Tainted Cough Syrup Not Sent to U.S.- India’s Drug Regulator
India’s drug regulator and the U.S. Food and Drug Administration have confirmed that Coldrif, a cough syrup linked to the deaths of around 17 children in India, was not shipped to the United States.
Syrup Linked to Child Fatalities
Investigations found that Coldrif contained extremely high levels of diethylene glycol (DEG)—a toxic chemical—far above permissible limits. In response, Indian authorities declared three cough syrups (Coldrif, Respifresh TR, and ReLife) unsafe and ordered their recall.
No Exports, U.S. Safety Assured
The Central Drugs Standard Control Organisation (CDSCO) informed the U.S. FDA that the contaminated products had not been exported outside India. The FDA said it remains vigilant to prevent any tainted drug from entering the U.S. market.
Oversight Lapses Under Scrutiny
The World Health Organization has flagged gaps in India’s pharmaceutical regulation, particularly in screening syrup products sold domestically. State and central agencies are now investigating manufacturing protocols and regulatory compliance at firms implicated in the tragedy.
Legal and Health Fallout
The owner of Sresan Pharmaceuticals, the company behind Coldrif, has been arrested. State governments have banned sales and ordered seizures of existing stocks. Health authorities warned caregivers to avoid giving cough or cold syrups to children under 2 years of age and to use extreme caution even up to age 5.
