Medical Device Industry Opposes Draft Bill Treating Devices as Drugs
India's medical device sector protests the draft bill equating devices with pharmaceuticals, citing potential harm to innovation and investment.
The Indian medical device industry, alongside patient safety groups and healthcare providers, is voicing strong opposition to the proposed Draft Drugs, Medical Devices and Cosmetics Bill, 2026. The concern centers around the draft's approach to regulating medical devices as if they are pharmaceutical products, which industry representatives argue could stifle manufacturing, deter investment, and hinder innovation.
Industry's Concerns Over Regulatory Approach
The draft bill has drawn criticism for its stringent regulatory framework that treats medical devices with the same rigor as pharmaceutical products. Industry associations have communicated their concerns to the Union Health Ministry, highlighting the potential negative impact on India's ambition to become a global hub for medical devices. The associations argue that medical devices, fundamentally engineering products, should not be subjected to the pharmaceutical-style regulations that the draft proposes.
In a formal letter dated August 8, industry representatives highlighted that the draft continues to use drug-centric language, including terms such as "adulterated," "spurious," and "misbranded." Such terminology, they argue, is inappropriate for medical devices, which require a different regulatory approach focusing on risk-based assessments, quality management, and post-market surveillance rather than penal measures.
Potential Impact on Manufacturing and Innovation
The proposed bill outlines criminal penalties, including imprisonment ranging from one to seven years for various infractions, such as labeling errors and documentation lapses. Industry stakeholders warn that such measures, which are not common in international regulations like those of the EU, US, Japan, UK, or Australia, could discourage manufacturing and innovation within India's medical device sector.
Globally, medical devices are typically regulated through administrative enforcement rather than criminal penalties. The draft bill's punitive approach contrasts with international practices, which favor risk-based conformity assessments and quality management systems.
Calls for a Revised Regulatory Framework
The medical device industry is urging the government to reconsider the draft bill's provisions, advocating for a regulatory framework that acknowledges the distinct nature of medical devices compared to pharmaceuticals. The current draft, according to industry leaders, lacks the necessary foundation to support the sector's growth and global competitiveness.
As the draft bill undergoes inter-ministerial consultation, stakeholders are hopeful that their feedback will lead to revisions that better align with international standards and support the development of India's medical device industry.