Medical Device Industry Challenges India's Draft Bill

India's medical device industry is rallying against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing it misclassifies medical devices as pharmaceuticals. Industry leaders and healthcare groups warn this approach could stifle innovation and deter investment in the burgeoning sector.

Industry Concerns Over Regulatory Approach

Medical device manufacturers, patient safety advocates, and healthcare providers have expressed that the draft bill's pharmaceutical-centric language and regulatory framework are unsuitable for medical devices, which are fundamentally engineering products. The bill proposes treating devices similarly to drugs, including imposing criminal penalties for regulatory breaches, a move that industry stakeholders argue is inappropriate.

Several associations have written to the Union Health Minister, urging a reconsideration of the bill. Their August 8 letter highlights that the bill's approach could undermine India's ambition to become a global hub for medical devices by discouraging manufacturing and innovation. The letter also notes that the bill fails to establish a robust regulatory foundation for the sector to thrive globally.

Calls for Risk-Based Regulation

Industry representatives argue that unlike pharmaceuticals, medical devices require a regulatory framework based on risk assessment, quality management systems, and post-market surveillance. They point out that international standards, such as those from the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, rely on administrative enforcement rather than criminal penalties.

The draft bill, however, suggests penalties ranging from one to seven years of imprisonment for issues like labeling errors, documentation lapses, and licensing problems, even if no harm occurs. This approach, according to industry experts, is not aligned with global practices, where administrative measures are preferred for regulatory compliance.

Potential Impact on Innovation and Investment

The medical device sector is concerned that the proposed regulatory changes could deter potential investors and innovators. The associations argue that the draft bill's drug-centric language, using terms like "adulterated," "spurious," and "misbranded," does not reflect the realities of the engineering and scientific distinctions of medical devices.

Stakeholders emphasize that an effective regulatory environment should support innovation and growth by providing clear, risk-based guidelines tailored to the unique nature of medical devices. They urge the government to revise the draft bill to better align with international practices, thereby fostering a conducive environment for investment and innovation in India’s medical device industry.