New Delhi: Parents across India have been urged to exercise greater caution while giving cough, cold and congestion medicines to young children, following a series of regulatory actions aimed at improving medicine safety and preventing inappropriate use.
The latest restriction concerns fixed-dose combination (FDC) medicines containing chlorpheniramine maleate and phenylephrine hydrochloride. The Centre has restricted the use of these combinations in children below four years of age and directed manufacturers to prominently display a warning stating that the medicines must not be used for children under four.
The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), which raised concerns over potential risks associated with the combination in young children and noted that safer alternatives are available.
Importantly, the latest order does not mean that every cough syrup or cold medicine has been banned for children below four years. The restriction specifically applies to FDC formulations containing the combination of chlorpheniramine maleate and phenylephrine hydrochloride.
Latest restriction targets specific drug combination
Chlorpheniramine is an antihistamine commonly used to help relieve allergy-related symptoms, while phenylephrine is used as a decongestant for a blocked or runny nose. The two ingredients are included in several combination medicines prescribed or used for symptoms such as sneezing, nasal congestion and the common cold.
Under the latest government action, the manufacture, sale and distribution of formulations containing this specific combination for use in children below four years have been restricted. Manufacturers have also been directed to carry the age-specific warning on labels, package inserts and promotional material.
The move builds on earlier regulatory action. In April 2025, the government had already imposed restrictions on certain fixed-dose formulations containing the same combination and required manufacturers to warn against their use in children below four. The latest action extends the restriction more broadly to formulations containing chlorpheniramine maleate and phenylephrine hydrochloride.
Why cough and cold medicines are under scrutiny
The latest decision comes amid growing concerns over the safety, quality and inappropriate use of cough and cold medicines among children.
In October 2025, the deaths of children in Madhya Pradesh following the consumption of contaminated cough syrup brought national attention to medicine safety. The episode also renewed concerns about the use of cough and cold formulations in very young children.
The World Health Organization subsequently issued a medical product alert concerning specific contaminated oral liquid medicines, including Coldrif, Respifresh TR and ReLife, after the detection of diethylene glycol (DEG), a toxic chemical capable of causing severe kidney injury and death.
The incident triggered wider discussions about manufacturing standards, quality control, prescription practices and the dangers of administering medicines to children without proper medical supervision.
Series of actions since 2025
The restriction on the chlorpheniramine-phenylephrine combination is part of a broader series of regulatory measures involving cough and syrup-based medicines.
In October 2025, the Union Health Ministry advised states and Union Territories not to prescribe or dispense cough and cold medicines to children below two years of age. It also urged greater caution in the use of such medicines among children up to five years.
In January 2026, Tamil Nadu banned the manufacture, sale, distribution and consumption of Almond Kit cough syrup after laboratory testing reportedly detected ethylene glycol, another toxic chemical.
A major change followed in June 2026, when the Centre removed syrups from an exemption under Schedule K of the Drugs Rules, 1945. The move effectively ended the earlier relaxed over-the-counter route for syrup-based medicines and strengthened requirements for their regulated dispensing.
The August 2026 restriction now specifically reinforces safety concerns surrounding the chlorpheniramine maleate and phenylephrine hydrochloride combination for children below four years.
Not every cough requires cough syrup
Doctors and health experts have repeatedly pointed out that a cough does not necessarily require cough syrup. In many children, coughing is a symptom of a viral respiratory infection and may improve with time and appropriate supportive care.
Cough and cold medicines generally provide temporary relief from symptoms and may not treat the underlying cause of the illness. The World Health Organization has also raised concerns about the limited benefits and potential safety risks associated with combination cough and cold products in young children.
Parents have therefore been advised not to choose medicines solely on the basis of a brand name, an old prescription or advice given for another child. A child’s age, weight, symptoms, medical history and the active ingredients in a formulation must all be considered before administering any medicine.
Parents advised to check ingredients carefully
The latest restrictions underline the importance of reading medicine labels and checking the active ingredients rather than relying only on familiar brand names.
Parents should avoid giving cough or cold medicines to children without appropriate medical advice, particularly when the child is very young. Medicines containing chlorpheniramine maleate along with phenylephrine hydrochloride should not be used in children below four years, in accordance with the latest government restriction.
A child experiencing breathing difficulty, persistent high fever, poor feeding, unusual drowsiness, dehydration or worsening symptoms should receive medical evaluation instead of being treated only with symptom-relieving medicines.
The government’s latest action reflects a broader shift towards more cautious, age-appropriate and medically supervised use of cough and cold medicines. For parents, the key message is clear: not every cough needs a syrup, and checking the ingredients and seeking proper medical advice can play an important role in protecting young children.