In response to alarming concerns both domestically and globally, India’s drug regulator has taken a decisive step by prohibiting the use of an anti-cold drug combination for children under the age of four. This decision comes in the wake of a distressing revelation that at least 141 child deaths globally have been linked to toxic cough syrups. Highlighting the severity of the situation within India, authorities have confirmed that since 2019, 12 children tragically lost their lives, while an additional four suffered severe disabilities after consuming locally produced cough syrups.
The specific drug combination in question contains chlorpheniramine maleate and phenylephrine, both of which are commonly used ingredients in medications designed to alleviate symptoms associated with the common cold. The concerns about these drugs extend beyond India’s borders, with reported deaths in countries such as Gambia, Uzbekistan, and Cameroon since the middle of the previous year. Drawing from these distressing incidents, India’s regulator has not only banned the use of this drug combination for young children but has also mandated appropriate labeling for all related products.
The recent tragic deaths linked to toxic cough syrups have raised significant concerns about the quality and safety of pharmaceutical exports from India, a country renowned as the “world’s pharmacy” for its provision of affordable life-saving drugs. In response to these alarming incidents, the Indian drug regulator issued a directive on December 18, mandating drugmakers to prominently label their products with a warning against using the fixed-drug combination (FDC) in children below the age of four.
Furthermore, in an effort to enhance safety measures and prevent future tragedies, India has instituted mandatory testing protocols for cough syrup exports since June. This move signals a heightened level of scrutiny over drug manufacturers, especially those whose products have been associated with child fatalities.
However, it’s worth noting that despite the grave implications, some of the drugmakers linked to these tragic incidents have vehemently denied any wrongdoing. In tandem with these domestic actions, the World Health Organization has also advised against the use of over-the-counter cough syrups or medications for treating cold symptoms in children below five years of age.
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