New Delhi: India’s drug regulator has ordered a sweeping crackdown on pharmaceutical units across the country after laboratory tests confirmed that ‘Coldrif’ cough syrup, manufactured in Tamil Nadu, contained diethylene glycol (DEG) — a toxic industrial solvent that has been linked to the deaths of 11 children in Madhya Pradesh and Rajasthan.
The Central Drugs Standard Control Organisation (CDSCO) has initiated risk-based inspections at 19 manufacturing units in six states, focusing on firms producing syrups and paediatric formulations. The move follows a joint investigation by the Tamil Nadu and Madhya Pradesh drug authorities, which found DEG contamination in samples of Coldrif, produced by Sresan Pharma, Kanchipuram.
“The findings are deeply concerning and merit an immediate nationwide quality audit,” a senior health ministry official said, adding that the CDSCO has directed all state regulators to intensify checks on manufacturing practices and raw material sourcing.
The discovery and the fallout
The alarm was first raised in Chhindwara, Madhya Pradesh, where several children died after consuming cough syrup. Initial state-level testing did not detect toxins, but when Tamil Nadu authorities examined samples from the manufacturer’s site, they found DEG levels far beyond permissible limits.
Following the report, the Tamil Nadu government banned the sale and manufacture of Coldrif, while Madhya Pradesh ordered an immediate withdrawal of the product from pharmacies. Rajasthan also reported two suspected deaths linked to the same brand.
Samples from the manufacturing site have now been sent to central laboratories for reconfirmation.
What makes DEG deadly
Diethylene glycol, commonly used in antifreeze and industrial applications, is not meant for human consumption. Ingesting even small amounts can cause acute kidney failure, liver damage, seizures, and death. Experts say contamination typically occurs when substandard or industrial-grade glycerine — cheaper but unfit for pharmaceuticals — is substituted in the production process.
The World Health Organisation (WHO) has repeatedly warned of cough syrups contaminated with DEG and EG, linking them to over 300 child deaths worldwide since 2022, reported the NDTV. To help regulators, WHO has developed new two-tier testing methods. These techniques include a thin-layer chromatography (TLC) for initial screening, which is later followed by gas chromatography for confirmation.
Regulatory crackdown widens
Acting on the preliminary findings, the CDSCO has dispatched inspection teams to multiple states, including Tamil Nadu, Maharashtra, Himachal Pradesh, Uttar Pradesh, Gujarat, and Uttarakhand.
Officials said the inspections will focus on verifying Good Manufacturing Practices (GMP), testing of raw materials like glycerine and propylene glycol, and ensuring suppliers’ traceability.
An inter-agency committee comprising representatives from ICMR, AIIMS Nagpur, NEERI, NIV Pune, and CDSCO will oversee the technical aspects of the probe. “The mandate is clear — identify lapses, hold offenders accountable, and prevent recurrence,” a health ministry source confirmed.
Meanwhile, families of the victims in Madhya Pradesh and Rajasthan are demanding criminal charges against the manufacturer and distributors. “We trusted the medicine to help our children; instead, it took their lives,” said a bereaved parent in Chhindwara.
Public outrage has intensified as the tragedy echoes previous instances where DEG-contaminated syrups killed children abroad, tarnishing India’s pharmaceutical image.
Systemic lapses under scrutiny
This latest episode has reignited questions about India’s fragmented drug regulation and the uneven enforcement of quality standards. Despite repeated warnings from global watchdogs, lapses in raw material testing and inter-state coordination persist.
Drug safety experts are now calling for a centralized raw material audit system, mandatory barcode tracking, and routine third-party testing of pediatric medicines.
Government’s next steps
The Union Health Ministry has said that all cough syrups and paediatric formulations across India will now undergo enhanced risk-based surveillance.
Officials have also instructed doctors to avoid prescribing combination syrups for children under two years of age until further notice. A public advisory has been issued urging parents to check packaging details and report adverse reactions immediately.
Past cases: 1998 J.J. Hospital tragedy
The discovery of diethylene glycol contamination is not new to India’s pharmaceutical history. Similar incidents — from the 1998 J.J. Hospital tragedy in Mumbai to recent deaths in Gambia — have repeatedly exposed gaps in oversight.
