India Bans Toxic Cough Syrup: State-Wise Actions after Children Deaths

The recent tragic deaths of children in India linked to contaminated cough syrups, specifically the batch of Coldrif syrup containing toxic diethylene glycol (DEG), triggered an urgent and comprehensive government response at both the central and state levels. This involved immediate bans on the offending batch and recalls of related products, enhanced regulatory inspections, and advisories to restrict cough syrup use in children.

Union Government Response

The Union Ministry of Health and Family Welfare convened a high-level meeting led by Union Health Secretary Punya Salila Srivastava with all States and Union Territories to review the issue and coordinate actions. The meeting emphasized strict enforcement of the Revised Schedule M guidelines for manufacturing and rational use of cough syrups, particularly avoiding unnecessary prescriptions for children under two years old.

A multidisciplinary central team, including officials from CDSCO, ICMR, Indian Council of Medical Research, and National Centre for Disease Control (NCDC), began risk-based inspections at 19 drug manufacturing units in six states to detect and prevent substandard medicines. The Center urged states to boost surveillance, ensure rapid reporting of adverse drug events, and use community reporting tools to detect safety issues early.

State-Level Regulatory Actions

Madhya Pradesh: The state reported 16 child deaths primarily in Chhindwara and implemented a total ban on the cough syrup batch linked to deaths, Coldrif syrup (batch SR-13) manufactured by Sresan Pharma in Tamil Nadu. The sale and manufacture of other products by this company were suspended. Madhya Pradesh also announced compensation of INR 400,000 to the families of deceased children and pledged full treatment support for affected children.

Rajasthan: Rapidly responded with surveillance, public awareness campaigns, bans, and technical investigations. The state mandated warning labels on cough syrups deemed potentially harmful to children and pregnant women and halted distribution of medicines supplied by implicated companies. Rajasthan conducted door-to-door surveys and extensive counseling for healthcare providers and the public.

Tamil Nadu: The source state for the syrup, Tamil Nadu banned the syrup’s sale and seized stocks immediately after toxic chemical contamination was confirmed. The state’s Food Safety and Drug Administration inspected and ordered the halt of production at the manufacturing facility. The syrup was found adulterated with diethylene glycol at dangerous concentrations (48% vs. permissible 0.1%).

Kerala and Telangana: Kerala banned the syrup following Tamil Nadu’s lead, while Telangana issued public warnings and alerts to prevent its use.

Maharashtra: Issued an immediate ban on Coldrif syrup batch SR-13 and ordered seizure of stocks, joining the states enforcing bans and public advisories.

Uttar Pradesh: Launched a probe and seized stocks of the suspicious syrup after reports of child deaths. The state enhanced sample testing of all cough syrups across pharmacies and hospitals with central data management to avoid duplicate sampling.

Gujarat: Ordered a detailed probe into harmful ingredients in cough syrups following the deaths reported in other states.

Overall Measures and Fact Check on Dry Cough Syrups

The government has directed enhanced compliance with drug manufacturing quality norms focused on pediatric products, pushing for rational use of cough syrups only when necessary since most childhood coughs are self-limiting and do not require medication. The advisory stresses avoiding cough syrups in children less than two years, as recommended by the Health Ministry.

The ban, however, has so far focused specifically on the contaminated batch of Coldrif syrup and similar products from the implicated manufacturer, not a blanket ban on all dry cough syrups. States are yet to impose a general ban on all dry cough syrups, but strict surveillance and testing continue across all medicine types to ensure safety.

Key Statements

Dr. Rajiv Bahl, Secretary, Department of Health Research and Director-General of ICMR, stated that children should ideally not be prescribed cough syrups or combination drugs due to risks of side effects. He noted that the National Joint Outbreak Response Team is operational and coordinating central agencies to assist states in managing such incidents

Dr. Sunita Sharma, Director General of Health Services, underlined the need for rational use of cough syrups, especially among pediatric populations. She remarked that cough medications have minimal proven benefits in children but carry significant risks, and that guidelines for parents, pharmacists, and doctors will soon be issued to ensure safe use.

Dr. Rajeev Raghuvanshi, Drugs Controller General of India, reiterated the need for strict adherence to Good Manufacturing Practices as per Revised Schedule M by all drug manufacturing units. He highlighted government schemes supporting infrastructure upgrades and urged states to ensure GMP compliance.