The recent deaths of at least 14 children in Madhya Pradesh, linked to the cough syrup Coldrif, have exposed critical failures within the state's drug regulation and monitoring system. The tragedy has raised serious questions about the oversight of pharmaceutical manufacturing and distribution, potentially endangering public health.
The outbreak, which began in August 2025, saw children predominantly from the Chhindwara district develop acute kidney failure after consuming Coldrif syrup, manufactured by Sresan Pharmaceuticals in Tamil Nadu. Investigations revealed that the syrup contained a staggering 48.6% of diethylene glycol (DEG), a toxic industrial solvent used in antifreeze and brake fluid. The permissible limit for DEG in cough syrup is less than 0.1%. DEG is highly toxic, and even small amounts can cause kidney damage, vomiting, abdominal pain, and altered mental states, potentially leading to death.
A timeline of critical lapses reveals a system struggling to protect its citizens. Doctors in Nagpur raised concerns about DEG poisoning as early as September 22nd, yet the Madhya Pradesh government denied any connection between the syrup and the deaths until October 3rd. This was when a Tamil Nadu drug testing laboratory confirmed the presence of the toxic substance and flagged over 364 manufacturing violations at Sresan Pharmaceuticals. The delay in response proved fatal, as children continued to consume the contaminated syrup.
Further investigation revealed that the Madhya Pradesh Food and Drug Administration (MPFDA) collected samples on September 26th but did not release its test report until October 4th, after Tamil Nadu had already banned Coldrif. This sluggish response highlights a lack of coordination and efficiency within the drug regulatory framework.
In response to the crisis, the Madhya Pradesh government has taken some measures, including arresting a doctor who prescribed the medicine and initiating action against three officials. A criminal case has been registered against Sresan Pharma, with charges including culpable homicide, drug adulteration, and violations of the Drugs and Cosmetics Act. If convicted, the company and its officials could face fines and jail terms.
The incident has triggered a nationwide investigation into pharmaceutical safety and regulatory failures. The Central Drugs Standard Control Organisation (CDSCO) has conducted risk-based inspections at manufacturing units across six states, focusing on 19 drugs, including cough syrups and antibiotics. The federal Health Ministry convened an emergency meeting with state health secretaries and drug control officials to enforce stricter oversight of cough syrup production, promote rational prescribing practices, and expand surveillance systems.
This is not an isolated incident. Contaminated cough syrups manufactured in India have been linked to the deaths of children in Gambia and Uzbekistan in 2022-2023. Similar tragedies involving DEG-contaminated medications have occurred in Nigeria, Haiti, and Jammu and Kashmir. These recurring incidents underscore systemic issues within India's pharmaceutical industry, including cost-cutting measures and poor quality control.
The Madhya Pradesh tragedy highlights the urgent need for comprehensive reforms in the drug regulatory system. This includes stricter enforcement of manufacturing standards, rigorous testing protocols, and improved coordination between state and central drug control agencies. Failure to address these systemic weaknesses will leave vulnerable populations at continued risk from unsafe medications.
