Parents in India have been urged to exercise greater caution when giving young children medicines for cough, cold and congestion. The latest move involves fixed-dose combination (FDC) medicines containing chlorpheniramine maleate and phenylephrine hydrochloride, which the Centre has now restricted for children below four years of age. The government has directed that all such formulations carry a prominent warning stating that they "shall not be used in children below four years of age." The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), which flagged potential risks in young children and noted that safer alternatives are available.

The latest restriction is not an isolated development. It follows a series of regulatory actions involving cough and cold medicines in India since 2025, including restrictions on specific drug combinations, a nationwide advisory against cough and cold medicines for very young children, action following deaths linked to contaminated cough syrups, and a major change making syrup-based medicines prescription-only.

For parents, however, an important distinction is crucial: the latest order does not mean that every cough syrup has been banned for children under four. It specifically targets FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride.

What has the government restricted now?

The latest notification restricts the manufacture, sale and distribution of all FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride for use in children below four.

These medicines are commonly used to relieve symptoms such as a blocked or runny nose, sneezing and other cold or allergy symptoms. Chlorpheniramine is an antihistamine, while phenylephrine is a decongestant.

The government said the combination could pose risks to children below four and that safer alternatives are available. Manufacturers must display the age-specific warning on the label, package insert and promotional material.

The move also has an important history. In April 2025, the government had already restricted certain FDC formulations containing the same two ingredients, requiring manufacturers to carry the warning against use in children below four. The August 2026 notification extends the restriction to all formulations containing the combination.

Why are cough medicines under greater scrutiny?

The latest action comes after a turbulent period for cough syrups in India.

In October 2025, NDTV reported extensively on the deaths of children in Madhya Pradesh following consumption of contaminated cough syrup. The controversy also highlighted a separate safety issue: Coldrif contained chlorpheniramine maleate and phenylephrine, a combination that had already been flagged as unsuitable for children under four.

The World Health Organization subsequently issued a medical product alert identifying specific contaminated oral liquid medicines in India, Coldrif, Respifresh TR and ReLife, after diethylene glycol (DEG) was detected. DEG is a toxic chemical that can cause severe kidney injury and death. 

The episode prompted a wider conversation about manufacturing standards, quality testing, prescribing practices and the risks of giving children medicines without appropriate medical supervision.

What other restrictions came in 2025 and 2026?

October 2025: Advisory for children under two

Following the contaminated cough syrup deaths, the Union Health Ministry advised states and Union Territories not to prescribe or dispense cough and cold medications to children below two years, while urging restraint in their use among children up to five years.

January 2026: Another cough syrup banned

In January 2026, Tamil Nadu banned the manufacture, sale, distribution and consumption of Almond Kit cough syrup after laboratory testing found ethylene glycol, another toxic chemical.

June 2026: Syrup medicines lose OTC exemption

In June, the Centre removed syrups from an exemption under Schedule K of the Drugs Rules, 1945. This effectively ended the earlier relaxed over-the-counter route for syrup-based medicines, including cough syrups, with pharmacies required to dispense them through regulated channels and against prescriptions.

August 2026: Specific FDCs restricted for under-fours

The latest move specifically addresses the chlorpheniramine-phenylephrine combination and reinforces the age-specific safety warning.

Do children need cough syrup for every cough?

Not necessarily. Cough is often a symptom of a viral respiratory infection and may resolve without specific cough medicines. The WHO has previously noted that medicines used for acute cough and cold in young children offer limited measurable benefit and that combination cough-and-cold products can pose safety concerns. Cough syrups generally provide temporary symptom relief rather than treating the underlying cause of a cough.

Parents should therefore avoid selecting a cough or cold medicine based solely on a previous prescription, another child's medicine or advice from a pharmacy. The child's age, weight, symptoms, underlying condition and the ingredients in the formulation all matter.

The takeaway for parents

The latest regulation is part of a broader shift towards more cautious and supervised use of cough and cold medicines in children.

Parents should check the active ingredients rather than relying only on a brand name and should not give a child a cough or cold medicine without appropriate medical advice. In particular, medicines containing chlorpheniramine maleate plus phenylephrine hydrochloride must not be used in children below four years, in line with the latest government restriction.

A cough that is accompanied by breathing difficulty, persistent high fever, poor feeding, unusual drowsiness, dehydration or worsening symptoms should be medically evaluated rather than simply suppressed with medication.



Disclaimer: This content including advice provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.