Industry Criticizes Draft Bill for Treating Medical Devices as Drugs
The medical device sector opposes the 2026 draft bill, arguing it aligns devices with pharmaceuticals, risking innovation and growth.
India's medical device industry is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inappropriately categorizes medical devices as pharmaceuticals. This draft legislation could stifle innovation and deter investment, according to industry representatives.
Medical Devices vs. Pharmaceuticals
The draft bill, currently under inter-ministerial review, aims to update the 86-year-old regulations governing pharmaceuticals in India. However, it has been met with resistance from associations representing manufacturers, healthcare providers, and patient groups. These stakeholders argue that the bill does not adequately distinguish between medical devices and pharmaceuticals, despite their distinct scientific, engineering, and regulatory differences.
In a letter dated August 8, addressed to the Union Health Minister, these associations emphasized that medical devices are primarily engineering products and should not be regulated as drugs. They warned that the draft bill's approach could hinder India's goal of becoming a global hub for medical device manufacturing.
Concerns Over Regulatory Language
Critics of the draft bill point out that it continues to use pharmaceutical-centric language, with terms such as "adulterated," "spurious," and "misbranded," which are inappropriate for engineering products. Furthermore, the bill proposes criminal penalties for regulatory lapses akin to those in the pharmaceutical sector, including imprisonment for issues like labeling errors or documentation mistakes, even when no harm occurs.
Globally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance rather than criminal penalties. The industry argues that this approach is consistent with practices in regions such as the European Union, United States, Japan, UK, and Australia, where administrative enforcement is the norm.
Impact on Innovation and Investment
The medical device sector fears that the draft bill, as it stands, will discourage investment and innovation. By imposing stringent pharmaceutical-style regulations on medical devices, the bill could create an unfavorable business environment, deterring both domestic and international companies from investing in India's medical device sector.
Industry leaders are urging the government to reconsider the draft bill, advocating for a regulatory framework that acknowledges the unique nature of medical devices. They believe that a more tailored approach would better support the growth and competitiveness of India's medical device industry on a global scale.