In the wake of a tragic series of child deaths potentially linked to contaminated cough syrups, the Indian government is taking decisive action, urging all states and Union Territories to strictly adhere to the revised drug norms outlined in Schedule M. This directive follows reports of at least nine children, all under the age of five, who have died since late August in Madhya Pradesh and Rajasthan after consuming cough syrup.
The cough syrup, identified as Coldrif, manufactured by Sresan Pharma, has been found to contain unacceptable levels of diethylene glycol (DEG). DEG is a toxic substance used in industrial solvents and can be fatal even in small amounts. Laboratory tests revealed that samples of the syrup contained 48.6% diethylene glycol.
The Union Health Ministry convened a high-level meeting, chaired by Union Health Secretary Punya Salila Srivastava, with all states and Union territories to review compliance with drug quality norms and promote the rational use of cough syrups, especially in pediatric populations. The ministry has emphasized the necessity for all drug manufacturers to comply with the Revised Schedule M and warned that strict action will be taken against violators.
In response to the crisis, multiple states have taken swift action. The Madhya Pradesh government has banned the sale of Coldrif cough syrup throughout the state, and also banned the sale of other products from the same manufacturer. Tamil Nadu and Kerala have also banned the product. Rajasthan has banned a specific syrup pending investigation.
A doctor in Madhya Pradesh has been detained for allegedly prescribing the banned syrup. Inspections of drug manufacturers are underway across multiple states to identify quality control lapses and recommend improvements to prevent future incidents. Nineteen medicine samples consumed by the affected children were collected from treating private practitioners and nearby retail stores.
The Directorate General of Health Services (DGHS) has issued an advisory calling for sensible use of cough syrups and cautioning against their prescription and dispensation to children below two years of age. The advisory stated that these medicines are generally not recommended for children below five years, and that use above this age should follow careful clinical supervision and adherence to appropriate dosing.
This is not the first time that cough syrups manufactured in India have come under global scrutiny. In 2022, the World Health Organization (WHO) issued global alerts after Indian-made cough syrups were linked to child deaths in Uzbekistan and The Gambia. These incidents have raised serious concerns about the quality control and regulatory oversight of pharmaceutical manufacturing in India.
The government is urging states to strengthen surveillance, reporting, and inter-state coordination through systems like IDSP-IHIP for quicker, more effective responses. In Uttar Pradesh, authorities have implemented a centralised data system to avoid duplicate sampling, and the Food Safety and Drug Administration has mandated strict compliance with safety norms. The Union Health Ministry has warned that licenses of drug manufacturers violating the norms will be revoked.
The recent deaths have prompted a central advisory against prescribing cold and cough medications to children aged below 2. The government is committed to ensuring the safety and well-being of its citizens and is taking all necessary steps to prevent such tragedies from happening again.
