Putting children’s cough syrup in a lollipop sounds like a kindness. For infants it is the wrong answer three times over: cough medicines are not meant for under-twos, hard sweets are a choking hazard, and medicine that tastes like candy invites overdoses. The research points instead to tablets 2 mm across, films that melt on the tongue and medicine given during breastfeeding. Indian companies already make several of these — but mostly for export, not for Indian children.
Cough Syrup in a Lollipop? For Babies, the Evidence Points to a 2 mm Tablet Instead
Start with the cough syrup
The question usually arrives as: why not put children’s cough syrup in a lollipop or a sweet, so they take it without a fight? For infants the first answer is that they should not be getting cough syrup at all. In October 2025, after the deaths of children in Madhya Pradesh and Rajasthan were linked to cough syrups, India’s Health Ministry advised that cough and cold medicines should not be prescribed or dispensed to children under two, and are generally not recommended under five. The US Food and Drug Administration warned against over-the-counter cough and cold products for children under two in 2008, because they had not been shown to be safe or effective at that age and had been linked to serious adverse events, including deaths.
India has also restricted the commonest combination. The drug regulator asked manufacturers in December 2023 to label the fixed-dose combination of chlorpheniramine and phenylephrine as not for children under four. A notification in April 2025 made the warning binding, and on 18 August 2026 the Health Ministry extended it to every formulation containing the two drugs. In September 2026 the government was reported to be considering a red warning against use under four on cough-syrup bottles generally.
The evidence for the gentlest alternative is modest but real. A Cochrane review of six small trials in 899 children aged 12 months to 18 years found that honey probably relieves cough more than no treatment, diphenhydramine or placebo, and may be about as good as dextromethorphan. Honey is not given to babies under one year because of the risk of infant botulism.
The lollipop literature
Medicine in a lollipop is not new. The best-known example is a prescription opioid. In 1989 anaesthetists at the University of Utah tested oral transmucosal fentanyl citrate — fentanyl in a sweetened lozenge on a stick — as a pre-operative sedative in 44 children. The children readily accepted it, and it sedated them, but at the highest dose three of 12 had brief drops in blood oxygen, and post-operative vomiting ran at 50–83%. The product was later sold for adult cancer pain as Actiq, and regulators worried from the start that a narcotic shaped like a sweet would attract children.
The rest of the literature falls into three groups:
- Herbal lollipops for tooth decay. Lollipops containing liquorice-root extract have been tested in preschool children with a high risk of caries; two a day for three weeks lowered levels of Streptococcus mutans, the main decay-causing bacterium. A 2020 systematic review found only three studies, only one of them high quality, and called the effect promising but asked for larger trials.
- Analgesic lollipops after surgery. A 2026 pilot from anaesthetists in Chile and Venezuela gave a diclofenac lollipop to 50 children aged 4–12 every eight hours after removal of tonsils and adenoids. Pain scores fell, 83% rated the taste and texture positively, and no adverse events were recorded — but there was no comparison group, so the study shows that the lollipop is acceptable, not that it works better than syrup or tablets.
- Laboratory formulations. Most papers on “medicated lollipops” are pharmacy-lab studies that make lollipops containing paracetamol, albendazole, cefixime, salbutamol or fexofenadine and measure how fast the drug dissolves. They report drug release in minutes, not outcomes in children; none of the ones found for this piece tested the lollipop in patients.
Every one of these was tested in children old enough to manage a hard sweet. None was tested in infants, and there is a reason.
Why sweets are the wrong vehicle for babies
Choking. The American Academy of Pediatrics advises against giving hard sweets to children under four. Hard candy was the food most often involved in non-fatal choking visits to US emergency departments in a study of children published in Pediatrics in 2013. A lollipop also cannot deliver a measured dose to a child who is not old enough to suck it steadily.
