From patent reform to public health risk? Analysing India’s 2024 patent amendments and their impact on access to medicines

India has long been recognised for its patent regime that seeks to balance innovation with public health. The Patents Act, 1970, along with the Patent Rules, 2003, has played a pivotal role in preventing the patenting of frivolous inventions while fostering a strong generic pharmaceutical industry. However, the Patent (Amendment) Rules, 2024 introduce significant procedural changes to the foreign disclosure mandate, pre-grant opposition mechanism and patent-working requirements, raising concerns about the dilution of key statutory safeguards. This article undertakes a doctrinal and legal-policy analysis of the 2024 amendments to Rule 12 (disclosure of foreign applications), Rule 55 (pre-grant opposition) and Rule 131/Form 27 (patent working requirement). This research critically examines the impact of the 2024 amendments on public health in light of India’s Free Trade Agreements (FTAs) negotiations with developed economies. The study assesses whether these changes reflect a strategic compromise to attract foreign investment or a fundamental shift in India’s patent policy. The paper argues that while regulatory upgrades may be warranted, the same should not be done at the cost of public health. It recommends revisiting the amendments to restore transparency, maintain strong patent opposition mechanisms and uphold India’s role as the ‘pharmacy of the developing world’.