Industry Pushback: Draft Bill Treating Medical Devices as Drugs Faces Criticism

The Indian medical device industry and healthcare groups are voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The contentious legislation seeks to regulate medical devices in the same manner as pharmaceuticals, a move that industry insiders warn could stifle innovation, deter investment, and undermine manufacturing efforts.

Industry Concerns Over Regulatory Approach

Key stakeholders, including manufacturers and healthcare providers, have expressed their discontent in communications to the Union health minister. They argue that the draft bill's approach fails to acknowledge the fundamental differences between engineering-based medical devices and pharmaceutical products. A letter dated August 8, seen by The Economic Times, highlights that the bill's drug-centric terminology and criminal penalties are inappropriate for the medical device sector.

Industry representatives emphasize that globally, medical devices are regulated through risk-based conformity assessments and quality management systems rather than criminal penalties for regulatory deviations. They point out that in regions like the EU, US, Japan, UK, and Australia, administrative actions, rather than imprisonment, are the norm for handling regulatory non-compliance.

Potential Impact on India's Medical Device Ambitions

The draft bill's provisions include imposing imprisonment ranging from one to seven years for issues such as labelling errors and documentation lapses, even when these do not result in harm. Industry experts fear that such stringent measures could discourage domestic manufacturing and foreign investment, jeopardizing India's goal of becoming a global hub for medical devices.

The draft legislation is currently undergoing inter-ministerial consultation as the government seeks to update the 86-year-old law governing pharmaceutical regulations. However, the medical device sector insists that the bill, in its current form, does not lay the proper regulatory groundwork required for the industry to flourish on the international stage.

Calls for a Revised Regulatory Framework

Associations representing the sector urge the government to reconsider the draft bill, advocating for a regulatory framework that recognizes the distinct nature of medical devices. They call for regulation that supports growth and innovation, aligning with international standards that focus on risk management and quality assurance rather than punitive measures.

The outcome of this legislative debate could have significant implications for the future of India's medical device industry, affecting its capacity to innovate and compete globally. The industry awaits further developments as discussions continue at the governmental level.