India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has stated that a specific combination cold medicine should not be used for children under four and instructed manufacturers to label medicines accordingly, as reported by Reuters.
This decision follows reports of at least 141 children worldwide who died after taking cough syrups.
- The regulator banned the use of an unapproved cold medicine in infants due to concerns about its promotion.
- Issued on December 18 and disclosed on Wednesday, the regulator's order mandates drug manufacturers to include a warning on their products stating that the "FDC should not be used in children below 4 years of age."
- This fixed drug combination includes chlorpheniramine maleate (IP 2mg) and phenylephrine (IP 5mg), commonly found in syrups or tablets to alleviate cold symptoms.
- Some popular drugs containing this combination include Solvin Cough Syrup, Ascoril Flu Syrup, T-Minic Oral Drops, and others.
This decision aligns with discussions and recommendations to avoid using this combination for infants.
- The order comes in response to a series of child deaths since 2019, with at least 141 linked to toxic cough syrups, including cases in Gambia, Uzbekistan, and Cameroon.
- In India, at least 12 children died, and four faced severe disabilities in 2019 after consuming locally-made cough syrups.
- These incidents have raised concerns about the quality of drug exports from India, known as the "world's pharmacy" for supplying essential drugs at affordable prices.
The World Health Organization (WHO) advises against using over-the-counter cough syrups or medicines to treat coughs and cold symptoms in children under five years old.
Since June, India has mandated testing for cough syrup exports and increased scrutiny of drugmakers.
Companies linked to child deaths due to cough syrups have denied any wrongdoing.