Medical Device Industry Rejects Draft Bill Equating Devices with Drugs

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices in the same manner as pharmaceuticals. Industry representatives argue that this approach could stifle innovation, deter investment, and damage the country's ambitions of becoming a global hub for medical device manufacturing.

Industry Pushback Against Drug-Centric Regulation

Associations representing manufacturers, traders, healthcare providers, and patient safety groups have collectively expressed their concerns. They have formally addressed the Union Health Minister, urging a reevaluation of the draft bill. The primary contention is that medical devices, being engineering products, should not be subjected to the same regulations designed for drugs.

The draft bill, currently undergoing inter-ministerial review, aims to replace an 86-year-old law that governs pharmaceutical regulations. However, the proposed legislation has been criticized for using drug-centric language and imposing criminal penalties for regulatory lapses related to medical devices. These penalties include imprisonment for issues such as labelling errors, documentation lapses, and engineering defects, even when no harm results.

Calls for Risk-Based Regulation

Industry leaders argue that globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties. They point out that regulatory frameworks in the European Union, the United States, Japan, the United Kingdom, and Australia prioritize administrative enforcement over imprisonment.

In a letter dated August 8, the associations highlighted that the draft bill fails to provide the necessary regulatory foundation for the medical device sector to grow and compete on a global scale. They emphasized the scientific, engineering, and regulatory distinctions between medical devices and pharmaceuticals, advocating for a separate regulatory framework tailored to the unique needs of the device industry.

Concerns Over Investment and Innovation

The industry fears that the proposed regulations could discourage investment and innovation. The potential criminalization of engineering deviations might deter manufacturers from operating in India, undermining efforts to establish the country as a leader in the global medical device market.

As the draft bill undergoes further scrutiny, stakeholders from the medical device sector continue to lobby for changes. They hope for a regulatory framework that recognizes the distinct nature of medical devices and supports the industry's growth and innovation without imposing punitive measures more suited to pharmaceuticals.