Government Tightens Curbs On Cough-Cold Drug Combinations For Children Under Four

The Centre has tightened restrictions on fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride, directing manufacturers to ensure that these medicines are not used in children below four years of age.

The move is aimed at protecting young children from the potential risks associated with the use of these drug combinations, particularly when safer alternatives are available.

The government, through a notification issued on Saturday, said the restriction would apply to all FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride. Manufacturers have also been directed to prominently carry an age-specific warning on the label, package insert and promotional material.

The mandatory warning will state: “Fixed Dose Combination shall not be used in children below four years of age.”

The latest order expands an earlier restriction issued in April 2025, which covered certain FDCs containing the two ingredients. The government has now extended the requirement to all formulations containing the combination.

The decision follows recommendations of an Expert Committee and the Drugs Technical Advisory Board (DTAB), which examined the safety of these combinations in young children.

The government said the use of such formulations could pose risks to children below four years and noted that safer alternatives are available.

The restriction has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the government to regulate or prohibit the manufacture, sale or distribution of a drug or formulation in the public interest.

Chlorpheniramine maleate is an antihistamine commonly used to relieve allergy-related symptoms such as a runny nose and sneezing, while phenylephrine is a decongestant used to reduce nasal congestion. The two ingredients are found in several combination medicines used for cold and respiratory symptoms.

The government's latest action highlights the growing concern over the use of multiple-ingredient medicines in young children, particularly when symptoms may often be managed through simpler and safer approaches.

FDCs combine two or more active pharmaceutical ingredients in a single dosage form. While such combinations can be useful in specific clinical situations, their use in children requires particular caution because children may respond differently to medicines and dosing errors can have greater consequences.

The latest notification does not amount to a blanket ban on the individual ingredients. Instead, it places an age-specific restriction on FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride, with manufacturers required to make the restriction clearly visible to consumers and healthcare professionals.

The government's decision also puts the onus on manufacturers to ensure that the warning is not buried in fine print. The age restriction will have to appear on the product label, package insert and promotional literature.

The move comes amid continuing efforts by drug regulators to strengthen safeguards around medicines used in children. In recent years, concerns over inappropriate prescribing, self-medication and the use of certain cough and cold preparations in young children have prompted greater scrutiny of paediatric formulations.

For parents, the notification reinforces a simple message — medicines for cough, cold and allergy symptoms should not be given to very young children without appropriate medical advice.

With the latest notification, manufacturers of affected formulations will have to ensure compliance with the new requirement. The government has said the restriction has been introduced “in the interest of public health”, particularly to safeguard children below four years of age.