Accidental overdose. A medicine that tastes and looks like a sweet invites children to take more of it. Melatonin gummies are the clearest recent case. The US Centers for Disease Control and Prevention reported that poison-centre calls about children swallowing melatonin rose 530% between 2012 and 2021, and that during 2019–2022 melatonin was involved in about 11,000 emergency visits by infants and young children for unsupervised ingestion, 7% of all such visits. In 47% of those cases the child had eaten gummies. Most cases were mild, but the data cover 4,097 hospitalisations and two deaths over the decade.
Dose control. A cough syrup in a sweet would also hide the dose. Paediatric doses are calculated by weight, and the problem with liquids is already measurement error with spoons and cups; a sweet that is half-eaten, shared or put down solves none of that.
What the trials actually show for infants
The surprising finding of the past 15 years is that babies can take solid medicines. A group at the University Children’s Hospital in Düsseldorf expected children to prefer syrup. Their own trials showed the opposite.
| Study | Children | Finding |
|---|---|---|
| Spomer et al., Arch Dis Child 2012 | 60, aged 6 months–6 years | A drug-free 2 mm mini-tablet was accepted at least as well as 3 ml of sweet syrup; infants of 6–12 months swallowed it fully |
| Klingmann et al., J Pediatr 2013 | 306, aged 6 months–5 years | Uncoated mini-tablets were more acceptable than syrup by 14.8 percentage points; no child inhaled one |
| Klingmann et al., J Pediatr 2015 | 151 newborns, 2–28 days | All accepted both the mini-tablet and 0.5 ml syrup; swallowing was better with the tablet by 10 points; none inhaled or coughed |
| Klingmann et al., Eur J Pharm Biopharm 2020 | 150 infants under 1 year | A 2 × 3 cm orodispersible film was more acceptable and better swallowed than syrup |
| Maier et al., PLOS ONE 2022 | 26 mother–infant pairs, UK neonatal unit | A solid vitamin B12 dose dissolved in breast milk during feeding raised infants’ B12 from a mean 533 to 1,871 pg/ml; 85% of mothers preferred it to a syringe |
| Goyanes et al., Int J Pharm 2019 | 4 children with maple syrup urine disease | 3D-printed chewable doses, flavoured and coloured to the child’s choice, kept blood levels closer to target than hand-made capsules |
From the PubMed abstracts of each study. The mini-tablet and film trials used drug-free placebos to test acceptability and swallowing, not the effect of any medicine.
Three other approaches are in use or close to it:
- Dispersible tablets. The World Health Organization’s guidance on medicines for children prefers “flexible solid” forms — tablets that dissolve in a little water or on the tongue — especially for low-income settings. They are more stable than syrups, easier to transport and need fewer potentially toxic additives. Dispersible amoxicillin for childhood pneumonia is the standard example, and in May 2024 the WHO prequalified arpraziquantel, a 150 mg dispersible tablet for schistosomiasis in children aged three months to six years, made less bitter for small children.
- The nipple shield delivery system. Developed by the JustMilk project, this is a thin silicone shield worn during breastfeeding that holds a dissolving insert, so the medicine is released into the milk the baby drinks. It has been tested with zinc in a breastfeeding simulator and in acceptability studies with mothers, including for HIV drugs to prevent mother-to-child transmission; it has not yet been licensed for a medicine. The UK vitamin B12 study above tested the same idea of giving a solid dose during a feed.
- Taste-masked and 3D-printed doses. Chewable printed doses, shaped and flavoured for a child, are being tested in hospital pharmacies for rare diseases that need exact, individual doses.
Where India stands
India’s paediatric market still runs on syrups and drops, and that is where its worst drug-safety disasters have happened. Coldrif, made by Sresan Pharmaceuticals in Tamil Nadu, was found to contain diethylene glycol at 48.6% in one batch; the deaths of 24 children in Madhya Pradesh were linked to it, the firm’s licence was revoked, and the WHO issued an alert on Coldrif and two other Indian syrups, Respifresh TR and ReLife. Indian-made syrups were linked earlier to child deaths in the Gambia and Uzbekistan.
