Medical Device Firms Challenge Draft Bill Equating Devices with Drugs

India's medical device industry is pushing back against a proposed legislative bill that categorizes medical devices alongside pharmaceuticals. Industry representatives argue that such classification could stifle innovation and deter investment in the sector. The draft Drugs, Medical Devices and Cosmetics Bill, 2026, which is currently undergoing inter-ministerial consultation, has sparked widespread concern among manufacturers, healthcare providers, and patient safety groups.

Industry Concerns Over Regulatory Framework

The core of the opposition centers on the draft bill's approach to regulating medical devices with the same rigor as pharmaceuticals. Industry leaders have expressed alarm over the potential criminal penalties for regulatory non-compliance, which they believe are more suited to pharmaceutical products rather than engineering-based medical devices. Associations have reached out to the Union Health Minister, emphasizing the need for a regulatory framework that acknowledges the distinct nature of medical devices.

In their communication dated August 8, industry representatives highlighted that the bill continues to use language and regulatory standards typically associated with pharmaceuticals. Terms such as "adulterated," "spurious," and "misbranded" are noted in the draft, along with severe penalties, including imprisonment for non-compliance, which the industry argues are inappropriate for medical devices.

Global Standards and Practices

Critics of the draft bill point to international practices where medical devices are regulated through risk-based assessments and quality management systems, rather than punitive measures. They cite regulatory models from regions such as the European Union, the United States, Japan, the United Kingdom, and Australia, where administrative enforcement is standard.

The draft bill proposes imprisonment of one to seven years for errors related to labeling, documentation, licensing, and post-market surveillance (PMS) reporting, even if no harm occurs. Industry voices warn that such stringent measures could dissuade global manufacturers from investing in India, potentially hindering the country's ambition to become a leading hub for medical devices.

Call for a Revised Approach

The proposed bill aims to replace a regulatory framework that has been in place for 86 years. While the government seeks to modernize regulations, stakeholders from the medical device sector are urging a thoughtful and differentiated approach that considers the unique characteristics of medical devices. They advocate for a regulatory system that fosters innovation while ensuring patient safety and compliance without resorting to criminalization.

As the draft bill awaits further consultation and potential revision, the medical device industry is hopeful that its concerns will be addressed, leading to a regulatory environment that supports growth and technological advancement.