“Crucial Measures: India Bans Cold Syrups for Children Under 4, Pharma Companies Instructed to Add Warning Labels”
“Crucial Measures: India Bans Cold Syrups for Children Under 4, Pharma Companies Instructed to Add Warning Labels”
Child Safety Alert: India Bans Certain Cough Syrups for Young Children, Pharma Companies Instructed to Add Warnings
Govt Bans Common Cold And Flu Syrups For Kids Below 4 Yrs, Asks Pharma Companies To Insert Warnings | Check List
Pharma firms manufacturing GlaxoSmithKline’s T-Minic Oral Drops, Glenmark’s Ascoril Flu Syrup, and IPCA Laboratories’ Solvin Cold Syrup, among others, have been asked by the regulator to insert a ‘warning’
New Delhi: Following the deaths of at least 141 children worldwide connected to cough syrups, The Drug Controller General of India (DCGI) has banned the use of an anti-cold medication combination in children under the age of four and mandated that drugs be labelled appropriately. The DCGI wrote a letter to all states and asked states and Union Territories to update the package insert of products made using a cocktail of two medicines chlorpheniramine maleate and phenylephrine.
According to a report in news18, Pharma firms manufacturing GlaxoSmithKline’s T-Minic Oral Drops, Glenmark’s Ascoril Flu Syrup, and IPCA Laboratories’ Solvin Cold Syrup, among others, have been asked by the regulator to insert a ‘warning’.
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 liter ature of the drug”.
According to Indian authorities, using cough syrups made in the country in 2019 resulted in at least 12 child deaths and four severely disabled children. The deaths have clouded the quality of exports from India, which is known as the “world’s pharmacy” because of its abundant supply of inexpensive life-saving medications.
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.
The fixed drug combination comprises chlorpheniramine maleate and phenylephrine – medication that is often used in syrups or tablets to treat common cold symptoms. The World Health Organization does not recommend the use of over-the-counter cough syrups or medicines for the treatment of coughs and cold symptoms in children younger than five years of age.
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.
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. India. Com
(JKNEWS NATION)
