NEW DELHI, India — The Government has imposed restrictions on the manufacture, sale and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, with a mandatory warning that these medicines must not be used in children below four years of age.
- Key Highlights:
- The restriction now applies to all FDC formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
- Manufacturers must display a clear warning against use in children below four years of age.
- The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board.
- The restriction has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health.
Government expands restriction on Chlorpheniramine Maleate and Phenylephrine Hydrochloride combinations
The latest government notification extends an earlier restriction on specific Fixed Dose Combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. The new requirement covers all formulations containing the two ingredients and introduces the same age-specific warning for children below four years.
The government said the decision has been taken as a health and safety measure for young children. It noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.
Mandatory warning for medicines used in children
Under the new requirement, manufacturers must clearly display the warning: “Fixed Dose Combination shall not be used in children below four years of age.”
The warning must appear on the medicine label, package insert and promotional literature associated with these formulations. This makes the age restriction a mandatory part of the information provided with the affected medicines.
The requirement applies to the manufacture, sale and distribution of all Fixed Dose Combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride covered by the latest notification.
Earlier restriction was issued in April 2025
The government had previously taken action concerning certain FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. Through a notification dated April 15, 2025, identified as S.O. 1717(E), those specified combinations were restricted subject to the same warning against use in children below four years.
The latest notification broadens the scope of that requirement. Instead of applying only to certain formulations, the warning and restriction now extend to all formulations containing the two specified ingredients.
Expert Committee and DTAB recommendations behind decision
The government said the decision was taken after considering recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB).
The assessment highlighted concerns associated with the use of these combinations in children below four years of age. The government also noted that safer alternatives are available for this age group.
The latest action therefore establishes a wider regulatory requirement for manufacturers of these Fixed Dose Combinations, with the age-specific warning required across relevant product information and promotional material.
Restriction issued under Drugs and Cosmetics Act
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940. The provision is being used in this case in the interest of public health.
The restriction becomes effective from the date of publication of the notification in the Official Gazette. Manufacturers are required to comply with the prescribed warning requirements for the affected formulations.
What manufacturers need to display
The government has specified three key locations where the age-related warning must be clearly presented for the affected combinations:
- Medicine label: The warning must be displayed on the product label.
- Package insert: The same restriction must be included in information provided with the medicine.
- Promotional literature: Associated promotional material must also carry the warning.
The prescribed wording specifically states that the Fixed Dose Combination shall not be used in children below four years of age. The requirement is intended to ensure that the age restriction is clearly communicated wherever information about these formulations is provided.
Official Gazette notification
The detailed government notification containing the regulatory order is available in the Official Gazette. The notification provides the formal basis for the restriction and its implementation.
Official Gazette PDF
The government said the measure is intended to safeguard the health and safety of young children and follows the recommendations of the Expert Committee and DTAB regarding the use of these combinations in children below four years of age.
Health information: This article reports the government’s regulatory notification and does not provide individual medical advice. Parents and caregivers should follow the instructions of qualified healthcare professionals regarding medicines for children.
Praveen Yadav is the Founder and Content Creator of The Nation Bulletin, an independent digital news platform focused on delivering timely, reliable and meaningful news from India and around the world.
