Medical Device Industry Opposes Draft Bill Equating Devices with Pharma

India's medical device industry is rallying against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which equates medical devices with pharmaceutical products. Industry leaders and healthcare groups argue this approach could stifle innovation and deter investment in the sector. The bill, currently under inter-ministerial consultation, has sparked significant concern among stakeholders who believe it could undermine India's goal to become a global hub for medical device manufacturing.

Concerns Over Regulatory Approach

Medical device associations and healthcare providers have expressed their reservations in a letter to the Union Health Minister, urging a reconsideration of the draft bill. They argue that medical devices, fundamentally engineering products, require a regulatory framework distinct from that of pharmaceuticals. The current draft, however, continues to apply a drug-centric regulatory language, using terms such as "adulterated" and "misbranded," and introducing criminal penalties for regulatory lapses.

The industry stresses that globally, medical devices are managed through risk-based conformity assessments and quality management systems rather than criminal penalties. "This is not practiced in EU MDR, US FDA, Japan PMDA, UK MHRA, or Australia TGA, where administrative enforcement is the norm," stated the letter.

Potential Impact on Innovation and Investment

The proposed bill includes provisions for imprisonment ranging from one to seven years for issues such as labeling errors and documentation lapses, even when no harm occurs. Industry representatives argue that such punitive measures could discourage manufacturing and innovation, potentially hampering India's ambitions in the medical device sector.

The associations emphasize that the draft bill does not provide the necessary regulatory foundation for the sector's growth and global competitiveness. They warn that the imposition of stringent pharmaceutical-style regulations on medical devices could lead to reduced foreign investment and slow down the pace of technological advancement in the industry.

Call for Sector-Specific Regulations

The medical device industry is advocating for a regulatory framework tailored specifically to the unique nature of medical devices. This would involve a shift from punitive measures to a focus on quality management and risk assessment. The aim is to create an environment conducive to innovation and growth while ensuring patient safety.

The government's move to revamp the 86-year-old law governing pharmaceuticals is seen as an opportunity to establish clear and distinct regulations for medical devices. Industry stakeholders are hopeful that ongoing consultations will lead to a more suitable regulatory approach that recognizes the distinct nature of medical devices and supports the sector's development.