Drug regulator to issue warning against Pholcodine in cough syrups

New Delhi: India's drug regulatory authority will soon be issuing a warning regarding cautious use of Pholcodine containing cough and cold remedies in the country amid concerns that they can trigger life threatening allergic reactions. Pholcodine is an opioid cough suppressant that helps mildly sedate a patient and suppress dry coughs. It is found in cough medications.

The World Health Organisation (WHO) had earlier issued a safety alert warning regulators around the world about the potential dangers of pholcodine use.

Pursuant to this, some regulatory authorities that have already withdrawn prescription and over- the-counter preparations containing Pholcodine from their markets include Therapeutic Goods Administration (TGA), Australia, the Medicines and Healthcare Products Regulatory Agency (MHRA), the United Kingdom, and the National Pharmaceutical Regulatory Agency (NPRA), Malaysia.


The matter regarding the use of Pholcodine containing cough and cold remedies and risk of perioperative was deliberated by the drug regulator's Subject Expert committee (SEC) in a meeting held last month.