Medical Device Industry Opposes India's Draft Bill on Regulatory Grounds

The Indian medical device industry, alongside healthcare providers and patient safety groups, has raised significant concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Stakeholders argue the draft bill's approach of treating medical devices as pharmaceutical products could stifle manufacturing, innovation, and investment in the sector.

Industry Pushback on Regulatory Approach

Associations representing manufacturers, traders, and healthcare providers have voiced their opposition, emphasizing that medical devices are fundamentally engineering products, not pharmaceuticals. They argue that applying drug-like regulations is inappropriate and potentially detrimental. In a letter addressed to the Union Health Minister on August 8, these groups have urged a reevaluation of the draft, warning it could thwart India's ambitions to become a global hub for medical devices.

The draft bill introduces criminal penalties for regulatory lapses, which the industry claims is excessive. Using terminology such as "adulterated," "spurious," and "misbranded"—terms traditionally associated with pharmaceuticals—further compounds the issue, according to industry representatives.

Concerns Over Penal Provisions

The proposed legislation stipulates imprisonment ranging from one to seven years for various infractions, including labeling errors and documentation lapses, even if no harm results. Industry leaders assert this punitive approach is not in line with international practices. They cite regulatory frameworks like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, which use administrative enforcement for similar issues.

These global standards focus on risk-based conformity assessments, quality management systems, post-market surveillance, and product recalls rather than criminal penalties, which the Indian draft bill currently proposes.

Implications for Growth and Innovation

The industry argues that the draft bill lacks the necessary regulatory foundation to foster growth and innovation in India's medical device sector. By treating medical devices as mere adjuncts to pharmaceuticals, the bill overlooks the distinct scientific and engineering differences between the two categories.

As the draft bill undergoes inter-ministerial consultation, stakeholders are hopeful for amendments that would align India’s regulatory framework with international norms, promoting a more conducive environment for the medical device industry to thrive.