The invisible pollutant : A legal and Eco-toxicological analysis of pharmaceuticals excipients under Article 21 of the Indian constitution

Ashwathy Suresh

The invisible pollutant : A legal and Eco-toxicological analysis of pharmaceuticals excipients under Article 21 of the Indian constitution

Author(s)	Ashwathy Suresh
Country	India
Abstract	While global environmental law has increasingly focused on the ecological risks posed by Active Pharmaceutical Ingredients, a significant gap remains in the regulation of pharmaceutical excipients. These substances including binders, coatings and surfactants constitute up to 90 percent of a medicinal product’s composition. Despite their substantial presence, they are legally classified as inactive under the Drugs and Cosmetics Act 1940 and are therefore excluded from rigorous Environmental Risk Assessments required for active substances. This paper challenges the assumption that excipients are environmentally harmless. It argues that commonly used excipients particularly synthetic polymers and surfactants function as emerging environmental contaminants. These substances contribute to aquatic toxicity and play a role in the growing microplastics crisis, raising serious concerns about their long-term ecological impact. Through a doctrinal legal analysis supported by a comparison with international regulatory frameworks such as the EU REACH regime, this study identifies a clear legislative gap in India’s environmental governance. The Environment Protection Act 1986 and the EIA Notification 2006 currently allow pharmaceutical formulation units to operate without strict environmental clearance requirements, thereby weakening regulatory oversight. The paper further argues that this regulatory gap amounts to a constitutional failure, as it undermines the Right to a Wholesome Environment under Article 21 of the Constitution. This right has been recently strengthened by the Supreme Court in the M K Ranjitsinh v Union of India 2024 judgment. An analysis of recent National Green Tribunal decisions, including those concerning Sakhi Lake, shows a judicial shift towards imposing strict liability based on overall environmental harm, even in the absence of specific statutory standards. The study concludes by proposing a cradle to grave regulatory approach. It recommends the mandatory integration of Eco pharmacovigilance and Green Chemistry audits within the pharmaceutical sector. Such measures are essential to ensure that industrial development is balanced with environmental protection and the principle of intergenerational equity.
Keywords	Pharmaceutical Excipients, Article 21, Eco pharmacovigilance, Micro-plastics, Regulatory Gap, Green Pharmacy.
Published In	Volume 8, Issue 2, March-April 2026
Published On	2026-03-23

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The invisible pollutant : A legal and Eco-toxicological analysis of pharmaceuticals excipients under Article 21 of the Indian constitution

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