Key Highlights
- The Uttar Pradesh government banned Coldrif cough syrup on October 5, 2025, following 14 child deaths in Madhya Pradesh due to kidney failure
- Laboratory tests revealed the syrup contained 48.6% diethylene glycol, far exceeding the permissible limit of 0.1%
- Tamil Nadu’s Sresan Pharmaceutical, the manufacturer, faces criminal proceedings and manufacturing license cancellation
Opening Overview
The Coldrif cough syrup ban represents one of India’s most urgent pharmaceutical safety crises in recent years, as state governments scramble to prevent further child casualties from contaminated medication. On October 5, 2025, Uttar Pradesh joined multiple states in prohibiting the sale of Coldrif cough syrup after devastating reports emerged of 14 children dying from kidney failure in Madhya Pradesh. The Coldrif cough syrup ban followed laboratory findings that revealed the medication contained deadly levels of diethylene glycol, a toxic industrial chemical that should never appear in pharmaceutical products. This crisis has prompted nationwide regulatory action and highlighted critical gaps in India’s pharmaceutical manufacturing oversight, with authorities now conducting emergency inspections across 19 drug manufacturing units in six states.
The Coldrif cough syrup ban extends beyond Uttar Pradesh, with Punjab, Tamil Nadu, and Rajasthan implementing similar prohibitions after tests confirmed contamination levels reaching 48.6% diethylene glycol, compared to the maximum permissible limit of just 0.1%. Health officials emphasize that even small amounts of this industrial solvent can prove fatal, particularly in young children whose metabolic systems cannot process such toxic substances.
🚨Price one has to pay for the rampant Corruption.
— D (@Deb_livnletliv) October 7, 2025
14 children lost their lives after consuming contaminated cough syrup, Coldrif, made by Shreesan Pharma.
No postmortem done till there was an outrage and police exhumed the body of a two-year-old girl in Chhindwara for an… pic.twitter.com/U6MnID4C9n
Deadly Contamination Sparks Multi-State Emergency Response
- Tamil Nadu drug authorities found Coldrif contained diethylene glycol at 486 times the permissible limit
- Central Drugs Standard Control Organisation initiated criminal proceedings against Sresan Pharmaceutical
The Coldrif cough syrup ban emerged after a systematic investigation revealed catastrophic manufacturing failures at Sresan Pharmaceutical’s Tamil Nadu facility. Laboratory analysis conducted by the Tamil Nadu Directorate of Drug Control discovered that Batch No SR-13 of Coldrif cough syrup ban contained 48.6% diethylene glycol, a chemical commonly used in antifreeze and industrial solvents that proves lethal when ingested by children. The World Health Organisation has repeatedly warned against such contamination, linking similar incidents to over 300 child deaths worldwide since 2022.
Fourteen children in Madhya Pradesh’s Chhindwara district died between August and October 2025 after consuming the contaminated medication, with symptoms including severe kidney failure, metabolic acidosis, and organ shutdown. The Coldrif cough syrup ban became inevitable as authorities discovered that ten deaths occurred specifically in Parasia subdivision, while the remaining fatalities were reported from Chhindwara city and Chaurai tehsil. Medical teams from AIIMS-Nagpur continue treating eight additional children, with three remaining in critical condition requiring intensive care support.
The Central Drugs Standard Control Organisation mobilized emergency response teams comprising epidemiologists, microbiologists, and drug inspectors to investigate the outbreak, collecting 19 medicine samples from affected areas for comprehensive chemical analysis. Among the tested samples, nine met quality standards, but the Coldrif cough syrup ban became mandatory after laboratory confirmation of deadly contamination levels that exceeded international safety thresholds by nearly 500 times.
Pharmaceutical Giant Faces Criminal Charges and License Revocation
- Sresan Pharmaceutical’s manufacturing license faces immediate cancellation following CDSCO inspection
- Tamil Nadu authorities issued show-cause notice questioning why the company’s drug license should remain valid
The Coldrif cough syrup ban has triggered severe regulatory consequences for Chennai-based Sresan Pharmaceutical, which operated as a private firm since 1990 before transitioning to sole proprietorship status. The Central Drugs Standard Control Organisation recommended immediate cancellation of the company’s manufacturing license after inspection findings revealed systemic quality control failures that allowed industrial-grade chemicals to contaminate pediatric medications. Criminal proceedings have been initiated against company officials responsible for the manufacturing processes that resulted in the Coldrif cough syrup ban and subsequent child fatalities.
