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The Government has restricted the manufacture, sale and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, requiring a warning that these medicines shall not be used in children below four years of age.
The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, and takes effect from the date of its publication in the Official Gazette.
It follows the recommendations of an Expert Committee and the Drugs Technical Advisory Board (DTAB), which noted risks to children under four and the availability of safer alternatives.
An earlier notification dated 15 April 2025 [S.O. 1717(E)] had restricted certain such FDCs; the new notification extends the requirement to all formulations containing the two ingredients.
Manufacturers must display the warning 'Fixed Dose Combination shall not be used in children below four years of age' on the label, the package insert and all promotional literature.
A Fixed Dose Combination is a formulation containing two or more active pharmaceutical ingredients combined in a fixed ratio within a single dosage form - one tablet, one capsule, one spoonful of syrup. FDCs have genuine uses: they simplify complex regimens, improve adherence and, in diseases like tuberculosis and HIV, are the international standard of care. The regulatory worry is the other kind - combinations assembled for marketing convenience rather than therapeutic logic. Here the doctor cannot titrate one ingredient without moving the other, adverse effects are harder to attribute, and a child receives a second drug they may not need at all. In the case at hand, Chlorpheniramine Maleate is an antihistamine and Phenylephrine Hydrochloride is a decongestant, and the pair is common in over-the-counter cough-and-cold preparations. Very young children metabolise such ingredients differently from adults, and dosing by body weight in a fixed-ratio syrup is imprecise, which is the concern behind the under-four restriction. This is why Section 26A exists as a standing power rather than a one-off: it lets the Centre act on a combination it judges unsafe or lacking therapeutic justification without waiting for fresh legislation, and it has been used repeatedly against FDCs.
Simple Analogy: An FDC is a set menu rather than an a la carte order. Convenient when the whole meal suits you - a problem when you needed only one dish and cannot send the rest back.
Empowers the Central Government, if satisfied that the use of a drug or cosmetic is likely to involve risk to human beings or animals, or that a drug lacks the therapeutic value claimed for it or contains ingredients without therapeutic justification, to regulate, restrict or prohibit its manufacture, sale or distribution in the public interest, by notification in the Official Gazette. This is the provision the present restriction rests on and the one routinely used against unsafe Fixed Dose Combinations. Contravention of a Section 26A notification attracts imprisonment of up to three years along with a fine.
Constitutes the Drugs Technical Advisory Board (DTAB) to advise the Central and State Governments on technical matters arising out of the administration of the Act. The DTAB's recommendation, alongside that of an Expert Committee, preceded this notification.
The parent legislation regulating the import, manufacture, distribution and sale of drugs and cosmetics in India. It is administered centrally through the Central Drugs Standard Control Organisation and enforced on the ground by State Drug Controllers, so a Central notification of this kind is executed through state licensing authorities.
A Section 26A restriction takes legal effect from the date the notification is published in the Official Gazette, not from the date of the press release - a distinction worth noting when a question asks when a restriction became operative.
India's National Regulatory Authority for drugs, cosmetics and medical devices. It approves new drugs and clinical trials, sets standards and coordinates the work of state drug control organisations. It functions under the Directorate General of Health Services, Ministry of Health and Family Welfare, and operates six zonal offices, four sub-zonal offices, thirteen port offices and seven laboratories.
The highest statutory body on technical matters relating to drugs in India, constituted under the Drugs and Cosmetics Act, 1940 to advise the Central and State Governments. Restrictions and bans on Fixed Dose Combinations characteristically travel through DTAB before notification. It comprises ex-officio and nominated members.
Heads CDSCO; responsible for approval of new drugs, clinical trials and licensing of certain drug categories, and serves as Member Secretary of the DTAB.
The technical arm of the Ministry of Health and Family Welfare, under which CDSCO functions; the DGHS chairs the DTAB.
Section 26A has been the standing instrument for action against irrational Fixed Dose Combinations, and litigation over such notifications has repeatedly turned on whether the statutory advisory process - Expert Committee and DTAB - was followed. That is why the release names both.
Irrational FDCs, particularly those bundling antibiotics, are a recognised driver of resistance, which is why India's drug regulator scrutinises combination products more closely than single-ingredient drugs.
CDSCO approves and notifies at the Centre, but licensing of manufacture and sale, and enforcement against a defaulting manufacturer, run through State Drug Controllers - a standard example of a cooperative-federalism regulatory design.
Children are not small adults pharmacologically; dosing by body weight in fixed-ratio syrups is imprecise, and age-band restrictions of this kind are the regulator's usual response.
GS Paper 2 > Governance > Statutory and Regulatory Bodies; Social Justice > Health
General Awareness > Acts, Bodies and Current Affairs
General Awareness > Government Bodies
The Drugs and Cosmetics Act, CDSCO and DTAB recur in UPSC Prelims governance questions and in SSC general awareness whenever a drug ban or restriction is in the news.
A formulation containing two or more active pharmaceutical ingredients in a fixed ratio in a single dosage form.
The Central Government's power to regulate, restrict or prohibit the manufacture, sale or distribution of a drug or cosmetic in the public interest, by Gazette notification.
Drugs Technical Advisory Board - the highest statutory technical advisory body on drugs, constituted under the Drugs and Cosmetics Act, 1940; chaired by the DGHS with the DCGI as Member Secretary.
Central Drugs Standard Control Organisation, India's National Regulatory Authority for drugs, headquartered at FDA Bhawan, Kotla Road, New Delhi, functioning under the DGHS in the Ministry of Health and Family Welfare.
Drugs Controller General of India, the head of CDSCO and Member Secretary of the DTAB.
An antihistamine widely used in cough-and-cold preparations.
A decongestant commonly combined with antihistamines in cold formulations.