Govt bans FDCs with 2 cold ingredients for children under 4
Synopsis
India's Health Ministry has extended age-specific restrictions on cold and decongestant FDCs — banning all formulations combining Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four. Backed by the DTAB and an expert committee, the move is part of a Supreme Court-directed sweep that has already banned 16 irrational FDCs this year.
Key Takeaways
The Union Health Ministry restricted all FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below 4 years on 22 August .
Manufacturers must display a mandatory warning on labels, package inserts, and promotional materials for these formulations.
The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940 and is effective from the date of Official Gazette publication.
The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB) .
In June 2025 , the ministry had separately banned 16 FDC drugs found to be irrational and without sufficient scientific backing.
The broader FDC review is being conducted pursuant to directions from the Supreme Court of India .
The Union Health Ministry on Saturday, 22 August imposed restrictions on the manufacturing, sale, and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age. The move, notified under Section 26A of the Drugs and Cosmetics Act, 1940, takes effect from the date of its publication in the Official Gazette.
What the Notification Mandates
Manufacturers of these formulations have been directed to prominently display the warning — 'Fixed Dose Combination shall not be used in children below four years of age' — on the label, package insert, and all promotional literature. The government noted that safer alternatives exist for this age group and that use of such combinations may pose health risks to young children.
The latest notification extends an earlier, narrower restriction on certain FDCs containing the same two active ingredients to cover all formulations with this combination, closing a gap that had allowed some products to remain on shelves without the age-specific warning.
Expert Backing and Regulatory Process
The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), the country's apex technical body on drug regulation. The ministry stated that the restriction is being enforced in the interest of public health, consistent with the government's broader effort to rationalise the FDC landscape in India.
Notably, this action is part of a wider regulatory sweep. In June 2025, the Ministry of Health and Family Welfare had prohibited the manufacturing, sale, and distribution of 16 FDC drugs for human use nationwide. Those banned combinations — spanning dermatological products, pain-relief and antispasmodic drugs, and antibiotic-based formulations — were found to be irrational and unsupported by sufficient scientific evidence.
Supreme Court Direction Behind the Sweep
The broader FDC review traces back to directions issued by the Supreme Court of India, which called for a comprehensive examination of FDCs available in the Indian market. Acting on those directions, the DTAB constituted a dedicated expert committee to assess the safety, efficacy, and therapeutic value of various combinations — the same process that produced the current restriction on cold and decongestant medicines for toddlers.
Impact on Patients and the Pharma Industry
The restriction primarily affects over-the-counter cold and decongestant syrups widely used in paediatric settings. Parents and caregivers will need to consult a doctor for alternatives when managing cold or nasal congestion symptoms in children under four. For pharmaceutical manufacturers, the directive requires immediate label and packaging changes as well as a review of promotional materials across retail and hospital channels.
With the DTAB continuing its review of FDCs across therapeutic categories, further restrictions on other drug combinations cannot be ruled out in the months ahead.
Point of View
Narrower restriction on the same two ingredients had to be extended to 'all formulations' reveals a structural flaw: India's FDC oversight has historically allowed manufacturers to reformulate around specific prohibitions. The Supreme Court's intervention and the DTAB review process are beginning to close that gap, but the pace remains slow relative to the scale of irrational FDCs still in circulation. The real test will be enforcement at the retail and distribution level, where label-compliance checks are notoriously weak.
NationPress
22 Aug 2026
Frequently Asked Questions
Which medicines have been restricted for children below four years?
All fixed dose combinations (FDCs) containing both Chlorpheniramine Maleate and Phenylephrine Hydrochloride — commonly found in cold and decongestant syrups — have been restricted for children below four years of age. The restriction covers manufacturing, sale, and distribution across India.
Why did the government impose this restriction?
The government acted on the recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB), which found that such combinations may pose health risks to children under four and that safer alternatives are available. The decision is part of a wider Supreme Court-directed review of FDCs in the Indian market.
What must manufacturers do to comply with the new notification?
Manufacturers must clearly display the warning 'Fixed Dose Combination shall not be used in children below four years of age' on the product label, package insert, and all promotional literature. The requirement is effective from the date of publication in the Official Gazette.
How does this relate to the 16 FDC drugs banned in June 2025?
In June 2025, the Ministry of Health and Family Welfare banned 16 FDC drugs found to be irrational and lacking sufficient scientific evidence, covering dermatological, pain-relief, antispasmodic, and antibiotic categories. The current restriction is a separate but related action under the same Supreme Court-mandated DTAB review process.
Under which law has this restriction been issued?
The restriction has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the central government to prohibit or restrict the manufacture, sale, or distribution of a drug in the interest of public health.
