Centre Blames Tamil Nadu Govt for Cough Syrup Tragedy

CDSCO finds lapses, negligence and failure of oversight by state drug regulator in allowing unregistered firm to operate

GG News Bureau
New Delhi, 11th Oct: The Central Drugs Standard Control Organisation (CDSCO) has held Tamil Nadu’s drug authorities responsible for the recent cough syrup tragedy that killed at least 23 children in Madhya Pradesh. The central regulator’s investigation revealed that “gross negligence” and “regulatory failure” on the part of the Tamil Nadu Drug Control Department enabled the distribution of the adulterated syrup, sources said.

The poisonous Coldrif syrup, manufactured by Tamil Nadu-based Sresan Pharmaceuticals, contained dangerously high levels of diethylene glycol (DEG) — a toxic chemical known to cause kidney failure, liver damage, and nervous system collapse. The syrup was never audited by any agency, nor was the company registered on the central drug monitoring portals, according to the CDSCO’s findings.

Sresan Pharma, licensed in 2011 and renewed in 2016, was operating without WHO-Good Manufacturing Practice (GMP) certification for decades. The central regulator has accused the state authorities of failing to enforce compliance and ignoring repeated directives from the Union government.

“Despite multiple reminders and review meetings, the Tamil Nadu regulator did not act on the Centre’s recommendations or share critical information,” said sources citing the CDSCO report. “The result was an unmonitored, unsafe product entering the market — leading to the tragic deaths of children.”

When a central inspection team visited the company’s factory in Kancheepuram, it found unbilled containers of DEG and evidence that 46–48% of the toxic chemical had been added to Coldrif syrup — far exceeding the legal limit of 0.1%. The facility was in “extremely poor hygienic condition,” officials noted.

The state authorities allegedly failed to inform the Centre even after Madhya Pradesh raised an alert. On October 3, when the CDSCO team reached the factory, the Tamil Nadu drug officer did not appear despite repeated calls, sources said. Later that night, state authorities sealed the factory and confirmed DEG contamination.

The CDSCO report further pointed out that Sresan Pharmaceuticals never registered on the mandatory SUGAM or national data portals used for tracking licensed drug manufacturers. State regulators are required to ensure compliance, but Tamil Nadu’s department failed to do so, the report stated.

Ranganathan Govindan, the company’s owner, was arrested two days ago after evading police for several days.

The Centre has called for stricter coordination between state and central agencies and a nationwide audit of all small-scale pharmaceutical units to prevent similar tragedies.

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