Inspectors have uncovered gross violations and unhygienic practices at Sresan Pharmaceutical in Kancheepuram, Tamil Nadu, whose Coldrif cough syrup has been linked to the deaths of 14 children in Madhya Pradesh and two in Rajasthan, officials said.
A 26-page government report details the shocking findings.
The Tamil Nadu Drugs Control Department carried out the inspection and identified more than 350 lapses in the manufacturing process. Officials categorised the violations as 'critical' and 'major', concluding that the company lacked basic facilities, qualified personnel, and proper procedures to ensure product safety.
Filthy Premises and No Quality Checks
The report states that Coldrif was produced in unhygienic conditions with non-functional air handling units, poor ventilation, and damaged or rusted equipment.
Inspectors noted that the plant’s layout contributed to contamination risks. The facility lacked a Quality Assurance department, and no authorised person was designated to oversee batch releases.
There were no standard operating procedures (SOPs) for product recalls or handling quality failures.
“The firm has not provided any gowning procedure, GMP drains, purified water system, pest control, or cleaning mechanism,” the report said. Products were stored in corridors and areas where air handling units were non-functional, exposing them to dust and cross-contamination.
Use of Non-Pharmaceutical Grade Chemicals
Officials found that the company had purchased 50 kilograms of propylene glycol without invoices, indicating illegal procurement. Traces of diethylene glycol (DEG), a highly toxic industrial solvent often used in brake fluids, paints, and plastics, were also detected in the syrup.
Substituting DEG for propylene glycol has been linked to mass poisoning incidents worldwide, including the recent deaths in Chhindwara.
The inspection revealed further lapses, including the use of plastic pipes for liquid transfer, absence of filtration systems, and disposal of chemical effluents directly into general drains. Purified water tanks used in critical manufacturing operations were reported to be unhygienic.
Also Read : Ministry says cough syrups not contaminated; TN bans ‘Coldrif’
Lapses Across Production Stages
Raw materials were released without testing or vendor approval, and no pharmacovigilance system was in place to track adverse reactions. Sampling was conducted in open environments, making contamination inevitable.
The company failed to prevent the entry of insects and rodents, with fly catchers and air curtains missing and production areas inadequately ventilated.
Major quality checks, including validation of analytical test methods and cleaning procedures, were never performed, and skilled manpower was lacking.
Government Crackdown
Following the inspection, the Tamil Nadu government banned the sale of Coldrif across the state from October 1 and ordered all existing stock to be removed from the market. Samples collected from the facility were later confirmed to be adulterated, a senior official told.
“We have sought an explanation from the manufacturer. Until further orders, production at the facility has been stopped,” the official added.
The deaths of children in Chhindwara have triggered a nationwide alert. Several states, including Madhya Pradesh, Rajasthan, and Tamil Nadu, have halted the sale and use of Coldrif pending further testing.
In Madhya Pradesh, three officials were suspended and the state drug controller was transferred after preliminary reports linked the fatalities to the contaminated syrup.
The findings suggest that the tragedy could have been prevented had the manufacturer adhered to even the most basic drug safety norms, officials said.
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