Centre Prohibits Cold Medicine Combinations Containing Chlorpheniramine and Phenylephrine for Children Under 4
The Union Ministry of Health and Family Welfare has prohibited the manufacture, sale, and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four years of age. Manufacturers are required to prominently display the warning on medicine labels, package inserts, and promotional material.
The Union Ministry of Health and Family Welfare has issued directions prohibiting the manufacture, sale, and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four years of age.
Expert Recommendations and Safety Grounds
"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, reports Hindustan Times. Health Ministry Bans 16 Fixed Dose Combination Drugs Across Country Over Safety and Efficacy Concerns.
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.
Background and Regulatory Action
The recent directive expands prior restrictions on specific formulations containing the two ingredients to cover all FDC variations. "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. Phenylephrine hydrochloride combined with chlorpheniramine maleate is commonly prescribed to relieve cold, flu, and allergy symptoms such as runny noses and sinus congestion. ‘Cough Syrup-Linked Deaths’: Centre Denies Contamination in Cough Syrups, Calls for Rational Use in Children in Advisory to States.
While online pharmacies note that the combination helps manage symptoms, it has also been associated with side effects ranging from mild headaches and nausea to more serious adverse impacts like irregular heartbeats and anxiety. The latest action forms part of a broader regulatory push by health authorities to phase out irrational or unapproved drug combinations from the Indian market.
(The above story first appeared on LatestLY on Aug 22, 2026 03:57 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).
