Medical Device Industry Challenges Draft Bill Treating Devices as Drugs

The medical device industry in India is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices under the same framework as pharmaceuticals. Industry representatives argue that this approach could stifle innovation and deter investment in the sector.

Industry Pushback Against Drug-Like Regulation

Medical device manufacturers, patient safety advocates, and healthcare providers have collectively voiced their opposition to the draft bill. They argue that the bill, which is under inter-ministerial review, fails to recognize the distinct nature of medical devices compared to pharmaceuticals. According to these stakeholders, medical devices are fundamentally engineering products, not pharmaceuticals, and should not be governed by drug regulations.

In a letter addressed to the Union Health Minister, various associations have highlighted their concerns. They emphasize that treating medical devices as pharmaceutical products could hinder India's goal of becoming a global leader in the medical device industry. The letter critiques the draft for using language typically associated with drug regulation, such as terms like "adulterated," "spurious," and "misbranded," and applying harsh penalties for regulatory lapses.

Concerns Over Criminalization and Innovation

The draft bill proposes severe penalties, including imprisonment ranging from 1 to 7 years for issues like labeling errors, documentation mistakes, and engineering defects, even when no actual harm is caused. This approach has been criticized as overly punitive and not aligned with international regulatory practices. In countries like the United States, the European Union, Japan, and Australia, regulatory frameworks focus on risk-based assessments, quality management systems, and post-market surveillance rather than criminal penalties.

The industry argues that such stringent measures could discourage innovation and manufacturing within India, pushing potential investors away. The current draft, they claim, does not provide the necessary regulatory foundation to support the growth and competitiveness of India's medical device sector on a global scale.

Call for Policy Reevaluation

Industry leaders are urging the government to reconsider the draft bill and develop a regulatory framework that acknowledges the unique characteristics of medical devices. They advocate for a system that encourages innovation and investment while ensuring patient safety through appropriate regulatory measures.

The debate over the draft bill highlights the ongoing challenges in balancing regulation with industry growth in India's burgeoning healthcare sector. As discussions continue, stakeholders are hopeful for a resolution that will foster a conducive environment for both safety and innovation.