Draft Bill Sparks Opposition from India's Medical Device Industry

India's medical device sector, alongside patient safety and healthcare advocacy groups, is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The core of their argument is the draft's classification of medical devices as pharmaceutical products, which they believe could stifle innovation and deter investment in the industry.

Concerns Over Regulatory Approach

Industry representatives argue that medical devices are fundamentally different from pharmaceuticals, being engineering-centric rather than chemistry-based. This distinction, they assert, should be reflected in the regulatory framework. The draft bill, however, suggests imposing criminal penalties for regulatory non-compliance, akin to those in the pharmaceutical sector, which stakeholders warn could negatively impact manufacturing and investment.

In a letter addressed to the Union Health Minister, associations representing manufacturers, traders, and healthcare providers have urged a re-evaluation of the draft. They caution that the bill's current form might hinder India's goal of becoming a global hub for medical devices. The letter emphasizes that the draft does not establish the necessary regulatory foundation for the sector's growth and competitiveness on the global stage.

Global Regulatory Practices

The draft's language and proposed penalties have drawn criticism for their drug-centric perspective. Terms such as "adulterated," "spurious," and "misbranded" are used, and the bill suggests criminalizing engineering deviations. Industry leaders highlight that internationally, regulatory bodies like the EU MDR, US FDA, and others focus on risk-based assessments and quality management, rather than imprisonment for non-compliance.

Proposed penalties include imprisonment ranging from one to seven years for issues such as labeling errors, documentation lapses, and even minor engineering defects, regardless of harm. Industry stakeholders argue that such measures are excessive and not aligned with practices in other major markets, where administrative enforcement is preferred.

Call for Reconsideration

The draft bill is currently under inter-ministerial review, with stakeholders hoping for amendments that recognize the unique nature of medical devices. As discussions continue, the medical device industry is advocating for a regulatory framework that supports innovation, investment, and manufacturing, ensuring that India can compete effectively in the global market.

As the government deliberates, the industry's feedback underscores the need for a balanced approach that protects patient safety while fostering growth and innovation within the medical device sector.