India has extended the age-specific safety warning it has already introduced to all fixed-dose combination (FDC) formulations that contain both Chlorpheniramine Maleate and Phenylephrine Hydrochloride ,used in young children.
According to a recent notification from the Health Ministry, manufacturers must clearly indicate that these fixed-dose combinations should not be used in children under the age of 4. This warning must be included on medicine labels, in package inserts, and in promotional material.
The measure is not a total ban on all cold remedies for young children, nor does it remove these formulations altogether from the Indian market; rather, it limits their manufacturing, sale, and distribution through mandating age-specific warnings.
Which Medicines Are Affected?
The rule applies to fixed-dose combinations containing both:
Chlorpheniramine Maleate is an antihistamine usually used to relieve symptoms such as sneezing and a runny nose.
Phenylephrine Hydrochloride is a decongestant used to relieve nasal congestion.
Some medications sold for the symptoms of colds and allergies contain these ingredients.
The key point is that the notice covers FDC formulations that contain both ingredients; it does not imply that all cough, cold or allergy medications have been banned for children under the age of four.
Why has the government made the rules more strict?
The decision was reached based on the recommendations of the Expert Committee and the Drugs Technical Advisory Board (DTAB).
The government has stated that using such combinations might pose risks to children under 4 years of age, given the availability of less risky alternatives. At its meeting on February 16, 2026, the DTAB looked into the matter and decided to extend the requirement for warnings to all relevant formulations.
The government took action pursuant to Section 26A of the Drugs and Cosmetics Act, 1940, which permits the government to act in the public interest.
The Restriction Has Been Developing for Several Years
It is not the first instance of regulatory action having been taken with respect to these medicines.
In December 2023, the Central Drugs Standard Control Organization told the drug controllers of each state and Union Territory to ensure that formulations containing 2 mg of Chlorpheniramine Maleate and 5 mg of Phenylephrine Hydrochloride per ml bore a warning stating that they should not be used in children under the age of 4 years.
On 15 April 2025, the government published S.O. 1717(E), which also required age-specific warnings for the fixed-dose combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride. This notice is included in the list of notifications issued by CDSCO in its Official Gazette.
The most recent notification, S.O. 4595(E), issued on August 18, 2026, extends the ban to include all appropriate FDC formulations containing the two ingredients, and was published in the Official Gazette on August 21, 2026.
What Changes for Manufacturers?
Manufacturers are required to display the warning:
– Fixed Dose Combinations should not be given to children under four years of age.
– It should appear on the label, on the package insert, and in the promotional literature accompanying these medicines.
– It came into effect from the date on which it was published in the Official Gazette. What Should Parents Know?
– Parents and caregivers ought to refrain from giving these specific fixed-dose combinations to children who are under four years of age.t is also important to check the active ingredients on medicine packaging rather than relying only on a brand name, since different products can contain different combinations.
– It is advisable for parents to consult a pediatrician or other qualified medical professional before giving cold remedies to very young children, especially if the symptoms persist or worsen.
The fact is that the new rule doesn’t prohibit all treatments for a child’s cold; it rather focuses on fixed-dose combinations that contain both Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
A Wider Focus on Pediatric Drug Safety
The most recent notification is an extension of regulations that started many years ago and expands the safety warning to apply to a wider variety of formulations.
For parents, the key message is simple:
A child under four years of age should not be given a medicine that contains both Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
This action is part of India’s initiative to improve the safety of drugs for children by providing parents, pharmacists, doctors, and manufacturers with more clear instructions on medicines intended for young children.
