A devastating audit has revealed critical failures in Madhya Pradesh's drug regulatory system, the epicenter of a recent cough syrup tragedy that claimed the lives of at least 21 children. The audit's findings highlight a systemic collapse in the mechanisms designed to protect public health, exposing a chain of negligence that extended from manufacturing to distribution.

The crisis began in August 2025 when children in the Chhindwara district started exhibiting symptoms of acute kidney failure. These cases were soon linked to Coldrif cough syrup, manufactured by Sresan Pharmaceuticals in Tamil Nadu. Laboratory analysis revealed that the syrup contained a staggering 48.6% concentration of diethylene glycol (DEG), a toxic industrial solvent, far exceeding the permissible limit of 0.1% for medicinal formulations. DEG is a poisonous substance that can cause serious kidney damage and severe brain damage.

The Madhya Pradesh government has banned the sale and distribution of Coldrif syrup and all other medicines manufactured by Sresan Pharmaceuticals. Other states, including Rajasthan, Maharashtra, Punjab, Kerala, Tamil Nadu, Uttar Pradesh, and Jharkhand, have also extended the ban.

The audit has brought to light a series of lapses that contributed to the tragedy. These include:

• Substandard raw materials: Investigations suggest that the use of substandard raw materials in the manufacturing process may have directly contributed to the contamination.
• Inadequate quality assurance: Severe lapses in quality assurance protocols at Sresan Pharmaceuticals allowed the contaminated syrup to reach the market.
• Failure of drug inspectors: In Madhya Pradesh, two drug inspectors were suspended for knowing about the adulteration but failing to act.
• ** তামিল Nadu regulatory failures:** A Comptroller and Auditor General (CAG) report last year red-flagged persistent shortfalls in drug testing in Tamil Nadu. Between 2016-17 and 2020-21, inspectors conducted only about 61% of scheduled drug inspections and collected roughly 49% of the required samples for quality testing. The report, which was tabled in the state Assembly on December 10, 2024, highlighted weaknesses in the drug regulatory ecosystem.
• Prescribing of the syrup: A government doctor in Chhindwara was arrested for prescribing the adulterated syrup to many of the deceased children at his private clinic.

In response to the tragedy, the Madhya Pradesh government has taken the following actions:

• Suspended two drug inspectors and a deputy director of Food & Drug Administration.
• Transferred a drug controller.
• Launched a campaign to recover the drug from households.
• Announced a compensation of ₹4 lakh for each deceased child's family and promised to cover medical expenses for all affected children.

The Drugs Controller General of India (DCGI) has ordered a nationwide review of Sresan Pharmaceuticals' products and initiated random testing of cough syrups produced by other manufacturers. The Central Drugs Standard Control Organisation (CDSCO) is launching a nationwide inspection and audit of cough syrup manufacturers. Authorities are seeking expert input and a streamlined monitoring system to tighten regulations and prevent future incidents.

The owner of Sresan Pharma has been arrested in Chennai. A Special Investigation Team (SIT) formed by the Madhya Pradesh government is tracing the entire supply chain, including chemical suppliers, distributors, and stockists linked to the Coldrif syrup.

This tragedy marks India's sixth recorded case of diethylene glycol (DEG) poisoning. The incident has raised serious questions about the effectiveness of India's drug regulation system and the safety of pharmaceutical products.