The Union government has restricted the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age, citing potential safety risks and the availability of safer alternatives.
The Health Ministry's notification requires manufacturers to carry a clear age-specific warning on the medicines. The government said the decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB).
The latest move applies to all FDC formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride when intended for children below four.
The government has directed that these combinations should not be used in this age group. The restriction covers their manufacture, sale and distribution, with the notification issued in the interest of public health under Section 26A of the Drugs and Cosmetics Act, 1940.
The notification takes effect from the date of its publication in the Official Gazette.
Warning Mandatory On Packs
Manufacturers have been instructed to prominently display the warning:
“Fixed Dose Combination shall not be used in children below four years of age.”
The warning must appear on product labels, package inserts and promotional literature associated with the affected formulations.
The requirement is intended to make the age restriction clear to consumers, healthcare professionals and others handling the medicines.
Two Ingredients Under Review
Chlorpheniramine Maleate is an antihistamine commonly used in medicines for allergy-related symptoms, while Phenylephrine Hydrochloride is a decongestant used to relieve nasal congestion.
The government's latest action specifically concerns fixed-dose combinations containing both ingredients. It should not be interpreted as a blanket ban on every medicine containing either ingredient individually.
The government said the combinations may pose risks to children below four and that safer alternatives are available.
Earlier Order In 2025
The latest notification expands an earlier government restriction.
According to the official government communication, a notification dated April 15, 2025, had already imposed an age-specific restriction on certain FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. The latest decision extends the requirement to all formulations containing the two ingredients.
The government has therefore broadened the regulatory coverage rather than introducing the issue for the first time.
Expert Panel Recommendations
The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board.
The government said the assessment considered the potential risks associated with the combinations in children below four and the availability of safer alternatives.
The action is part of the government's wider scrutiny of fixed-dose combinations to ensure that medicines available in the country have appropriate safety and therapeutic justification.
Wider FDC Safety Review
The latest restriction comes after another significant regulatory action earlier this year.
In June 2026, the Ministry of Health and Family Welfare prohibited the manufacture, sale and distribution of 16 FDC medicines for human use following a review of their safety and therapeutic justification. The government said that action also followed recommendations from an Expert Committee constituted under the DTAB framework.
The government has continued to emphasise rational medicine use and patient safety as part of its FDC review process.
What Parents Should Know
The latest order specifically establishes that FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride should not be used in children below four years.
Parents and caregivers should not assume that a medicine is suitable for a young child merely because it is marketed for cough, cold or allergy symptoms. Medication for children should be used according to the advice of a qualified healthcare professional.
The new warning requirement is intended to make the age restriction clearly visible on affected medicines.
WHAT THE ORDER MEANS
The government has not announced a blanket ban on all cough-and-cold medicines. Instead, the new notification restricts the manufacture, sale and distribution of FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years.
The key change is that the age-specific restriction now applies to all formulations containing the two ingredients, following the earlier 2025 restriction on certain formulations.
Manufacturers must clearly communicate the restriction through labels, package inserts and promotional material.
HEALTH TAKEAWAY
The Union government's latest drug-safety action places tighter controls on Chlorpheniramine Maleate and Phenylephrine Hydrochloride FDCs for children below four years.
The Health Ministry said the decision was taken because these combinations may pose risks to young children and safer alternatives are available. The move follows recommendations from an Expert Committee and DTAB and has been issued under Section 26A of the Drugs and Cosmetics Act, 1940.
Primary Source: Press Information Bureau (PIB), Government of India
Official Drug-Regulator Reference: CDSCO – FDC Information
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