New Delhi: The Central Government has tightened restrictions on medicines containing the fixed-dose combination (FDC) of Chlorpheniramine Maleate and Phenylephrine Hydrochloride, directing manufacturers to clearly warn that such formulations must not be used in children below four years of age.
The decision, announced by the Ministry of Health and Family Welfare, applies to the manufacture, sale and distribution of all FDC formulations containing the two ingredients.
The latest notification expands the scope of an earlier government order issued on April 15, which had imposed similar restrictions on certain combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
Why Has The Government Restricted These Medicines For Children?
The decision follows recommendations made by an Expert Committee and the Drugs Technical Advisory Board (DTAB).
According to the government, the use of these fixed-dose combinations may pose risks to children younger than four, while safer alternatives are available.
Chlorpheniramine Maleate is an antihistamine used to provide relief from allergy-related symptoms, while Phenylephrine Hydrochloride is a decongestant commonly found in formulations used for symptoms such as nasal congestion.
The restriction does not amount to a blanket ban on these formulations. Instead, it specifically requires that they not be used for children below four years of age.
What Warning Will Medicine Labels Carry?
Drug manufacturers have been directed to prominently carry the following warning:
“Fixed Dose Combination shall not be used in children below four years of age.”
The warning must be displayed on the medicine label, package insert and promotional literature related to the affected formulations.
The measure is intended to ensure that parents, caregivers and healthcare professionals are clearly informed about the age restriction before the medicine is administered.
New Rule Comes Into Effect Immediately
The latest notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the government to regulate or prohibit drugs when considered necessary in the interest of public health.
The restriction comes into force from the date of its publication in the Official Gazette.
The move broadens the April 15 notification by bringing all fixed-dose formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride under the age-specific warning requirement.
Parents and caregivers should check the composition and label of cold or allergy medicines before giving them to young children and seek guidance from a qualified healthcare professional when medication is required.
