Medical Device Industry Challenges Draft Bill on Regulatory Grounds

India's medical device industry, alongside healthcare groups and patient safety advocates, is voicing strong opposition to a proposed legislative change that could reshape how medical devices are regulated in the country. The draft Drugs, Medical Devices and Cosmetics Bill, 2026, has sparked concerns by proposing to treat medical devices similarly to pharmaceuticals, a move that industry stakeholders argue could stifle innovation, manufacturing, and investment.

Industry Concerns Over Regulatory Approach

Key industry associations have expressed their apprehension in a letter to the Union Health Minister, highlighting that the draft bill fails to recognize the fundamental differences between medical devices and pharmaceutical products. The letter, dated August 8, criticizes the bill for using drug-centric terms such as "adulterated," "spurious," and "misbranded," and for imposing criminal penalties for regulatory non-compliance, which is atypical for the industry.

According to the associations, the proposed legislation threatens India's ambitions to become a global hub for medical device manufacturing. They argue that medical devices are engineering products, not pharmaceuticals, and thus require distinct regulatory frameworks that focus on risk-based conformity assessments, quality management systems, and post-market surveillance.

Comparative Global Practices

The letter points out that international regulatory bodies like the EU's MDR, the US FDA, Japan's PMDA, the UK's MHRA, and Australia's TGA typically employ administrative enforcement measures rather than criminal penalties. In these regions, regulatory frameworks emphasize quality assurance and post-market oversight rather than punitive measures for non-harmful errors such as labelling mistakes or documentation lapses.

The draft bill's provision for imprisonment ranging from one to seven years for such lapses is seen as excessively stringent by industry players. They warn that such measures could deter potential investors and innovators, ultimately undermining the sector's growth prospects.

Call for Revised Legislation

Industry stakeholders are urging the government to reconsider the draft bill, advocating for a regulatory framework that aligns with international best practices and recognizes the unique nature of medical devices. They emphasize the need for legislation that fosters innovation and investment while ensuring patient safety through effective, non-punitive regulatory mechanisms.

The bill is currently under inter-ministerial consultation, and it remains to be seen how the government will address the concerns raised by the medical device industry. With India's medical device sector poised for significant growth, the outcome of this legislative process could have far-reaching implications for the industry and its global competitiveness.