Drug combination used to treat cold, allergy banned for children under four

The combination medicine is used to ease symptoms of common cold and allergies, and may cause dizziness and  dryness of the mouth, among other side effects.

A notification issued by the health ministry on 15 April directed that all formulations of this fixed-dose combination must now carry a clear warning label stating: “Fixed dose combinations shall not be used in children below four years of age."

It said this warning message must be printed on the label, package insert, and any promotional literature associated with the product.

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"The Centre is satisfied that it is necessary and expedient in public interest to regulate the manufacture, sale and distribution of this drug combination," said the official notification issued under Section 26A of the Drugs and Cosmetics Act, 1940.

This decision comes after an extensive review by the Subject Expert Committee appointed by the government, which identified potential risks to young children while confirming the availability of safer alternatives.

Experts flag side effects

Their assessment was later endorsed by the Drugs Technical Advisory Board (part of the Central Drugs Standard Control Organization), which called for regulatory action under Section 26A of the Drugs and Cosmetics Act of 1940.

Acting on these recommendations, the government has now formally restricted the use of the syrup in young children and made compliance with the new labelling condition mandatory for its continued manufacture, sale and distribution in the country.

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The move follows initial restrictions imposed in December 2023, when the use of the same drug combination was banned for children below four years.

However, the latest action aims to further strengthen compliance by requiring visible warnings on packaging to prevent misuse and protect infant health.

Misuse risk in infants

Explaining the risks to the health of children under four years from the drug combo Chlorpheniramine Maleate and Phenylephrine Hydrochloride, Dr. Dhiren Gupta, senior consultant paediatrician at New Delhi's Sir Ganga Ram Hospital, said that drowsiness, dizziness, dry mouth/nose/throat, headache, upset stomach, constipation, or sleep troubles may occur to children. “Smaller the baby, less the capacity to convey the side effects. Fixed drug combinations lead to inappropriate drug delivery," he said.

“Many companies in India are manufacturing this formulation having Chlorpheniramine Maleate + Phenylephrine Hydrochloride— it is an antihistamine and decongestant fixed-dose combination which is used to treat the symptoms of common cold, runny nose, watery eyes, sinus inflammation, throat congestion and allergies," said Uday Bhaskar, former director general of Pharmaceuticals Export Promotion Council of India, which functions under the ministry of commerce. 

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“It will not treat the cause of symptoms. It gives drowsiness. It’s a prescription medication in India and OTC (over the counter) in the USA. The stricter labelling will control medical stores not to openly sell this drug without the prescription of a doctor because it is a prescription drug and not recommended for children below four years," he added.