Industry Challenges India's Draft Bill on Medical Devices

The Indian medical device sector is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, citing concerns that it inaccurately categorizes medical devices as pharmaceutical products. This misclassification, according to industry leaders, could lead to detrimental effects on manufacturing, investment, and innovation within the sector.

Concerns Over Regulatory Approach

Industry groups, including manufacturers, healthcare providers, and patient safety advocates, have reached out to the Union health minister. They argue that the draft bill's treatment of medical devices as pharmaceuticals imposes unnecessary criminal penalties for regulatory lapses, which could deter investment and impede India's goal of becoming a global hub for medical devices.

The industry emphasizes that medical devices are fundamentally different from pharmaceuticals. Unlike drugs, which are chemically-based, medical devices are engineering products that require distinct regulatory frameworks. This distinction is crucial for fostering innovation and ensuring that regulations are appropriate to the nature of the products.

Global Standards and Practices

The draft bill proposes penalties including imprisonment for issues such as labeling errors or documentation lapses, even when no harm results. This approach contrasts with international practices, where regulatory bodies like the EU MDR, US FDA, and UK's MHRA focus on administrative enforcement rather than criminalization for such discrepancies.

In a letter dated August 8, industry associations highlighted that the draft bill's language heavily borrows from drug regulations, using terms like "adulterated" and "spurious" which are not suitable for engineering products. The letter calls for a risk-based regulatory approach that aligns with international standards, incorporating quality management systems and post-market surveillance.

Call for a Revised Regulatory Framework

Stakeholders are urging the government to rethink the draft bill, proposing a regulatory framework that recognizes the unique nature of medical devices. They argue that the current draft does not provide the necessary foundation for the sector to thrive and compete globally.

The pushback from the medical device sector is part of a broader conversation on how best to regulate an industry that is vital to healthcare innovation and patient safety. As the draft bill undergoes inter-ministerial consultation, the industry remains hopeful for revisions that will support growth and innovation without imposing undue burdens.