In response to a tragic series of child deaths allegedly linked to consumption of Coldrif Cough Syrup, the Ministry of Health and Family Welfare announced a ban on the purchase, utilisation, and distribution of the Cough Syrup.
The Root Cause:
The Coldrif Cough Syrup crisis began in September 2025, when health authorities in Madhya Pradesh reported the sudden deaths of 14 children, all of whom had consumed Coldrif Cough Syrup manufactured by M/s Sresan Pharmaceuticals, Puducherry.
Laboratory tests revealed the presence of Diethylene Glycol, a toxic industrial solvent known to cause kidney failure and death. The situation escalated when over 20 children died in Chhindwara, Madhya Pradesh, under similar circumstances.
As reported, in Rajasthan, 3 children died due to consumption of this Cough Syrup lending to the suspension of the Drug Controller and a halt on 19 medicines, intensifying nationwide scrutiny.
In MP, a government paediatrician was subsequently arrested under Section 105 and 276 of the Bharatiya Nyaya Sanhita, 2023, along with Section 27-A of the Drugs and Cosmetics Act, 1940, for prescribing this syrup.
The doctor stated that he was falsely implicated, arguing that the syrup had been approved and recommended by the Central Drugs Standard Control Organization (‘CDSCO’).
The State emphasised that the ingredients in the prescribed syrup are harmful and instructed that such medications should not be administered to children under the age of 4.
The Advisory:
In a swift and decisive response to emerging health concerns, the Employees’ State Insurance Corporation (‘ESIC’) has issued a nationwide advisory halting all activities related to Coldrif Cough Syrup.
On 3-10-2025, ESIC issued guidance on the rational use of cough syrup in children. In the paediatric population, cough syrup usage is not recommended:
-
Strictly under the age of 2 years
-
Under careful evaluation below the age of 5 years
It is advised that healthcare facilities and clinical establishments adhere to good manufacturing practices. States and Union Territories are instructed to implement the advisory across all government dispensaries and hospitals.
ESIC initiated an internal review and began coordinating with relevant health and regulatory authorities to assess the situation.
On 7-10-2025, the Health Ministry emphasized the importance of rational drug use and patient safety, reiterating the need for judicious prescribing and dispensing of cough syrups for children.
It was directed to ensure:
-
Circulation of Advisory
-
Sensitise patients
-
Educate Medical officers/Nursing Officers
ESIC mandated compliance and made Heads of Institutions responsible for implementing the advisory.
On 8-10-2025, the ESIC issued the directions for strict compliance regarding:
-
Purchase, issuance, distribution, and utilisation of Coldrif Cough Syrup is strictly prohibited.
-
Withdraw issued stock without delay.
-
Return available stock to the original procurement source.
-
Submit compliance confirmation to ESIC Headquarters promptly.
All ESIC-run and government affiliated institutions are required to comply with the directive immediately. Medical Superintendents, Store In-Charges, and Pharmacy Officers have to ensure that no further issuance or use of the syrup occurs and that all stock is properly accounted for and returned.
The advisory underscores the importance of vigilant pharmacovigilance and rapid response to potential drug-related hazards. ESIC’s proactive measures reflect its commitment to patient safety and public health. Patients and caregivers are advised to:
-
Avoid consuming Coldrif Cough Syrup.
-
Seek medical attention if symptoms occur after its use.
-
Report possession or usage to the nearest health facility.
The WHO Alert:
On 13-10-2025, the World Health Organisation (‘WHO’) issued a Medical Product Alert identifying three contaminated cough syrups, Coldrif, Respifresh TR, and ReLife1, linked to child deaths in India. The syrups contained Diethylene Glycol, a toxic solvent causing acute kidney injury and fatalities. The products identified are considered substandard as they fail to meet their quality standards.
WHO urges health-care professionals to report substandard product detections and adverse effects and advises increased surveillance across formal and informal supply chains.