India’s medical device industry, healthcare providers and patient safety groups have opposed the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it places medical devices under a regulatory framework designed primarily for pharmaceuticals. They have urged the Union Health Ministry to reconsider the proposed provisions, warning that the approach could affect investment, manufacturing and innovation in the sector.
Several industry associations have also written to the Union Health Minister, stating that the draft does not provide an appropriate regulatory foundation for the medical device sector to expand and compete globally.
Medical Devices Differ from Pharmaceuticals
The industry maintains that medical devices are fundamentally engineering products rather than pharmaceutical products and therefore require a distinct regulatory approach. According to the associations, the draft continues to use drug-centric terminology such as “adulterated,” “spurious” and “misbranded” for medical devices.
Furthermore, the groups have argued that international regulatory systems generally assess medical devices through risk-based conformity assessments, quality management systems, post-market surveillance and product recalls, rather than relying primarily on criminal penalties.
Concerns Over Criminal Penalties
The proposed legislation has also raised concerns over criminalisation of regulatory and technical lapses. The draft reportedly proposes imprisonment ranging from one to seven years for issues including labelling errors, documentation lapses, licensing violations, post-market surveillance reporting failures and certain engineering defects, even when these do not result in patient harm.
As per The Economic Times, industry representatives have warned that such provisions could discourage investment and manufacturing while affecting India’s ambition to become a global medical device hub.
Industry Seeks Risk-Based Regulation
Consequently, industry groups are calling for a regulatory framework that recognises the scientific and engineering differences between medical devices and medicines. They believe a proportionate, risk-based system would support patient safety while encouraging innovation, domestic manufacturing and global competitiveness.
The draft Bill is currently undergoing inter-ministerial consultation, and stakeholders have urged the government to review the provisions before finalising the legislation.