Indian Medical Device Industry Pushes Back Against Draft Bill

India's medical device industry is voicing strong objections to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the draft bill erroneously categorizes medical devices as pharmaceuticals, a move they believe could stifle innovation and deter investment in the sector.

Industry Concerns Over Regulatory Approach

Medical device manufacturers, along with patient safety groups and healthcare providers, have expressed their concerns through formal communications to the Union health minister. They argue that the draft bill's approach could undermine India's potential to emerge as a global hub for medical devices by imposing pharmaceutical-style regulations on engineering products. The industry contends that medical devices, fundamentally different from drugs, should not be governed by the same stringent penalties, especially when such measures are not aligned with international standards.

According to stakeholders, the draft bill fails to establish a suitable regulatory framework for medical devices, treating them as an extension of pharmaceuticals. The bill's language includes terms such as "adulterated" and "spurious," which are more applicable to pharmaceuticals than to engineering products. Industry representatives have pointed out that globally, medical devices are regulated through risk-based assessments and quality management systems, rather than through criminal penalties.

Impact on Manufacturing and Innovation

The draft legislation proposes imprisonment ranging from one to seven years for labeling errors, documentation lapses, licensing issues, and other deviations, even if no harm occurs. Industry experts warn that such measures could discourage domestic manufacturing and innovation, as they are not consistent with regulatory practices in regions like the EU, US, Japan, UK, or Australia, where administrative enforcement is preferred.

The draft bill is currently under inter-ministerial consultation, and the medical device industry is urging the government to reconsider its approach. They advocate for a regulatory environment that recognizes the distinct nature of medical devices and supports the sector's growth and competitiveness on a global scale.

Calls for a Distinct Regulatory Framework

In their letter dated August 8, industry associations emphasized the need for a regulatory foundation that aligns with global standards and fosters innovation. They argue that the draft bill's current provisions could hamper India's ambitions to become a leader in the medical device industry.

As the draft bill undergoes further consultations, the medical device industry remains hopeful for revisions that will better reflect the unique characteristics of medical devices and support the sector's development.