Counterfeit Medicines And Genuine Harm: An Inquiry Into The Silent Ecological Crisis In India

Abstract

The environmental consequences of the counterfeit medicines have largely remained peripheral in India’s policy debates, largely suppressed by concerns around patient safety and drug efficacy. Yet, the harm they cause goes beyond the clinics, it seeps into water bodies, soils, and ecosystems. India, where pharmaceutical production is vast and regulatory enforcement is uneven, the challenge is even more complex.

This study explores the ecological fall-out of unregulated counterfeit drug production, and evaluates how India’s legal framework handles this dual crisis, which is public and environmental. While laws exists, like the Drugs and Cosmetics Act (1940), the Environment (Protection) Act (1986), and the Waste Management Rules (2016), their enforcement remains scattered and sometimes null. Agencies like the CDSCO focus on drug safety but not the waste, while Pollution Control Boards often overlook pharmaceutical counterfeiting altogether, creating a blind spots where environmental damage goes blatantly unchecked.

The study also mainly calls for rethinking, although not discarding, the existing structure - by integrating environmental oversights into pharma governance. It proposes a stronger coordination between the drugs and environmental regulators, extending Extended Producer Responsibility (EPR) to pharma, and improving the public systems for proper medicine disposal. It also emphasises the urgent need for targeted research on the environmental toxicity of counterfeit APIs (where the research gap intensifies). Ultimately, the paper argues that public health extends beyond the human body- it includes the environment that sustains us.