Medical Device Industry Opposes India's Draft Bill on Regulation

India's medical device manufacturers and healthcare groups are raising objections to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it erroneously treats medical devices as pharmaceuticals. This opposition comes amid concerns that such regulatory changes could stifle innovation and deter investment in the sector.

Concerns Over Regulatory Approach

Industry associations, patient safety groups, and healthcare providers have voiced their concerns, emphasizing that medical devices are fundamentally different from drugs. These groups have written to the Union Health Minister urging a reconsideration of the draft legislation, which they believe could impede India's goal of becoming a global hub for medical device manufacturing.

Critics of the draft bill argue that it fails to establish an appropriate regulatory framework for medical devices, which are primarily engineering-based products. They assert that the inclusion of pharmaceuticals-style language—using terms like "adulterated," "spurious," and "misbranded"—is inappropriate for medical devices. Moreover, the bill proposes criminal penalties for regulatory violations, which the industry argues are disproportionate and more suited to drug regulation.

Global Standards and Practices

The draft bill suggests imprisonment terms ranging from one to seven years for issues such as labeling errors and documentation mistakes, even when no harm is caused. This approach diverges from international practices where administrative enforcement is preferred. Industry groups highlight that countries like the United States, Japan, the United Kingdom, and Australia employ risk-based assessments and quality management systems, rather than criminal penalties, for regulating medical devices.

According to the letter sent by these associations on August 8, the draft continues to treat medical devices as an adjunct to pharmaceuticals, despite the clear scientific, engineering, and regulatory distinctions between the two categories. The associations argue that the draft does not provide the necessary regulatory foundation for the sector to thrive and compete on a global scale.

Call for Revisions

The draft bill, which is currently under inter-ministerial consultation, has sparked significant debate within the industry. Stakeholders are calling for revisions that recognize the unique nature of medical devices and establish a regulatory environment that supports growth and innovation. By aligning more closely with international standards, they believe India can better position itself as a leader in the global medical device market.

As the government moves forward with the proposed changes, the medical device industry remains hopeful that its concerns will be addressed to foster an environment conducive to innovation and investment.