The Union Health Ministry said on Friday (October 3, 2025) that tests had confirmed that contaminants causing serious kidney injury were not present in the cough syrups, linked to the recent deaths of children in Madhya Pradesh and Rajasthan.
While the deaths in Madhya Pradesh were attributed to Coldrif syrup, the cases in Rajasthan were linked to the consumption of a dextromethorphan-based formulation.
Following the deaths in Madhya Pradesh, a joint team consisting of representatives from the National Centre for Disease Control (NCDC), the National Institute of Virology (NIV), the Central Drugs Standard Control Organisation (CDSCO), and other institutes visited the State. They collected samples of cough syrups as well as blood and other samples from patients.
One leptospirosis case
“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 Madhya Pradesh State Food and Drug Administration (SFDA) also tested three samples and confirmed the absence of DEG/EG. Further, blood/cerebrospinal fluid samples have been tested by NIV, Pune, for common pathogens. One case has been found positive for leptospirosis,’’ said a release issued by the Health Ministry on Friday. It further said that samples of water, entomological vectors, and respiratory specimens are under further investigation by the NEERI, NIV Pune, and other laboratories.
A multi-disciplinary team comprising experts from the NCDC, NIV, ICMR, AIIMS Nagpur, and the State health authorities is investigating all possible causes behind the reported cases.
As regards the reports related to death of two children in Rajasthan because of the consumption of a contaminated cough syrup, the Ministry clarified that the product in question does not contain propylene glycol, which can be a potential source of contaminants, DEG/EG. “Additionally, the product under reference is a dextromethorphan-based formulation, which is not recommended for paediatric use,’’ said the note.
Contaminated, says T.N.
However, the Tamil Nadu’s Drugs Control Department on Friday issued an immediate stop production order to the manufacturer of Coldrif syrup after an analysis by the Government Drugs Testing Laboratory found Batch No. SR-13 to be “not of standard quality” and “adulterated with diethylene glycol” (DEG). A show-cause notice has been served on the manufacturer for cancellation of its licence.
S. Gurubharathi, the 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.
Previous instances
DEG is a toxic chemical known to cause severe kidney damage. India has faced such crises before. In 2020, 12 children in Jammu died after drinking a contaminated cough syrup. In 2022, at least 70 children in the Gambia died, their deaths linked to Indian syrups laced with DEG.
In Rajasthan, the 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 administered cough syrup at home without medical advice,” Ravi Prakash Sharma, director (Public Health), said in Jaipur on Friday.
Mr. Sharma said the doctors at the government health facilities in Sikar and Bharatpur had not prescribed dextromethorphan (DXM) drug to the children in both incidents. “As per protocol, this generic cough syrup is not prescribed to children,” he said. In another case in Sikar district, the Health Department has initiated suspension proceedings against a doctor and a pharmacist for wrongly prescribing a DXM-based cough syrup to a child in violation of the medical protocol.
However, Kayson Pharma, the firm based at Sarna Doongar village in Jaipur district, 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 thorough investigation into the quality of all medicines, including Dextromethorphan Hydrobromide Syrup IP 13.5 mg/5 ml, manufactured by the pharma company.
Advisory
The Union Health Ministry has issued an advisory to all States and Union Territories on rational use of cough syrups in children. While 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 also cautioned against prescribing cough syrups to children below two years of age. Even in older children, such medicines should be used with care, it said.
The Ministry emphasised the importance of supportive measures such as hydration and rest, and directed the States to ensure the guidance is disseminated widely across all health centres.
Mr. Sharma said the Rajasthan Health Department too had issued an advisory asking the medicos to strictly ensure that the medicines are given only against valid prescriptions. The public at large have also been advised not to consume medicines without consulting doctors.
Published – October 03, 2025 10:16 pm IST