Paediatric guide · India · Updated 2026
Cough Syrup for Children in India (2026): The Age Rules, and What to Do Instead
There is no “best paediatric cough syrup” to name any more, and below five years the question is usually whether to medicate at all. An advisory issued by the Directorate General of Health Services on 3 October 2025 states that cough and cold medications should not be prescribed or dispensed to children under 2 years, and are generally not recommended below 5 years.2 Since June 2026 syrup formulations have also lost their Schedule K exemption, so they reach a child through a prescription and a licensed pharmacy.1
Step 1 · Screen
Signs that override everything else on this page
A young child cannot describe breathlessness, so the assessment has to be made by watching. If any of the following is present, stop reading and seek medical care. Nothing further down this page applies until a doctor has seen the child.
Seek medical review promptly
In any child
- Difficulty breathing, fast breathing, or breathlessness at rest.
- Blood in what the child coughs up.
- Chest pain with the cough.
- A cough persisting beyond three weeks.5
- Unexplained weight loss, night sweats, or a fever that is not settling. In India these also raise the question of tuberculosis.
- Rash, facial or throat swelling, or breathing difficulty after a dose. Stop the medicine and seek care.
- A child who is getting worse rather than better.
In an infant or toddler specifically
- Feeding poorly, or refusing feeds.
- Fewer wet nappies than usual.
- Drowsy, floppy, or difficult to rouse.
- Grunting with each breath, flaring nostrils, or the skin pulling in under or between the ribs.
- Pauses in breathing, or a blue tinge to the lips or tongue.
- Any cough at all in a child under 2 years, because medication is not an option in that age group and the cause needs identifying.2
Emergency: a child under 6 who cannot swallow fluids or saliva, or who has difficulty breathing, needs emergency care rather than a pharmacy visit.6
Regulatory status
What changed for children, and when
Three separate instruments now govern this. They are different kinds of rule, they were issued by different bodies, and they bind differently. Any page that merges them into one sentence is getting it wrong.
The advisory that set the age limits
Directorate General of Health Services, 3 October 2025
Issued to all States and Union Territories, the advisory states that cough and cold medications should not be prescribed or dispensed to children under 2 years, and are generally not recommended below 5 years. Above that age, any use should follow careful clinical evaluation with close supervision, strict adherence to appropriate dosing, the shortest effective duration, and avoidance of multiple drug combinations. It records that most acute cough illnesses in children are self-limiting and often resolve without pharmacological intervention, and places hydration, rest and supportive measures as the first-line approach.2
The amendment that changed how syrups are sold
Drugs (Fifth Amendment) Rules, 2026
Notified as G.S.R. 477(E) dated 9 June 2026, following a draft published on 30 December 2025 and consultation with the Drugs Technical Advisory Board. The word “Syrups” was omitted from item (7) against serial number 13 of Schedule K of the Drugs Rules, 1945.1 That entry was the household-remedy exemption, which had allowed a defined set of medicines to be sold without a formal retail sale licence in villages of population under 1,000 where no licensed dealer was nearby. The entry read “syrups, lozenges, pills and tablets for cough”, and only the word “syrups” was deleted, so lozenges, pills and tablets for cough remain within the exemption.7
A point of accuracy worth making, because most reporting compressed it: the amendment acted on the exemption framework, not on the legal classification of any individual product, and India does not maintain a comprehensive over-the-counter list.7 The practical effect for a parent is nonetheless clear. A cough syrup for a child now comes through a doctor and a licensed pharmacy rather than off an open shelf.
The formulary position
Draft National Formulary of India 2026
Released by the Indian Pharmacopoeia Commission for public review in April 2026, the draft carries the same under-2 and under-5 positions and, in the paediatric entry for this class, lists no dose at all below two years. It frames cough as a protective mechanism rather than a symptom to be suppressed, and situates the guidance within the chapter covering asthma, chronic obstructive pulmonary disease and allergic rhinitis, where the inhaled route is preferred for airway disease.13
Status note: this was a draft issued for comment. Treat it as the direction of travel and confirm the final adopted text before relying on it as settled.
