[Answered] Discuss the growing concern about spurious and substandard drugs in India and their implications for public health and governance. Suggest measures that state governments should take to address this issue.

India, often called the ‘pharmacy of the world,’ is grappling with a growing crisis of spurious and substandard (NSQ) drugs. Recent incidents in Karnataka and West Bengal, where contaminated ringer lactate solution caused multiple deaths, highlight systemic failures in drug regulation. Despite the severe public health risks and political fallout, states have not taken adequate steps to reform their drug regulatory mechanisms.

Implications for Public Health and Governance

• Public Health Risks: Spurious drugs lead to prolonged illness, treatment failures, and fatalities. Contaminated injectables pose immediate life-threatening risks. Antimicrobial resistance is exacerbated by substandard antibiotics.
• Regulatory and Legal Failures: The fragmented regulatory framework under the Drugs & Cosmetics Act, of 1940, creates inefficiencies, as 37 different state regulators lack coordination. The absence of a national mandatory recall system delays the removal of dangerous drugs from the market. The Jan Vishwas Act (2023) weakens deterrence by making NSQ drug sales a compoundable offense, allowing offenders to escape with a meager ₹20,000 fine.
• Political and Economic Fallout: Deaths due to contaminated drugs lead to public outrage and political backlash. India’s reputation as a global pharmaceutical hub is at risk, impacting exports.

Measures for State Governments

• Mandatory Drug Recalls and Regulatory Action: Impose recall duties on drug inspectors, leveraging Sections 18A, 18B, and 22(c) of the Drugs & Cosmetics Act. Conduct surprise inspections and enforce stricter penalties on violators.
• Improving Transparency and Public Awareness: Publish recall details, including batch numbers, in newspapers and electronic media. Require senior health officials to provide public updates on recall actions.
• Enhanced Market Surveillance and Testing: Increase drug sample testing, prioritizing high-risk medicines like injectables and antibiotics. Adopt a targeted sampling strategy, similar to Tamil Nadu’s model.
• Legal and Policy Reforms: Demand a national recall law to ensure faster removal of NSQ drugs. Strengthen inter-state data sharing to prevent drugs failing in one state from circulating in another.

Conclusion

State governments must act decisively to eliminate substandard drugs through rigorous recalls, increased transparency, and stricter enforcement. Without urgent reforms, public health risks will persist, eroding trust in India’s healthcare system and pharmaceutical industry.