New Delhi: The Ministry of Health and Family Welfare has restricted the manufacture, sale and distribution of every fixed-dose combination medicine containing chlorpheniramine maleate and phenylephrine hydrochloride.
These two ingredients are commonly found in over-the-counter cough and cold syrups, for use in children below the age of four.
What these ingredients do
Chlorpheniramine maleate is an antihistamine used to ease symptoms such as sneezing and a runny nose, while phenylephrine hydrochloride is a decongestant intended to clear a blocked nose.
Pharmaceutical companies frequently combine the two into a single syrup or drop formulation marketed for children’s colds and allergies.
The regulatory trail
This latest restriction builds on ground the government had already covered.
Back in April 2025, an earlier notification (S.O. 1717(E)) had restricted only certain formulations carrying this combination. The new order widens that net to cover every formulation containing the two ingredients, regardless of brand.
The decision rests on a review by the Drugs Technical Advisory Board (DTAB), India’s top scientific advisory panel on drug regulation.
The board met in February to examine whether the combination posed risks specific to very young children. After deliberation, the board concluded that use of these formulations should not extend to children under four.
Why young children are at greater risk
Infants and toddlers metabolise medication differently from older children and adults, which makes side effects harder to predict and manage.
Antihistamines like chlorpheniramine can cause unusual drowsiness in young children, and in some cases even the opposite, restlessness or agitation, while decongestants like phenylephrine can affect heart rate and blood pressure. Regulators cited the availability of safer treatment options for cold and allergy symptoms in this age group as one reason the restriction was considered necessary.
How it will be implemented
The order was issued under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the Central Government to restrict a drug’s manufacture, sale or distribution when it is satisfied that doing so serves the public interest.
Pharmaceutical companies are now required to carry an explicit age-restriction warning on the medicine’s label, its package insert, and any promotional material for the product.
