Contaminated Cough Syrup Crisis in India
Recent deaths of children in Rajasthan and Madhya Pradesh due to contaminated Coldrif cough syrup highlight significant issues in India's pharmaceutical quality control.
Key Incident Details
- Lab tests found diethylene glycol (DEG) levels up to 48.6% in the syrup.
- World Health Organization (WHO) links similar contamination to over 300 child deaths globally since 2022.
- DEG is lethal, often used in antifreeze and brake fluids, causing kidney failure.
Manufacturing and Distribution Failures
- Good Manufacturing Practices (GMP): Existing protocols should prevent such contamination, requiring rigorous testing and quality checks.
- Supply Chain Vulnerabilities: The contaminated batch moved from Sresan Pharmaceuticals, Tamil Nadu, through various intermediaries without proper checks.
- Storage Conditions: Emphasis on quality control in storage is lacking, especially for OTC medications.
- Track and Trace Systems: Slow systemic response to the issue, highlighting inadequate distribution network frameworks for rapid identification and recall.
Medical and Pharmacy Responsibilities
- Medical Responsibility: Arrest of a senior paediatrician raises questions about systemic failures in prescribing medications safely.
- Pharmacy Practice: Requires a shift towards active pharmaceutical care rather than mere medication dispensation.
Public Awareness and Health Communication
- Low Patient Awareness: There is a need for better communication about medication safety and adverse effects in local languages.
- Health Campaigns: Must prioritize pharmaceutical safety and awareness, particularly for vulnerable populations.
Recommendations for Improvement
- Quality Focus: Proactive measures and matching production capacity with quality assurance capabilities are essential.
- Regulatory Reforms: Need for unannounced inspections, random batch testing, and severe penalties for non-compliance.
- Improved Training and Testing: Strengthening state drug control systems with better training and modern facilities.
- National Warning System: Development of a comprehensive adverse event-reporting system for quicker identification of problematic drugs.
India's standing as a global pharmacy relies on ensuring the safety of its medicines domestically. Neglecting this responsibility could undermine trust both nationally and internationally.
