Loading…
The Union Health Ministry, by a gazette notification dated 18 August 2026, barred the use in children below four years of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, including syrups and drops.
The order was issued under Section 26A of the Drugs and Cosmetics Act, 1940, and follows an Expert Committee assessment considered by the Drugs Technical Advisory Board.
Every such pack must now carry the warning: 'Fixed Dose Combination shall not be used in children below four years of age', on the label, package insert and promotional literature.
It is an age-specific restriction, not a blanket ban on cough and cold medicines; it widens an order of 15 April 2025 that covered only specified formulations.
It follows the ban on 16 irrational fixed dose combinations notified on 11 June 2026.
An FDC is a medicine containing two or more active pharmaceutical ingredients in a single dosage form - one tablet, one syrup. FDCs can be rational, as in anti-tuberculosis or antiretroviral therapy where the combination improves adherence, or irrational, where ingredients are bundled without evidence that they work better together or where one ingredient adds risk without benefit. India regulates them under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, and a new FDC needs approval as a new drug. The recurring regulatory problem is that combinations already in the market must be reviewed retrospectively, which is what Section 26A action does.
Simple Analogy: A rational FDC is a set meal designed by a nutritionist; an irrational one is whatever the kitchen had left, served on a single plate and priced as a set.
Empowers the Central Government, if satisfied that it is necessary or expedient in the public interest, to regulate, restrict or prohibit the manufacture, sale or distribution of a drug - the provision behind every major FDC ban in India.
The framework governing the import, manufacture, distribution and sale of drugs, including the approval and labelling of fixed dose combinations.
The highest statutory technical body under the Act, which advises the Central Government and the states on technical matters; its consideration of the Expert Committee's findings preceded this order.
India's national drug regulator - approves new drugs and clinical trials, sets standards and coordinates enforcement with state drug controllers; functions under the Directorate General of Health Services
Statutory technical advisory body under the Drugs and Cosmetics Act, 1940 that advises the Centre and states on technical questions, including the rationality of fixed dose combinations
The Union ministry that issues prohibition and restriction notifications under Section 26A
The Centre banned 156 fixed dose combination medicines, including combinations of antibiotics, painkillers and multivitamins, after a review found health risks.
A notification restricted specified formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years.
Sixteen irrational fixed dose combinations were prohibited by gazette notification under Section 26A, following an Expert Committee finding that the available evidence did not support their rationality.
The restriction is extended to ALL formulations containing the two ingredients, with a mandatory warning on labels, package inserts and promotional literature.
GS Paper II > Issues relating to health, regulatory bodies and government policies
General Awareness > Current affairs, Acts and regulators
General Awareness > Current events of national importance
General Awareness > Regulators and public policy
A medicine containing two or more active pharmaceutical ingredients in a single dosage form.
The provision of the Drugs and Cosmetics Act, 1940 that lets the Centre regulate, restrict or prohibit a drug in the public interest.
A drug that blocks histamine action to relieve allergy symptoms - Chlorpheniramine Maleate is one.
A drug that narrows blood vessels in the nasal lining to reduce congestion - Phenylephrine Hydrochloride is one.
Drugs Technical Advisory Board, the highest statutory technical advisory body on drugs under the 1940 Act.