UPSC Editorial Analysis: India’s Cough Syrup Tragedy

General Studies-2; Topic: Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

Introduction

• The deaths of at least 16 children in Madhya Pradesh and Rajasthan after consuming the Coldrif cough syrup have exposed glaring weaknesses in India’s drug manufacturing and regulatory ecosystem.
• The syrup reportedly contained 48% diethylene glycol (DEG)—an industrial solvent 480 times higher than the permissible limit of 0.1%. DEG, used in antifreeze and brake fluid, is lethal if ingested, causing kidney and liver failure.
• The tragedy is a grim reminder that India’s pharmaceutical prowess must be matched by strong regulatory vigilance and ethical accountability.

Root Causes Behind the Tragedy

• Deliberate negligence or cost-cutting by manufacturers
  • DEG and ethylene glycol are cheaper alternatives to pharmaceutical-grade glycerin or propylene glycol.
  • Manufacturers are aware of the toxicity, implying criminal negligence rather than ignorance.
• Weak compliance with Good Manufacturing Practices (GMP)
  • Many units still operate without registering under the revised GMP norms (Schedule M) despite multiple extensions by the government.
  • Inconsistent inspections and lax certification allow unsafe production to continue unchecked.
• Regulatory fragmentation
  • India’s drug regulation is split between the Central Drugs Standard Control Organisation (CDSCO) and state drug controllers.
  • Overlapping jurisdictions, limited staff, and inadequate lab capacity cause enforcement gaps.
• Erratic laboratory testing
  • Some early state lab tests found no contamination, raising doubts about testing reliability and sample integrity.
  • Uneven quality among state labs undermines trust in results.
• Irrational prescribing practices
  • Despite WHO and ICMR advisories that cough and cold medicines should not be given to children below five, many doctors and pharmacists routinely prescribe them.
• Weak deterrence and accountability
  • Prosecution after previous incidents has been minimal.
  • The low conviction rate encourages repeat violations.

Consequences and Wider Implications

• Humanitarian disaster and loss of public trust
  • The deaths of children have caused nationwide outrage and fear among parents.
  • It erodes faith in India’s medical system and domestic pharmaceutical products.
• Legal and human-rights dimension
  • Under Article 21 of the Constitution, citizens have a right to safe medicines. Failure of the state to prevent such deaths constitutes a violation of the right to life.
  • The National Human Rights Commission (NHRC) has issued notices to the concerned states.
• Damage to India’s global pharmaceutical reputation
  • India, known as the “pharmacy of the world,” faces scrutiny from importing nations.
  • WHO alerts after similar deaths in Gambia and Uzbekistan have already affected export credibility.
• Economic and legal repercussions
  • Export bans, trade barriers, and lawsuits could hurt India’s pharma sector, which contributes over 2% to GDP.
• Moral hazard in enforcement
  • The arrest of the prescribing doctor has triggered protests by the Indian Medical Association (IMA), which argues that the manufacturer and regulators should be held accountable instead of scapegoating individuals.

Systemic Gaps Exposed

• Inadequate regulatory capacity
  • Many state drug authorities lack skilled manpower and modern testing facilities.
  • The 2024 CDSCO inspection drive found that over one-third of manufacturing units violated norms and faced closure.
• Rule enforcement deficit
  • The Drugs and Cosmetics Act (1940) and Rules (1945) are outdated, and penalties are weak compared to the profits earned from non-compliance.
• Poor inter-agency coordination
  • Health departments, police, and laboratories often work in silos.
  • There is no unified database for unsafe drugs or recall alerts.
• Weak pharmacovigilance system
  • Post-marketing surveillance and reporting of adverse drug reactions are minimal.
  • Patients and doctors rarely report suspected drug toxicity.
• Lack of transparency and public alerts
  • Information about contaminated batches or regulatory violations is not proactively shared with consumers.

Way Forward

• Strict enforcement of revised GMP (Schedule M)
  • No further extensions; non-compliant units must be shut down.
  • Make GMP certification mandatory for both export and domestic production.
• Risk-based and surprise inspections
  • CDSCO has begun risk-based audits in multiple states, including Himachal Pradesh and Uttar Pradesh.
  • Random testing and unannounced inspections deter malpractice.
• Modernize laboratories and supply-chain tracking
  • Invest in accredited labs with advanced toxicology and spectroscopy facilities.
  • Introduce AI-based barcode tracking for raw materials and solvents.
• Fast-track prosecution and stricter penalties
  • Criminal cases against the manufacturers must be expedited under Section 27A of the Drugs and Cosmetics Act for adulteration.
  • Exemplary punishment can create deterrence.

• Regulation of pharmacies and OTC drugs
  • Enforce prescription-only sale of paediatric syrups.
  • Penalize chemists selling drugs without medical advice.
• Public reporting mechanisms
  • Create a national toll-free helpline and app for reporting suspected drug toxicity or spurious medicines.

• Single, autonomous national drug authority
  • Merge central and state regulatory powers into a unified body akin to the US FDA model for accountability and uniformity.
• Adopt global best practices
  • Align with WHO’s Medical Product Alert System and ensure every export batch is independently tested before shipment.

Conclusion

• The recurring tragedies caused by contaminated cough syrups reveal that India’s problem is not of lack of laws, but of enforcement and accountability.
• India’s pharmaceutical leadership can remain credible only when the safety of its citizens and children is placed above profit. Every life lost to a preventable regulatory failure is a collective national failure—and must never be repeated.