Govt Bans These Cold And Flu Syrups for Children Below 4 Years: Complete List Inside

The banned medicine is a combination of decongestants, antihistamines, and pain relievers, commonly used to treat symptoms like runny nose, cough, and fever.

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Written By: Satata Karmakar | Updated : December 20, 2023 9:02 PM IST

The country's apex health regulatory agency, the Central Drugs Standard Control Organisation (CDSCO), has decided to ban the use of a popular anti-cold cocktail medicine combination among infants and children below four years of age due to serious safety concerns. The decision comes after concerns were raised about the potential risks associated with the drug, particularly for young children.

According to the reports, pharma firms manufacturing GlaxoSmithKline's T-Minic Oral Drops, Glenmark's Ascoril Flu Syrup, and IPCA Laboratories' Solvin Cold Syrup, among others, have been asked by the CDSCO to include a 'warning' regarding the use of this combination in their products. Paediatricians quoted in the report expressed concerns about the widespread use of this combination among children, often due to self-medication and self-prescription by parents.

CDSCO Bans Anti-Cold Combination Medicine for Children Under Four, Raising Safety Concerns

In a letter, the regulatory board has asked all the Indian states and Union Territories to update the package insert of products made using a cocktail of two medicines chlorpheniramine maleate and phenylephrine.

These two combinations are known to help in providing quick relief to cold and flu symptoms, including watery eyes, runny nose, sneezing, and nasal or throat itching. While chlorpheniramine maleate functions as an anti-allergic, phenylephrine acts as a decongestant, narrowing small blood vessels to provide relief from nasal congestion or stuffiness.

The fixed-dose combination (FDC) had previously faced scrutiny for being deemed "irrational," but a government committee approved it based on reasonable evidence. In a letter, the CDSCO acknowledged the approval of the FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop per ml on July 17, 2015. However, concerns were later raised regarding its use among infants and children.

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