The background to all of it was the contamination episode of October 2025, when the Central Drugs Standard Control Organisation reported diethylene glycol in oral liquid medicines and the World Health Organization issued a medical product alert naming the affected products after clusters of acute kidney injury and child deaths in Madhya Pradesh and Rajasthan.3 Manufacturers reading this from the other side of the counter can follow the quality-system implications through our Schedule M compliance dashboard.
Step 2 · Eligibility
Age band checker
Age is the most restrictive variable in Indian paediatric cough rules. Select a band to see the position that currently applies. This tool reports rules and advisory positions only. It gives no doses, names no products, and is not a substitute for a prescription.
Not appropriate
Under 12 months
Cough and cold medications should not be prescribed or dispensed to children under 2 years. Honey is also unsuitable below 12 months because of the risk of infant botulism, and hot drinks should not be given to small children. Any cough in an infant needs medical assessment rather than a home remedy, because the causes that matter at this age are not ones a parent can rule out.
Sources: 2, 5, 10
Reference
The paediatric age rules at a glance
Indian positions first. Below the divider are published positions from other regulators. They are not Indian law. They are included because they are dated, specific and useful for understanding an ingredient’s paediatric safety profile.
| Rule or advisory | Age restriction | Instrument and date | Issued by | Ref |
|---|---|---|---|---|
| Cough and cold medications not to be prescribed or dispensed | Under 2 years | Advisory, 3 Oct 2025 | DGHS, MoHFW | 2 |
| Generally not recommended | Under 5 years | Advisory, 3 Oct 2025 | DGHS, MoHFW | 2 |
| Careful evaluation, shortest effective duration, avoid multiple drug combinations | 5 years and above | Advisory, 3 Oct 2025 | DGHS, MoHFW | 2 |
| No dose listed for this class in the paediatric entry | Under 2 years | Draft NFI 2026 (status: draft) | Indian Pharmacopoeia Commission | 13 |
| FDC of chlorpheniramine maleate with phenylephrine hydrochloride: label warning that it is not to be used in this age group | Under 4 years | DCGI direction, 18 Dec 2023; later gazette restriction under s.26A | CDSCO, on SEC and DTAB recommendation | 8 |
| Certain dextromethorphan fixed-dose combinations restricted, chiefly with antihistamines and decongestants | Under 4 years | CDSCO restriction; confirmed by PIB Fact Check Unit, Oct 2025 | CDSCO | 11 |
| Syrups removed from the Schedule K household-remedy exemption | All ages | G.S.R. 477(E), 9 Jun 2026 | MoHFW | 1 |
| Honey not to be given | Under 12 months | Standing safety position | NHS; Mayo Clinic | 5, 10 |
| The following are not Indian law | ||||
| Over-the-counter cough and cold remedies, including decongestants | Not under 6 years | Guidance, current | NHS, United Kingdom | 6 |
| Guaifenesin and ipecacuanha cough medicines | Not under 6 years; pharmacy-supervised 6 to 12 | MHRA position | Cited in NICE NG120 | 4 |
| Dextromethorphan, over-the-counter products | Not under 12 years | MHRA position | Cited in NICE NG120 | 4 |
| Codeine for cough and cold | Contraindicated under 12 years; not recommended 12 to 18 with breathing problems | PRAC recommendation, 2015 | European Medicines Agency | 16 |
| Mucolytics including carbocisteine and acetylcysteine contraindicated | Under 2 years | Decision of April 2010; Italy followed | Afssaps, France | 14 |
| Products containing an antihistamine or a decongestant not recommended | Under 2 years | Standing position | US Food and Drug Administration | 20 |
Step 3 · Supportive care
What to do when a syrup is not appropriate
This is not a consolation prize. Adequate hydration, rest and supportive measures are what the October 2025 advisory names as the first-line approach for children.2 For most acute coughs there is nothing better available.
