The independent advisory committee of the US drug regulator Food and Drug Administration (FDA) has unanimously declared that phenylephrine, a commonly used ingredient in cough and cold medications, is ineffective.
Phenylephrine, which is intended to relieve nasal symptoms caused by colds and allergies, has been a component of over-the-counter cough and cold drugs for the past 50 years.
It is the most frequently encountered ingredient in these medications, accounting for $1.8 billion in sales in the US in just one year.
This ingredient is present in various combinations of cough and cold medications, including well-known brands such as Vicks and Tylenol in the US.
In India, leading pharmaceutical companies incorporate phenylephrine into commonly manufactured drugs. Examples include Asoril Flu by Glenmark, Wikoryl AF by
Alembic, and T Minic by
GSK.
Experts do not anticipate an immediate reaction, as the FDA panel has not raised safety concerns.
Additionally, alternatives to this ingredient may be limited. For instance, pseudoephedrine is an alternative, but it has its own limitations due to concerns about consumer misuse.
While the committee's recommendation is not binding, the next actions taken by the USFDA will be closely monitored.
If the FDA were to revoke its designation of phenylephrine as safe and effective, companies might be required to withdraw medications containing this ingredient from the market.
Back home in India, such a step might prompt the Drug Controller General of India (DCGI) to conduct its own research. However, experts believe that the impact would be
limited unless the Indian drug regulator issues a warning against the ingredient, leading to informed consumers refraining from purchasing medications containing it.
