Medical Device Sector Challenges Draft Bill on Regulatory Grounds

India's medical device industry, alongside healthcare providers and patient safety groups, is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which seeks to treat medical devices in the same regulatory framework as pharmaceuticals, has sparked concerns that it could stifle innovation, deter investment, and hinder India's aspirations to become a global hub for medical devices.

Industry Concerns Over Regulatory Approach

Industry representatives argue that medical devices, fundamentally engineering products, should not be subjected to the same regulatory standards as pharmaceuticals. The draft bill proposes stringent penalties, including criminal charges for regulatory lapses, which stakeholders claim are inappropriate for the sector. They warn that such measures could significantly impact manufacturing and development within the industry.

Associations representing manufacturers, traders, and healthcare providers have communicated their concerns to the Union Health Minister, emphasizing the need for a regulatory framework that recognizes the distinct nature of medical devices. In their letter dated August 8, these groups highlighted that the draft bill fails to establish a conducive regulatory environment for growth and innovation in the sector.

Global Regulatory Practices Highlighted

The draft bill's approach contrasts with international practices where medical devices are regulated through risk-based assessments and quality management systems rather than criminalization. Critics point out that regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA favor administrative enforcement over imprisonment for non-compliance. The industry argues that adopting similar frameworks could better support the sector’s development.

Specific concerns include the use of pharmaceutical-centric language in the bill, such as terms like "adulterated" and "spurious," which do not fit the engineering-focused nature of medical devices. The proposed penalties for documentation errors, labelling mistakes, and other minor infractions are seen as overly harsh, especially when no harm has occurred.

Call for Reconsideration and Sector-Specific Regulation

The medical device industry is urging the government to revisit the draft bill, advocating for a regulatory structure that aligns with scientific and engineering realities. Stakeholders believe that a tailored approach could enhance India's competitiveness and attract international investment, ultimately fostering innovation and growth in the medical device sector.

As the draft bill undergoes inter-ministerial consultation, the industry continues to push for changes that reflect the unique characteristics of medical devices, aiming for regulations that support rather than hinder the sector's potential.