Any age
Fluids and feeds
Keep the child drinking. For an infant that means continuing breast or formula feeds, more often and in smaller volumes if a blocked nose makes feeding hard. Watch wet nappies as the practical measure of whether it is working.
Any age
Clearing the nose
Much of a young child’s cough comes from secretions running down the back of the throat. Saline nasal drops before feeds and sleep, with gentle suction for an infant, address the cause rather than the reflex, and carry no drug exposure.
Any age
Position and air
A slightly upright position for feeds and settling helps. Keep the room free of smoke and cooking fumes, which are among the most common aggravators of a child’s cough in Indian homes and the easiest to remove.
12 months and above only
Honey
Honey probably relieves cough symptoms more than no treatment, than diphenhydramine, and than placebo, and shows little or no difference compared with dextromethorphan. Most children in those trials were treated for a single night, so read it as short-term comfort, not a cure.9
Absolute limit: never below 12 months, because of the risk of infant botulism. Do not give hot drinks to small children.5,10
Any age
Time
Most coughs clear without treatment within about three weeks.5 Indian advisory guidance makes the same point for children specifically: most acute cough illnesses are self-limiting and often resolve without any medicine.2
What not to reach for
Someone else’s prescription
A syrup prescribed for an older sibling, or left over from a previous illness, is the most common route by which a restricted formulation reaches a child it was never meant for. Check the age warning on the label against the child in front of you, every time.
Step 4 · Prepare for the consultation
What the doctor needs to know
Since a prescription is required in any case, the useful preparation is not choosing a product. It is being able to describe the cough precisely enough that the consultation reaches the cause.
Observation
The six that change the answer
- How many days it has been going on.
- Whether anything comes up, and if so what it looks like.
- Whether it is worse at night, on waking, or with activity.
- Whether there is fever, and how it has behaved over the days.
- Whether feeding, drinking or sleep have changed.
- Whether anyone at home or in the crèche has the same thing, or a chronic cough.
Also mention
Everything already given
Every medicine the child has had in the last few days, including anything bought without a prescription, anything left over from an earlier illness, and any ayurvedic or herbal preparation. Herbal preparations can interact with prescription medicines, and combination products are the commonest route to accidental duplication of the same active ingredient.
Also mention asthma, any known allergy, and any previous reaction to a medicine.
Assumption
“It is a wet cough, so it needs an expectorant”
The sound of a cough is a poor guide in a small child, and the class of medicine that follows from that guess is precisely the one with a documented infant safety signal. Mucolytics were contraindicated below 2 years in France in April 2010 after 59 cases of paradoxically increased bronchial secretions were reported, at a median age of 5 months.14
Assumption
“Herbal means it is safe for a toddler”
A herbal or ayurvedic syrup is still an oral liquid, made with the same high-risk solvents that were at the centre of the 2025 contamination episode, and the advisory position below 5 years is written around cough and cold medications generally rather than around one category.2,3
Assumption
“A wheeze means the syrup should have a bronchodilator in it”
Airway narrowing is a clinical finding, not something to read off a label. National advisory guidance asks that multiple drug combinations be avoided in children, and the draft formulary’s stated logic for airway disease favours the inhaled route.2,13
Assumption
“It worked for my older child”
The restrictions are drawn at 2, 4 and 5 years precisely because the same formulation carries a different risk at a different age. A product appropriate for a seven-year-old may carry an explicit label warning against use in a three-year-old.8
Different question
When cough is the presenting sign of something else
A cough that changes character, a cough with wheeze, a cough in a child with asthma or a known lung condition, a cough that follows a choking episode, a cough with a fever that will not settle, or a cough lasting beyond three weeks is a diagnostic question rather than a symptom to be softened.4,5 In the Indian context a persistent cough with weight loss or night sweats also raises tuberculosis, which no syrup addresses.
