India: Food and Drugs Law

In a significant ruling between Food Safety and Standards Authority of India v. G. Subramania Koushik & Ors. addressing consumer awareness and food safety, the Madras High Court has upheld its earlier directions requiring precautionary labelling on plastic/PET-bottled drinking water and sugar and salt sold in plastic packaging, indicating the possible presence of microplastics and nanoplastics. The decision highlights the importance of consumer disclosure, particularly where scientific research has identified potential health concerns but the precise extent of the associated risks remains under investigation.

India's pharmaceutical and healthcare regulatory landscape in August 2026 witnessed significant reforms spanning medical devices, drug safety, clinical trials, and professional registration. From stricter controls on pediatric medications to streamlined ethics review processes, these developments reshape compliance obligations and market access pathways for life sciences stakeholders.

For a woman battling metastatic breast cancer on a retired bank employee’s pension, the cost of a single 21-day course of targeted therapy, more than Rs. 58,000, was not merely a medical burden. It raised a larger legal question: can the Government use the statutory power available to it under the Patents Act to make a patented, life-saving medicine available to patients who cannot afford its market price?

For years, an FSSAI licence came bundled with a question every food business operator eventually had to answer: when does it expire, and when must it be renewed? In 2026, that question has fundamentally changed.

Intellectual property (“IP”) law and food safety law have traditionally been treated as separate domains, administered by different authorities, under different statutes, and animated by different objects. IP law governs a proprietor’s exclusive rights over a mark and the consequences of its unauthorized use; food safety law governs the safety, labelling and honest presentation of food to the public.

The Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) is among the most stringent criminal statutes in India, aiming to curb the menace of drug trafficking and substance abuse. One of the most debated legal concepts under this Act is the idea of "possession" particularly the distinction between "conscious possession" and "mere presence" near narcotic substances.

India has remained on the US Trade Representative's Priority Watch List for over 15 years due to ongoing disputes over intellectual property protection, particularly concerning pharmaceutical patents, compulsory licensing, and data exclusivity. With the recent India-EU Free Trade Agreement signed in January 2026, questions arise about whether this landmark deal will alter the dynamics of US-India trade negotiations and India's controversial IP stance.

India's healthcare, pharmaceutical, and medical devices sectors have witnessed significant regulatory and policy developments from April to May 2026, including the nationwide expansion of mental healthcare services, the launch of the JANANI digital platform for maternal and child healthcare, and proposed amendments to medical device regulations.

The Food Safety and Standards Authority of India (FSSAI), established as a statutory body under the Food Safety and Standards Act, 2006, has consistently endeavoured to safeguard public health through the formulation...