Government restricts fixed dose combinations containing 2 chemical compounds for young children
The Indian government has mandated that all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride must carry a warning label prohibiting their use in children under four years old. This decision follows expert committee recommendations regarding the safety of these medications for young children.
Why it matters
Regulatory oversight of pediatric medications is vital for preventing adverse health outcomes and ensuring consumer safety.
In a significant step to safeguard the health and safety of young children, the government has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines shall not be used in children below four years of age.
Earlier, vide a notification dated April 15, 2025, the government had restricted certain fixed dose combinations (FDCs) containing the two chemical compounds, subject to the same age-specific warning.
The latest notification extends this requirement to all formulations containing these two ingredients.
The decision followed recommendations by an expert committee and the Drugs Technical Advisory Board (DTAB).
The government noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.
Get smarter about the news
Sign up free for a feed built around what you actually care about, Dive Deeper research on any story, and the full text of every article.
Create free accountAlready have an account? Sign in