The country’s apex health regulatory agency, the Central Drugs Standard Control Organisation (CDSCO), has decided to ban the use of a popular anti-cold cocktail medicine combination among infants and children below four years of age. 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 literature 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.