Published Apr 14, 2026 | 11:48 AM ⚊ Updated Apr 14, 2026 | 11:48 AM
Cough syrup (Representational image. Credit: iStock)
Synopsis: India’s updated National Formulary of India (NFI) 2026 has said cough syrups have no role in children below two years of age. At the heart of its guidance is a simple but often misunderstood idea. Cough, the formulary explains, is not merely a symptom to be suppressed but a natural defence mechanism of the body.
India’s updated National Formulary of India (NFI) 2026 delivers a clear and cautionary message to doctors and parents alike: Cough syrups have no role in children below two years of age.
Released by the Indian Pharmacopoeia Commission, the formulary is the country’s official reference for how medicines should be prescribed and used. Its recommendations carry weight across clinical practice, pharmacy, and public health.
At the heart of its guidance is a simple but often misunderstood idea. Cough, the formulary explains, is not merely a symptom to be suppressed but a natural defence mechanism of the body.
The NFI 2026 is the authoritative national reference for medicines used in India. It sets out approved indications, doses, contraindications, precautions, and adverse effects for drugs across all therapeutic categories, and its guidance carries significant weight for clinicians, pharmacists, and policymakers.
Also Read: TNHDA flags regulatory gaps in drug monitoring after toxic cough syrup tragedy
The NFI 2026 dedicates a section to antitussives under its chapter on drugs for respiratory diseases. It opens with a clinically important reminder about the nature of cough itself.
“Cough acts as a protective reflex. It is helpful in the expulsion of respiratory secretion and other foreign particles from the respiratory tract,” said the formulary.
The formulary draws a firm line between the two types of cough.
“Cough is of non-productive and productive types. A non-productive cough should be suppressed, whereas a productive cough should not be suppressed. Cough suppressants are used only for the control of non-productive cough,” said the formulary.
Only two cough suppressants are listed in the formulary: codeine and dextromethorphan.
Codeine, a controlled opioid under India’s Narcotic Drugs and Psychotropic Substances Act 1985, is approved as a cough suppressant only in adults and in children above 12 years of age. No paediatric dose is given below that threshold.
Dextromethorphan, the ingredient most commonly found in over-the-counter cough syrups, is listed for dry cough in tablet and syrup formulations. Its youngest paediatric dose is for children aged 2–6 years (15 mg every 12 hours). For children aged 6–12 years, the dose is 30 mg every 12 hours.
There is no recommended dose for children under two years. Not anywhere in the formulary.
The formulary also flags specific caution for dextromethorphan in atopic children and those with asthma, renal impairment, or liver disease.
This absence of any dose for children below two is not an oversight. It reflects the established safety concern that cough and cold preparations carry disproportionate risks in very young children, including respiratory depression, sedation, and cardiovascular effects, with little demonstrated benefit.
Also Read: WHO sounds alarm on toxic Indian cough syrups linked to 23 child deaths
The guidance on cough sits within a larger chapter covering asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis.
For asthma and COPD, the formulary consistently favours the inhalation route. Inhaled beta-2 agonists, corticosteroids, and anticholinergics form the backbone of treatment.
The rationale is spelt out directly in the NFI 2026.
“The disease process in asthma and COPD is primarily localised in the respiratory system. Therefore, the inhalation route is preferred because of high efficacy, quicker onset of action, limited systemic absorption, thus leading to fewer systemic adverse effects,” said the formulary.
The formulary discusses a range of devices, including metered dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulisers.
It notes that very young children and the elderly may struggle to coordinate their breathing with MDIs, and recommends volumetric spacers to improve drug delivery and reduce unwanted oropharyngeal deposition.
Nebulisers, the formulary notes, are particularly suited to young children.
“Nebulised drugs can be delivered during tidal breathing, and it is possible to deliver a higher dose of the drug. They are often used in managing acute exacerbations of asthma and COPD… in children and infants.”
For mild asthma, short-acting beta-2 agonists such as salbutamol serve as the primary reliever. In acute severe asthma, nebulised salbutamol is used alongside ipratropium bromide, with systemic corticosteroids added for most patients. Intravenous magnesium sulphate is an option when first-line treatment fails.
Allergic rhinitis is managed primarily with intranasal corticosteroids and antihistamines, with leukotriene receptor antagonists such as montelukast used as second-line agents.
(Edited by Muhammed Fazil.)