The Indian Academy of Pediatrics puts it directly in its office-practice guidance: the majority of conditions presenting with cough need only symptomatic and supportive therapy, and there is no role for haphazard over-the-counter use.18
Step 5 · Understand the label
Ingredient classes and their paediatric limits
Once a prescription exists, the useful skill is reading it. Understanding the class is more informative than memorising brands, and it is how you check that the age warning on the pack matches the child it was written for.
Class
Cough suppressants
Intended to reduce the cough reflex in a dry, non-productive cough. Dextromethorphan is the main agent of this class in India.
Limits to know: dextromethorphan is not banned in India. The Press Information Bureau’s Fact Check Unit described claims of an outright ban as misleading; what CDSCO restricted is a set of fixed-dose combinations containing it, chiefly with antihistamines and decongestants, barred in children below 4 years.11 Codeine for cough and cold is contraindicated below 12 years by the European Medicines Agency and is not recommended between 12 and 18 where breathing problems are present.16 Dextromethorphan also carries a recognised misuse risk at high doses, which matters in a household with adolescents.
Class
Sedating antihistamines
Added where an allergic component or post-nasal drip is thought to contribute. Older antihistamines of this group cause drowsiness.
Limits to know: the fixed-dose combination of chlorpheniramine maleate with phenylephrine hydrochloride is restricted in children below 4 years in India, and manufacturers were directed to carry that warning on the label, package insert and promotional literature.8 Cochrane review of over-the-counter cough medicines flagged antihistamines and centrally acting antitussives in children specifically as agents known to have the potential to cause serious harm.12
Class
Decongestants
Added where nasal congestion accompanies the cough. Phenylephrine is the common one in Indian combination syrups.
Limits to know: its under-4 restriction in India comes through the chlorpheniramine combination above.8 UK guidance advises against over-the-counter cough and cold remedies including decongestants in children under 6 unless a doctor or pharmacist has advised it.6 Separately, and on efficacy rather than safety grounds, the US Food and Drug Administration issued a proposed order in November 2024 to remove oral phenylephrine as an over-the-counter nasal decongestant because it is not effective for that use.17 That is a United States proposal, not an Indian rule, and it was not finalised at the time of writing.
Class
Expectorants and mucolytics
Intended to make secretions easier to shift in a productive cough. This group dominates Indian paediatric formulations, which is why its limits deserve more attention than they usually get.
Limits to know: guaifenesin-containing cough medicines are restricted below 6 years in the UK and pharmacy-supervised for ages 6 to 12.4 France contraindicated mucolytics below 2 years in April 2010, covering carbocisteine and acetylcysteine among others, after 59 cases of paradoxically increased bronchorrhoea in infants were reported to its pharmacovigilance system; Italy followed, and Cochrane review concluded these agents appear safe only above two years, with limited efficacy.14 Ambroxol and bromhexine were reviewed EU-wide from April 2014 over anaphylactic and severe cutaneous reactions, with Belgium also questioning the benefit-risk balance below 6 years; the outcome retained the products with updated safety information rather than a paediatric ban.15
Class
Bronchodilators in combination syrups
Beta-2 agonists sometimes combined with an expectorant where airway narrowing is thought to accompany a productive cough.
Limits to know: this belongs firmly inside a prescribed treatment plan, not a self-selected one. National advisory guidance asks that multiple drug combinations be avoided in children,2 and the draft National Formulary’s stated rationale for asthma and airway disease favours the inhaled route because the disease process is localised to the respiratory system.13 Worth noting that in the Cochrane honey review, honey probably reduced cough duration better than salbutamol did.9
Class
Herbal, ayurvedic and honey-based preparations
Widely used and widely assumed to sit outside the rules. They do not.
