Medical Device Firms Oppose Draft Bill, Cite Pharma-Like Regulations

India's medical device sector is raising alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the legislation's approach to regulation could stifle innovation and deter investment. Industry leaders and healthcare groups have voiced their opposition, emphasizing that medical devices differ fundamentally from pharmaceuticals and should not be subjected to the same regulatory framework.

Industry Concerns Over Regulatory Approach

The central argument put forth by industry stakeholders is that medical devices, being engineering products, require a distinct regulatory approach compared to pharmaceuticals. The draft bill, critics say, does not acknowledge these differences and instead proposes a framework that mirrors the regulation of drugs. This includes criminal penalties for regulatory lapses, which industry representatives argue could discourage manufacturing and innovation.

A coalition of associations representing manufacturers, traders, healthcare providers, and patient groups has formally communicated their concerns to the Union Health Minister. They assert that the draft bill, in its current form, could hinder India’s progress towards becoming a global hub for medical device production.

Global Practices Highlighted

In their feedback, industry representatives have pointed out that the bill's stringent measures are not aligned with global practices. They cite international regulatory frameworks from regions like the EU, US, Japan, and Australia, where administrative enforcement is favored over criminal penalties for non-compliance. These frameworks typically rely on risk-based conformity assessments, quality management systems, and post-market surveillance.

The draft bill, however, proposes imprisonment for a range of infractions, including labelling errors and documentation lapses, even when there is no resultant harm. The industry argues that such measures could create a hostile environment for innovation and discourage new entrants into the market.

Call for Distinct Regulatory Framework

The letter from the associations underscores the need for a regulatory foundation that recognizes the unique nature of medical devices. They argue that terms like "adulterated," "spurious," and "misbranded," which are traditionally associated with pharmaceuticals, are inappropriate for the medical device sector. Instead, they advocate for a framework that supports growth and innovation while ensuring safety and efficacy.

The draft bill is currently undergoing inter-ministerial consultations, and the industry is hopeful that their feedback will be considered. As the debate continues, the outcome could have significant implications for the future of India's medical device industry and its position in the global market.