Medical Device Industry Pushes Back Against India's Draft Bill

India's medical device industry, alongside healthcare and patient safety groups, is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Stakeholders argue that the draft bill, which treats medical devices similarly to pharmaceuticals, could stifle innovation, deter investment, and harm the country's ambitions to become a global hub for medical device manufacturing.

Concerns Over Regulatory Approach

Industry representatives have expressed significant concerns over the draft bill's approach, which they claim inappropriately categorizes medical devices as pharmaceutical products. In an August 8 letter to the Union Health Minister, multiple associations representing manufacturers, traders, and healthcare providers highlighted that this regulatory framework fails to recognize the fundamental differences between engineering-based medical devices and pharmaceutical products.

The letter, seen by ET, criticized the draft for employing drug-centric terminology, such as "adulterated," "spurious," and "misbranded," and applying pharmaceutical-style criminal penalties to engineering deviations. The associations argue that such an approach could negatively impact the sector by imposing harsh penalties, including imprisonment, for minor labelling errors or documentation lapses.

Global Regulatory Standards

The industry contends that the proposed bill's punitive measures are not in line with international standards. Globally, regulatory bodies such as the EU MDR, US FDA, Japan's PMDA, the UK's MHRA, and Australia's TGA employ administrative enforcement rather than criminal penalties for compliance issues. These organizations typically use risk-based conformity assessments, quality management systems, and post-market surveillance to regulate medical devices.

The draft bill currently under inter-ministerial consultation proposes penalties ranging from one to seven years of imprisonment for various regulatory infractions, even in cases where no harm results from the lapses. Industry leaders warn that such stringent measures could deter potential investors and manufacturers from operating in India, thereby hindering the growth of the medical device sector.

Call for Reconsideration

Stakeholders are urging the government to reconsider the draft bill's provisions, advocating for a regulatory framework that supports the unique nature of medical devices. By distinguishing these products from pharmaceuticals, the industry believes that India can foster an environment conducive to innovation and global competitiveness.

The medical device industry is seeking a regulatory foundation that aligns with international best practices, ensuring that India can continue to grow its reputation as a leader in medical device manufacturing. With the draft bill still under review, stakeholders hope that their concerns will prompt a reevaluation of the proposed regulations to better support the sector's development.