Medical Device Industry Challenges Draft Bill Equating Devices with Drugs

India's medical device industry is expressing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the legislation inappropriately categorizes medical devices as pharmaceutical products. Industry representatives, along with healthcare providers and patient safety groups, have voiced concerns that such a classification could stifle innovation and deter investment in the sector.

Industry Pushback Against Regulatory Changes

Various associations representing manufacturers, traders, and healthcare providers have formally communicated their concerns to the Union Health Minister. They argue that treating medical devices as pharmaceuticals under the new bill imposes unnecessary regulatory burdens, including criminal penalties for lapses that do not cause harm. The draft bill proposes imprisonment for issues such as labelling errors and documentation mistakes, which industry leaders say are typically addressed through administrative measures in other major markets.

In their letter dated August 8, industry groups emphasized that medical devices are fundamentally engineering products rather than pharmaceutical compounds, necessitating distinct regulatory approaches. They argue that the proposed bill lacks the necessary framework to support the growth and global competitiveness of India's medical device industry.

Global Standards Highlighted

The medical device sector has pointed out that regulatory practices in the European Union, United States, Japan, United Kingdom, and Australia do not criminalize engineering deviations. Instead, these regions employ risk-based assessments and quality management systems to ensure compliance and safety. The draft bill, however, maintains a drug-centric approach with language and penalties more suited to pharmaceuticals.

The associations stress that such stringent measures could discourage both domestic manufacturing and foreign investment, undermining India's potential as a global hub for medical devices. They urge the government to reconsider the bill's provisions to better align with international standards and practices.

Call for Policy Reevaluation

The draft bill is part of a broader effort to update the 86-year-old laws governing pharmaceuticals and medical devices in India. While the government aims to modernize regulatory frameworks, industry stakeholders argue that the current draft does not adequately reflect the unique characteristics and needs of medical devices.

As the bill undergoes inter-ministerial consultations, stakeholders are hopeful that their feedback will prompt revisions that support the sector's growth and innovation. They call for a tailored regulatory approach that recognizes the distinct nature of medical devices and fosters an environment conducive to advancement and competitiveness.