[Answered] Critically analyze the role of regulatory and oversight gaps in recurrent public health tragedies like contaminated medicines. Examine the reforms needed to strengthen drug control mechanisms.

Introduction

According to the WHO (2023), 1 in 10 medical products in low- and middle-income countries is substandard or falsified. Indias recurring contaminated syrup tragedies expose deep regulatory and institutional fragilities.

The Recurring Public Health Tragedy: A Regulatory Failure

1. Historical continuity: Since 1986, India has faced at least five major diethylene glycol (DEG) contamination episodes — from Mumbais J.J. Hospital deaths to incidents in The Gambia (2022) and Uzbekistan (2023).
2. Recent episode: The 2024 Coldrif cough syrup deaths in Madhya Pradesh and Rajasthan again exposed the lack of proactive quality assurance. DEG, a toxic solvent used industrially, continues to leak into pharmaceutical supply chains.
3. Systemic lapse: Instead of targeting negligent manufacturers, enforcement agencies often scapegoat frontline practitioners—highlighted by the arrest of a government paediatrician instead of accountability within drug regulatory frameworks.

Role of Regulatory and Oversight Gaps

1. Fragmented regulatory structure: India has a dual regulatory system — the Central Drugs Standard Control Organisation (CDSCO) and State Drug Controllers — leading to overlaps and poor coordination. State authorities often lack laboratory capacity, manpower, and autonomy.
2. Lax enforcement of standards: The Schedule M (Good Manufacturing Practices) guidelines remain poorly implemented; only 15% of licensed units reportedly comply with full GMP norms (PIB, 2023).
3. Inadequate surveillance mechanisms: The Pharmacovigilance Programme of India (PvPI) lacks timely recall mechanisms and post-market surveillance. Risk-based inspections are infrequent and often reactive, following deaths rather than anticipating failures.
4. Weak international credibility: The WHO global alert (2022) on Indian-made syrups linked to child deaths in The Gambia and Uzbekistan dented Indias image as the pharmacy of the Global South. Export regulatory oversight is inconsistent — many small firms bypass stringent testing protocols for cost efficiency.
5. Ethical and governance deficit: The absence of corporate accountability and public disclosure norms encourages underreporting. Lack of whistleblower protection further erodes institutional transparency.

Broader Public Health and Ethical Implications

1. Violation of Right to Health: As recognized in Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996), access to safe medicines is integral to Article 21s Right to Life.
2. Erosion of public trust: Repeated incidents weaken public confidence in both domestic and export drug markets, undermining health diplomacy.
3. One Health dimension: Poor pharmaceutical waste management and chemical contamination have spillover effects on ecosystems and food safety, expanding the risk to zoonotic health.

Reform Measures to Strengthen Drug Control Mechanisms

1. Institutional restructuring: Establish a National Drug Authority on the lines of the U.S. FDA, ensuring uniform licensing, inspection, and recall powers.
2. Digital and AI integration: Use blockchain-based supply chain monitoring and AI-enabled pharmacovigilance to detect anomalies in real-time.
3. Legislative modernization: Expedite passage of the Drugs, Medical Devices and Cosmetics Bill, 2023, which mandates stringent compliance, penalizes non-conformity, and enhances recall provisions.
4. Capacity building: Enhance testing infrastructure—India has only 38 central and state drug laboratories for over 10,000 manufacturing units.
5. International collaboration: Align domestic standards with WHO-GMP certification and PIC/S guidelines to ensure global credibility.
6. Public transparency: A publicly accessible Drug Quality Index can ensure accountability and empower consumers.

Conclusion

As Amartya Sens Development as Freedom asserts, real development expands human capabilities. Ensuring drug safety through robust regulation embodies freedom from preventable suffering—a moral and constitutional imperative for Indias health sovereignty.