Limits to know: honey must never be given below 12 months because of botulism risk, and hot drinks should not be given to small children.5,10 Above 12 months, honey has better trial support than most of what it competes with.9 A polyherbal syrup, however, is still an oral liquid manufactured with the same solvent supply chain, and the under-5 advisory position is written around cough and cold medications as a category. Tell the doctor about any herbal preparation the child is already taking. For a worked example of how one such formulation is put together, see our review of an ayurvedic cough syrup.
Reading the regulation
What kind of rule is each of these?
Reporting tends to call all of them a ban. They are not the same instrument, they do not bind the same people, and they do not change in the same way. This distinction is the difference between understanding the position and repeating a headline.
| Instrument | Example here | What it does | Who it binds in practice |
|---|---|---|---|
| Advisory from DGHS | Under-2 and under-5 positions, 3 Oct 2025 | Directs States, UTs, district health authorities and clinical establishments to implement and disseminate a prescribing position | Prescribers and dispensers, through State health administration rather than through penal provisions of the drug law |
| Gazette notification under s.26A, Drugs and Cosmetics Act, 1940 | Restriction on the chlorpheniramine and phenylephrine FDC | Regulates or prohibits manufacture, sale and distribution of a specified formulation in the public interest, on DTAB recommendation | Manufacturers and sellers, with legal force |
| Amendment to a Schedule of the Drugs Rules, 1945 | G.S.R. 477(E), removing “Syrups” from Schedule K | Withdraws a licensing exemption. It changes the route of supply, not the classification of the molecule | Retailers and the supply chain, from the date of gazette publication |
| Mandated label and package-insert warning | “Not to be used in children below 4 years of age” | Requires a specific warning on label, insert and promotional literature | Manufacturers; and it is the line a parent can actually check on the pack |
| National Formulary entry | Draft NFI 2026 paediatric cough guidance | Sets the national reference position on indications, doses, contraindications and precautions | Prescribers and pharmacists as an authoritative reference; a draft binds no one until adopted |
| WHO Medical Product Alert | Alert No. 5 of 2025 on contaminated oral liquids | Names specific affected products and batches internationally | National regulators, who then act domestically; it is not itself Indian law |
Evidence
The part most paediatric cough pages leave out
Efficacy
The evidence is weak, and the review is dated
Cochrane review of over-the-counter cough medicines, covering 29 trials and 4,835 people of whom 1,036 were children, found no good evidence for or against their effectiveness in acute cough, and said this should be weighed when considering antihistamines and centrally acting antitussives in children, drugs known to have the potential to cause serious harm.12
Be fair to it: that review incorporates evidence only up to 2012, and Cochrane put out a call in 2026 for a new author team precisely because it needs updating.12 Weak evidence is not the same as evidence of no effect. It does mean the expected gain is comfort of uncertain size.
Natural course
Most children’s coughs settle on their own
Most coughs clear without treatment within about three weeks.5 Indian advisory guidance says the same for children: most acute cough illnesses are self-limiting and often resolve without pharmacological intervention, with hydration, rest and supportive measures as the first-line approach.2
That is also why the risk calculation shifts so sharply with age. When the untreated course is good and the expected benefit is small, a small risk is enough to make the medicine the worse option.
Step 6 · Verify
Prescription and pack checks before the first dose
The child deaths investigated in 2025 were contamination events, not dosing errors. Diethylene glycol and ethylene glycol are industrial solvents with no place in a medicine, and no parent can test for a contaminant at home.3 What you can check is the supply route and the label. Nothing below is stored or sent; the list resets when you reload the page.
0 of 6 checks cleared
If a batch is recalled: stop use and return it to the pharmacy. Adverse reactions can be reported through the Pharmacovigilance Programme of India. A contamination event is a manufacturing quality failure, and no amount of careful shopping protects against a solvent substitution upstream. Buying through licensed channels is what narrows the exposure.
