Several pharmaceutical companies appeared multiple times in the December report with different products failing quality tests.
Published Jan 22, 2026 | 10:44 AM ⚊ Updated Jan 22, 2026 | 10:45 AM
Cough syrup (Representational image. Credit: iStock)
Synopsis: Tamil Nadu drug labs flagged 24 substandard cough syrups in December 2025, including Sresan’s Respolite-D, just weeks after its toxic Coldrif killed children. The CDSCO report shows 167 failed drugs nationwide, with counterfeit cardiovascular medicines and excipient contamination compounding risks. Widespread failures across antibiotics, paediatric syrups, and injectables expose systemic lapses in India’s pharmaceutical quality control.
Tamil Nadu state drug testing laboratories have detected 24 substandard cough syrups in December 2025, including another product from Sresan Pharmaceutical, the same company whose contaminated cough syrup killed at least 20 to 23 children just two months earlier.
The Sresan product flagged in December, a cough syrup called Respolite-D, failed content quality tests at the Drug Testing Laboratory in Madurai. This detection came barely eight weeks after authorities sealed the company’s Kancheepuram factory, arrested owner G Ranganathan, and revoked its manufacturing licence following the discovery that its Coldrif cough syrup contained 48.6 percent diethylene glycol, a toxic industrial solvent that caused acute kidney failure in children across Madhya Pradesh and Rajasthan in October 2025.
The December 2025 report from Central Drugs Standard Control Organisation (CDSCO) reveals that Tamil Nadu accounted for over half of all cough syrup failures detected nationwide last month, raising serious questions about quality control in the pharmaceutical sector.
The 24 cough syrups that failed in Tamil Nadu represent 51 percent of the 47 respiratory medications flagged as not of standard quality across India during the same period.
The monthly report paints a troubling picture of drug quality across India, with 167 pharmaceutical products flagged as not of standard quality and seven identified as spurious or counterfeit drugs. The failures span critical medications including antibiotics, cardiovascular drugs, pain relievers, and paediatric formulations, affecting patients across multiple states.
All 24 cough syrups that failed quality tests in Tamil Nadu were found to have content failures, meaning they contained incorrect amounts of active ingredients. This uniform pattern suggests either deliberate cost-cutting through underdosing or a complete breakdown of manufacturing quality control systems, rather than isolated contamination incidents.
The Drug Testing Laboratory in Madurai detected 15 of these substandard products, whilst the Drug Testing Laboratory in Chennai identified nine others.
Among the failed products were 11 paediatric formulations, including syrups specifically marketed for children such as Pediacold DM, Brokuff LS Junior Syrup, and Caredex Junior.
Nine of these paediatric products, representing 82 percent of children’s medicines that failed, had incorrect drug content, raising particular concern given that dosing margins for children are narrower and miscalculations can have serious health consequences.
The December report identified seven batches of spurious drugs, all marked as “under investigation” with manufacturers yet to be determined. These counterfeit products included two batches of Chymoral Forte, an anti-inflammatory enzyme preparation, and three batches of Telma and Telma-AM, critical cardiovascular medications used for blood pressure control.
One batch each of Montina-L antiallergic tablets and Pantop-D SR gastrointestinal medication were also confirmed as spurious.
The counterfeit cardiovascular medications are particularly concerning given that substandard or fake drugs for blood pressure control could have serious health consequences for patients relying on them for daily management of hypertension.
The legitimate manufacturers whose brand names were used on these counterfeit products have all formally denied producing the implicated batches.
“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug,” said CDSCO in its report.
The spurious drugs were detected across multiple laboratories, including the Food and Drugs Analytical Laboratory in Mumbai, the Regional Drugs Testing Laboratory in Chandigarh, and the Food and Drugs Laboratory in Vadodara, suggesting a widespread distribution network for these counterfeit products.
Manufacturing dates on the spurious products ranged from February 2024 to January 2025, indicating these counterfeits had been in circulation for six to 18 months before detection.
Several pharmaceutical companies appeared multiple times in the December report with different products failing quality tests. Apple Formulations Private Limited, based in Uttarakhand, had three cough syrup products fail content tests, all detected by Tamil Nadu laboratories.
Crest Lifesciences Private Limited from Himachal Pradesh had two batches of its RespiFresh-AD cough and cold formula fail, both found to have content issues by the Madurai laboratory.
Alop Medi-Sciences Private Limited, also from Himachal Pradesh, had two different cough syrup formulations fail content tests. Baseman Healthcare Inc, a Tamil Nadu manufacturer, had two products flagged for content failures.
Elixia Pharmaceuticals, another Tamil Nadu-based company, had two batches of the same product, Cafact-LS syrup, fail content tests in Chennai.
Beyond cough syrups, Mancare Laboratories Private Limited from Uttarakhand had seven separate batches of Albendazole tablets fail dissolution tests, all detected by the State Drug Testing Laboratory in Raipur, Chhattisgarh.
Gujarat Ambuja Exports Limited had multiple batches of sorbitol solution flagged for containing ethylene glycol impurities exceeding permissible limits, detected by central laboratories in Hyderabad.
Beyond cough syrups, the December report documented widespread quality failures across essential medicines. Injectable medications showed particularly concerning defects, with multiple products failing particulate matter tests, meaning they contained visible particles that could cause serious complications if administered intravenously.
Products from manufacturers including Sunvet Healthcare, Hindustan Medicines Private Limited, Agron Remedies Private Limited, and Welcure Remedies all failed particulate matter standards.
Antibiotics and combination drugs showed assay and dissolution failures, indicating patients may not be receiving therapeutic doses of critical medications. Products containing rabeprazole and domperidone, commonly prescribed for acid reflux and gastric problems, had multiple failures across different manufacturers.
Several formulations from companies including Spanker Biotech Limited, Torque Pharmaceuticals Private Limited, and Martin & Brown Bio-Sciences Private Limited failed dissolution or assay tests for rabeprazole content.
Cardiovascular medications beyond the spurious drugs also showed quality issues. Telmisartan tablets from multiple manufacturers, including Bennet Pharmaceuticals Limited and Swiss Garnier Life Sciences, failed dissolution tests.
These failures occurred in products from legitimate manufacturers with valid licences, detected by state laboratories in Kerala and Jammu and Kashmir.
Several batches of pharmaceutical excipients, the inactive ingredients used to formulate medicines, were found to contain dangerous levels of toxic glycol impurities. Gujarat Ambuja Exports Limited had multiple batches of sorbitol solution exceed permissible limits for ethylene glycol, detected by the Central Drugs Testing Laboratory in Hyderabad.
The same manufacturer’s sorbitol batches also failed angle of rotation tests at the Central Drugs Testing Laboratory in Chennai.
Polyethylene glycol and polymeg batches from other manufacturers were found to contain excessive amounts of diethylene glycol and ethylene glycol, the same class of toxic solvents that caused the Sresan Pharma tragedy.
These excipient contaminations are particularly dangerous because they can affect multiple finished pharmaceutical products that use these ingredients, potentially causing widespread harm before detection.
(Edited by Amit Vasudev)
