Medical Device Firms Oppose Draft Bill Treating Them Like Pharma
India's medical device sector challenges a draft bill that equates devices with pharmaceuticals, fearing it will stifle innovation and investment.
The Indian medical device industry is rallying against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unfairly equates medical devices with pharmaceuticals. Stakeholders fear this classification could impede manufacturing, innovation, and investment within the sector, potentially derailing India's aspirations of becoming a global hub for medical devices.
Industry Pushback Against the Draft Bill
Multiple associations, representing manufacturers, traders, healthcare providers, and patient advocacy groups, have voiced their concerns through formal communications to the Union Health Minister. These groups argue that the draft bill's approach to regulate medical devices as pharmaceuticals is fundamentally flawed. Unlike drugs, medical devices are engineering products and should not be subjected to the same regulatory framework.
The draft bill is currently under inter-ministerial review and aims to replace an 86-year-old law that governs pharmaceutical regulations in India. Critics of the draft bill highlight that it lacks a robust regulatory foundation necessary for the growth and competitiveness of India's medical device sector on the global stage.
Concerns Over Criminal Penalties
One major point of contention is the draft bill's application of pharmaceutical-centric language and penalties to medical devices. Terms like "adulterated," "spurious," and "misbranded" are borrowed from drug regulations and are deemed inappropriate for engineering devices. Moreover, the bill proposes criminal penalties, including imprisonment ranging from one to seven years for labeling errors, documentation lapses, and other regulatory infractions.
Industry representatives argue that such stringent measures could discourage innovation and investment, as they are not aligned with international practices. In comparison, regions like the EU, US, Japan, UK, and Australia use administrative enforcement mechanisms, focusing on risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminalization.
Call for Regulatory Reforms
The medical device industry is urging the government to reconsider the draft bill's provisions to better align with international standards. They advocate for a regulatory framework that supports innovation and growth without imposing undue burdens on manufacturers. The current draft, they argue, does not adequately address the unique characteristics and requirements of medical devices, treating them instead as an adjunct to pharmaceuticals.
The outcome of this debate could significantly impact India's position in the global medical device market. As the draft bill undergoes further scrutiny, industry stakeholders hope for amendments that will foster a conducive environment for the medical device sector to thrive.