Updated December 20th, 2023 at 21:23 IST
Common cold, flu syrups for children below 4 years likely to be BANNED | Deets here
"Fixed drug combination (FDC) should not be used in children below 4 years of age".
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has introduced a regulation restricting the use of anti-cold fixed drug combinations in children under the age of 4. For the unversed, this combination is used to treat symptoms associated with cold and flu, encompassing conditions such as coughing, sneezing, and watery eyes, among others.
The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has instructed drug regulators in all states and union territories to direct manufacturers of the fixed drug combination (FDC) containing Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg per drop/ml to include a warning on the label and package insert/promotional literature stating that the FDC should not be used in children below 4 years of age.
In the letter, the DCGI stated that the FDC was declared as rational by the Professor Kokate Committee and based on its recommendation, this office had issued NOC for continued manufacturing and marketing of the FDC on July 17, 2015, under the 18-month policy decision. "Subsequently concerns have been raised regarding the promotion of unapproved anti-cold drug formulation for infants," he said.
The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on June 6.
"The committee recommended that the FDC should not be used in children below four years of age and accordingly the firms should mention warnings in this regard on label and package insert. The recommendation of the SEC has been considered by this office," the letter stated.
"Accordingly, you are requested to direct all the manufacturers of said FDC under your 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 DCGI's letter dated December 18.
This comes nearly weeks after the Indian Pharmacopoeia Commission (IPC) cautioned people against the use of Meftal, a medicine used to treat menstrual cramps, rheumatoid arthritis, osteoarthritis, dysmenorrhea, mild to moderate pain, inflammation, fever, and dental pain. Meftal is a combination of two drugs, dicyclomine and mefenamic acid.
(With PTI inputs)
Published December 20th, 2023 at 21:16 IST