2025 India Cough Syrup Crisis Lawsuit

2025 India Cough Syrup Crisis

The products

In 2025, a series of child deaths in India was traced to cough syrups adulterated with industrial chemicals. The crisis struck primarily in the central state of Madhya Pradesh and the neighboring state of Rajasthan. Infants and toddlers presenting with common cold symptoms rapidly developed severe dehydration and acute kidney injury after consuming locally sold cough medicines.

The Madhya Pradesh cases were traced to Coldrif, a cough syrup manufactured by Sresan Pharmaceuticals in Tamil Nadu. Laboratory testing found that the product contained extremely high levels of diethylene glycol (DEG), an industrial solvent; the tested samples contained roughly 48.6 percent DEG, far beyond permissible limits. Two additional syrups manufactured in Gujarat, Respifresh TR and ReLife, also tested positive for DEG, though no deaths were reported in connection with them.

In Rajasthan, a separate incident involved a generic cough syrup containing the active ingredient dextromethorphan hydrobromide, manufactured by Kayson Pharma in Jaipur and distributed through the state's free medicine scheme. That product did not test positive for diethylene glycol, but the deaths prompted authorities to suspect contamination or overdose.

Who was harmed

Officials reported that 24 children, mostly under age five, died in connection with Coldrif poisoning in Madhya Pradesh, with several additional children hospitalized. In Rajasthan, three children aged two to five died in the districts of Sikar and Bharatpur after taking the government-dispensed syrup.

The World Health Organization was notified of the outbreak and issued a Medical Product Alert confirming that specific batches of Coldrif, Respifresh TR, and ReLife contained toxic DEG, advising healthcare professionals worldwide to avoid the products in children and to report any cases. The U.S. Food and Drug Administration reported that none of the contaminated syrups had been exported to the United States and recommended vigilance in other markets.

Investigation and litigation

Indian authorities, led by the Central Drugs Standard Control Organisation (CDSCO) together with state regulators, collected samples of cough syrups, antipyretics, and antibiotics from six states for testing. Most randomly sampled syrups from general pharmacies tested negative for DEG, indicating the problem was confined to specific batches. Inspectors obtained samples of Coldrif directly from the Sresan plant, and the facility was subsequently sealed, with inspectors reporting unsafe and abandoned conditions on site.

Criminal proceedings followed the regulatory response. Police filed a criminal complaint naming Sresan's owner in a manslaughter case, and a prescribing doctor was arrested on charges of negligent prescribing. Per Reuters, the charge sheet cited violations of the Drugs and Cosmetics Act, including adulteration of drugs and culpable homicide not amounting to murder; if convicted, the company's owner faces life imprisonment.

Outcome

In 2025 the crisis closed with recalls of the affected products and suspension of the relevant licenses. Tamil Nadu's drug control department cancelled all manufacturing licenses of Sresan Pharma, Gujarat recalled the two additional DEG-positive syrups and ordered the manufacturers to suspend production of all drugs, and Rajasthan suspended distribution of all Kayson Pharma products under its free medicine scheme. The episode is recorded in this entry as a recall resolved in 2025.