Published Aug 23, 2026 | 10:37 PM ⚊ Updated Aug 23, 2026 | 10:37 PM
Cough Syrup. Representational image. (iStock)
Synopsis: The Union Health Ministry has restricted the manufacture, sale and distribution of fixed-dose cough-and-cold drug combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, citing risks to children below four years of age. Manufacturers must now carry a clear warning stating that the medicines should not be used in children under four on labels, package inserts and promotional material.
The Union Ministry of Health and Family Welfare has restricted the manufacture, sale and distribution of all formulations of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, citing the potential risk they pose to children below four years of age.
Under the notification issued on 18 August, manufacturers of these formulations must carry the warning: “fixed dose combination shall not be used in children below four years of age” on the drug label, package insert or promotional literature.
The restriction has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, and came into force from the date of publication in the Official Gazette.
The latest order follows an earlier notification issued by the government on 15 April 2025, which had imposed a similar restriction on formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
According to the Health Ministry, the government was satisfied that the use of other FDCs containing the two ingredients was likely to involve risks to children below four years of age.
The notification states, “the Central Government is satisfied that the use of other drug fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride is likely to involve risk to children below four years of age and whereas safer alternatives to such drugs are available.”
An Expert Committee constituted by the Ministry examined FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride and recommended extending the same warning to all such formulations manufactured or imported and marketed in India.
The notification states that the committee “further recommended that the same warning should be applicable on all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride manufactured or imported and marketed in India.”
The proposal was subsequently examined by the Drugs Technical Advisory Board (DTAB), which considered the matter at its meeting on 16 February 2026.
The notification said the DTAB examined the proposal “to restrict the manufacture for sale or for distribution of all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride”, in addition to the restriction imposed through the 15 April 2025 notification.
Following detailed deliberations, the Board agreed that the formulations should not be used in children below four years.
The government said the DTAB had concluded that “such formulations shall not be used in children below four years of age.”
Based on the Board’s recommendations, the government said it was necessary to regulate the manufacture, sale and distribution of these formulations in the public interest.
