Toxic cough syrup tragedy in Madhya Pradesh reignites concerns over India’s recurring drug safety lapses

In Madhya Pradesh's Chhindwara district, a doctor has been arrested following the deaths of 11 children allegedly linked to a contaminated cough syrup.

The medicine in question, Coldrif, manufactured by Sresan Pharmaceuticals, is suspected of being “Not of Standard Quality (NSQ)” and found to contain dangerously high levels of diethylene glycol (DEG) — a toxic chemical known to cause acute kidney damage and failure.

Authorities say this batch of Coldrif, labelled SR-13 (manufactured in May 2025), showed contamination with approximately 48.6% v/v DEG.

The state government has banned the sale and distribution of Coldrif and all other products from Sresan Pharmaceuticals, pending further investigation.

The outrage is wider than just one district. Similar deaths have been reported in Rajasthan and Kerala. In Rajasthan, several children died after consuming a government-supplied cough syrup under the free medicine scheme, followed by serious illnesses.

Kerala suspended the sale of Coldrif as a precaution, even though that specific batch was not reported sold in the state.

In response, the central government through the Directorate General of Health Services (DGHS) issued an advisory to all states and Union Territories to practice judicious prescribing and dispensing of cough syrups for children. The advisory emphasizes that:

-cough and cold medicines are generally not recommended for children under two years,

-even up to age five, use must be carefully assessed, limit dosing, duration, avoid multiple-drug combinations.

The current episode is not the first in recent years. In 2024, the CDSCO (Central Drugs Standard Control Organization) report tested over 7,000 batches of cough syrups and found many failing quality standards — some having issues with DEG/ethylene glycol, microbial growth, improper assay, etc.

Earlier, India also suspended licenses of companies after World Health Organization alerts about contaminated cough syrups exported to other countries, contributing to child deaths.

The immediate legal actions include an FIR against the prescribing doctor (Dr. Praveen Soni of Chhindwara) and the manufacturer.

State regulators are seizing stocks: in Chhindwara alone, 433 bottles of the suspect batch were frozen, and 222 of them had already been sold.

This tragedy points to several recurring issues: gaps in pharmaceutical quality control, lax oversight in the regulatory framework, challenges in real-time monitoring of drug batches, and sometimes casual prescribing of syrups that may contain multiple active ingredients or whose safety in young children is not well-established.

The easy availability of such medicines, sometimes under government free supply schemes, amplifies risk. Regulatory bodies and health experts are now calling for stricter manufacturing audits, better labelling, faster recall mechanisms, and stricter rules around prescribing to young children.