India Bans Anti-Cold Drug Combination for Children Under 4 After Global Deaths Linked to Cough Syrups

India Bans Anti-Cold Drug Combination for Children Under 4 After Global Deaths Linked to Cough Syrups

VoM News Desk | December 21, 2023 | 11:08 AM IST | Health | Follow on Google News

India Bans Anti-Cold Drug Combination for Children Under 4 After Global Deaths Linked to Cough Syrups

India Bans Anti-Cold Drug Combination for Children Under 4 After Global Deaths Linked to Cough Syrups

India’s drug regulator has prohibited the use of a combination anti-cold drug in children below the age of four, directing drug labeling to reflect this new restriction. This decision comes in response to concerns raised globally about the promotion of an unapproved formulation of anti-cold drugs for infants, which has been linked to numerous deaths, amounting to at least 141 cases worldwide.

The regulatory action stems from a series of child deaths associated with toxic cough syrups produced in India, including incidents in Gambia, Uzbekistan, and Cameroon since the middle of the previous year, where 141 deaths were recorded. Within India itself, authorities reported 12 child deaths and severe disabilities in four other children in 2019, all linked to domestically manufactured cough syrups.

Referred to as the “world’s pharmacy” for its production of affordable life-saving drugs, India’s regulatory body issued an order on December 18 (publicly disclosed later) mandating drug manufacturers to label their products with a warning stating that the “FDC should not be used in children below 4 years of age.” This fixed drug combination comprises chlorpheniramine maleate and phenylephrine, commonly found in syrups or tablets for treating cold symptoms.

Citing recommendations by the World Health Organization, the use of over-the-counter cough syrups or medicines for children under the age of five for treating cold symptoms is not advised.

To address these concerns and strengthen oversight, India has introduced compulsory testing for exported cough syrups since June and intensified scrutiny of pharmaceutical companies. Despite these measures, the drugmakers associated with cough syrups linked to child deaths have refuted any allegations of wrongdoing.

India Bans Anti-Cold Drug Combination for Children Under 4 After Global Deaths Linked to Cough Syrups: In case of rectification of any error in this Article, Visit on Correction Policy or Register your Query

VoM News Desk

VoM News is an online web portal in jammu Kashmir offers regional, National & global news.