Diethylene glycol gets into syrups through the solvents and sweeteners that liquids need — propylene glycol, glycerin and sorbitol — when a manufacturer buys a contaminated or substituted batch and does not test it. A dispersible tablet, mini-tablet or film for the same drug needs little or none of those solvents. Switching the youngest children away from syrups would remove one route for the poison, as well as making doses easier to measure.
A lollipop would not. It is a sugar matrix, and hard-boiled sweets are made from the same sugars and syrups; it carries the choking and accidental-overdose risks above, and for infants it delivers a class of medicine India has already told doctors not to prescribe.
Indian companies already make them — for other markets
India does not lack the technology. Its drug makers produce child-friendly solid medicines and oral films at scale, but the paediatric products go mainly to donor-funded HIV and tuberculosis programmes abroad, and the films mainly to adult markets in Europe.
| Company | Product | Status |
|---|---|---|
| Cipla, Mumbai | Lopinavir/ritonavir 40/10 mg oral pellets in capsules, sprinkled on food, for HIV in children under three | US FDA tentative approval, May 2015 — the first solid form of the drug for that age, replacing a bitter syrup that contained about 40% alcohol and needed refrigeration |
| Cipla, with DNDi | Quadrimune “4-in-1”: four HIV drugs as strawberry-flavoured granules in capsules | Priced at under US$1 a day for children up to 14 kg; registered in 2023 in the DR Congo, Kenya, Mali, Mozambique and Uganda |
| Macleods and Viatris | Dolutegravir 10 mg scored dispersible tablet, strawberry-flavoured, for children from four weeks | US$4.50 a pack, about US$36 a year for a 10–13.9 kg child, under a 2020 agreement with CHAI and Unitaid |
| Macleods | Dispersible TB combinations for children (rifampicin, isoniazid, pyrazinamide) | Launched with TB Alliance in 2015 at US$2.95 for 84 tablets; US$15.54 for a six-month course through the Global Drug Facility |
| Laurus Labs, Hyderabad | Dolutegravir orodispersible film for infants and children | US FDA tentative approval, May 2023; described by the company as the first such film |
| ZIM Labs, Nagpur | Oral thin films; drug pellets and granules supplied to other manufacturers | EU-GMP film plant rated at 324 million strips a year; EU approvals for sildenafil, rizatriptan and, with Neuraxpharm, buprenorphine films; films were about 18% of revenue in FY2024 |
| Shilpa Medicare, Raichur | Orodispersible films and skin patches from its Bengaluru plant | EU approvals for tadalafil and rivaroxaban films; plant passed an EMA inspection in March 2025 |
| Aavishkar, Hyderabad | Oral thin films | Mainly nutraceutical and nicotine strips |
From company announcements, regulators’ decisions as reported, and the DNDi, CHAI, Unitaid and TB Alliance releases cited below. “Tentative approval” means the FDA found the product met its standards for supply under the US PEPFAR programme while patents block sale in the US.
The pattern is clear. Indian firms have shown they can make mini-pellets, dispersible tablets and films for babies when an international buyer — PEPFAR, the Global Fund, Unitaid — asks for them and pays. The films they sell in Europe are for erectile dysfunction, migraine, blood clots and opioid dependence. The domestic paediatric market, where most medicines are bought privately and prescribed by brand, still asks for syrups and drops, and gets them. A film or mini-tablet costs more to develop, and there is no Indian requirement or procurement preference for them yet. India’s drug regulator did approve an ondansetron oral film for nausea as early as 2010, so the route exists.
What would fix this
- The Central Drugs Standard Control Organisation should make the warning against cough and cold medicines for children under two binding, by notification and on labels, rather than leaving it as an advisory that, according to complaints reported in 2026, some doctors have ignored.
