Medical Device Industry Opposes Draft Bill Treating Devices as Drugs

India's medical device industry and healthcare groups are raising strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it improperly categorizes medical devices as pharmaceutical products. The bill's provisions, which include severe penalties for regulatory non-compliance, are seen as detrimental to manufacturing, investment, and innovation within the sector.

Industry Concerns Over Regulatory Approach

Several associations, representing manufacturers, traders, healthcare providers, and patient groups, have formally communicated their concerns to the Union Health Minister. They argue that the bill's approach could undermine India’s potential to become a global hub for medical devices. The draft legislation aims to replace the outdated 86-year-old law currently governing pharmaceutical regulations in India.

Critics of the bill emphasize that medical devices, being engineering products, differ significantly from pharmaceuticals and thus require distinct regulatory frameworks. The industry's primary contention is that the draft bill continues to conflate the two categories, using drug-centric terminology such as “adulterated,” “spurious,” and “misbranded.” These terms, they argue, are inappropriate for the regulation of medical devices.

Impact of Criminal Penalties

The draft bill proposes severe penalties, including imprisonment ranging from one to seven years for various infractions such as labeling errors, documentation mistakes, and licensing issues, even when no harm has occurred. This approach, the industry argues, is not aligned with international practices, where administrative enforcement is preferred. Regulatory bodies in regions like the European Union, the United States, Japan, the United Kingdom, and Australia typically employ risk-based assessments and quality management systems rather than criminal penalties.

The letter from the industry, dated August 8, underscores the need for a regulatory framework that supports growth, innovation, and global competitiveness for India’s medical devices sector. It highlights the necessity of moving away from a pharmaceutical-centric regulatory mindset towards one that recognizes the unique characteristics and requirements of medical devices.

Call for Reconsideration

As the draft bill undergoes inter-ministerial consultations, the medical device sector is calling for a reassessment of its provisions. They stress that the current draft does not provide the necessary regulatory foundation for the industry to thrive. The associations seek a framework that facilitates risk-based conformity assessments, comprehensive quality management systems, and effective post-market surveillance without resorting to criminalization.

The ongoing debate underscores a critical moment for India's regulatory landscape as it seeks to balance the need for stringent oversight with the fostering of a conducive environment for innovation and investment in medical technologies.