Medical Device Industry Opposes Indian Draft Bill Equating Devices with Drugs

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which aims to regulate medical devices in the same manner as pharmaceuticals. Industry leaders, patient safety advocates, and healthcare providers argue that such an approach could stifle innovation, deter investment, and negatively impact manufacturing.

Concerns Over Equating Devices with Drugs

Key stakeholders have expressed that medical devices, being engineering products, have distinct characteristics from pharmaceutical products and should not be subjected to the same regulatory framework. The draft bill’s current language, which includes terms like "adulterated," "spurious," and "misbranded," traditionally used for drugs, has been criticized for being inappropriate when applied to medical devices.

The draft bill, currently under inter-ministerial consultation, proposes criminal penalties for regulatory infractions, including imprisonment for labeling errors and documentation lapses. Industry representatives argue that such punitive measures are not aligned with international practices, where administrative enforcement is preferred. They highlight that regions like the EU, US, Japan, UK, and Australia employ risk-based assessments and quality management systems rather than criminal penalties.

Potential Impact on India's Medical Device Ambitions

Medical device associations have communicated their concerns to the Union Health Ministry, emphasizing that the draft bill could undermine India’s aspirations to become a global hub for medical device manufacturing. They argue that the current draft fails to provide a robust regulatory foundation necessary for the sector’s growth and global competitiveness.

According to a letter sent by these associations on August 8, the draft bill's approach could discourage foreign and domestic investment in the sector. The industry is urging the government to reconsider the draft to create a more conducive environment for innovation and manufacturing, which are crucial for the sector's development.

Call for Regulatory Revisions

The medical device industry is advocating for a regulatory framework that recognizes the unique nature of medical devices and aligns with global best practices. They suggest that India should adopt risk-based conformity assessments and post-market surveillance models similar to those used by international regulatory bodies.

The government’s move to update the 86-year-old law governing pharmaceuticals has been acknowledged as necessary. However, industry stakeholders insist that the new regulations should differentiate clearly between pharmaceuticals and medical devices to foster an environment that supports technological advancement and patient safety.

As discussions around the draft bill continue, the medical device sector remains hopeful for regulatory adjustments that reflect the sector’s specific needs and contribute to its growth and innovation on a global scale.