Industry Pushback: Medical Devices Are Not Pharmaceuticals, Firms Say
Medical device makers oppose India's 2026 draft bill, arguing it treats devices like drugs, stifling innovation and investment.
India's medical device industry, alongside patient safety advocates and healthcare providers, is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The contention lies in the bill's approach to regulating medical devices similarly to pharmaceuticals, which industry representatives argue could stifle innovation, deter investment, and harm manufacturing.
Concerns Over Regulatory Approach
Industry groups have expressed that the draft bill, currently under inter-ministerial review, lacks an appropriate regulatory framework necessary for the growth and global competitiveness of India's medical device sector. They argue that medical devices, fundamentally engineering products, require a distinct regulatory approach compared to pharmaceuticals.
In a letter dated August 8, several associations, including those representing manufacturers and healthcare providers, urged the Union health minister to reconsider the proposed bill. The letter criticized the draft for using pharmaceutical-centric language and imposing criminal penalties for regulatory lapses related to medical devices.
Comparison to Global Standards
The draft legislation proposes imprisonment of one to seven years for issues such as labeling errors, documentation lapses, and engineering defects, even if no harm arises. Critics highlight that such punitive measures are not aligned with international practices. They point out that regions like the EU, US, Japan, UK, and Australia adopt administrative enforcement and risk-based assessments, rather than criminalization, to regulate medical devices.
According to the industry, the bill’s approach could hinder India's ambition to become a global hub for medical device manufacturing by discouraging investment and innovation. They emphasize the importance of distinguishing between pharmaceuticals and medical devices in regulatory language and strategy.
Call for Policy Revisions
Industry leaders argue for a regulatory framework that supports post-market surveillance, quality management systems, and risk-based conformity assessments, rather than imposing harsh penalties. They advocate for a system that encourages innovation and supports the sector's growth.
The pushback from the medical device sector highlights the need for a nuanced regulatory approach that aligns with global standards while addressing the unique characteristics of medical devices. As the draft bill undergoes further consultation, stakeholders continue to call for revisions that reflect the distinct nature of medical devices compared to pharmaceuticals.