The death of 12 children in two states — Madhya Pradesh and Rajasthan — from a deadly toxin detected in the cough syrups prescribed to them shows what ails drug regulation in the country. 

Background

• The tragedy occurred after children consumed the Coldrif, cough syrup.
• Contaminant: Laboratory tests confirmed that the syrup was contaminated with Diethylene Glycol (DEG).
  • DEG is a toxic industrial solvent commonly used in antifreeze agents and brake fluids. It causes severe damage to the liver, kidneys, and nervous system.
• Levels: The Coldrif syrup was found to contain 48% DEG, which is 480 times higher than the permitted limit of 0.1%.
• Domestic and Global Precedent: Similar incidents have occurred earlier — Indian-manufactured cough syrups caused deaths in Gambia and Uzbekistan India also witnessed DEG contamination crises in 1986 and 1998.
• Industrial Negligence: The case is seen as a clear instance of industrial negligence and poor manufacturing practices, as the company reportedly sold this syrup for nearly 20 years.

Challenges in Drug Regulation

• Dual Regulation and Accountability: India’s drug regulation system is divided between the Central Drugs Standard Control Organisation (CDSCO) and State Drug Controllers. 
  • This dual structure results in poor coordination, unclear inspection routines, and missing accountability. 
  • The lack of regulatory clarity allowed Coldrif to remain in circulation for two decades.
• Self-Medication: There is a possibility that the deaths resulted from instances of self-medication by parents, coupled with the neglect of a 2013 health advisory that cautioned against administering Coldrif to children below four years of age.

Way Forward

• Mandatory Batch-Level Testing: Every new batch of drugs should be subjected to compulsory laboratory testing.
• Ensuring Safety Through Random Contaminant Audits: Random audits must be conducted to specifically check for contaminants such as DEG.
• Clear Regulatory Hierarchy: A clear hierarchy with well-defined responsibilities must be established between central and state regulators.
• Criminal Prosecution: Negligent companies should face a lifetime ban, and their directors must be held criminally accountable through prosecution and imprisonment.

Conclusion

Such contamination incidents threaten to erode India’s reputation as the “Pharmacy of the World.” Restoring global confidence requires strict regulatory enforcement and unwavering commitment to pharmaceutical safety.

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