Under mounting global scrutiny, India has cracked down on paediatric cough syrups, with the health ministry proposing to bar prescription of cough and cold medications for babies below two years of age and also discouraging them for children below five, according to two government officials and documents reviewed by Mint.
The move, part of the draft National Formulary of India (NFI) 2026 published by the Indian Pharmacopoeia Commission (IPC), under the health ministry, marks a sharp regulatory tightening after contamination-linked deaths, with implications for prescribing practices and a fast-growing market.
The NFI draft has standardized information on drug dosages, indications, contra-indications and side-effects for doctors and pharmacists.
The development assumes importance for India’s cough syrup market, that was valued at $262.5 million in 2024 and is projected to grow to $743 million by 2035.
This regulatory tightening follows alarm over discovery of toxic industrial solvents, including diethylene glycol (DEG) and ethylene glycol (EG), in liquid oral formulations, which could lead to acute kidney failure and even death, thereby denting India’s image as the ‘pharmacy of the world’.
The draft highlights the life-threatening risks of DEG and EG contamination and follows a Directorate General of Health Services (DGHS) October advisory to states to address the public health crisis following deaths in Rajasthan and Madhya Pradesh.
“As we look back at the historical precedents, the tragic deaths linked to cough syrups were primarily caused by poisonous ingredients like diethylene glycol (DEG), which induces severe poisoning symptoms. Cough syrups are not recommended in infants and children till age of 5 years without medical advice,” said one of the two officials cited above. "Most liquid orals in the market consist of cough syrups, making up to 60-70% of production. To address this, the Indian Pharmacopoeia Commission has updated monographs for high-risk excipients—glycerin, propylene glycol, sorbitol solution and liquid maltitol—all of which are likely to contain DEG as an impurity. It is now mandatory for manufacturers to use pharmacopoeial grade solvents and strictly test every lot in approved laboratories.”
“We have circulated the NFI 2026 among our member companies for comments,” said an official from the Indian Drugs Manufacturers Association (Idma).
“In our continuous efforts to ensure rational drug use and patient safety in pediatric care, this advisory reiterates the judicious prescribing and dispensing of cough syrups for children. Cough and cold medications should not be prescribed or dispensed to children under 2 years," according to the draft NFI reviewed by Mint. "These are generally not recommended for ages below 5 years and above that, any use should follow careful clinical evaluation with close supervision and strict adherence to appropriate dosing, the shortest effective duration and avoiding multiple drugs combinations.”
“Inappropriate use of cough syrups—especially those containing multiple active agents—has limited therapeutic benefit and poses potential safety risks in young children,” the document said. “The public should be sensitized to strictly adhere to prescriptions issued by registered medical practitioners and to avoid self-medication or use of cough syrups without medical advice, particularly in the paediatric population.
To fix the onus, the draft also sought an independent testing of inputs by pharmaceutical firms. “Licensee shall either in his own laboratory or in any laboratory approved by licensing authority test each batch or lot of the raw material used by him for the manufacture of the product and also each batch of the final product and shall maintain records of the same,” it said.
Over the last few years, Indian-manufactured cough syrups have been linked to over 140 deaths in several nations, including Gambia, Uzbekistan and Cameroon due to ethylene glycol poisoning. In India, use of Coldrif syrup led to at least 24 deaths in late 2025.
This health ministry's move comes in the wake of recall of several products, including Coldrif (Sresan Pharmaceuticals), Re-Life Syrup (Shape Pharma), Respifresh-TR (Rednex Pharmaceuticals) and Dextromethorphan Hydrobromide Syrup (Jaipur-based Kaysons Pharma Ltd).
A person at Shape Pharma who did not wish to be named told Mint over phone that the cough syrup recall took place in October last year and that the matter was still under investigation.
Queries emailed to the spokespersons of the health ministry and the Drugs Controller General of India (DCGI) on Thursday, and Shape Pharma and Kaysons Pharma on Friday remained unanswered until press time. Sresan Pharmaceuticals and Rednex Pharmaceuticals couldn't be reached.
Avoidable risk
Public health experts say cough syrups are generally unnecessary for children under five years of age.
“Cough syrups are generally unnecessary for children under five years, as cough is a natural protective reflex that helps clear airway secretions. Suppression of this reflex, especially in productive (wet) cough, may impair mucus clearance and potentially increase the risk of complications," said Dr. Dhiren Gupta, paediatric co-director at the division of intensive care, pulmonology and allergy at Sir Ganga Ram Hospital, New Delhi. "In young children, the management should focus on treating the underlying cause—most commonly viral, but also bacterial or allergic conditions—rather than only suppressing the symptom.”
“Non-pharmacological measures such as adequate hydration, saline nasal drops, and the use of honey (in children above one year) are preferred. Medical supervision is important to ensure safe and appropriate management,” Dr. Gupta added.
The pharmaceutical industry cheered the government's move.
Hari Kiran Chereddi, managing director and chief executive at HRV Pharma, said the NFI 2026 directive needs to be implemented urgently.
“Good manufacturing practice is the single most important protective mechanism in existence when it comes to standing between a factory and a child's life," Cheredee said. “The issues with paediatric cough syrups are at multiple levels: substandard solvent usage, no proper batch testing and poor enforcement of existing regulations.”