Indian Medical Device Sector Opposes Draft Bill Treating Devices as Drugs

The Indian medical device industry and healthcare groups have voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. They argue that the bill's approach of treating medical devices similarly to pharmaceuticals could severely impact manufacturing, investment, and innovation within the sector.

Industry Concerns Over Regulatory Approach

Various associations representing manufacturers, traders, healthcare providers, and patient safety groups have communicated their concerns to the Union Health Minister. They assert that the draft bill's framework is not conducive to fostering a robust medical device sector in India. The industry's representatives emphasize that medical devices are fundamentally different from pharmaceuticals, being engineering products rather than drugs, and require distinct regulatory measures.

The letter submitted by these associations on August 8 highlights that the draft bill fails to establish an appropriate regulatory foundation necessary for the sector's growth and global competitiveness. The existing language in the bill continues to treat medical devices as an adjunct to pharmaceuticals, overlooking the clear scientific and regulatory distinctions between the two categories.

Potential Impact on Innovation and Investment

The draft bill's proposal to impose criminal penalties for regulatory lapses—such as labeling errors, documentation issues, and engineering defects—has particularly alarmed industry stakeholders. The bill suggests imprisonment terms ranging from one to seven years for such infractions, even when no harm results. Industry leaders argue that this approach mirrors a drug-centric regulatory framework, which is not suitable for medical devices.

Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than through criminal penalties. The letter from the associations points out that major regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA do not practice criminalization for regulatory deviations, instead opting for administrative enforcement.

Call for Reevaluation of the Draft Bill

The opposition to the draft bill underscores a critical call for reevaluation of its provisions, with industry leaders warning that the current approach could deter investment and discourage local manufacturing. They argue this is counterproductive to India's ambition of becoming a global hub for medical devices.

The draft bill is currently under inter-ministerial consultation, and the industry hopes for amendments that better reflect the unique nature of medical devices, aligning with international best practices to support innovation and growth.