The World Health Organization (WHO) has sought official clarification from Indian authorities on whether a batch of the cough syrup Coldrif, recently linked to the deaths of several children, was exported to other countries. The global health body said it would assess the need to issue a Global Medical Products Alert once it receives formal confirmation from New Delhi.
Background & Context:
At least 17 children under the age of five have died in the past month after consuming Coldrif cough syrup, which laboratory analysis found to contain diethylene glycol (DEG), a toxic industrial solvent at levels nearly 500 times higher than permissible limits. Health officials confirmed the fatalities occurred across multiple districts, prompting an immediate recall of the product and criminal investigations against its manufacturer.
DEG is used in antifreeze and brake fluids and has been responsible for numerous poisoning deaths worldwide. The affected children reportedly developed acute kidney failure and neurological complications shortly after consuming the syrup.
The cough syrup, manufactured by Sresan Pharmaceuticals in Madhya Pradesh, was part of batch SR-13, produced in May 2025 and set to expire in April 2027. The batch has been banned in several Indian states after toxicology reports confirmed extreme contamination.
Following the incident, India’s Central Drugs Standard Control Organisation (CDSCO) and state-level drug regulators initiated a nationwide audit of pharmaceutical manufacturing and quality control practices. Early findings suggest testing lapses both in raw material procurement and finished product quality checks, a systemic issue that has plagued parts of India’s generic drug industry.
The WHO’s intervention highlights the international implications of the tragedy.
India is one of the world’s largest exporters of generic medicines, supplying drugs to more than 150 countries. If the contaminated batch was exported, it could have cross-border health consequences, triggering global recalls and renewed debate over manufacturing oversight.
Why This Matters?
The Coldrif case revives memories of previous DEG contamination tragedies, most notably the 2022 Gambia incident, in which over 70 children died after consuming Indian-made cough syrups. The WHO had issued a medical product alert at the time, warning of “unacceptable levels of contaminants.” Repeated contamination scandals threaten to erode international confidence in India’s billion dollar pharmaceutical export sector, a cornerstone of its global health diplomacy. The government faces mounting pressure to strengthen post-market surveillance, enforce stricter testing norms, and improve transparency in drug manufacturing and export practices.
What Happens Next?:
The Ministry of Health and Family Welfare and the CDSCO are expected to submit a detailed report to the WHO, outlining the extent of distribution and whether the implicated batch was exported. The WHO will decide whether to issue a Global Medical Products Alert based on those findings. Meanwhile, state authorities are conducting field investigations, collecting product samples, and monitoring for any additional cases. Experts are urging India to establish a centralized pharmacovigilance database and enforce tighter control over solvent use and batch validation protocols.
The Coldrif case once again highlights the need for stronger global drug-quality governance, international cooperation on pharmaceutical safety, and an unwavering commitment to protect children from preventable tragedies.
