The Karnataka Government Monday issued a circular banning the use of cold and cough syrup for children below 2 years of age. It also prohibited the precription and use of Coldrif cough syrup which has been linked to the recent deaths of multiple children who allegedly consumed a contaminated batch of the medicine in Madhya Pradesh and Rajasthan. The circular issued by the Department of Health and Family Welfare stated that for children between 2 and 5 years of age, cold and cough syrups should generally be avoided unless clearly indicated, and prescribed only after proper clinical evaluation. “For older children, cough syrups, if required, must be used only after thorough clinical assessment, in the lowest effective dose and for the shortest duration, and fixed dose. Also, multi-drug combinations (irrational combinations, oral bronchodilators, cough suppressants) should be avoided,” it said. “All healthcare providers shall adhere to the Standard Treatment Protocols / Therapeutic Guidelines issued by the Ministry of Health and Family Welfare and the Integrated Management of Neonatal and Childhood Illness (IMNCI) guidelines for the clinical management of cough and respiratory symptoms in children," the circular read. In line with the Centre’s circular on the matter, the department also said that non-pharmacological measures such as adequate hydration, rest, supportive measures and a nutritious diet should be encouraged. All healthcare facilities shall ensure procurement of products only from Good Manufacturing Practice (GMP)-compliant licensed manufacturers. District and taluk health authorities shall ensure wide dissemination of the advisory among paediatricians, general practitioners, pharmacists, and nursing staff and health institutions under their jurisdiction. Random inspections may be conducted to ensure compliance with the above instructions. Any adverse events or suspected cases of cough syrup-related toxicity or death, as well as any unusual or unexplained increase in incidence of cough among children or the community, must be promptly investigated and reported on the portal of the Integrated Disease Surveillance Programme (IDSP) Division, Directorate of Health & Family Welfare. Violations of these instructions — including irrational prescription, over-the-counter sale, or use of unapproved fixed-dose combinations — will attract statutory action under the Karnataka Private Medical Establishments (KPME) Act, 2007, as well as under the Drugs and Cosmetics Act, 1940 and Rules, 1945, the circular stated. Ban on Coldrif Meanwhile, a note shared by the Food Safety and Drug Administration Commissioner of Karnataka read, “In view of recent incidents where deaths have been caused in children in Madhya Pradesh and Rajasthan due to consumption of Coldrif syrup, batch no. SR-13, Mfg date: May 2024, Expiry Date: April 2027, Manufactured by M/s Sreesan Pharma, Kanchipuram- 602106 and Dextromethorphan Hydrobromide Syrup IP, Manufactured by M/s Kaysons Pharma, Jaipur. An advisory on national use of cough syrup in the paediatric population has been issued by the Director General of Health Science dated 03.10.2025." "In this regard the state licensing authority has requested to all district health authorities, medical institutions, government hospitals, PHCs, CHCs, retail/stockists/distributors/ against the purchase, prescription and sale of these batches drugs/combination of cough syrup of the said company in the state of Karnataka and also to recall these drugs, found if any, under intimation to concerned jurisdictional assistant drugs controller office for further necessary action," it read. ‘Testing samples of other syrups as precaution’ State Health Minister Dinesh Gundu Rao said they are monitoring the situation in other states. “I assure parents that it has not been supplied in our state. We have started testing samples of other cough syrups as a precautionary measure, and our department will release guidelines for parents today,” he stated. “We are pushing for a centralised system to share information about substandard medicines across states. A website will allow all states to stay informed about such incidents, regardless of where they occur. We are urging the central government to launch such a platform to ensure better coordination and safety,” Rao said. On Friday, the Directorate General of Health Services (DGHS) issued an advisory to all states and Union territories on the rational use of cough syrups in children, following the deaths of at least 14 children in Madhya Pradesh and Rajasthan in this connection.
