Pharmaceutical Oversight Gaps and Public Health Risks

Context

• Incident: Adulterated cough syrup Coldrif caused 20 child deaths in Madhya Pradesh, mainly in Chhindwara (17), Betul (2), and Pandhurna (1). Five children remain under treatment for kidney failure.
• Culprit: Sresan Pharmaceuticals (Tamil Nadu) — syrup contaminated with over 45% diethylene glycol, a toxic chemical.
• Timeline:
  • Recent deaths: 2 children died on Tuesday, 1 on Monday, 17 prior deaths.
  • States affected: Madhya Pradesh and Rajasthan.

Relevance

• GS2 – Governance & Public Policy
  • Regulatory governance of pharmaceuticals (CDSCO, Schedule M, CAPA, ONDLS).
  • Accountability and legal frameworks for public health.
  • Role of judiciary in ensuring public safety.
• GS3 – Health & Human Development
  • Child health, toxicology, pharmaceutical quality management.
  • Public health policy, preventive measures, emergency response systems.
  • Importance of research and quality standards in MSME pharma.

Key Issues Highlighted

1. Drug Safety and Regulatory Compliance
   1. Schedule M (Revised): Central govt’s pharmaceutical manufacturing regulations include:
      1. Corrective and Preventive Action (CAPA): Quality management methodology to investigate and resolve manufacturing issues.
      2. Online National Drugs Licensing System (ONDLS): Digital, single-window licensing system for uniform approval processes across states.
   2. Current Status:
      1. 18 state drug authorities have adopted ONDLS.
      2. No state fully compliant with CAPA guidelines, crucial for proactive quality maintenance.
      3. 3,838 of 5,308 MSME pharma companies comply with revised Schedule M GMP.
2. Regulatory Failures
   1. Manufacturer allegedly blacklisted earlier but still supplied syrup.
   2. Gaps in inspection and monitoring allowed toxic syrup to reach children.
3. Legal & Ethical Dimensions
   1. Arrest of Dr. Praveen Soni (paediatrician) for prescribing the syrup triggered a doctors’ strike, highlighting:
      1. Debate over liability: prescribing vs. manufacturing.
      2. Doctors demand action against manufacturers, not individual prescribers.
   2. Special Investigation Team (SIT) formed to probe the case.
4. Political & Social Response
   1. Congress demands judicial probe and compensation to victims’ families.
   2. State government committing to cover treatment costs.
   3. Public outrage over preventable child deaths.

Underlying Causes

• Toxic Contaminant: Diethylene glycol — causes acute kidney failure, liver damage, death.
• Weak Regulatory Enforcement:
  • Poor CAPA implementation.
  • Incomplete adoption of ONDLS & Schedule M compliance checks.
• Systemic Issues in Pharma Oversight:
  • Small and medium pharma units often inadequately monitored.
  • Lack of real-time auditing and accountability mechanisms.

Policy and Governance Dimensions

1. Strengthen Drug Regulation
   1. Ensure full CAPA compliance across all states.
   2. Strict enforcement of GMP (Good Manufacturing Practices), inspections, and penalties.
   3. Continuous monitoring via ONDLS and digital tracking of pharmaceutical products.
2. Liability Clarity
   1. Distinguish prescriber vs manufacturer responsibility in legal and policy frameworks.
   2. Create guidelines to protect healthcare providers from undue criminalisation when prescribing approved drugs.
3. Public Health Measures
   1. Immediate recall of toxic batches.
   2. Emergency treatment protocols for affected children.
   3. Awareness campaigns on risks of unverified or adulterated medicines.
4. Judicial Oversight
   1. Demand for judicial probe to investigate negligence in production, approval, and distribution.
   2. Compensation mechanisms for victims and families.
5. Long-Term Measures
   1. Strengthen pharmaceutical quality audits and lab testing infrastructure.
   2. Mandatory digital tracking of drug batches.
   3. Training and accountability for drug inspectors and regulators.