Medical Device Firms Resist Draft Bill Treating Devices as Drugs

India's medical device sector is raising alarms over the proposed Draft Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices similarly to pharmaceuticals. Key industry players, along with healthcare and patient safety groups, argue that this approach could stifle innovation, deter investment, and hinder the nation's goal of becoming a global hub for medical devices.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, has sparked opposition from various industry associations. These groups have communicated their concerns through a letter to the Union Health Minister, emphasizing the need for a regulatory framework that acknowledges the distinct nature of medical devices compared to pharmaceuticals. The letter criticizes the draft for retaining drug-centric terminology such as "adulterated" and "spurious" and for imposing severe penalties similar to those in the pharmaceutical sector.

Industry representatives argue that medical devices, being engineering products, should be regulated through risk-based assessments and quality management systems. They point out that international standards from the EU, US, Japan, UK, and Australia focus on administrative enforcement rather than criminal penalties for regulatory lapses.

Potential Impact on Innovation and Investment

Stakeholders warn that the draft bill, by imposing imprisonment of 1-7 years for errors in labeling, documentation, and other compliance areas, could deter investment and innovation. The stringent penalties could discourage manufacturers and investors from engaging in the Indian market, undermining the country’s aspirations to become a leader in medical device production and innovation.

Medical device firms stress the importance of a regulatory environment that supports growth and technological advancement. The current draft, they argue, lacks the necessary foundation to foster a competitive and innovative industry. The associations have urged the government to revise the bill to better align with global best practices, ensuring that the regulatory framework supports rather than hinders the sector's development.

Call for a Distinct Regulatory Framework

The medical device industry’s pushback highlights the need for a distinct regulatory framework that separates medical devices from pharmaceuticals. By recognizing the unique characteristics of medical devices, the government can create policies that encourage innovation while ensuring patient safety. Industry leaders are hopeful that their feedback will lead to a more balanced approach that supports the sector’s growth without compromising on regulatory standards.