Last Updated:
On Friday, Tamil Nadu issued a stop-production order against the company and served a show-cause notice for licence cancellation
DEG is sometimes used illegally as a cheap substitute for pharmaceutical-grade ingredients and is known to cause acute kidney failure and death, especially in children. Representational image/AI-generated
In a dramatic turn of events, just hours after the Union Health Ministry said that cough syrup samples linked to child deaths in Madhya Pradesh and Rajasthan did not contain toxic contaminants, Tamil Nadu’s Drugs Control Department has found toxic diethylene glycol (DEG) in a syrup manufactured by a Kanchipuram-based firm, Sresan Pharmaceuticals, and ordered an immediate halt in production.
Recommended Stories
Tamil Nadu-based Sresan Pharmaceutical, one of the two companies under scanner after the deaths of around 11 children in Madhya Pradesh and Rajasthan, has been flagged by its home regulator.
According to S Gurubharathi, deputy director of Drugs Control and Licensing Authority, Tamil Nadu, testing has confirmed Coldrif Syrup (Batch No. SR-13) was contaminated with DEG at a concentration of 48.6% w/v, a level experts say is dangerously high. “We have suspended the licence of the firm immediately,” he told News18 over a call.
DEG is a toxic industrial solvent that has no place in medicines. It is sometimes used illegally as a cheap substitute for pharmaceutical-grade ingredients and is known to cause acute kidney failure and death, especially in children. India has seen multiple DEG-linked tragedies, including in Jammu in 2020, where 12 children died. Internationally, DEG poisoning through Indian-made syrups was linked to child deaths in The Gambia and Uzbekistan in 2022, prompting WHO warnings.
Tamil Nadu’s Rapid Action
While Tamil Nadu’s controlling authority’s top official, Gurubharathi, in a written note, confirmed the presence of toxic materials in the cough syrups to News18, the Union Health Ministry released a different statement.
The ministry cited tests by the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), and Central Drugs Standard Control Organisation (CDSCO) and stated: “As per the test results, none of the samples contained Diethylene Glycol (DEG) or Ethylene Glycol (EG), contaminants that are known to cause serious kidney injury.”
According to Tamil Nadu’s findings, the state Drugs Control Department said it was alerted by the Madhya Pradesh authority on October 1 and began inspection of Sresan Pharmaceutical’s plant within 30 minutes.
“During in-depth investigation, several non-compliances with respect to Revised Schedule M (GMP) and Schedule L1 (GLP) of the Drugs Rules, 1945 were noticed at the said manufacturing facility,” Gurubharathi said in the note shared with News18. Inspectors found that the batch was produced using non-pharmacopoeial grade propylene glycol, which may have been contaminated with DEG.
“Our report focused on raw materials (three active pharmaceutical ingredients in this drug) along with impurities, whereas other government reports have analysed only raw materials. Propylene glycol will only be found when we run testing for finding impurities. We focused on propylene glycol testing specifically,” said Gurubharathi.
Samples of Coldrif Syrup and four other formulations — Respolite D syrup, Hepsandin Syrup – were seized for urgent analysis. Stocks across Tamil Nadu were frozen, and alerts were sent to Odisha and Puducherry.
The Chennai Drugs Testing Laboratory claimed that they prioritised the analysis, completing it in 24 hours. The report declared Coldrif Syrup “not of standard quality and adulterated with Diethylene Glycol (48.6% w/v), a poisonous substance which may render the content injurious to health.” It said, no ethylene glycol was detected, and the other four syrups tested were standard quality.
Stop-Production Order and Licence Action
On October 3, Tamil Nadu issued a stop-production order against the company and served a show-cause notice for licence cancellation.
“This is the first instance in the country where the entire investigation — inspection, sampling, analysis of the alleged drug, and a stop-production order — was completed within two days of receiving information,” said the Deputy Director of Drugs Control and Licensing Authority of Tamil Nadu.
The department has urged the public to avoid the Coldrif Syrup (batch SR-13) and immediately report any stocks to authorities.
About the Author
Himani Chandna, Senior Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particular…Read More
Himani Chandna, Senior Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particular… Read More
October 03, 2025, 21:12 IST
Loading comments…
Read More
 "Should lenders be allowed to ‘kill’ financed phones if EMIs aren’t paid?")