- The Indian Pharmacopoeia Commission should publish monographs and quality standards for mini-tablets, orodispersible films and dispersible tablets for children, so that Indian manufacturers have a clear route to make them and state regulators a standard to test them against.
- The Ministry of Health and Family Welfare should prefer dispersible and other solid child formulations in the National List of Essential Medicines and in state free-medicine schemes, following the WHO’s guidance, so that public procurement does for Indian children what donor procurement has done for HIV and TB treatment abroad — and gives Cipla, Macleods, Laurus, ZIM, Shilpa and others a domestic market for what they already make.
- The Food Safety and Standards Authority of India and the CDSCO should jointly bar the sale of medicines or supplements for children in lollipop, gummy or sweet form without child-resistant packaging and a dose limit per pack, before such products become common in India.
- The Indian Council of Medical Research should fund acceptability trials of mini-tablets and films in Indian infants, so that the German and UK results are tested where the syrup problem is largest.
These are proposals from this blog, not recommendations any agency has adopted.
Sources and caveats
The clinical studies are from their PubMed abstracts: Streisand et al., Anesthesia & Analgesia 1989 (fentanyl lozenge); Nuvvula et al., Oral Health & Preventive Dentistry 2020 (systematic review of liquorice lollipops); Veraza et al., Cureus 2026 (diclofenac lollipop); Spomer et al., Archives of Disease in Childhood 2012; Klingmann et al., Journal of Pediatrics 2013 and 2015; Klingmann et al., European Journal of Pharmaceutics and Biopharmaceutics 2020; Maier et al., PLOS ONE 2022; Goyanes et al., International Journal of Pharmaceutics 2019 (as summarised in later reviews); Galgon et al., European Journal of Pharmaceutics and Biopharmaceutics 2022 (JustMilk). The laboratory lollipop formulations are from papers indexed on ResearchGate, Academia and De Gruyter and were not read in full. The regulatory concern about the fentanyl lozenge is as summarised in secondary literature. The honey review is Oduwole et al., Cochrane 2018. The WHO guidance is “Development of paediatric medicines: points to consider in formulation” (Technical Report Series 970, Annex 5). Arpraziquantel’s EMA opinion (December 2023) and WHO prequalification (May 2024) are from the Pediatric Praziquantel Consortium and Merck KGaA. The melatonin figures are from the CDC’s Morbidity and Mortality Weekly Report (2022 and 2024). The choking statement is the American Academy of Pediatrics’ guidance; the 2013 Pediatrics finding on hard candy is as reported in the press. India’s advisory of 3 October 2025 is from All India Radio; the chlorpheniramine–phenylephrine warnings are from Medical Dialogues, ETV Bharat and the Health Ministry’s post of 22 August 2026; the proposed red label is from Business Standard and Medical Dialogues (September 2026); the Coldrif figures are from The Tribune, Chemistry World and All India Radio. The description of how diethylene glycol enters syrups is general knowledge about the contamination cases, not a finding about any one product. The company table is from: Fierce Pharma, DNDi and i-Base (Cipla pellets, 2015); DNDi, Unitaid and i-Base (Quadrimune); the Clinton Health Access Initiative (dolutegravir 10 mg pricing); TB Alliance, Unitaid and the Treatment Action Group (paediatric TB combinations); ThePrint, 2 May 2023 (Laurus film); ZIM Laboratories’ website and FY2024 annual report and press reports of its EU approvals; Medical Dialogues and Business Upturn (Shilpa Medicare); Nutritional Outlook and Tracxn (Aavishkar); and CDSCO’s list of drugs approved in 2010 (ondansetron film). Company claims, including “first”, are the companies’ own. This piece is not medical advice: ask a doctor before giving any medicine to a child.
About this article: Researched, written and edited by Umashankar Triplicane Dwarakanathan, with AI research assistance; every figure is meant to trace to the primary source cited. See the Editorial Policy for how sourcing, AI use and corrections work.