Medical Device Sector Challenges Draft Bill's Pharma-Like Regulations

The Indian medical device industry is voicing strong objections to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which it claims wrongly categorizes medical devices alongside pharmaceuticals. Industry stakeholders warn that such a move could stifle innovation, deter investment, and harm India's aspirations to become a global leader in medical device manufacturing.

Industry Concerns Over Regulatory Approach

Key associations representing manufacturers, healthcare providers, and patient safety groups have reached out to the Union Health Minister, expressing their concerns about the draft bill. They argue that the legislation's approach of treating medical devices as pharmaceuticals is fundamentally flawed. The groups' letter highlights that medical devices are distinctly engineering products, requiring a different regulatory framework than drugs.

The draft bill introduces criminal penalties for regulatory non-compliance, including imprisonment for labeling errors, documentation lapses, and engineering defects, even in the absence of harm. This punitive approach contrasts sharply with international norms, where administrative measures are typically employed. Critics argue that such stringent measures could discourage investment and innovation in India's medical device sector.

Calls for a Revised Regulatory Framework

The industry advocates for a regulatory framework that recognizes the unique characteristics of medical devices. Globally, devices are subject to risk-based conformity assessments, quality management systems, and post-market surveillance, rather than criminal penalties. The letter from industry groups emphasizes that these practices are standard in regions like the EU, US, Japan, UK, and Australia.

Currently, the draft bill is under inter-ministerial consultation, aiming to replace an 86-year-old law governing pharmaceutical regulations in India. However, stakeholders argue that the draft lacks the necessary foundation to support growth and competitiveness in the medical device sector.

Potential Impact on India's Medical Device Industry

India's medical device industry is at a critical juncture, with ambitions to expand its global footprint. However, the proposed regulatory changes could undermine these efforts. Industry representatives caution that the bill's approach could lead to a regulatory environment that is more restrictive than necessary, potentially driving manufacturing and investment opportunities away from India.

As the government navigates the complexities of drafting new regulations, stakeholders are calling for a more nuanced approach that aligns with international best practices and acknowledges the distinct nature of medical devices. The outcome of this legislative process will be closely watched by both domestic and international players in the medical device industry.