An inspection by the Tamil Nadu Drugs Control Department revealed major lapses at Sresan Pharmaceuticals’ factory in Kancheepura. The department’s report detailed over 350 regulatory violations, including unhygienic conditions and illegal use of non-pharma-grade chemicals. Inspectors reported that up to 48 per cent of an industrial liquid had been added to the syrup, far exceeding the permissible limit of 0.1 per cent. Despite lacking good manufacturing practices (GMP) certification, the company continued to produce and sell the drug. The regulatory body issued a stop-production order and suspended the company’s licence.
Authorities found Sresan Pharmaceuticals had acquired 50 kilograms of propylene glycol without invoices, indicating illegal procurement. Laboratory analysis confirmed the presence of diethylene glycol, a solvent used in industrial applications like brake fluids and paints. Officials noted that substituting diethylene glycol for propylene glycol has previously caused mass poisoning incidents. The inspection also revealed use of plastic pipes for transferring liquids, lack of filtration systems, and discharge of chemical effluents into ordinary drains.
The inspection highlighted severely unhygienic factory conditions, including the absence of air handling units, poor ventilation, and damaged equipment. Water tanks used in production were in poor condition, and the facility lacked basic environmental controls.
The report stated: "The firm has not provided any gowning procedure, GMP drains, purified water system, pest control, or cleaning mechanism." There were no measures to prevent insects or rodents, and the production areas were not ventilated with filtered air.
Following these violations, the Tamil Nadu government imposed a statewide ban on Coldrif syrup as of October 1, and ordered the removal of all existing stock. Laboratory tests confirmed product adulteration.
A senior official announced: "We have sought an explanation from the manufacturer. Until further orders, production at the facility has been stopped," as cited by PTI.
States including Madhya Pradesh, Rajasthan, and Tamil Nadu have halted sales and started further investigations. Other lapses included releasing raw materials without proper testing and the absence of any quality assurance or pharmacovigilance systems at the facility.