Pediatric experts are calling for urgent regulatory action after revealing that most cough syrups sold in India still lack warning labels prohibiting their use in children under two years of age, despite a deadly contamination crisis that claimed at least 24 young lives in October.
Dr. Sanjiv Singh Rawat, chairperson of the Indian Academy of Pediatrics National Respiratory Chapter, highlighted the regulatory gap on Saturday at PedPulmocon 2025, the organization’s 37th annual conference in Nagpur. “The absence of such labels poses a serious risk of misuse, especially when parents purchase syrups over the counter without medical advice,” he said.
Contamination Tragedy Sparks Safety Debate
The call for warning labels follows October’s outbreak of cough syrup poisoning in Madhya Pradesh and Rajasthan, where children died after consuming syrups contaminated with diethylene glycol, an industrial toxin. Laboratory tests found that Coldrif syrup, manufactured by Sresan Pharmaceuticals, contained 48.6% diethylene glycol—far exceeding the permissible limit of 0.1%.
The World Health Organization issued a medical product alert on October 13, confirming contamination in three products and recommending immediate recalls. A subsequent inspection of the Tamil Nadu manufacturing facility revealed 364 violations of manufacturing rules, including the use of unqualified staff, contaminated water, and absence of quality assurance protocols.
Dr. Rawat emphasized that the children did not die from the standard cough syrup formulation but from pharmaceutical manufacturing failures. “The government is trying to blame doctors, but the contamination was a regulatory failure,” he said. He stressed that while cough syrups are not recommended for children below two due to risks of excessive drowsiness and aspiration, they do not cause death unless contaminated.
The IAP is urging the Health Ministry to mandate bold warning labels stating “Not to be used in children below two years without prescription” and to regulate over-the-counter sales similar to cigarette packet warnings. Mumbai-based pediatric pulmonologist Dr. Indu Khosla questioned how certain cough syrups remain available in Indian markets despite being unavailable abroad.
India records approximately 350,000 pneumonia deaths in children annually—the highest globally—largely due to malnutrition, delayed treatment access, and underutilization of vaccines, according to Dr. Suchit Bagde, a Nagpur-based pediatrician.