Industry note
What changed on the manufacturing side
Readers who make oral liquids rather than buy them are looking at a different set of obligations arising from the same events. After the high-level review of 5 October 2025, risk-based inspections began at 19 manufacturing units across six states, with emphasis on strict compliance with the Revised Schedule M.19
The more structural change was to solvent traceability. CDSCO directed that manufacturers of pharmaceutical-grade high-risk solvents register on the ONDLS portal and upload, batch by batch, quantity, certificate of analysis and details of the vendors supplied. The listed high-risk solvents include glycerin, propylene glycol, maltitol, sorbitol, hydrogenated starch hydrolysate, polyethylene glycol and ethyl alcohol.19 For a paediatric syrup line, the practical consequences are incoming testing on every container of every lot of these excipients rather than reliance on a supplier certificate, verified chain of custody back to the original manufacturer, and finished-product release testing that would actually detect a solvent substitution.
The paediatric label warnings are a compliance item in their own right. Where a formulation contains a restricted fixed-dose combination, the mandated warning must appear on the label, the package insert and the promotional literature.8 We advise on this through our regulatory compliance consultation and our Schedule M compliance dashboard.
FAQs
Questions parents ask
No. The advisory issued by the Directorate General of Health Services on 3 October 2025 states that cough and cold medications should not be prescribed or dispensed to children under 2 years. The draft National Formulary of India 2026 carries the same position and lists no dose for this class below two years. A cough in a child this young needs medical assessment rather than a medicine.
There is no single minimum age, which is why four numbers matter rather than one. Below 2 years these medications are not to be prescribed or dispensed. Below 5 years they are generally not recommended. Certain fixed-dose combinations carry an explicit label restriction below 4 years. And honey, which is not a medicine, must not be given below 12 months. Above 5 years there is no blanket bar, but use should follow careful clinical evaluation, with the shortest effective duration and no unnecessary drug combinations.
In practice, yes. The Drugs (Fifth Amendment) Rules, 2026, notified as G.S.R. 477(E) on 9 June 2026, removed the word “Syrups” from the Schedule K household-remedy exemption under the Drugs Rules, 1945. That exemption had allowed certain medicines to be sold without a formal retail sale licence in villages of population under 1,000. With it withdrawn, syrup formulations come through licensed pharmacies. Strictly, the amendment acted on the exemption framework rather than reclassifying any individual molecule, but the route for a parent is now doctor first, pharmacy second.
Two restrictions sit at the under-4 line. The fixed-dose combination of chlorpheniramine maleate with phenylephrine hydrochloride carries a mandated warning that it is not to be used in children below 4 years, directed by the Drugs Controller General of India in December 2023 following a Subject Expert Committee recommendation, and subsequently restricted by gazette notification on the Drugs Technical Advisory Board’s advice. Separately, certain dextromethorphan fixed-dose combinations, chiefly those combined with antihistamines and decongestants, are restricted below 4 years. Check the composition printed on your pack rather than the brand name.
No. The Press Information Bureau’s Fact Check Unit described a widely circulated claim of an outright ban as misleading in October 2025. What the Central Drugs Standard Control Organisation restricted is a set of fixed-dose combinations containing dextromethorphan hydrobromide, primarily those combined with antihistamines and decongestants, with use barred in children below 4 years.
From 12 months, and never below it. Below one year honey carries a risk of infant botulism, and the rule is absolute rather than dose-dependent. Above 12 months it has better trial support than most alternatives: Cochrane review of six randomised trials in 899 children found honey probably relieves cough symptoms more than no treatment, diphenhydramine or placebo, probably reduces cough duration better than placebo and salbutamol, and shows little or no difference compared with dextromethorphan. Most children in those trials were treated for a single night, so treat it as short-term comfort. Do not give hot drinks to small children.
The evidence is weak. Cochrane review of over-the-counter cough medicines found no good evidence for or against their effectiveness in acute cough, and noted that this should weigh on any decision to use antihistamines or centrally acting antitussives in children, which are known to have the potential to cause serious harm. That review runs only to 2012 and Cochrane has called for it to be updated, so read it as genuine uncertainty rather than proof of no effect. Meanwhile, most coughs settle without treatment within about three weeks.
