Daijiworld Media Network - New Delhi

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

The latest order expands an earlier notification issued by the Centre on April 15, 2025, which had restricted certain FDCs containing the two ingredients with 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, a runny nose and itchy eyes. Phenylephrine is a decongestant, and the two ingredients are commonly combined in medicines intended to provide relief from cold and allergy symptoms.

According to experts, medicines containing these ingredients can have potential side effects, including skin rashes, allergic reactions such as hives, itching and swelling of the lips, face or tongue. They may also cause difficulty in passing urine, heart palpitations, sudden eye pain and blurred vision.

Under the latest notification, manufacturers have been directed to prominently 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 the formulations.

The government issued the order under Section 26A of the Drugs and Cosmetics Act, 1940, citing public health concerns. The restriction will come into effect from the date of its publication in the Official Gazette.

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

Accepting the board's recommendations, the government noted that the use of these combinations may pose risks to children below four years of age and that safer alternatives are available.

The move is aimed at preventing potentially inappropriate use of these medicines among young children and strengthening safeguards governing the use of cold and cough formulations in the country.