Under the new requirement, manufacturers must prominently carry a warning stating that these combinations must not be used in children below four years of age.
The latest decision expands an earlier restriction issued by the Government through its notification dated April 15, 2025 [S.O. 1717(E)], which covered specified FDCs containing the two ingredients. The new notification brings all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride under the age-specific safety requirement.
The decision follows recommendations made by an Expert Committee and the Drugs Technical Advisory Board (DTAB). The Government has noted concerns regarding the use of these combinations in children below four years and has also taken into account the availability of safer alternatives.
As part of the new directions, pharmaceutical manufacturers will be required to clearly display the warning:
“Fixed Dose Combination shall not be used in children below four years of age.”
The warning must appear on the product label, package insert and promotional literature associated with the formulations.
The Government has issued the notification under Section 26A of the Drugs and Cosmetics Act, 1940, citing public health considerations. The restrictions will come into effect from the date of publication of the notification in the Official Gazette.
Official Gazette notification: Read the Government notification