Chlorpheniramine Maleate and Phenylephrine Hydrochloride

Prelims: Current events of national and international importance| Health

Why in News?

The Union Health Ministry has tightened restrictions on FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride.

Manufacturers must carry a clear warning – “FDC shall not be used in children below four years of age.”
The restriction covers their manufacture, sale and distribution.

Fixed-Dose Combinations (FDCs) is a medicine containing two or more active pharmaceutical ingredients in a fixed proportion

In 2023, CDSCO directed manufacturers of a particular chlorpheniramine + phenylephrine formulation to carry a warning.
In April 2025, Restrictions were imposed on certain FDCs.
August 2026, Warning requirement extended to all FDCs containing the two ingredients.
Chlorpheniramine is an antihistamine. It can reduce allergy symptoms such as a runny nose and sneezing.
Phenylephrine is a decongestant, intended to relieve a blocked nose.

The present action specifically concerns the combination of these two drugs, not every medicine containing either ingredient individually.
Children vulnerability –
Young children are more vulnerable to adverse drug reactions.
Their bodies process medicines differently from adults.
Incorrect dosing can have proportionately greater consequences.
The Expert Committee and Drugs Technical Advisory Board (DTAB) found potential risks associated with these combinations.
Safer alternatives are available for managing common cold symptoms.
Rules significance – Highlights concerns over irrational or unnecessary use of multi-ingredient cold medicines in children.
It reduces the risk of accidental overdose and reinforces the importance of age- and weight-appropriate dosing.

Central Drugs Standard Control Organisation (CDSCO)

It is the national regulatory authority of India for pharmaceuticals, medical devices, and cosmetics.
Operating under – Directorate General of Health Services
Nodal ministry – Ministry of Health & Family Welfare.
Headquarters – New Delhi.
The agency is headed by the Drugs Controller General of India (DCGI).

FDC

Reference