“Health is not merely the absence of disease — it is a social right, and its violation reflects the structural violence embedded in our institutions.”

In response to recent deaths of children linked to cough syrups contaminated with Diethylene Glycol (DEG), the Union Health Ministry has directed the strict implementation of revised Schedule M norms under the Drugs and Cosmetics Act, 1940. These norms are designed to overhaul drug manufacturing standards across India, aligning them with WHO Good Manufacturing Practices (GMP).

But beyond the technocratic vocabulary of “compliance,” “risk management,” and “data integrity,” this issue reveals deeper sociological questions:

• Who is responsible when public health fails?
• What does this say about state capacity, corporate accountability, and citizenship?
• How does global capitalism shape pharmaceutical safety?

Public Health as a Social Institution

Health is not just a biomedical concern — it is a social product shaped by class, governance, and institutional structures.

Talcott Parsons – Sick Role and Health as Functionality:

Parsons viewed health systems as functional prerequisites for society — keeping individuals productive. But when the health system itself fails, especially through preventable deaths due to poor-quality drugs, the functionalist ideal collapses.

• The DEG-linked deaths show that market forces have overtaken social responsibility.
• Children, the most vulnerable, suffer due to institutional neglect, violating the basic social contract.

➤ The pharmaceutical industry is failing in its social role — putting profits before people, in direct violation of the normative expectations of a welfare society.

State, Regulation, and Biopolitics

The revised Schedule M emphasizes quality control, data transparency (ALCOA+), and pharmacovigilance. But why were such reforms delayed until a crisis forced them?

Michel Foucault – Biopolitics and Governmentality:

Foucault explained how modern states exercise control over bodies and populations through subtle regulatory mechanisms — what he termed biopolitics.

• The Indian state, through Schedule M, is reasserting biopolitical control over drug manufacturing.
• However, the delay in enforcement, despite multiple incidents of adulterated drugs (in Gambia, Uzbekistan, India), reveals a weak regulatory state.

➤ Biopower is only effective when state capacity is matched with political will. In India, fragmented regulation and bureaucratic inertia often render such controls reactive rather than preventive.

Global Capitalism and the “Pharmacy of the World”

India is often celebrated as the “Pharmacy of the Global South”, exporting generic drugs to over 200 countries. But this global reach raises ethical concerns.

Immanuel Wallerstein – World Systems Theory:

India occupies a semi-peripheral role in the global pharmaceutical system — producing cheap generics for both domestic use and export, often under pressure to cut costs and scale fast.

• This creates a dual standard — high-quality drugs for the West, substandard ones for poor countries and India’s own poor.
• The 2022 Gambia tragedy, where DEG-contaminated Indian syrups killed children, exemplifies global inequality in health governance.

➤ Pharmaceutical safety reflects core-periphery dynamics — where profit flows north, and risks stay south.

Corporate Power, Ethics, and Risk Society

The inclusion of Quality Risk Management (QRM) and pharmacovigilance in Schedule M reflects a growing concern with systemic risk in modern societies.

 Ulrich Beck – Risk Society:

Beck argued that modernity creates new, manufactured risks (e.g., toxic chemicals, drug side effects) that are technologically complex and often invisible until disaster strikes.

• Pharmaceutical contamination is not just a “mistake,” but a structural risk arising from cost-cutting, lax regulation, and ethical compromise.
• The emphasis on ALCOA+ principles in data management shows how risk containment is now bureaucratised — but not necessarily democratised.

➤In the risk society, science and technology do not just solve problems — they also create new ones, especially when corporate accountability is weak.

Policy, Public Trust, and Structural Violence

Every regulatory failure reduces citizen trust in institutions. In India, where public health infrastructure is already under strain, such tragedies create public fear and resentment.

Johan Galtung – Structural Violence:

Galtung defined structural violence as harm caused by unjust systems — not through bullets, but through neglect, inequality, and inaction.

• When poor children die due to adulterated drugs, it reflects systemic neglect — of the poor, of regulations, and of ethical production.
• This is not just corporate failure, but structural violence against those without voice or power.

➤Drug safety is a moral issue, not just a technical one — and the failure to protect the vulnerable is a form of institutionalised violence.

Key Features of Revised Schedule M – Sociological Interpretation

Way Forward: A Sociologically Informed Public Health Framework

1. Strengthen Regulatory State Capacity: Invest in more labs, inspectors, and training at both central and state levels.
2. Decentralise Oversight: Empower local health institutions and civil society watchdogs to monitor compliance.
3. Enforce Ethical Production: Incentivise ethical behaviour, not just cost-efficiency, in pharma firms.
4. Public Awareness and Reporting: Create mechanisms for citizens and doctors to report drug failures without fear.

Make Health a Right, Not a Commodity: Align pharmaceutical regulation with universal health ethics, not just market logic.