Tamil Nadu’s Food and Drug Administration issued a formal notice to Sresan Pharmaceutical, demanding explanations for why their drug manufacturing license should not be canceled immediately. The company, which describes itself as a trader of cough syrups, protein powders, and herbal child growth preparations on business platforms, now faces comprehensive regulatory scrutiny across all its product lines. Authorities have ordered the immediate halt of production at the Kancheepuram facility and mandated the removal of all Sresan products from retail circulation pending comprehensive safety testing.
The Coldrif cough syrup ban exposes broader pharmaceutical industry vulnerabilities, particularly regarding excipient supply chain management and quality control protocols. Diethylene glycol contamination typically occurs when industrial-grade chemicals are fraudulently substituted for pharmaceutical-grade glycerine, either through intentional adulteration or systemic manufacturing errors. The Union Health Ministry has emphasized that the Coldrif cough syrup ban serves as a critical reminder for all pharmaceutical manufacturers to maintain strict adherence to revised Schedule M norms under the Drugs and Cosmetics Act, 1940.
Government Implements Emergency Surveillance and Quality Control Measures
- Risk-based inspections launched across 19 pharmaceutical manufacturing units in six states
- Union Health Ministry mandates strict compliance with revised Schedule M manufacturing norms
The Coldrif cough syrup ban has catalyzed comprehensive reforms in India’s pharmaceutical oversight mechanisms, with the Union Health Ministry convening emergency meetings with all state and union territory health authorities on October 4, 2025. Union Health Secretary Punya Salila Srivastava chaired the high-level consultation that addressed critical gaps in drug quality compliance and emphasized the rational use of cough syrups, particularly for pediatric populations where most respiratory symptoms resolve without pharmacological intervention.
Following the Coldrif cough syrup ban, authorities initiated risk-based inspections across 19 drug manufacturing facilities in six states, targeting systemic quality assurance weaknesses that could enable similar contamination incidents. The Central Drugs Standard Control Organisation has deployed specialized teams to examine manufacturing processes, supply chain verification, and adherence to Good Manufacturing Practices as outlined in the revised Schedule M guidelines. These inspections focus specifically on excipient sourcing, chemical testing protocols, and documentation systems that ensure pharmaceutical-grade materials meet international safety standards.
The Coldrif cough syrup ban has prompted the Health Ministry to issue comprehensive advisories discouraging the prescription of cough medications for children under two years of age, citing minimal proven therapeutic benefits and significant safety risks. Dr. Rajiv Bahl, Secretary of the Department of Health Research, emphasized that healthcare providers should avoid prescribing combination cough preparations to prevent adverse effects and potential overdosing scenarios. The ministry plans to release detailed guidelines for parents, pharmacists, and medical practitioners regarding rational pediatric medication use, ensuring the Coldrif cough syrup ban serves as a catalyst for broader pharmaceutical safety improvements.
State governments received directives to strengthen surveillance systems, enhance reporting mechanisms from both government and private healthcare facilities, and improve inter-state coordination for rapid outbreak response to unusual health events. The Coldrif cough syrup ban demonstrates the critical importance of robust pharmacovigilance systems that can detect and respond to contaminated medications before they cause widespread harm to vulnerable populations.
Closing Assessment
The Coldrif cough syrup ban represents a watershed moment for pharmaceutical safety in India, exposing critical vulnerabilities in manufacturing oversight that allowed deadly industrial chemicals to contaminate children’s medications. With 14 young lives lost and multiple states implementing emergency prohibitions, this crisis underscores the urgent need for strengthened quality control mechanisms and enhanced regulatory enforcement across the pharmaceutical industry. The Coldrif cough syrup ban has triggered comprehensive reforms including criminal proceedings against manufacturers, mandatory compliance with revised Schedule M norms, and expanded surveillance systems designed to prevent similar tragedies.
As authorities continue investigating the full scope of contamination and treating affected children in intensive care facilities, the Coldrif cough syrup ban serves as a stark reminder that pharmaceutical safety cannot be compromised, particularly when vulnerable pediatric populations depend on these medications for basic healthcare needs. The coordinated response across multiple states demonstrates India’s commitment to protecting public health through decisive regulatory action, though the ultimate cost of this Coldrif cough syrup ban remains the irreplaceable loss of young lives that could have been prevented through proper manufacturing standards and quality assurance protocols.
