The Union Health Ministry said on Friday (October 3, 2025) that tests had confirmed that cough syrups linked to the recent deaths of children in Madhya Pradesh and Rajasthan did not contain contaminants causing serious kidney injury .
However, the Tamil Nadu’s Drugs Control Department issued an immediate stop production order to the manufacturer of the Coldrif brand of cough syrup after an analysis by the Government Drugs Testing Laboratory found a batch to be “not of standard quality” and “adulterated with diethylene glycol”.
The nine deaths in Madhya Pradesh were attributed to Coldrif, while the two cases in Rajasthan were linked to the consumption of a dextromethorphan-based formulation.
Following the deaths in Madhya Pradesh, a joint team of representatives from the National Centre for Disease Control, the National Institute of Virology (NIV), the Central Drugs Standard Control Organisation, and other institutes visited the State. They collected samples of cough syrups and blood and other samples from patients.
“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,” the Ministry said.
One leptospirosis case
The Madhya Pradesh State Food and Drug Administration tested three samples and confirmed the absence of DEG and EG. Further, blood and cerebrospinal fluid samples have been tested by the NIV, Pune, for common pathogens. One case has been found positive for leptospirosis, said a release from the Health Ministry. Samples of water and respiratory specimens were under further investigation by the NEERI, NIV Pune, and other laboratories, it added.
As regards the reports related to death of two children in Rajasthan, the Ministry clarified that the product in question did not contain propylene glycol, which can be a potential source of DEG and EG.
“Additionally, the product under reference is a dextromethorphan-based formulation, which is not recommended for paediatric use,” said the note.
The Rajasthan Medical and Health Department has ruled out any connection between the deaths and the cough syrup given under the Chief Minister’s free medicine scheme.
“An inquiry report has confirmed that the [two] children were given cough syrup at home without medical advice,” Ravi Prakash Sharma, Director (Public Health), said in Jaipur.
Mr. Sharma said the doctors at the government health facilities in Sikar and Bharatpur had not prescribed dextromethorphan drug in both incidents. “This generic cough syrup is not prescribed for children,” he said.
However, Kayson Pharma, the firm based at Sarna Doongar village in Jaipur, which supplies drugs for the Chief Minister’s free medicine scheme, has come under the State government’s scanner. The Health Department has ordered a probe into the quality of all medicines manufactured by the firm.
India has faced such crises before. In 2020, 12 children died in Jammu after drinking a contaminated cough syrup. In 2022, 70 children died in the Gambia, allegedly due to Indian syrups laced with DEG.
Show-cause notice
The Tamil Nadu government has issued a show-cause notice to the manufacturer.
S. Gurubharathi, Deputy Director of Drugs Control and Licensing Authority-cum-Controlling Authority, Tamil Nadu, confirmed the finding. The Drugs Control Department said it had taken immediate regulatory action after receiving information on the deaths in Madhya Pradesh attributed to the drug containing paracetamol, phenylephrine hydrochloride, chlorpheniramine maleate syrup (Coldrif Syrup), Batch No. SR-13 (manufacturing date of May 2025 and expiry date of April 2027) manufactured by Sresan Pharmaceutical Manufacturer, Sunguvarchathiram, Kancheepuram district.
Advisory
The Union Health Ministry has issued an advisory to all States and Union Territories on rational use of cough syrups in children. Advocating for safe, limited and only-under-prescription use of cough syrups, it said that cough in children is usually a self-limiting condition. It cautioned against prescribing cough syrups to children below two years of age.
Published – October 03, 2025 10:16 pm IST
