India's Medical Device Sector Opposes New Regulatory Draft Bill

The draft Drugs, Medical Devices and Cosmetics Bill, 2026, has sparked significant opposition from India's medical device industry and healthcare groups. These stakeholders argue that the proposed regulation, which treats medical devices similarly to pharmaceutical products, could negatively impact manufacturing, investment, and innovation within the sector.

Industry Concerns Over Regulatory Approach

Several associations representing manufacturers, healthcare providers, and patient safety groups have formally expressed their concerns. They have written to the Union Health Minister, urging a reconsideration of the draft bill. The industry contends that the bill's approach fails to recognize the fundamental differences between medical devices and pharmaceuticals. Unlike drugs, medical devices are engineering products, and their regulation should not follow the same framework as pharmaceuticals.

The draft bill's language and punitive measures, such as criminal penalties for regulatory lapses, have been particularly contentious. Industry representatives argue that terms like "adulterated," "spurious," and "misbranded" are more applicable to pharmaceuticals and do not suit the engineering nature of medical devices.

Global Regulatory Standards

Critics of the draft bill point out that the proposed regulations are not aligned with international practices. In regions like the European Union, the United States, Japan, and Australia, regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA employ risk-based conformity assessments, quality management systems, and post-market surveillance for medical devices. These frameworks focus on administrative enforcement rather than criminalization.

The draft bill proposes imprisonment terms ranging from one to seven years for various infractions, including labeling errors, documentation lapses, and licensing issues, even when no actual harm occurs. Industry advocates argue that such stringent measures could deter investment and innovation, hindering India's goal of becoming a global hub for medical devices.

Call for a Distinct Regulatory Framework

In their communication to the government, industry associations emphasized the need for a distinct regulatory framework that reflects the unique characteristics of medical devices. They argue that the current draft does not provide the foundational support required for the sector's growth and global competitiveness.

The draft bill is part of a broader initiative to overhaul the 86-year-old law governing India's pharmaceutical regulations. It is currently under inter-ministerial consultation, providing an opportunity for stakeholders to influence the final outcome. The medical device industry remains hopeful that their concerns will be addressed to foster a more conducive environment for innovation and investment.