The Central Drugs Standard Control Organisation (CDSCO) is planning to ban a popular anti-cold cocktail medicine combination among infants and children below four years of age.
The decision comes after a Subject Expert Committee (SEC) which advises the drug regulator on matters related to drug approval and trials on pulmonary segment recommended such a measure observing that the combination should not be used in children below four years.
In a letter issued on December 18 by the DCGI Dr Rajeev Singh Raghuvanshi, all manufacturers of common cold fixed dose combination (FDC) of chlorpheniramine maleate IP 2mg with phenylephrine HCL IP 5 mg per ml drops are mandated to mention a warning to restrict the use of the combination in children below four years of age, on the label and package insert and promotional literature.
Moreover, the DCGI in a letter to all State and Union Territory drug controllers, requested to direct the manufacturers of the FDC under their jurisdiction to mention the warning “FDC should not be used in children below 4 years of age” on the label and package insert/promotional literature of the drug.
According to the letter, concerns were raised regarding promotion of unapproved anti-cold drug formulation for infants. “Action taken in this regard may be intimated to this office,” added the drug regulator.
The drug combination is taken to relieve cold and flu symptoms like watery eyes, runny nose, sneezing, and nasal or throat itching.
“The FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop per ml was declared as rational by Prof. Kokate’s committee and based on the recommendation of the committee, this office has issued No Objection Certificate (NOC) for continued manufacturing and marketing of subject FDC on 17.07.2015 under the 18 months policy decision,” said the letter, seen by Financial Express.com.
Chlorpheniramine Maleate is an antiallergic drug and Phenylephrine is a decongestant.
It is noteworthy that the popular combination is manufactured by companies like Glaxo SmithKline Pharmaceuticals Ltd’s T-Minic, Wanbury Ltd’s Coriminic, Alembic Pharmaceuticals Ltd’s Wikoryl AF, Wanbury Ltd’s Coriminic QR, Glenmark Pharmaceuticals Ltd’s Ascoril Flu, Ipca Laboratories Ltd’s Solvin Cold AF, among others. These drugmakers will have to add the warning to the package as per the DCGI directive.
Manufacturers should “mention warning ‘FDC should not be used in children below 4 years age’ on label and package insert/promotional literature of the drug”, the letter said.