This is the assumption that carries the most specific paediatric signal, so it is worth being careful with. In April 2010 the French medicines agency contraindicated mucolytics, including carbocisteine and acetylcysteine, in children below 2 years, after 59 cases of paradoxically increased bronchial secretions in infants were reported to its pharmacovigilance system at a median age of 5 months. Italy followed, and Cochrane review concluded these agents show limited efficacy and appear safe only above two years. Guaifenesin-containing cough medicines are not for children under 6 in the UK and are pharmacy-supervised from 6 to 12. In India the choice sits with the prescriber, but the sound of a cough is not a good enough basis for that choice in a small child.
Duration is only one of the triggers, and often not the first one. A cough beyond three weeks warrants review. But breathing difficulty, blood in what the child brings up, poor feeding, fewer wet nappies, drowsiness, a fever that is not settling, or a child deteriorating rather than improving all need attention immediately, whatever the duration. In a child under 2 years, any cough should be assessed rather than treated at home, because medication is not an option in that age group.
Indian advisory guidance names adequate hydration, rest and supportive measures as the first-line approach. In practice that means keeping fluids or feeds going, saline nasal drops with gentle suction for an infant since much of a young child’s cough comes from post-nasal secretions, a slightly upright position for settling, and an environment free of smoke and cooking fumes. From 12 months, honey is a reasonable addition. Below 12 months it is not. If the child is not improving, or any warning sign appears, the answer is assessment rather than a different remedy.
In October 2025 the Central Drugs Standard Control Organisation reported diethylene glycol in oral liquid medicines to the World Health Organization, which issued Medical Product Alert No. 5 of 2025 naming the affected products, following clusters of acute kidney injury and child deaths in Madhya Pradesh and Rajasthan. Diethylene glycol and ethylene glycol are industrial solvents that can cause acute kidney injury. This was a manufacturing quality failure, not a dosing error, which is why no consumer test exists. What you can do is buy through the licensed route, check that batch number, manufacturing and expiry dates are legible on both carton and bottle, confirm the manufacturer name, address and licence number appear on the pack, and check that the product and batch are not covered by a current recall notice.
The June 2026 amendment deleted only the word “syrups” from the Schedule K entry, which read “syrups, lozenges, pills and tablets for cough”, so lozenges, pills and tablets for cough remain within that exemption. That is a regulatory answer, not a paediatric recommendation. Lozenges are a choking hazard in small children, and the under-2 and under-5 advisory positions cover cough and cold medications as a category regardless of dosage form. The escalation signs on this page apply either way.
Regulatory or formulation question about paediatric oral liquids?
Laafon Galaxy Pharmaceuticals advises on pharmaceutical quality, regulatory affairs and manufacturing compliance. For clinical advice about your own child, please consult a registered medical practitioner or paediatrician.
References
- Ministry of Health and Family Welfare, Government of India. Drugs (Fifth Amendment) Rules, 2026. Notification G.S.R. 477(E) dated 9 June 2026, omitting the word “Syrups” from item (7) against serial number 13 of Schedule K of the Drugs Rules, 1945; draft published 30 December 2025. Reported in: All India Organisation of Chemists and Druggists press note, 16 June 2026, via medicaldialogues.in.
- Directorate General of Health Services, Ministry of Health and Family Welfare. Advisory to all States and Union Territories on rational use of cough syrups in the paediatric population, 3 October 2025. ddnews.gov.in; see also Press Information Bureau, pib.gov.in.
- World Health Organization. Medical Product Alert No. 5/2025: substandard (contaminated) oral liquid medicines. Geneva: WHO; 13 October 2025. who.int.
- National Institute for Health and Care Excellence. Cough (acute): antimicrobial prescribing. NICE guideline NG120, summary of the evidence. London: NICE; 2019. nice.org.uk.
- National Health Service. Cough. NHS; 2024. nhs.uk.
