In a major step for pediatric drug safety, the Ministry of Health and Family Welfare has officially banned the use of the fixed dose combination (FDC) of Chlorpheniramine Maleate and Phenylephrine Hydrochloride in children below the age of 4 years.
This combination is commonly found in over-the-counter cold and allergy syrups used to treat symptoms like cough, cold, and nasal congestion in children. The ban was announced through a Gazette Notification dated April 15, 2025, and is effective immediately.
❗ Why Was This FDC Banned for Children Under 4?
Two expert bodies – the Subject Expert Committee and the Drugs Technical Advisory Board (DTAB) – carefully studied the use of this drug combination. They found that it could pose health risks to young children and recommended that it should not be used for those below 4 years of age.
The Health Ministry stated:
“The Central Government is satisfied that the use of this drug combination involves risk to children under four years and safer alternatives are available.”
🧃 What’s in the Government’s New Rule?
According to the Gazette Notification, manufacturers must now:
- Stop using this combination in syrups meant for children under 4
- Print a clear warning on the label, package insert, and promotional materials that says:
🔴 “Fixed dose combination shall not be used in children below four years of age”
If companies do not follow this rule, they can face regulatory action, including a ban on the manufacturing and sale of the product.
⚕️ What Should Doctors and Pharmacists Do?
Healthcare professionals must now stop recommending or prescribing this FDC to children below 4 years of age.
Doctors should also educate parents about safer alternatives and advise against using over-the-counter syrups that do not carry the new warning label.
📢 Key Takeaways
- ❌ FDC of Chlorpheniramine + Phenylephrine banned for children under 4
- ✅ Warning labels are now mandatory on packaging and literature
- 🧪 Safer alternatives are available and should be used instead
- 🛑 Applies to all forms of the drug, especially pediatric cold syrups
- 📅 Rule is effective immediately from April 15, 2025
✅ Final Thoughts
This move by the Central Government is a critical step toward ensuring safe medication use in children. Parents and caregivers often rely on syrups without knowing the risks involved. With this clear restriction, both manufacturers and medical professionals must work together to promote safer pediatric practices.
📩 Call to Action
👩⚕️ Are you a doctor, pharmacist, or pediatrician?
👉 Review your current prescriptions and patient instructions immediately.
👉 Advise parents on the correct medications for children under four.
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