When Medicine Turns Poison - the Urgent Need for a New Quality Paradigm in Indian Pharmaceuticals

Once again, the nation grieves. The recent Chhindwara, Madhya Pradesh tragedy - where at least 21 children died after consuming cough syrups tainted with diethylene glycol (DEG) - is a grim reminder that history keeps repeating itself. Despite decades of lessons and regulatory reform, toxic solvents continue to infiltrate medicines meant to heal.

This episode follows a long line of catastrophes: the Coldbest-PC poisoning in 2020 (Jammu & Kashmir), Gurgaon (1998), and Mumbai (1986) - each claiming innocent lives, mostly children, through the same chemical villain. The international parallels are equally distressing: The Gambia (2022), Uzbekistan (2022), Indonesia (2022), and Panama (2006). The pattern is depressingly consistent - industrial-grade solvents masquerading as pharmaceutical excipients, weak oversight, and inadequate analytical vigilance.

DEG and its cousin ethylene glycol (EG) are sweet tasting, viscous liquids commonly used in antifreeze and industrial solvents. Their similarity to pharmaceutical grade glycerin and propylene glycol makes them ideal for fraudulent substitution. Even trace contamination (≥0.1%) can be fatal; ingestion leads to acute renal failure, hepatic necrosis, metabolic acidosis, and death. The Coldrif sample from Chhindwara contained 48.6% DEG, over 500 times the permissible limit.

The Central Drugs Standard Control Organisation (CDSCO) responded swiftly. In a circular dated October 7, 2025, the Drug Controller General of India (DCGI) directed all State and UT drug controllers to ensure strict compliance with the Drugs Rules, 1945, mandating the testing of raw materials and excipients before use in manufacturing. The letter emphasized vendor qualification, record maintenance, and routine inspections to prevent such lapses.

Concurrently, the Indian Pharmacopoeia Commission (IPC) issued critical updates to the Indian Pharmacopoeia (IP) (Amendment List 09, October 10, 2025), inserting mandatory gas chromatographic (GC) testing for DEG and EG in all oral liquid formulations. The revised monographs now prescribe impurity limits of not more than 0.10% each for DEG and EG across excipients such as glycerin, propylene glycol, sorbitol (70%), and liquid maltitol.

This alignment with global pharmacopoeias (USP, BP, WHO) is a major step toward harmonization. Moreover, the introduction of official reference standards (IPRS) for DEG, EG, and key excipients now provides analytical laboratories with validated calibration materials -an important infrastructural advance.

Yet, the core of India’s pharmaceutical contamination crisis is not scientific - it is systemic. As highlighted in Chandramouli’s review (Diethylene Glycol Poisoning: A Review of Negligence, Death, and Regulatory Failure), the failures lie in fragmented enforcement, limited testing infrastructure, and supplier fraud. Certificates of Analysis are frequently falsified, and smaller manufacturers often bypass independent excipient testing due to cost pressures.

Compounding this is India’s dual regulatory system, where state drug authorities and the central regulator share overlapping jurisdiction - leading to inconsistent enforcement and delayed action. Routine gas chromatography screening remains rare, especially in small and medium enterprises that dominate India’s domestic syrup market.

While recent policy reforms - such as mandatory pre-export testing of cough syrups, adoption of revised Schedule M (WHO-GMP alignment), and risk-based inspections - represent progress, they remain reactive.Preventing future DEG tragedies demands a preventive, traceable, and digitally transparent ecosystem.

1. Mandatory Excipient Testing at Source: Each consignment of glycerin, propylene glycol, or sorbitol must be tested for DEG/EG before release to production - no exemptions.

2. Digital Supply Chain Traceability: Blockchain-based tracking of excipient batches, suppliers, and COAs can expose adulteration early.

3. Accredited Laboratory Network: Establishing a national network of GMP-compliant testing facilities under the IPC and CDSCO would enable affordable, real-time quality checks.

4. Severe Penalties and Accountability: Adulteration must be prosecuted as criminal homicide, not mere negligence, when resulting in deaths.

5. Public Transparency: The publication of quarterly quality bulletins, similar to FDA enforcement reports, would build public and global trust.

Every child lost to contaminated medicine is not just a regulatory failure - it is a moral indictment of complacency. The pharmacopoeial updates and DCGI advisories are encouraging, but without uncompromising implementation and ethical responsibility, they risk becoming bureaucratic checkboxes.

The Indian pharmaceutical sector - a global powerhouse by volume - must now prove itself a leader in safety and integrity. Science has given us the tools; it is discipline, transparency, and moral courage that will save lives.