The World Health Organization (WHO) is warning of the potential risks associated with the unregulated export of contaminated cough syrups, particularly through informal channels. This concern follows the recent deaths of children in Madhya Pradesh and Rajasthan, India, which have been linked to the consumption of cough syrups tainted with diethylene glycol (DEG), a toxic substance.

DEG and ethylene glycol (EG) are industrial solvents and antifreeze agents that can be fatal, even in small amounts, especially for children. These chemicals are sometimes substituted for glycerine or propylene glycol, which are legitimate ingredients in cough syrups, due to their lower cost.

In response to WHO's concerns, the Central Drugs Standard Control Organisation (CDSCO) in India confirmed the presence of DEG in at least three oral syrup medicines: Coldrif, Respifresh TR, and ReLife. While the CDSCO stated that none of these products were exported from India, the WHO maintains that the risk of unregulated exports cannot be ruled out. The WHO is encouraging National Regulatory Authorities (NRAs) to conduct market surveillance, particularly in informal and unregulated markets.

The WHO has requested clarification from the Indian government regarding the possible export of Coldrif cough syrup, which is linked to the deaths of at least 17 children, to other countries. Tests revealed that Coldrif syrup contained a dangerously high level of diethylene glycol, nearly 500 times the permissible limit.

This is not an isolated incident. In 2022 and 2023, more than 300 children died across multiple countries due to toxic cough syrups. The WHO has been working with 15 countries to track these dangerous medicines. Previous incidents have involved cough syrups made in India that were linked to child deaths in Gambia and Uzbekistan.

These incidents raise concerns about pharmaceutical safety standards, particularly in India, a major supplier of generic medicines worldwide. The WHO's involvement could lead to global regulatory implications for Indian drug exports.

Indian authorities have taken steps to address the issue. The CDSCO has issued alerts to all states, instructing them to ensure testing at every stage of manufacturing, from raw materials to the finished product. States and union territories have been asked to monitor manufacturers for compliance and maintain strict records of tests. The owner of Sresan Pharmaceuticals, the maker of Coldrif, has been arrested.

The WHO has also urged all countries to increase surveillance and offer support to concerned countries that lack the resources to test their own medicines. The organization has long recommended against giving cough syrups to children under 5, citing limited evidence of their effectiveness and potential side effects.

The WHO emphasizes the urgent need to identify and remove any contaminated pharmaceutical material in circulation. The organization is also calling for strengthened regulatory frameworks to prevent future tragedies and to ensure the safety of medicines for domestic use and export.