Government restricts Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four

The Union Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age. The order was issued under Section 26A of the Drugs and Cosmetics Act, 1940, and it applies to all such formulations, including syrups and drops.

Fixed-dose combinations in drug regulation

A fixed-dose combination, or FDC, is a medicine that contains two or more active pharmaceutical ingredients in a single dosage form. In India, FDCs are regulated under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, for safety, efficacy and rational use. Chlorpheniramine Maleate is an antihistamine used for allergy symptoms, and Phenylephrine Hydrochloride is a nasal decongestant used in cold preparations. These ingredients are commonly found in over-the-counter cough and cold medicines.

Section 26A and statutory control

Section 26A of the Drugs and Cosmetics Act, 1940 empowers the Central Government to regulate or prohibit the manufacture, sale and distribution of a drug in the public interest. The provision is used when a drug is considered unsafe, ineffective or irrational for a specified use. The current order requires the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on medicine packs, labels, package inserts and promotional materials. The restriction is age-specific and does not amount to a blanket prohibition on all cough and cold medicines.

Regulatory bodies and safety review

The decision followed assessment by an Expert Committee and consideration by the Drugs Technical Advisory Board, or DTAB. The Central Drugs Standard Control Organisation, or CDSCO, is the national regulator that oversees drug approval, quality control and enforcement in India. The order expands an earlier notification dated 15 April 2025 that had restricted specific formulations containing the same ingredients. It also follows earlier action in June 2026, when 16 other irrational fixed-dose combinations for human use were banned.

Important Facts for Exams

• Section 26A of the Drugs and Cosmetics Act, 1940 allows the Central Government to prohibit a drug in public interest.
• Fixed-dose combinations are medicines that combine two or more active ingredients in one formulation.
• DTAB stands for Drugs Technical Advisory Board, which advises the government on drug-related technical matters.
• CDSCO stands for Central Drugs Standard Control Organisation, the national drug regulatory authority of India.

Pediatric drug safety

Children under four years of age are covered by the new restriction on these cough and cold formulations. The mandatory warning applies to all relevant packaging and promotional material from the date of publication in the Official Gazette.