A Night cough, Day of Mourning

 Night cough leads to Day of mourning

DR B.S.CHAKRAVARTHY

Professor and HOD Department of pediatrics Andhra Medical College/KGH

13/10/2025

I am writing with a heavy heart. Several recent child deaths linked to contaminated cough syrup are a stark reminder that medicines meant to heal can become poisons when quality systems fail. Investigations in Madhya Pradesh found a locally sold cough syrup with diethylene glycol (DEG) at levels nearly 500 times above the permitted limit, and two other syrups were also reported contaminated. National authorities halted production at the implicated plants; the World Health Organization has issued a global alert so that any stray stocks are identified and removed. These tragedies echo earlier international incidents tied to DEG/ethylene glycol contamination and point to systemic lapses in raw-material sourcing, testing of finished syrups, and supply-chain vigilance. (Reuters)

As a pediatrician, I have seen how DEG poisoning presents: a child with fever and cough is given a “simple” syrup; within hours to days there is vomiting, lethargy, decreased urine output, progressing to acute kidney injury and metabolic acidosis. The link is often missed until multiple cases cluster. These poisonings are preventable. International and Indian standards limit DEG/EG in oral liquid medicines to trace levels; the problem is not lack of rules but gaps in compliance—especially failure to test each batch of solvents like glycerin or propylene glycol and, critically, the final bottled product. In the current episode, regulators have now moved to mandate DEG/EG testing in finished syrups, alongside raw-material checks, and have launched risk-based inspections of manufacturers across states. (OC Academy)

Closer to home, in Andhra Pradesh—specifically Visakhapatnam—drug control officials have seized 5,900 bottles of a pediatric cold/cough syrup from a wholesale agency. The combination was prohibited for children under four years and the product lacked mandated warnings; this action reflects heightened vigilance after the national alerts. While these seized bottles were not the same brands linked to the deaths, the enforcement sends an important signal: pediatric cough and cold products must meet safety, labeling, and prescription requirements before they reach our children. (The New Indian Express)

For parents and caregivers, my advice is simple and strict. Do not give over-the-counter cough or cold syrups to young children, especially those under five years, unless prescribed by a qualified doctor. For a routine viral cough, prefer non-drug measures: fluids, honey for children over one year, saline nasal drops, humidified air, and watchful waiting. If any medicine is prescribed, check the brand name, batch number, and expiry on a properly printed label; avoid unsealed or decanted bottles. Seek care immediately if the child develops persistent vomiting, drowsiness, reduced urine, fast breathing, or unusual behavior after taking a syrup. Keep the bottle and prescription so the treating team can trace the source if needed. These small steps can save lives when minutes matter. (Partnership for Safe Medicines)

For my colleagues in healthcare, we must prescribe judiciously and document precisely. Avoid fixed-dose cough/cold combinations in young children that offer little benefit and potential harm. When you do prescribe a syrup, specify brand and manufacturer, record batch numbers when feasible in hospital settings, and counsel families about warning signs and safe storage. Report any suspected adverse drug reaction or cluster of unexplained renal failure immediately to pharmacovigilance and state drug control authorities; rapid notification is how these outbreaks are detected and stopped. In our wards, when unexplained AKI appears in multiple children with a recent history of cough syrup use, send the product for laboratory analysis, manage aggressively with fluid/electrolyte correction and dialysis when indicated, and alert infection-control and hospital administration the same day. (U.S. Food and Drug Administration)

For manufacturers, this is the moment to go beyond minimal compliance. Test every incoming lot of excipients such as glycerin, sorbitol, and propylene glycol using validated methods that can detect trace DEG/EG; reject any supplier that cannot produce authentic certificates of analysis with audit trails. Just as important, test every batch of the finished, bottled product for DEG/EG before release; contamination can occur during compounding, bottling, or due to adulterated diluents, so raw-material testing alone is not sufficient. Strengthen vendor qualification, serialization, and tamper-evident packaging; maintain complete electronic batch records; and ensure that labeling and age-specific warnings meet current requirements. When a failure is detected, recall fast and communicate transparently with regulators, clinicians, and the public. The credibility of India’s pharma industry depends on this. (The Times of India)

For distributors and the supply chain, store only from licensed manufacturers and approved distributors, never from grey markets. Keep temperature-appropriate storage, maintain batch-wise logs, and refuse products without complete documentation. Cooperate with surprise inspections, quarantine suspect stocks immediately, and participate in trace-and-recall drills so that when alerts come, action is measured in hours, not weeks. Recent enforcement actions—including license cancellations and warehouse seizures tied to the implicated syrups—show what happens when this discipline breaks. (The Times of India)

In Andhra Pradesh and the Visakhapatnam region, we are coordinating closely with the Drugs Control Administration. At AMC/KGH, I have asked our teams to implement a standing protocol: no routine pediatric use of OTC cough/cold syrups in hospital formularies; pharmacy verification of age-appropriateness and labels at issue; a red-flag alert to nephrology and PICU for any cluster of AKI in children; immediate preservation and testing of suspect products through accredited labs; and real-time reporting to state regulators and pharmacovigilance. We are also running caregiver education in OPDs on non-drug cough care and safe medicine practices. The recent seizures in Vizag affirm that vigilance is active locally; we will keep working with authorities to ensure suspect products are kept out of homes and hospitals. (The New Indian Express)

Finally, I want to speak directly to families. A child’s cough is frightening, but most are viral and self-limited; the bottle on the chemist’s shelf is not always the answer. Trust your pediatrician, ask questions, and keep records of what your child takes. And to our partners in industry and regulation: the bar must be set at zero tolerance for contamination. The children we lost demand that we learn fast and fix the system—so that a night cough never again ends in a day of mourning. (Reuters)