The Indian government has officially banned the use of several widely sold cough syrups for children under four years of age, citing potential safety concerns. According to a notification dated April 15, the Centre has directed manufacturers to prominently display warning labels on all affected products.
Drugs Like Ascoril Flu, Alex, T-Minic, and Maxtra Affected
The restriction impacts popular pediatric medications such as Ascoril Flu Drops, Alex (by Glenmark), T-Minic (by Haleon), and Maxtra (by Zuventus Healthcare), among others. These formulations often contain a fixed-dose combination (FDC) of chlorpheniramine maleate and phenylephrine hydrochloride, which are now prohibited for use in children below four.
As reported in The Economic Times, the Drugs Technical Advisory Board (DTAB) and the Subject Expert Committee conducted a thorough review before recommending the ban. Both bodies concluded that these combinations pose health risks when administered to toddlers.
Government Mandates Clear Warning Labels
To enforce the ban, the Drug Controller General of India (DCGI) has instructed pharmaceutical companies to clearly state the following on all labels, inserts, and promotional materials:
Do not use the fixed dose combination in children below four years of age.
This directive prevents misuse and ensures that parents and healthcare providers stay adequately informed.
Industry Reacts to Sudden Implementation
Pharmaceutical companies are now racing to comply with the new regulation. A spokesperson from Glenmark confirmed,
“We have already initiated the necessary label updates and remain committed to ensuring patient safety and regulatory adherence.”
However, industry insiders have expressed concerns over the abruptness of the change. One executive, speaking to The Economic Times on condition of anonymity, said, “This notification has come as a surprise. The authorities didn’t give us sufficient time to transition. It’s unclear how we are expected to withdraw products immediately, especially without clarity on dosage strengths.”
International Scrutiny of Phenylephrine
This move follows global scrutiny of the ingredients involved. The US Food and Drug Administration (FDA) has also proposed removing oral phenylephrine from over-the-counter (OTC) medications. Studies suggested it was ineffective for nasal decongestion.