The central government on Saturday issued directions prohibiting the manufacture, sale, and distribution of all combination medicines containing two specific ingredients for children under four years of age. As per the Ministry of Health and Family Welfare, all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride are prohibited for children below four years of age.
“The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB), which highlighted its potential risks for children and noted the availability of safer alternatives,” the ministry informed.
Under the latest notification, manufacturers are required to prominently display the warning: “Fixed Dose Combination shall not be used in children below four years of age” on medicine labels, package inserts and promotional material.
The latest notification expands the ban to all FDCs, following an earlier April 2025 notice imposed similar restrictions on certain formulations containing the two ingredients.
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“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,” the ministry said.
About The Restricted Ingredients
Phenylephrine hydrochloride with chlorpheniramine maleate is a combined medication to relieve cold, flu, and allergy symptoms.
Various websites dealing with online pharmacies mention that this particular combination of drugs is effective against runny nose and aids in getting proper rest, but also note several side effects, such as headaches and nausea, which are classified as mild. On the other hand, some websites mention serious adverse effects, including irregular heartbeats, anxiety, painful urination, and rash.
The ministry did not comment much on potential negative side effects of this particular combination on the health of young children. The ministry's decision followed the recommendation of a government-commissioned expert committee, which concluded that the combination of drugs was dangerous for children and that there were already alternative medications available on the market.
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The latest addition to the list of the government-banned combinations falls under the broad category of dozens of other restricted, “irrational” combinations. The ministry has terminated 50 such combinations in the last year alone, reports Economic Times.
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