By: IPP Bureau
Last updated : August 24, 2026 7:03 am
As per recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB, the use of these combinations may pose risks to children below four years of age
The Government has imposed restrictions on the manufacture, sale and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines must not be used in children below four years of age.
The latest notification extends an earlier restriction issued on April 15, 2025, which covered certain FDCs containing the two ingredients. The government has now brought all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride under the age-specific warning requirement.
The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB). The government said the use of these combinations may pose risks to children below four years of age and noted that safer alternatives are available.
Manufacturers have been directed to prominently display the warning “Fixed Dose Combination shall not be used in children below four years of age” on the product label, package insert and promotional literature associated with the formulations.
The restriction has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and takes effect from the date of publication in the Official Gazette.
The move strengthens regulatory safeguards around the use of combination medicines in young children and brings all FDCs containing the two specified ingredients under a uniform age-related warning.