India restricts Chlorpheniramine-Phenylephrine drugs for children below 4

India restricts Chlorpheniramine-Phenylephrine drugs for children below 4

Mangalore Today News Network

New Delhi, Aug 24, 2026: The Ministry of Health and Family Welfare (MoHFW) has restricted the manufacture, sale and distribution of all fixed-dose combination (FDC) drugs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, commonly used in cold and cough medicines, citing potential risks to children below four years of age.

The latest order expands an earlier restriction issued by the Centre on April 15, 2025, covering certain FDCs containing these ingredients and requiring an age-specific warning. The new order extends the restriction to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.

Chlorpheniramine is a first-generation antihistamine used to relieve symptoms associated with allergies, hay fever and the common cold, including sneezing, runny nose and itchy eyes. Phenylephrine is a decongestant, and the combination may cause side effects such as skin rashes, allergic reactions, itching, swelling of the lips, face or tongue, difficulty passing urine, heart palpitations, sudden eye pain and blurred vision.

Manufacturers have been directed to prominently display the warning: “Fixed Dose Combination shall not be used in children below four years of age” on the product label, package insert and promotional literature.

The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health, and will come into effect from the date of its publication in the Official Gazette.

The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). The DTAB concluded that restricting the manufacture, sale and distribution of such combinations for human use was necessary and expedient in the public interest.

The government accepted the board’s recommendations, noting that these combinations may pose risks to children below four years of age and that safer alternatives are available.