Chlorpheniramine Maleate and Phenylephrine Hydrochloride
Prelims:
Public health
Mains:
GS Paper II-
Public health
Current affairs:
The
Government has restricted the manufacture, sale and distribution of all Fixed
Dose Combinations (FDCs) containing Chlorpheniramine Maleate and
Phenylephrine Hydrochloride, requiring them to carry a clear warning that
they shall not be used in children below four years of age.
Highlights:
1.
The
Government has now mandated that all FDC formulations containing these two
ingredients must carry a warning that they shall not be used in children below
four years of age, citing potential risks and the availability of safer
alternatives.
2.
The
warning must be displayed on the:
i.
Label
ii.
Package
insert
iii.
Promotional
literature
3.
The
notification has been issued under Section 26A of the Drugs and Cosmetics
Act, 1940.
4.
Significance:
i.
The
measure seeks to strengthen the health and safety of young children.
ii.
Extending
the restriction to all formulations containing the two ingredients
creates broader and more consistent coverage.
iii.
Mandatory
warnings help communicate age-specific safety restrictions to users.
iv.
The
measure demonstrates the role of expert assessment and regulatory
intervention in ensuring the safe use of medicines.
5.
About
Chlorpheniramine Maleate and Phenylephrine Hydrochloride:
The Chlorpheniramine Maleate +
Phenylephrine Hydrochloride combination brings together an antihistamine and
a decongestant and is used for symptomatic relief of upper-respiratory
symptoms such as runny nose and nasal congestion. The Indian Pharmacopoeia
specifically contains standards for Phenylephrine Hydrochloride and
Chlorpheniramine Maleate Drops and Syrup.
Source: PIB-
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2302237®=48&lang=2