India Bans Selected 4 Cough Syrups for Children Below 4 Years Over Health Concerns
The Indian government has officially banned the production, sale, and distribution of all formulations of the fixed-dose combination (FDC) of chlorpheniramine maleate and phenylephrine hydrochloride for children under four years of age. This is due to increasing concerns about child safety associated with some over-the-counter cough medicines.
As per a government notification dated April 15, firms can only continue to produce and sell these formulations if their packaging, labeling, and advertisements bear a prominent warning indicating:
"This fixed-dose combination should not be used in children below 4 years of age."
As per Expert Committee and DTAB Recommendations
This regulatory move comes after a thorough review by the Drugs Technical Advisory Board (DTAB) and a subject expert committee. The panel decided that the application of such formulations in children below four years should be limited because of the risk to health.
The fixed-dose combination in question is widely used in cold and allergy medications. It has been applied in several OTC cough syrups that are found in pharmacies across India.
Prohibited Cough Syrups for Kids Under 4 Years
Some of the products caught in the snare include:
- Ascoril Flu Drops
- Alex Syrup types (Glenmark)
- T-Minic Syrup (GSK's Haleon)
- Maxtra Syrup (Juventus Healthcare)
These syrups were commonly prescribed to treat cough and cold in children.
Official Statement
The notice states:
"The central government is satisfied that regulating the manufacture, sale, and distribution of these formulations through a ban is necessary in the interest of public health."
