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New Delhi: The Drug Controller General of India (DCGI) has asked the manufacturers of popular anti-flu and anti-cold combination drugs to carry a warning on these formulations against their use in infants and kids younger than four years of age.
In a notification issued on 18 December by the CDSCO (Central Drugs Standard Control Organisation), the DCGI head Rajeev Singh Raghuvanshi has written to drug controllers of all states and Union Territories (UT) to ensure that manufacturers of Chlorpheniramine Maleate and Phenylephrine must put a warning on the products which are not to be prescribed for infants and children below the age of four.
The letter read that manufacturers should “mention warning ‘Fixed Dose Combination (FDC) should not be used in children below four years age’ on label and package insert/promotional literature of the drug”.
The regulator, in the letter, mentioned that “The FDC of Chlorpheniramine Maleate IP 2mg+Phenylephrine HCI IP 5mg drop per ml was declared as rational by Prof. Kokate 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.”
Earlier in June, the government had banned 14 such FDC drugs, citing that there is no therapeutic justification for these medicines. A fixed dose combination is the combination of two or more drugs in certain fixed dosage combinations. If it were combined for the first time, it would fall under the definition of a new drug.
“Subsequently, concerns have been raised regarding the promotion of unapproved anti-cold drug formulations for infants,” the letter said.
The Subject Expert Committee (SEC) reviewed the combination of these two medications earlier in June in response to new concerns.
Finally, on 6 June, the Subject Expert Committee (Pulmonary) ruled, after carefully examining the drug’s usage in light of the concerns raised, that children under the age of four should not take the combination.
Noting this, DCGI has now decided that based on the recommendations of the SEC, manufacturers should “mention warnings in this regard on label and package insert and accordingly, the firms should mention a warning in this regard on label and package insert.”
“Accordingly, you are requested to direct all the manufacturers of said FDC under your jurisdiction to mention warning ‘FDC should not be used in children below four years of age’ on label and package insert/promotional literature of the drug,” it read.
Chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes, cough, runny nose, and sneezing. Phenylephrine too serves the same purposes such as temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (such as sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.
Pharma companies such as Glaxo SmithKline Pharmaceuticals Ltd., Glenmark Pharmaceuticals Ltd., and Ipca Laboratories Ltd will now have to change the packaging.
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Published: 20 Dec 2023, 10:29 PM IST
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