Medical Device Industry Challenges India's Draft Bill Regulations

India's medical device industry, alongside healthcare providers and patient safety groups, has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The bill, which seeks to regulate medical devices similarly to pharmaceuticals, has raised alarms about potential negative impacts on manufacturing, investment, and innovation.

Industry leaders argue that the draft bill's approach fails to recognize the fundamental differences between medical devices and pharmaceutical products. Unlike drugs, medical devices are engineering products and should not be subjected to the same regulatory framework. The draft bill, currently under inter-ministerial review, has been criticized for its drug-centric language and for imposing stringent penalties, including imprisonment, for regulatory lapses in the medical device sector.

Concerns Over Regulatory Framework

In a letter dated August 8, several associations representing manufacturers, traders, and healthcare providers expressed their concerns to the Union Health Minister. They highlighted that the draft bill could deter investment and hinder India's goal of becoming a global leader in medical device manufacturing. The associations stressed that the bill does not provide the necessary regulatory foundation for the sector to thrive and innovate on a global scale.

The letter pointed out that the bill continues to treat medical devices as adjuncts to pharmaceuticals, despite clear distinctions in scientific and regulatory requirements. Terms such as "adulterated," "spurious," and "misbranded" are predominantly used in the context of pharmaceuticals and are not suitable for the medical device sector, which relies on engineering and technological advancements.

Global Regulatory Practices

Critics of the draft bill emphasize that globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties. The bill's provision for imprisonment ranging from one to seven years for issues like labeling errors or documentation lapses is seen as excessively harsh. Industry representatives noted that such practices are not in line with regulatory norms in the EU, US, Japan, UK, or Australia, where administrative enforcement is preferred.

By aligning more closely with international standards, the Indian medical device sector could enhance its competitiveness and foster innovation. The current draft bill, however, is seen as a step backward in achieving these objectives.

The ongoing debate highlights the need for a regulatory framework that recognizes the unique nature of medical devices. As discussions continue, stakeholders are hopeful for amendments that will support the growth and development of India's burgeoning medical device industry without stifling innovation or investment.