RATIONALISING A COUGH SYRUP BAN IN INDIA, AND STEPS AHEAD

Paediatricians across the country have welcomed the move to restrict use of a common cold drug combination for children under the age of four and emphasised the need to not medicate unless warranted; pharmacists however, flagged confusion over whether prescriptions can be honoured and what should be done with existing stock

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Last month, the Central government restricted use of a common cold drug combination for children under the age of four, and also asked manufacturers to include a warning on the label and package insert or the promotional literature of these drugs in this regard.

This fixed drug combination (FDC), present in several popular brands of cough syrups for children, consists of chlorpheniramine maleate and phenylephrine hydrochloride. While chlorpheniramine is an antihistamine, used to relieve allergy-like conditions such as a runny nose, watery eyes and sneezing, phenylephrine is a decongestant that works by narrowing small blood vessels, providing temporary relief from inflammation.

In a gazette notification issued on April 15, the Union Ministry of Health stated that this FDC was likely to involve risk to children below four years of age and safer alternatives to this drug are available. The matter was examined by a Subject Expert Committee, following which the restrictions were imposed.

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Good news for paediatricians

For paediatricians across the country, the ban is a welcome move. Rajath Athreya, lead neonatologist and senior consultant paediatrician at Rainbow Children’s Hospital, Sarjapur Road in Bengaluru said the combination of a sedative antihistamine like chlorpheniramine maleate along with phenylephrine was irrational in the first place. “Phenylephrine, which is a decongestant, can also have effects on heart beat and blood pressure. These effects are unpredictable in young children and hence, there has been concern about the use of the drug in this age group,” he said.