21 Dec 2023

Are cough and cold syrups safe for children? DCGI issued this warning

The Drugs Controller General of India (DCGI) has prohibited the usage of cough and cold syrup for children below the age of four. Additionally, directives have been issued to ensure proper labeling of these medicines. The decision was prompted by the revelation that 141 children worldwide had died after consuming cough syrup manufactured in India.

In a letter dated December 18, DCGI communicated with all states regarding Fixed Drugs Combination (FDC). The communication emphasized that the cough syrup, comprising chlorpheniramine maleate and phenylephrine, must clearly specify the quantity of each ingredient present—a detail currently absent from many syrups.

Chlorpheniramine maleate functions as an anti-allergic drug (antihistamine), while phenylephrine serves as a decongestant.

This drug combination is effective in alleviating symptoms of common cold or sinus inflammation, such as runny nose, sneezing, and nasal congestion. However, it's important to note that this medication does not treat infections.

Syrups or tablets containing this drug combination are commonly used to address common cold symptoms. Companies have been instructed to explicitly state that FDC should not be used in medicines intended for children under the age of four.

Death of children in Gambia and Uzbekistan

In 2022, an alarming incident involved the alleged death of approximately 70 children, all below the age of 5, due to syrups manufactured by Maiden Pharma. The cause of death was attributed to kidney injury, and the Gambian government investigation identified an Indian company as the manufacturer of the medicines responsible for the deaths. The symptoms observed in these cases were consistent.

Simultaneously, the Uzbekistan government accused cough syrup made in India of causing the death of 18 children in their country. The Uzbek Health Ministry asserted that the fatalities occurred after the consumption of DOK-1 MAX cough syrup, produced by Merian Biotech in Noida.

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