The Central Drugs Standard Control Organization has banned the use of anti-cold fixed drugs in children below four years of age. Drugs Controller General of India Rajiv Raghuvanshi has informed the drug regulators of all the states and union territories regarding the package or medicine of Chlorpheniramine Maleate 2mg (chlorpheniramine maleate IP 2mg) + Phenylephrine HCL IP 5mg drop/ml (phenylephrine HCL IP 5mg drop/ml). A warning must be written on the vial. It will be clearly written in this warning that this medicine should not be given to children below 4 years of age.
DCGI had earlier found it correct
DCGI wrote in the letter that Professor Koket Committee had justified this drug combination. And on the basis of its recommendation, this office had issued NOC on 17 July 2015 to continue manufacturing and marketing under the policy decision for 18 months.
She said that after this, concerns have been raised about unapproved anti-cold drug formulations for newborn children. The matter was discussed in the Subject Expert Committee meeting on June 6.
According to the letter, the committee recommended that this drug combination should not be used in children below four years of age and accordingly the companies should give warnings on the label and package. This decision has been taken on the basis of SEC’s recommendation.
