Context: The Directorate General of Health Services (DGHS) under the Ministry of Health and Family Welfare has issued a fresh advisory to all States and Union Territories on the rational use of cough syrups in children. The move comes after reports of child deaths in Rajasthan and Madhya Pradesh, allegedly linked to syrups containing Dextromethorphan.
About Dextromethorphan
- Dextromethorphan (DXM) is a cough suppressant used in many over-the-counter syrups.
- It acts on the brain’s cough centre to reduce coughing but can cause serious side effects in children — such as drowsiness, breathing difficulty, and accidental overdose.
- Long-term effects on the developing brain remain unclear, making it unsafe for paediatric use.
Key Guidelines Issued by DGHS
- Avoid Routine Use: Most coughs in children are self-limiting and do not require medication.
- Age Restriction: Cough syrups must not be prescribed for children below two years.
- Clinical Evaluation: For older children, use only after proper medical evaluation — with accurate dosage and for the shortest possible duration.
- Avoid Polypharmacy: Syrups containing multiple drug combinations should be avoided.
- Non-Drug Remedies: Encourage hydration, steam inhalation, and rest as safer alternatives.
- Pharma Compliance: Manufacturers must strictly follow Good Manufacturing Practices (GMP) and use pharmaceutical-grade excipients.
Contamination and Safety Investigations
- The Health Ministry clarified that syrups linked to the incidents were free from diethylene glycol (DEG) and ethylene glycol (EG) — two highly toxic industrial chemicals responsible for several global poisoning incidents.
- In Rajasthan, the formulation in question contained Dextromethorphan, which is not recommended for children under national and WHO safety standards.
Chemical Toxicity Explained
- Diethylene Glycol (DEG): Used in antifreeze; causes kidney failure, neurological damage, and death.
- Ethylene Glycol (EG): Another toxic antifreeze component that leads to acute kidney injury if ingested.
Significance
- Reinforces paediatric drug safety and the need for rational prescription practices.
- Aims to prevent avoidable child fatalities from inappropriate or contaminated medicines.
- Strengthens pharmaceutical quality control and public health accountability.
Conclusion:
The DGHS advisory highlights India’s growing vigilance in paediatric pharmacovigilance. Rational use of medicines, strict enforcement of safety standards, and public awareness are key to protecting children from preventable drug-related tragedies.