New Delhi: The government last week prohibited the use of certain cough syrup brands for those below four years of age, citing safety issues.
The drug regulator has asked manufacturers to clearly mention warnings on the labels and package inserts.
The drugs, widely prescribed and sold under various brand names, include Ascoril Flu Drops and some variants of Alex by Glenmark, T-Minic sold by Haleon (formerly GlaxosmithKline), and Maxtra (Zuventus healthcare), among others.
According to the notification, the sale of all formulations of fixed dose combinations (FDC) of chlorpheniramine maleate and phenylephrine hydrochloride have been restricted for sale, manufacture and distribution, subject to a condition that the manufacturers will mention the warning "fixed dose combination shall not be used in children below four years of age" on the label and package insert or the promotional literature of the drug, the notification dated April 15 said.
The decision comes after the Drugs Technical Advisory Board (DTAB), India's apex drug body and Subject Expert Committee, examined the FDC and recommended that all formulations of the same combination should be prohibited for use in children below four years of age.
The "banned" FDC is a common used formulation found in many over-the-counter (OTC) medicines and syrups used to treat cold and allergy.
Chlorpheniramine maleate and phenylephrine hydrochloride are a combination medication used to relieve symptoms of allergies and cold. Chlorpheniramine is an antihistamine that reduces allergic reactions. Phenylephrine is a decongestant that shrinks blood vessels and relieves stuffiness in the nose.
"The Central government is satisfied that it is necessary and expedient in public interest to regulate by way of restriction, the manufacture for sale and distribution for human use of the said drug in the country," said the notification. ET has seen a copy of the notification.
A Glenmark spokesperson said the company has already initiated the necessary label updates. "We remain committed to ensuring patient safety and regulatory adherence," the spokesperson said in a statement to ET.
An industry executive said it will take some time to remove the existing products from the market and replace them with the new warning. "This notification has come as a surprise to us. The government should have given some time for this transition. How do they expect us to remove the product from the market with immediate effect as the notification says? There is utter confusion as even the strengths are not mentioned in the notification," said an executive on the condition of anonymity.
Last year, even the US Food and Drug Administration (FDA) proposed the removal of oral phenylephrine as an active ingredient in OTC medications for nasal congestion relief after they found it was ineffective.
Both Haleon and Zuventus did not respond to ET's query till the press time on Thursday.
The drug regulator has asked manufacturers to clearly mention warnings on the labels and package inserts.
The drugs, widely prescribed and sold under various brand names, include Ascoril Flu Drops and some variants of Alex by Glenmark, T-Minic sold by Haleon (formerly GlaxosmithKline), and Maxtra (Zuventus healthcare), among others.
According to the notification, the sale of all formulations of fixed dose combinations (FDC) of chlorpheniramine maleate and phenylephrine hydrochloride have been restricted for sale, manufacture and distribution, subject to a condition that the manufacturers will mention the warning "fixed dose combination shall not be used in children below four years of age" on the label and package insert or the promotional literature of the drug, the notification dated April 15 said.
The decision comes after the Drugs Technical Advisory Board (DTAB), India's apex drug body and Subject Expert Committee, examined the FDC and recommended that all formulations of the same combination should be prohibited for use in children below four years of age.
The "banned" FDC is a common used formulation found in many over-the-counter (OTC) medicines and syrups used to treat cold and allergy.
Chlorpheniramine maleate and phenylephrine hydrochloride are a combination medication used to relieve symptoms of allergies and cold. Chlorpheniramine is an antihistamine that reduces allergic reactions. Phenylephrine is a decongestant that shrinks blood vessels and relieves stuffiness in the nose.
"The Central government is satisfied that it is necessary and expedient in public interest to regulate by way of restriction, the manufacture for sale and distribution for human use of the said drug in the country," said the notification. ET has seen a copy of the notification.
A Glenmark spokesperson said the company has already initiated the necessary label updates. "We remain committed to ensuring patient safety and regulatory adherence," the spokesperson said in a statement to ET.
An industry executive said it will take some time to remove the existing products from the market and replace them with the new warning. "This notification has come as a surprise to us. The government should have given some time for this transition. How do they expect us to remove the product from the market with immediate effect as the notification says? There is utter confusion as even the strengths are not mentioned in the notification," said an executive on the condition of anonymity.
Last year, even the US Food and Drug Administration (FDA) proposed the removal of oral phenylephrine as an active ingredient in OTC medications for nasal congestion relief after they found it was ineffective.
Both Haleon and Zuventus did not respond to ET's query till the press time on Thursday.
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