The World Health Organization (WHO) has called for stronger action from India to curb the sale of toxic cough syrups following the tragic deaths of at least 24 children who consumed Coldrif, a cough medicine produced by Sresan Pharma. Tests revealed the syrup contained diethylene glycol at nearly 500 times the permissible limit, highlighting severe lapses in India’s pharmaceutical oversight. This incident, occurring just two years after global commitments to tighten regulations following the deaths of over 300 children worldwide from similar toxins in Indian and Indonesian medicines, underscores ongoing enforcement challenges.

While India has introduced a rule mandating contaminant testing for medicines destined for export, no such requirement exists for domestically sold syrups, creating a significant regulatory gap, according to WHO official Rutendo Kuwana. “They have made some strides,” said Kuwana, who leads the WHO’s efforts on substandard and falsified medicines, but he emphasized that “there’s a lot that needs to be done” given India’s vast market and numerous manufacturers. The lack of testing for local products remains a critical concern, with the WHO stressing that medicines, including raw materials, should be rigorously tested throughout production.

India’s plans to phase out mandatory export testing by year-end, once companies upgrade to international standards, have raised further concerns. The WHO insists that testing must remain integral at all production stages, not just as a final step. India’s Central Drugs Standard Control Organisation (CDSCO) has acknowledged that some firms fail to test raw materials and final products as required by law, yet neither the CDSCO nor Sresan Pharma responded to Reuters’ requests for comment. The absence of accountability, with no recorded prosecutions despite previous incidents, has been labeled a “big disappointment” by Kuwana.

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The WHO has been proactive, developing a cost-effective testing method for toxins like diethylene glycol and sharing it through training sessions attended by countries like Pakistan. Although India did not participate, it has confirmed using the method. Kuwana stressed the moral and criminal implications of such failures, stating, “This is not just selling fake shoes... it has devastating consequences.” As India grapples with its regulatory challenges, the WHO’s call for action underscores the urgent need to protect vulnerable populations from substandard medicines.

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