The Special Investigation Team (SIT) probing the Coldrif tragedy, which has claimed the lives of 23 children in Madhya Pradesh and other districts, has stated that the cough syrup contained "industrial-grade stuff". The SIT is now meticulously mapping the supply chain of the contaminated cough syrup, from the procurement of raw materials to its distribution, to determine accountability at each stage.
The investigation was launched following the deaths of children, primarily under the age of five, who suffered acute kidney failure after consuming Coldrif cough syrup. Laboratory tests revealed that the syrup contained a dangerously high concentration (48.6%) of diethylene glycol (DEG). DEG is a toxic industrial solvent typically used in products like brake fluids and antifreeze. The permissible limit of DEG is 0.1%, making the detected concentration nearly 480 times the acceptable level.
The owner of Sresan Pharmaceuticals, G. Ranganathan, a 75-year-old veteran in the pharmaceutical industry, was arrested in Chennai and brought to Madhya Pradesh on transit remand. The Tamil Nadu government has sealed Sresan Pharmaceuticals' facility in Sunguvarchatram, Kanchipuram district, after confirming the presence of DEG in the Coldrif syrup. Furthermore, they have initiated the process of permanently cancelling the company's license. An inspection report revealed over 360 major violations of Good Manufacturing Practices (GMP) at the facility, including the use of rusty equipment and non-pharmaceutical grade chemicals.
The Madhya Pradesh Police have registered a criminal case against Ranganathan under various sections of the Bharatiya Nyaya Sanhita. Authorities in several states have issued urgent alerts to seize all existing stocks of Coldrif syrup and other products manufactured by the firm to prevent further casualties.
In response to the crisis, multiple states have taken action. The Delhi government has banned the sale, purchase, and distribution of Coldrif cough syrup after it was declared "not of standard quality". The Kerala government also suspended the sale and distribution of Coldrif syrup. The Union Health Ministry has ordered strict compliance with revised Schedule M norms, which include updated GMP standards under the Drugs and Cosmetics Act, 1940. These norms, effective by December 31, 2025, mandate quality risk management, supply chain traceability, DEG/EG testing, data integrity, and pharmacovigilance systems.
The incident has raised serious concerns about the state of pharmaceutical safety oversight in India. The presence of such a high concentration of DEG suggests a deliberate substitution rather than accidental contamination, enabled by weak accountability enforcement and compromised supply chains. The Central Drugs Standard Control Organisation (CDSCO) is now scrutinizing state-level drug inspection mechanisms following revelations that Sresan Pharmaceuticals was allowed to operate for years despite major lapses.
