India looks to bar cough syrup for babies under two
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
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