DCGI Directs Immediate Inspection of Coldrif Plant, Kancheepuram

DCGI Directs Immediate Inspection of Coldrif Plant, Kancheepuram

India Pharma Outlook Team | Friday, 03 October 2025

 Coldrif cough syrup, Coldrif contamination

The suspicion of Coldrif cough syrup contamination has led to Immediate Inspection following reports of child fatalities in Madhya Pradesh and Rajasthan.

Drug Controller General of India (DCGI) Dr Rajivsingh Reghuvanshi ordered an inspection of the manufacturing company in Sunguvarchatram, Kancheepuram district, Tamil Nadu, as soon as he learned of the deaths.

Dr M K Sreenivasan, Deputy Drug Controller at the CDSCO south zone office in Chennai, stated that officials are already inspecting the plant and that samples of multiple batches are being collected to be tested at drug testing labs as soon as possible. Dr Sreenivasan described the inspection as risk-based inspection to proactively counter the possible public health danger, and said an initial report is expected within 48 hours.

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The Drug Control Department (DCA) in Tamil Nadu has restricted the manufacture and sale of Coldrif. All stocks at the company have been frozen, while drug inspectors throughout Tamil Nadu have imposed a complete halt to distribution. DCA Director S Gurubharathi said, including in the context of recent public holidays, that the crisis was taken seriously, and that offices and labs worked around the clock to facilitate resolution.

Precautionary actions were also taken in Puducherry, with authorities confirming no Coldrif was distributed, but requested guarantees that the supply chain was examined in detail.

At the same time, the Union Health Ministry has initiated a multi-agency inquiry following initial indications that diethylene glycol (DEG), a toxic industrial solvent that can lead to fatal kidney damage, was present. Samples from the sick patients have been sent to the Virology Institute in Pune for urgent testing, with the results expected to guide future legal and regulatory action.

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