Pharmaceutical Safety Crisis in India: Lessons from the Coldrif Cough Syrup Tragedy
Pharmaceutical Safety Crisis in India: Lessons from the Coldrif Cough Syrup Tragedy
The tragic deaths of children due to contaminated cough syrup have once again exposed vulnerabilities in India’s pharmaceutical safety framework. At least sixteen children, most under five years of age, lost their lives after consuming Coldrif cough syrup manufactured by Sresan Pharmaceuticals in Tamil Nadu. Laboratory investigations revealed that the contaminated batch contained a staggering 48.6% diethylene glycol (DEG), nearly 480 times the permissible limit of 0.1%. This alarming incident highlights not only regulatory and manufacturing lapses but also the urgent need for reforms to protect public health in India.
Understanding the Toxic Contaminants: DEG and EG
Diethylene glycol (DEG) and ethylene glycol (EG) are industrial solvents, commonly used in products such as brake fluids, antifreeze, paints, plastics, and certain household chemicals. While useful in industrial processes, they are highly toxic to humans and have no role in medicinal formulations.
In contrast, propylene glycol is the standard pharmaceutical-grade solvent used safely in syrups to dissolve active ingredients. Unfortunately, some manufacturers substitute DEG or EG for propylene glycol because it is cheaper, creating a deadly risk. Once ingested, DEG is metabolized in the liver into toxic compounds such as oxalic acid. These metabolites crystallize in the kidneys, blocking tubules and causing rapid kidney failure. Death can occur within days, especially in young children, highlighting the lethal consequences of such contamination.
India’s Troubled History with Toxic Syrups
The Coldrif tragedy is part of a distressing historical pattern in India:
- 1998: Thirty-three children died in Gurugram, Haryana, after consuming syrup contaminated with DEG, and 150 children in Delhi suffered acute kidney failure.
- 2020: Seventeen children died in Ramnagar, Jammu and Kashmir, due to DEG-tainted cough syrup.
- 2022: Indian-made cough syrups were linked to seventy child deaths in The Gambia and eighteen in Uzbekistan, raising international alarm.
Despite repeated warnings, these incidents indicate systemic gaps in both drug manufacturing oversight and regulatory enforcement. The recurrence of such tragedies underlines the critical need for proactive and preventive measures.
Regulatory Framework and its Shortcomings
India’s pharmaceutical regulation operates under the Drugs and Cosmetics Act, 1940, and the accompanying Drugs and Cosmetics Rules, 1945. It follows a dual control model: the Central Drugs Standard Control Organisation (CDSCO), led by the Drugs Controller General of India (DCGI), manages licensing, new drug approvals, and policy direction. Meanwhile, State Drug Controllers oversee local manufacturing licenses, inspections, and enforcement.
Schedule M of the Rules prescribes Good Manufacturing Practices (GMP), detailing requirements for premises, equipment, hygiene, documentation, and quality assurance. These standards are mandatory to ensure drugs meet safety, efficacy, and quality benchmarks. Yet, inconsistent implementation across states often leaves regulatory enforcement uneven, allowing unsafe drugs to enter the market.
Major Issues and Structural Challenges
India’s dual regulatory system, while designed for decentralization, leads to uneven oversight. While CDSCO sets national standards, their enforcement depends heavily on the capacity of State Drug Controllers, resulting in variability in drug safety. Some states may rigorously enforce GMP, while others struggle with resource constraints, creating loopholes that compromise national safety.
A 2023 parliamentary review revealed that almost half of India’s state drug testing laboratories lack adequate equipment and qualified personnel. Many operate with outdated techniques, limiting their ability to detect harmful contaminants in time. These infrastructural and staffing deficits exacerbate systemic vulnerabilities, particularly in remote or underserved regions.
The detection of 48.6% DEG in Coldrif syrup indicates deliberate adulteration rather than accidental contamination. Systemic weaknesses make such malpractice possible, including:
- Insufficient testing of raw materials at manufacturing facilities.
- Compromised supply chains with substandard or mislabeled ingredients.
- Cross-contamination due to improperly cleaned equipment.
- Intentional substitution of industrial-grade solvents for profit maximization.
Weak accountability structures, where the focus is on license cancellation rather than criminal prosecution, allow negligent practices to persist.
Implementing GMP and other regulatory standards requires significant capital investment. Small and medium pharmaceutical enterprises often lack financial resources to upgrade facilities or adopt modern testing methods. Without support mechanisms such as low-interest loans or subsidies, many small firms may be unable to comply, creating a paradox where safety measures may unintentionally threaten the viability of smaller manufacturers.
Government Response and Reforms
Following the Coldrif incident, the Union Health Ministry enforced stricter adherence to revised Schedule M and GMP norms, effective from December 31, 2025. The new regulations mandate:
- Quality Risk Management to identify and mitigate contamination risks.
- Supply Chain Traceability to ensure accountability from raw material sourcing to finished product.
- Mandatory DEG/EG Testing to prevent toxic contamination.
- Data Integrity Protocols and Pharmacovigilance Systems for real-time monitoring.
Several state governments also took action. Rajasthan banned cough syrups containing Dextromethorphan for children under five, while Madhya Pradesh prohibited Coldrif syrup statewide and requested a detailed investigation at the Kanchipuram facility. The Health Ministry advised against prescribing cough-cold medications for children under two and emphasized careful dosing and clinical supervision for those up to five years old. Non-compliant manufacturers now face license suspension or cancellation, signaling a stronger commitment to accountability.
The Way Forward: Building a Safer Pharmaceutical Ecosystem
The Coldrif tragedy demonstrates that comprehensive reforms are required to ensure pharmaceutical safety:
- Unified Regulatory Authority: Consolidating enforcement under CDSCO or a new Unified Drug Safety Authority can harmonize safety standards nationwide.
- Equal Standards for Domestic and Export Markets: The stringent testing applied to exported drugs should be mandatory for domestic sales as well.
- Laboratory Modernization: State drug testing facilities must receive advanced analytical instruments and training for personnel.
- Financial Support for SMEs: Loans, subsidies, and technical support can help smaller firms achieve compliance without risking business closure.
- Centralized Pharmacovigilance: A national system linking hospitals, pharmacies, and regulators can detect adverse reactions or contaminated batches in real time.
- Criminal Accountability: Corporate promoters and responsible personnel must face legal consequences, ensuring deterrence beyond license cancellation.
Conclusion
The deaths caused by contaminated Coldrif cough syrup reveal deep-rooted vulnerabilities in India’s pharmaceutical safety framework. While the government’s push for stricter GMP and Schedule M compliance is a significant step forward, true reform requires consistent enforcement, modernized infrastructure, and robust accountability mechanisms.
India’s reputation as the “Pharmacy of the World” depends on trust, quality, and safety. Medicines are meant to heal, never harm, and this principle must guide every aspect of drug manufacturing and regulation. By combining technological upgrades, financial support, and legal accountability, India can prevent future tragedies and ensure the safety of its most vulnerable citizens, its children.