The Central Drugs Standard Control Organisation (CDSCO) has informed the World Health Organisation (WHO) that three cough syrups — Coldrif, Respifresh TR, and ReLife — have been recalled and their production stopped. The regulator confirmed that none of these products were exported from India, according to a PTI report.
The WHO had contacted Indian authorities following media reports from Madhya Pradesh and Rajasthan, describing clusters of child deaths and illnesses with symptoms such as acute renal failure and acute encephalitis syndrome, suspected to be linked to certain oral syrups.
The global health agency expressed concern about informal export routes and gaps in India’s screening for diethylene glycol (DEG) and ethylene glycol (EG), urging authorities to trace the source of contamination and remove affected products from circulation.
Meanwhile, the Drugs Controller General of India (DCGI) issued an advisory to all state and Union Territory regulators on October 7, instructing stricter quality checks on cough syrup manufacturing. Inspections had revealed lapses in testing raw materials and ingredients, with several firms failing to test each batch before use.
The CDSCO has launched a nationwide audit of cough syrup manufacturers, requiring states to submit a list of syrup makers for inspections over the next month, focusing on companies with past quality concerns, product packaging, and manufacturing practices.
Sources noted that Chennai-based Sresan Pharma, manufacturer of Coldrif syrup, had not been on the central regulator’s radar, as Tamil Nadu’s state drug authority conducted inspections independently.
The Centre had earlier mandated warning labels on certain fixed-dose cough syrups in December 2023, advising that combinations containing chlorpheniramine maleate and phenylephrine hydrochloride should not be given to children under four years.
The recall follows multiple child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrup, prompting swift regulatory action and international attention.
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