- National Health Service. Colds, coughs and ear infections in children. NHS; 2024. nhs.uk.
- Business Today. Explainer: why the government has ended a key exemption for cough syrups. 16 June 2026. businesstoday.in.
- Central Drugs Standard Control Organisation. Direction of the Drugs Controller General of India to State and UT drug controllers on the fixed-dose combination of chlorpheniramine maleate IP 2 mg with phenylephrine hydrochloride IP 5 mg, 18 December 2023, following the Subject Expert Committee (Pulmonary) recommendation of 6 June 2023; subsequently restricted by gazette notification under section 26A on the recommendation of the Drugs Technical Advisory Board. Reported in tribuneindia.com.
- Oduwole O, Udoh EE, Oyo-Ita A, Meremikwu MM. Honey for acute cough in children. Cochrane Database of Systematic Reviews. 2018, Issue 4. Art. No.: CD007094. doi:10.1002/14651858.CD007094.pub5.
- Mayo Clinic. Honey: an effective cough remedy? Rochester: Mayo Foundation for Medical Education and Research. mayoclinic.org.
- Press Information Bureau Fact Check Unit. Government dismisses rumours of ban on dextromethorphan cough syrups, 8 October 2025. newsonair.gov.in.
- Smith SM, Schroeder K, Fahey T. Over-the-counter (OTC) medications for acute cough in children and adults in community settings. Cochrane Database of Systematic Reviews. 2014, Issue 11. Art. No.: CD001831. doi:10.1002/14651858.CD001831.pub5. See also Cochrane’s 2026 call for an author team to update this review, cochrane.org.
- Indian Pharmacopoeia Commission. Draft National Formulary of India 2026, issued for public review and comment, April 2026. ipc.gov.in. Status at the time of writing: draft.
- Chalumeau M, Duijvestijn YCM. Acetylcysteine and carbocysteine for acute upper and lower respiratory tract infections in paediatric patients without chronic broncho-pulmonary disease. Cochrane Database of Systematic Reviews. 2013. Art. No.: CD003124. doi:10.1002/14651858.CD003124.pub4. Reporting the April 2010 Afssaps decision contraindicating mucolytics below 2 years in France, and 59 cases of paradoxical bronchorrhoea; see also Mallet P et al., PLOS One 2011;6(7):e22792.
- European Medicines Agency. Ambroxol and bromhexine, Article 31 referral: review started 4 April 2014 at the request of Belgium; safety information updated on allergic and severe cutaneous adverse reactions. ema.europa.eu.
- European Medicines Agency. PRAC recommends restrictions on the use of codeine for cough and cold in children, 2015. ema.europa.eu.
- US Food and Drug Administration. Proposed order to remove oral phenylephrine as an OTC monograph nasal decongestant active ingredient on grounds of lack of effectiveness, 7 November 2024; comment period closed 7 May 2025. Not finalised at the time of writing. fda.gov.
- Indian Academy of Pediatrics. Management of Cough in Office Practice. IAP Standard Treatment Guidelines. iapindia.org.
- Central Drugs Standard Control Organisation. Directions following the high-level meeting of 5 October 2025: risk-based inspections at 19 manufacturing units across six states, and registration of pharmaceutical-grade high-risk solvent manufacturers on the ONDLS portal with batch-wise quantity, certificate of analysis and vendor details. Reported in tribuneindia.com and newsonair.gov.in.
- Summerlin J, Eiland LS. The use and safety of cough and cold medications in the pediatric population. J Pediatr Pharmacol Ther. 2025;30(1):17-26. doi:10.5863/1551-6776-30.1.17.
This page is educational and is not a diagnosis, a prescription, or a substitute for clinical assessment. It recommends no brand and states no doses; both come from your child’s doctor and the approved product label. Regulatory positions change, and the rules summarised here reflect the sources listed above at the time of writing. Verify current status with a registered medical practitioner or pharmacist before acting. Reviewed by Dr. Yogesh Chaudhary.
