Medical Device Industry Challenges Indian Draft Bill on Regulation

India's medical device industry has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The sector argues that the proposed legislation, which treats medical devices similarly to pharmaceuticals, could adversely affect manufacturing, investment, and innovation. Industry leaders and healthcare groups have expressed concerns that the bill's regulatory approach is inappropriate for medical devices, which are fundamentally different from drugs.

Concerns Over Regulatory Approach

On August 8, several associations representing manufacturers, healthcare providers, and patient safety groups wrote to the Union Health Minister. They urged a reconsideration of the draft bill, warning that it could hinder India's aspirations to become a global leader in medical device manufacturing. The letter highlighted that medical devices are engineering products and should not be regulated as pharmaceuticals. It argued that the draft bill does not provide the necessary regulatory framework for the sector's growth and global competitiveness.

Potential Impact on Innovation and Investment

The draft bill's language has also raised alarms within the industry. It employs terms traditionally associated with pharmaceuticals, such as "adulterated," "spurious," and "misbranded," and suggests criminal penalties for regulatory lapses. Industry representatives argue that such measures are excessive for medical devices, which are typically regulated through risk-based assessments and quality management systems. They pointed out that major markets like the EU, US, Japan, and Australia rely on administrative enforcement rather than criminal penalties for similar issues.

Call for Risk-Based Regulation

Industry stakeholders have called for a regulatory framework that aligns with international standards, emphasizing risk-based conformity assessments, post-market surveillance, and recalls. They argue that the current draft bill's focus on criminal penalties for issues like labeling errors, documentation lapses, and licensing problems is disproportionate, especially when no harm occurs. The sector advocates for a system that supports innovation and manufacturing without imposing undue burdens.

The draft bill is currently under inter-ministerial consultation, and its final form will have significant implications for the future of India's medical device industry. As the government seeks to update its 86-year-old pharmaceutical regulations, the medical device sector hopes for a more tailored approach that recognizes the unique nature of its products.