Saturday, 22 August 2026
The Central Government has introduced stricter safety measures for medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, making it clear that these fixed-dose combinations must not be used for children below four years of age.
Under the latest Health Ministry notification, manufacturers of all formulations containing the two ingredients have been instructed to carry a prominent warning stating that the combination “shall not be used in children below four years of age.” The warning must appear on the product label, package insert and promotional material.
Decision Follows Expert Review
The government said the decision was taken after recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB). Authorities have flagged potential risks associated with the use of these combinations in very young children, while noting that safer alternatives are available.
The latest action builds on restrictions introduced in April 2025, which applied to certain formulations containing the same ingredients. The new notification extends the age-specific warning requirement to all such formulations.
Part of Wider Drug Safety Measures
The move comes amid increased regulatory scrutiny of fixed-dose combinations, commonly known as FDCs. These medicines contain two or more active ingredients in a single formulation.
In June this year, the government also prohibited the manufacture, sale and distribution of 16 FDC medicines for human use following recommendations from the relevant expert and regulatory bodies.
What the New Rule Means
The latest measure specifically targets the use of Chlorpheniramine Maleate and Phenylephrine Hydrochloride combinations in children below four years. Drug manufacturers must ensure that the age-related warning is clearly visible wherever the product information is provided.
The government says the measure is aimed at protecting young children and encouraging the use of safer treatment options where appropriate.
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health.
In essence, the Centre has strengthened safeguards around these commonly used drug combinations, putting a clear age restriction on their use in children below four.
