No pest control, cleaning & filtration systems, air handling units: Report identifies 350 lapses in factory where ‘Coldrif’ was made

A Tamil Nadu government report has detailed extensive violations at Sresan Pharmaceutical, manufacturer of the Coldrif cough syrup associated with the deaths of 14 children in Madhya Pradesh and two in Rajasthan. The 26-page report, accessed by India Today TV, was compiled following an inspection by the Tamil Nadu Drugs Control Department. 

Investigators found over 350 lapses, identifying both critical and major failings. Sresan Pharmaceutical lacked basic facilities, had no qualified personnel, and failed to implement procedures necessary for product safety. Several states have suspended sale and use of the syrup pending further analysis and legal action.

Inspectors observed that Coldrif syrup was produced in severely unhygienic conditions. The facility had no air handling units, poor ventilation, and damaged equipment, contributing to contamination risks. The report noted that purified water tanks used in critical manufacturing operations were found in unhygienic conditions, highlighting poor facility management. The plant's layout and lack of adequate systems further increased the likelihood of contamination.

The investigation found that the company's Quality Assurance department did not exist, and there was no authorised person to supervise batch releases. Standard operating procedures for product recalls or managing quality failures were absent. The report stated: "The firm has not provided any gowning procedure, GMP drains, purified water system, pest control, or cleaning mechanism." Medicines were stored in inappropriate areas, where air handling units were not functioning, exposing products to dust and potential cross-contamination.

The report disclosed that Sresan Pharmaceutical had acquired 50 kilograms of propylene glycol without invoices, indicating illegal procurement. Samples also revealed the presence of diethylene glycol (DEG), a toxic industrial solvent typically used in brake fluids and paints. Officials emphasised that substituting DEG for propylene glycol is a known cause of mass poisoning incidents, including the recent deaths in Chhindwara. Additional findings included the use of plastic pipes for transferring liquids, lack of filtration systems, and the pumping of chemical effluents into general drains.

Lapses included releasing raw materials without proper testing or vendor approvals, and the absence of any pharmacovigilance system to monitor adverse reactions. Sampling of products occurred in open environments, increasing the risk of contamination. The report noted: “There were no measures to prevent the entry of insects or rodents. Fly catchers and air curtains were missing. The production areas were not ventilated with filtered air," emphasising poor environmental controls.

Following the inspection, the Tamil Nadu government imposed a state-wide ban on Coldrif syrup from October 1, instructing the removal of all current stocks from the market. Laboratory analysis confirmed product adulteration. A senior government official announced: "We have sought an explanation from the manufacturer. Until further orders, production at the facility has been stopped," as cited by PTI. In the wake of the linked child fatalities, states such as Madhya Pradesh, Rajasthan, and Tamil Nadu have halted sales and initiated further investigations.