another dose or switch medications, never suspecting the first tablets were defective.
Given that Paracetamol ranks among India’s most widely consumed over-the-counter medicines, purchased without prescription and stocked in nearly every household, the scale of exposure to these substandard batches could run into millions of doses before recalls take effect.
Punjab’s State Drug Testing Laboratory reported 15 substandard medicines in October, with 12 of them being Buprenorphine and Naloxone sublingual tablets — medications prescribed for treating opioid addiction.
Multiple batches from Ethicare Pharmaceuticals in Gujarat failed content tests: batches ADN5001, ADL5001, ATN5006, ATN4007, and ATL4001 all showed incorrect amounts of active ingredients. Swift Life Sciences in Dehradun had four batches fail: SLTG25022, SLTC24010, and SLTE25016 all showed content failures, with some batches containing Naloxone at 112 percent to 116.9 percent of claimed amounts — patients received higher doses than prescribed. Qubit Pharmaceuticals in Sirhind also had batches fail content requirements.
These failures matter because Buprenorphine dosing requires precision. Too little triggers severe withdrawal symptoms in recovering addicts. Too much can cause an overdose, particularly in combination with other substances. The medications work by occupying opioid receptors in the brain without producing the full effects of drugs like heroin, allowing people to function while gradually reducing dependence.
When content uniformity fails, some tablets in a batch may have much higher or lower concentrations than labelled. A person taking what they believe is a stable daily dose could experience withdrawal one day and excessive sedation the next, depending on which tablet they happened to take from the strip.
(Edited by Muhammed Fazil.)
