The Union ministry of health and family welfare on Saturday announced that it has banned Fixed Dose Combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride for use in children below four years of age.
The decision has been taken following the recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB). The Drugs Technical Advisory Board (DTAB), which advises the ministry’s drugs regulatory authority—the Central Drugs Standard Control Organisation (CDSCO)—constitutes an expert committee to examine various FDCs and identify those that are “irrational, lack therapeutic justification or may pose risks to human health. Based on the scientific assessment and recommendations of the expert committee, the government then takes action.
The government in 2016 announced a ban on 344 FDCs following recommendations from an expert panel. Between 2023 and 2025, a total of 205 FDCs were banned as part of the exercise to phase out unapproved fixed-dose combination drugs from the Indian market. Many of the FDCs banned over the years were also among those 344 drug combinations.
“The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and is effective from the date of its publication in the Official Gazette,” it added.
