Medical Device Industry Criticizes Draft Bill's Pharma-Like Regulations

India's medical device industry and healthcare advocates are rallying against the proposed Drugs, Medical Devices, and Cosmetics Bill, 2026, which they argue improperly categorizes medical devices alongside pharmaceuticals. This grouping, they claim, could stifle innovation, hinder manufacturing, and deter investment in the sector.

Concerns Over Regulatory Approach

The opposition centers on the draft bill's approach, which applies pharmaceutical-style regulations to medical devices. Key industry groups, including manufacturers, healthcare providers, and patient safety organizations, have expressed their concerns through a formal letter to the Union health minister. They emphasize that medical devices are fundamentally engineering products, distinct from pharmaceuticals, and require a different regulatory framework.

“The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions between the two categories,” stated the letter, dated August 8. The industry argues that the bill's drug-centric language, which includes terms like “adulterated,” “spurious,” and “misbranded,” inappropriately applies criminal penalties for regulatory deviations.

Potential Impact on India's Medical Device Ambitions

Critics of the bill warn that it could jeopardize India's goal of becoming a global hub for medical device manufacturing and innovation. The bill imposes criminal penalties, including imprisonment of one to seven years for labeling errors, documentation lapses, and engineering defects, even when these do not result in harm. This approach contrasts with international norms, where administrative enforcement is more common. For instance, regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA typically rely on risk-based conformity assessments and quality management systems rather than criminalization.

The draft bill is currently under inter-ministerial review, as the government aims to overhaul the existing 86-year-old law governing pharmaceuticals and medical devices in India. However, stakeholders insist that a regulatory framework tailored specifically for medical devices is crucial for the sector's growth and global competitiveness.

Call for a Revised Regulatory Framework

Industry leaders are urging the government to consider a risk-based regulatory framework that aligns with international standards and supports the sector's unique needs. They advocate for a system that includes quality management, post-market surveillance, and recalls, rather than punitive measures that could stifle innovation and deter new entrants.

The debate highlights the ongoing challenge of balancing regulation with innovation in the healthcare sector. As the Indian government seeks to modernize its regulatory landscape, stakeholders are calling for a nuanced approach that recognizes the distinct characteristics of medical devices and supports the industry’s potential to contribute to global healthcare advancements.