Navigating the Food-Pharma Divide: A Critical Study of FSSAI, Market Regulations, and Health Law Compliance in India.

Abstract

The rapid growth of processed foods, health supplements, and packaged goods in India has made food safety law far more complex than traditional adulteration control. Under the Food Safety and Standards Act (FSSA), 2006, the Food Safety and Standards Authority of India (FSSAI) constantly struggles to define clear legal boundaries between everyday food products, nutraceuticals, and actual medicines governed by the Drugs and Cosmetics Act, 1940. This paper examines the legal and regulatory framework governing India’s food sector, with a specific focus on jurisdictional overlaps between FSSAI and the Central Drugs Standard Control Organisation (CDSCO). It evaluates statutory conflicts and the principle of overriding effect under Section 89 of the FSSA, 2006, as interpreted by the Supreme Court in Manik Hiru Jhangiani v. State of Madhya Pradesh (2023). Furthermore, the study analyses the practical enforcement of the FSS (Labelling and Display) Regulations, 2020, examining recent crackdowns on deceptive packaging, misleading health claims, and judicial pushes toward mandatory Front-of-Pack Warning Labels (FOPL). Finally, it investigates the operational and economic challenges faced by Food Business Operators (FBOs) navigating licensing under the Food Safety Compliance System (FoSCoS) portal. By analysing core statutory provisions and evolving judicial trends, this article highlights structural gaps in India’s food safety ecosystem and proposes practical legal reforms to balance public health protection with commercial growth.