New Delhi, India — The World Health Organization has alerted the public regarding three cough syrups that may have contributed to multiple child fatalities in India over the past month. This advisory, issued on Monday, highlights specific batches of the products Coldrif, Respifresh TR, and ReLife, which were produced by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma.
Testing revealed that these oral preparations contained dangerous levels of diethylene glycol (DEG), a substance known for its toxicity, particularly in young children. The WHO’s findings have raised serious concerns, as toxic levels in medications produced in India are not a novel issue. Earlier this year, the international community noted similar problems when cough syrups exported from India were linked to the deaths of dozens of children in both Uzbekistan and The Gambia.
In response to the recent advisory, Indian state authorities have taken decisive steps, directly halting production at the implicated companies. Product authorizations have also been suspended, and contaminated batches have been recalled, ensuring they are not distributed further. The WHO emphasized that there is no indication of illegal export of these dangerous products at this time. However, it cautioned global health authorities to remain vigilant regarding potential risks associated with unregulated supply chains from these manufacturers.
The situation intensified following reports from Tamil Nadu, where Sresan Pharmaceuticals operates. Investigations revealed that at least 19 children in Madhya Pradesh suffered severe health complications and subsequently died after using Coldrif syrup. Ajau Pandey, a local health official, detailed that symptoms began with common respiratory issues before escalating to renal failure, leading to fatalities.
In the wake of the discoveries, law enforcement in Tamil Nadu arrested the owner of Sresan Pharmaceuticals. Additionally, two senior drug inspectors were stripped of their licenses after failing to conduct necessary inspections of the pharmaceutical plants, with disciplinary measures expected to follow. Superintendent Pandey noted ongoing investigations targeting a physician from Tamil Nadu who prescribed the problematic syrup.
The WHO’s warning emerged after the agency identified clusters of acute illnesses and child fatalities in India in late September. Shortly thereafter, India’s Central Drugs Standard Control Organization confirmed finding DEG in at least three cough syrups frequented by affected children.
This is not the first time India has faced scrutiny over its pharmaceutical sector. In late 2022, the production of cough syrups from Maiden Pharmaceuticals was halted after various brands were discovered to contain dangerously high concentrations of hazardous chemicals. Those products are believed to have been involved in the deaths of over 60 children in The Gambia and around 20 in Indonesia.
The recent episode underscores the urgent need for strict oversight and regulatory compliance within India’s vast generic pharmaceutical industry, raising alarms about the safety and quality of medications reaching vulnerable populations.