Medical Device Sector Pushes Back Against India's Draft Bill
Industry leaders argue the 2026 draft bill could stifle innovation by treating devices as pharma products.
India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the draft legislation could stifle innovation and deter investment. Industry leaders and healthcare groups contend that the bill's approach of treating medical devices similarly to pharmaceuticals could have adverse effects on manufacturing and the sector's growth.
Concerns Over Regulatory Approach
The draft bill aims to replace the existing 86-year-old law governing pharmaceuticals in India. However, it has drawn criticism for its failure to acknowledge the fundamental differences between medical devices and pharmaceutical products. Associations representing manufacturers, traders, and healthcare providers have expressed their concerns in a letter to the Union Health Minister, warning that the draft's approach could hinder India's ambition to become a global hub for medical devices.
According to the letter, which was dated August 8, the draft continues to use drug-centric terminology, such as "adulterated," "spurious," and "misbranded," applying these terms to medical devices. This, the industry argues, is inappropriate given the engineering nature of medical devices, which require distinct regulatory standards.
Industry's Call for a Rethink
The medical device sector insists that the draft bill does not provide the necessary regulatory framework to foster growth and innovation. Industry leaders argue that, unlike pharmaceuticals, medical devices are typically regulated through risk-based conformity assessments, quality management systems, and post-market surveillance. They point out that global standards in regions like the EU, US, Japan, UK, and Australia focus on administrative enforcement rather than criminal penalties for regulatory lapses.
One of the contentious points is the bill's proposal to impose imprisonment of one to seven years for issues such as labelling errors, documentation lapses, and engineering defects, even when no harm occurs. Industry representatives argue that such penalties are not common practice in other major markets and could discourage both domestic and foreign investment in India's medical device sector.
Impact on India's Global Aspirations
The draft bill's reception among industry stakeholders suggests a significant pushback against its current form. The medical device industry is urging the government to reconsider the draft's provisions to ensure they align with international standards and support the sector's growth. As the draft bill undergoes inter-ministerial consultations, the outcome will be closely watched by industry players and healthcare providers.
As the debate continues, the medical device industry remains hopeful that revisions will be made to reflect the unique needs and challenges of the sector. Whether the government will heed these calls remains to be seen, but the stakes are high for India's positioning in the global medical device market.