As cough syrup deaths rise, WHO seeks answers from India on the toxic medication exports

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The World Health Organization (WHO) has formally requested clarification from the Indian government on whether a cough syrup linked to the deaths of at least 21 children across states has been exported internationally.

The death toll has risen as the tragedy, which began in Madhya Pradesh’s Chhindwara district, spreads to neighbouring regions. Chhindwara itself, which has borne the brunt of the tragedy with 18 fatalities, reported another death, while five children remain in a critical condition in hospitals in Nagpur, as per TOI.

The UN body’s concern places a renewed spotlight on India’s pharmaceutical industry, which has been under intensified global scrutiny since 2023 following a series of deaths abroad linked to Indian-made syrups.

The product in question, Coldrif syrup, is manufactured by Tamil Nadu-based Sresan Pharmaceuticals, a company now under investigation. The child fatalities, all involving children under the age of five, occurred in Madhya Pradesh and Rajasthan. Preliminary reports suggest the syrup contained diethylene glycol (DEG), a toxic compound commonly used as an antifreeze.

According to a senior WHO official cited by The Hindu, the global health body is awaiting a response from Indian authorities before deciding on issuing a formal Global Medical Products Alert. This potential alert would serve to warn other nations if the product is found to have entered the global supply chain.

In response to the domestic tragedy, a nationwide compliance drive has been initiated. The trade body, the All India Organisation of Chemists and Druggists (AIOCD), issued an urgent advisory to manufacturers and marketers on Wednesday. The communication stresses the “mandatory” requirement for all cough and cold preparations to “clearly indicate” usage restrictions for children below four years of age.

This directive reinforces an order from the Central Drugs Standard Control Organisation (CDSCO) dated December 18, 2023. That order specifically prohibited the use of a particular fixed-dose combination, which includes ingredients found in Coldrif, for children below four. It also mandated that a clear warning to this effect be displayed on the label and package insert.

The AIOCD advisory noted that non-compliance has been observed in the market, with some stocks missing or obscuring this critical safety information. It has urged all companies to immediately review their products to ensure full conformity with the statutory labelling norms to prevent “potential misuse.”

This incident echoes measures already taken by the Central government, which, following the deaths of over 140 children in The Gambia, Uzbekistan and Cameroon linked to Indian syrups, mandated additional testing for cough syrup exports at government laboratories.

Meanwhile, the owner of Sresan Pharmaceuticals has been arrested. Officials confirmed that Madhya Pradesh police took G Ranganathan into custody in Chennai on Wednesday night, following a case registered against his company in connection with the child deaths across multiple states.