TN issues show-cause notice to Coldrif maker after 16 deaths
What's the story
The Tamil Nadu Drugs Control Department has issued a show-cause notice to Sresan Pharmaceuticals in Kancheepuram, after the deaths of 16 children; 14 children in Madhya Pradesh and two in Rajasthan. The children died allegedly after consuming the company's Coldrif cough syrup. The notice demands key details from the company within five days, including total drug quantity manufactured and invoices for raw materials and for propylene glycol, packing material details, and the medicine's master formula.
Manufacturing lapses
Over 350 lapses found during inspection
According to India Today, a government inspection of Sresan Pharmaceuticals found over 350 lapses in the manufacturing process, which were categorized as 'critical' and 'major.' The firm was found to lack basic facilities and qualified staff. Inspectors also observed unhygienic conditions, poor ventilation, damaged equipment, and absence of air handling units. Non-pharma grade chemicals were used in production, including toxic diethylene glycol (DEG), a lethal industrial solvent.
Product ban
Sale of Coldrif syrup banned in Tamil Nadu
They also discovered that the raw ingredients were purportedly released without testing, and there was no pharmacovigilance mechanism in place to monitor adverse reactions. Production areas were unventilated, lacked fly catchers and air curtains, and items were stored in hallways prone to dust and contamination. In light of the inspection findings, Tamil Nadu has banned the sale of Coldrif syrup from October 1 and ordered its removal from the market. Production at the facility has been halted pending further investigation.
Administrative action
3 officials suspended, state drug controller transferred
The deaths in Chhindwara have triggered a nationwide alert, with Madhya Pradesh, Rajasthan, and Tamil Nadu stopping sales and use of Coldrif syrup. In Madhya Pradesh, three officials have been suspended and the state drug controller has been transferred after preliminary reports linked the deaths to contaminated syrup. Per reports, batch SR-13 of Coldrif, consumed by children in Chhindwara, was manufactured in May 2025 and valid until April 2027. It circulated freely in the market for months before being flagged.
Health crisis
Diethylene glycol levels almost 500 times permissible limit
Notably, apart from Coldrif, other syrups produced at the same plant, including Respolite D, GL, ST, and Hepsandin, passed quality tests. Tests on the kidneys of deceased children showed high levels of diethylene glycol poisoning. Batch SR-13 had 48.6% diethylene glycol, almost 500 times the permissible limit. Between August and September, doctors in Chhindwara recommended the syrup to children with fever and cough. Several of them quickly suffered acute renal failure thereafter.