The Union health and family welfare ministry has restricted the manufacture, sale and distribution of all fixed-dose combinations containing chlorpheniramine maleate and phenylephrine hydrochloride for use in treating the common cold in infants and young children below four years of age, in India’s ₹4,500 crore cough, cold and anti-allergic retail market.
The regulatory action follows safety recommendations from an expert committee and the Drugs Technical Advisory Board, against the backdrop of toxic syrup tragedies linked to contamination with diethylene glycol and ethylene glycol. Mint explains:
What is the clinical reason behind barring this combination for infants and young children?
Chlorpheniramine maleate is a first-generation antihistamine, while phenylephrine hydrochloride acts as a vasoconstrictor and nasal decongestant. Fixed-dose formulations combining the two prevent independent dose adjustment of either ingredient. In children under four, hepatic metabolism and renal clearance can vary widely. The expert panel concluded that this inability to adjust individual doses poses significant toxicity risks without demonstrating greater therapeutic benefits than single-agent therapies.
What specific health hazards and adverse reactions do these compounds trigger in pediatric patients?
Chlorpheniramine can cause central nervous system depression, lethargy, respiratory depression, paradoxical excitability and seizures in infants and young children. Phenylephrine carries cardiovascular risks, including acute hypertension, cardiac arrhythmias and tachycardia. With fixed-dose combinations, accidental overdosing or double-dosing can occur, potentially leading to severe toxicity, hallucinations and loss of consciousness.
“This measure could significantly contribute to improving the safety of drugs in young children. For Children, drugs used to treat cough, cold, and allergy symptoms need to be administered with utmost caution. Combination drugs can lead to exposure to certain chemicals, which might be unnecessary in such cases and might even lead to side effects,” said Dr Shruti Kainth, senior consultant-obstetrics and gynecology, Cocoon Hospital, Chandigarh.
How does India's regulatory action align with international medical practice?
The decision aligns domestic regulations with standards set by the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency and the World Health Organization. Major global regulators advise against or prohibit over-the-counter multi-ingredient cough and cold formulations for children under four to six years of age, citing a lack of evidence of clinical efficacy and documented risks of severe adverse events and fatal overdoses.
What is the market size and corporate footprint of these formulations in India?
India’s overall cough, cold and anti-allergic retail market is valued at over ₹4,500 crore annually, with paediatric drops and syrups accounting for hundreds of crores in sales, according to data from the All India Organisation of Chemists and Druggists and IQVIA.
The market includes formulations from major pharmaceutical companies such as Mankind Pharma, Glenmark Pharmaceuticals, Cipla and Zydus Lifesciences. The restriction directly affects these generic syrups, oral drops and trade formulations sold across the country.
What operational requirements must pharmaceutical companies and healthcare providers follow?
Drug manufacturers must immediately print the warning, “Fixed-dose combination shall not be used in children below four years of age”, on all labels, package inserts, and promotional literature. Companies and distributors cannot market these products for infant or toddler use.
For children under four years presenting with upper respiratory symptoms, clinical protocols shift to single-ingredient antipyretics such as paracetamol for fever, normal saline nasal drops for congestion, and standard oral hydration.