Medical Device Industry Opposes Bill Equating Devices with Drugs

India's medical device industry and healthcare groups are voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The industry argues that the bill's approach of treating medical devices as pharmaceutical products could stifle manufacturing, innovation, and investment, according to sources familiar with the matter.

Concerns Over Regulatory Framework

Key stakeholders, including associations representing manufacturers and healthcare providers, have formally urged the Union Health Minister to reconsider the proposed regulations. They argue that the bill's framework does not adequately distinguish between medical devices and pharmaceuticals, thus failing to provide the necessary foundation for growth and competition in the global market.

In a letter dated August 8, industry representatives highlighted that the bill continues to use drug-centric language, applying terms like "adulterated," "spurious," and "misbranded" to engineering products. This approach, they say, aligns more with pharmaceutical regulation than with the engineering and scientific nature of medical devices.

Potential Impact on Innovation and Investment

The draft legislation proposes criminal penalties, including imprisonment for one to seven years, for regulatory lapses such as labeling errors and documentation issues, even if no harm occurs. Industry leaders warn that these stringent measures could deter investment and innovation, hindering India's aspirations to become a leading hub for medical devices.

Globally, medical devices are typically regulated through risk-based assessments, quality management systems, post-market surveillance, and recalls, rather than criminal penalties. The industry notes that such administrative enforcement is standard practice in regions like the EU, USA, Japan, the UK, and Australia.

Call for a Revised Approach

The medical device sector is advocating for a regulatory framework that recognizes the distinct nature of medical devices compared to pharmaceuticals. They argue that the bill, currently under inter-ministerial consultation, should reflect the engineering and design-specific risks associated with medical devices, rather than imposing pharmaceutical-style regulations.

As the government seeks to replace the 86-year-old law governing pharmaceutical regulations, industry leaders are hopeful that their concerns will be addressed to ensure a thriving environment for India's medical device sector. The outcome of this legislative process could significantly impact the future trajectory of the industry.