Medical Device Firms Object to Drug-Like Regulation in New Bill

India's medical device industry is raising concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes treating medical devices as pharmaceutical products. Industry leaders argue that the bill could negatively impact manufacturing, investment, and innovation in the sector.

Industry Pushback Against Bill

Key stakeholders, including manufacturers, healthcare providers, and patient safety groups, have expressed their opposition to the draft bill. They have collectively written to the Union Health Minister, urging a reconsideration of the proposed regulations. These groups warn that the bill, in its current form, could deter investment and hinder India's aspirations to become a global hub for medical devices.

Distinction Between Devices and Drugs

The medical device industry emphasizes that medical devices are fundamentally different from pharmaceuticals. Devices are engineering products and should not be subject to the same regulatory framework as drugs. The draft bill, however, continues to use pharmaceutical-centric language, applying terms like "adulterated" and "spurious" to medical devices, and proposes criminal penalties for regulatory lapses similar to those in the pharmaceutical sector.

Concerns Over Criminal Penalties

One of the primary concerns is the introduction of severe penalties, including imprisonment of 1-7 years for issues such as labeling errors and documentation lapses, even when no harm occurs. Industry representatives argue that this approach is not aligned with global practices. For instance, regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA typically employ administrative enforcement rather than criminal penalties.

Call for Risk-Based Regulation

The letter to the health ministry highlights the need for a regulatory framework that supports growth and innovation in the medical device sector. It advocates for risk-based conformity assessments, quality management systems, and post-market surveillance, which are standard practices in international markets.

The draft bill is currently undergoing inter-ministerial consultations, and the industry hopes that their concerns will be addressed to foster a conducive environment for the development of medical devices in India.