Medical Device Industry Challenges Draft Bill on Regulatory Grounds

The draft Drugs, Medical Devices and Cosmetics Bill, 2026, has sparked significant concern among India's medical device industry, healthcare providers, and patient safety groups. These stakeholders have voiced opposition to the bill, arguing that it inappropriately categorizes medical devices as pharmaceuticals, which could stifle innovation and deter investment in the sector.

Industry's Concerns Over Regulatory Approach

Representatives from various associations, including manufacturers and healthcare providers, have reached out to the Union health minister, urging a reevaluation of the draft bill. They argue that the bill's current form could hinder India's aspirations to become a global leader in medical device manufacturing. The draft is under inter-ministerial review and aims to replace the existing 86-year-old pharmaceutical regulations.

Critics argue that the bill fails to acknowledge the distinct differences between medical devices and pharmaceuticals. They highlight that devices are engineering products and require different regulatory frameworks. The draft's language, which includes terms such as "adulterated," "spurious," and "misbranded," is seen as inappropriate for devices and more suited to drug regulation.

Potential Impact on Innovation and Investment

The industry has expressed that the bill imposes severe penalties, including imprisonment for up to seven years, for infractions such as labeling errors, documentation mistakes, and licensing issues, even in cases where no harm is done. Such stringent measures, they argue, are not aligned with international practices in regions like the EU, US, Japan, UK, or Australia, where administrative enforcement is preferred over criminal penalties.

The letter submitted by the industry associations on August 8 emphasizes that the draft bill does not provide a conducive foundation for the growth and global competitiveness of India's medical device sector. They stress the need for a regulatory framework that supports innovation and investment while maintaining high safety standards.

Call for Risk-Based Regulation

Globally, medical devices are regulated through risk-based conformity assessments and quality management systems. The current draft bill's approach contrasts sharply with these practices, which typically involve post-market surveillance and recalls rather than punitive measures. Industry stakeholders are advocating for a regulatory environment that mirrors these global standards to promote a thriving medical device sector in India.

The ongoing debate surrounding the draft Drugs, Medical Devices and Cosmetics Bill, 2026, underscores the critical need for tailored regulations that recognize the unique characteristics of medical devices. As the government continues its consultations, industry leaders remain hopeful for revisions that will foster a more supportive landscape for innovation and growth.