Sresan Pharma's Coldrif Syrup Banned After 48.6% Toxic Diethylene Glycol Detected

Diethylene glycol (DEG) is an organic compound found in household products but also as a counterfeit solvent in medicines. DEG poisonings are characterized by acute kidney injury (AKI).Diethylene glycol (DEG) is nephrotoxic, potentially resulting in high morbidity and mortality. Its main nephrotoxic by-product is diglycolic acid (DGA).

State authorities in Tamil Nadu conducted tests on samples collected directly from Sresan Pharma's Kanchipuram manufacturing site and confirmed DEG contamination. Earlier, the Madhya Pradesh Food and Drug Administration (MPFDA) had analysed three of 13 collected samples, which were reportedly free of contamination.

“As part of the ongoing investigation, it is further informed that a total of six samples were collected by CDSCO, which were tested, and all 6 were found to be free of DEG/EG. Simultaneously, MPFDA had informed that out of 13 samples collected by their team, 3 were analysed, which were found to be free of DEG/EG. At the request of the MP Govt, Tamil Nadu FDA had taken samples of Coldrif Cough Syrup from the manufacturing premises of M/S Sresan Pharma in Kanchipuram, Tamil Nadu. The results of testing these samples were shared with us late yesterday evening, 3rd October 2025. The samples are found to contain DEG beyond the permissible limit,” the Ministry was quoted as saying by ET.

In response, the Tamil Nadu government has banned the sale of Coldrif syrup across the state from October 1 and ordered withdrawal of existing stocks. Production at Sresan Pharma’s Kanchipuram facility has been suspended pending further investigation. The syrup had been distributed in Madhya Pradesh, Rajasthan, and Puducherry, reports PTI.

As per ANI report, the Office of the Controller Food and Drugs Administration, Madhya Pradesh, issued a formal order stating:

"As you are aware that deaths of children have been reported in Chhindwara District of Madhya Pradesh. In this regard, the Office of the Director of Drugs Control, Tamil Nadu, Chennai has informed that 'Coldrif Syrup' has been declared NSQ (Not of Standard Quality) with respect to samples, as it contains Diethylene Glycol (48.6% w/v), a poisonous substance which may render the contents injurious to health. It is directed to stop further sale and distribution of 'Coldrif Syrup' immediately."

The order also directed the halt of sale and distribution of all other products manufactured by Sresan Pharma in the larger public interest.

Authorities have launched risk-based inspections across six states where 19 drug samples were collected. A multidisciplinary panel including experts from NIV, ICMR-NEERI, CDSCO, and AIIMS Nagpur is investigating the samples and other related factors to determine the cause of the deaths, reports ET.

In Madhya Pradesh, authorities have restricted the sale of both Coldrif and Nesto DS syrups. Officials confirmed that 594 bottles had been distributed to three local distributors, with some consignments still pending test results. Families reported that affected children’s initial cold and cough symptoms escalated into severe kidney complications.

So far, nine child fatalities have been reported in Madhya Pradesh, while Rajasthan has recorded two infant deaths.

Meanwhile, the Union Health Ministry has issued an advisory to all states and Union Territories instructing that cough and cold syrups should not be prescribed to children under two years of age. The Directorate General of Health Services (DGHS) has reiterated that cough and cold medicines should not be prescribed or dispensed to children below two years of age. Such drugs are generally discouraged for those under five, and for older children, their use must be strictly based on clinical evaluation, with careful dosing, close supervision, short treatment duration, and avoidance of multiple drug combinations. The advisory also urged that the public be made more aware of the importance of adhering to prescriptions.