Medical Device Industry Challenges India's Proposed Regulatory Bill

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inappropriately categorizes medical devices alongside pharmaceuticals. Concerns are being raised about potential negative impacts on manufacturing, innovation, and investment in the sector.

Industry Pushback Against Regulatory Approach

Various industry associations, including those representing manufacturers, traders, and healthcare providers, have formally expressed their concerns to the Union Health Minister. They argue that medical devices, which are fundamentally engineering products, should not be regulated under the same framework as pharmaceuticals. The draft bill, according to these groups, fails to recognize the distinct scientific and regulatory differences between medical devices and drugs.

The draft legislation introduces criminal penalties for regulatory lapses, such as labelling errors and documentation issues. Industry representatives warn that such measures could stifle innovation and discourage investment, hindering India's goal of becoming a global leader in medical device manufacturing. The bill proposes imprisonment terms ranging from one to seven years for various infractions, a move that industry stakeholders argue is excessive and not in line with international regulatory practices.

Global Standards and Industry Concerns

Globally, medical devices are typically regulated through risk-based assessments, quality management systems, and post-market surveillance rather than through punitive measures. Industry leaders point out that major regulatory bodies, such as the US FDA, EU MDR, and Japan's PMDA, utilize administrative enforcement rather than criminal penalties for compliance issues.

The associations behind the opposition have highlighted that the draft bill's language remains drug-centric, using terms like "adulterated" and "spurious," which are inappropriate for engineering products. This approach, they argue, could undermine the regulatory environment needed for the sector to thrive and compete internationally.

Currently, the draft bill is under inter-ministerial consultation, with stakeholders hoping for revisions that consider the unique nature of medical devices. The industry is advocating for a regulatory framework that facilitates growth and innovation while maintaining safety and efficacy standards.