In October 2025, reports of children dying after consuming contaminated cough syrup in a district of Madhya Pradesh shocked the country. Now, in June 2026, the Government of India has made some regulatory changes and removed all syrups, including cough syrups, from Schedule K, which allowed the availability of syrups at non-pharmacy retail stores in villages or settings that have populations of less than 1,000. Now, the medicated syrups cannot be sold in retail stores across the country. They need a doctor’s prescription for sale.
The Madhya Pradesh cough syrup tragedy led to investigations and has shaped this policy decision. However, claims that this latest decision makes a doctor’s prescription mandatory for cough syrups are misleading because most medicated cough syrups — except herbal ones — contain ingredients that have always required a doctor’s prescription for sale or purchase. But that rule was not being followed.
This policy decision reinforces the requirement for a mandatory prescription. Amongst all syrups, cough syrups are widely misused in India. Many are bought without diagnosis, used for viral colds — where they offer little benefit — given to young children despite safety concerns or are consumed repeatedly because the sweet liquid appears harmless.
Some formulations contain antihistamines, decongestants, sedatives, opioids or alcohol-like solvents, which may do more harm than good. Certain syrups are also abused by adolescents and adults. A prescription requirement can slow such casual purchases, force a clinical encounter and remind citizens that cough syrup is a medicine, not a comfort drink.
Yet this is only one part of the story. For many worried parents, a child’s cough is distressing and a doctor’s visit often feels incomplete unless a syrup is prescribed. Patients often demand such prescriptions and if a doctor refuses, some even go to another doctor to get it. Old prescriptions are also reused to buy the same medicine for similar symptoms. The new regulation could reduce such misuse, reinforce the need for a proper prescription and alter the behaviour that drives misuse.
However, this change is not sufficient. The cough syrup tragedy was not primarily caused by the absence of a prescription. It was caused by a contaminated product reaching children. When diethylene glycol or ethylene glycol — industrial chemicals that should never be present in medicines — enter a syrup, the failure lies upstream: in manufacturing, raw material procurement, testing, licensing, inspection and recall.
Some other countries offer useful lessons. In the US, many cough and cold medicines are available over the counter, but regulators warn against their use by children under two and manufacturers generally label them against use in children under four. In the UK, several cough and cold preparations are not recommended for children under six, while use in those aged six to 12 is pharmacy-supervised. Australia has discouraged their use in young children and strengthened labelling. These countries do not rely only on prescriptions. They use age restrictions, warning labels, pharmacist counselling, poison-control systems, adverse-event reporting and surveillance.
India needs a layered approach. First, cough and cold syrups should not be prescribed or dispensed for children below two years, except on specialist advice. For older children, standard care should begin with fluids, fever control when needed, saline drops, honey after one year of age and advice on warning signs requiring medical care. Most coughs are viral in nature and self-limiting and do not need a syrup for cure.
Second, manufacturing regulation must be strengthened. Every oral liquid medicine should be tested for toxic glycols when excipients such as glycerine, propylene glycol or sorbitol are used. Testing should be batch-wise, auditable and traceable. Raw material suppliers must be licensed and tracked. Drug regulators need trained inspectors, modern laboratories, digital records and independence from pressure. Repeated violations should lead to prosecution and licence cancellation.
Third, faster recall is needed. Once a contaminated product is suspected, information should move in hours, not days. A national digital drug recall platform linked to batch numbers, pharmacies, doctors, hospitals and the public can save lives. Every bottle should carry a QR code through which parents can verify the manufacturer, batch number, expiry date and recall status.
Fourth, doctors should mention diagnosis and age-appropriate dose and duration in the prescription. Combination cough syrups should not be used casually. Pharmacists should record sales, counsel caregivers and refuse unsafe requests. Professional bodies should issue simple, practical guidance that can be followed in busy clinics and pharmacies.
Finally, communities must be treated as partners. Anganwadi workers, ASHAs, schoolteachers, paediatricians, family physicians and local media can spread three messages: do not self-medicate young children; do not reuse old syrups; and seek urgent care if a child develops reduced urination, persistent vomiting, drowsiness, fast breathing or worsening illness after any medicine. Panchayats and resident welfare associations can hold medicine-safety days where families learn how to check, store and discard medicines safely.
The authorities must know that changing the point of sale does not secure the medicine-safety chain. The real task is to build a system where medicines are well made, prescriptions are rational, pharmacists are accountable, citizens are informed and regulators act before tragedy strikes. India should move from crisis-driven control to everyday drug safety.
