Chlorpheniramine–Phenylephrine FDCs Banned
The Union Ministry of Health and Family Welfare has extended restrictions on all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age. The latest notification for restrictions on Chlorpheniramine Phenylephrine FDC was issued under Section 26A of the Drugs and Cosmetics Act, 1940, following recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB).
What are Fixed-Dose Combinations?
A Fixed-Dose Combination (FDC) is a medicine containing two or more active pharmaceutical ingredients in a single dosage form. FDCs are used for conditions where combining medicines can provide therapeutic benefits, but their safety and rationality must be assessed carefully.
The restricted combination contains:
- Chlorpheniramine Maleate – an antihistamine commonly used for allergy-related symptoms.
- Phenylephrine Hydrochloride – a decongestant used to relieve nasal congestion.
The latest notification extends the earlier 15 April 2025 restriction to all formulations containing the two ingredients.
Section 26A of Drugs and Cosmetics Act
Section 26A empowers the Central Government to regulate or prohibit the manufacture, sale or distribution of a drug in the public interest.
In this case, the government stated that these combinations could involve risks for children below four years and that safer alternatives were available. The Expert Committee examined the additional formulations, while the DTAB considered the proposal on 16 February 2026 before recommending the restriction.
Manufacturers must prominently carry the warning:
“Fixed Dose Combination shall not be used in children below four years of age.”
The warning must appear on the label, package insert and promotional literature associated with the formulations.
Regulatory Institutions
The decision highlights the role of India’s drug-regulatory framework:
- Ministry of Health and Family Welfare: Responsible for central health and pharmaceutical policy.
- CDSCO: India’s national regulatory authority for drugs and medical devices.
- DTAB: Provides technical advice to the Central Government on matters under the Drugs and Cosmetics Act.
- Expert Committees: Examine scientific and safety aspects of medicines and formulations.
Important Facts for Exams
- Act involved: Drugs and Cosmetics Act, 1940.
- Relevant provision: Section 26A.
- Restricted combination: Chlorpheniramine Maleate + Phenylephrine Hydrochloride.
- Age group: Children below four years.
- Earlier notification: 15 April 2025.
- Latest notification: August 2026.
- DTAB: Drugs Technical Advisory Board.
- CDSCO: Central Drugs Standard Control Organisation.
- FDC: Fixed-Dose Combination.
- The latest order extends the restriction to all formulations containing the specified two ingredients rather than constituting a blanket ban on all cough-and-cold medicines.
Exam takeaway: This is an example of public-health regulation under Section 26A, where the Central Government can restrict a drug based on safety concerns and expert regulatory advice.
