DGCI issued a letterto all states, directing them to update the package inserts for products containing the combination of chlorpheniramine maleate and phenylephrine.
Published Dec 21, 2023 | 12:19 PM ⚊ Updated Dec 21, 2023 | 12:19 PM
Doctors advice consulting with a paediatrician before giving a child any medication. (Creative Commons)
The Drugs Controller General of India (DCGI), the nation’s regulatory authority for pharmaceuticals, has banned the administration of a combination of anti-cold drugs in children under the age of four.
The regulatory body issued a letter on Monday, 18 December, to all states, directing them to update the package inserts for products containing the combination of chlorpheniramine maleate and phenylephrine.
The official order regarding this fixed-drug combination (FDC), disclosed on Wednesday, mandates that drug manufacturers must prominently label their products with a warning against the use of the FDC in children under the age of four.
According to the letter, “FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop/ml was declared as rational by the Prof Kokate Committee and based on the recommendation of the committee, this office has issued an NOC for continued manufacturing and marketing of subject FDC on 17 July 2015, under the 18 months policy decision.”
This directive has been issued in response to the unfortunate deaths of at least 141 children worldwide that have been associated with cough syrups.
The regulatory authority highlighted concerns regarding the promotion of an unapproved formulation of an anti-cold drug in infants. Following discussions on this matter, a recommendation was made to discourage the use of this particular drug combination in the specified age group.
The letter further stated that the concern has come to their notice after the promotion of unapproved anti-cold drug formulation for infants. “Subsequently, concerns have been raised regarding promotion of unapproved anti-cold drug formulation for infants. The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on 6 June 2023, wherein, in light of the issue regarding the use of the FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml was discussed before the committee.”
“The committee recommended that the FDC should not be used in children below four years of age and accordingly, the firms should mention warning in this regard on label and package insert,” the letter read.
The letter stated that the decision has been taken after the recommendation of the SEC and it has been directed to all the manufacturers to issue a clear warning — FDC should not be used in children below 4 years of age — on the label and package insert/promotional literature of the drug.
“This directive is a response to India’s efforts to learn from a series of child fatalities since 2019, which authorities have attributed to toxic cough syrups manufactured within the country,” it further stated.
These incidents include at least 141 deaths reported in Gambia, Uzbekistan, and Cameroon since the middle of the last year. Domestically, Indian authorities have reported that, in 2019, at least 12 children lost their lives and four others suffered severe disabilities after consuming cough syrups produced within the country.
These tragic events have raised concerns about the quality of pharmaceutical exports from India, often recognised as the “world’s pharmacy” for its provision of life-saving medications at affordable prices.
Notably, the World Health Organization (WHO) does not endorse the use of over-the-counter cough syrups or medications for treating coughs and cold symptoms in children below five years of age.
Taking proactive measures, India has implemented mandatory testing for cough syrup exports since June and has intensified scrutiny of pharmaceutical manufacturers.
